Presents: The 68th Annual Pharmacy Spring Seminar Ferris State University Live Webinar May 24-25, 2021
Dear Alumni and Friends,
The PowerPoints and/or Handouts are all attached below in order of the agenda. It has been suggested by our IT person that you upload the most updated version of Zoom so you can navigate the breakrooms for the vendors and other great features. Feel free to call or email me if you have any questions, [email protected] or 231-591-2252. Disclosure statement is at the end of the file.
Thank you for supporting the College of Pharmacy!
5/20/2021
Legal & Ethical Issues with the Disclosure No one involved in the planning or presentation of this activity has any relevant financial Federal Walmart Lawsuit relationships to disclose.
Accreditation
Michigan Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education (ACPE) to provide continuing education for pharmacists and pharmacy technicians. Ferris State University Credit amount subject to change. Pharmacists & Pharmacy Technicians Michigan Pharmacists Association designates this activity for 1.0 contact hours for pharmacists and pharmacy technicians. Pharmacists and pharmacy technicians should claim only credit College of Pharmacy Spring Seminar commensurate with the extent of their participation in the activity.
Learning Objectives CSA Laws and
1. Interpret the Controlled Substances Act’s requirements for proper dispensing. Regulations 2. Summarize key concerns in the federal Walmart lawsuit.
3. Discuss ethical issues in balancing patient care and drug diversion.
Controlled Substances Act Controlled Substances Act
• Comprehensively regulates every participant in the supply change “[W]ell established rules requiring [its pharmacists] to scrutinize • Designed to prevent diversion (the illegal misuse) of CS’s controlled-substance prescriptions to ensure they were valid. . . .”
• Places responsibility on each registrant to help prevent misuse of CS’s “[I]ssued by prescribers in a legitimate manner for legitimate purposes[.]
Pharmacies have “critical gatekeeping responsibilities . . . when deciding whether to fill individuals’ prescriptions for controlled substances. . . .” Pharmacists are required to “recognize, investigate, and resolve signs of a prescription’s invalidity – ‘red flags,’ in pharmacy terminology – prior to filling a Pharmacies are “required to take steps to prevent the diversion of the controlled substance prescription.” prescription drugs” it sells.
Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020). Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020).
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Corresponding Responsibility Corresponding Responsibility
Corresponding responsibility is a process, not a checklist. A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a • Proper license(s) and DEA The patient All of this is corresponding responsibility rests with the pharmacist who fills the and along with a registration is required to prescribe. documented prescriber A physical medical and a and a prescription. An order purporting to be a prescription issued not in the usual course in the meet each examination evaluation to treatment is prescription patient’s of professional treatment or in legitimate and authorized research is not a prescription • DEA expects pharmacists to have other to is conducted, establish a selected. is issued. medical a system in place to validate establish a diagnosis within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the record prescriptive authority. relationship. person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
Source: 21 CFR 1306.04, MAC R. 338.3162. 8
Corresponding Responsibility: Red Flags You can’t, unless you can.
Document and Verify prescriber’s Ensure the Avoid dispensing resolve all red license and DEA prescription has all certain drug “Red flags may arise based on the prescriber who issued the prescription registration required information combinations flags before dispensing (e.g., where a prescriber issues many more prescriptions of opioids for higher quantities than do comparable prescribers), the prescription itself (e.g., where the combination of drugs prescribed is frequently sought by individuals known to abuse or misuse prescription drugs for nonmedical purposes), or the individual presenting the prescription (e.g., where a patient repeatedly Use Prescription Know guidelines and seeks early refills.” Know and follow educate prescribers Drug Monitoring Provide access to REMS program and patients on Programs naloxone requirements proper use and MAPS disposal of opioids
Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020).
Red Flags A distinction in size?
“When a pharmacist identifies red flags but is able to resolve them, the pharmacist has an additional professional responsibility: to document the resolution of the red flags.” “[G]iven the sheer number of pharmacies it operates, Walmart was uniquely “In other words, pharmacists [are] trained that … as part of the usual course of well positioned to prevent the illegal diversion of opioids.” professional pharmacy practice [they are to] investigate and either (a) resolve the red flag before dispensing and document the resolution, or (b) refuse to fill the prescription. The documentation ensures that the information about the red flag and its resolution is available for future reference, and the absence of documentation can indicate that the pharmacist did not successfully resolve the red flag.”
Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020). Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020).
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Imputed Knowledge (Allegation)
Pharmacists identified specific, unresolvable red flags. Pharmacists reported “refusal-to-fill” prescriptions on forms and other methods to Government communicate with its compliance team. The compliance team assessed the validity of the reported concerns but did not Concerns inform other pharmacists when it had concerns about a prescriber.
“[O]n many occasions, [pharmacists] filled prescriptions written by prescribers … identified as problem or even ‘pill-mill’ prescribers.”
Take home point: Am I required to have a system to prevent dispensing of any prescription from a problematic prescriber at all locations under common ownership?
Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020).
A Battle for Seconds (Allegation) Don’t Ignore Your Surveys (Allegation)
The government’s position: “We are not adequately staffed for safely filling the volume of prescriptions that are brought to this pharmacy. We are spread too thin….” Retailers “operate pharmacies primarily to draw customers into their stores with the expectation that those customers will buy other, non-pharmacy goods.” “[W]e do not have enough pharmacist help. I feel overwhelmed and like we are Look at the annual reports. “[P]harmacy business could ‘result in the loss of cross- being asked to do more and more…. We are being forced to not focus on the store or –club selling opportunities and, in turn, adversely affect our overall net sales, patients in front of us….” other results of operations, cash flows and liquidity.” “More bodies in the pharmacy are required to adequately serve our patients, both Look at internal emails. An “email [was] sent to certain pharmacists [and] stated that in a timely and safe manner.” ‘shower wait times keep patients in store.’” “[Staffing] is too low for a pharmacy and is dangerous for patients if the staff Look at internal reports. “[M]anagers told pharmacists to ‘[h]ustle to the customer, hustle from station to station’ because filling prescriptions ‘is a battle for seconds.’” And always feels overwhelmed or rushed while working on patients prescriptions.” corporate goals were set “to fill prescriptions in less than 20 minutes.” Take home point: Take home point: When you ask a question, do something about the identified concerns. But certainly Remove controlled substances from all of your pharmacy’s performance metrics. the government ignored all of the positive survey responses too.
Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020). Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020).
Don’t Ignore Your Surveys (Allegation) Don’t Ignore Your Surveys (Allegation)
“I feel corporately we are expected to get things too quickly. The “I feel corporately we are expected to get things too quickly. The expectation times seem unrealistic wi expectation times seem unrealistic wi Take home point: Take home point: When you ask a question, do something about the identified concerns. But When you ask a question, do something about the identified concerns. But certainly the government ignored all of the positive survey responses too. certainly the government ignored all of the positive survey responses too.
Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020). Source: United States v. Walmart Inc. and Wal-Mart Stores East, LP, No. 1:99-mc-09999 (D. Del. filed Dec. 22, 2020).
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Code of Ethics
Adopted by Michigan Pharmacists Association in 1996.
The principles that form the fundamental basis of the roles and Ethical Dilemmas responsibilities of pharmacists.
Based on moral obligations and virtues
Established to guide pharmacists in relationships with patients, health professionals and society
Available at: https://www.michiganpharmacists.org/codeofethics.
Code of Ethics Ethical Dilemma
A pharmacist: A situation in which there is a choice between at least two courses of action, neither of which is obviously morally preferable. Respects the covenantal relationship between the patient and pharmacist.
Promotes the good of every patient in a caring, compassionate and confidential • Exist with two competing interests manner. Respects the autonomy and dignity of each patient. Acts with honesty and integrity in professional relationships. Maintains professional competence. Respects the values and abilities of colleagues and other health professionals. Serves individual, community and societal needs. Seeks justice in the distribution of health resources.
Kruijtbosch, M., Göttgens-Jansen, W., Floor-Schreudering, A., van Leeuwen, E., & Bouvy, M. L. (2018). Moral dilemmas of community pharmacists: a narrative study. Available at: https://www.michiganpharmacists.org/codeofethics. International journal of clinical pharmacy, 40(1), 74–83. https://doi.org/10.1007/s11096-017-0561-0
Ethical Dilemma: Refill Too Soon Ethical Dilemma: Misuse
Patients who had (or were suspected to have) drug abuse or addiction Drug misuse can lead to side effects or affect the effectiveness of the problems requested for refills too soon. prescribed medicine.
The drugs involved are typically opioids or benzodiazepines. Pharmacists express concern about:
Pharmacists grappled with the problem of 1. Confronting patients without losing their trust. 2. Dispensing without addressing the issue also had drawbacks. 1. Possibly sustaining addictive behavior on the one hand, and 2. The need to retain patients’ trust and to relieve pain or anxiety on the other.
Kruijtbosch, M., Göttgens-Jansen, W., Floor-Schreudering, A., van Leeuwen, E., & Bouvy, M. L. (2018). Moral dilemmas of community pharmacists: a narrative study. Kruijtbosch, M., Göttgens-Jansen, W., Floor-Schreudering, A., van Leeuwen, E., & Bouvy, M. L. (2018). Moral dilemmas of community pharmacists: a narrative study. International journal of clinical pharmacy, 40(1), 74–83. https://doi.org/10.1007/s11096-017-0561-0 International journal of clinical pharmacy, 40(1), 74–83. https://doi.org/10.1007/s11096-017-0561-0
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Learning Assessment
What is not a component of a pharmacist’s duty when dispensing controlled substances?
A. Independently determine the prescription is for a legitimate medical purpose. Q&A B. Be reasonably assured the prescription was issued in the usual course of professional practice.
C. Use red flags to identify possible concerns with the validity of a controlled substance prescription.
D. Resolve all red flags before dispensing.
E. Dispense concerning CS prescriptions after prescriber verification.
Learning Assessment Learning Assessment
Which of the following are categories of red flags?
True or false: A. Prescriber
B. Patient Ethical dilemmas, sometimes described as two competing interests where the C. Prescription choices both have moral responsibilities, are easily resolved.
D. All of the above
5 Case 1:99-mc-09999 Document 1446 Filed 12/22/20 Page 1 of 160 PageID #: 149706
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
) UNITED STATES OF AMERICA, ) ) Plaintiff, ) Jury Trial Demanded ) v. ) Case No. ______) WALMART INC. AND WAL-MART STORES ) EAST, LP, ) ) Defendants. ) )
COMPLAINT
Case 1:99-mc-09999 Document 1446 Filed 12/22/20 Page 2 of 160 PageID #: 149707
TABLE OF CONTENTS
INTRODUCTION ...... 5 A. As a pharmacy, Walmart violated the rules for dispensing controlled substances...... 8 B. As a distributor, Walmart violated its duty to detect and report suspicious orders of controlled substances...... 12 C. Walmart systematically violated the CSA even as it recognized the prescription drug abuse epidemic gripping the nation...... 14
PARTIES ...... 16
JURISDICTION AND VENUE ...... 17
I. WALMART’S CSA OBLIGATIONS AS A PHARMACY AND A DISTRIBUTOR...... 17 A. Controlled substances generally...... 17 B. The CSA creates a closed system for regulating controlled substances...... 19 C. A pharmacy must comply with certain rules before it fills a controlled-substance prescription...... 20 1. The pharmacist must determine whether the prescription was issued in the usual course of professional practice and for a legitimate medical purpose...... 22 2. The pharmacist also must adhere to professional pharmacist practice standards, which require identifying and resolving any “red flags.” ...... 23 3. Violations of these dispensing rules subject the pharmacy to civil penalties and other appropriate relief...... 25 D. Distributors must abide by certain legal obligations when they receive controlled- substance orders from pharmacies...... 27 1. Distributors must detect and report suspicious orders...... 27 2. Failure to report suspicious orders subjects the distributor to civil penalties...... 28
II. WALMART, AS A PHARMACY, VIOLATED THE CSA...... 29 A. Walmart impeded its pharmacists’ ability to comply with the legal requirements for dispensing controlled substances...... 31 1. Walmart managers pressured pharmacists to fill prescriptions as quickly as possible...... 31 2. Walmart’s compliance unit chose not to give its pharmacists the information and authority it knew they needed to comply with the rules...... 36 a. Consistent with the CSA, Walmart’s own policy required pharmacists to identify and resolve red flags, and to document any resolution of red flags...... 36 b. After Walmart was accused of dispensing violations, it committed to adopting a nationwide compliance program to identify red flags and prevent diversion...... 40 c. While Walmart’s compliance unit did compile red-flag information, it chose not to disseminate that information to pharmacists...... 41 d. Walmart prohibited its pharmacists from refusing to fill, as a blanket matter, all prescriptions issued by pill-mill prescribers...... 48
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B. Even after Walmart pharmacists identified pill-mill prescribers who were issuing invalid prescriptions, Walmart kept filling their prescriptions...... 50 1. D.C.: “95% of the prescriptions from this prescriber are for controlled substances” ...... 52 2. F.B.: “Always writes excessive quantities for all of his patients” ...... 53 3. F.T.: Prescribed “too many [drugs] for one person to take” ...... 56 4. G.G.: “gives patients what they want and [does] not practice real medicine.” ...... 57 5. G.H. and R.M.: “well known as a pill mill” ...... 60 6. H.D.: “filling for him is a risk that keeps me up at night”; “our concerns are falling upon deaf ears” ...... 63 7. J.F.: Prescriber of very heavy doses ...... 67 8. J.I.: A “known pill-mill doctor” ...... 69 9. M.L.: “continually writes for high quantities of narcotics” ...... 71 10. M.M.: A “known pill mill” who sent his patients to Walmart ...... 72 11. M.N-A.: “many DEA red flags present” ...... 76 12. P.T.: “too many questions regarding the ethics and integrity of this physician” ...... 77 13. R.K.: Filling prescriptions from this “pill mill” was “putting pharmacists and Walmart in a bad situation legally” ...... 79 14. R.M.: Prescriptions “are likely not prescribed for ethical purposes” ...... 81 15. R.P.: “horrendous prescribing practices”; “customers that were under the influence tell me that this doctor will write whatever they want” ...... 83 16. R.W.: Prescribed “cocktails” and recommended patients fill at Walmart ...... 85 17. S.K.: “there is no way that many 25 year olds need 120 to 240 oxycodone per month” ...... 86 18. V.S.: A “shady doctor” who “writes only controlled medications for every patient” ...... 89 19. W.W.: A “pill mill prescriber” for “drug-seekers” ...... 90 20. Z.B.: A “questionable” prescriber sending patients to fill at Walmart ...... 92 C. Walmart filled many prescriptions showing, on their face, such glaring red flags that its pharmacists would have known that the prescriptions had a very high probability of being invalid...... 94 1. Red Flag No. 1: Dangerous combinations of opioids ...... 95 2. Red Flag No. 2: Dangerous “cocktails” of opioids and non-opioids...... 101 3. Red Flag No. 3: Repeated fills of very high dosages of opioids ...... 108 4. Red Flag No. 4: Schedule IIs filled unusually early ...... 109 D. Walmart filled many invalid prescriptions that were the same or similar to other prescriptions Walmart pharmacists had previously identified as invalid for the same customer ...... 112
III. IN ITS ROLE AS A DISTRIBUTOR, WALMART VIOLATED THE CSA...... 116 A. Walmart had access to a wealth of information and data such that it could readily have designed a system to adequately detect suspicious orders ...... 116
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1. Walmart’s self-distribution to its own pharmacies gave it extensive knowledge and data about dispensing patterns and orders...... 116 2. Walmart had information on the millions of orders for controlled substances its pharmacies placed with—and received from—independent distributors ...... 120 B. For years, Walmart knew of significant defects with its policies and procedures for detecting and reporting suspicious orders, but failed to fix them ...... 121 1. Prior to August 2015, Walmart had a rudimentary suspicious-order monitoring system that failed to adequately detect and report suspicious orders...... 121 a. Walmart failed to detect and report orders of unusual frequency or pattern ...... 124 b. Walmart failed to adequately detect and report unusually large orders...... 125 c. Walmart ignored specific signs of diversion from its own pharmacies...... 136 d. Walmart failed to adequately staff and train its compliance personnel, and shipped flagged orders before compliance personnel could examine them...... 138 e. Walmart routinely failed to investigate flagged “orders of interest” and report any orders to DEA that Walmart was unable to clear...... 141 f. Walmart often failed to document its evaluation of flagged orders, which deprived Walmart of crucial information needed to assess subsequent orders...... 144 2. From August 2015 through November 2017, Walmart adopted a modified system for detecting and reporting suspicious orders, but this system remained defective ... 145 a. Despite the modifications to Reddwerks, many of the same flaws remained ...... 146 b. Walmart continued to fail to report unusually large orders...... 147 c. Walmart set hard limits for pharmacies that had already placed suspicious orders—then disregarded those hard limits ...... 151 C. Walmart’s flawed approach to monitoring pharmacy orders resulted in a failure to detect and report at least hundreds of thousands of suspicious orders ...... 153 D. Walmart’s failure to detect and report suspicious orders deprived Walmart of the opportunity, during the prescription drug abuse epidemic, to timely address potentially unlawful conduct ...... 154
CLAIMS FOR RELIEF ...... 157
PRAYER FOR RELIEF ...... 159
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The United States of America files this Complaint against Walmart Inc. and Wal-Mart
Stores East, LP (collectively “Walmart”), and alleges as follows:
INTRODUCTION
1. The United States of America brings this civil enforcement action against
Walmart for violations of the Comprehensive Drug Abuse Prevention and Control Act of 1970
(“Controlled Substances Act” or “CSA”), 21 U.S.C. §§ 801 et seq.
2. The CSA comprehensively regulates every participant in the supply chain for
controlled substances, from manufacturers to wholesale distributors to retail pharmacies.
Because controlled substances by definition are drugs with the potential for abuse, this
comprehensive scheme is designed to prevent the “diversion”—i.e., the illegal misuse—of
controlled substances, including prescription opioids. Under the CSA, every participant in the
supply chain bears responsibility for preventing the misuse of controlled substances.
3. Walmart operates more than 5,000 pharmacies nationwide that dispense
prescription opioids and other controlled substances. In addition, until 2018, Walmart acted as a
wholesale distributor of controlled substances for its own pharmacies.
4. As both a pharmacy and a distributor, Walmart assumed critical gatekeeping
responsibilities under the CSA. At two stages—when deciding whether to fill its pharmacies’
wholesale orders for controlled substances from its distribution warehouse, and when deciding
whether to fill individuals’ prescriptions for controlled substances—Walmart was required by the
CSA to take steps to prevent the diversion of the prescription drugs it sold.
5. As a nationwide dispenser and distributor of opioids, and given the sheer number
of pharmacies it operates, Walmart was uniquely well positioned to prevent the illegal diversion
of opioids. Yet, for years, as the prescription drug abuse epidemic ravaged the country, Walmart
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abdicated those responsibilities.
6. First, as a pharmacy, Walmart knowingly violated well established rules requiring
it to scrutinize controlled-substance prescriptions to ensure that they were valid—that is, issued
by prescribers in a legitimate manner for legitimate purposes, not for purposes of abuse or other
diversion. These rules required Walmart to recognize, investigate, and resolve signs of a
prescription’s invalidity—“red flags,” in pharmacy terminology—prior to filling a controlled-
substance prescription. Walmart was well aware of these rules, but made little effort to ensure
that it complied with them. In fact, Walmart made it difficult for its pharmacists to follow the
rules. Walmart managers put enormous pressure on pharmacists to fill prescriptions—requiring
pharmacists to process a high volume of prescriptions as fast as possible, while at the same time
denying them the authority to categorically refuse to fill prescriptions issued by prescribers the
pharmacists knew were continually issuing invalid prescriptions. And while Walmart’s
compliance unit collected voluminous information indicating that Walmart was routinely being
asked to fill invalid controlled-substance prescriptions, that unit for years withheld that
information from pharmacists and allowed them to continue dispensing opioids based on invalid
prescriptions.
7. As a result of Walmart’s failures to take seriously its gatekeeping duties as a
pharmacy, Walmart—during the prescription drug abuse epidemic—unlawfully filled thousands
upon thousands of invalid controlled-substance prescriptions.
a. Walmart filled prescriptions issued by prescribers who Walmart
pharmacists had repeatedly reported were acting as egregious “pill mills”—even when
Walmart was alerted that other pharmacies were not filling prescriptions for those
prescribers. In fact, some of those pill-mill prescribers specifically told their patients to
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fill their prescriptions at Walmart.
b. Walmart also filled prescriptions with glaringly obvious red flags,
such as prescriptions for “trinities” and other well-known and highly dangerous drug
“cocktails” that Walmart pharmacists knew were predominantly sought by individuals
engaging in drug abuse.
c. And Walmart filled prescriptions that were the same or similar to
other prescriptions it had previously recognized as invalid for the same customer—which
meant that when a Walmart pharmacist recognized that a customer’s prescription was
invalid, the customer could simply shop around for another Walmart pharmacist or store
to fill the same or a similar prescription.
8. Second, as a wholesale distributor, Walmart had a basic obligation to detect
suspicious orders placed by its own pharmacies for controlled substances, and to report those
orders to the Drug Enforcement Administration (“DEA”). Walmart knew that this rule was
designed to prevent diversion of controlled substances and that it would face civil penalties and
other potential enforcement if it failed to comply. And compliance could have been readily
accomplished, as Walmart had not only adequate resources but also a wealth of information
about its pharmacies. But for years, Walmart kept in place a system that it knew was failing to
adequately detect and report suspicious orders. Walmart periodically considered fixing its
system, but time and time again it chose not to spend the time, money, and effort needed to bring
its process into compliance.
9. Because Walmart shirked this key legal obligation as a distributor, Walmart failed
to detect and report at least hundreds of thousands of suspicious orders. This failure enabled
Walmart’s pharmacies to place and receive controlled-substance orders that went essentially
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unmonitored, even when those orders were suspicious and could have revealed that diversion
was ongoing.
10. Predictably, Walmart’s violations of the CSA as both a pharmacy and a
distributor had disastrous results, harming individuals who filled their controlled-substance
prescriptions at Walmart and then abused the drugs. And given the nationwide scale of those
violations, Walmart’s failures to follow basic legal rules helped fuel a national crisis.
11. Accordingly, the United States seeks civil penalties under the CSA and
appropriate injunctive relief.
A. As a pharmacy, Walmart violated the rules for dispensing controlled substances.
12. Walmart is one of the country’s largest pharmacy chains. It operates more than
5,000 pharmacies at Walmart-branded and Sam’s Club-branded retail stores nationwide.
Through its pharmacies, Walmart dispenses controlled substances to individuals.
13. As the final step in the supply chain before individuals receive controlled
substances, pharmacies are the last line of defense in preventing abuse and misuse of controlled
substances. The CSA and its implementing regulations therefore require pharmacies to comply
with certain legal requirements before filling controlled-substance prescriptions.
14. Specifically, under the CSA, pharmacies may dispense controlled substances only
pursuant to a valid prescription. A prescription must satisfy two requirements to be valid—or, in
CSA terminology, “effective.” It must be issued (1) for a legitimate medical purpose and (2) by
a medical practitioner acting in the usual course of his or her professional practice. See 21
C.F.R. § 1306.04(a).
15. Additionally, in filling prescriptions for controlled substances, pharmacists are
required to adhere to the usual course of professional pharmacy practice. See id. § 1306.06.
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When presented with a controlled-substance prescription, the pharmacist, in order to act in the
usual course of professional practice, must identify and resolve any “red flags”—signs indicating
the invalidity of the prescription—before filling the prescription.
16. Walmart knew from its own past experience that if its pharmacists failed to
comply with their legal obligations when dispensing controlled substances, Walmart could face
enforcement action. As discussed below in Part II.A.2.b, DEA initiated an administrative
proceeding in 2009 seeking to revoke Walmart’s registration for a pharmacy that DEA alleged
had failed to comply with its legal obligations when filling controlled-substance prescriptions.
17. To resolve that proceeding, Walmart entered into an agreement with DEA in 2011
in which Walmart agreed to adopt a national compliance program intended to ensure that it
fulfilled its legal obligations when filling controlled-substance prescriptions. Walmart also
agreed to collect reports from its pharmacists when those pharmacists determined that controlled-
substance prescriptions were invalid and refused to fill them.
18. The many refusal-to-fill reports that Walmart collected were shocking. They
revealed, over and over again, that all across the country, Walmart pharmacies were regularly
being presented with invalid prescriptions. For example, Walmart pharmacists alerted
Walmart’s compliance unit to numerous prescribers who were “known pill mills,” did “not
practice real medicine,” had “horrendous prescribing practices,” and continually issued high-
dose controlled-substance prescriptions for many individuals. In addition, the reports showed
that Walmart pharmacists were repeatedly being presented with other prescriptions showing such
obvious red flags on their face that Walmart pharmacists recognized the prescriptions as invalid.
19. While Walmart’s compliance unit collected and compiled all this information
about invalid prescriptions, it chose, for years, not to alert Walmart pharmacists so that they
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could use that information to determine whether to fill similar prescriptions. As a director in the
compliance unit, B.N., acknowledged in an email, rather than analyzing the refusal-to-fill
reports, the compliance unit viewed “[d]riving sales and patient awareness” as “a far better use of
our Market Directors and Market Manager’s time.”
20. At the same time, Walmart’s managers made it exceedingly difficult for its
pharmacists to comply with their legal obligations, by pressuring them to fill prescriptions as
quickly as possible. Managers told pharmacists that prescriptions had to be filled quickly
because “shorter wait times keep patients in store.” They urged pharmacists to speed up the time
it took to fill each prescription because filling prescriptions “is a battle of seconds” and “[w]ait
times are our Achilles heel!” Pharmacists, in turn, complained to Walmart’s compliance unit
that the high volume of prescriptions, combined with Walmart’s low staffing, “doesn’t allow
time for individual evaluation of prescriptions.”
21. Walmart’s approach led it to fill thousands upon thousands of controlled-
substance prescriptions that Walmart knew, in multiple ways, were highly likely to be invalid.
22. First, as discussed below in Part II.B, Walmart filled prescriptions that it knew
were issued by “pill-mill” prescribers. Walmart’s compliance unit had compiled extensive
evidence that these particular prescribers were writing prescriptions that were invalid—outside
the usual course of professional practice, without a legitimate medical purpose, or both.
Pharmacists reported that some prescribers told their patients to fill prescriptions at Walmart.
For example, one pharmacist reported learning that a prescriber “tells his patients that only Wal-
Mart will fill his prescriptions.” Pharmacists made the urgency of their reports clear. For
example, one pharmacist reported that he had “too much invested in [his] career and family to
continue to risk” filling prescriptions for a pill-mill prescriber. But the compliance unit
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knowingly withheld this information from Walmart pharmacists, even though it was apparent
that Walmart pharmacists would be presented with many more prescriptions from these same
problem prescribers. And, sure enough, for years, despite these unresolved red flags, Walmart
continued to fill many more prescriptions issued by these known pill-mill prescribers.
23. Second, as discussed below in Part II.C, Walmart filled numerous prescriptions
that, on their face, showed such obvious red flags—such as highly dangerous, commonly abused
“cocktails” of drugs, sometimes in alarmingly high quantities—that Walmart pharmacists would
have known that the prescriptions had a very high probability of being invalid.
24. Third, as discussed below in Part II.D, Walmart filled many prescriptions that
pharmacists knew were invalid because the prescriptions presented the same or similar red flags
as the same or similar prescriptions other Walmart pharmacists had previously recognized as
invalid for the same patient.
25. In all, from June 26, 2013, to the present (hereinafter referred to as the
“Dispensing Violations Period”), Walmart filled thousands upon thousands of invalid
prescriptions and, in doing so, repeatedly violated the CSA dispensing requirements identified in
21 C.F.R. § 1306.04(a) and § 1306.06. Walmart filled prescriptions that it knew were not issued
for a legitimate medical purpose, or were not issued by a medical practitioner acting in the usual
course of his or her professional practice, or both, in violation of section 1306.04(a). And by
filling those prescriptions despite the red flags, Walmart pharmacists failed to adhere to the usual
course of professional pharmacy practice, in violation of section 1306.06.
26. Walmart violated the CSA each time it violated 21 C.F.R. § 1306.04(a) or
§ 1306.06 in dispensing a controlled substance. See 21 U.S.C. § 842(a)(1). For each violation,
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Walmart is liable for a civil penalty. See 21 U.S.C. § 842(c)(1). The Court also may grant
injunctive relief to address and restrain these violations. See 21 U.S.C. § 843(f).
B. As a distributor, Walmart violated its duty to detect and report suspicious orders of controlled substances.
27. As relevant to this Complaint, Walmart also operated as a distributor of controlled
substances between June 26, 2013, and November 29, 2017 (hereinafter referred to as the
“Distribution Violations Period”). In this role, Walmart shipped controlled substances to its own
pharmacies around the country.
28. Distributors of controlled substances are required by the CSA to “design and
operate a system to disclose to the registrant suspicious orders of controlled substances,” and
“shall inform” DEA of those suspicious orders “when discovered.” See 21 C.F.R. § 1301.74(b).
Thus, a distributor must itself detect and identify suspicious orders and report them to DEA.
This requirement protects against diversion and abuse by requiring distributors to monitor
pharmacies for warning signs of such misconduct.
29. The regulation provides that suspicious orders “include orders of unusual size,
orders deviating substantially from a normal pattern, and orders of unusual frequency.” Id. In
other words, orders that are unusual in one or more of those three ways—size, pattern, or
frequency—are deemed “suspicious orders,” and a distributor must detect and report them. The
regulation does not limit “suspicious orders” to those three categories, however. It states, non-
exclusively, that suspicious orders “include” those categories.
30. As discussed below in Part III.A, because Walmart acted as its own distributor for
controlled substances, it had a special advantage: Walmart had access to extensive data and
other information that gave it the ability—had it wanted to—to investigate the circumstances
underlying orders for controlled substances.
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31. Nevertheless, as discussed below in Part III.B, for years Walmart maintained a
wholly inadequate system for detecting and reporting suspicious controlled-substance orders
placed by its pharmacies. Because Walmart’s suspicious-order monitoring system suffered from
numerous flaws, Walmart routinely failed to detect and report orders that exhibited unusual
frequency, deviated from the normal ordering pattern, or were of unusual size. Although
Walmart knew its flawed system did not comply with the CSA, for years Walmart failed to use
its ample resources to remedy these deficiencies.
32. Walmart’s compliance unit knew that Walmart could face penalties for not
complying with its obligation to detect and report suspicious orders. For example, in 2014,
Walmart considered modifying Walmart’s system to “avoid DEA enforcement as a result of non-
compliance with 21 CFR 1301.74(b).”
33. But rather than bringing its system into compliance with its legal obligations to
detect and report all suspicious orders, Walmart again prioritized speed. Members of Walmart’s
compliance unit complained that its system for receiving and shipping orders was so fast that it
allowed only “limited time for evaluation” of each order, that there were “too many orders to
review each line [of alerts] in detail,” and that Walmart’s system “did not allow alerted orders to
be ‘held’ pending evaluation.”
34. Because Walmart prioritized speed, it failed to detect and report most of the
suspicious orders that it received from its pharmacies. As discussed below in Part III.C, due to
Walmart’s defective systems, Walmart failed to detect and report at least hundreds of thousands
of suspicious orders of controlled substances during the Distribution Violations Period. Over an
approximately four-year period, a time during which Walmart shipped an estimated 37.5 million
controlled-substance orders to its pharmacies, it reported only 204 suspicious orders to DEA—in
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other words, almost none. By comparison, during the same time period, Walmart’s back-up
distributor, McKesson Corporation, which filled orders only when Walmart could not and which
therefore shipped far fewer than 37.5 million orders, reported to DEA more than 13,000
suspicious orders from Walmart pharmacies.
35. Walmart’s grossly inadequate suspicious-order monitoring program contributed to
its failure to stop diversion of controlled substances at its pharmacies, as discussed below in Part
III.D. Walmart’s systematic, years-long failure to detect and report each of its suspicious orders
created a major obstacle to efforts to combat the prescription drug abuse epidemic. Had the
company identified and investigated its hundreds of thousands of suspicious orders, it could have
stopped the pharmacies that were placing those orders from unlawfully filling controlled-
substance prescriptions or otherwise contributing to the diversion of controlled substances.
36. Even when Walmart did detect a suspicious order, it often already had shipped the
order and did not have it shipped back. As a Senior Manager for Logistics observed in an email,
“if we see an issue that suggests the product shouldn’t have shipped, we just leave it at the store
and let it enter the market,” even though having the order shipped back “feels like the more
socially responsible approach….”
37. Each time Walmart failed to comply with its legal obligation to detect and report a
suspicious order, it violated the CSA. Pursuant to 21 U.S.C. § 842(a)(5), it is unlawful for a
distributor to refuse or negligently fail to make or furnish reports, notifications, or information
that are required under the CSA. For each violation of 21 U.S.C. § 842(a)(5), Walmart is liable
for a civil penalty. See 21 U.S.C. § 842(c)(1)(A), (B).
C. Walmart systematically violated the CSA even as it recognized the prescription drug abuse epidemic gripping the nation.
38. During the very period when Walmart was systematically failing to comply with
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its legal responsibilities to protect against the diversion of prescription drugs, the prescription
drug abuse epidemic in the United States was exploding.
39. Between 1999 and 2018, more than 232,000 people died in the United States from
overdoses involving prescription opioids.
https://www.cdc.gov/drugoverdose/data/prescribing/overview.html (last visited October 26,
2020). Such deaths “were more than four times higher in 2018 than in 1999.” Id.
40. In 2016 alone, opioid overdoses caused more than 42,000 deaths—more than any
previous year on record. U.S. Department of Health and Human Services, About the Epidemic,
https://www.hhs.gov/opioids/about-the-epidemic (last visited October 26, 2020). An estimated
40 percent of those deaths—more than 16,800—involved prescription opioids. Id.
41. Indeed, there were so many opioid-related deaths in 2015 and 2016 that the
epidemic caused U.S. life expectancy to decrease in both years. CDC in Action: 2018 Response
to the Opioid Crisis, https://www.cdc.gov/opioids/pdf/Overdose-Snapshot-2018_Final_508.pdf
(last visited Dec. 15, 2020). This was the first two-year decrease in life expectancy in over half a
century. See National Vital Statistics Reports, Vol. 68, No. 7, June 24, 2019, at Table 19,
https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_07-508.pdf (last visited Nov. 17, 2020).
42. Walmart was well aware of the severity and scope of the prescription drug abuse
epidemic. As early as October 2013, Walmart acknowledged that “drug overdose, (the majority
being Rx [prescription] Meds), is now the number one cause of accidental deaths in the U.S.”
43. Nevertheless, Walmart routinely ignored the very legal requirements that could
have helped stem the epidemic. In doing so, Walmart endangered its customers and contributed
to the prescription drug abuse epidemic that has claimed hundreds of thousands of lives.
44. Walmart’s violations described above had grave consequences. Some individuals
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who filled invalid prescriptions for controlled substances at Walmart died soon thereafter of
overdoses related to those prescriptions.
PARTIES
45. Plaintiff is the United States of America.
46. Defendant Walmart Inc., formerly known as Wal-Mart Stores, Inc., is a
multinational retail corporation incorporated in the State of Delaware.
47. Along with retail stores and other business units, Walmart Inc. operates one of the
largest pharmacy chains in the United States, consisting of more than 5,000 DEA-registered
pharmacies located in Walmart and Sam’s Club retail stores in the United States and its
territories. As a pharmacy chain, Walmart Inc. dispenses controlled substances through its
agents and employees.
48. Until 2018, Walmart Inc. also acted as a distributor of controlled substances for
its pharmacies around the country. From 2000 to approximately May 2018, Walmart Inc.
operated at least six distribution centers that distributed controlled substances to its pharmacies
in the United States. The distribution centers were located in Bentonville, Arkansas; Rogers,
Arkansas; Tifton, Georgia; Crawfordsville, Indiana; Hanford, California; and Williamsport,
Maryland. Collectively, Walmart self-distributed to its pharmacies tens of millions of shipments
of controlled substances.
49. The DEA registrant for those distribution centers was Defendant Wal-Mart Stores
East, LP. Wal-Mart Stores East, LP is also incorporated in Delaware.
50. At all times relevant to this action, Walmart Inc. was responsible for the
compliance of the pharmacies and the distribution centers with all provisions of the CSA and the
regulations promulgated under the CSA.
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51. For ease of reference, Defendants Walmart Inc. and Wal-Mart Stores East, LP are
generally referred to herein as “Walmart” except where identification of the particular entity is
significant. In addition, where it is useful to identify the business segment or refer to a brand
(such as “Walmart-branded stores” or “Sam’s Club-branded stores”), the distinction between
those business segments or brands is drawn.
JURISDICTION AND VENUE
52. This Court has subject matter jurisdiction over this action under 28 U.S.C.
§§ 1331, 1345, and 1355(a), and 21 U.S.C. § 842(c)(1) and § 843(f)(2).
53. This Court has personal jurisdiction over both Defendants because both are
incorporated in Delaware.
54. Venue is proper in this district under 28 U.S.C. § 1395(a) and 21 U.S.C. § 843(f)
because both Defendants can be found and reside in this district.
I. WALMART’S CSA OBLIGATIONS AS A PHARMACY AND A DISTRIBUTOR.
A. Controlled substances generally.
55. The CSA creates a category of drugs, known as “controlled substances,” that are
subject to strict federal monitoring and regulation based on their potential for abuse. Controlled
substances are categorized into five schedules based on several factors, including whether they
have a currently accepted medical use to treat patients, their abuse potential, and the likelihood
they will cause dependence if abused. A drug becomes a “controlled substance” when it is added
to one of these schedules.
56. Schedule I drugs are those deemed not to have an accepted medical use. The
remaining schedules—Schedules II through V—are relevant to this case. The drugs in these
schedules have legitimate medical purposes and, in the case of Schedules II through IV, require a
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prescription. See 21 U.S.C. § 829.
57. Schedule II lists controlled substances that have “a high potential for abuse”; that,
if abused, “may lead to severe psychological or physical dependence”; but that nonetheless have
“a currently accepted medical use in treatment in the United States or a currently accepted
medical use with severe restrictions.” See 21 U.S.C. § 812(b)(2). Schedule II includes opioid-
based painkillers such as oxycodone, hydrocodone, and methadone, and stimulants such as
amphetamine. See 21 C.F.R. § 1308.12.
58. Schedule III lists controlled substances that have “a potential for abuse less than
the drugs or other substances in schedules I and II”; that, if abused, “may lead to moderate or low
physical dependence or high psychological dependence”; but that nonetheless have “a currently
accepted medical use in treatment in the United States.” See 21 U.S.C. § 812(b)(3). Schedule III
includes buprenorphine, a medication approved to treat opioid use disorder. See 21 C.F.R.
§ 1308.13.
59. Schedule IV lists controlled substances that have “a low potential for abuse
relative to the drugs or other substances in schedule III”; that, if abused, “may lead to limited
physical dependence or psychological dependence relative to the drugs or other substances in
schedule III”; but that nonetheless have “a currently accepted medical use in treatment in the
United States.” See 21 U.S.C. § 812(b)(4). Schedule IV includes alprazolam (commonly sold
under the brand name Xanax), diazepam (commonly sold under the brand name Valium), and
lorazepam (commonly sold under the brand name Ativan). See 21 C.F.R. § 1308.14. Each of
these three drugs belongs to a class of medications called benzodiazepines, which act on the
brain and nerves to produce a calming effect. Schedule IV also includes carisoprodol, a muscle
relaxant that is often sold under the brand name Soma, and zolpidem, an insomnia medication
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that is often sold under the brand name Ambien. As explained later, carisoprodol and zolpidem
are components of dangerous drug “cocktails” sought by individuals known to abuse or misuse
prescription drugs.
60. Schedule V lists controlled substances that have “a low potential for abuse
relative to the drugs or other substances in schedule IV”; that, if abused, “may lead to limited
physical dependence or psychological dependence relative to the drugs or other substances in
schedule IV”; but that nonetheless have “a currently accepted medical use in treatment in the
United States.” See 21 U.S.C. § 812(b)(5). Schedule V includes certain dosages of
promethazine-codeine. See 21 C.F.R. § 1308.15.
B. The CSA creates a closed system for regulating controlled substances.
61. Through the CSA, Congress sought to prevent diversion and abuse of controlled
substances. To accomplish this goal, the CSA created a “closed” system for regulating and
monitoring controlled substances, under which it is unlawful to distribute, dispense, or possess
any controlled substance except in a manner authorized by law. The CSA and its implementing
regulations govern every step in the handling of certain drugs, from their production in a
manufacturing facility to their distribution from a warehouse, and from their prescription by a
medical practitioner to their dispensing by a pharmacy filling a prescription.
62. The system is “closed” in that each part of the supply chain—including
manufacturers, distributors, prescribers, and pharmacies—must register with DEA and comply
with the CSA and its implementing regulations. See 21 U.S.C. §§ 822(a)(2) and 823(f).
63. Entities who register with DEA (known as “registrants”) agree to comply with the
CSA and its implementing regulations, and may manufacture, distribute, prescribe, or dispense
controlled substances only to the extent authorized by their registration and the law. See 21
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U.S.C. §§ 822(a)–(b), 823(f).
C. A pharmacy must comply with certain rules before it fills a controlled- substance prescription.
64. Ordinarily, the last step in the closed distribution system is the pharmacy that,
after being presented with a prescription, dispenses a controlled substance to the end user.
65. As noted above, Walmart operated pharmacies that “dispensed” controlled
substances. “Dispensing” generally means delivering a controlled substance to an end user
pursuant to a physician’s prescription. See 21 U.S.C. § 802(10); 21 C.F.R. §§ 1300.01,
1306.03(a).
66. The CSA designates pharmacies as “practitioners” that are permitted to handle
controlled substances if they adhere to the course of “professional practice.” The CSA defines
the term “practitioner” to include a physician, pharmacy, or other person permitted by law to
distribute or dispense a controlled substance “in the course of professional practice or research.”
See 21 U.S.C. § 802(21).
67. Pharmacies that wish to dispense controlled substances are required under the
CSA to register with the Attorney General. See 21 U.S.C. § 823(f) (“The Attorney General shall
register … pharmacies, as distinguished from pharmacists … to dispense … controlled
substances….”). The Attorney General has delegated this authority to DEA. See 28 C.F.R.
§ 0.100; 21 C.F.R. § 1300.01.
68. DEA reviews applications for registration (and renewals of registration) by
pharmacies and, where necessary, pursues revocations of registrations. In deciding whether to
issue or deny a registration for a pharmacy, DEA considers various factors, including whether
the applicant for a registration has complied with the laws relating to controlled substances and
its other conduct related to public health and safety. See 21 U.S.C. § 823(f).
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69. Pharmacists who dispense controlled substance as an “agent or employee” of a
pharmacy registered with DEA need not register individually with DEA. See 21 U.S.C.
§§ 822(c)(1), 823(f).
70. In general, the CSA prohibits pharmacies from dispensing most controlled
substances without a “prescription issued by a practitioner.” See 21 U.S.C. § 829(a) (“no
controlled substances in schedule II, which is a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act, may be dispensed without the written prescription of a
practitioner”), § 829(b) (requiring a prescription for dispensing controlled substances in Schedule
III or IV).
71. The CSA makes it unlawful “for any person … to … dispense a controlled
substance in violation of section 829.” 21 U.S.C. § 842(a)(1).
72. The Attorney General has promulgated, in 21 C.F.R. Part 1306 (“Prescriptions”),
rules for when prescriptions may be filled pursuant to a prescription in accordance with 21
U.S.C. § 829. See 21 C.F.R. § 1306.01 (“Rules governing the issuance, filling, and filing of
prescriptions pursuant to [21 U.S.C. § 829] are set forth generally in this section and specifically
by the sections of this part.”).
73. As relevant here, Part 1306 sets forth three rules pharmacies must follow when
dispensing controlled substances. For each controlled-substance prescription, a pharmacist must
(1) determine that the prescription was issued by a medical practitioner adhering to the usual
course of his or her professional practice, (2) determine that the prescription is for a legitimate
medical purpose, and (3) in filling the prescription, adhere to the usual course of his or her own
professional pharmacy practice.
74. Walmart was required to adhere to these three requirements in its role as a
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pharmacy dispensing controlled substances.
1. The pharmacist must determine whether the prescription was issued in the usual course of professional practice and for a legitimate medical purpose.
75. 21 C.F.R. § 1306.04(a) defines certain requirements for a controlled-substance
prescription to be valid or “effective” and also imposes obligations on both the medical
practitioner who issues the prescription and the person who fills the prescription.
76. To be valid or effective, a prescription for a controlled substance must meet two
requirements. First, it must be issued by a medical practitioner acting in the usual course of his
professional practice. See § 1306.04(a) (“A prescription for a controlled substance to be
effective must be issued … by an individual practitioner acting in the usual course of his
professional practice…. An order purporting to be a prescription issued not in the usual course
of professional treatment … is not a prescription within the meaning and intent of section 309 of
the Act (21 U.S.C. 829) ….”).
77. Second, the prescription must be issued for a legitimate medical purpose. See
§ 1306.04(a) (“A prescription for a controlled substance to be effective must be issued for a
legitimate medical purpose…”). For example, a prescription is not issued for a legitimate
medical purpose if it is issued or sought for nonmedical use or abuse by a patient.
78. While section 1306.04(a) imposes a responsibility on prescribers (medical
practitioners) to issue valid prescriptions, it also imposes a “corresponding responsibility” on the
pharmacist who fills the prescription to independently determine that the prescription is valid—
that is, was issued for a legitimate medical purpose, and in the usual course of professional
practice. See § 1306.04(a) (“The responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a corresponding responsibility
rests with the pharmacist who fills the prescription.”). The pharmacist’s corresponding
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responsibility includes, inter alia, identifying and attempting to resolve red flags; to document
the resolution if the red flag is resolved; and to refuse to fill the prescription if the red flag is not
resolved.
2. The pharmacist also must adhere to professional pharmacist practice standards, which require identifying and resolving any “red flags.”
79. A third relevant rule that a pharmacist must follow in filling prescriptions for
controlled substances is found in section 1306.06, which requires that the pharmacist’s conduct
must adhere to the usual course of his or her professional practice as a pharmacist. See 21 C.F.R.
§ 1306.06 (requiring that “[a] prescription for a controlled substance may only be filled by a
pharmacist, acting in the usual course of his professional practice….”). This requirement follows
the CSA’s general approach that a practitioner is permitted to handle controlled substances when
consistent with the “course of professional practice.” See 21 U.S.C. § 802(21).
80. Pharmacists are professionals who must be licensed by the states in which they
practice. A basic licensing requirement common across states is a Doctor of Pharmacy
(“Pharm.D.”) degree, which is granted upon successful completion of a doctoral-level program
that typically requires three to four years of study. After successfully attaining a Pharm.D.
degree, practicing pharmacists must pass two licensing exams.
81. Pharmacists are trained about the role they play in preventing prescription drug
abuse and diversion. For example, the Accreditation Council for Pharmacy Education, which
publishes accreditation standards and guidelines for Pharm.D. programs, requires that the Pharm.
D. curriculum include a discussion of the laws regulating pharmacy practice and the mitigation
of drug abuse and diversion.
82. In evaluating the validity of a controlled-substance prescription, pharmacists
cannot rely exclusively on the fact that it was issued by a medical practitioner. Rather, to assess
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a prescription’s validity, a pharmacist must consider any signs that a prescription may be invalid
or that the controlled substances may be abused or misused.
83. Pharmacists call these signs of invalidity “red flags.” Red flags may arise based
on the prescriber who issued the prescription (e.g., where a prescriber issues many more
prescriptions of opioids for higher quantities than do comparable prescribers), the prescription
itself (e.g., where the combination of drugs prescribed is frequently sought by individuals known
to abuse or misuse prescription drugs for nonmedical purposes), or the individual presenting the
prescription (e.g., where a patient repeatedly seeks early refills).
84. One of the key professional responsibilities of a pharmacist, when presented with
a prescription for controlled substances, is to identify and resolve any “red flags” before filling
the prescription.
85. This pharmacist responsibility—to identify any red flags and resolve them before
filling a controlled-substance prescription—is well recognized in the professional field of
pharmacy. This responsibility is discussed in the training of pharmacists, by pharmacists at
professional conferences, and in training materials prepared by pharmacy boards.
86. This responsibility also has been recognized as an important safeguard against the
abuse of controlled substances. For example, in 2014, the National Association of Boards of
Pharmacy released a video called “Red Flags,” which observed that “by recognizing red flags to
help establish the validity of a prescription, the pharmacist becomes the last line of defense in
preventing misuse.” The video states, “problem prescriptions can often be identified by using
common sense, practicing good pharmacy, and looking for red flags that suggest the prescription
may not be legitimate.”
87. When a pharmacist identifies red flags but is able to resolve them, the pharmacist
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has an additional professional responsibility: to document the resolution of the red flags. In other
words, pharmacists were trained that, when presented with a controlled-substance prescription
bearing a significant red flag, they needed—as part of the usual course of professional pharmacy
practice—to investigate and either (a) resolve the red flag before dispensing and document the
resolution, or (b) refuse to fill the prescription. The documentation ensures that the information
about the red flag and its resolution is available for future reference, and the absence of
documentation can indicate that the pharmacist did not successfully resolve the red flag.
88. Because this obligation—to identify any red flags relating to a prescription for
controlled substances, to resolve them before filling the prescription, and to document any
resolution of red flags—is a well-recognized responsibility of a pharmacist in the professional
practice of pharmacy, failing to fulfill this responsibility is a violation of 21 C.F.R. § 1306.06,
which requires that a pharmacist’s conduct, when filling controlled-substance prescriptions, must
adhere to the usual course of his or her professional practice as a pharmacist.
3. Violations of these dispensing rules subject the pharmacy to civil penalties and other appropriate relief.
89. The CSA makes it unlawful “for any person … subject to the requirements of Part
C [21 U.S.C. §§ 821–32] to distribute or dispense a controlled substance in violation of section
829.” 21 U.S.C. § 842(a)(1) (emphasis added). A person dispensing controlled substances not in
compliance with any of the three requirements identified above violates 21 U.S.C. § 829 and thus
21 U.SC. § 842(a)(1).
90. In general, under the CSA, a person is liable for a civil penalty for each violation
of 21 U.S.C. § 842(a)(1) regardless of whether the violation was committed knowingly.
Compare 21 U.S.C. § 842(c)(1)(A) (“any person who violates this section shall … be subject to a
civil penalty”) with 21 U.S.C. § 842(c)(2)(A) (providing that a person who “knowingly” commits
25 Case 1:99-mc-09999 Document 1446 Filed 12/22/20 Page 26 of 160 PageID #: 149731
a violation of § 842 may be prosecuted criminally).
91. The Attorney General has provided, through regulation, that a person is liable for
penalties for violations of § 1306.04(a) relating to filling prescriptions only where the person
violates that rule “knowingly.” 21 U.S.C. § 1306.04(a) (“the person knowingly filling such a
purported prescription, as well as the person issuing it, shall be subject to the penalties provided
for violations of the provisions of law relating to controlled substances.”). Accordingly, a person
is liable for a civil penalty for violating § 1306.04(a) only if that person “knowingly” filled a
prescription that was (1) issued by a medical practitioner not adhering to the usual course of his
or her professional practice, or (2) not for a legitimate medical purpose.
92. In contrast, 21 C.F.R. § 1306.06—requiring that the pharmacist’s conduct must
adhere to the usual course of his or her professional practice as a pharmacist—does not require a
showing of a “knowing” violation.
93. The CSA provides that a person who violates 21 U.S.C. § 842(a)(1) shall, with
respect to any such violation, be subject to a civil penalty not to exceed $25,000 for each
violation on or before November 2, 2015, and not to exceed $67,627 for each violation after
November 2, 2015. See 21 U.S.C. § 842(c)(1)(A); 28 C.F.R. § 85.5.
94. When a corporation’s agents or employees violate the rules for dispensing
controlled substances, the corporate entity may be held liable for the civil penalty. Corporations
must comply with the CSA when they engage in activities covered by the CSA or its
implementing regulations, such as operating a pharmacy that dispenses controlled substances.
See 21 U.S.C. §§ 822(b), 823(f). While the CSA, in 21 U.S.C. § 842(a)(1) and (c)(1), makes a
“person” liable for civil penalties, a corporate entity may be the “person” that fills prescriptions
through its agents, as the CSA’s regulations expressly define “person” to include corporations.
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See 21 C.F.R. §§ 1300.01, 1306.02.
95. The CSA also authorizes the Attorney General to seek “appropriate declaratory
and injunctive relief relating to violations of … section 842 … of this title,” 21 U.S.C.
§ 843(f)(1), and permits the Court to issue an order “tailored to restrain violations of … section
842 of this title.” 21 U.S.C. § 843(f)(3).
D. Distributors must abide by certain legal obligations when they receive controlled-substance orders from pharmacies.
96. The CSA defines a “distributor” as a person or an entity that delivers (other than
by administering or dispensing) a controlled substance. The CSA defines “delivery” as the
“actual, constructive, or attempted transfer of a controlled substance….” See 21 U.S.C.
§§ 802(8), (11).
97. Many pharmacies obtain controlled substances from independent distributors, but
Walmart—as noted above—served as its own drug distributor until 2018, and operated several
dedicated distribution facilities during the Distribution Violations Period.
98. Distributors of controlled substances are required by the CSA to register with
DEA and to maintain effective controls against the diversion of controlled substances for
illegitimate uses. See 21 U.S.C. § 823(b)(1) (requiring the Attorney General, in registering a
distributor, to consider whether the distributor has shown “maintenance of effective control
against diversion of particular controlled substances into other than legitimate medical, scientific,
and industrial channels.”). The Attorney General has delegated this authority to DEA. See 28
C.F.R. § 0.100; 21 C.F.R. § 1300.01.
1. Distributors must detect and report suspicious orders.
99. Under the CSA, it is unlawful for a distributor to distribute a controlled substance
“[e]xcept as authorized by this subchapter.” 21 U.S.C. § 841(a) (“Except as authorized by this
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subchapter, it shall be unlawful for any person knowingly or intentionally (1) to . . . distribute . . .
a controlled substance”).
100. The CSA provides the Attorney General broad authority to “promulgate and
enforce any rules, regulations and procedures which he may deem necessary and appropriate for
the efficient execution of his functions under this subchapter.” 21 U.S.C. § 871(b); see also 21
U.S.C. § 821 (“The Attorney General is authorized to promulgate rules and regulations ….
relating to the registration and control of the manufacture, distribution, and dispensing of
controlled substances…”). The Attorney General has issued numerous regulations establishing
an extensive regulatory regime. See 21 C.F.R. §§ 1300.01-1321.01.
101. The Attorney General, by regulation, has long required distributors to design and
operate a system to detect suspicious orders of controlled substances, and to report those orders
to DEA. See 21 C.F.R. § 1301.74(b). This provision reads, in full: “The registrant shall design
and operate a system to disclose to the registrant suspicious orders of controlled substances. The
registrant shall inform the Field Division Office of the Administration in his area of suspicious
orders when discovered by the registrant. Suspicious orders include orders of unusual size,
orders deviating substantially from a normal pattern, and orders of unusual frequency.” Id. In
other words, orders that are unusual in one of those three ways—size, pattern, or frequency—are
deemed “suspicious orders,” and a distributor must detect and report them to DEA. “Suspicious
orders,” however, are not limited to those three categories, which are non-exclusive.
2. Failure to report suspicious orders subjects the distributor to civil penalties.
102. If a distributor fails to detect and report a suspicious order, it violates the law.
Under 21 U.S.C. § 842(a)(5), it is unlawful for any person, including a distributor, “to refuse or
negligently fail to make, keep, or furnish any record, report, notification, … or information
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required under this subchapter….”
103. A distributor is liable for a civil penalty for each violation of 21 U.S.C.
§ 842(a)(5) regardless of whether the violation was committed knowingly. Contrast 21 U.S.C.
§ 842(c)(1)(A) (“any person who violates this section shall … be subject to a civil penalty”) with
21 U.S.C. § 842(c)(2)(A) (providing that a person who “knowingly” commits a violation of
§ 842 may be prosecuted criminally).
104. The CSA provides that a person who violates 21 U.S.C. § 842(a)(5) shall, with
respect to any such violation, be subject to a civil penalty not to exceed $10,000 for each
violation on or before November 2, 2015, and not to exceed $15,691 for each violation after
November 2, 2015. See 21 U.S.C. § 842(c)(1)(A), (B); 28 C.F.R. § 85.5.
II. WALMART, AS A PHARMACY, VIOLATED THE CSA.
105. During the Dispensing Violations Period, from June 26, 2013, to the present,
Walmart violated the CSA’s dispensing rules on a sweeping national scale, filling enormous
numbers of invalid controlled-substance prescriptions.
106. These numerous, widespread dispensing violations were the inevitable result of
Walmart’s failure to take seriously its duty to comply with its CSA obligations, and of the ways
Walmart made it difficult for its pharmacists to fulfill those compliance obligations. As
discussed below in Part II.A, Walmart pressured its pharmacists to fill prescriptions as fast as
possible, leaving them little time to take the steps needed to determine whether controlled-
substance prescriptions were valid. While Walmart compiled “red-flag” information about
problem prescribers, it did not alert its pharmacists to this information, even though they needed
that information to determine whether prescriptions were valid. Walmart also deprived its
pharmacists of the tools and support they needed in order to comply with their dispensing
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obligations.
107. Walmart knew that many controlled-substance prescriptions it filled were not
issued for a legitimate medical purpose, or were not issued in the usual course of professional
medical practice, or both. Walmart, through its agents and employees, gained this knowledge in
a number of ways.
108. First, on many occasions, Walmart filled prescriptions written by prescribers its
own pharmacists repeatedly had identified as problem or even “pill-mill” prescribers.
Pharmacists identified specific red flags that they had found unresolvable, and that had led them
to refuse to fill prescriptions as invalid and to distrust any prescriptions written by the
prescribers. Pharmacists reported these pill-mill prescribers through “refusal-to-fill” forms and
other direct communications that they submitted to Walmart’s compliance unit, which operated
from the company’s Home Office and oversaw nationwide dispensing operations. Walmart’s
compliance unit managers collected and compiled this red-flag information but then chose not to
alert other pharmacists to this red-flag information for their use in assessing the validity of
prescriptions. See Part II.B below.
109. Second, on their face, certain prescriptions presented obvious red flags relating to
the amount, dose, or combination of drugs prescribed, or the prescribing patterns. These
prescriptions were so dangerous, and so indicative of prescription drug abuse or other diversion,
that Walmart pharmacists would have known the prescriptions had a very high probability of
invalidity. See Part II.C below.
110. Third, on some occasions, a Walmart pharmacist would determine that a
prescription was invalid based on the presence of obvious, unresolved red flags and refuse to fill
it. Then another Walmart pharmacist—presented with the same or similar red flags—would fill
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the prescription or a similar one for the same patient, under circumstances indicating that the
pharmacist had recognized the red flags but filled the prescription without resolving them. See
Part II.D below.
111. From these unresolved red flags, Walmart became aware that it was routinely
being asked to fill prescriptions that were not issued for a legitimate medical purpose and/or that
were written by prescribers not acting in the usual course of their professional practice. In filling
such prescriptions, Walmart thus violated one or both requirements of 21 C.F.R. § 1306.04(a).
112. Walmart also violated 21 C.F.R. § 1306.06 because, in filling numerous
controlled-substance prescriptions despite the obvious red flags, Walmart pharmacists failed to
comply with their own professional pharmacy practice standards. In many instances they failed
to resolve the red flags, and, upon information and belief, also failed to document any resolution
of the red flags.
A. Walmart impeded its pharmacists’ ability to comply with the legal requirements for dispensing controlled substances.
1. Walmart managers pressured pharmacists to fill prescriptions as quickly as possible.
113. During the Dispensing Violations Period, from June 26, 2013, to the present,
Walmart pharmacies typically were staffed by a pharmacy manager (a pharmacist), line
pharmacists, and pharmacy technicians. Pharmacy managers reported to market directors, who
oversaw multiple pharmacies. Market directors reported to market managers, who were
responsible for multiple areas of operation. Walmart’s pharmacies ultimately reported to
corporate executives in the Health and Wellness Division at Walmart’s Home Office in
Bentonville, Arkansas.
114. Retailers like Walmart operate pharmacies primarily to draw customers into their
stores with the expectation that those customers will buy other, non-pharmacy goods. For
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example, Walmart observed in its fiscal year 2017 annual report that risks to its pharmacy
business could “result in the loss of cross-store or -club selling opportunities and, in turn,
adversely affect our overall net sales, other results of operations, cash flows and liquidity.” In
another example, Sam’s Club at times offered drastic discounts on opioids that helped drive
customer traffic to its stores.
115. To retain customers, Walmart managers repeatedly told pharmacists to fill
prescriptions as quickly as possible. For example, a December 17, 2014 email to certain
pharmacists stated that “shorter wait times keep patients in store.” Other emails urged that if
prescriptions were not filled quickly, customers would shop elsewhere.
116. Even though Walmart pharmacists had legal requirements to satisfy before they
could fill controlled-substance prescriptions, Walmart managers told pharmacists to “[h]ustle to
the customer, hustle from station to station” because filling prescriptions “is a battle of seconds.”
117. Managers sent the pharmacists data showing the previous day’s prescription
volumes and wait times, and the managers used this data to create competition among
pharmacies. Managers ranked stores for the volumes of prescriptions filled and congratulated
pharmacists when the pharmacy dispensed high volumes.
118. In various emails, Walmart Health and Wellness Directors set a goal for
pharmacists to fill prescriptions in less than 20 minutes—a goal that they later shortened to less
than 15 minutes. When pharmacists pointed out the steps required to fill prescriptions, the
directors stated that pharmacists should complete all the necessary procedures in 15 minutes or
less.
119. Walmart also adopted, as early as 2013, plans for pharmacies, called Pharmacy
Facility Management Incentive Plans, that used the number of prescriptions filled by a pharmacy
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employee’s store as a factor in determining whether the pharmacy employee was entitled to
monetary incentive awards.
120. Walmart pharmacists reported feeling unable to do their jobs properly because
Walmart pharmacies lacked sufficient staff and the company added resources only when the
situation became unmanageable.
121. In addition, Walmart conducted surveys of many of its pharmacy employees in
June 2012, July 2014, and October 2014. In response, a substantial number of pharmacy
employees reported that their pharmacy lacked sufficient staff to handle the workload. For
example, in June 2012, only 59% of the employees reported having sufficient staff to handle the
workload. By October 2014, only 43% reported having sufficient staff. In both the June 2012
and October 2014 surveys, a substantial proportion of pharmacy employees reported that they
felt rushed with processing prescriptions.
122. Many pharmacy employees responded to the surveys with specific written pleas
for more staffing and time to carry out their duties in filling prescriptions. For example, in
response to the October 2014 survey, pharmacy employees reported:
• “We are not adequately staffed for safely filling the volume of prescriptions that are
brought to this pharmacy. We are spread too thin….”
• “[W]e do not have enough pharmacist help. I feel overwhelmed and like we are being
asked to do more and more…. We are being forced to not focus on the patients in front
of us….”
• “More bodies in the pharmacy are required to adequately serve our patients, both in a
timely and safe manner.”
• “[Staffing] is too low for a pharmacy and is dangerous for patients if the staff always
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feels overwhelmed or rushed while working on patients [sic] prescriptions.”
• “Since … new Control Class II Change for Hydrocodone we have been added more
responsibility and time consuming tasks, but our allotted hours for pharmacy staff has not
changed…. [T]his can add to pharmacy staff being more rushed to fill Rx, therefore
more chance of mistakes happening in the pharmacy.” (Emphasis omitted.)
• “Inadequate staffing is a big safety issue as it results in each person juggling more than
they should, and opens up the potential for mistakes to occur as a result.”
• “We are always under staff[.] [sic] This pharmacy is in [a] busy location, we do a lot of
CII [Controlled Substances, Schedule II] and we do have drive thru which takes longer
time and needs more staff.”
• “I feel that corporately we are expected to get things [sic] too quickly. The expectation
times seem unrealistic with the lack of staffing and amount of work we are expected to
get done….”
• “I think that someone should come in on a busy day when we do the most scripts and
immunizations and just see how we really need man power to ensure safety and accuracy
as opposed to not having enough technicians and feeling rushed and behind all the time to
save money. One mistake could potentially cost more than it would to have an extra
body to keep everything safer and feel less overwhelmed.”
• “[Need to] have upper management understand the time constraints with the new cii
[Controlled Substance, Schedule II] hydrocodone issues.”
• “I have worked for Walmart for over 10 years and generally feel that pharmacist staffing
is generally inadequate to provide an environment for a pharmacist to perform tasks in a
manner that is truly safe.”
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• “We don’t have enough staff to keep each station caught up at all times. And that is a
huge red flag for possible errors.”
• “Upper management is totally disengaged over faulty equipment and computer programs
that put[s] [prescription] processing at enormous risk—they are culpable! This is coupled
with inadequate staffing and poor management support over simple logistical challenges
that exceed the pharmacy’s ability/authority to resolve.”
• “Our [District Manager] continually sends our pharmacy nasty emails and chastises us for
not having a [sic] high enough numbers in our input and fill accuracy and times. We are
therefore instructed to cheat the system ….”
• “[B]ecause of the constant harassment from our market manager about us not getting
[prescriptions] done in 20 min, we often take shortcuts in filling and counseling rx’s that
could lead to patient safety issues.”
• “[I]f patient safety is the concern, numbers should not matter more than the patients [sic]
health. [M]arket manager and store manager are to [sic] preoccupied with sales and
numbers[. T]hey prefer us to rush and get rx out….”
• “I think that professionals need more time to complete the jobs that they were schooled to
do.”
• “Us being critisized [sic] b[y] our Health and Wellness Director about not getting
prescriptions out in 20 minutes causes the pharmacy to take short cuts and affects patient
safety.” (Emphasis omitted.)
These survey results and the comments were compiled and reviewed at Walmart’s Health and
Wellness Division.
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2. Walmart’s compliance unit chose not to give its pharmacists the information and authority it knew they needed to comply with the rules.
123. Walmart’s pharmacy operations were part of the company’s Health and Wellness
Division. The Health and Wellness Division included a compliance team, located at Walmart’s
Home Office, that was responsible for ensuring that pharmacy operations complied with all
relevant federal and state laws. This compliance unit included managers who fielded questions
about legal compliance from Walmart’s agents in the field, including pharmacists and
distribution center staff.
124. Walmart’s Health and Wellness compliance unit helped to develop Walmart’s
internal guidance and procedure documents.
a. Consistent with the CSA, Walmart’s own policy required pharmacists to identify and resolve red flags, and to document any resolution of red flags.
125. Walmart’s compliance policies regarding its obligations as a pharmacy under the
CSA were maintained in a Pharmacy Operations Manual (“POM”), which served as a central
resource for its pharmacies at both Walmart and Sam’s Club stores.
126. In these policies, Walmart acknowledged that it had to comply with important
legal requirements when dispensing controlled substances.
127. In March 2009, Walmart added to its POM a policy (“POM 1311”) entitled
“Practitioner/Patient Relationship.” According to a Senior Director of Pharmacy Professional
Services and Government Relations, POM 1311 “provides guidance on the pharmacist’s
responsibility to ensure that a prescription has been issued for a valid purpose….” The policy
thus would serve as a “reference for pharmacists regarding,” among other things, “‘prescription-
mills’.”
128. From its inception, POM 1311 provided a non-exhaustive list of factors indicating
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when a proper prescriber-patient relationship may not exist. For example, these factors included
prescriptions for a large quantity of certain medications or prescriptions with markings
suggesting the prescription has been rejected by another pharmacy. The policy also stated that
“[i]f the pharmacist does not reasonably believe that a valid prescriber-patient relationship exists,
the pharmacist may not dispense the prescription.”
129. Walmart issued an amended version of POM 1311 in or about March 2011 that
remained in effect at least through January 2014. POM 1311 (2011) identified the same red flags
as the prior version and added two more: prescriptions written by an out-of-state prescriber and
prescriptions “written by a doctor or for a patient for whom the pharmacy has rejected other
prescriptions for a failure to have an appropriate doctor-patient relationship.” This list was “by
no means all inclusive.” POM 1311 (2011).
130. Walmart’s POM 1311 (2011) recognized that “federal rules and the laws of many
states” require a proper prescriber-patient relationship for a prescription to be valid. The policy
acknowledged that pharmacists should not blindly accept a prescriber’s assurances: “Simply
because the prescriber verifies that he or she has seen the patient does not mean that an
‘appropriate’ patient prescriber relationship exists; if other signs of an inappropriate relationship
are present, the pharmacist can still exercise his or her judgment and not fill the prescription at
issue.” Similarly, the policy stated that “pharmacists must consider whether the patient and the
doctor have a relationship, but the relationship is not valid because it is being used for abuse or
diversion.”
131. POM 1311 (2011) recognized that a pharmacist should dispense a controlled-
substance prescription only if the pharmacist was able to resolve any red flags, and that the
pharmacist should document the resolution of those red flags. Under the policy, if a pharmacist
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had concerns about a prescription, the pharmacist was permitted to fill the prescription only if the
pharmacist “reasonably believe[d]” after speaking with the prescriber that the prescription was
valid. In such circumstances, pharmacists still were directed to “make a notation on the
prescription specifying” the pharmacist’s name, the name of the prescriber, the date of the
conversation, and the notation “proper relationship verified.”
132. In or about April 2015, as prescription drug abuse continued to escalate
throughout the United States, Walmart revised POM 1311 again and specifically addressed
pharmacists’ obligations with respect to controlled-substance prescriptions, explaining that the
CSA imposed a “corresponding responsibility” on pharmacists to dispense controlled-substance
prescriptions only if they were written for a legitimate medical purpose and based on a proper
prescriber-patient relationship. POM 1311 (2015) quoted directly from 21 C.F.R. § 1306.04 and
explained that this regulation was the basis for nearly all criminal actions taken by DEA against
pharmacies and pharmacists.
133. POM 1311 (2015) listed several red flags that DEA had identified as signs that a
prescription was not issued for a legitimate medical purpose. Walmart acknowledged that red
flags could relate to concerns about a prescriber, the prescription itself, or a patient. The red
flags Walmart identified included the following:
Prescriber Red Flags:
• Prescription is written by a prescriber outside of the pharmacy’s trade area.
• Prescriber routinely prescribes a large number (or percentage) of prescriptions
for controlled substances relative to prescriptions for non-controlled
substances.
• Prescriber prescribes the same medication, with the same directions, for the
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same quantity for a large number of individuals.
• Prescriber routinely writes for large doses of controlled substances.
• Prescriber provides the same diagnosis for the majority of individuals.
• Prescriber engages in the unauthorized practice of medicine, including writing
prescriptions outside of scope of practice and/or not having a proper
relationship with the patient.
Patient Red Flags:
• Individual insists on paying cash, or insists on paying cash for controlled
substances even though insurance is on file.
• Evidence of “doctor shopping” exists.
• Evidence of “pharmacy shopping” exists.
• Individual resides outside of the trade area of [the] pharmacy.
• The individual’s statements and conduct or behavior suggest abuse of
controlled substances.
• Individual asks for certain drugs prone to abuse by color, trade name or
markings and/or uses “street names.”
• Individual routinely attempts to obtain an early refill on controlled substances.
• Individuals have suspicious relationships with each other. For example:
multiple patients filling prescriptions from one address; prescriptions being
presented by someone other than the patient; groups of patients arriving all
with prescriptions for the same medication from the same doctor.
Prescription Red Flags:
• Prescriptions presented represent a “cocktail” of commonly abused drugs or
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are presented in a combination that can cause medical complications.
• Prescription presented is for an unusually large quantity or high starting dose.
• Prescription appears to be altered or duplicated.
• Prescription has an electronically generated or rubber-stamped signature.
134. POM 1311 (2015) stated that, before a pharmacist filled a controlled-substance
prescription with any of these red flags, the red flags “should be evaluated, resolved, and
documented.” Thus, POM 1311 (2015) shows Walmart’s recognition of its legal obligations
under the CSA to identify and resolve any red flags, and document the resolution of those red
flags, when deciding whether to fill prescriptions for controlled substances.
b. After Walmart was accused of dispensing violations, it committed to adopting a nationwide compliance program to identify red flags and prevent diversion.
135. Walmart, after it faced an enforcement proceeding where DEA accused Walmart
of violating its dispensing violations, recognized the need to identify red flags to comply with a
pharmacy’s dispensing obligations.
136. In March 2011, DEA and Walmart entered into a nationwide memorandum of
agreement (“MOA”) to resolve an administrative action predicated upon a California Walmart
pharmacy’s alleged failure to comply with its dispensing obligations when filling controlled-
substance prescriptions, including filling such prescriptions where the prescription was not
issued for a legitimate medical purpose or by a prescriber acting within the usual course of
professional practice.
137. The MOA was in effect from March 2011 through March 2015. In the MOA,
Walmart committed to, among other things, “maintain a compliance program, updated as
necessary, designed to detect and prevent diversion of controlled substances as required by the
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Controlled Substances Act.”
138. In the MOA, Walmart recognized that in order to comply with its regulatory
obligation not to dispense controlled substances based on prescriptions “issued by physicians for
other than a legitimate medical purpose and/or outside the usual course of professional practice
…”, Walmart needed to create a process that would ensure that its pharmacists were identifying
common signs of diversion. Specifically, the MOA required that Walmart’s compliance program
would include procedures to ensure that pharmacists identified red flags:
The program shall include procedures to identify the common signs associated with the diversion of controlled substances including but not limited to, doctor-shopping, requests for early refills, altered or forged prescriptions, prescriptions written by doctors not licensed to practice medicine in the jurisdiction where the patient is located, and prescriptions written for other than a legitimate medical purpose by an individual acting outside the usual course of his professional practice.
139. In the MOA, Walmart also agreed that if one of its pharmacists did conclude that
a prescription was not issued for a legitimate medical purpose by a practitioner acting in the
usual course of professional practice, was forged, or had been altered, and refused to fill that
prescription, Walmart would notify the local DEA field office within seven business days of the
refusal to fill.
140. As explained below, Walmart failed to adopt the robust compliance program it
had promised DEA it would adopt. It did gather information from its pharmacists as required by
its MOA with DEA. But Walmart then took an approach that effectively denied its pharmacists
the information they needed in order to comply with their legal obligations when dispensing
controlled substances.
c. While Walmart’s compliance unit did compile red-flag information, it chose not to disseminate that information to pharmacists.
141. Walmart maintained, in the ordinary course of business, extensive prescription
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and dispensing data relevant to determining whether a prescription presented red flags. Indeed,
Walmart was obligated to maintain data about dispensing, including the quantities and strengths
of controlled substances dispensed. See 21 C.F.R. § 1304.22(c).
142. In addition, Walmart’s compliance unit received reports submitted by Walmart
pharmacists about problematic prescribers or patients. These reports were submitted to the
compliance unit via “refusal-to-fill” forms or other direct communications. These reports
contained various types of information, such as the name of the prescriber and patient, the
prescriber’s address and DEA registration number, the controlled substances that had been
refused, and the reasons for the refusal. These reports often included, for example, alarming
details about pill-mill prescribers whose prescriptions had been refused.
143. As was apparent from Walmart’s refusal-to-fill form, some red flags were
sufficiently serious that a pharmacist could determine that a prescription was invalid and refuse
to fill the prescription without contacting the prescriber. A version of the refusal-to-fill form
asked whether the pharmacist had attempted to validate the prescription. If the pharmacist did
not attempt validation, the form required the pharmacist to explain how he or she was able to
“affirmatively conclude” that a prescription was forged or fraudulent or that there was no valid
prescriber-patient relationship. The form thus recognized that there would be instances when a
pharmacist could conclude—without contacting the prescriber—that there was no valid
prescriber-patient relationship and that the prescriber was thus not acting in accordance with
usual medical practice.
144. Walmart pharmacists did determine in many instances that a prescription was
invalid based solely on the identity of the prescriber. For example, in December 2013, a
pharmacist in North Fort Myers, Florida, concluded that a prescription written by W.W.,
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discussed below, was invalid without calling W.W., but based solely on the fact that W.W.
“continually writes narcotics” at an office that was “basically a walk in pain clinic.”
145. Pharmacists emailed the completed refusal-to-fill forms to Walmart’s compliance
unit. The emails went to a central email address, which was monitored by a senior compliance
manager in the Health and Wellness Division.
146. From 2011 to 2015, during the period when Walmart was under the MOA with
DEA and had committed to report refusals to fill, Walmart’s compliance unit gathered into a
spreadsheet the information it received from the refusal-to-fill forms. Walmart provided some of
this information to DEA, though it did so after removing comments from the refusal-to-fill
forms, which meant that DEA generally did not see the explanations from pharmacists about
why they had refused to fill a prescription.
147. Through these refusal-to-fill forms, Walmart’s compliance unit learned about
prescribers who were acting as “pill mills” and writing prescriptions for drugs based on patients’
drug-seeking requests rather than medical needs, prescribers who were writing prescriptions for
the same drugs and dosages for large numbers of patients, prescriptions for “cocktails” of drugs
known to be abused, and prescriptions for excessive quantities of controlled substances.
Walmart’s compliance unit also learned about patients who were hostile and appeared
intoxicated or who were doctor and pharmacy “shoppers”—that is, individuals who received
prescriptions from multiple doctors and/or filled their prescriptions at multiple pharmacies, to
avoid attention to excessive quantities or combinations suggesting abuse. All of these are red
flags.
148. Often, the red-flag information contained in the refusal-to-fill forms was not
reliably shared—even at the pharmacy level among coworkers. Walmart lacked any effective
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process to share red-flag information between pharmacists at the same store who did not have
overlapping shifts or with “floating” pharmacists who worked only sporadically at any particular
pharmacy.
149. Walmart’s compliance unit would have recognized that this information from the
refusal-to-fill forms indicated at least a high probability that prescribers were issuing
prescriptions that were not for a legitimate medical purpose or were not acting in the usual
course of professional conduct. The compliance unit also would have recognized that this
information was needed by Walmart pharmacists to carry out their legal and professional
obligations to consider and resolve red flags presented by future prescriptions.
150. But, for years, Walmart’s compliance unit chose not to disseminate this
information to alert pharmacists to the significant volume of red-flag information associated with
many of the prescriptions they were being asked to fill. Moreover, Walmart pharmacists knew
that Walmart did not have a system that alerted them about the red flags regarding particular
prescribers or patients reported to the compliance unit.
151. Walmart’s compliance unit could have chosen some method to alert pharmacists
to the red-flag information when a related prescription was presented. For example, Walmart’s
system notified a pharmacist when a medical doctor’s license had expired by placing an “edit” in
its computer system and by sending out “e-alerts” to its pharmacies to alert them not to fill a
doctor’s prescriptions. In addition, Walmart’s system alerted pharmacists to certain dangerous or
deadly drug combinations. But pharmacists were not similarly notified in any way of high-risk
prescribers who represented a danger to patients’ health.
152. Furthermore, the extremely tight time pressures Walmart placed on pharmacists to
fill prescriptions made it impractical, if not impossible, for Walmart pharmacists to learn red-flag
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information by contacting Walmart’s compliance unit before filling each prescription.
153. For years, Walmart’s compliance unit knowingly failed to take necessary steps to
ensure that the red-flag information in its possession actually alerted Walmart pharmacists to any
red flags they needed to consider. Walmart’s compliance unit did not even disseminate such
information to pharmacists at Walmart pharmacies that were near the problem prescribers’
medical practices or near Walmart pharmacies that had previously refused to fill prescriptions
written by problem prescribers.
154. Walmart recognized that individuals presenting prescriptions that were refused by
one Walmart pharmacy might try to get them filled at another, nearby Walmart pharmacy. As a
Walmart Market Health and Wellness Director observed in May 2014, “these patients and
prescriptions will simply move to another location and I was hoping we had a process for
flagging doctors that are under investigation so all locations are aware?” A senior manager in
Walmart’s compliance unit responded that “[t]here is no communication we can put out” and
failed to identify any process Walmart had adopted to ensure pharmacists learned of any red
flags related to such prescribers.
155. Rather than using the refusal-to-fill forms to ensure that its pharmacists were
informed of red flags and could identify invalid prescriptions, Walmart’s compliance unit
appeared to view the refusal-to-fill forms as useful only for a very narrow purpose: responding to
complaints from prescribers or patients about prescriptions that Walmart had refused to fill. As
B.N., a senior manager (who in June 2014 became a director) in the compliance unit, explained
in an email on March 26, 2013, “The documentation of these refusals is to provide details of the
incident for the purposes of supporting the Pharmacists in their decision should any complaint be
filed by a prescriber or patient with the Medical Board or Board of Pharmacy.” Walmart’s
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compliance unit routinely used this same boilerplate language in responding to pharmacists who
followed up on refusal-to-fill forms—even when those pharmacists raised specific concerns
about whether they should continue to fill prescriptions issued by prescribers whose conduct
appeared improper.
156. Walmart’s compliance unit recognized that its system was not delivering to its
pharmacists the information about red flags the pharmacists needed. In 2013, a Walmart
“Controlled Substances Work Group” reported that it needed to “[e]stablish a process for the
analysis of refusal to fill data and reporting problematic prescribers or patients internally.” Also
in 2013, Walmart’s compliance unit established a “Success Measure” that it would “[d]eliver a
process for reporting prescribers or patients internally.” The Work Group recognized that, to
accomplish this goal, it would need to “[d]etermine how to disseminate refusal to fill decisions
and/or problematic prescribers and patients within the same trade area or to the entire corporate
entity.”
157. Until mid-2015, Walmart did not even have a system that enabled its pharmacists
to search for refusal-to-fill information completed by other pharmacists. The only ways a
Walmart pharmacist could learn about previous refusals to fill were through word of mouth or by
requesting red-flag information from Walmart’s compliance unit before filling a prescription.
158. Even though Walmart had committed, under its 2011 MOA with DEA, to
“maintain a compliance program, updated as necessary, designed to detect and prevent diversion
of controlled substances,” Walmart chose for years not to even analyze the red-flag information
it collected or to develop a system to disseminate this information to its pharmacists.
159. Instead, Walmart decided to focus on sales. In 2015, B.N., a compliance director,
told a vice president in Health and Wellness Operations that during the MOA, the compliance
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unit had “not invested a great amount of effort” in data analysis. He explained that “[d]riving
sales and patient awareness” was “a far better use of our Market Directors and Market Manager’s
time.”
160. In approximately 2015, Walmart began to make some refusal-to-fill information
at least retrievable by other pharmacists. At that time, Walmart introduced a new platform for
pharmacy compliance known as “Archer.” Walmart pharmacists were instructed to submit
refusal-to-fill forms through Archer. With the introduction of Archer, pharmacists were able to
search for refusal-to-fill forms submitted by other pharmacists for specific prescribers or
patients.
161. But the new Archer system still did not ensure that pharmacists were alerted to
red-flag information. Walmart pharmacists were not automatically notified of the adverse
information. Nor were they able to review all comments other pharmacists had made on refusal-
to-fill forms.
162. Walmart also failed to train pharmacists on the availability and use of these
refusal-to-fill forms in Archer. Many Walmart pharmacists did not even know that they could
search refusal-to-fill forms. In fact, Walmart did not update POM 1311 until February 2017 to
inform its pharmacists that one resource for evaluating and resolving red flags was previous
refusal-to-fill documentation in Archer.
163. For most of the Dispensing Violations Period, Walmart’s compliance unit
generally did nothing to resolve the red flags that had been reported. And by not following up,
the company often avoided obtaining readily available information that would have corroborated,
rather than resolved, the red flags. For example, Walmart often failed to retrieve relevant
information that was accessible from state databases for prescription drug monitoring, from the
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public records of state medical licensing boards, and from public criminal records. It also often
failed to contact other pharmacies that had decided not to fill prescriptions for a prescriber. In
fact, according to some pharmacists, Walmart’s compliance unit often did not even take the most
basic step of speaking with the pharmacist who had refused to fill the prescription.
164. Upon information and belief, even as of recently, Walmart still had not adopted a
system that affirmatively alerts pharmacists, in some way, to the critical red-flag information in a
manner that enables its pharmacists to comply with their legal duties. At the same time, Walmart
has continued to tout on its website how it has used its pharmacy data to “enhance, customize
and optimize the shopping experience” and to “make Walmart pharmacies more efficient.”
165. Accordingly, throughout the Dispensing Violations Period, Walmart’s compliance
unit gathered—through refusal-to-fill forms and other communications—a large volume of red-
flag information about numerous high-risk prescribers and patients. But Walmart elected not to
take any steps to ensure that its pharmacists received this critical red-flag information that they
needed in order to comply with their legal obligations in dispensing controlled substances.
d. Walmart prohibited its pharmacists from refusing to fill, as a blanket matter, all prescriptions issued by pill-mill prescribers.
166. Even when pharmacists determined by themselves that prescribers were acting as
pill mills, Walmart’s compliance unit refused to let the pharmacists categorically refuse to fill all
prescriptions issued by such prescribers. Rather, the compliance unit told pharmacists that they
needed to consider each individual prescription—an approach that made it impractical for
pharmacists to reject all prescriptions issued by these pill-mill prescribers, particularly given the
strict time pressures Walmart imposed on its pharmacists for filling prescriptions.
167. As noted above, in refusal-to-fill forms and other communications, Walmart
pharmacists alerted Walmart’s compliance unit to prescribers who were acting as “pill-mill”
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prescribers and routinely issuing prescriptions not in the usual course of professional practice or
not for legitimate medical purposes. Walmart pharmacists repeatedly asked if they could refuse
to fill all controlled-substance prescriptions from a problem prescriber operating as a pill mill.
168. In response, Walmart’s compliance unit instructed these pharmacists that they
were not permitted to refuse to fill as a blanket matter. Rather, as B.N. explained in an email, an
individual pharmacist was required to operate only on an “individual prescription basis” and no
“blanket refusals are allowed.”
169. Walmart’s compliance unit so often told pharmacists not to impose blanket
refusals to fill that managers in Walmart’s compliance unit commonly provided this response
using boilerplate text pasted into response emails.
170. Walmart’s POM 1311 (2011) confirmed Walmart’s prohibition on blanket
refusals to fill by pharmacists. It stated: “Blanket refusals of prescriptions are not allowed. A
pharmacist must make an individual assessment of each prescription and determine that it was
not based on a valid prescriber-patient relationship or for a valid medical reason before refusing
to fill.”
171. Walmart’s compliance unit also often advised pharmacists that “no blanket
refusals are allowed by the Boards of Pharmacy,” but—as Walmart’s compliance unit knew—
this sweeping statement was unsupported. In early 2014, the compliance unit acknowledged its
uncertainty when it designated the need “to determine if pharmacists may exercise their
discretion to impose blanket refusals” as a “Key Deliverable” it needed to accomplish.
172. In rejecting pleas from its pharmacists that they should be allowed to use their
professional judgment to categorically refuse to fill prescriptions, Walmart’s compliance unit
made clear that a pharmacist was not permitted to determine, in his or her own professional
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judgment, that all prescriptions (or certain kinds of controlled-substance prescriptions) issued by
a problem prescriber were invalid. Rather, Walmart required the pharmacist to still consider
each individual prescription issued by a pill-mill prescriber, and to fill out a refusal-to-fill form
for each individual prescription issued by that prescriber.
173. These instructions effectively led Walmart pharmacists to continue to fill
prescriptions issued by prescribers whom those Walmart pharmacists had reported as “pill-mill”
prescribers because the alternative—filling out a refusal-to-fill form for every prescription issued
by a pill-mill prescriber—was impractical. If a pharmacist had to take this prescription-by-
prescription approach with a pill-mill prescriber, filling out the refusal-to-fill form for each
prescription would consume all the pharmacist’s time.
174. For example, as one Walmart pharmacy manager in Texas explained to B.N. in an
email on February 6, 2015, “[i]f all of us got together and started filling out refusal to fill” forms
for one pill-mill prescriber, “that is all we would do all day long[]. . . .” Stressing how dire the
situation was, she reported, “[o]ther chains are refusing to fill for him which makes our burden
even greater. Please help us.” But the compliance unit still refused to allow the pharmacists to
blanket refuse all of that pill-mill prescriber’s prescriptions.
175. Later, Walmart began permitting blanket refusals. Walmart also began reviewing
problem prescribers in a centralized manner, and began issuing corporate blocks for certain
prescribers, preventing any Walmart pharmacist from filling controlled-substance prescriptions
issued by those prescribers.
B. Even after Walmart pharmacists identified pill-mill prescribers who were issuing invalid prescriptions, Walmart kept filling their prescriptions.
176. The approach taken by Walmart’s compliance unit and managers—pressuring
pharmacists to fill high volumes of prescriptions very quickly, while at the same time
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withholding from those pharmacists the red-flag information and support they needed to fulfill
their gatekeeping duties when dispensing controlled substances—resulted in thousands of
violations, all across the country, of Walmart’s dispensing obligations.
177. In particular, even after Walmart pharmacists informed the compliance unit about
pill-mill prescribers whose practices raised egregious red flags, Walmart continued to fill invalid
prescriptions issued by those prescribers, including in some instances prescriptions for the very
same controlled substances about which its pharmacists had sounded the alarms.
178. Below are 20 examples of the numerous prescribers whose egregious and
unprofessional prescribing practices were known to Walmart. The examples are organized in
alphabetical order by the prescribers’ initials. In each example, Walmart pharmacists repeatedly
recognized, and reported to Walmart’s compliance unit, that a particular prescriber was issuing
prescriptions without a legitimate medical purpose or outside the usual course of professional
practice. In each example, Walmart’s compliance unit knew that its pharmacists were continuing
to be presented with prescriptions issued by those prescribers, and that, based on the reported red
flags, there was a very high probability that the prescribers were regularly issuing invalid
controlled-substance prescriptions.
179. In each example, despite possessing this knowledge of red flags, Walmart’s
compliance unit did not notify its pharmacists of the information the compliance unit had
compiled. Nor did Walmart afford any of its pharmacists the time, guidance, and tools they
needed to prevent the filling of further invalid prescriptions. Rather, in each example, despite
Walmart’s knowledge of prescriber red flags indicating a very high probability that the
prescriber regularly issued invalid prescriptions for controlled substances, Walmart continued to
fill hundreds, and in some cases thousands, of prescriptions by the same problem prescriber.
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1. D.C.: “95% of the prescriptions from this prescriber are for controlled substances”
180. D.C. was a doctor of osteopathic medicine who practiced in Wilmington,
Delaware.
181. In 2014 and 2015, a Walmart pharmacist at Store 5436 in Wilmington, Delaware,
refused to fill prescriptions written by D.C. because he identified unresolved red flags including
doctor shopping (“Checked PMP [prescription monitoring program] and saw multiple doctors
prescribing similar medications”; “Pt [patient] had received scripts for Percocet from Dr. [C.],
Dr. [Y.], and Dr. [W.] in the past two months for 20-30 day supplies”) and early refills (“Refilled
early too many times … PT says purse was stolen in december leading to an extra fill but could
not explain the other fills. Pt had filled Xanax prescriptions 5 times in december and twice in
january.”).
182. Store 5436 was not the only Walmart location where D.C.’s prescribing habits
raised red flags. On May 19, 2016, M.J., Walmart’s Director of Controlled Substances, reported
to DEA that the pharmacy at Store 3802 in Middletown, Delaware, had placed a suspicious order
for oxycodone-acetaminophen 10/325mg. She noted that, even counting all of the prescribers
whose prescriptions were filled at that pharmacy, D.C. prescribed 46 percent of the oxycodone-
acetaminophen 10/325mg at this pharmacy. Additionally, she noted that 95 percent of the
prescriptions from D.C. were for controlled substances, and that 81 percent of what he prescribed
was oxycodone-acetaminophen 10/325mg. Finally, she reported that for nearly two-and-a-half
years, from January 1, 2014, until May 19, 2016, this pharmacy had not reported a single refusal
to fill.
183. Even after M.J. learned that 81 percent of D.C.’s prescriptions were for a single
opioid medication at a single strength—oxycodone-acetaminophen 10/325mg—Walmart
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pharmacies continued to dispense this same prescription written by D.C. In fact, after the May
2016 suspicious-order report for the pharmacy at Store 3802, Walmart dispensed over 300
oxycodone-acetaminophen 10/325mg prescriptions written by D.C.
184. From May 19, 2016, through July 12, 2017, despite Walmart’s knowledge of red
flags indicating a very high probability that D.C. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 650 controlled-substance prescriptions written
by D.C., including more than 80 where the patient was from a different state than D.C.
185. On August 2, 2019, the Delaware Division of Public Health announced that the
Delaware Secretary of State had temporarily suspended D.C.’s medical license and controlled-
substance registration, following an investigation by the Delaware Attorney General’s Office
into his prescribing and treatment practices. The Secretary found that there was an imminent
danger to the public health or safety based on the state’s serious allegations, which included that
D.C. routinely prescribed controlled substances to two undercover officers and eight patients
without conducting a meaningful initial evaluation or examination of the patients and without
discussing the risks and benefits of using the controlled substances. The state also alleged that
he documented physical examinations, complaints, and discussions that had not occurred.
2. F.B.: “Always writes excessive quantities for all of his patients”
186. F.B. was a doctor who practiced at various locations in and around Savannah,
Georgia, including a clinic that specialized in footwear for diabetics.
187. As early as June 2012, Walmart pharmacists expressed their concerns about F.B.
to Walmart’s compliance unit. On June 6, 2012, a Walmart pharmacist working at Store 635 in
Savannah, Georgia, refused to fill a prescription for carisoprodol 350mg, reporting that “DR[.]
[F.B.] prescribed A MONTH SUPPLY OF controlled drug (NOT a PAIN CLINIC).” In
September 2013, a pharmacist at Store 605 in Savannah, Georgia, recognized that F.B. was a
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“suspicious md” and that the individual seeking to fill the prescription “currently sees a pain
management doc[to]r so she should not be filling [oxycodone-acetaminophen 10/325mg] from
this general prac[ti]tioner.” The following month, another pharmacist at Store 605 wrote that
F.B. was “writing outside of his scope of practice.” In 2014, Walmart pharmacists reported that
F.B. “is known to write multiple controls for large quant[itie]s” and “always writes excessive
quantities for all of his patients.”
188. Walmart pharmacists also reported that they refused to fill F.B.’s prescriptions
because the customer had refused to wait for a prescription until the pharmacist had contacted
F.B. or because F.B. had refused to provide information to the pharmacist. When presented with
a controlled-substance prescription where a red flag appears, a pharmacist may attempt to contact
the prescriber to determine if the prescription is valid. A patient’s unwillingness to wait until
such contact has been made and a prescriber’s unwillingness to communicate with a pharmacist
are additional red flags that can indicate that the prescription is not, in fact, valid. For example,
in October 2012, a pharmacist at Store 1024 in Swainsboro, Georgia, refused to fill a prescription
for carisoprodol 350mg because F.B.’s DEA registration number was not on the prescription and
the individual “refused to wait for me to call during Dr office hours.” In numerous instances,
beginning as early as February 2013, Walmart pharmacists complained about their inability to
contact F.B., writing that “[i]t would be hard to verify the patient prescriber relationship since
this office lacks open communication with our pharmacy via phone,” F.B. “won[’]t return
messages to verify rx,” and he “is impossible to get in touch with.”
189. In February 2014, a pharmacist at Store 4556 in Savannah refused to fill a
prescription for customer B.W. for oxycodone-acetaminophen 10/325mg. On the refusal-to-fill
form, she recounted a conversation she had had with F.B.: “He asked why I needed to verify a
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class 3 narcotic …. When I told [F.B.] that generic Percocet was a class 2 narcotic his response
to me was, ‘Oxycodone with Acetaminophen is a class 3 narcotic not a class 2 narcotic, you
should be ashamed of yourself that you do no[]t know this. I would not have prescribed it if it
was a schedule 2 narcotic.’ Based upon the fact that [F.B.] is not even aware of the medication
he is prescribing (and he prescribes it frequently) I cannot ethically fill the prescription.” That
same day, however, Walmart filled a prescription for B.W. for alprazolam 4mg, also written by
F.B.
190. As other pharmacies in Savannah stopped dispensing F.B.’s prescriptions,
individuals turned to Walmart to get them filled. In June 2015, a pharmacist at Store 605 in
Savannah observed that “[e]ach weekend – we are beginning to see [an] influx of the same
prescriptions written for MANY patients from [F.B.]…. Each weekend, at least 10 patients
call/come in pharmacy with Percocet 10/325 #120, Xanax 2 mg #90, Adderall 30mg #90 and
sometimes Soma 350mg #90.” The pharmacist also told Walmart’s compliance unit that “[o]ther
pharmacies in our area (ie-Kroger) are no longer taking any of [F.B.’s] prescriptions.”
191. From June 26, 2013, through January 2017, despite Walmart’s knowledge of red
flags indicating a very high probability that F.B. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 500 controlled-substance prescriptions written
by F.B. for Medicare patients. Over 200 of those prescriptions were for Schedule II controlled
substances.
192. In October 2019, a federal jury convicted F.B. on multiple counts of unlawful
dispensing of controlled substances and healthcare fraud. Evidence introduced at trial revealed
that F.B. prescribed the “classic trinity” cocktail of opioids, alprazolam, and carisoprodol to
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Medicare patients at a higher rate than did any other physician in the United States. F.B. was
sentenced to 20 years in prison.
3. F.T.: Prescribed “too many [drugs] for one person to take”
193. F.T., an orthopedist, operated a pain management clinic with offices in Tampa
and Punta Gorda, Florida.
194. Evidence of F.T.’s improper prescribing was observed by Walmart pharmacists—
and reported up to Walmart’s compliance unit—as early as July 2012.
195. Between July 2012 and September 2013, in refusal-to-fill forms to Walmart’s
compliance unit, Walmart pharmacists reported that they had refused to fill prescriptions after
identifying multiple unresolved red flags regarding F.T. For example, pharmacists reported that
F.T.’s patients appeared impaired and had used multiple pharmacies, including one individual
who had been to more than 10 pharmacies during the preceding year. Pharmacists also identified
obvious red flags on the face of the prescriptions, which ordered inappropriate quantities or
combinations, such as combinations that posed the risk of respiratory depression and, in one
instance, a quantity of Schedule II drugs that was “too many … for one person to take.”
196. During that same time period, at least five different pharmacists at different
Walmart pharmacies reported, in at least 12 refusal-to-fill forms, that they had refused
prescriptions because F.T., the customer, or both were outside the store’s area.
197. According to reports from Walmart pharmacists, two different customers told
pharmacists in December 2013 and May 2014 that they needed their medications to prevent
withdrawals. One of those individuals, who presented a methadone prescription, also had
oxycodone in her fill history and presented prescriptions for both herself and her husband. The
other customer would frequently come in with several other individuals who, a pharmacist
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reported, “always appear high.”
198. Reports of F.T.’s inappropriate prescribing practices continued in 2015, with
pharmacists reporting, in January and May 2015, prescriptions issued by F.T. for quantities
exceeding Walmart’s internally set limits for methadone 10mg and inappropriate combinations
of opioids and methadone.
199. Walmart continued filling F.T.’s prescriptions. From June 26, 2013, through
November 2015, despite Walmart’s knowledge of red flags indicating a very high probability
that F.T. regularly issued invalid prescriptions for controlled substances, Walmart filled more
than 1,000 of F.T.’s controlled-substance prescriptions, including more than 200 prescriptions
paid for in cash.
200. In December 2017, F.T. was sentenced to 12 years and seven months in prison
after being found guilty at trial of causing the dispensing, without a legitimate medical purpose
and not in the usual course of professional practice, of oxycodone, hydromorphone, morphine,
and hydrocodone, all Schedule II opioids.
4. G.G.: “gives patients what they want and [does] not practice real medicine.”
201. G.G., an osteopathic physician based in Oakland City, Indiana, has a record of
criminal and professional misconduct dating back to 2005. That year, the Medical Licensing
Board of Indiana suspended his osteopathic physician’s license on an emergency basis, finding
that he presented a “clear and immediate danger to the public health and safety” because he had
allowed an unlicensed individual to prescribe drugs using G.G.’s DEA registration number and
to treat G.G.’s patients. G.G. had hired that individual knowing that the individual was not
licensed to practice medicine and had paid him $20 per hour.
202. G.G. led his patients to believe that the individual was legitimately practicing
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medicine and also led the Medicaid program to believe that G.G. had provided services that
were, in fact, provided by the unlicensed employee. For that, G.G. pleaded guilty to Medicaid
fraud in 2006. He resolved the Medical Licensing Board action in 2006 by agreeing, among
other things, to the indefinite probation of his medical license.
203. G.G. attempted to remove the probationary status from his Indiana license, but the
Medical Licensing Board of Indiana denied his petition in October 2015, finding that G.G.
prescribed and/or administered controlled substances to patients, including a known drug addict,
“outside the safe and generally accepted medical principles and protocols regulating the practice
of medicine” and “without objective evidence of medical necessity.”
204. While G.G.’s license was in probationary status, Walmart pharmacists learned
that other pharmacies in G.G.’s area had imposed a ban on filling his prescriptions. A Walmart
pharmacist at Store 2563 in Paoli, Indiana, reported this ban to Walmart’s compliance unit in a
November 2013 refusal-to-fill form. The pharmacist reported that G.G. had been “[b]anned
companywide by CVS and most local pharmacies near where he practices in Oakland City which
is nearly 2 hours from this location.” The pharmacist also reported in the form that G.G. had a
“history of inappropriate practices” and was “on a watchlist with the Office of the Inspector
General for the state of Indiana.” Another pharmacist from Store 2563 informed Walmart’s
compliance unit in October 2014 that pharmacies in G.G.’s local area would not fill his
prescriptions.
205. On December 10, 2013, G.G. himself stated explicitly to a pharmacist at Store
1263 in Evansville, Indiana, that he prescribed what patients wanted, not what they medically
needed. As the pharmacist reported in the refusal-to-fill form: “Doctor declared that he knew it
[Ambien 10mg prescription] was above the recommended dose and he couldn’t convince the
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patient to stop taking it. Doctor wrote the rx due to that[’]s what the patient wanted.” This
refusal to fill occurred at 9:30 a.m. on December 10; on that same day, a different Walmart
pharmacy in Evansville (Store 1341) filled a prescription for the same patient for the same drug,
zolpidem (of which Ambien is a brand name).
206. Again, in May 2014, a Walmart pharmacist reported to Walmart’s compliance
unit, through a refusal-to-fill form, that G.G. “gives patients what they want and [does] not
practice real medicine.” By this time, two Walmart pharmacies, in Evansville and Washington,
Indiana, had identified G.G. as a known “pill pusher” or “pill shop doctor,” and the pharmacy in
Evansville reported that “[b]esides [W]almart no other pharmacies in the tr[i]state will fill for the
md.”
207. Also in May 2014, a Walmart pharmacist reported to the compliance unit, on a
refusal-to-fill form, that G.G. had admitted to an alarming abdication of his professional
responsibility: “Dr. [G.G.]. said he does not keep track of patients; he expects us to.”
208. G.G. again revealed his disregard for his patients’ health when a Walmart
pharmacist attempted to validate prescriptions for Adderall and Suboxone (brand name of the
drug combination of buprenorphine and naxolone) in September 2014. In a refusal-to-fill form,
the pharmacist explained that the patient was getting 30-day supplies of Adderall and Suboxone
about every two weeks, all prescribed by G.G. She believed that the “patient looks like they are
abusing the meds and the dr doesn’t seem to care.”
209. The warnings continued into 2015, including one from the pharmacy at Store 870
in Jasper, Indiana, which reported G.G. as a “questionable doctor” and, by February 2015, would
no longer would fill G.G.’s prescriptions.
210. Because G.G. prescribed controlled substances based on his patients’ desires
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rather than any legitimate medical need, Medicaid patients would “flock” to him even though he
was not a Medicaid provider, according to a refusal-to-fill form submitted by a Walmart
pharmacist in March 2015. And, in return, G.G. got what he wanted: “He charges them
[Medicaid patients] cash to give them what they want.”
211. From December 1, 2013, through September 2015, despite Walmart’s knowledge
of red flags indicating a very high probability that G.G. regularly issued invalid prescriptions for
controlled substances, Walmart filled over 3,500 controlled-substance prescriptions written by
G.G., including approximately 625 paid for in cash and nearly 200 involving a patient from a
different state than G.G. and/or the pharmacy.
5. G.H. and R.M.: “well known as a pill mill”
212. G.H. practiced pain management in Roland, Oklahoma. R.M. was the president
and medical director of the clinic where G.H. practiced.
213. Walmart pharmacists repeatedly reported that G.H. refused to provide verification
for opioid prescriptions. For example, a Walmart pharmacist at the pharmacy in Store 2744 in
Fort Smith, Arkansas, reported to Walmart’s compliance unit in March and April 2013 that G.H.
refused to verify an oxycodone 30mg prescription when contacted and went so far as to block the
pharmacy’s telephone number.
214. In August 2013, a pharmacist at Store 8 in Morrilton, Arkansas, attempted to
contact G.H. to verify an oxycodone 30mg prescription presented by a customer who was seeing
multiple doctors and getting prescriptions filled at multiple pharmacies, but the pharmacist did
not receive a return call. The pharmacist reported to Walmart’s compliance unit that he had
learned from another pharmacy in G.H.’s area that the pharmacy routinely turned away his
patients because of “questionable prescribing habits.”
215. Pharmacists also submitted refusal-to-fill forms to Walmart’s compliance unit for
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specific prescriptions issued by R.M. These prescriptions, which were presented to pharmacies
at Store 380 in Waldron, Arkansas, and Store 55 in Booneville, Arkansas, showed multiple red
flags that the pharmacist could not resolve, in that (a) they were written by an out-of-state
prescriber; (b) one of R.M.’s patients had just been arrested for “delivery of OxyContin” when
he presented a prescription in August 2013 for oxycodone, methadone, and Valium; and (c) a
husband and wife both presented prescriptions in April 2014 from R.M. for high doses of
controlled substances that presented a significant risk of respiratory depression.
216. By September 2013, a pharmacist who acted as the pharmacy manager at a
different Walmart store in Fort Smith, Arkansas, Store 8134, was sufficiently concerned about
the prescribing practices of the doctors at R.M.’s clinic that the pharmacist reported to a Walmart
market manager in the Health and Wellness Division: “[D]epending on how long it might take
co[r]porate to decide on what to do, we might start to refuse to fill prescriptions for some
patients. I have too much invested in my career and family to continue to risk it.” The
pharmacist identified both G.H. and R.M. as the doctors responsible for the clinic’s improper
prescribing.
217. The market manager forwarded the pharmacy manager’s email to Walmart’s
compliance unit. In reply, B.N., a senior manager in the compliance unit, stated that pharmacists
should exercise their independent judgment and refuse a prescription they deem invalid, but he
also stated that Walmart had a policy that prohibited a blanket refusal to fill on any particular
prescriber.
218. In the same email, B.N., using boilerplate language, explained that the
“documentation of these refusals is to provide details of the incident for the purposes of
supporting the Pharmacists in their decision should any complaint be filed by a prescriber or
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patient with the Medical Board or Board of Pharmacy.” B.N. made clear that the refusal-to-fill
forms were used by Walmart to protect against future complaints, not to provide other
pharmacists with information about prescribers.
219. B.N. explained that he was aware that prescriptions from problematic prescribers
would continue to be presented to Walmart pharmacists because “the traffic [to Sam’s Clubs]
and routines of these patients have already been established” by the “drastic” discounts that
Sam’s Club once offered for oxycodone.
220. The reports from Walmart pharmacists about the improper prescribing practices
of G.H. and R.M. were not shared with pharmacists at other Walmart pharmacies.
221. From September 2013 through June 2014, despite Walmart’s knowledge of red
flags indicating a very high probability that G.H. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 1,000 of G.H.’s controlled-substance
prescriptions, including more than 200 paid for in cash, more than 1,000 dispensed to patients
with addresses outside of Oklahoma, and more than 100 written close in time for dangerous
combinations.
222. From October 2013 through February 2015, despite Walmart’s knowledge of red
flags indicating a very high probability that R.M. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 6,500 controlled-substance prescriptions written
by R.M. These prescriptions included nearly 600 prescriptions filled between October 2013 and
December 2014 by Store 8134, the store that sent the September 2013 email described above.
223. R.M. later admitted that he managed the clinic “like a pill mill that herded patients
through the Clinic and prescribed [controlled and dangerous substances] in large quantities based
upon little to no physical examination or with no legitimate medical purpose.”
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224. In 2014, the Oklahoma State Board of Medical Licensure and Supervision filed
complaints against G.H. and R.M. As described in the complaints, “[t]he business model of the
… Clinic was designed to provide massive amounts of high dose [controlled and dangerous
substances] to patients under the veil of a legitimate pain management clinic …. In time, the …
Clinic became so well known as a pill mill that people were traveling to it from as far away as
Colorado.”
225. R.M. voluntarily surrendered his medical license in May 2015, admitting that he
prescribed controlled substances for other than legitimate purposes or outside the usual course of
professional practice.
226. In July 2015, the Oklahoma State Board of Medical Licensure and Supervision
revoked G.H.’s license after an evidentiary hearing finding that, among other things, G.H.
engaged in the “indiscriminate or excessive prescribing, dispensing or administering of
Controlled or Narcotic drugs.”
6. H.D.: “filling for him is a risk that keeps me up at night”; “our concerns are falling upon deaf ears”
227. H.D. was a doctor who practiced in east Texas.
228. Between at least 2011 and 2017, Walmart pharmacies filled large numbers of
controlled-substance prescriptions written by H.D.
229. H.D.’s prescribing practices and his patients raised numerous red flags identified
in Walmart’s own policies and by DEA, including, among others, questionable or repeated drug
combinations or “cocktails,” excessive quantities of controlled substances, cash-paying patients,
and requests for early refills.
230. Beginning no later than 2014, Walmart pharmacists reported to Walmart’s
compliance unit that H.D. was likely a pill-mill doctor and even enumerated, in writing, the
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unresolved red flags associated with his prescribing practices.
231. On February 10, 2014, a Walmart employee emailed a Walmart Market Health
and Wellness Director stating that another pharmacy, and possibly Walgreens as well, were
“refusing all prescriptions” from H.D. That same day, the email was forwarded to a senior
employee with Walmart’s compliance unit in Bentonville, Arkansas. The Market Health and
Wellness Director stated that the pharmacist brought up “a good point” and asked: “If our
competitors will not fill for them, should we stop as well?” The senior employee from
Walmart’s compliance unit responded that Walmart leaves fill decisions to the pharmacists’
“professional judgment” and that Walmart continued “to look at new ideas.”
232. Beginning in at least February 2014, Walmart employees received—and relayed
to Walmart’s compliance unit—numerous warnings that DEA was investigating H.D.’s
prescribing practices.
233. On November 23, 2014, an assistant manager at the pharmacy at Store 975 in
Durant, Oklahoma, emailed a fellow Walmart employee explaining that “the corporate offices of
Target and Kroger have told their pharmacists that they are not allowed to fill [controlled
substances] from [H.D.] at all period.” (Emphasis added.) The assistant manager stated that
Kroger’s “corporate offices sent out a letter saying that they weren’t to fill for him due to some
legal issues being investigated with his practice and prescribing and they didn’t want their
pharmacists ‘put at risk’ filling these medications that were not needed and overdosing of his
patients.” (Emphasis added.)
234. On February 5, 2015, a Walmart pharmacy manager in Sherman, Texas, sent an
email to a Walmart senior director in pharmacy operations, explaining the concern that H.D.
“may be a pill mill.” The email identified concerning red flags about H.D.’s prescribing
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practices, including that he booked patients ten minutes apart, most patients paid with cash, and
he refused to answer calls from the pharmacy with questions about prescriptions.
235. The next day, a pharmacy manager from Store 147 in Denison, Texas, sent an
email to Walmart’s compliance unit about H.D.—copying employees from other Walmart
pharmacies—explaining that the situation “has gotten worse,” that she and other pharmacists
“are all concerned about our jobs and about filling for a pill mill doctor,” that her understanding
was that other chain pharmacies were refusing to fill prescriptions issued by H.D., and that “I am
in my 29th year with [W]almart and have never had a situation this bad with a doctor.” The
email was then forwarded to B.N., a director in the compliance unit.
236. In an email on February 6, 2015, another Walmart employee at Store 147
commented that at least some of H.D.’s prescriptions were not legal and that “[f]illing for him is
a risk that keeps me up at night.” Other emails reporting that Walmart pharmacists believed that
H.D. was a pill-mill doctor were sent or forwarded to multiple employees at Walmart’s
compliance unit.
237. Despite the many reports from Walmart pharmacists about H.D.’s egregious
prescribing patterns, the compliance unit prohibited those pharmacists from refusing to fill
H.D.’s prescriptions as a blanket matter. On December 23, 2014, a pharmacy manager at Store
147 emailed Walmart’s compliance unit regarding H.D. and explained that H.D. was “under
investigation by the DEA” and that “Walmart is getting slammed with [Schedule II controlled
substances] and other control [sic] substances from” him. She further explained that “Target,
Walgreens, Kroger, Medicine Shoppe will not honor prescriptions from” H.D. B.N. responded
the next day, explaining, in part, that “[b]eing under investigation is simply a red flag to consider
when using your professional judgment” and that “an investigation of itself is not a good reason
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to discontinue filling legitimate prescriptions.” B.N. stated, “[r]emember we are not allowed to
blanket refuse to fill for any prescriber.” In response, another Walmart pharmacist emailed,
stating that while she preferred “to go through the proper channels in situations like this, … it
seems as if our concerns are falling upon deaf ears.” She warned: “This situation is serious and I
am considering contacting the Medical Board/DEA/DPS on my own.”
238. Despite all the reports of unresolved red flags, Walmart filled controlled-
substance prescriptions written by H.D. for at least three more years.
239. Between February 10, 2014, and March 12, 2017, Walmart pharmacists not only
identified red flags associated with H.D.’s prescriptions, but repeatedly appealed to Walmart’s
compliance unit to address their concerns. But during that period, despite Walmart’s knowledge
of red flags indicating a very high probability that H.D. regularly issued invalid prescriptions for
controlled substances, Walmart filled approximately 14,700 controlled-substance prescriptions
(an average of over 13 such prescriptions per day) written by H.D., amounting to over 1,500,000
dosage units. Among many others, Walmart filled the following prescriptions written by H.D.
during this period:
• Over 4,800 hydrocodone prescriptions;
• Over 1,170 alprazolam prescriptions;
• Over 1,200 oxycodone prescriptions;
• Over 800 morphine prescriptions; and
• Over 550 fentanyl prescriptions.
240. From 2011 through 2017, approximately 180 different Walmart pharmacies filled
controlled-substance prescriptions written by H.D. H.D.’s practice remained in Texas during this
period, while these Walmart pharmacies were located in approximately 143 different towns or
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cities across 21 different states.
241. On July 6, 2017, a federal grand jury indicted H.D. for CSA violations and other
federal crimes. H.D. was later convicted and, in May 2019, was sentenced to 20 years in prison.
242. On July 20, 2017, based on the indictment, the Texas Medical Board temporarily
suspended H.D.’s medical license “after determining his continuation in the practice of medicine
pose[d] a continuing threat to public welfare” because of the “alleged pattern of practice which
includes prescribing dangerous controlled substances with a risk of abuse and diversion for no
legitimate medical purpose[.]”
7. J.F.: Prescriber of very heavy doses
243. J.F., an internal medicine doctor, practiced in Silver City, New Mexico.
244. Walmart pharmacists identified, and reported to the compliance unit, unresolved
red flags about J.F.’s prescribing, including J.F.’s prescriptions for a highly abused combination
of an opioid, a benzodiazepine, and carisoprodol. A pharmacist at Store 4341 in Truth or
Consequences, New Mexico, attempted without success to resolve the red flags raised by a
prescription for customer T.A. by calling J.F.’s office. The pharmacist reported in a refusal-to-
fill form that the pharmacist had called to “confirm the use of Opio[i]d/Soma/Xanax together and
discussed the cocktail abusive behavior requested by many patients.” J.F.’s staff thanked the
pharmacist for bringing the matter to their attention but cancelled the Xanax order, without
offering any legitimate medical purpose for the drugs.
245. Nonetheless, the same pharmacy at Store 4341 that had refused to fill the
“cocktail” of drugs prescribed by J.F. for T.A. dispensed an opioid, a benzodiazepine, and
carisoprodol to T.A. on the same day or one day apart, doing so each month from July through
October 2014 and in April and May 2015. Based on the failure of J.F.’s office to provide a
medical justification for this combination for T.A., these prescriptions were invalid.
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246. Walmart pharmacists also saw that J.F.’s patients engaged in pharmacy and
doctor shopping. As early as December 10, 2013, a pharmacist at Store 1357 in Silver City, New
Mexico, refused to fill one of J.F.’s prescriptions because, as the pharmacist reported to the
compliance unit in a refusal-to-fill form, the patient was “traveling from Las Cruces to see a Dr
in Silver City” and the “PMP shows [the patient] is getting narcotics from multiple doctors and
filling at multiple pharmacies.” Nine days later, the pharmacist refused to fill another
prescription for a different patient because, as the pharmacist reported in a refusal-to-fill form,
the “PMP showed [the patient] filling at multiple pharmacies and by multiple doctors” and
“[u]pon questioning [the patient] revealed he lives in Arizona.” The pharmacist submitted
additional refusal-to-fill forms for J.F.’s prescriptions in 2014, 2015, and 2016 that reported
more instances of pharmacy and doctor shopping by J.F.’s patients.
247. At least seven Walmart pharmacists from six pharmacies in New Mexico
submitted refusal-to-fill forms between December 2013 and April 2016 reporting their inability
to resolve red flags raised by J.F.’s prescriptions, including that his patients sought early refills,
were pharmacy and doctor shoppers, and were suspected of using the drugs for other than
legitimate medical purposes.
248. In May 2016, the New Mexico Medical Board summarily suspended J.F.’s license
after its investigation revealed egregious conduct reflecting an abandonment of the legitimate
practice of medicine. Some of the findings the Board stated in its Notice of Summary
Suspension were that J.F. prescribed large dosages of opioids to 680 patients in 2015 alone;
prescribed controlled substances to patients from nine states outside New Mexico; prescribed a
highly abused combination of controlled substances that is “known to cause fatal drug
interactions when prescribed together”; ignored evidence that his patients were abusing and/or
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diverting controlled substances; and prescribed multiple controlled substances to a patient who
died as “the direct result of toxic effects” from the drugs that J.F. had prescribed. To resolve this
action, J.F. voluntarily surrendered his medical license in May 2017.
249. From December 2013, when Walmart pharmacists informed the compliance unit
that J.F’s patients were seeking early refills and were engaged in pharmacy and doctor shopping,
through May 2016, Walmart—despite its knowledge of red flags indicating a very high
probability that J.F. regularly issued invalid prescriptions for controlled substances—filled more
than 15,000 controlled-substance prescriptions written by J.F., including more than 400 paid for
in cash and more than 250 involving a patient from a different state than J.F. and/or the
pharmacy.
8. J.I.: A “known pill-mill doctor”
250. J.I. was a pain management doctor in Clearwater, Florida.
251. As early as 2013, several Walmart pharmacists alerted Walmart’s compliance
unit, through refusal-to-fill forms, that J.I.’s prescribing practices were alarming.
252. From June 2012 through July 2015, Walmart’s compliance unit received more
than 100 refusal-to-fill forms about J.I. and learned that J.I. prescribed opioids in excessive
amounts and in dangerous combinations with other opioids, amphetamines, benzodiazepines, and
muscle relaxers.
253. Refusal-to-fill forms submitted in 2014 repeatedly warned Walmart’s compliance
unit that J.I.’s prescribing practices were “questionable.” For example, a pharmacist at Store
1712 in Largo, Florida, reported in a refusal-to-fill form dated April 3, 2014, that J.I. was a
“known pill-mill doctor” and then reported in August 2014 that she was a “MILL PILL DR
[sic].”
254. Walmart pharmacists also alerted Walmart’s compliance unit that J.I. had a public
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history of actions taken against her by regulatory authorities based on improper controlled-
substance prescribing. In July 2013, April 2014, and July 2015, three different pharmacists in
three different Florida Walmart pharmacies refused to fill prescriptions issued by J.I. The
pharmacists reported on the forms that J.I. had “previous issues with dea,” that she was a “very
questionable doctor who has been investigated and suspended previously,” and that there were “3
complaints under prescriber’s license for CII [Schedule II controlled substances] prescribing.”
Specifically, DEA had revoked J.I.’s registration in 2006 after she prescribed controlled
substances to three undercover law enforcement officers who had admitted to her that they
actually were not suffering from any pain. Her registration later was restored, but she was
required for a period of one year to provide DEA with monthly reports about her controlled-
substance prescriptions. In three separate administrative complaints filed in 2013, the Florida
Department of Health alleged that J.I. prescribed excessive and/or inappropriate amounts of
opioids without adequate justification.
255. Walmart’s compliance unit did not provide any of this information to its
pharmacists, who continued to fill prescriptions written by J.I. From July 2013 through March
2017, despite Walmart’s knowledge of red flags indicating a very high probability that J.I.
regularly issued invalid prescriptions for controlled substances, Walmart dispensed more than
8,000 controlled-substance prescriptions written by J.I., including more than 1,000 that were paid
for in cash and more than 100 that raised significant red flags on the face of the prescription
based on their dangerous combinations.
256. J.I. pleaded guilty in September 2018 to federal healthcare fraud charges,
admitting that she wrote prescriptions, including prescriptions for controlled substances, in the
name of certain individuals but then gave the prescriptions to their family members, never
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having seen or examined the individuals J.I. knew would be the ultimate users of the drugs. She
was sentenced to six months of imprisonment and permanently surrendered her medical license
and DEA registration.
9. M.L.: “continually writes for high quantities of narcotics”
257. M.L. was a nurse practitioner who practiced at a pain clinic in Colorado Springs,
Colorado.
258. In September 2013, a Walmart pharmacist at Store 3582 in Colorado Springs
reported M.L.’s inappropriate prescribing to Walmart’s compliance unit. The pharmacist faxed
an M.L. prescription to Walmart’s compliance unit and submitted a refusal-to-fill form
explaining that M.L. “continually writes for high quantities of narcotics.” The rejected
prescription was for a huge amount: 600 tablets of oxycodone 30mg, providing up to 20 tablets
per day, which exceeded a daily limit set by Walmart as a computerized “edit” that alerted
pharmacists when a certain threshold was exceeded.
259. Walmart pharmacists repeatedly reported that, when M.L. was contacted about
problematic prescriptions, he failed to justify the prescriptions.
260. On March 6, 2015, a Walmart pharmacist at Store 3582 in Colorado Springs
refused to fill an oxycodone 30mg prescription after speaking with someone in M.L’s office who
was able to provide only “nonspecific” answers to questions about the existence of a treatment
plan or the consideration of treatment options for the patient. But it does not appear that
Walmart provided any alert to other pharmacies about this refusal to fill. And just three days
later, on March 9, a nearby Walmart pharmacy at Store 4335 in Falcon, Colorado, dispensed 360
tablets of oxycodone 30mg for the same patient based on a prescription from M.L.
261. Two months later, in May 2015, a Walmart pharmacist at Store 3582 in Colorado
Springs spoke with M.L. by telephone, informing him that three Walmart pharmacists were
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uncomfortable filling a prescription for the same patient due to the high quantity of oxycodone
30mg (15 tablets per day). M.L. failed to offer any justification, but responded simply “ok.” By
May 2015, Walmart already had filled five of M.L.’s prescriptions for oxycodone 30mg for this
same patient, and each prescription was for a very large amount of oxycodone—300 to 360
tablets, which would allow the patient to take 8 to 12 tablets every day for 30 days.
262. Between November 2013 and March 2016, despite Walmart’s knowledge of red
flags indicating a very high probability that M.L. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 5,000 controlled-substance prescriptions issued
by M.L. Of those 4,000 prescriptions, more than 400 were for dangerous combinations,
including prescriptions for two immediate-release opioids simultaneously or close in time and
prescriptions for dangerous and abused “cocktails” of drugs.
263. M.L. had received a January 2013 admonition by the Colorado State Board of
Nursing for prescribing “excessive” dosages of OxyContin (a brand name of oxycodone) that
were inconsistent with the patient’s underlying condition. According to the letter of admonition,
the letter became a permanent public portion of M.L.’s record.
264. In January 2017, M.L. surrendered his nursing license and prescribing authority to
settle a disciplinary action related to his prescribing habits. He admitted that his treatment plans
for 12 of 12 chart-audited patients were “inappropriate,” and that he had continued opioid
therapy in cases where the patient was not benefitting and despite a patient’s violation of an
opioid agreement. He also admitted that his documentation was “substandard,” in part because it
failed to explain his increases in opioid therapy.
10. M.M.: A “known pill mill” who sent his patients to Walmart
265. M.M., a doctor in Orlando, Florida, was arrested in June 2010 in “Operation Pain
Killer,” as reported in the local press, and charged with illegal trafficking of a dangerous
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combination of controlled substances (hydrocodone, oxycodone, carisoprodol, and alprazolam).
He pleaded nolo contendere in February 2013 to an amended charge of racketeering based on the
attempted delivery of hydrocodone.
266. M.M. also faced disciplinary action by the State of Florida. Florida’s Department
of Health filed multiple administrative complaints in October 2011 and an amended complaint in
April 2013, all related to his illegal prescribing habits under the guise of practicing medicine.
The allegations included that he prescribed excessive amounts of the highly abused “cocktail” of
oxycodone, Soma, and Xanax; prescribed controlled substances without following standard
practices such as regular urine screens; and prescribed combinations and quantities without
medical justification. He also allegedly let a patient choose her own drugs, wrote prescriptions
knowing the patient’s intent to distribute the drugs, and lied in his medical records to falsely state
that a patient suffered from pain.
267. Because the Florida Department of Health records were public, Walmart’s
compliance unit learned about the disciplinary action in September 2012. That month, a
Walmart pharmacist at Store 943 in Winter Park, Florida, discovered the Department of Health
complaints and reported in a refusal-to-fill form on September 24, 2012, that M.M. had “several
complaints” on file with the “dept of health.”
268. Walmart’s compliance unit also was aware of M.M.’s criminal conviction just a
few weeks after M.M.’s plea. On February 23, 2013, a pharmacist at Store 5106 in Oviedo,
Florida, reported, in a refusal-to-fill form, M.M.’s arrest and plea to racketeering. The
pharmacist also reported in the form that he had rejected an oxycodone-acetaminophen
prescription written by M.M. This refusal was included in a spreadsheet summary that was sent
to B.N., a senior manager in the compliance unit, in April 2013. A Senior Director of Quality
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Improvement and Clinical Services was copied on the email and suggested in May 2013 to a
Senior Director of Health and Wellness Practice Compliance that they discuss the list of refusals.
269. The same pharmacist who had reported M.M.’s arrest in February 2013 rejected at
least 10 additional prescriptions between March 2013 and June 2016, each time citing the
criminal action in a refusal-to-fill form. Other Walmart pharmacists also reported M.M.’s
criminal charges in refusal-to-fill forms and described him as suspicious.
270. During this same period, even after Walmart pharmacists had informed the
compliance unit of M.M.’s criminal conviction and pending Department of Health complaints,
Walmart continued to fill thousands of M.M.’s prescriptions.
271. M.M. also failed to justify the medical purpose of a prescription when contacted
by a Walmart pharmacist. On October 1, 2014, M.M. spoke with a pharmacist at Store 890 in
Orlando, Florida, who had refused a prescription for Tylenol # 4 (a brand name of
acetaminophen/codeine phosphate 300/60mg). When the pharmacist explained that the patient
spoke with slurred speech and already was on tramadol and Fioricet (a brand name drug
containing acetaminophen, butalbital, and caffeine), M.M. did not justify his prescription, as he
should have if rejection would deprive the patient of medically necessary medication. Instead,
according to the refusal-to-fill form, the “doctor stated it would be my call” after the pharmacist
explained the reasons she was refusing to fill the prescription.
272. In October 2015, a pharmacy associate suggested to the compliance unit that
Walmart had violated its CSA dispensing obligations by filling M.M.’s prescriptions. The
associate reported in an email that the pharmacy in Store 4142 in Orlando had filled 43
prescriptions for Schedule II drugs written by M.M. in less than three months, describing him as
a “known pill mill” and citing one of the three Department of Health administrative actions that
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were then pending. The associate “believe[d] this is something that should be looked into before
the DEA comes knocking on our door.” The associate’s email was sent or forwarded to a Market
Health and Wellness Director, a Corporate Compliance Director, a Controlled Substances
Director, and B.N., also a Director of Corporate Compliance.
273. M.M.’s prescribing habits were so clearly outside the usual course of professional
practice that Walmart pharmacists were told that non-Walmart pharmacies had stopped filling his
prescriptions. On January 22, 2016, a pharmacist at Store 2881 in Kissimmee, Florida, reported
in a refusal-to-fill form that a patient had asked the pharmacist where he could go to fill the
prescription. The patient said that M.M. had instructed him not to take his prescription to Publix,
Target, Walgreens, or Winn Dixie, but said that “[another pharmacy chain] and Walmart were
ok.” Even after being told that Walmart’s major competitors were refusing M.M.’s
prescriptions, Walmart filled more than 850 prescriptions from M.M.
274. The above-described reports are just a small sample of all the egregious red flags
reported by Walmart pharmacists, who repeatedly told the compliance unit that M.M. wrote
prescriptions for illegitimate purposes, without a valid doctor-patient relationship, for
inappropriate therapies and excessive quantities, and for a high percentage of controlled
substances. The pharmacists also reported other red flags related to his patients, who were
doctor and pharmacy shoppers, paid in cash, or sought early refills, and some of whom presented
to pharmacies appearing intoxicated.
275. M.M. ultimately declined to contest the allegations in the three administrative
complaints against him, leading to his voluntary relinquishment of his medical license, effective
April 2016.
276. The volume of refusal-to-fill forms also reflected the consistently egregious
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nature of M.M.’s prescribing practices. Walmart’s compliance unit received approximately 200
refusal-to-fill forms from Walmart pharmacists at approximately 45 different pharmacies
between July 2012 and June 2016.
277. From June 26, 2013, through August 2016, despite Walmart’s knowledge of red
flags indicating a very high probability that M.M. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 8,000 controlled-substance prescriptions written
by M.M. Of those, more than 1,350 were paid for in cash.
11. M.N-A.: “many DEA red flags present”
278. M.N-A. was a neurologist in Charleston, West Virginia.
279. In two refusal-to-fill forms submitted in July 2015, Walmart pharmacists reported
that non-Walmart pharmacies near Walmart Store 2036 in South Charleston, West Virginia, had
stopped filling M.N-A.’s prescriptions.
280. One of those refusal-to-fill forms also reported many other red flags raised by
M.N-A.’s prescriptions: “There were many DEA red flags present which led us to turning the
script away such as patient traveling a long distance to the pharmacy, duplication of prescribing
habits from physician, patient trying to force the pharmacy to fill the prescription and acting in
an [un]usual manner.” One of the customers told the Walmart pharmacist that “Rite Aid, Kroger
and Larry’s Pharmacy” would not fill her prescription. A Rite-Aid pharmacist also spoke
directly with a pharmacist at the South Charleston store and reported that Rite-Aid had stopped
filling for M.N-A.
281. One of the refusals by a Walmart pharmacist in July 2015 was for a Norco
10/325mg (a brand name of hydrocodone-acetaminophen 10/325mg) prescription for patient
V.C. Despite the red flags noted by Store 2036, another Walmart pharmacy in South Charleston,
Store 6457, filled M.N-A.’s prescriptions for V.C. for hydrocodone-acetaminophen 10/325mg
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every month from August 2015 through May 2016.
282. By February 2017, a Walmart pharmacist at Store 4278 in Quincy, West Virginia,
reported to Walmart’s compliance unit, including M.J., a director in the compliance unit, that she
had decided that all of M.N-A.’s prescriptions should be refused.
283. From July 2015 through July 2018, despite Walmart’s knowledge of red flags
indicating a very high probability that M.N-A. regularly issued invalid prescriptions for
controlled substances, Walmart filled nearly 3,000 controlled-substance prescriptions written by
M.N-A.
284. M.N-A. lost his medical license and was criminally convicted as a result of his
unlawful prescriptions. The West Virginia Board of Medicine began investigating M.N-A. after
11 of his patients died of drug overdoses. In January 2018, M.N-A. resolved that matter by
agreeing to limitations on his prescriptions of opioids, benzodiazepines, and Xanax and agreeing
to terminate his pain management practice. Thereafter, in July 2018, M.N-A. was indicted on
federal drug trafficking charges. That case was resolved when M.N-A. pleaded guilty to
prescribing Schedule II controlled substances without a legitimate medical purpose. In his plea
agreement, M.N-A. agreed to permanently surrender his West Virginia medical license. M.N-A.
and the West Virginia Board of Medicine effectuated the surrender of his license in an amended
consent order filed in August 2020.
12. P.T.: “too many questions regarding the ethics and integrity of this physician”
285. P.T. was an internal medicine doctor practicing in Milford, Delaware.
286. In 2013, pharmacists at Store 1741 in Milford observed that P.T.’s patients
traveled long distances to get pain medications from him. For example, on November 26, 2013,
a pharmacist refused to fill a prescription for oxycodone and methadone based on unresolved red
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flags, explaining, “[p]atient from out of state – never a patient here – Dr. [P.T.] RX-he is not a
pain mgmt specialist – Patient unable to give valid reason for needing Rx’s.” That same day,
another pharmacist at Store 1741 refused to fill a prescription for Percocet 7.5/325mg, citing
unresolved red flags: “Pt is from MD, travel 45 mins to see Dr [P.T.] and was unable to provide
a valid reason why she has to come to DE.” Just a few days later, the same pharmacist refused to
fill an oxycodone 15mg prescription, citing more unresolved red flags: “Pt is from maryland and
have a dr in md but comes to de to see dr [P.T.] for narcotic medicines. Was not able to give me
a valid reason why his other primary care dr can not take care of his pain medicine.”
287. On January 20, 2014, a pharmacist at Store 1741 in Milford refused to fill a
prescription for oxycodone 15mg and identified P.T. as a problem prescriber, writing, “Dr
redflag [sic] he says he is pain mgn but he is not and prescribe[s] large number of narcotis [sic]
in the area.”
288. The very next day, January 21, 2014, a pharmacist from Store 2791 in
Georgetown, Delaware, reported in her refusal-to-fill forms that she refused to fill four
oxycodone 15mg prescriptions from four different P.T. patients. In each instance, she reported,
“I have questions about the ethics and integrity of this physician as well as his doctor patient
relationships and prescribing for a legitimate health need.”
289. The patients continued to arrive at Store 2791, and the same pharmacist refused to
fill on numerous other occasions. Eventually, she expanded her explanation for refusing one of
P.T.’s prescriptions, reporting, “I have too many questions regarding the ethics and integrity of
this physician. I have concerns about his doctor patient relationships as well as prescribing for a
legitimate health need. Red Flags: not pain management and most Rx written for oxycodone 15
mg and methadone 10 mg for same qt and sig. Also, Rx did not have quantity spelled out as
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required by law. I let the patient know this as he may have problems filling elsewhere.”
290. Despite the clear identification of many unresolved red flags, Walmart continued
to fill for P.T. until his DEA registration was surrendered for cause in November 2014. For
instance, even after Store 1741 identified P.T. as a “red flag” in January 2014, that pharmacy
alone—despite Walmart’s knowledge of red flags indicating a very high probability that P.T.
regularly issued invalid prescriptions for controlled substances—filled over 150 controlled-
substance prescriptions written by P.T., and all Walmart pharmacies filled over 1,000 controlled-
substance prescriptions written by P.T.
291. In June 2018, a federal grand jury indicted P.T. for unlawful distribution and
dispensing of controlled substances. P.T. is awaiting trial.
13. R.K.: Filling prescriptions from this “pill mill” was “putting pharmacists and Walmart in a bad situation legally”
292. R.K. was a doctor of osteopathic medicine who practiced in Mt. Carmel and
Shamokin, Pennsylvania.
293. In 2013 and 2014, Walmart pharmacists at Store 2481 in Coal Township,
Pennsylvania, refused to fill prescriptions written by R.K., noting in their refusal-to-fill forms
numerous unresolved red flags including therapeutic duplication, R.K.’s writing two
prescriptions for the same drug for the same individual four days apart, a patient’s residing about
60 miles from R.K.’s location, early refills, cash payment, and a large number of controlled-
substance prescriptions in a 30-day time period.
294. On September 23, 2016, a Walmart pharmacist at Store 2481 emailed a Walmart
Health and Wellness Director to raise her concerns about R.K., explaining that he “prescribes for
oxycodone 30 mg in amounts of 150 [tablets], oxycodone 20 mg 150 [tablets] at a time,
oxycodone 10 mg for 360 [tablets], Percocet 5/325 for 240 [tablets] routinely, Percocet 10/325
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for 240 [tablets] at a time and norco 5/325 and 10/325 always over 120 [tablets], Xanax 0.5 mg
and 1 mg always over 120 [tablets], and adipex and Adderall are usually written together for the
same person.” Additionally, “[t]hrough the pdmp we find him giving multiple rxs to the same
patient for the same drug and they are using different pharmacies.” The pharmacist highlighted
that “[t]wo pharmacies in town will no longer accept his rxs for narcotics.” This email was
forwarded up the Walmart corporate chain, including to M.J., a director in the compliance unit.
295. Despite these unresolved red flags, within the next two weeks Walmart filled
prescriptions for some of the exact drugs, in large quantities, that the Walmart pharmacist had
said were typical for R.K., including 150 tablets of hydrocodone-acetaminophen 10/325mg
(brand name Norco) for one individual, 240 tablets of oxycodone-acetaminophen 5/325 (brand
name Percocet) for another, and 270 tablets of alprazolam (brand name Xanax) for a third
individual.
296. On September 30, 2016, a Walmart pharmacy manager at Store 2535 in Saint
Clair, Pennsylvania, emailed a Market Health and Wellness Director to inform her that R.K. “is
currently under investigation by the DEA for what we believe is a pill mill operation.” The
pharmacy manager wrote that “Rite Aid has sent him a blanket denial letter.” The pharmacy
manager further expressed his belief that “if we continue to accept [R.K.’s] prescriptions we are
putting pharmacists and Walmart in a bad situation legally as the levels are beyond normal
usage.” As a result, he asked Walmart to “consider following suit with blanket denial to protect
everyone involved.” His request to institute a blanket denial was rejected when the Market
Health and Wellness Director forwarded his email to M.J., a director in the compliance unit, and
asked for guidance. The director’s instructions for the pharmacist were to consider each of
R.K.’s prescriptions individually.
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297. Despite the numerous warning signs, Walmart, including its pharmacy in Coal
Township, Pennsylvania, continued to fill thousands of R.K.’s prescriptions. Since January 1,
2015, Walmart—despite its knowledge of red flags indicating a very high probability that R.K.
regularly issued invalid prescriptions for controlled substances—dispensed over 8,000
controlled-substance prescriptions written by R.K. Over 5,000 of those prescriptions were
dispensed by Store 2481 in Coal Township, where pharmacists had raised warnings about R.K.
in 2013 and 2014.
298. Ultimately, in December 2017, a federal grand jury indicted R.K. in a 19-count
indictment charging, among other things, the unlawful distribution and dispensing of controlled
substances, including violations of federal drug laws resulting in the death of five patients. R.K.
is awaiting trial.
14. R.M.: Prescriptions “are likely not prescribed for ethical purposes”
299. R.M. was a family medicine doctor who practiced in the Miami, Florida, area.
300. On January 2, 2014, a Walmart pharmacist at Store 1590 in Hialeah, Florida (near
Miami), refused to fill multiple prescriptions from R.M., each time explaining that R.M.’s
prescribing was “questionable.” Several months later, this pharmacist refused to fill a
prescription because R.M. was “prescribing typical cocktail and consistent pattern of prescribing
with all prescriptions brought to pharmacy.”
301. R.M.’s patients did not attempt to fill his prescriptions only in the Miami area.
They fanned out across the United States, presenting Walmart pharmacies with red-flag
prescriptions in many different states. In some cases, Walmart pharmacists refused to fill R.M.’s
prescriptions, recognizing that the distances his patients traveled were an unresolved red flag.
For example, on January 2, 2014, a Walmart pharmacist at Store 2931 in Salisbury, Maryland,
refused to fill one of R.M.’s prescriptions, writing that the “rx is from a doctor in Florida. There
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are several instances [where] Rxs came from Florida [and] were misused.” The following
month, in February 2014, a Walmart pharmacist at Store 1072 in Tifton, Georgia, refused to fill
an R.M. prescription, reporting in the refusal-to-fill form unresolved red flags including, among
other things, that the patient had acted erratically and changed her story multiple times. Then, in
November 2014, a Walmart pharmacist at Store 159 in Columbia, Missouri, refused to fill a
prescription written by R.M. because “[p]atient is from Kentucky, doctor from Florida, reason to
believe that patient and doctor do not have legitimate relationship.”
302. Nevertheless, many Walmart pharmacies continued to fill R.M.’s prescriptions,
including pharmacies in Alabama, Arizona, Arkansas, Colorado, Connecticut, Delaware,
Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Minnesota, Mississippi,
Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma,
Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.
303. Walmart’s dispensing of R.M.’s prescriptions outside of Florida did not reflect
isolated incidents. For example, from July 2014 until October 2015, Walmart pharmacies in
Utah dispensed 250 Schedule II controlled-substance prescriptions written by R.M., the majority
of which were for oxycodone 30mg, the highest strength available. Between December 2013
and July 2015, Walmart pharmacies in Missouri dispensed 67 Schedule II controlled-substance
prescriptions, again the majority of which were for oxycodone 30mg. And from June 2014 until
November 2015, Walmart pharmacies in Arkansas dispensed 55 of R.M.’s Schedule II
controlled-substance prescriptions—39 of those for oxycodone 30mg.
304. On June 24, 2015, a Walmart pharmacist at Store 1828 in Plover, Wisconsin,
emailed a Market Health and Wellness Director, providing a “list of patients from Kentucky that
have been visiting pharmacies in all of central Wisconsin recently.” The employee explained
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that the patients “are bringing in prescriptions from [R.M.] in Hialeah, FL … for Oxycodone
30mg, Percocet, Diazepam and Methadone.” The pharmacist concluded, “[t]his is just an alert of
our assumptions that these prescriptions are likely not prescribed for ethical purposes.”
(Emphasis added.) The email was shared with a Walmart director in the compliance unit.
305. In November 2015, a federal grand jury indicted R.M. for violations of federal
controlled-substance laws.
306. Despite Walmart’s knowledge of red flags indicating a very high probability that
R.M. regularly issued invalid prescriptions for controlled substances, Walmart filled more than
300 controlled-substance prescriptions written by R.M. from June 2015 through May 2016, six
months after R.M. had been indicted.
307. In June 2020, R.M. pleaded guilty to conspiracy to dispense and distribute
oxycodone.
15. R.P.: “horrendous prescribing practices”; “customers that were under the influence tell me that this doctor will write whatever they want”
308. R.P. was a family medicine doctor in Orlando, Florida.
309. No later than August 2012, Walmart pharmacists had begun to report to
Walmart’s compliance unit, in refusal-to-fill forms, alarming concerns about R.P.’s controlled-
substance prescriptions.
310. For example, in February 2013, a Walmart pharmacist at Store 1374 in Altamonte
Springs, Florida, submitted a refusal-to-fill form warning that R.P. was prescribing “multiple
large quantity rx to patients indiscriminately all c2 [Schedule II controlled substances] or control
only.” A few months later, in May 2013, the same pharmacist submitted more warnings about
R.P. to Walmart’s compliance unit, reporting in refusal-to-fill forms, “do not fill for md” because
of “horrendous prescribing practices” in “an accordion of control scripts.”
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311. In March 2014, a pharmacist at Store 3862 in Holly Hill, Florida, reported having
“several customers that were under the influence tell me that this doctor will write whatever they
want for them except Percocet.” A pharmacist at Store 4332 in Orlando, Florida, likewise
reported in February 2014 that R.P. was prescribing drugs not based on legitimate medical
purposes but to satisfy his patients’ drug habits: “Prescriber[’]s writing for all most [sic] all
patients the medication the patient ask for it.”
312. Many of R.P.’s patients fit a typical pattern of drug seekers who abused or
otherwise diverted the drugs and were not true pain patients. They sought early refills, traveled
long distances, filled multiple prescriptions from multiple prescribers at multiple pharmacies, did
not have a verifiable relationship with R.P., presented forged prescriptions, appeared drugged or
drunk, and/or became agitated or verbally abusive when their prescriptions were refused.
313. Walmart pharmacists submitted to the compliance unit a steady stream of more
than 50 refusal-to-fill forms about R.P. through at least June 2015.
314. Nevertheless, from June 26, 2013, through August 2018, Walmart—despite its
knowledge of red flags indicating a very high probability that R.P. regularly issued invalid
prescriptions for controlled substances—filled over 18,000 controlled-substance prescriptions
written by R.P., including more than 4,000 that were paid for in cash and more than 500 where
the patient was from a different state than R.P. and/or the pharmacy.
315. In March 2018, R.P. was permanently barred by the Florida Board of Medicine
from prescribing Schedule I through IV controlled substances; treating any patients for chronic
non-malignant pain; and owning, operating, or working at any pain management clinic. The
administrative complaint leading to the disciplinary action alleged that R.P. had prescribed
controlled substances, including fentanyl, not in the course of professional practice to a patient
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who died in 2013 of an overdose from fentanyl toxicity.
16. R.W.: Prescribed “cocktails” and recommended patients fill at Walmart
316. R.W. was a medical doctor who practiced primarily in McKinney, Texas.
317. No later than 2014, Walmart pharmacy managers had notified Walmart’s
compliance unit, in emails, of alarming, unresolved red flags about R.W.’s prescriptions.
Between February and December 2014, three different pharmacy managers at Store 5311 in
McKinney, Texas; Store 4906 in McKinney, Texas; and Store 147 in Denison, Texas, reported to
various Walmart managers in the compliance unit, including B.N., that R.W.’s prescribing habits
had become so concerning that non-Walmart pharmacies in the area had stopped filling his
prescriptions and that R.W. was telling his patients to fill their prescriptions at Walmart. In
December 2014, one Walmart pharmacy manager reported that four competing pharmacy chains
had implemented corporate blocks on filling R.W.’s prescriptions and that three other competing
pharmacy chains and three independent pharmacies would fill a prescription from R.W. only
after taking additional steps to verify the validity of a prescription.
318. A Walmart pharmacist at Store 947 in Sherman, Texas, reported in a February
2014 refusal-to-fill form that one of R.W.’s patients had attempted to fill a prescription for a drug
“cocktail” 20 days early. The patient claimed that his medication had been stolen in a car
accident, but the police, whom the pharmacist contacted, could not confirm that claim.
319. From February 2014 through November 2016, despite Walmart’s knowledge of
red flags indicating a very high probability that R.W. regularly issued invalid prescriptions for
controlled substances, Walmart filled more than 9,000 controlled-substance prescriptions written
by R.W. Of the more than 9,000 prescriptions from R.W. that Walmart filled, more than 700
were paid for in cash.
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320. Many of these controlled-substance prescriptions were alarming, as confirmed by
a Walmart pharmacy employee who was interviewed by DEA agents in December 2016, when a
search warrant was executed at the pharmacy in Store 206 in McKinney, Texas. The employee
observed that the number of R.W.’s prescriptions filled by her pharmacy had significantly
increased from 2014 to 2016, while competitor pharmacies had stopped filling R.W.’s
prescriptions. She stated that she had observed multiple red flags in R.W.’s prescribing habits:
prescriptions for “cocktails” of drugs that she knew were abused, high-dose opioids for long
periods of time, and excessive quantities of opioids. She also stated that she believed several of
R.W.’s patients did not need the medications for medical purposes, based on their disruptive
behavior, including their complaints that they could not get early refills and their demands that
they needed their medications “NOW!”
321. A pharmacist who also was interviewed during the same DEA search told DEA
agents that, in retrospect, she would not have filled several of R.W.’s prescriptions. She
admitted to continuing to fill his prescriptions despite the concerns triggered by the number of
the prescriptions he wrote for the same “cocktail” of drugs, the number of individuals who
traveled long distances to get their prescriptions filled at her pharmacy, and the fact that other
area pharmacies had stopped filling R.W.’s prescriptions.
322. R.W. was later convicted on federal drug-trafficking charges stemming from his
prescriptions for three controlled substances that comprise a commonly abused “cocktail,” which
were issued outside the usual course of professional practice and without a legitimate medical
purpose. R.W. pleaded guilty and was sentenced in February 2018 to 10 years of imprisonment.
17. S.K.: “there is no way that many 25 year olds need 120 to 240 oxycodone per month”
323. S.K. was a medical doctor who practiced in New Bern, North Carolina.
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324. As early as March 2013, Walmart pharmacists emailed Walmart’s compliance
unit to report that S.K.’s prescribing patterns were alarming. A Walmart pharmacist at Store
1300 in New Bern, North Carolina, spoke to and then emailed a Market Health and Wellness
Director seeking guidance because “SOP [standard operating procedure] is not enough-they
assure patient relationship and provide diagnosis codes, but there is no way that many 25 year
olds need 120 to 240 oxycodone per month.” Because of S.K.’s egregious prescribing patterns,
the pharmacist reported that four competitor pharmacies in the area were no longer accepting
S.K.’s prescriptions because they questioned whether there was a “legitimate medical need.”
The email was sent to a senior director of corporate compliance in the Health and Wellness
Division, and then to B.N., a senior manager in the compliance unit, who responded by simply
citing the company’s refusal-to-fill policy.
325. S.K. began sending patients to more distant pharmacies when local pharmacies
started rejecting his prescriptions. Walmart’s compliance unit learned about this troubling
practice of S.K. in refusal-to-fill forms submitted by Walmart pharmacists between August 2013
and October 2013. In August 2013, a pharmacist at Store 3864 in Jacksonville, North Carolina,
about 35 miles from New Bern, reported that a customer said S.K. had “told him to come to our
particular store.” The next month, a pharmacist at Store 1236 in Goldsboro, North Carolina,
more than 50 miles from New Bern, reported that the patient had “let it slip that Walgreens
refused to fill the rx” before the patient presented it to Walmart. And in October 2013, a patient
admitted to a Walmart pharmacist in Havelock, North Carolina, about 20 miles from New Bern,
that “other pharmacies will not fill for this doc[t]or either.”
326. In another clear sign that S.K. was not operating a legitimate medical office, a
Walmart pharmacist at Store 3825 in Havelock, North Carolina, reported in an October 2013
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refusal-to-fill form that S.K.’s office was not open during the day for pharmacists to call for
verification. S.K. was, however, available late at night and answered his own phone to validate
prescriptions.
327. A Walmart pharmacist at Store 3864 in Jacksonville, North Carolina, recognized
that S.K.’s attempts to validate his prescriptions were insufficient because S.K.’s prescribing
practices showed unresolved red flags. In a refusal-to-fill form submitted by that pharmacist in
August 2013, the pharmacist reported S.K. “is always in the office after hours up to 9 PM to
answer the phone himself to say prescriptions are valid.” In addition, the patient had driven a
long way to the pharmacy and had been to four different pharmacies in the preceding five
months.
328. Between July 2013 and July 2015, multiple Walmart pharmacists submitted to the
Walmart compliance unit more than 70 refusal-to-fill forms for S.K., listing a catalogue of
unresolved red flags, including that S.K. prescribed large quantities of opioids, lacked valid
relationships with his patients, and kept odd hours. Other red flags included that some of S.K.’s
patients traveled long distances to fill their prescriptions at Walmart; paid in cash; were hostile,
including one customer who “demand[ed] narcotics,” requiring that security be called; were very
irritable or became upset; and were pharmacy shoppers.
329. In July 2014, Walmart’s compliance unit was again alerted to reports that S.K.
told his patients that other area pharmacies had stopped filling his prescriptions. Specifically, the
pharmacist at Store 3864 reported learning that S.K. “tells his patients that only Wal-Mart will
fill his prescriptions” and “all other pharmacies in the area refuse to fill for this prescriber.”
330. About 40 percent of S.K.’s controlled-substance prescriptions were paid for in
cash, another red flag of abuse.
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331. From June 26, 2015, through June 2016, Walmart—despite its knowledge of red
flags indicating a very high probability that S.K. regularly issued invalid prescriptions for
controlled substances—dispensed more than 1,000 controlled-substance prescriptions written by
S.K.
332. S.K. was arrested in June 2016 on federal drug-trafficking charges arising from
his opioid prescriptions. He was convicted of numerous federal felony charges, including five
counts of unlawful prescribing of oxycodone outside the scope of professional practice and
without a legitimate medical purpose, and in September 2020, was sentenced to 20 years of
imprisonment.
18. V.S.: A “shady doctor” who “writes only controlled medications for every patient”
333. V.S. practiced as a gynecologist in Bradenton, Florida.
334. As early as December 2013, a Walmart pharmacist at Store 528 in Bradenton
filled out a refusal-to-fill form alerting Walmart’s compliance unit to V.S.’s high-risk prescribing
practices, declining to fill a prescription for oxycodone and methadone because the patient was
also on Xanax, which in combination with oxycodone and methadone created a “high risk of
respiratory depression.”
335. In 2014, several Walmart pharmacists alerted Walmart’s compliance unit to
concerns about V.S.’s prescribing practices. On a refusal-to-fill form submitted in April 2014, a
Walmart pharmacist at Store 1171 in Sarasota, Florida, noted the unusual fact that V.S. was a
gynecologist working at a pain clinic. In May 2014, the same pharmacist submitted a refusal-to-
fill form reporting that V.S.’s therapies did not appear to be individualized and that V.S. “writes
only for c-2’s,” that is, only for Schedule II controlled substances. Similarly, in June 2014,
another pharmacist reported that V.S. “writes only controlled medications for every patient
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seen.” In September 2014, a third pharmacist submitted a refusal-to-fill form describing V.S. as
a “[s]hady doctor.”
336. Walmart pharmacists further reported that some of V.S.’s patients presented as
drug-seekers rather than legitimate pain patients. For example, a Walmart pharmacist at Store
3474 in Bradenton reported in January 2014 that two customers, who were “slurring their words
and showed signs of drug seeking behavior/narcotic abuse,” arrived together, one with a
prescription from V.S. for oxycodone, methadone, Soma, and Valium, a “cocktail of abuse,”
according to the pharmacist, and the other saying that he also had his medications filled at that
pharmacy.
337. Between January and July 2014, Walmart pharmacists from two different Florida
pharmacies reported in refusal-to-fill forms that V.S.’s patients appeared “impaired,” “glassy
eyed,” “possibly intoxicated,” or “possibly inebriated,” or they slurred their speech.
338. Despite the alarming and unresolved red flags identified in these reports, Walmart
pharmacies continued to fill large numbers of V.S.’s controlled-substance prescriptions. During
the period from January 2014 through January 2018, Walmart—despite its knowledge of red
flags indicating a very high probability that V.S. regularly issued invalid prescriptions for
controlled substances—filled more than 3,500 of V.S.’s controlled-substance prescriptions,
including more than 600 prescriptions paid for in cash.
339. V.S. let his Florida medical license expire in January 2018. In May 2018, a
Walmart employee in the compliance unit was notified that V.S. no longer held a state license to
practice medicine or an active DEA registration.
19. W.W.: A “pill mill prescriber” for “drug-seekers”
340. W.W. was a doctor who practiced in Fort Myers, Florida.
341. Beginning in 2013, pharmacists at multiple Walmart stores reported egregious
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and obvious signs that W.W. was operating a pill mill, as his prescriptions raised red flags that
Walmart pharmacists identified and could not resolve.
342. In May 2013, a pharmacist at Store 3417 in Naples, Florida, reported, in a refusal-
to-fill form submitted to Walmart’s compliance unit, obvious signs that W.W. was operating a
pill mill: “History with patients from this office – we get frequent calls seeking this medication
[oxycodone 30mg], daily nagging, patients arriving in car loads, hysteria at drop off, patients
sitting in parking lot waiting for FedEx to come; will not fill from this office anymore ….” Later
in 2013, the pharmacy in Store 3417 repeatedly reported, in refusal-to-fill forms, the store’s
problems with “drug-seekers” coming from W.W.’s office in the “same car at same time for
same meds.”
343. A pharmacist from another Walmart pharmacy, Store 5321 in Fort Myers, Florida,
reported that W.W. was a pill-mill doctor whose prescriptions should not be filled. Three
different pharmacists working at this pharmacy submitted a total of at least six refusal-to-fill
forms between July 2013 and February 2015 reporting that W.W. was “running a pill mill,” was
known for doing so, and was “well reputed for over prescribing C-2 narcotics.”
344. In December 2013, yet another Walmart pharmacy, located in Store 5391 in
Naples, Florida, reported that W.W. was a “know[n] pill mill prescriber in the [F]ort [M]yers
area.” A pharmacist working at Store 5391 had submitted a refusal-to-fill form earlier that year,
in June 2013, reporting the details showing that W.W. was running a pill mill: W.W. accepted
only cash; he engaged in pattern prescribing, once for large quantities of oxycodone until he
switched to hydromorphone; and he deployed a “newer technique” of splitting prescriptions in
half to “give the appearance of smaller quantities being dispensed.”
345. Pharmacists from Stores 3417 and 623 reported in at least four refusal-to-fill
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forms in 2013 that W.W. “continually prescribes narcotics [and] not much else,” and that his
patients were doctor and pharmacy shoppers, some of whom appeared “sever[e]ly impaired and
high.”
346. By March 2014, a pharmacist from yet another Walmart pharmacy, located in
Store 987 in Fort Myers, Florida, had concluded that W.W. “does not prescribe for purposes that
I feel are legit[i]mate.”
347. The Tennessee Board of Medical Examiners revoked W.W.’s medical license on
January 30, 2014, as a result of his failure to supervise nursing staff in what the board described
as “egregious prescribing habits” related to controlled substances. W.W.’s licenses to practice
medicine in Colorado, Kentucky, and Florida were later suspended or revoked.
348. By December 2014, Walmart’s compliance unit knew from a refusal-to-fill form
submitted by Store 3417 in Naples, Florida, that W.W.’s license had been suspended by two
states “due to mishandling of controlled substances.” The same pharmacy reported the same red-
flag information in January 2015.
349. From June 2013 through June 2015, Walmart—despite its knowledge of red flags
indicating a very high probability that W.W. regularly issued invalid prescriptions for controlled
substances—filled more than 700 of W.W.’s prescriptions. Of those prescriptions, about 100
were filled from January through June 2015, after Walmart’s compliance unit was informed in
December 2014 of the suspension of W.W.’s medical license in two states.
20. Z.B.: A “questionable” prescriber sending patients to fill at Walmart
350. Z.B. was an anesthesiologist who operated a pain management clinic in Tampa,
Florida.
351. Walmart pharmacists repeatedly informed Walmart’s compliance unit, through
refusal-to-fill forms, of unresolved red flags indicating that Z.B.’s patients were not legitimate
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pain patients. As early as December 2013, a Walmart pharmacist at Store 959 in Bushnell,
Florida, reported Z.B. in a refusal-to-fill form as a “questionable” prescriber, after rejecting a
prescription for oxycodone and morphine sulfate.
352. In particular, Walmart pharmacists reported to Walmart’s compliance unit that
Z.B.’s patients appeared to be pharmacy shoppers who brought prescriptions to Walmart because
other pharmacies would not fill their prescriptions. For example, a pharmacist from Store 959
reported on a refusal-to-fill form that the individual was “travelling long distance to get rx filled”
and “says local pharmacies doesn[’]t want to fill his rx.”
353. Walmart pharmacists reported to the compliance unit, in at least four additional
refusal-to-fill forms submitted in 2014 and 2015 from Store 959, that multiple individuals for
whom Z.B. had written prescriptions traveled long distances to the Bushnell pharmacy to get
their prescriptions filled.
354. Refusal-to-fill forms submitted from other Walmart pharmacies in 2013 and 2014
similarly alerted Walmart’s compliance unit that individuals whose controlled-substance
prescriptions were issued by Z.B. were seeking out Walmart pharmacies to fill those
prescriptions. For example, one form noted that a Z.B. patient had admitted to a Walmart
pharmacist at Store 1245 in Lakeland, Florida, that he was pharmacy shopping. The patient
explained that although he lived in Ocala, Florida, and went to a doctor in Tampa, Florida—
about 85 miles away—he had come to get his prescription filled in Lakeland on the
recommendation of a friend. Pharmacists in Orlando and Ocala also encountered Z.B. patients
who had “passed many pharmacies” on the way to fill their prescriptions at Walmart.
355. Between January 2014 and April 2017, Walmart—despite its knowledge of red
flags indicating a very high probability that Z.B. regularly issued invalid prescriptions for
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controlled substances—dispensed more than 3,000 controlled-substance prescriptions written by
Z.B., including more than 500 prescriptions paid for in cash and more than 100 dispensed to a
patient from a different state than Z.B. and/or the pharmacy.
356. Z.B. is awaiting trial on federal charges that he caused the dispensing of
controlled substances (specifically, oxycodone, methadone, morphine, oxymorphone, and
alprazolam) without a legitimate medical purpose and outside the usual course of professional
practice.
C. Walmart filled many prescriptions showing, on their face, such glaring red flags that its pharmacists would have known that the prescriptions had a very high probability of being invalid.
357. Walmart pharmacists also dispensed numerous controlled-substance prescriptions
exhibiting, on their face, red flags—including the dose or amount prescribed, combination of
drugs, or prescribing pattern—that Walmart pharmacists would have recognized as indicating a
high probability that the prescriptions were invalid. But on numerous occasions, Walmart
pharmacists filled the prescriptions without resolving the red flags. For example, Walmart’s
compliance unit found repeatedly that prescriptions showing obvious red flags had been filled
with no documentation by the pharmacist that the red flags had been resolved. Upon information
and belief, this failure by Walmart pharmacists to resolve obvious red flags and document the
resolution before filling the prescription occurred frequently, as Walmart pharmacists were
subject to enormous pressure to fill prescriptions extremely quickly—as more fully set forth
above in paragraphs 115 through 122 above—and received little training before 2018 on how to
handle prescriptions raising red flags.
358. Walmart’s compliance unit did not take steps that ensured that its pharmacists
identified red flags on the face of prescriptions. Walmart had the ability in its software to set
computerized “edits” that could alert pharmacists to aspects of a prescription that showed
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obvious red flags. But Walmart’s compliance unit did not design its system to automatically
alert pharmacists to the red flags described below.
359. Moreover, as set forth below, on occasions when Walmart pharmacists did take
note of one of the red flags discussed below, the pharmacists concluded that the red flag was not
resolvable, i.e., that the prescriptions should be rejected without further inquiry because the
prescriptions could not have been issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of professional practice.
1. Red Flag No. 1: Dangerous combinations of opioids
360. As trained pharmacists were aware, and as Walmart itself recognized in POM
1311 (2015), prescriptions can show obvious red flags on their face when they are “presented in
a combination that can cause medical complications” or are “for an unusually large quantity or
high starting dose.”
361. One combination that presented obvious red flags, but that Walmart pharmacists
repeatedly filled, was prescriptions for multiple immediate-release opioids. Immediate-release
opioids (in contrast to extended-release or long-acting opioids) release the drugs more quickly
into the bloodstream and generally have a shorter analgesic effect than extended-release drugs.
Pharmacists would recognize an obvious red flag when multiple prescriptions for immediate-
release opioids were presented at the same time or sufficiently close in time that the supplies
would have overlapped.
362. Walmart pharmacists filled different varieties of these duplicative prescriptions on
the same day or close in time. For example, they filled prescriptions for as many as three
immediate-release opioids, prescriptions for two different strengths of immediate-release
oxycodone, and prescriptions for both oxycodone and hydromorphone (another immediate-
release opioid).
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363. By filling duplicative prescriptions for multiple immediate-release opioids,
Walmart dispensed, in some cases, opioids that had a sum total morphine milligram equivalent
(“MME,” a measure of the potency of a dose of opioids) that reached dangerous levels. These
prescriptions thus raised the same concern that Walmart acknowledged in POM 1311 (2015)
when it included prescriptions for unusually large quantities as a red flag.
364. Some Walmart pharmacists correctly concluded that duplicative prescriptions for
multiple immediate-release opioids could and should be rejected without further inquiry. For
example, in June 2013, one Walmart pharmacist refused to fill a prescription written by
prescriber R.P. for Norco 10/325 (a brand name of hydrocodone-acetaminophen 10/325mg
tablets) and Percocet 10/325 (a brand name of oxycodone-acetaminophen 10/325mg) because
“both are immediate release and should not be taken together.”
365. In April 2015, another Walmart pharmacist, located in Oklahoma, refused to fill a
prescription for an immediate-release opioid (oxycodone 15mg) because the individual already
had filled another prescription for a different immediate-release opioid. As the pharmacist
explained in a refusal-to-fill form, the individual had “already filled an rx for 180 [tablets of]
[o]xycodone 30mg at another pharmacy.” The pharmacist commented, “I don’t know a reason to
be on both.”
366. These pharmacists recognized that taking multiple drugs that had the same
purpose carried medical risks and that substantially all of the corresponding prescriptions were
invalid. Nevertheless, between June 2013 and June 2018, Walmart pharmacists filled thousands
of prescriptions for multiple immediate-release opioids on the same day or close in time, in some
cases for not only two but three or more immediate-release drugs. Moreover, Walmart
pharmacists filled many of these multiple-opioid combinations where additional red flags were
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present, including that (i) the prescribing patterns continued for multiple months and (ii) the
prescriptions were written by problem prescribers (including one or more of those discussed
above).
367. As an example, for customer J.R., Walmart dispensed three different types of
immediate-release oxycodone (oxycodone in strengths of 15mg, 20mg, and 30mg) every month
from April to September 2013, including twice in May 2013. All of those prescriptions were
written by G.H., whose pill-mill prescribing is discussed above. The same Walmart pharmacy
dispensed all of those drugs to J.R., almost always at the same time. At times, J.R.’s average
daily MME was well over 300, more than three times the MME recommended by the Centers for
Disease Control (“CDC”) in all but the most extreme cases.
368. Walmart pharmacists also repeatedly filled prescriptions for both immediate-
release oxycodone 30mg (the highest strength available for immediate-release oxycodone) and
immediate-release oxycodone 15mg at the same time or close enough in time that there was
significant overlap and, in some cases, did so for multiple months for the same individual.
369. One of the individuals who received this type of duplicative therapy was D.S.
Walmart dispensed to D.S. 168 tablets of oxycodone 30mg and 168 tablets of oxycodone 15mg
on the same date, nearly every month, from August 2015 until December 2017. In other words,
over this period, Walmart dispensed a total of 5,208 tablets of oxycodone 30mg and 5,208 tablets
of oxycodone 15mg to D.S. If taken as directed on the prescriptions, these drugs produced a
total daily MME of 405—more than four times the recommended CDC maximum in all but the
most extreme cases.
370. As another example, for customer D.W., a Walmart pharmacy in Arkansas
dispensed oxycodone 30mg (126 to 222 tablets) and oxycodone 15mg (84 to 148 tablets) nearly
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every month from January through August 2015. D.W.’s prescriptions were written by an
Oklahoma prescriber, J.R. J.R. issued prescriptions for the same duplicative opioids (oxycodone
15mg and 30mg) to two other individuals as well; Walmart filled those prescriptions for at least
three months in a row.
371. For other individuals, Walmart pharmacists repeatedly filled prescriptions that
were for two different opioids, but nonetheless were duplicative because both drugs were
immediate-release. For example, Walmart pharmacists filled prescriptions for both immediate-
release oxycodone and immediate-release hydromorphone and, in many cases, for the highest
strength available for both medications (30mg in the case of oxycodone and 8mg for
hydromorphone).
372. These prescriptions not only were duplicative but also combined a powerful
opioid, oxycodone, with an even more powerful one, hydromorphone. One milligram of
hydromorphone equates to four MME. By comparison, one milligram of oxycodone equates to
one-and-a-half MME.
373. As an example, for customer K.R., Walmart filled more than 20 prescriptions for
hydromorphone 8mg and 20 prescriptions for oxycodone 30mg over a 12-month period. K.R.
routinely received prescriptions for these two drugs from the same Walmart pharmacy on the
same day. All of those prescriptions were written by M.L., whose problematic prescribing is
described above. Furthermore, the quantities dispensed were extraordinarily large: at times, had
K.R. been taking both drugs as prescribed, K.R.’s daily MME would have exceeded 1,000—
more than 10 times the CDC maximum in all but the most extreme cases. In total, over this
period, Walmart dispensed 3,960 tablets of oxycodone 30mg and 4,624 tablets of
hydromorphone 8mg to K.R.
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374. All told, from June 2013 forward, Walmart pharmacists filled thousands of
prescriptions for these dangerous combinations of immediate-release opioids. Walmart
pharmacists would have known that substantially all of these prescriptions they filled created
dangerously duplicative immediate-release opioid combinations and were invalid.
375. Another opioid combination that trained pharmacists recognized as raising
obvious red flags on their face was a combination of an immediate-release opioid and
methadone, another powerful opioid.
376. Methadone is generally a longer-acting drug. Compared to an immediate-release
opioid, it generally takes longer for the user to feel its effects, but those effects may last longer.
For this reason, when taken in combination with an immediate-release opioid, methadone can be
particularly dangerous; its long-acting properties may lead the user to take higher amounts of
immediate-release opioids to achieve the desired euphoria or painkilling effects in the short term,
but the long-term depressive effects of methadone can lead to excessive respiratory depression
and death when combined with the effects of another opioid.
377. At least one Walmart pharmacist concluded that prescriptions for this
combination present an unresolvable red flag. In January 2014, a Walmart pharmacist in
Bradenton, Florida, refused to fill a prescription for oxycodone and methadone written by
prescriber V.S. because “[m]ethadone should not be taken with other opioids or with
benzodiazepines per pain management guidelines and per gold standard [due to] high risk of
respiratory depression.” The same pharmacist, working in a pharmacy in Sarasota, Florida,
refused to fill a prescription for Dilaudid (a brand name of hydromorphone) and methadone
written by prescriber F.T. (whose problematic prescribing is described above) in March 2014 for
the same reason: “Inappropriate therapy per pain management guidelines, it is not recommended
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to take methadone with other opioids [due to] high risk of respiratory depression.”
378. Other Walmart pharmacists nonetheless repeatedly filled prescriptions for both an
immediate-release opioid and methadone at the same time or close in time. In some instances,
Walmart filled these prescriptions for months. In many cases, Walmart pharmacists filled the
highest strength available in methadone (10mg), as well as the highest strength available in the
immediate-release opioid (for example, oxycodone 30mg).
379. By way of example, for customer C.B., Walmart dispensed at least 240
methadone 10mg tablets plus at least 108 oxycodone 30mg tablets every month from June 2017
to July 2018. The same Walmart pharmacy dispensed all of those drugs to C.B. and always
dispensed the methadone and oxycodone together.
380. On the same day that Walmart dispensed those dangerous combinations to C.B.,
the same Walmart pharmacy dispensed the same dangerous combinations—in the same quantity
and days’ supply, and based on prescriptions written by the same prescriber—to M.B., who
shared the same last name as C.B. and, according to Walmart’s own data, lived at the same
address.
381. Similarly, during a four-year period from February 2013 through February 2017,
and based on prescriptions written by H.D. (whose problematic prescribing is discussed above),
Walmart frequently dispensed to customer T.S. 200 or more tablets of methadone 10mg and 100
or more tablets of oxycodone 30mg, which resulted in a combined average of at least 950 MME
per day if T.S. took those quantities of drugs together. In November 2013 alone, a Walmart
pharmacy dispensed 690 opioid pills to T.S., all in the highest strength available. Specifically,
that Walmart pharmacy filled two separate prescriptions for 225 tablets of methadone 10mg and
two separate prescriptions for 120 tablets of oxycodone 30mg during that one month.
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382. The doses and quantities of opioid painkillers that Walmart regularly dispensed to
T.S. from February 2013 to February 2017 appear generally too high for any one person to take,
and therefore strongly suggest the pills were being diverted to persons other than T.S. Walmart
also dispensed some of those Schedule II drugs early—including eight or more days early on at
least two occasions—which further indicates the high probability that those prescriptions were
being diverted to others.
383. All told, from June 2013 forward, Walmart pharmacists filled thousands of
prescriptions comprising this dangerous opioid-methadone combination. Hundreds of those
prescriptions were paid for in cash, and hundreds more were dispensed to individuals who were
from a different state than the prescriber or pharmacy. Walmart pharmacists would have known
that substantially all of these prescriptions were invalid.
2. Red Flag No. 2: Dangerous “cocktails” of opioids and non-opioids
384. Certain combinations of different types of medications present red flags. As
trained pharmacists were aware, and as Walmart itself recognized in POM 1311 (2015), red flags
include prescriptions “that represent a ‘cocktail’ of commonly abused drugs.” A compliance unit
director explained in an internal email in February 2016 that “[a] cocktail is a red flag that should
alert the [pharmacist] to use their professional judgment to refuse to fill the [prescription].”
385. These combinations included not only duplicative opioids, but also other
dangerous combinations including an opioid and other, non-opioid “potentiator” drugs—that is,
drugs that increased the euphoric effect brought on by opioids, but that also increased the risk of
abuse and overdose. These dangerous opioid/non-opioid “cocktails” signaled abuse and
indicated that substantially all of these particular prescription combinations were illegitimate.
386. Walmart pharmacists filled thousands of prescriptions that fall into four distinct
“trinity” categories of combinations of opioid/non-opioid prescriptions that on their face
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presented an obvious red flag as to the prescriptions’ validity. Each category was known to be
popular among individuals who were abusing or misusing prescription drugs.
387. The classic trinity. First, Walmart pharmacists repeatedly filled prescription
drug cocktails consisting of (a) an opioid; (b) a benzodiazepine; and (c) the muscle-relaxer
carisoprodol (brand name Soma). This combination, sometimes referred to as the “classic
trinity,” had been described in DEA administrative decisions as early as 2008. Specifically, the
three drugs taken together produce enhanced euphoric effects beyond the effect of the individual
drug. For similar reasons, however, the classic-trinity combination creates a heightened risk of
overdose and death.
388. Walmart pharmacists filled many of these “classic trinity” drug cocktails when
the three drugs were filled either at the same time or with significant overlap and where
additional red flags were present, including, among other things, (i) where a significant supply
was prescribed for each drug; and (ii) when the filling pattern for the combination continued for
multiple months.
389. Some of these “classic trinity” prescriptions also were written by problem
prescribers, such as those described above. By way of example, S.F. was a patient of J.I., whose
problematic prescribing and pill-mill activity are described above. Pharmacists at Store 1712 in
Largo, Florida—the same pharmacy that identified J.I. as a “MILL PILL DR [sic]”—dispensed
“classic trinity” cocktails to S.F. based on prescriptions from J.I. nearly every month for three
years between February 2014 and February 2017. More than half of the time, Walmart
dispensed both 120 pills of hydrocodone-acetaminophen 10/325mg (i.e., Vicodin) and 60 pills of
morphine sulfate extended release, in addition to the potentiating benzodiazepines and muscle
relaxers.
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390. Another instance involved a “classic trinity” prescription written by J.F., whose
problematic prescribing is described above. A pharmacist at Store 4341 in Truth or
Consequences, New Mexico, dispensed an opioid, a benzodiazepine, and carisoprodol to
customer T.A. on the same day or one day apart each month from July through October 2014 and
in April and May 2015, based on prescriptions written by J.F.
391. The zolpidem trinity. Second, Walmart pharmacists repeatedly filled a different,
but similarly dangerous, combination, sometimes referred to as the “zolpidem trinity,” consisting
of (a) an opioid, (b) a benzodiazepine, and (c) the sedative zolpidem (brand name Ambien). The
“zolpidem trinity” is dangerous because the addition of a sedative to two other central-nervous-
system depressants may lead to accidental overdose.
392. As with the “classic trinity,” Walmart pharmacists filled many of these “zolpidem
trinity” combinations where additional red flags were present, including, among other things, (i)
when such prescriptions were filled either at the same time or with significant overlap, (ii) when
a significant supply was prescribed for each drug, or (iii) when the filling pattern for the
combination continued for multiple months.
393. Some of these “zolpidem trinity” prescriptions were also issued by problem
prescribers, such as those described above. By way of example, from August 2013 to March
2014, Walmart dispensed to customer T.H. “zolpidem trinity” cocktails every month. Those
cocktails—all of which were prescribed by H.D., whose pill-mill activity is described above—
invariably comprised 120 tablets of oxycodone 30mg, the highest strength of immediate-release
oxycodone available; 120 tablets of alprazolam 1mg (i.e., Xanax), the second-highest strength of
immediate-release alprazolam available; and 30 tablets of 10mg zolpidem (i.e., Ambien), the
highest strength of immediate-release zolpidem available. Each month that Walmart dispensed
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those trinity combinations, the same store also gave T.H. 180 tablets of hydrocodone-
acetaminophen 10/325mg (i.e., Vicodin). In five of the eight months, Walmart also dispensed 60
tablets of morphine sulfate extended-release 60mg. In other words, every month for eight
straight months, Walmart gave T.H. 300-360 opioid pills in addition to two potentiating drugs
that increase the risk of abuse and overdose.
394. The stimulant trinity. Third, Walmart pharmacists repeatedly filled a similarly
dangerous drug cocktail sometimes referred to as the “stimulant trinity” or “blackout trinity,”
consisting of (a) an opioid, (b) a benzodiazepine, and (c) a stimulant. The “stimulant trinity” is
dangerous, given that the effects of the stimulant may lead the user to overdose on the opioid
and/or the benzodiazepine in an effort to achieve the desired euphoria.
395. Walmart pharmacists repeatedly filled “stimulant trinity” cocktails under
circumstances where additional red flags were present, including, among other things, (i) when
such prescriptions were filled either at the same time or with significant overlap, (ii) where a
significant supply was prescribed for each drug, or (iii) when the filling pattern for the
combination continued for multiple months.
396. For example, for customer K.C., Walmart dispensed a “stimulant trinity” every
month between March and May 2014, then again almost every month between May 2016 and
April 2017. Those cocktails invariably comprised 120 tablets of oxycodone 30mg, 45 tablets of
clonazepam 2mg, and 30 tablets of amphetamine-dextroamphetamine 30mg. The same Walmart
pharmacy filled all of those prescriptions, frequently on the same day or within a few days of one
another. In addition, that same Walmart pharmacy also gave K.C. a second opioid every month.
397. Similarly, for customer J.H., Walmart dispensed a “stimulant trinity” every month
from January 2015 to July 2015, all based on prescriptions written by S.L. All of the trinity
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combinations that Walmart provided to J.H. were dispensed either on the same day or within a
few days of one another, and were often accompanied by additional tablets of extended-release
oxycodone 80mg (specifically, for the brand OxyContin). With only two exceptions, all of those
pills were dispensed from the same Walmart pharmacy.
398. Another of S.L.’s patients, H.T., received so many opioids, benzodiazepines,
stimulants, and sedatives from Walmart between April 2014 and June 2015 that H.T. could make
multiple trinity combinations with them nearly every month. There was no apparent legitimate
medical need for all of the pills that Walmart dispensed to H.T., and the likely explanation is
diversion to other individuals. That Walmart pharmacists, on multiple occasions, dispensed the
Schedule II drugs seven or more days early further indicates the invalidity of the prescriptions
and supports the inference of diversion.
399. Walmart pharmacists recognized the risks presented by the trinity combinations.
A pharmacist at Walmart Store 63 in Wagoner, Oklahoma, refused to fill an oxycodone 30mg
prescription on February 19, 2015, because the “dosage and quantity [was] inap[p]ropriate for
chronic pain management.” The pharmacist also recognized from the information that was
available through Walmart’s computer system that individual H.T. also had prescriptions for
“Soma, Adderall, Ambien, Tramadol, MS Contin, and Xanax,” which in combination with the
oxycodone, were “potentially dangerous,” including possibly leading to “CNS [central nervous
system] depression.”
400. Nevertheless, four days later, on February 23, 2015, a Walmart pharmacist at
Store 374 in Coweta, Oklahoma, filled an oxycodone 30mg prescription that was written on
February 18, 2015, dispensing 480 tablets to H.T., enough for H.T. to take 16 tablets every day
for 30 days.
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401. The trinity plus. Fourth, Walmart pharmacists repeatedly dispensed a drug
cocktail consisting of (a) two or more different immediate-release opioids (including different
strengths of the same opioid); (b) a benzodiazepine; and (c) either carisoprodol or zolpidem.
This “trinity plus” combination creates many of the same risks of abuse or overdose as the other
“trinity” combinations, but with the addition of another opioid, has an increased risk of abuse,
overdose, or death.
402. Walmart pharmacists repeatedly dispensed “trinity plus” drug cocktails under
circumstances where additional red flags were present, including, among other things, (i) when
the four drugs were filled either at the same time or with significant overlap; (ii) where a
significant supply was prescribed for each drug; or (iii) when the filling pattern for the
combination continued for multiple months.
403. In addition, “trinity plus” prescriptions were written by problem prescribers. By
way of example, in 2017, for customer C.J., Walmart filled prescriptions for a “trinity plus”
combination in May, twice in June, and once more in July. Those combinations—which were
written by a prescriber whose prescriptions over the years presented what one Walmart
pharmacist described as “unresolvable red flags”—invariably included 120 tablets of oxycodone
30mg; 60 or more tablets of hydromorphone 2mg; 90 tablets of lorazepam 1mg; and 60 tablets of
carisoprodol 350mg, some of which were paid for in cash even though C.J. was covered by
Medicaid.
404. As another example, nearly every month from November 2014 until December
2015, Walmart filled prescriptions for a patient of Oklahoma prescriber J.R. for 30 tablets of
zolpidem 10mg, 60 to 90 tablets of alprazolam 2mg, 120 tablets of oxycodone 15mg or 30mg,
and 120 tablets of a second opioid—oxycodone-acetaminophen 10/325mg.
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405. Similarly, Walmart filled, on a monthly basis, the zolpidem trinity “plus”
prescriptions for T.G. of Arkansas from April through December 2014. Specifically, each month
Walmart dispensed two opioids—240 tablets of oxycodone 30mg and 240 tablets
hydromorphone 40mg, totaling 488 MME per day; 120 tablets of diazepam 10mg; and 30 tablets
of zolpidem 10mg. These prescriptions were written by prescriber H.T. of Missouri, for whom
such cocktails were not uncommon. A Walmart pharmacist in Joplin, Missouri, refused to fill
prescriptions written by H.T. because, among other things, she “routinely writes for a ‘cocktail’
of commonly abused drugs or combo that can cause medical complications” and she “writes for
large doses of controlled substances.”
406. More recently, Walmart filled the classic trinity for customer K.M., including two
opioids (oxycodone 15mg and hydrocodone-acetaminophen 10/325mg) each month from March
until August 2017 and then again from November 2017 until June 2018. These prescriptions
were all written by Missouri prescriber P.G.
407. All of these trinity prescriptions, on their face, presented significant red flags that
a Walmart pharmacist would have recognized as indicating that the prescription was not issued
for a legitimate medical purpose or in the usual course of medical practice. Walmart pharmacists
would have known that substantially all of the prescriptions they filled to create dangerous trinity
and “trinity plus” combinations were invalid.
408. All told, from June 2013 forward, Walmart pharmacists filled thousands of
prescriptions comprising these dangerous trinity combinations, many of which presented
additional red flags of abuse or other diversion. Hundreds of them, for instance, were paid for in
cash, and hundreds more were dispensed to patients who were from a different state than the
prescriber and/or pharmacy.
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3. Red Flag No. 3: Repeated fills of very high dosages of opioids
409. As trained pharmacists were aware, and as Walmart recognized in POM 1311
(2015), certain prescriptions presented red flags if they were “for an unusually large quantity or
high starting dose.” Walmart pharmacists often reported in refusal-to-fill forms that
prescriptions for high dosages were a red flag.
410. Nevertheless, for some individuals, Walmart pharmacists repeatedly filled
prescriptions for extraordinarily high dosages of potent opioids. For many of those individuals,
each opioid prescription resulted in average daily MME many times higher than the CDC-
recommended maximum of 90 MME in all but the most extreme cases. In fact, for numerous
individuals, Walmart dispensed such high quantities of high-strength opioids that the average
daily MME across the opioid prescriptions filled by the individual at Walmart exceeded 800
MME.
411. Such high dosages and quantities of opioids are needed only extremely
infrequently and are highly unlikely to be prescribed in the usual course of professional treatment
except in the treatment of terminal illness. As a result, these prescriptions, on their face,
presented an obvious red flag.
412. By way of example, on 16 separate occasions from March 2014 to September
2014, Walmart gave customer M.P. 1,500 tablets of hydrocodone-acetaminophen 10/300mg for a
16-day supply—enough for M.P. to take 93 pills per day. Walmart filled all those prescriptions
even though each of those prescriptions was written by H.D. (whose pill-mill conduct is
described above) and gave M.P. a massive average daily MME of 937, more than 10 times the
maximum CDC recommendation in all but the most extreme cases.
413. Similarly, from December 23, 2013, to January 9, 2014, Walmart gave customer
S.C. 765 tablets of hydrocodone-acetaminophen 7.5/325mg plus 236 tablets of hydrocodone-
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acetaminophen 7.5/500mg plus 180 tablets of hydrocodone-acetaminophen 10/325mg. Put
simply, a single Walmart pharmacy dispensed 1,181 opioid pills to S.C. over the course of only
18 days. On December 23, 2013, alone, Walmart gave S.C. 236 tablets of hydrocodone-
acetaminophen 7.5/500mg for a two-day supply—enough pills for S.C. to take 118 per day.
Given the risk of acetaminophen toxicity or opioid overdose, it is not physically possible to take
that many tablets of hydrocodone-acetaminophen 7.5/500mg in such a short period. Walmart
dispensed the drugs anyway.
414. For customer D.M., Walmart dispensed excessive quantities of not just one, but
three, potent opioids. Specifically, every month from December 2014 to September 2015,
Walmart gave D.M. 30 fentanyl 100mcg/hr patches plus 450 methadone 10mg pills plus 328 to
480 oxycodone 30mg pills. The methadone alone was enough to give D.M. an average daily
MME of 1,800, and yet the same Walmart store that dispensed those massive quantities of
methadone also gave D.M. fentanyl (an extremely potent opioid) and the highest strength of
immediate-release oxycodone available.
415. All told, from June 2013 forward, Walmart pharmacists filled numerous high-
MME prescriptions, many of which presented additional red flags of abuse or other diversion.
For instance, some of them were paid for in cash, and many more were dispensed to individuals
who were from a different state than the prescriber and/or pharmacy. In addition, many of these
prescriptions were written by some of the problematic prescribers described above.
416. Thus, Walmart pharmacists would have known that substantially all of the very
high-MME prescriptions they filled were illegitimate.
4. Red Flag No. 4: Schedule IIs filled unusually early
417. As trained pharmacists were aware, when an individual requests to fill a
controlled-substance prescription significantly early, it raises a red flag regarding abuse or other
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diversion because it suggests that the individual is either taking a higher quantity than prescribed
or diverting at least some of the pills to other individuals.
418. Walmart repeatedly filled prescriptions for Schedule II controlled substances
significantly early, well before the individual should have exhausted the previously dispensed
supply from an earlier prescription. These prescriptions were filled so early that they indicate
that Walmart pharmacists would have known that substantially all of them were illegitimate.
419. Because a prescription for a given controlled substance requires the dosage,
quantity, and directions for use, see 21 C.F.R. § 1306.05(a), there is a specific date on which the
supply of drugs dispensed pursuant to that prescription will be exhausted. For example, if a
prescriber prescribes a drug of a particular dose, directs that it be taken six times per day, and
prescribes a total of 180 tablets, the prescription authorizes a 30-day supply of drugs for the
individual. If the individual follows the prescriber’s directions, the 180 tablets will run out on
the 30th day of taking the drugs.
420. Under 21 C.F.R. § 1306.12(a), “the refilling of a prescription for a controlled
substance listed in Schedule II is prohibited.” As a result, a pharmacy may dispense Schedule II
controlled substances only pursuant to a new prescription written for the patient by a prescriber;
it may not refill the earlier prescription. In certain circumstances, prescribers may, on the same
date, issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day
supply of a Schedule II controlled substance, but in doing so, the prescriber must provide
“written instructions” on each prescription “indicating the earliest date on which a pharmacy
may fill each prescription.” 21 C.F.R. § 1306.12(b)(1).
421. In either case, when an individual requests to fill a prescription well before the
previous supply has been exhausted or before the date that the prescriber has authorized the
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prescription to be filled, it raises a significant red flag that the individual may have been abusing
the drugs by taking more than the directed dose or that the individual has been diverting the
drugs by selling them or otherwise distributing them to others.
422. Walmart has recognized that early refills could signal abuse. In POM 1311
(2015), Walmart recognized that a red flag is present when an “[i]ndividual routinely attempts to
obtain an early refill on controlled substances.” And in at least one communication, one of
Walmart’s corporate compliance managers, B.N., indicated that when there was a pattern of
early refill requests, the pattern may “indicate that the prescription is being used in a manner
other than how the … drug was prescribed.”
423. Furthermore, Walmart had a policy, POM 1318 (2011), that directly addressed
filling controlled substances early. It recognized that “[p]harmacists are … tasked by regulatory
agencies with monitoring for signs of misuse or abuse of medications, in particular controlled
substances,” and indicated that Walmart’s pharmacy management software, Connexus, alerted
pharmacists when requests were made to fill prescriptions more than 72 hours ahead of the next
permitted fill date of a controlled-substance prescription.
424. POM 1318 (2011) required the pharmacist to evaluate “the circumstances for the
request and the patient’s medication and previous refill history.” Furthermore, POM 1318
(2011) stated that “[i]f the pharmacist overrides the warning and allows the refill to go through,
whether the approval was obtained from the prescriber or in the exercise of the pharmacist’s
professional judgment, then Walmart, through the Connexus system, requires the pharmacist to
document the reason for the override.” The policy emphasized that “[i]t is important that
pharmacists thoroughly and accurately document any details associated with their decisions to
override early refill warnings, including any discussions with or approval from the prescriber.”
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425. Some of the prescriptions that Walmart pharmacists filled significantly early were
written by problem prescribers that Walmart knew to be dangerous, including some of the
prescribers described above. Moreover, many of these prescriptions showed additional red flags.
Hundreds of them were paid for in cash, and hundreds more were dispensed to patients who were
from a different state than the prescriber and/or pharmacy.
426. All told, from June 2013 forward, Walmart pharmacists filled thousands of these
early prescriptions. These prescriptions were filled so early that they indicate that Walmart
pharmacists would have known that substantially all of them were illegitimate.
D. Walmart filled many invalid prescriptions that were same or similar to other prescriptions Walmart pharmacists had previously identified as invalid for the same customer.
427. On numerous occasions, Walmart pharmacists filled a controlled-substance
prescription that showed red flags, where the prescription was the same as or similar to a
prescription that another Walmart pharmacist had previously recognized as invalid and had
refused to fill for the same patient. In other words, even when one or more Walmart pharmacists
had recognized that obvious red flags made a prescription invalid, another Walmart pharmacist
filled the prescription or a similar one. Because the prescription had the same or similar red
flags, the pharmacist who filled the prescription would have known that the prescription was
invalid.
428. For example, on February 6, 2014, a pharmacist at Store 528 refused to fill
prescriptions for lorazepam 1mg and oxycodone-acetaminophen 10/325mg because four
different prescribers had been writing prescriptions for the same individual since December—a
red flag that the individual was doctor shopping. The same pharmacy, however, filled those
prescriptions for lorazepam 1mg and oxycodone-acetaminophen 10/325mg less than two weeks
later, on February 17, 2014, and February 20, 2014.
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429. On March 31, 2014, a pharmacist at Store 2459 in Sarasota, Florida, refused to fill
an individual’s prescriptions for methadone 10mg, Dilaudid 4mg, and Valium 10mg after
concluding that the prescriptions were “inappropriate” because they were for high quantities,
and “[p]er pain management guidelines methadone should not be taken with other opioids and
benzodiazepines [due to] high risk of respiratory depression.” The refusal-to-fill form also
stated that the prescriptions were written by a physician who “frequently writes prescriptions for
inappropriate/excessive naroctics [sic].” Nevertheless, the following day, a nearby store in
Bradenton, Florida, Store 528, filled all three prescriptions, dispensing 30 tablets of diazepam
10mg (Valium), 100 tablets of hydromorphone 4mg (Dilaudid), and 150 tablets of methadone
10mg.
430. On April 4, 2014, a Walmart pharmacist at Store 5831 refused to fill a
prescription for hydromorphone 8mg, recognizing that it was an “excessive dos[e]” of a short-
acting opioid. Five days later, on April 9, 2014, a pharmacist at the same store filled that same
prescription for 100 tablets of hydromorphone 8mg.
431. On April 12, 2014, a Walmart pharmacist at Store 2459 refused to fill a
prescription for hydromorphone 4mg. The refusal-to-fill form from Store 2459 explained that
the patient was taking a combination of drugs that “[p]er pain management guidelines … should
not be taken together [due to] high risk of respiratory depression.” The form also noted that “this
physician frequently writes rx’s for very large quantities of narcotics, and is an out of area
physician.” Two days later, a pharmacist at Store 1004 filled that prescription for 150 tablets of
hydromorphone 4mg.
432. On April 14, 2014, a Walmart pharmacist at Store 3370 refused to fill a
prescription for oxycodone 30mg because the individual was taking “a dangerous cocktail of
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medications” and “the red flag and risk of over dose/dependence is high in this situation
esp[ecially] in the addition of high streng[th] narcotics such as oxycodone.” On April 28, 2014,
a pharmacist at the same store filled that prescription.
433. On August 22, 2014, pharmacists at Walmart stores in Inverness and Lecanto,
Florida, refused to fill an MS Contin 60mg prescription for a patient, with the pharmacists
reporting in refusal-to-fill forms that the patient was “pharmacy shopping” and “has been to
numerous pharmacies throughout Florida and has been to doctors from Brandon and Tampa.”
Just three days later, a Walmart pharmacist in Sebring, Florida, filled the same prescription.
434. On February 19, 2015, a Walmart pharmacist at Store 63 in Wagoner, Oklahoma,
refused to fill a prescription for oxycodone 30mg for an individual because the “dosage and
quantity [was] inap[p]ropriate for chronic pain management.” The pharmacist pointed out that
the individual also had prescriptions for “Soma, Adderall, Ambien, Tramadol, MS Contin, and
Xanax,” which in combination with the oxycodone, were “potentially dangerous,” including
possibly leading to “CNS [central nervous system] depression.” Four days later, on February 23,
2015, a Walmart pharmacist in Coweta, Oklahoma, filled that prescription for 480 tablets of
oxycodone 30mg.
435. From at least March 2016 to February 2017, Walmart pharmacists refused to fill
prescriptions from a Wyoming prescriber, D.R.C., where the prescriptions presented obvious red
flags—yet those same prescriptions were subsequently filled by other Walmart pharmacists.
436. In March 2016, a Walmart pharmacist refused to fill a hydrocodone-
acetaminophen 10/325mg prescription written by D.R.C., citing numerous red flags. Despite
these red flags, the pharmacy filled a prescription for the same medication for that individual in
April, June, and August 2016 and filled a very similar prescription in July 2016.
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437. On January 15, 2017, M.J., a Walmart director in the compliance unit, sent an
email to several of her colleagues concerning the large “suspicious order” of oxycodone-
acetaminophen 10/325mg placed by Store 4471 in Rawlins, Wyoming. The email noted that
D.R.C. “[p]rescribes 66% of the Oxycodone/[acetaminophen] 10/325mg dispensed at this
location,” that “93% of the prescriptions” for one particular high-dose opioid were for very high
quantities, and that “[s]everal of [D.R.C.’s] patients are being prescribed a ‘cocktail’ including
an opioid, benzodiazepine and carisoprodol.” At that Walmart pharmacy, a pharmacist
technician and her pharmacy colleagues had a running joke that D.R.C.’s prescriptions were like
fast-food orders: “I need a #1” referred to yet another D.R.C. prescription for hydrocodone.
438. Then, on January 23, 2017, Store 4471 refused a high-dose opioid prescription for
a patient, explaining that D.R.C. “[w]rites prescriptions outside of scope of practice.” Yet, later
that same day, a different pharmacist at Store 4471 dispensed the same medication to the same
patient, and the pharmacy did so again in February and March 2017.
439. Likewise, on February 21, 2017, a pharmacist at Store 4471 refused to fill an
oxycodone-acetaminophen 10/325mg prescription written by D.R.C., explaining that D.R.C.
wrote “prescriptions outside of scope of practice,” and that there was evidence of “pharmacy
shopping.” Six days later, Store 4471 filled this prescription, despite the continued presence of
these red flags.
440. In sum, in the various ways outlined in this Part, Walmart dispensed thousands
upon thousands of prescriptions that its pharmacists would have known were invalid (or had a
very high probability of being invalid), and, by filling these controlled-substance prescriptions
despite the red flags, it also failed to comply with the usual course of professional pharmacist
practice. Each time it did so, it violated its dispensing obligations under 21 C.F.R. § 1306.04(a)
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and § 1306.06.
III. IN ITS ROLE AS A DISTRIBUTOR, WALMART VIOLATED THE CSA.
478. As alleged above, Walmart acted as a distributor of controlled substances,
delivering large shipments to its pharmacies throughout the country. It also violated the CSA at
least hundreds of thousands of times by failing to design and operate a system to detect and
report suspicious orders to DEA.
479. The Attorney General, by regulation, has long required distributors to design and
operate a system to detect suspicious orders of controlled substances, and to report those orders
to DEA. See 21 C.F.R. § 1301.74(b) (“The registrant shall design and operate a system to
disclose to the registrant suspicious orders of controlled substances. The registrant shall inform
the Field Division Office of the Administration in his area of suspicious orders when discovered
by the registrant.”). Suspicious orders “include” orders that are unusual in size, pattern, or
frequency, but are not limited to only those three categories. Id.
480. As explained below, Walmart failed to comply with its obligation under 21 C.F.R.
§ 1301.74(b) and did not report at least hundreds of thousands of suspicious orders.
A. Walmart had access to a wealth of information and data such that it could readily have designed a system to adequately detect suspicious orders.
1. Walmart’s self-distribution to its own pharmacies gave it extensive knowledge and data about dispensing patterns and orders.
481. From 2000 to approximately May 2018, Walmart self-distributed tens of millions
of shipments of controlled substances to Walmart-branded and Sam’s Club-branded pharmacies.
482. Walmart operated at least six distribution centers (“DCs”) that distributed
controlled substances to its pharmacies in the United States: Bentonville, Arkansas (“DC 6045”);
Rogers, Arkansas (“DC 6001”); Tifton, Georgia (“DC 6013”); Crawfordsville, Indiana (“DC
6028”); Hanford, California (“DC 6032”); and Williamsport, Maryland (“DC 6046”). Of these
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distribution centers, only Bentonville (“DC 6045”) distributed Schedule II controlled substances.
483. Throughout the period from 2012 to 2018, Walmart was the largest self-
distributor in the country for oxycodone, hydromorphone, and hydrocodone in terms of both
dosage units and grams.
484. Because Walmart acted as its own distributor, it had access to extensive data and
other information that independent distributors would not ordinarily have.
485. In particular, Walmart had a wealth of dispensing information that gave it the
ability to investigate the circumstances underlying orders for controlled substances. Walmart
had data about individuals who filled controlled-substance prescriptions at its pharmacies, the
identities of the medical providers who were prescribing controlled substances for those
individuals, and reports from its own pharmacists raising concerns.
486. Walmart had access to additional data and other information that it could have
used to inform its decision as to whether an order was suspicious or not, including but not limited
to:
a. instances in which a pharmacist had refused to fill prescriptions written by
particular prescribers;
b. knowledge of “pill mill” prescribers whose patients filled prescriptions at
Walmart pharmacies and the specific controlled substances that they often
unlawfully prescribed to patients;
c. knowledge of Walmart’s own pharmacists, pharmacy managers, and market
directors;
d. the distance between prescribers, patients, and pharmacies;
e. information concerning patients who paid cash for controlled-substance
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prescriptions;
f. drug diversion trends; and
g. previous DEA Form 106 (Theft and Loss) filings.
487. Walmart also had access to distribution-related data and other information,
including but not limited to:
a. the number of bottles of controlled substances that each of its pharmacies had
already ordered in any given week;
b. historical order quantities and patterns;
c. order and shipment history for orders that Walmart pharmacies placed with
independent distributors (e.g., McKesson Corporation and AmerisourceBergen
Corporation), including reports warning when a pharmacy was nearing an
independent distributor’s threshold and information about instances when an
independent distributor had refused to ship the order and reported the order to
DEA as suspicious;
d. orders that had been previously flagged for its pharmacies;
e. analytics concerning each pharmacy’s ratio of controlled-substance purchases to
non-controlled-substance purchases;
f. previous suspicious-order reports for its pharmacies; and
g. prior and current suspicious order monitoring (“SOM”) remediation plans,
discussed below, for its pharmacies.
488. Walmart had the capability to use sophisticated data analytics to enhance and
optimize its pharmacy operations. Walmart has emphasized that it relies on “big data” in its
pharmacy operations to “enhance, customize and optimize the shopping experience” and “to
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make Walmart pharmacies more efficient,” namely by using the data to “help[] the pharmacy
with staff scheduling and to reduce the amount of time it takes a prescription to be filled.”
https://corporate.walmart.com/newsroom/innovation/20170807/5-ways-walmart-uses-big-data-
to-help-customers (last visited December 18, 2020).
489. Although Walmart had the ability to use all this data and other information to
detect suspicious orders, it chose not to do so, as explained in detail in Part III.B below.
490. In addition to all of the data and other information to which Walmart had access,
certain corporate employees had visibility into and control over Walmart’s dispensing and
distribution policies and practices.
491. In September 2015, Walmart created a “Health and Wellness Controlled
Substance Advisory Panel” to oversee “the Health and Wellness Division’s Controlled Substance
Compliance Program (“Program”), which addresses compliance with state and federal laws,
regulations and standards of conduct related to controlled substance dispensing and distribution.”
492. One member of the Controlled Substance Advisory Panel, M.J., was, at times,
responsible for developing both dispensing and distribution policies and practices.
493. Among her many responsibilities, M.J. reviewed “pill mill” prescribers as part of
Walmart’s “prescriber review committee,” modified the refusal-to-fill policy and other policies
related to dispensing, and handled dispensing data.
494. Additionally, M.J. oversaw Walmart’s distribution compliance with respect to
both high-level policy and day-to-day implementation of the SOM program. She was
responsible for executing Walmart’s SOM policies and “developed [a] strategy for a much more
comprehensive program than was initially developed.” And M.J. was one of two people charged
with determining which orders placed by Walmart pharmacies were suspicious and therefore had
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to be reported to DEA.
495. Although Walmart had access to all of this information and its corporate
employees were aware of and had control over both the dispensing and distribution practices,
Walmart failed to use this information and corporate knowledge in its SOM program.
2. Walmart had information on the millions of orders for controlled substances its pharmacies placed with—and received from— independent distributors.
496. In addition to the data and other information it had about its own distribution and
dispensing, Walmart also had access to data and other information about the millions of orders
shipped from independent distributors.
497. During the Distribution Violations Period, Walmart-branded pharmacies generally
first placed all of their orders with Walmart’s own distribution centers. Walmart-branded
pharmacies generally received controlled substances from McKesson Corporation (“McKesson”)
when Walmart’s distribution centers could not fulfill the order.
498. During the Distribution Violations Period, Walmart-branded pharmacies received
millions of controlled-substance orders from McKesson.
499. During the Distribution Violations Period, Sam’s Club-branded pharmacies used
AmerisourceBergen Corporation (“AmerisourceBergen”) as their primary distributor. Walmart’s
distribution centers served as a back-up distributor to Sam’s Club-branded pharmacies.
500. During the Distribution Violations Period, Sam’s Club-branded pharmacies
received over a million controlled-substance orders from AmerisourceBergen.
501. Despite having information about how often and how much Walmart-branded
pharmacies and Sam’s Club-branded pharmacies ordered from independent distributors, Walmart
did not account for these orders and shipments in its SOM program.
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B. For years, Walmart knew of significant defects with its policies and procedures for detecting and reporting suspicious orders, but failed to fix them.
502. Both before and during the Distribution Violations Period, Walmart’s SOM
program contained significant defects that prevented Walmart from detecting and reporting at
least hundreds of thousands of suspicious orders that its pharmacies placed with its distribution
centers.
503. As explained below, numerous internal documents demonstrate that Walmart
knew throughout this period of significant defects with its SOM program.
504. During the Distribution Violations Period, Walmart’s SOM program—including
the systems, policies, and procedures that Walmart employed to monitor suspicious orders—
changed and went through multiple iterations.
505. However, these changes were not sufficient to fix the known defects and meet
Walmart’s legal obligation under 21 C.F.R. § 1301.74(b) to detect and report suspicious orders.
1. Prior to August 2015, Walmart had a rudimentary suspicious-order monitoring system that failed to adequately detect and report suspicious orders.
506. On or about December 27, 2007, DEA sent letters to all registered distributors of
controlled substances, including Walmart, reminding them of their legal obligation under 21
C.F.R. § 1301.74(b) to detect and report suspicious orders to DEA.
507. In the December 27, 2007 letter, DEA advised distributors that failing to comply
with their obligations could lead to great harm: “[A]ll registrants—manufacturers, distributors,
pharmacies, and practitioners—share responsibility for maintaining appropriate safeguards
against diversion. Nonetheless, given the extent of prescription drug abuse in the United States,
along with the dangerous and potentially lethal consequences of such abuse, even just one
distributor that uses its DEA registration to facilitate diversion can cause enormous harm.”
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508. Nevertheless, prior to November 2010, Walmart had no written policies or
procedures related to the identification or reporting of suspicious orders.
509. In November 2010, Walmart adopted Pharmacy Manual 21-402 (“Controlled
Substance Monitoring”).
510. This policy simply required certain Walmart employees to review a monthly
report, known as a “control drug stock exception report,” after the controlled substances had
been shipped to the pharmacies and identify any controlled substances that constituted more than
3.99% of a pharmacy’s total controlled and non-controlled-substance purchases during the prior
month.
511. Under Pharmacy Manual 21-402 (November 2010), Walmart failed to detect
many unusual orders. First, the monthly reports did not identify specific controlled-substance
orders that were unusually large. Instead, the reports aggregated all shipments of particular
controlled substances and then compared those aggregated totals to see if they exceeded 3.99%
of a pharmacy’s total shipments that month. As a result, many unusually large orders were not
flagged because they were subsumed in the aggregated totals. Second, the policy did not require
Walmart to flag any orders that were otherwise suspicious (e.g., exhibiting an unusual frequency
or unusual pattern).
512. Pharmacy Manual 21-402 (November 2010) did not describe these aggregated
totals as “suspicious orders” or even state that Walmart was required to detect and report
suspicious orders to DEA.
513. By mid-2014, Walmart officials recognized that Walmart was at risk of
enforcement from DEA because it was not detecting and reporting suspicious orders as required
by 21 C.F.R. § 1301.74(b). In an attachment to a June 12, 2014 email sent by M.J. (then
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Director of Compliance), Walmart considered modifying its SOM system “to help Walmart
avoid DEA enforcement as a result of non-compliance with 21 CFR 1301.74(b).”
514. In that same June 12, 2014 email, Walmart attached a risk assessment in which it
observed that its system for monitoring suspicious orders was an “existing risk” and “emerging
risk” for which it had “no processes in place.” Walmart’s own assessment was that the risk that
its pharmacies would place suspicious orders with its own distribution centers was “likely,” the
second-highest of five levels on Walmart’s scale of likelihood of risks.
515. In July 2014, Walmart revised Pharmacy Manual 21-402 and titled the revised
policy “Evaluating Orders of Interest and Suspicious Order Reporting.”
516. Unlike the 2010 version of the policy, Pharmacy Manual 21-402 (July 2014)
instructed compliance unit personnel to evaluate individual orders as they were placed—rather
than monthly aggregated totals after Walmart’s distribution centers had already shipped the
controlled substances—and report any suspicious orders to DEA.
517. Pharmacy Manual 21-402 (July 2014) called for Walmart first to identify “orders
of interest” from among all controlled-substance orders, and then to investigate those “orders of
interest” to determine whether they were indeed “suspicious orders” subject to reporting to DEA.
As detailed below, however, both steps of this system failed. The criteria Walmart adopted for
flagging “orders of interest” in the first instance were plainly inadequate, allowing many
suspicious orders to evade any scrutiny. And Walmart routinely failed to investigate orders that
were flagged as “orders of interest” to ascertain whether they were suspicious, prioritizing
expeditious distribution of controlled substances to meet its pharmacies’ and pharmacists’
demands over compliance with DEA regulations.
518. As a result of these defects, even under the revised SOM policy, Walmart
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reported only a miniscule percentage of its pharmacies’ suspicious orders.
a. Walmart failed to detect and report orders of unusual frequency or pattern.
519. Pharmacy Manual 21-402 (July 2014) stated that Walmart must evaluate orders
with “[u]nusual characteristics,” which it defined to include orders showing “unusual size,”
“unusual frequency,” and “unusual pattern.”
520. Despite the requirements in 21 C.F.R. § 1301.74(b) and in Walmart’s own SOM
policy to detect and report orders showing “unusual frequency” and “unusual pattern,”
Walmart’s SOM system focused exclusively on the size of orders. It contained no processes to
detect or report orders with unusual frequency or unusual pattern.
521. During the Distribution Violations Period, most of Walmart’s six distribution
centers used a system called Reddwerks as their order fulfillment system. Reddwerks tracked
orders placed by Walmart pharmacies, as well as shipments from Walmart distribution centers
back to the pharmacies in fulfillment of those orders.
522. Although the Reddwerks system was not designed for monitoring suspicious
orders, Walmart used it for that purpose. Specifically, Walmart used Reddwerks to set “order
alerts”—sometimes known as “thresholds”—that would flag only orders over a certain quantity.
523. Walmart had an opportunity to design a system that would have detected unusual
ordering patterns. As early as February 2014, Mu Sigma, an outside consultant that advised
Walmart about the development of its SOM program, informed Walmart that it could revise that
program to detect Walmart pharmacies’ unusual ordering patterns and combinations, which
could indicate that a particular Walmart pharmacy was dispensing dangerous drug “cocktails.”
524. Despite this offer from Mu Sigma, Walmart did not revise its SOM program in
that way or any other way to detect unusual, dangerous patterns during the Distribution
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Violations Period.
525. Walmart knew that its SOM system was deficient in that it ignored pattern and
frequency, in violation of the law. In an internal presentation from October 2014, just a few
months after the July 2014 SOM policy had been put in place, Walmart recognized that
Reddwerks “[f]lags only identify ‘unusual size.’” That deficiency remained uncorrected for
years.
526. Because Walmart’s system was not designed to flag orders for unusual frequency
and unusual pattern, Walmart did not report any of these orders to DEA, in violation of the law.
b. Walmart failed to adequately detect and report unusually large orders.
527. Despite Walmart’s sole focus on order size, its monitoring still failed to detect
significant numbers of orders of “unusual size.”
528. There were several different flaws in Walmart’s approach to monitoring the size
of orders, as explained below.
i. In setting order-size thresholds and limits, Walmart disregarded the differences among its pharmacies and the differences among controlled substances.
529. Sometime prior to the adoption of Pharmacy Manual 21-402 in July 2014,
Walmart’s SOM program began using weekly size “thresholds” and “hard limits” for the
quantity of controlled substances that each of its pharmacies could order from the six Walmart
distribution centers.
530. An order that hit a “threshold” was supposed to trigger a temporary “hold” of that
order for further evaluation.
531. A “hard limit” nominally served as the maximum amount that a pharmacy could
order of a particular drug, but as explained below, Walmart sometimes ignored its own hard
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limits, allowing its pharmacies to order and receive quantities greater than the hard limit.
532. The thresholds and hard limits ignored significant differences between
pharmacies. Walmart knew that its pharmacies varied significantly in many respects. For
instance, some served sparsely populated rural communities, while others served suburban or
urban communities with larger populations. Likewise, depending on location, Walmart
pharmacies might face differing levels of competition from other retail chain pharmacies or
independent pharmacies. Customer characteristics also differed in material ways, such as age
and diagnoses, which affected the types and amounts of controlled substances each pharmacy
needed to stock and dispense to meet customer demand.
533. Despite its knowledge of these variations among pharmacies, Walmart applied the
same numeric thresholds to each of its pharmacies and did not tailor its order-size thresholds.
Regardless of the attributes of the pharmacy placing an order, Walmart’s SOM system uniformly
flagged the following weekly order totals:
a. Schedule II controlled substances that exceeded 20 bottles,
b. Schedule III-V controlled substances that exceeded 50 bottles, and
c. 30% above four-week average (if 11 bottles or greater).
534. In a document titled “Overview of SOM Project Progress,” which was attached to
a November 23, 2014 email from a senior manager of logistics to other compliance unit
personnel, Walmart acknowledged that thresholds for its pharmacies were set “regardless of
store history.”
535. In addition, Walmart had no supporting rationale for its decision to set a 50-bottle
threshold for Schedule III, IV, and V controlled substances. The “Overview of SOM Project
Progress” stated that Walmart lacked any documentation showing why 50 bottles had been
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selected as a threshold for certain controlled substances.
536. This arbitrary, one-one-size-fits-all threshold for all Schedule III, IV, and V
controlled substances meant that a pharmacy could order the same amount—up to 50 bottles—of
a highly addictive Schedule III narcotic as it could order of a Schedule V controlled substance
with a lower potential for abuse.
537. As a result of Walmart’s one-size-fits-all approach in setting thresholds and hard
limits, Walmart failed to detect and report many unusually large orders.
ii. Walmart routinely shipped, and did not report, orders exceeding its hard limit for oxycodone 30mg.
538. Starting in or about July 2012, Walmart implemented a “hard limit” of 20 bottles
of oxycodone 30mg per week, per pharmacy.
539. Oxycodone 30mg was the only controlled substance and only dosage strength for
which Walmart imposed a “hard limit” on the number of bottles its pharmacies could order each
week.
540. Despite this singular focus on this one drug formulation, Walmart frequently
disregarded its own 20-bottle “hard limit” for oxycodone 30mg, a highly addictive Schedule II
controlled substance.
541. Between June 2013 and July 2015, on at least 216 separate occasions, Walmart
shipped to its pharmacies more than 20 bottles of oxycodone 30mg in one week.
542. This problem was concentrated in a handful of pharmacies. Approximately half
of the instances where Walmart disregarded its own hard limit of 20 bottles of oxycodone 30mg
went to only six pharmacies: Store 5350 in Salt Lake City, Utah; Store 1560 in Las Vegas,
Nevada; Store 5697 in Milwaukee, Wisconsin; Store 2708 in Temecula, California; Store 130 in
Muskogee, Oklahoma; and Store 5047 in Audubon, New Jersey.
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543. For example, during a 12-week period in 2015, Store 130 in Muskogee,
Oklahoma, received more than 20 bottles of oxycodone 30mg in 11 of those weeks, for a total of
248 bottles. These suspiciously large orders of oxycodone 30mg and Walmart’s failure to report
them to DEA are particularly egregious because, as set forth above, Walmart also knew that S.L.
was operating a pill-mill practice in Muskogee and his patients were using Store 130 to fill
unlawful prescriptions. Walmart pharmacists at Store 130 had reported to Walmart compliance
personnel that “there is a significant drug abuse problem in town” and that “many” of S.L.’s
patients “don’t take [their prescribed] meds, they sell them – sometimes before they even leave
the store.”
544. By way of another example, over a 14-week period in 2014, Walmart repeatedly
shipped well over 20 bottles of oxycodone 30mg to Store 5350 in Salt Lake City, Utah. Walmart
ultimately shipped a total of 399 bottles to this pharmacy over these 14 weeks. Moreover, during
the broader time period of June 2013 through July 2015, on 41 separate occasions, Walmart sent
weekly shipments totaling more than 20 bottles of oxycodone 30mg to Store 5350.
545. Despite repeatedly violating its own hard limit, Walmart did not report to DEA as
suspicious any of the orders resulting in the shipments identified above.
iii. Walmart’s size thresholds were based on the number of bottles—rather than the number of dosage units in those bottles—which made those thresholds ineffective at detecting unusually large orders.
546. Prior to August 2015, Walmart’s size thresholds were based on the number of
bottles, rather than on the number of dosage units included in each bottle.
547. In the “Overview of SOM Project Progress,” Walmart recognized this deficiency,
noting that “[m]onitoring level = 50 bottles (regardless of store history, bottle size, etc) or order
amount >30% over rolling 4 week average.” (Emphasis added.)
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548. Because of this flaw, pharmacies could evade the bottle-based thresholds,
obtaining more dosage units of controlled substances without scrutiny by ordering bottles
containing more pills.
549. For example, in two shipments on December 12 and 13, 2013, Store 7259 in
Georgetown, Kentucky, received a total of 10 bottles of oxycodone hydrochloride-
acetaminophen 5/325mg, each containing 500 pills. Store 7259 thus received 5,000 dosage units
in one week. Store 7259 could have obtained the same number of dosage units by ordering
bottles containing only 100 pills per bottle, but then it would have ordered 50 bottles and
exceeded the 20-bottle threshold. Instead, Store 7259 was able to receive 2.5 times as many pills
while evading scrutiny—and potential reporting to DEA as a suspicious order—because it stayed
below the 20-bottle threshold simply by ordering a larger bottle size.
550. In another instance, on February 26 and 27, 2014, Store 2156 in Middle Island,
New York, received a total of nine bottles of oxycodone hydrochloride-acetaminophen 5/325mg,
each containing 500 pills. Store 2156 thus received 4,500 dosage units in one week. If Store
2156 had ordered bottles containing only 100 pills per bottle, the pharmacy would have had to
order 45 bottles to obtain the equivalent dosage units, which would have exceeded the 20-bottle
threshold for evaluation of Schedule II controlled-substance orders. Instead, Store 2156 was able
to receive over two times as many pills while evading scrutiny—and potential reporting to DEA
as a suspicious order—because it stayed below the 20-bottle threshold simply by ordering a
larger bottle size.
551. Throughout this period, Walmart knew that setting thresholds based on bottle
quantity rather than dosage-unit quantity presented a potential loophole for pharmacies to order
excessive amounts of controlled substances.
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552. In a memorandum drafted on or about October 11, 2013, E.O., the General
Manager of DC 6046 in Williamsport, Maryland, pointed out that “several control … items have
changed from a 100 count bottle to a 1000 count bottle,” such that a pharmacy that had
previously ordered 20 bottles of a controlled substance for a total of 2,000 dosage units was now
able to order 20 bottles of that same controlled substance for a total of 20,000 dosage units. E.O.
concluded that “[t]he system now should flag pills verses [sic] bottles.”
553. Although Walmart recognized as early as October 2013 that relying on order-size
thresholds based on the number of bottles presented problems, Walmart delayed fixing this
problem and did not implement order-size thresholds based on the number of dosage units until
at least August 2015.
iv. Walmart’s size thresholds were based on specific National Drug Code numbers—rather than drug type and strength—which made them ineffective at detecting unusually large orders.
554. Another flaw in Walmart’s size thresholds was that Walmart’s SOM program did
not aggregate and flag multiple orders placed by a pharmacy for the same drug and strength, if
those orders were for products that had different National Drug Codes because they were made
by different manufacturers. A National Drug Code (“NDC”) is a unique, three-segment number
which serves as a universal product identifier for drugs.
555. For example, in 2014, DC 6045 shipped Store 5350 in Salt Lake City, Utah,
several orders of oxycodone 30mg that were unusual when aggregated. Over the course of one
week from November 25-28, 2014, Store 5350 received 16 bottles of oxycodone 30mg (NDC
10702000901) and 19 bottles of oxycodone 30mg (NDC 228287911), but neither weekly
shipment total—based on NDC alone—was flagged as exceeding 20 bottles. Each order
exceeding the weekly hard limit of 20 bottles of oxycodone 30mg should have been flagged and
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reported to DEA as suspicious, but Store 5350 evaded the 20-bottle hard limit because the NDCs
differed, allowing Store 5350 to receive 35 bottles of oxycodone 30mg in one week, almost
twice the hard limit because of this loophole.
556. In another example, Store 2837 in Las Vegas, Nevada, received shipments of 12
bottles of oxycodone 30mg (NDC 10702000901) and 18 bottles of oxycodone 30mg (NDC
228287911) from DC 6045 on January 8, 2014. This weekly total of 30 bottles of oxycodone
30mg exceeded the 20-bottle hard limit, but was not flagged and reported to DEA as suspicious
because Walmart failed to monitor for differing NDCs for the same drug strength.
557. Walmart’s failure to close this NDC loophole enabled the oxycodone 30mg hard
limit of 20 bottles to be exceeded at least 146 times between June 26, 2013, and July 31, 2015.
558. This problem of not evaluating the orders in the aggregate was not limited to
orders of oxycodone 30mg, but extended to other Schedule II controlled substances. Because
Walmart did not monitor Schedule II orders of the same drug and strength with different NDCs,
Walmart’s SOM system failed to flag at least 1,500 weekly shipments of other Schedule II
controlled substances with a combined weekly total above 20 bottles for further evaluation.
v. When Walmart flagged orders of unusual size, it often “cut” or reduced the size of the orders, but failed to report them to DEA.
559. Walmart also avoided reporting suspicious orders by “cutting,” i.e., reducing the
size of orders that would otherwise raise concerns, down to a size Walmart considered
acceptable. Specifically, when Walmart received an order from one of its pharmacies above the
threshold of 20 bottles for a Schedule II controlled substance, or 50 bottles for a Schedule III, IV
or V controlled substance, Walmart often “cut” that order down to 20 or 50 bottles.
560. For instance, on October 16, 2014, J.A., Operations Manager at DC 6045,
circulated a report to other Walmart compliance personnel, including to M.J., showing several
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orders greater than 50 bottles that had been “cut” down to 50 bottles and shipped out to
pharmacies the prior day:
561. Walmart did not send DEA a suspicious-order report for any of the cut orders
listed above.
562. After Walmart set the 20-bottle hard limit for oxycodone 30mg orders in or about
July 2012, the company’s policy was that oxycodone 30mg orders exceeding the 20-bottle
weekly limit were to be flagged and “cut” down so that the pharmacy would receive no more
than 20 bottles.
563. In an October 14, 2013 email, J.A. stated that DC 6045—which was the only
Walmart distribution center that distributed oxycodone 30mg—had a “standing” cut for
oxycodone 30mg and that “[a]ny order over 20 bottles of this item is cut back to 20 bottles.”
564. Although Walmart cut these orders and shipped the reduced (but still substantial)
quantities of controlled substances to its pharmacies, Walmart did not report these unusually
large orders to DEA.
565. Walmart’s practice of cutting these unusually large orders and shipping the
reduced portion without reporting the original large orders to DEA disguised the large quantities
that its pharmacies repeatedly ordered.
566. Worse still, Walmart knew that its practice of shipping “cut” orders violated DEA
regulations.
567. For example, in a February 2015 meeting, DEA diversion investigators informed
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Walmart that Walmart’s practice of receiving an order, reducing the quantity of the order, and
shipping that reduced quantity without reporting the order as suspicious to DEA violated 21
C.F.R. § 1301.74(b).
568. Despite this knowledge, Walmart continued to unlawfully cut and ship orders
without reporting them to DEA through at least November 29, 2017.
vi. Walmart ignored shipments of controlled substances that its pharmacies were also receiving from independent distributors.
569. Walmart recognized and knew that the SOM program had an additional, critical
shortcoming: Walmart-branded pharmacies and Sam’s Club-branded pharmacies ordered and
received at least hundreds of thousands of shipments of controlled substances from McKesson
and AmerisourceBergen, respectively, but Walmart did not factor in these shipments from
independent distributors when considering whether the pharmacies had exceeded order-size
thresholds and hard limits.
570. McKesson, as a back-up supplier for Walmart-branded pharmacies, shipped at
least hundreds of thousands of controlled-substance orders to Walmart-branded pharmacies from
June 2013 through July 2015.
571. AmerisourceBergen was the primary distributor for Sam’s Club-branded
pharmacies, and Walmart was a back-up supplier. As the primary distributor,
AmerisourceBergen shipped at least hundreds of thousands of controlled-substance orders to
Sam’s Club-branded pharmacies from June 2013 through July 2015.
572. For Schedule II controlled substances, Walmart required its pharmacies to place
all orders through DC 6045—even orders that would ultimately be fulfilled by independent
distributors when DC 6045 was out of stock or did not carry a particular Schedule II controlled
substance.
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573. Schedule III, IV, and V controlled substances were handled differently. For
Schedule III, IV, and V controlled substances, sometimes pharmacies placed orders directly with
independent distributors rather than channeling all orders through a Walmart distribution center
first.
574. There were two problems with how Walmart’s SOM system accounted for orders
from independent distributors.
575. First, even when Walmart knew that the independent distributor would ultimately
fulfill an order, and thereby push the pharmacy’s weekly order total above Walmart’s order-size
thresholds (e.g., 20 bottles, 50 bottles, or 30% above the four-week average), Walmart passed the
order along to the independent distributor for fulfillment without evaluating whether the order
was suspicious. Had Walmart been abiding by its legal obligation to detect and report suspicious
orders, Walmart would have reported that order to DEA.
576. Because of this system failure and other failures to monitor orders with
independent distributors, between June 2013 and July 2015, Walmart unlawfully failed to detect
and report to DEA thousands of its pharmacies’ unusually large orders.
577. Second, Walmart’s compliance personnel did not even know of some orders
fulfilled by independent distributors because Walmart pharmacies could bypass Walmart
distribution centers altogether and order directly from independent distributors. Walmart’s SOM
system did not identify these orders, leaving Walmart’s compliance unit in the dark about the
quantity of Schedule III, IV, and V controlled substances ordered from independent distributors.
Because Walmart did not identify these orders, it of course did not evaluate them.
578. Walmart recognized that its SOM system had this blind spot. In an October 2014
internal presentation assessing the efficacy of its SOM system, Walmart noted that “McKesson
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orders are not considered in evaluation.” Likewise, the “Overview of SOM Project Progress”
attached to a November 23, 2014 email stated that Walmart had “[n]o process for including
McKesson orders in evaluation.”
vii. Walmart attributed unusually large orders to “errors” to avoid reporting them as suspicious orders.
579. Walmart made up other reasons for not reporting unusually large orders to DEA.
In particular, Walmart began classifying unusually large orders as “errors” in order to justify
rejecting the order or reducing the size of the order, even when there was no basis for thinking
the pharmacies had intended to order a smaller quantity.
580. In an email dated August 27, 2014, K.S., Senior Manager for Logistics, advised
that “‘[c]utting’ an order should only be an option if the order is an error (eg store intended to
order 10 bottles, ordered 100).” (Emphasis added.)
581. Although Walmart was aware that it should limit “cutting” orders to true “errors,”
J.A., the operations manager for DC 6045, stretched the meaning of “error” so broadly that it
would conceal all sorts of suspicious activity.
582. In an internal email dated November 5, 2014, concerning the use of “error” as a
reason code for cutting orders, J.A. wrote: “Many things could be considered an ‘error’ other
than just mis-keying an order. Such as, due to the change of Hydro to a CII some pharmacist[s]
feel the need to stock up. The company feels 50 bottles is enough and pharmacist shouldn’t
stock up, thus an error in decision making. And many other reasons not confined to mis-
keying.” (On October 6, 2014, hydrocodone was reclassified from a Schedule III controlled
substance to a Schedule II controlled substance, which reflected DEA’s concern regarding the
abuse and diversion potential of hydrocodone.)
583. Walmart thus expanded its definition of “error” beyond its pharmacies’
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unintentional mistakes to include their deliberate placement of unusually large orders. This
overly expansive definition of “error” caused Walmart to fail to report suspicious orders to DEA.
c. Walmart ignored specific signs of diversion from its own pharmacies.
584. In addition to altogether failing to detect orders of unusual frequency or pattern
and failing to adequately detect orders of unusual size, Walmart’s SOM program also ignored
signs that diversion was occurring at certain pharmacies.
585. As noted above, 21 C.F.R. § 1301.74(b) defines suspicious orders as including
orders that are suspicious for reasons other than unusual size, unusual frequency, or deviating
from the normal pattern, but does not limit the definition to these three categories.
586. Nevertheless, in addition to ignoring the three categories listed in the regulation,
Walmart’s compliance unit ignored other warning signs that orders placed by certain pharmacies
were suspicious. These signs included concerns expressed by pharmacists to compliance
personnel about prescriptions written by “pill mill” prescribers and illegal diversion occurring
inside Walmart stores.
587. For instance, in a series of emails, the pharmacy manager of Store 147 in
Denison, Texas, warned Walmart’s compliance unit about a Texas prescriber, H.D., who is
discussed above. Despite these concerns, Walmart took no action to limit the shipment of
controlled substances to Store 147, which routinely filled prescriptions issued by H.D., and failed
to notify DEA of suspicious orders from those stores.
588. Likewise, Walmart received numerous warnings regarding North Carolina
prescriber S.K., as discussed above. Over a period of two years from July 2013 to July 2015,
Walmart’s compliance unit received more than 70 warnings from pharmacy managers and
pharmacists at Walmart pharmacies in North Carolina about S.K., including warnings about his
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practice of prescribing high volumes of Schedule II controlled substances.
589. Walmart pharmacists submitted more than 70 refusal-to-fill forms that warned
that S.K.’s prescriptions had no legitimate medical purpose and raised numerous and repeated
red flags related to S.K., his patients, and the prescriptions he wrote. For example, one refusal-
to-fill form by a pharmacist from Store 3825 in Havelock, North Carolina, explained that S.K.
“only writes for large qty [sic] of narcotic medications.” The next day, another pharmacist at
Store 3864 in Jacksonville, North Carolina, submitted a refusal-to-fill form about another one of
S.K.’s opioid prescriptions and warned that the prescription was “written by a doctor that is
known to give large quantities of c2 [i.e., Schedule II] prescriptions and no other ones.”
(Emphasis omitted.) Nine months later, a pharmacist at Store 7238 in Grantsboro, North
Carolina, reported in a refusal-to-fill form that S.K.’s patient “appeared intoxicated (slurred
speech [sic], unstable, glossy eyes)” and that the “prescription [was] written for [a] large
quantity.” (Emphasis omitted.)
590. Despite knowing about all of these warnings of diversion from its own
pharmacists, Walmart took no action to limit the shipment of controlled substances to
pharmacies routinely filling prescriptions issued by S.K. and did not report any suspicious orders
for Stores 3825, 3864, or 7238 to DEA.
591. As another example, Walmart’s compliance unit had ample warning that Z.B.,
who is discussed above, was a “pill mill” doctor whose patients traveled great distances to visit
his pain clinic in Tampa, Florida, and/or to fill his prescriptions at Walmart pharmacies located
within a large radius from his pain clinic.
592. Fifty-five miles from Tampa, Store 959 in Bushnell, Florida, was the largest
Walmart dispenser of Z.B.’s prescriptions. Pharmacists at that store submitted several refusal-to-
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fill forms relating to Z.B., and one of the pharmacists noted, among other things, “prescriber
questionable.”
593. In June 2016, M.J., Director of Controlled Substances, notified Walmart’s
Regional Health and Wellness Director for Florida, Alabama, Mississippi, and Georgia that Z.B.
was one of the top three prescribers for oxycodone 30mg at Store 5654 in Tampa, that 75 percent
of Z.B.’s prescriptions for oxycodone 30mg were for quantities of 120 dosage units or greater,
and that the top-three drugs prescribed by Z.B. were oxycodone 30mg, hydromorphone 8mg, and
methadone 10mg.
594. A month-and-a-half later, in mid-August 2016, M.J. told B.N., a director in the
compliance unit, and other Walmart compliance personnel that Z.B. was the number-one
prescriber of oxycodone 30mg at Store 5964 in Tampa, accounting for 14 percent of all such
prescriptions dispensed by Store 5964.
595. Despite all of these warning signs of diversion, Walmart took no action to limit
the shipment of controlled substances to pharmacies routinely filling prescriptions issued by Z.B.
and did not report any suspicious orders for Stores 959, 5654, or 5964 to DEA.
d. Walmart failed to adequately staff and train its compliance personnel, and shipped flagged orders before compliance personnel could examine them.
596. During the Distribution Violations Period, Walmart was the largest private
employer in the United States. For the fiscal year ending January 2015, Walmart employed 2.2
million associates worldwide, with approximately 1.4 million domestic employees.
597. Yet during this period, Walmart failed to devote sufficient personnel to operate its
SOM program. Instead, Walmart was woefully understaffed for reviewing flagged orders from
its 5,000 pharmacies and determining which of those orders were suspicious, and therefore, had
to be reported to DEA.
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598. For at least part of the time from June 2013 through July 2015, compliance
personnel working in Walmart’s Home Office were not involved in detecting suspicious orders.
K.S., a Senior Manager for Logistics, has stated that “any decisions that needed to be made were
being left to the distribution center….”
599. Walmart recognized this arrangement as inadequate and, in the “Overview of
SOM Project Progress” attached to a November 23, 2014 email, listed several problems
associated with Walmart’s failure to involve Home Office compliance personnel in monitoring
suspicious orders, including:
a. “Inconsistent application of monitoring standards by associate across DC
facilities”;
b. “No consistent training for associates”;
c. “No dedicated [Home Office] resource”; and
d. “SOM policy only included DC associate responsibilities – no [Home Office]
involvement or cross-functional collaboration.”
600. Walmart’s distribution centers were not staffed with enough personnel to evaluate
all flagged orders.
601. Of particular concern was that Walmart failed to devote sufficient staff to
monitoring orders of Schedule II controlled substances, which were the most dangerous
controlled substances that Walmart distributed. All Schedule II controlled substances distributed
by Walmart were distributed via DC 6045 in Bentonville, Arkansas. DC 6045 filled Schedule II
orders itself, and it served as the intermediary between Walmart’s pharmacies and the
independent distributors when DC 6045 could not fill Schedule II orders on its own. At one
point, there were only three employees at DC 6045 to review and evaluate hundreds of orders for
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Schedule II controlled substances that Walmart’s own thresholds had flagged each day (and
many more after hydrocodone was reclassified as a Schedule II drug effective October 6, 2014).
602. Walmart also did not allow its staff adequate time to examine flagged orders for
Schedule II drugs placed with DC 6045. Although Walmart policy called for a temporary “hold”
to evaluate orders that had tripped the company’s thresholds, that “hold” was often overridden in
favor of expeditious shipping to satisfy its pharmacies. At least at one point in time, if DC 6045
flagged orders exceeding 50 bottles but did not receive an instruction by 3 p.m. that same day as
to whether the order was suspicious or appropriate for shipment, the distribution center shipped
the unusually large order without notifying DEA.
603. At other distribution centers, Walmart similarly failed to provide its staff with the
ability to evaluate the stream of orders from its pharmacies.
604. For example, DC 6046 in Williamsport, Maryland, refused to devote adequate
resources and personnel to properly evaluating orders that Walmart’s SOM system had flagged
for evaluation. As a result, it chose not to review every flagged order. In a memorandum
circulated on or about October 11, 2013, E.O., an operations manager at DC 6046, stated that
there were “too many orders to review each line [of Reddwerks orders alerts] in detail.”
605. A year later, the problem had not been fixed. An internal presentation from
October 2014 recognized that “[a]ll flags must be cleared before production on any items can
begin, so there is limited time for evaluation.” (Emphasis added.)
606. Walmart also failed to provide consistent, adequate training to the employees
responsible for suspicious-order monitoring functions.
607. First, Walmart assigned SOM functions such as detecting, rejecting, and reporting
suspicious orders, approving orders in excess of a threshold, and cutting orders to or below
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thresholds, to distribution center personnel who Walmart knew had limited or no prior
experience with suspicious-order monitoring or even with regulatory compliance of any kind.
608. Second, Walmart failed to provide these employees with training specific to
monitoring suspicious orders of controlled substances, including appropriate training regarding
drug diversion trends and the prescription drug abuse epidemic. Walmart provided its staff with
no training program, training materials, or written policies, procedures, or criteria specific to
suspicious-order monitoring.
609. For example, J.A., the operations manager at DC 6045, possessed neither
adequate experience nor training when he was charged with determining which Schedule II
orders were suspicious. Walmart provided J.A. with no formal training and no written policies
or procedures specific to suspicious-order monitoring. Instead, J.A. relied on on-the-job
experience working with Schedule II drugs and “just looking at orders and just, you know, if
something looked unusual, then that’s what I looked at.”
e. Walmart routinely failed to investigate flagged “orders of interest” and report any orders to DEA that Walmart was unable to clear.
610. During this time period, Walmart set the following thresholds to flag unusually
large orders for investigation: more than 20 bottles for Schedule II controlled substances, more
than 50 bottles for Schedule III, IV, and V controlled substances, and order amounts that were
30% above the four-week average.
611. Pharmacy Manual 21-402 (July 2014) required Walmart to hold and evaluate all
orders flagged by its SOM system. The manual referred to such orders as “orders of interest”
and noted specifically that they “warrant[ed] follow-up evaluation to determine whether … [they
are] suspicious.”
612. Consistent with the manual, K.S., a Senior Manager for Logistics, stated in an
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August 27, 2014 email: “Our obligation is to monitor all orders, investigate ‘orders of interest’
(potentially ‘suspicious’ orders), hold any ‘order of interest’ until/unless the order is
investigated and cleared and report any ‘suspicious’ orders to DEA.” (Emphasis added.)
613. Despite this clear policy, Walmart routinely failed to investigate thousands of
flagged orders.
614. For example, Walmart generated an internal report referred to as an “Over 20
report,” which flagged all orders for Schedule II controlled substances that were greater than 20
bottles. Walmart referred to orders of more than 20 bottles of Schedule II controlled substances
as “orders of interest” that warranted additional evaluation.
615. But in many cases, no Walmart personnel at any level completed any
investigation of these “Over 20” orders of powerful Schedule II controlled substances.
616. Walmart did not use these Over 20 reports to detect suspicious orders and report
them to DEA. Walmart has admitted that it shipped all Schedule II orders of between 21 and 50
bottles that its pharmacies placed—without conducting any meaningful investigation into those
orders, and sometimes conducting no investigation at all.
617. From June 26, 2013, to July 31, 2015, Walmart shipped its pharmacies at least
66,000 Schedule II orders in which the weekly totals ranged from 21 to 50 bottles.
618. In addition, one of Walmart’s distribution centers—DC 6001 in Rogers,
Arkansas—routinely shipped orders it had flagged for review, without reviewing them.
619. For at least part of the Distribution Violations Period, DC 6001 did not use
Reddwerks to identify suspicious orders but, instead, used a system called KNAPP.
620. KNAPP was an order fulfillment system, but it had very limited ability to detect
unusual orders of controlled substances.
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621. Under the KNAPP system, once an order was “flagged” by DC 6001 for further
evaluation, the system could not “hold” that specific order while the order was scrutinized to
determine if it was suspicious or not. Instead, due to limitations of the KNAPP system, if DC
6001 held a pharmacy’s order for further evaluation, then all the other orders would also be held
and not shipped.
622. In an email dated August 25, 2014, K.S., a Senior Manager for Logistics, noted
that some Walmart employees were “uncomfortable with our inability to find a systemic or
manual solution that would allow us to ‘hold’ orders pending evaluation.” The email further
stated that Practice Compliance “would prefer to move all of the Control drug business out of
6001 and to McKesson until the KNAPP solution is in place.”
623. However, Walmart did not move its controlled-substance business from DC 6001
to McKesson, instead continuing to use KNAPP and operate a system that Walmart knew was
flawed.
624. The “Overview of SOM Project Progress” listed specific deficiencies with
KNAPP, noting that:
a. “[DC] 6001 had very limited ability to monitor orders – KNAPP does not include
monitoring functionality”; and
b. “System (Reddwerks or KNAPP) did not allow alerted orders to be ‘held’ pending
evaluation.”
625. Because KNAPP did not enable Walmart to hold an order while evaluating that
order, Walmart routinely shipped suspicious orders without evaluating them and without
reporting them to DEA. In fact, during this time, DC 6001 reported no suspicious orders at all.
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f. Walmart often failed to document its evaluation of flagged orders, which deprived Walmart of crucial information needed to assess subsequent orders.
626. Walmart’s SOM policy required compliance personnel to evaluate flagged orders
and then document those evaluations.
627. Under Pharmacy Manual 21-402 (July 2014), Walmart’s evaluations of flagged
orders were to be documented using the “Order of Interest Evaluation Form.” The policy stated
that “[a]ll documentation related to Order of Interest evaluations, determination of Suspicious
Orders, and federal and state reporting must be retained for three years.”
628. Likewise, Walmart’s Practice Compliance division adopted a policy in January
2015, referred to as “Controlled Substances Suspicious Order Monitoring,” which required
Walmart to “document the final conclusion of the evaluation” and “retain documentation of any
reports made to the DEA and state agencies.”
629. However, prior to 2015, Walmart had no system or process in place to document
and retain this information.
630. Walmart recognized this flaw with its SOM system. The October 2014 internal
presentation noted that there was “[n]o defined process for tracking why DC cuts or clears
specific orders.” Likewise, the “Overview of SOM Project Progress” acknowledged that
Walmart had “[n]o process for documenting order evaluations or reporting decisions.”
631. In those instances when Walmart conducted some due diligence on flagged
orders, it often did not record the factual information it may have gathered about the order or the
conclusion it made as to whether or not the order was suspicious.
632. For example, from June 26, 2013, through July 31, 2015, Walmart shipped tens of
thousands of weekly orders of Schedule II controlled substances and Schedule III narcotics that
exceeded Walmart’s own established thresholds without documenting facts about those
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shipments necessary to determine if those orders or future orders from the same pharmacies were
suspicious.
633. Because Walmart did not maintain these records, Walmart compliance personnel
charged with scrutinizing and determining whether an order from one of its more than 5,000
pharmacies was suspicious lacked the necessary facts to complete their important gatekeeping
role with respect to other orders.
2. From August 2015 through November 2017, Walmart adopted a modified system for detecting and reporting suspicious orders, but this system remained defective.
634. As explained above, Walmart recognized the extensive flaws with its SOM
program and the limitations of the Reddwerks and KNAPP systems.
635. Walmart attempted to address the flaws with a few modifications to its existing
Reddwerks system.
636. Walmart hired a consulting firm, Mu Sigma, to review a statistical methodology
for identifying suspicious orders that Walmart had designed on its own. Walmart’s proposed
statistical methodology would implement pharmacy-specific and drug-specific thresholds to
replace the 20-bottle and 50-bottle thresholds that Walmart had been using in Reddwerks.
637. Mu Sigma reviewed Walmart’s proposed revisions to its system and identified
several flaws with the proposed statistical methodology. According to a January 2014 Mu Sigma
report to Walmart, the “shortcomings” in Walmart’s proposed approach included an inability to
detect patterns over time and one-size-fits-all minimum thresholds.
638. Mu Sigma proposed a more effective methodology that would capture outlier
orders missed by Walmart’s proposed approach.
639. Walmart rejected Mu Sigma’s proposed approach in part due to cost. In March
2014, K.S., a Senior Manager for Logistics, expressed, “[Mu Sigma] quoted us $185,000 for the
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work which, I think, is ridiculous.”
640. That year, Walmart reported operating profit of approximately $27 billion.
641. In or about August 2015, Walmart implemented the statistical methodology that
Mu Sigma had informed Walmart was flawed.
642. Walmart continued to use this modified system from approximately August 2015
through November 29, 2017.
a. Despite the modifications to Reddwerks, many of the same flaws remained.
643. Walmart’s modifications to Reddwerks failed to fix many of the serious defects
from its prior SOM program.
644. Walmart’s modified SOM program still failed to detect whether orders were of an
unusual frequency or unusual pattern, much less report those kinds of unusual orders.
645. Walmart’s modified SOM program continued to ignore known incidents of
diversion occurring at its pharmacies.
646. Walmart’s modified SOM program still did not consider whether a pharmacy was
ordering the same controlled substance of the same drug strength, but with multiple NDCs. As
noted above, this system defect permitted pharmacies to place orders well beyond the size
thresholds without those orders ever being flagged.
647. In addition, Walmart’s modified SOM program, when determining whether an
order placed with a Walmart distribution center was suspicious, continued to ignore at least
hundreds of thousands of orders that its pharmacies placed with independent distributors.
648. Walmart still had no visibility into orders that Sam’s Club-branded pharmacies
placed directly with AmerisourceBergen. For example, in November 2015, a pharmacist at a
Sam’s Club-branded store requested a threshold increase directly from AmerisourceBergen,
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bypassing Walmart’s compliance unit. In a December 2015 email, M.J., a Director of Controlled
Substances, recognized that threshold-increase requests made by Sam’s Club-branded
pharmacies directly to AmerisourceBergen limited Walmart’s “visibility into Sam’s from a SOM
standpoint.”
649. Even as late as May 2017, Walmart had the same lack of visibility into orders that
Walmart-branded pharmacies placed directly with McKesson. In a May 3, 2017 email, M.J.
discussed the rollout of a new project that would “reduce the number of orders going directly to
McKesson from the pharmacy. Those direct to McKesson orders limit our ability to get full
visibility to what pharmacies order and this project will be very helpful to us.”
650. As a consequence of these continuing problems with its SOM system, Walmart
failed to report at least hundreds of thousands of suspicious orders to DEA, in violation of the
law.
b. Walmart continued to fail to report unusually large orders.
i. Walmart’s use of average order sizes to set thresholds in the midst of the ongoing prescription drug abuse epidemic failed to detect unusually large orders.
651. In mid-2015, Walmart changed the Reddwerks thresholds that it used to detect
unusually large orders placed by its pharmacies.
652. Walmart modified its prior approach of applying uniform numeric thresholds to
its pharmacies’ orders (i.e., the 20-bottle threshold for Schedule II drugs and the 50-bottle
threshold for Schedule III, IV, and V drugs). Instead, it imposed pharmacy-specific, drug-
specific, weekly thresholds.
653. To set these new thresholds, however, Walmart chose a flawed approach that
would detect suspicious orders only in the rarest of instances. For pharmacies that typically
ordered large quantities, Walmart flagged all orders that were more than three standard
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deviations from that pharmacy’s average order size for that drug. For pharmacies that typically
ordered smaller quantities, Walmart flagged all orders that were more than three standard
deviations from the average order size of all of Walmart pharmacies’ orders for that drug.
654. Walmart adopted this approach despite knowing that it was likely to cause
Walmart not to detect many orders that were outliers. In early 2014, Mu Sigma, the consulting
firm working with Walmart to validate its proposed new methodology, had warned Walmart that
Walmart’s approach might not detect some unusually large orders.
655. Also, in setting pharmacy-specific thresholds, Walmart chose baselines that were
flawed. Walmart used pharmacy averages based on orders from a 52-week period during a time
when, as Walmart was well aware, the prescription drug abuse epidemic was raging across the
country.
656. Had Walmart lawfully rejected and reported suspicious orders before it modified
the Reddwerks system, then these order averages would have been lower. But by relying on
already excessive orders to calculate a pharmacy’s average order, Walmart created an inflated
average that masked the suspicious nature of those—and subsequent—orders.
657. Walmart’s decision to set thresholds for pharmacies based on inflated pharmacy
averages caused Walmart to fail to report suspicious orders.
ii. Walmart’s minimum threshold was too high to detect orders that were unusually large for some pharmacies.
658. As described above, the modified Reddwerks system set pharmacy-specific, drug-
specific order-size thresholds based on pharmacy averages.
659. The lowest possible threshold for any controlled substance was 2,000 dosage units
per week. Walmart had simply decided that the minimum threshold for flagging an order—no
matter which pharmacy had placed the order and how small that pharmacy’s average order plus
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three standard deviations was—would be 2,000 dosage units per week.
660. For many of Walmart’s pharmacies, the 2,000-unit minimum threshold for
triggering suspicious-order monitoring was far too high to enable Walmart to detect whether an
order was unusually large.
661. Some pharmacies, for instance, typically ordered far below 2,000 dosage units of
particular drugs in any given week. This minimum threshold meant that those pharmacies could
place an order for an unusually large quantity for that pharmacy without that order ever being
flagged.
662. The inadequacy of the 2,000-unit minimum threshold for detecting unusually
large orders is illustrated by considering a hypothetical Walmart pharmacy’s orders. For
example, suppose that over the course of a year, a Walmart pharmacy had received an average of
350 units of oxycodone-acetaminophen 5/325mg per week, and its average plus three standard
deviations was 1,100 units of oxycodone-acetaminophen 5/325mg. In that scenario, under the
modified SOM system, Walmart would have significantly raised that pharmacy’s threshold from
1,100 dosage units to the minimum threshold of 2,000 dosage units. Accordingly, that pharmacy
could have placed an unusually large order of oxycodone-acetaminophen 5/325mg—more than
five times its average amount of this powerful opioid—without that order being flagged as an
unusual size for that pharmacy.
663. As a result of the 2,000-unit minimum threshold, Walmart failed to detect
aberrant order sizes for those pharmacies that typically ordered smaller amounts of drugs and,
therefore, failed to report many suspicious orders to DEA.
iii. Walmart continued to fail to report to DEA unusually large orders by cutting those orders.
664. From August 2015 through November 2017, Walmart continued to manipulate its
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SOM program in a manner that avoided reporting unusually large-sized orders to DEA.
665. During this period, for some orders that exceeded size thresholds, Walmart
continued to “cut,” i.e., reduce the size of, those orders, without reporting the initial order to
DEA, and then shipped the reduced order.
666. Walmart engaged in cutting orders on a routine basis. For example, over the
course of four separate weeks in the fall of 2015, Walmart cut and shipped more than 50 orders
without ever reporting these orders to DEA.
667. Upon information and belief, Walmart continued to cut unusually large orders
without reporting them to DEA, through at least November 29, 2017.
668. Sometimes, Walmart did not simply reduce an unusually large order, but rejected
the order altogether without filing a suspicious-order report with DEA. Over the course of four
separate weeks in the fall of 2015, Walmart rejected more than 30 orders by cutting those orders
down to zero bottles. Walmart did not file a suspicious-order report for any of these rejected
orders.
669. Upon information and belief, Walmart continued to cut certain unusually large
orders to zero bottles through at least November 29, 2017.
670. Sometimes, Walmart recorded in Archer that it was not filling the original order,
but instead cut the order down to the maximum threshold amount, without further explanation.
In other words, Walmart’s response to an unusually large order was to ship the pharmacy the
largest amount it could ship that was consistent with the threshold—without any apparent
investigation of the unusually large order and without reporting the order to DEA.
671. For instance, on September 24, 2015, Store 3633 in Waynesboro, Pennsylvania,
placed an order for 12 bottles of buprenorphine HCL 8mg. The order was flagged in Walmart’s
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SOM system and went to the Home Office for evaluation. Home Office personnel called the
pharmacy at Store 3633, which in turn related that the pharmacy “just wanted to receive the
weekly threshold.” On September 24, 2015, Walmart’s Home Office “cut” the order down to 11
bottles. Walmart never reported the initial suspicious order of 12 bottles to DEA. The “reason
code” for the cut order in Reddwerks was listed simply as “Error-System(POS).”
672. The next day, on September 25, 2015, Store 3633 placed an additional order for
two bottles of buprenorphine HCL 8mg. The order was flagged in Walmart’s SOM system and
went to the Home Office for evaluation. Walmart’s Home Office “cut” the order down to zero
bottles. Walmart never reported the suspicious order of two bottles to DEA. The “reason code”
for the cut order in Reddwerks was listed as “Error-System(POS).”
673. The same day, Walmart took the same approach with an order from a different
pharmacy. On September 25, 2015, Store 2281 in West Mifflin, Pennsylvania, placed an order
for nine bottles of buprenorphine HCL 8mg. The order was flagged in Walmart’s SOM system
and went to the Home Office for evaluation. Home Office personnel called the pharmacy at
Store 2281, which in turn related that the pharmacy “would only like to receive the weekly
threshold amount.” On September 25, 2015, Walmart’s Home Office “cut” the order down to
four bottles. Walmart never reported the suspicious order of nine bottles to DEA. The “reason
code” for the cut order in Reddwerks was listed as “Error-System(POS).”
674. At other times, Walmart would record in Archer that the original order was a
“mistake” or “error,” without any explanation of the nature of the alleged mistake or error.
c. Walmart set hard limits for pharmacies that had already placed suspicious orders—then disregarded those hard limits.
675. Another problem with Walmart’s SOM system during this time period was that
Walmart allowed its pharmacies to exceed hard limits that it had imposed on certain controlled
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substances following the submission of a suspicious-order report to DEA.
676. In those rare instances when Walmart filed a suspicious-order report with DEA
for an unusual order placed by a pharmacy, Walmart would sometimes put the pharmacy on a
“remediation plan.” When a Walmart pharmacy was placed on a remediation plan, Walmart
would often reduce the quantity of the particular drug and strength that had been the subject of
the suspicious-order report. Walmart accomplished this reduction by assigning the pharmacy a
weekly hard limit for that drug. The duration of the remediation plan was usually one to two
months.
677. Walmart distribution centers often blatantly disregarded the weekly hard limit set
in remediation plans.
678. For example, Walmart placed Store 2530 in Rutland, Vermont, on a two-month
remediation plan following the March 2, 2017 placement of a suspicious order of 23 bottles of
buprenorphine HCL 8mg, an order that brought that pharmacy’s weekly total to 65 bottles. The
remediation plan limited Store 2530 to a weekly hard limit of 50 bottles for this drug through
May 5, 2017. However, during two separate weeks over the course of the remediation period,
Walmart shipped 71 bottles and 67 bottles, respectively, to Store 2530 without reporting these
orders to DEA.
679. Store 2530 exceeded its remediation-plan hard limit for two additional weeks
when it was on the remediation plan by placing buprenorphine HCL 8mg orders fulfilled by both
McKesson and Walmart. Over a one-week period in April 2017, Walmart shipped 50 bottles of
buprenorphine HCL 8mg to Store 2530, and McKesson shipped two bottles, for a total of 52
bottles, exceeding the remediation plan hard limit by two bottles. During the last week of Store
2530’s remediation plan in May 2017, Walmart shipped 50 bottles of buprenorphine HCL 8mg
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to the pharmacy, and McKesson shipped 106 bottles. The total of 156 bottles in that one week
was more than three times Store 2530’s remediation-plan hard limit of 50 bottles.
680. In another example, following an August 23, 2017 suspicious order of 42 bottles
of hydrocodone-acetaminophen 10/325mg for a total weekly order of 79 bottles, Walmart placed
Store 130 in Muskogee, Oklahoma, on a remediation plan for hydrocodone-acetaminophen
10/325mg. The remediation plan limited Store 130 to a weekly hard limit of 50 bottles of
hydrocodone-acetaminophen 10/325mg from August 25, 2017, through October 20, 2017. Yet
during at least during one week of the remediation plan, Walmart shipped 61 bottles to the
pharmacy, ignoring the 50-bottle weekly limit without reporting this order to DEA.
C. Walmart’s flawed approach to monitoring pharmacy orders resulted in a failure to detect and report at least hundreds of thousands of suspicious orders.
681. All of the significant shortcomings from the initial Reddwerks system and the
modified Reddwerks system rendered Walmart’s SOM program ineffective and, as a result,
Walmart failed to detect and report suspicious orders to DEA, as required by law.
682. The United States estimates that from June 26, 2013, through November 29, 2017,
Walmart shipped approximately 15.2 million orders of Schedule II controlled substances and
Schedule III narcotics to its own pharmacies. This figure does not include any other Schedule III
controlled substances, or any Schedule IV and Schedule V controlled substances. The United
States estimates that from June 26, 2013, through November 29, 2017, Walmart shipped
approximately 37.5 million Schedule II, III, IV and V orders to its pharmacies.
683. During the same time period, Walmart reported only 204 suspicious orders to
DEA—an infinitesimal percentage.
684. Walmart’s ultralow rate of suspicious-order reporting is incredible. The small
number of suspicious orders Walmart reported cannot be credibly attributed to a lack of unusual
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or otherwise suspicious orders placed by its pharmacies.
685. By comparison, McKesson, the independent distributor that served as the back-up
distributor to Walmart-branded pharmacies, received far fewer orders from Walmart’s
pharmacies but reported to DEA more than 13,000 suspicious orders from Walmart pharmacies
between June 26, 2013, and November 29, 2017.
686. Walmart’s failure to report suspicious orders stems from Walmart’s decisions to
operate a system that failed to detect suspicious orders and to manipulate that system to avoid
reporting to DEA those suspicious orders that were detected.
D. Walmart’s failure to detect and report suspicious orders deprived Walmart of the opportunity, during the prescription drug abuse epidemic, to timely address potentially unlawful conduct.
687. Walmart’s failure to detect and report suspicious orders not only violated the law,
but also inhibited Walmart’s ability to timely investigate the suspicious orders and uncover
potentially unlawful conduct.
688. Before reporting suspicious orders to DEA, Walmart first had to identify the
suspicious orders for itself. The regulation explains that the distributor must design and operate
a system “to disclose to the registrant suspicious orders of controlled substances.” 21 C.F.R.
§ 1301.74(b) (emphasis added).
689. If Walmart had properly identified suspicious orders in the first place, as required
by the regulation, steps could have been taken to investigate the orders.
690. For example, under a policy Walmart adopted in 2015, once it identified a
suspicious order, it would develop a “remediation plan” for the pharmacy that placed the
suspicious order. Under this policy, Walmart would conduct an investigation into the reasons for
the unusual order. This investigation could include engaging Walmart’s Global Investigations
group to open a review of the ordering pharmacy and requiring an on-site visit by Health and
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Wellness Operations to conduct a review and additional training at the pharmacy. The policy
required Walmart to “document the final conclusion of the evaluation” and “retain
documentation of any reports made to the DEA and state agencies.” Also, under the policy,
Walmart could increase oversight of future orders from the pharmacy.
691. If Walmart had complied with its obligation to detect and report suspicious
orders, it would have investigated the reasons for those orders and initiated remediation plans. It
thus could have taken steps that might have led to the timely detection of unlawful, improper, or
dangerous conduct. For example, Walmart could have discovered that the unusually high
demand for a controlled substance at a particular pharmacy was resulting from dispensing at that
pharmacy for a “pill mill” prescriber.
692. For the at least hundreds of thousands of suspicious orders that Walmart never
even identified, Walmart did not institute remediation plans to inquire into the orders, and it
never informed DEA of those suspicious orders.
693. When Walmart fulfilled suspicious orders, Walmart’s approach allowed
dangerous controlled substances to enter the market. Even in those circumstances where
Walmart recognized that certain orders were “suspicious” after those orders had already been
shipped to its stores, Walmart’s failure to report those orders and take other remedial steps
allowed the ordered drugs to “enter the market.” As a Senior Manager for Logistics wrote in an
August 20, 2014 email, “[t]he alternative to pulling the order back is to simply continue to follow
the process we have today. We can add further evaluation of orders after shipment but, if we see
an issue that suggests that product shouldn’t have been shipped, we just leave it at the store and
let it enter the market. Given the choices, [having the store] ship… the product back feels like
the more socially responsible approach, but the [Distribution Center] will do whatever leadership
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wants them to do.”
694. Walmart’s systematic failure, for years, to comply with its legal obligation to
detect and report each of its suspicious orders thus created a major obstacle to efforts to combat
the prescription drug abuse epidemic.
695. Walmart also financially benefited from these violations of law. Walmart chose
to avoid the expense of creating and implementing a proper program for monitoring and
reporting suspicious orders. For example, Walmart avoided the expense of creating and
implementing a remediation plan for each suspicious order, which could have imposed burdens
on Walmart and might also have uncovered improper activity that Walmart would have to
remediate. Likewise, Walmart avoided the expense of paying for adequate numbers of
compliance personnel. Most critically, Walmart profited by providing its pharmacies with
unusually large quantities of controlled substances to sell, and from selling other products to
customers who came to Walmart stores only because Walmart pharmacies would readily provide
these controlled substances.
696. In sum, Walmart chose, for years, to disregard a well-established legal obligation
on a systematic basis and a huge scale involving at least hundreds of thousands of orders of
controlled substances. In doing so, Walmart substantially benefited itself while increasing the
risk of undetected unlawful conduct and serious widespread harm to Americans in the midst of a
nationwide prescription drug abuse epidemic.
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CLAIMS FOR RELIEF
FIRST CLAIM (For civil penalties and other relief, based on violations of 21 U.S.C. §§ 842(a)(1) & 829 and 21 C.F.R. § 1306.04(a))
697. The United States incorporates by reference each of the preceding paragraphs as if
fully set forth herein.
698. During the Dispensing Violations Period, from June 26, 2013, to the present,
Walmart repeatedly violated 21 U.S.C. §§ 842(a)(1) and 829, and 21 C.F.R. § 1306.04(a),
because it, through its agents and employees, knowingly dispensed controlled substances
pursuant to prescriptions that were either not issued in the usual course of professional treatment,
not for a legitimate medical purpose, or both.
699. Walmart violated these provisions on multiple occasions, with the precise number
of violations to be established at trial.
700. For each violation, Walmart is liable for a civil penalty as provided under 21
U.S.C. § 842(c)(1)(A).
701. The United States also requests that the Court issue an order granting appropriate
injunctive relief tailored to restrain Walmart’s violations of 21 U.S.C. § 842. See 21 U.S.C.
§ 843(f).
SECOND CLAIM (For civil penalties and other relief, based on violations of 21 U.S.C. §§ 842(a)(1) & 829 and 21 C.F.R. § 1306.06)
702. The United States incorporates by reference each of the preceding paragraphs as if
fully set forth herein.
703. During the Dispensing Violations Period, from June 26, 2013, to the present,
Walmart repeatedly violated 21 U.S.C. §§ 842(a)(1) and 829, and 21 C.F.R. § 1306.06, because
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it, through its agents and employees, did not adhere to the usual course of the professional
practice of pharmacy in filling prescriptions for controlled substances.
704. Walmart violated these provisions on multiple occasions, with the precise number
of violations to be established at trial.
705. For each violation, Walmart is liable for a civil penalty as provided under 21
U.S.C. § 842(c)(1)(A).
706. The United States also requests that the Court issue an order granting appropriate
injunctive relief tailored to restrain Walmart’s violations of 21 U.S.C. § 842. See 21 U.S.C.
§ 843(f).
THIRD CLAIM (For civil penalties, based on violations of 21 U.S.C. § 842(a)(5) and 21 C.F.R. § 1301.74(b))
707. The United States incorporates by reference each of the preceding paragraphs as if
fully set forth herein.
708. During the Distribution Violations Period, from June 26, 2013, through
November 29, 2017, Walmart refused or negligently failed to report suspicious orders to DEA, in
violation of 21 U.S.C. § 842(a)(5) and 21 C.F.R. § 1301.74(b).
709. Walmart violated 21 U.S.C. § 842(a)(5) and 21 C.F.R. § 1301.74(b) on multiple
occasions, with the precise number of violations to be established at trial.
710. For each violation, Walmart is liable for a civil penalty as provided under 21
U.S.C. § 842(c)(1)(B).
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PRAYER FOR RELIEF
WHEREFORE, the United States respectfully requests judgment to be entered in its favor
and against Walmart as follows:
a. Awarding a sum equal to civil penalties to the maximum amount allowed by law;
b. Granting injunctive relief to address and restrain Walmart’s violations of law; and
c. Granting the United States such further relief as the Court may deem proper.
Respectfully submitted,
Dated: December 22, 2020
JEFFREY BOSSERT CLARK JASON R. DUNN Acting Assistant Attorney General United States Attorney for the Civil Division District of Colorado
DANIEL J. FEITH /s/ Kevin T. Traskos Deputy Assistant Attorney General KEVIN T. TRASKOS AMANDA A. ROCQUE /s/ Gustav W. Eyler JASAND P. MOCK GUSTAV W. EYLER Special Attorneys to the Attorney General Director 1801 California Street, Suite 1600 Pro hac admission pending Denver, CO 80202 ADAM E. LYONS [email protected] Senior Litigation Counsel 303-454-0100 Pro hac admission pending JOSHUA FOWKES Pro hac admission pending MARIA CHAPA LOPEZ KATHLEEN B. GILCHRIST United States Attorney for the Pro hac admission pending Middle District of Florida AMY KAPLAN Pro hac admission pending /s/ Katherine M. Ho Trial Attorneys KATHERINE M. HO U.S. Department of Justice LACY R. HARWELL, JR. Civil Division LINDSAY S. GRIFFIN Consumer Protection Branch CAROLYN B. TAPIE P.O. Box 386 Special Attorneys to the Attorney General Washington, DC 20044 400 West Washington Street, Suite 3100 [email protected] Orlando, FL 32801 202-307-0066 [email protected] 407-648-7500
159 Case 1:99-mc-09999 Document 1446 Filed 12/22/20 Page 160 of 160 PageID #: 149865
DAVID C. WEISS SETH D. DuCHARME United States Attorney for the Acting United States Attorney for the District of Delaware Eastern District of New York
/s/ Laura D. Hatcher /s/ Elliot M. Schachner LAURA D. HATCHER ELLIOT M. SCHACHNER DYLAN STEINBERG JAMES KNAPP Assistant United States Attorneys JOLIE APICELLA 1313 N. Market Street MEGAN FREISMUTH Wilmington, DE 19801 Special Attorneys to the Attorney General [email protected] 271 Cadman Plaza East 302-573-6277 Brooklyn, NY 11201 [email protected] 718-254-7000
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Pharmacy Law Update Disclosure No one involved in the planning or presentation of this activity has any relevant financial 2021 relationships to disclose.
Accreditation
Michigan Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education (ACPE) to provide continuing education for pharmacists and pharmacy technicians. Ferris State University Credit amount subject to change. Pharmacists & Pharmacy Technicians Michigan Pharmacists Association designates this activity for 1.0 contact hours for pharmacists and pharmacy technicians. Pharmacists and pharmacy technicians should claim only credit College of Pharmacy Spring Seminar commensurate with the extent of their participation in the activity.
Learning Objectives What’s changed?
1. Suspicious order reporting requirements
2. Mandatory electronic prescribing
1. Summarize Michigan pharmacy laws that changed in the past 12 months. 3. Remote pharmacy license
2. Explain changes needed to be made to comply with recent law changes. 4. Temporary regulations for COVID-19 pandemic
3. Interpret and apply laws to contemporary pharmacy practice. 5. Prescriptive authority for APRN’s
6. Continuing education requirements for pharmacists
Suspicious Orders
SUPPORT Substance Use-Disorder Prevention that Promotes Opioid Act Recovery and Treatment for Patients and Communities Act
(or the SUPPORT for Patients and Communities Act)
DEA Previously Suspicious Order Monitoring (SOM) programs and reporting requirements only applied to manufacturers and distributors
Now SOM program and reporting applies to all DEA registrants that distribute controlled substances, but not reverse distributers or exporters
Source: 21 USC 832; see also DEA Pharmacist’s Manual 2020.
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Suspicious Orders Suspicious Order Monitoring Program
Purpose Identify, stop, and report suspicious orders; in addition to the responsibility of each registrant to maintain effective controls against diversion. Requirements 1) Design and operate a system to identify suspicious orders
Defined A “suspicious order” may include, but is not limited to– 2) Ensure the system complies with applicable privacy laws 3) Upon discovering a suspicious order or series of orders, notify the An unusual size CS order; Drug Enforcement Administration (report to database) and the Special A CS order that substantially deviates from a normal pattern Agent in Charge of your DEA Division Office (Detroit)
Unusual frequency for the CS order
Source: 21 USC 802(57), 832. Source: 21 USC 802(57), 832.
DEA’s Pharmacist’s Manual Professional Standards
“A pharmacist is required to exercise sound professional judgment, and to The 2020 edition replaces previous 2010 edition. adhere to professional standards, when making a determination about the legitimacy of a controlled substance prescription.”
Notable changes: The determination is made before dispensing the prescription Professional standards Failure to resolve a concern that a prescription is “doubtful, questionable, Partial dispensing of controlled substances (CARA amendment) or suspicious medical legitimacy” is a felony
Bringing CS’s from the home to the hospital Pharmacists who deliberately ignore a high probability that a prescription is not legitimate may be prosecuted
Available at: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046)(EO-DEA154)_Pharmacist_Manual.pdf. Available at: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046)(EO-DEA154)_Pharmacist_Manual.pdf.
Corresponding Responsibility Corresponding Responsibility
Corresponding responsibility is a process, not a checklist. A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a • Proper license(s) and DEA The patient All of this is corresponding responsibility rests with the pharmacist who fills the and along with a registration is required to prescribe. documented prescriber A physical medical and a and a prescription. An order purporting to be a prescription issued not in the usual course in the meet each examination evaluation to treatment is prescription patient’s of professional treatment or in legitimate and authorized research is not a prescription • DEA expects pharmacists to have other to is conducted, establish a selected. is issued. medical a system in place to validate establish a diagnosis within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the record prescriptive authority. relationship. person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
Source: 21 CFR 1306.04, MAC R. 338.3162. 12
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Corresponding Responsibility: Partial Dispensing You can’t, unless you can. A partial dispensing is not a refill. If a CS is partially dispensed, another law may change the Rx’s expiration date. Document and Verify prescriber’s Ensure the Avoid dispensing resolve all red license and DEA prescription has all certain drug registration required information combinations flags before Schedule II dispensing No refills allowed The prescription expires 90 days after it is issued
Schedule III and IV May be refilled up to 5 times The prescription expires 6 months after it is issued Use Prescription Know guidelines and Know and follow educate prescribers Drug Monitoring Provide access to Schedule V REMS program and patients on Programs naloxone May be refilled as indicated by the prescriber requirements proper use and The prescription expires 1 year after it is issued MAPS disposal of opioids
Source: Mich. Admin. R. 338.3168.
Partial Dispensing Bringing CS’s to the Hospital
• Total quantity dispensed can never exceed the total quantity prescribed Patients admitted to a hospital by ambulance/EMS, there is no family present, and the patient has in his or her possession dispensed CS medications • Partial dispensing of schedule III-V’s allowed Hospital can secure the medication in the patient’s room with personal belongings and not take • Partially dispensed III-V’s expire 6 months after issued (caution with C-5’s!) possession Turn the medication over to a member of the patient’s household to return them to the house or Inventory Rule (i.e. have enough inventory to supply prescribed quantity) have them disposed Must dispense remaining quantity within 72 hours of first partial filling Provide a mail-back package to a member of the patient’s household Notify prescriber if not dispensed Or follow a state law for disposing abandoned CS’s Hospice/LTCF Rule DEA references in part: Pharmacist must record on Rx the patient is terminally ill or a LTCF patient May partially dispense for 60 days from the issue date “The DEA understands that there may be circumstances where there is no authorized Any remainder is void person to dispose of the controlled substances, such as when controlled substances are abandoned at a school or summer camp, and return to the ultimate user is not feasible. In Patient/Prescriber Rule such instances, the affected entities should contact local law enforcement or their local Patient or prescriber request (not pharmacist), may partially dispense for 30 days from the date issued DEA office for guidance on proper disposal procedures.”
Source: Source: 21 USC 829(f), 21 CFR 1306.23 and Mich. Admin. R. 338.3166. Source: DEA Pharmacist’s Manual, pp. 88-89 (2020 version). See also 79 FR 53546.
Mandatory e-Prescribing
Beginning January 1, 2022*, all prescriptions must be transmitted to the pharmacy electronically. Electronic Prescribing Pharmacists: • May dispense non-electronic prescriptions in good faith (no duty to verify a valid exception)
• Shall exercise professional judgment regarding the accuracy, validity, and authenticity of the transmitted prescription
* Automatically delayed if CMS’s Part D e-prescribing mandate is delayed.
Source: MCL 333.17754a.
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Mandatory e-Prescribing Exceptions
Veterinarians Prescriptions that do not require a patient name (e.g., EPT, epinephrine Prescriptions issued during a autoinjector, naloxone, etc.) temporary technological or electrical failure Prescriptions issued under a research protocol Physicians with a waiver from LARA Prescriptions the physician reasonably Emergency schedule II prescriptions believes e-prescribing makes make it Remote Pharmacy impractical to obtain the drug in a Prescriptions to be filled in another timely manner and the patient’s state condition will be adversely affected* Out-of-state prescriptions Prescriptions issued and dispensed in the same health care facility** Prescriptions with content: Not supported by NCPDP SCRIPT * Physician must document in medical record Standard ** Hospital, hospice, dialysis treatment clinic, Mandated by FDA that cannot be freestanding surgical outpatient facility, SNF’s, LTC transmitted facility with ongoing nursing care
Source: MCL 333.17754a.
Remote Pharmacy Remote Pharmacy
Surveillance system • All pharmacies must be in Michigan A real-time, continuous audio and visual camera • Operate under common ownership Remote system that connects a pharmacist at a parent pharmacy Remote pharmacies are not required to pharmacy with a remote pharmacy for the • Remote pharmacy is not within 10 miles of operate under the personal charge of a purposes of providing oversight and security another pharmacy Remote surveillance Exception for hospitals, mental health facilities, or pharmacy pharmacist waiver issued by BOP Telepharmacy system BOP shall only grant a waiver if applicant demonstrates to the satisfaction of the board the An interoperable computer system that meets all proposed remote pharmacy is in an area where there Staffed by a qualified technician and of the following requirements: (a) Shares real-time is limited access to pharmacy services and there are Parent data and uses a real-time audio and video link to compelling circumstances to justify waiving the pharmacy overseen using a surveillance system connect a pharmacist at a parent pharmacy with a requirement and a telepharmacy system by a remote pharmacy operated by the parent pharmacist pharmacy. (b) Uses a camera that is of sufficient • Must have a PIC quality and resolution to allow a pharmacist at a May serve as PIC at up to 3 pharmacies parent pharmacy who is reviewing a prescription 8 hours/week at each pharmacy to visually identify the markings on tablets and capsules at the remote pharmacy.
Source: MCL 333.17742a, 17742b, and 17748. Source: MCL 333.17742a, 17742b, and 17709(4)-(5).
Remote Pharmacy
Qualified technician • Must be a fully licensed pharmacy technician (not a temporary or limited license) Temporary Laws for • Must have at least 1,000 hours of experience working in a pharmacy after licensed (includes a temporary license) • Must have PTCB or NHA certification COVID-19 Pandemic If a pharmacist is not present at the parent pharmacy [to supervise the remote pharmacy], the remote pharmacy must be closed for business unless a pharmacist is present at the remote pharmacy.
A remote pharmacy shall not dispense more than an average of 150 prescriptions per day during a 90-day period.
Source: MCL 333.17742b.
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Temporary Pharmacy Laws
In effect • Operate a temporary pharmacy (no sterile • Operate a remote pharmacy without a license Michigan compounding) • Waived non-resident licensing to do business in • Dispense and administer a drug to treat an Mich. individual with COVID-19 (under • Pharmacies may not ship CS’s, unless Board of Pharmacy CDC/NIH/MDHHS protocol) shortage
• Substitute a therapeutically equivalent drug if a • Wholesalers and manufacturers to distribute critical shortage (inform patient and notify CS’s to hospitals, manufacturers, or prescriber) wholesalers
• Allow a pharmacy to confirm delivery of a prescription drug, excluding a controlled Expired substance, by any reasonable means • Emergency refill of up to a 60-day supply for • Remote preceptorship allowed non-controlled drug Source: MCL 333.17713
Primer on Administrative Rulemaking Midlevel Prescribing in Michigan
Midlevel Must submit to Joint Committee on Administrative Rules (JCAR) prescribers Physician’s assistants’ and APRN’s (i.e., NMW, NP, CNS) within 1 year from public hearing. If it has been more than 1 year, must hold another public hearing.
Post‐ Pre‐Hearing Public Adopted by File with Prescriptive RFR Hearing JCAR Draft Rules Hearing Department Great Seal authority All midlevel prescribers require a practice agreement Draft Rules PA’s prescribe independently for all drugs Request for Rules Rulemaking, become APRN’s prescribe independently for non-controlled substances; submitted by the The APA gives the public several opportunities to provide input. effective 7 board, Dept., public days after CS’s are prescribed under delegation or advisory filed with the committee Great Seal. Scope of practice Unless limited by a practice agreement, all midlevel prescribers except NMW’s scope include the human; NMW’s limited to maternity care of women before, during and after pregnancy as well as the neonate
Source: Act 306 of 1969, available at http://legislature.mi.gov/doc.aspx?mcl-Act-306-of-1969; see also MCL 24.247.
Summary of Prescriptive Authority and Scope of Practice for Michigan Pharmacies (Laws last updated January 14, 2021) Out‐of‐State Prescriptions Filled Michigan Prescribers Canada Michigan in Michigan Credential Midlevel Prescribing in Michigan Scope of Practice Rx Only CS’s Rx Only CS’s Rx Only CS’s
MD, DO humans
DVM/VMD animals Yes Yes Yes Yes No Must have Michigan CS license DDS/DMD mouth and DEA registration for CS’s Previously NP’s and NMW’s were limited to prescribing no more than a 30 DPM hand, foot, ankle day supply of schedule 2 drugs (i.e. Multiple C2 Prescription Yes, if certified for OD eyes therapeutic pharmaceutical agents only Rule didn’t apply) Must have Michigan CS license and DEA registration for schedule 3‐5 and dihydrocodeinone combination drugs Yes, with practice agreement Humans signed by MD, DO, or DPM No PA unless also holds a (or podiatry) Must have Michigan CS license Michigan license Now All APRN’s, including CNS’s may prescribe up to a 90-day and DEA registration for CS’s No (May 3, 2021) supply of schedule 2 drugs NP humans, By delegation subject to practice agreement Yes, with practice from MD or DO CNS agreement Requires DEA registration and not more than 90‐day supply NMW maternity care
By delegation with Other licensed health By delegation collaborative practicePhar 735 agreement | Spring 2021 No Source: Mich. Admin. R. 338.119 and 338.2411, promulgated April 26, 2021. See also MCL 333.17201(1)(a), 17211a(1). professional 30 Must have DEA registration© Charlie for Mollien CS’s
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When Do New CE Rules Apply to Me?
• CE rule changes do not apply until after you renew your license
• The license cycle for pharmacy profession licenses changed when LARA moved to the new MIPLUS licensing platform
Continuing Education • Your first renewal on the MIPLUS system gave you a 2+ year license • All licenses now expire every 2 years based its original issue date Filed with the Great Seal December 22, 2020 • Your CE requirements during the one-time 2+ year cycle do not change; you get Effective December 29, 2020 a little extra time to complete your CE
• CE requirements apply to pharmacist and special retired volunteer pharmacist licenses
CE Rule Clarifications CE Rule Clarifications
CE applies to special retired volunteer pharmacist licenses Requests for Board-approved CE must be submitted 70 days before CE is only required if your license cycle is a full 2-year cycle date of scheduled board meeting
One-time training identifying victims of human trafficking and if you hold a CS license a one-time training in opioids and other controlled substances Board-approved CE valid to be delivered for 3 years awareness is required • Any changes to speakers or course content must be approved by the board 70 days in advance, unless emergency requires lesser time You cannot take the same CE course twice in a license cycle
Keep proof of CE 4 years from date license is renewed
Submit CE waivers to LARA before license expires Specific CE certificate content requirements listed in the rule
Source: Mich. Admin. R. 338.3043. Source: Mich. Admin. R. 338.3043.
New Pharmacy Law & Ethics Topic Acceptable CE Activities
Topic Hours Activity Limits Pharmacy Ethics and Jurisprudence 1 Accreditation Council for Pharmacy Education (ACPE) Pain and Symptom management* 1 Michigan Board of Pharmacy-approved programs Live CE Canadian Council for Accreditation of Pharmacy Programs (CCAPP) (Live courses or programs that provide for direct interaction between faculty and participants, 10 including but not limited to, lectures, symposia, live teleconferences, and workshops) Any state board of pharmacy approved program Postgraduate pharmacy practice or pharmacy administration courses, 12 hours/Quarter Credit * Pain and symptom management must behavior management, psychology of pain, pharmacology, behavior modification, taken at ACPE or CCAPP accredited school or college of pharmacy 18 hours/Semester Credit stress management, clinical applications, and drug interventions as they relate to professional practice ACPE-approved provider home study programs Up to 20 hours/renewal Preceptorship (must be 1:1 ratio) 5 hours of CE for 120 • No more than 12 hours of CE may be earned in a 24-hour period hours of in-person preceptorship • Must earn 30 hours of CE during each 2-year renewal cycle (up to 5 hours/renewal)
Source: Mich. Admin. R. 338.3041. Source: Mich. Admin. R. 338.3044.
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Acceptable CE Activities
Activity Limits Renewing pharmacist license in another state with “substantially equivalent” subject matter and total hours Initial publication of an article or chapter related to pharmacy practice 10 hours per publication, (e.g., pharmacy textbook chapter, peer-reviewed journal article) up to 10 hours/renewal Successfully completing BPS certification 10 hours/passing score General Rules Up to 20 hours/renewal Presenting a CE program, but not if it is part of your job responsibility Double hours Filed with the Great Seal December 22, 2020 Up to 10 hours/renewal Effective December 29, 2020
• Rules indicate specific proof required for each activity type if audited
Source: Mich. Admin. R. 338.3044.
Pharmacist Intern License Pharmacist License Exams
May be licensed up to 180 days after graduating from ACPE-accredited school or college of pharmacy If you’re not success passing the NAPLEX or MPJE after 3 attempts, must complete courses that provide a thorough review of area(s) failed before 1-year license permitted for graduates of non-accredited schools or sitting for the exam a 4th or 5th time colleges of pharmacy who pass NABP’s Foreign Pharmacy Graduate Equivalency Examination® (may be renewed 1 time) Retake pharmacy law course if MPJE failed 5 times
Must notify the board within 30 days if no longer actively enrolled in an Repeat pharmacy school if NAPLEX failed 5 times approved education program
Source: Mich. Admin. R. 338.513 and 515. Source: Mich. Admin. R. 338.519.
Pharmacist License Reinstatement Inspections
The requirements to reinstate a lapsed license were updated and clarified. Michigan has a 60-day grace period to renew your license.
In addition to usual license application requirements: Non-resident pharmacies must be inspected every 2 years Lapsed Lapsed Lapsed In Michigan, inspections may be performed by LARA or NABP more than 3 years, 0-3 years 8 years or more but less than 8 years Required for a new pharmacy license Retake NAPLEX within 2 years of applying Required to provide sterile compounding services, then every 18 months Retake MPJE (LARA, NABP-VPP, accreditation body, non-resident agencies using NABP’s inspection blueprint) Internship Internship 200 hours 400 hours CE requirements completed (30 hours looking back 2 years prior to application)
Source: Mich. Admin. R. 338.525. Source: Mich. Admin. R. 338.534.
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LARA Notifications Outsourcing Facility
Action Time frame 1. Automated device Rules 32 and 33 2. Discontinue sterile compounding Within 30 days Michigan licenses as a pharmacy 3. Complaint/Gov’t Investigation Against Sterile Within 30 days Compounding Pharmacy in Another State Must be accredited 4. Criminal Conviction Within 30 days Must comply with current USP standards, as of December 22, 2020 5. Emergency C-II Rx Not Provided Required to be registered with and inspected by FDA before licensure 6. Loss/Theft of Controlled Substances Within 10 days of discover Submit biannual report provided to FDA to LARA 7. License Action in Another State Within 30 days (a listing of all drugs compounded in previous 6 months) 8. MAPS correction Within 7 days Must follow cGMP 9. Name/Address/E-mail Address Change Within 30 days PIC must be proficient in compounding practices 10. PIC or Ownership Change Within 30 days Participate in seminars Study appropriate literature 11. Pharmacy closure 15 day before Consult with colleagues 12. Pharmacist Intern not active in school Within 30 days Complete a compounding certification program approved by the board
Source: 1. R. 338.588, 2. R. 338.535, 3. 333.17748a(5), 4. 333.16222, 5. R. 338.3165, 6. R. 338.3143, 7. 333.16222, 8. 338.3162d, 9. 333.16192, 10. 333.17748, 11. 338.538, 12. R. 338.513. Source: Mich. Admin. R. 338.532 and 533.
Automated Devices Upcoming Changes
Clarified definition A mechanical system that performs an operation or activity, other than compounding or administration, relating to the storage, packaging, dispensing, or delivery of a drug and that collects, controls, and maintains transaction information. 1. Implicit bias training for licensed health care professionals Clarified its use at a pharmacy A pharmacy or at the same physical address as the pharmacy provided that the location of the 2. Compounding MOU automated device is owned and operated by the same legal entity as the pharmacy. 3. Board of Pharmacy Rule Changes
Notification A pharmacy that operates an automated device under this section to deliver a drug or device directly to an ultimate user or health care provider shall notify the department of the automated device’s location on a form provided by the department. An automated device located within a licensed pharmacy must be used only by a pharmacist or his or her pharmacy personnel under the personal charge of a pharmacist.
Source: Mich. Admin. R. 338.588.
Implicit Bias Training Implicit Bias Defined
Governor Whitmer issued Executive Directive 2020-7 to improve equity in the delivery of health care services in Michigan • COVID-19 data reported by the state has revealed disparities in health outcomes associated with demographic factors such as race, ethnicity, and gender. Such disparities can unintentionally arise due to implicit bias. • The directive requires health workers to obtain training on how to recognize and mitigate implicit bias to Implicit bias: An attitude or internalized stereotype that affects an reduce the disparities and provide the best health care to all patients under the care of health care workers licensed under Article 15 of the Public Health Code, except for persons practicing under Part 188 individual’s perception, action, or decision making in an (Veterinary Medicine). unconscious manner and often contributes to unequal treatment of people based on race, ethnicity, nationality, Mich. Admin. R. 338.7004 (proposed rule 2020-109 LR (Public Health Code – General Rules) gender, gender identity, sexual orientation, religion, socioeconomic status, age, disability, or other characteristic. Licensed pharmacists, pharmacy interns, and pharmacy technicians Expected to finish rulemaking process May 19, 2021 New Training requirement, not a continuing education requirement
Source: Mich. Admin. R. 338.7001(c)
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Frequency of Implicit Bias Training Implicit Bias Training Requirements
Starting one year after the rule is adopted, likely May 19, 2021. . . Purpose: Reducing barriers and disparities in access to and delivery of health care services Topics: Training must cover one (or more) of the following topics: Applying for License Renewing License 1. Information on implicit bias, equitable access to health care, serving a diverse population, diversity and inclusion initiatives, and cultural sensitivity, 2 hours of training within the 5 1 hour of training each license 2. Strategies to remedy the negative impact of implicit bias by recognizing and years before applying for a renewal cycle understanding how it impacts perception, judgment, and actions that may result in inequitable decision making, failure to effectively communicate, and result in barriers and license disparities in the access to and delivery of health care services, 3. The historical basis and present consequences of implicit biases based on an individual’s characteristics, or 4. Discussion of current research on implicit bias in the access to and delivery of health It takes 2 hours of training to get a license care services. and 1 hour of training each renewal cycle to keep your license. Training must include strategies to reduce disparities in access to and delivery of health care services and the administration of pre- and post-test implicit bias assessments.
Implicit Bias Training Requirements Implicit Bias Training Requirements
This is a live training requirement. You must prove you completed the required training. Live synchronous interaction by teleconference or webinar Attest upon licensure renewal training was completed Live presentation Reminder! You are attesting on the date you renew the training is already done, not that it will be done before the end of the license cycle – the same for CPE Interactive online instruction requirements. Training must be provided by one of the following: Keep documentation 6 years from the date you renew your license (or apply)
Nationally-recognized or state-recognized health-related organization LARA will conduct audits to ensure health care professionals comply with the rule
By or in conjunction with a state or federal agency If I’m audited, how do I prove to LARA I completed the training?
Educational program approved by any Article 15 board (but not veterinarians) Certificate issued by the training program that includes the date of the training, the program sponsor’s name, the title of the program, and licensee’s or registrant’s (e.g., ACPE continuing education programs) name. Accredited college or university Self-attestation by the licensee or registrant that includes the date of the training, the program sponsor’s name, the title of the program, and licensee’s or registrant’s name Organization specializing in diversity, equity, and inclusion issues
Compounding Other Pending Rulesets
1. Animal Euthanasia and Sedation Rules (draft rule language published 4/28/21)
2. Pharmacy Technicians (draft rule language published 12/23/20) Technology-assisted final product verification Training programs will not require accreditation Training program must be completed within 2 years Keep proof of CE 4 years (was 3 years) after renewal application submitted Determine whether to sign Memorandum of Understanding Additional methods to earn CE
3. Central Fill Pharmacies
4. Controlled Substances (draft rule language published 3/5/21)
5. General Rules
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Learning Assessment
Q&A True or False Suspicious order monitoring and reporting laws that once only applied to manufacturers and wholesalers now apply to pharmacies if they transfer medication to another DEA registrant.
Learning Assessment Learning Assessment
Which is true about when a pharmacist may partially dispense a prescription issued for a schedule 2 medication? Future implicit bias training is a:
A. At the request of the patient before the prescription expires in 90 days.
B. Within 72 hours of dispensing a first fill limited by the patient’s insurance A. One-and-done training requirement. benefit to a 7-day supply. B. Future training requirement that applies to each license cycle.
C. Within 60 days, as many times as needed up to the quantity C. Training requirement that applies to every licensed health professional prescribed, for a terminally ill or LTCF patient. under the Public Health Code. D. Within 72 hours of dispensing a first fill if the pharmacy does not have adequate inventory, even if the first fill was 88 days after its issue date.
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Thomas J. Silhavy Gram‐negative Bacteria: Structural and Therapeutic Considerations
Nonsense syllables
BamA, SecY, SurA
George N. Holcolm
1884: Hans Christian Gram
Bladen, H.A. and Mergenhagen, S.E. (1964) Ultrastructure of Veillonella and morphological correlation of an outer membrane with particles associated with endotoxic activity. J. Bacteriol. 88:1482-1492.
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Science 156:1451-55 (1967)
Glauert, A.M. and Thornely, M.J. (1969) Ann. Rev. Microbiol. 23:159-198.
Fractionation Lipopolysaccharide
• Miura, T., and Mizushima, S. (1968) Separation by density gradient centrifugation of two types of membranes from spheroplast membrane of Escherichia coli K12. Biochim Biophys Acta 150, 159– 161.
• Schnaitman, C.A. (1970). Protein composition of the cell wall and cytoplasmic membrane of Escherichia coli. J Bacteriol 104, 890‐901.
• Osborn, M.J., Gander, J.E., Parisi, E., and Carson, J. (1972). Mechanism of assembly of the outer membrane of Salmonella typhimurium. Isolation and characterization of cytoplasmic and outer membrane. J Biol Chem 247, 3962‐3972.
Lipopolysaccharide Proteins
• Kamio, Y., Nikaido, H. (1976) Outer membrane of Salmonella typhimurium: accessibility of • Braun, V. (1975) Covalent lipoprotein from the outer membrane of Escherichia coli. Biochim phospholipid head groups to phospholipase C and cyanogen bromide activated dextran in the Biophys Acta 415, 335–377. external medium. Biochemistry 15, 2561–2570. • Chen, R., Schmidmayr, W., Kramer, C., Chen‐Schmeisser, U., and Henning, U. (1980) Primary • Ray, B.L., Painter, G., and Raetz, C.R.H. (1984) The biosynthesis of Gram‐negative endotoxin: structure of major outer membrane protein II* (ompA protein) of Escherichia coli K‐12. Proc. Natl. Formation of lipid A disaccharides from monosaccharides in extracts of Escherichia coli. J. Biol. Acad. Sci. USA 77:4592‐4596. Chem. 259,4852‐4859.
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Lipoproteins Proteins - OmpA
O +1 HN Cys O OH S
O O
O
“The outer membrane contains substantial amounts of protein and phospholipid and in addition, most or all of the lipopolysaccharide of the cell envelope. Synthesis of lipopolysaccharide and other constituents of the outer membrane poses a special problem in that the final product is localized in a structure physically separated from essential intracytoplasmic precursors by a presumptive permeability barrier imposed by the cytoplasmic membrane.” Juliana Malinverni
The cellular machineries required for OM biogenesis Outer membrane collaborators
Daniel Kahne (Harvard University)
Natividad Ruiz (Ohio State University)
Konovalova et al, Ann Rev Microbiol, 2017
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Stress Responses: Security Guards of the Bacterial Cell Envelope
Monitor, Notify, Minimize Damage
Rcs
σE
Cpx
Konovalova et al, Ann Rev Microbiol, 2017
Gram-Negative Envelope The Gram-negative cell envelope is double trouble for antibiotic development
E. coli
100 nm
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The cellular machineries required for OM biogenesis
There is great need for research into the antibiotic permeability barriers of bacteria, particularly of Gram-negative organisms, and the physical properties of chemicals that can overcome these barriers.
Konovalova et al, Ann Rev Microbiol, 2017
Terry Roemer
Scott Walker Hao Wang Juliana Malinverni Carl Balibar Nate RigelJaclyn Schwalm Dante Ricci
Parallel Chaperone Pathways skp and surA are a synthetic lethal pair
5 5/20/2021
The essential σE stress response pathway
rpoE_S2R is a suppressor of synthetic lethal skp surA double mutants
rpoE
rpoE_S2R upregulates production of σE
Levels of the σE protein Positive Feed-back Loop
Anna Konovalova Marcin Grabowicz Konovalova et al, J.Bacteriol. 2016
rpoE_S2R does not increase activity of the σE envelope stress response rpoE_S2R enhances kinetics of the σE envelope stress response
S2R Steady-state σE activity Positive Feed-back Loop rpoE
WT
WT Response
time
rpoES2R
Konovalova et al, J.Bacteriol. 2016
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Rationale of the screen Batimastat rpoES2R would be more resistant than WT to drugs which inhibit Bam pathway Anti-cancer drug (angiogenesis rpoES2R would be more resistant than WT to drugs which inhibit σE pathway inhibitor)
Matrix metalloproteinase inhibitor
55,000 small molecules active against efflux-deficient E. coli but not Gram- Reached Phase III, but not marketed, positive bacteria no oral administration
Commercially available
Formula: C23H31N3O4S2 Batimastat Molar mass: 477.64 g/mol
RseP is a molecular target for batimastat Batimastat inhibits σE activity in the cell
σE activity PmicA-GFP
Konovalova*, Grabowicz* et al, PNAS, 2018 Konovalova*, Grabowicz* et al, PNAS, 2018
RseP is a molecular target for batimastat Inhibition of the σE response causes toxic accumulation of unfolded OMPs
log2 MIC shift (relative to the parent)
ompA ompC 3 pTrc99 0 pTrc99::degP 3
Konovalova*, Grabowicz* et al, PNAS, 2018 Konovalova*, Grabowicz* et al, PNAS, 2018
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Batimastat provides a unique and specific way The Gram-negative cell envelope is to identify chemical inhibitors of the Bam complex double trouble for antibiotic development
log2 MIC shift (relative to the parent)
bamA101 -3 bamB -2 bamC 0 bamD_L13P -2 bamE -1 ompA ompC 3 pTrc99 0 100 nm pTrc99::degP 3
Konovalova*, Grabowicz* et al, PNAS, 2018
The -barrel assembly machine (BAM) Small molecule screening strategy
BamA BamAB
OM
BamD BamB
BamE BamC
BamCDE Iadanza et al., Nat Communications, 2016 PDB: 5LJO
MRL-494 MRL-494 fits the screening criteria
MIC (µM) E. coli (WT) E. coli (ΔtolC)
MRL-494 25 25
Rifampicin 25 -
Rifampicin + 0.25X MIC 0.195 - MRL-494
Hart*, Mitchell* et al, PNAS, 2019
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MRL-494 passes the “batimastat litmus test”
Both drugs present at 0.25X MIC Angela Mitchell Betsy Hart Hart*, Mitchell* et al, PNAS, 2019
MRL-494 blocks OMP assembly BamAE470K is resistant to MRL-494 Side view view Top
Both drugs present at 0.25X MIC Gu et al, Nature, 2016 (PDB: 5D0O) Hart*, Mitchell* et al, PNAS, 2019
MRL-494 binds to BamA MRL-494 is active against both Gram-negative and Gram-positive bacteria
CETSA (cellular thermal shift assay) Classification Strain MIC (µM) E. coli 25 K. pneumoniae 100 Gram-negative A. baumannii 200 P. aeruginosa 100
S. aureus (methicillin- 12.5 resistant) Gram-positive B. subtilis rpoB18 25
Hart*, Mitchell* et al, PNAS, 2019 Hart*, Mitchell* et al, PNAS, 2019
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MRL-494 distinctly kills Gram-negative and Gram- Monitoring membrane permeability with positive cells TO-PRO-3 iodide
MRL-494 Nisin
Hart*, Mitchell* et al, PNAS, 2019
MRL-494 does not breach the Gram-negative membrane Gram-negative Gram-positive B. subtilis TOPRO-640ex-670em TOPRO-640ex-670em TOPRO-640ex-670em
FSC-A
E. coli FSC-A FSC-A TOPRO-640ex-670em TOPRO-640ex-670em TOPRO-640ex-670em
FSC-A FSC-A FSC-A Hart*, Mitchell* et al, PNAS, 2019
Gram-negative Gram-positive Gram-negative Gram-positive
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Gram-negative Gram-positive Conclusions (resistant) MRL-494 inhibits OMP biogenesis in Gram-negatives by binding to BamA at the cell surface
MRL-494 is the founding member of a new class of antibiotics that acts at the cell surface to kill Gram-negative bacteria
MRL-494 will never reach the clinic, but it is a useful research tool
MRL-494 binds to BamA E470K
CETSA (cellular thermal shift assay)
Betsy Hart Dante Ricci Hart*, Mitchell* et al, PNAS, 2019
Subunit interactions in the Bam holocomplex
E bamA 37°C B A D allele bamA+ +
C bamAE373K -
Ricci et al, PNAS, 2012
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The BamA-BamCDE interaction is perturbed
in bamAE373K bamA 37°C allele E bamA+ + B A D bamAE373K - bamA E373K C E373K- + E470K
Ricci et al, PNAS, 2012
Conclusions
bamAE470K is a gain-of-function allele that allows function even in the presence of MRL-494
bamAE470K bypasses the essentiality of bamD
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The Gram-negative cell envelope Conclusions is double trouble for antibiotic development
BamA BamD does not play a OM catalytic role in OMP assembly, but rather
BamD functions to regulate the BamB activity of BamA
BamE BamC 100 nm
Carl Balibar Todd Black Angela Mitchell Scott Walker Terry Roemer Xiaoqing Han Betsy Hart Juliana Malinverni Frances Rodgriguez-Rivera Jessica Sheng Ronald Painter Adam Schwaid Anna Konovalova Daniel Rile Smaranda Bodea Marcin Grabowicz Paul Mann Qian Si Dante Ricci Hao Wang Michelle Homsher Nate Rigel Charles Garlisi Holly Sutterlin Jaclyn Schwalm Brad Sherborne Deborah Rothman
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FERRIS STATE UNIVERSITY, COLLEGE OF PHARMACY DISCLOSURE 68TH ANNUAL SPRING SEMINAR MAY 25, 2021 • Michael D. Tiberg, PharmD – has no relevant financial or COVID-19 UPDATE: nonfinancial relationships to disclose HOPE FOR RECOVERY
Michael D. Tiberg, Pharm.D., BCPS (AQ-ID) Clinical Pharmacy Specialist in Infectious Diseases Antimicrobial Stewardship Advisors, LLC Munson Medical Center Traverse City, MI
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OBJECTIVES – PHARMACY TECHNICIANS OBJECTIVES – PHARMACISTS
At the end of this activity, pharmacy technicians should be At the end of this activity, pharmacists should be able to: able to: 1. Describe the current state of antiviral agents available and 1. Identify the most common adverse reactions noted with in development for the treatment of COVID-19. the antiviral agent remdesivir which is being used for SARS- 2. Identify adjunctive therapies (e.g. monoclonal antibody CoV-2. therapy, antithrombotic therapy) that are often necessary in 2. Recognize the monoclonal therapies available in the the COVID-19 patient. outpatient and hospitalized patient setting for COVID-19. 3. Recognize (e.g. platform, efficacy, and ADR) the current 3. List the current COVID-19 vaccines available in the U.S. COVID-19 vaccines available in the U.S.
3 4
THE CORONAVIRUS NOMENCLATURE COVID-19 UPDATE OUTLINE
The virus was named by the International • SARS-CoV-2 Committee on Taxonomy of Viruses (ICTV) Cases Adjunctive therapies Antivirals The syndrome was named by the World • 2019-nCoV COVID-19 Vaccines Health Organization (WHO)
Demographics
5 6
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• Large, enveloped, positive strand RNA viruses • Family of viruses, some causing illness in people and others that Coronavirus circulate among animals, zoonotic pathogens • 4 subfamilies: alpha, beta, delta and gamma SARS-COV-2 VARIANTS
Recent notable • 2002 Severe Acute Respiratory Syndrome (SARS) coronaviruses • 2012 Middle Eastern Respiratory Syndrome (MERS)
• Alpha and beta can infect humans and animals, COVID-19 is a Betacoronavirus Human coronavirus • Coronaviruses account for 10-30% of all URTI (i.e. common colds) • Zoonosis - "spillover" • SARS-CoV-2 infects the lung via alveolar epithelial cells by ACE2 receptors
del Rio C., Malani P. JAMA 2020 published online Feb. 28, 2020 CDC.gov accessed Jan. 30, 2020 Fauci A. JAMA 2020 published online Jan. 27, 2020 7 Rubin R. JAMA. 2021;325(13):1241‐1243. doi:10.1001/jama.2021.3370 8 Padres CI, Maston HD, Fauci AS. JAMA 2020 published online Jan. 23, 2020
SARS-COV-2 VARIANTS SARS-COV-2 VARIANTS
https://covid.cdc.gov/covid‐data‐tracker/#variant‐proportions accessed May 8, 2021 9 https://covid.cdc.gov/covid‐data‐tracker/#variant‐proportions accessed May 8, 2021 10
COVID-19 TREATMENT GUIDELINES
11 12 Gandhi RT et al. N Engl J Med 2020;383:1757‐66
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COVID-19 TREATMENTS, ADJUNCTIVE THERAPIES AND ANTIINFLAMMATORY THERAPY SARS-COV-2 VACCINES
Agent Dose/Route/ Mechanism of Comments Frequency/ action Duration (adult) Antiinflammatory Therapy Tocilizumab Adult dosing: Interleukin-6 inhibitor Use with (Actemra) (intravenously) dexamethasone VTE prophylaxis >40-65 kg: 400mg with/without remdesivir >65-90kg: 600mg who experience rapid Convalescent plasma >90kg: 800mg respiratory (max. 800mg/dose) x 1 decompensation d/t Monoclonal antibodies dose COVID-19 Antivirals Baricitinib 4mg orally every 24 Selective inhibitor of Should be considered in (Olumiant) hours x 14 days or until JAK 1 & 2 those patients not able SARS-CoV-2 vaccines hospital discharge to tolerate which ever is first dexamethasone. Should always be used with remdesivir.
13 COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021 14
ANTIINFLAMMATORY THERAPY CORTICOSTEROID THERAPY STEROIDS: CRITERIA FOR USE
Agents Dose/Route/ P’Kinetics Comments Frequency/ Duration* Requires invasive mech. ventilation Dexamethasone 6mg IV/PO daily x 10 Long-acting, half-life 36- RECOVERY trial Requires oxygen or ECMO * days 72 hours with minimal suppl. delivery mineralcorticoid activity through a high flow No benefit in Prednisone 40mg PO daily or in 2 Intermediate-acting, patients who did device or non- mechanical divided doses daily x 10 half-life of 12-36 hours Hospitalized not require suppl. # oxygen ventilation days Suspected COVID- Methylprednisone 32mg IV/PO daily or in Intermediate-acting, 19 or lab. 2 divided doses daily x half-life of 12-36 hours confirmed SARS- CoV-2 infection 10 days Hydrocortisone 160mg IV/PO daily or in Short-acting, half-life 8- 2 to 4 divided doses 12 hours, high • * For patients who are within 24 hours of admission to the ICU plus tocilizumab daily x 10 days mineralcorticoid activity • # For patients with rapidly increasing oxygen demands add tocilizumab (+/- remdesivir) * Steroids should be continued for up to 10 days or until hospital discharge, which ever comes first. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021 15 16 COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021
VTE PROPHYLAXIS IN COVID-19 TREATMENT WITH PATIENTS WITH COVID-19 CONVALESCENT PLASMA
VTE Prophylaxis in NIH Guidelines (criteria Comments Patients With COVID-19 for use April 21, 2021 update) Non-hospitalized patients Should not be initiated. Unless contraindicated heparin or low molecular weight heparin Hospitalized patients (non- Should receive prophylactic dose are preferred for hospitalized pregnant) anticoagulation. patients. Hospitalized children Indications for VTE prophylaxis should be the same in children without COVID-19. Hospitalized pregnant patients In severe COVID-19 prophylactic dose anticoagulation is recommended unless contraindicated. Upon discharge VTE prophylaxis after discharge is not recommended.
Casadell A et al. J Clin Invest 2020 published online accessed March 26, 2020
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021 17 18
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COVID-19 TREATMENT WITH COVID-19 TREATMENT WITH CONVALESCENT PLASMA CONVALESCENT PLASMA
Convalescent plasma NIH Guidelines (criteria Comments (High-titer) for use April 21, 2021 Transfusion- transmitted update) infections Serious adverse events after Hospitalized patients with 1.Panel recommends against the RECOVERY trial – open label, COVID-19 who do not have use in mech. ventilated patients. randomized controlled platform administration were impaired immunity 2.Panel recommends against the trial – convalescent plasma vs. infrequent and consistent Allergic Pyrexia use in non-mech. ventilated usual care: stopped early due to with risks associated with reactions except in a clinical trial. futility. plasma infusion. Adverse Hospitalized patients with Insufficient data for the panel to Several case reports indicate COVID-19 who do have recommend either for or against that patients with impaired Events impaired immunity use. immunity may experience persistent SARS-CoV-2 viral replication with resistance risk. Febrile non- Anaphylaxis Non-hospitalized patients with Insufficient data for the panel to C3PO trial – stopped early due hemolytic rxn. COVID-19 recommend either for or against to interim analysis indicated no rxn. use except in a clinical trial. benefit Convalescent plasma is not authorized for non-hospitalized patients with COVID-19 under the EUA 19 COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021 20
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021
EUA - MONOCLONAL ANTIBODIES
Monoclonal antibodies (mAb) are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, in this case the SARS-CoV-2.
Like other RNA viruses SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.
Lloyd, EC et al. JAMA 2021 doi:10.1001/JAMA.2021.1225 https://www.fda.gov/news‐events/press‐announcements/coronavirus‐covid‐19‐update‐fda‐revokes‐emergency‐use‐authorization‐monoclonal‐antibody‐bamlanivimab accessed April 20, 2021
21 22 https://combatcovid.hhs.gov
Q-PT EUA MONOCLONAL EUA MONOCLONAL ANTIBODIES FOR COVID-19* ANTIBODIES FOR COVID-19
Agent Dose/Frequency/ NIH Guidelines Comments Duration* (criteria for use April 21, (Age > 12 years, Wt. > 2021 update) Bamlanivimab and Casirivimab and 40kg) Bamlanivimab Etesevimab Imdevimab Bamlanivimab and Bamlanivimab 700mg Recommends the use of COVID-19 mAb not As of mid-March 2021, • EUA - March 2021 • EUA - February 2021 • EUA - November 2020 Etesevimab plus etesevimab either of these products authorized for those that: 1400mg administered for: (1) Are hospitalized due ~ 20% of the viruses • FDA revokes EUA April 16, • Authorized for the • Authorized for the sequenced in the U.S. 2021 treatment of mild to treatment of mild to together via IV infusion (1) Outpatients with to COVID-19 were reported as • The FDA has determined moderate COVID-19 in moderate COVID-19 in as a single dose. mild to moderate (2) Require oxygen COVID-19 who therapy due to variants expected to that the known and adults and pediatric patients adults and pediatric patients Casirivimab and Casirivimab 1.2 gm plus with a (+) SARS-CoV-2 test, with a (+) SARS-CoV-2 test, are at high risk. COVID-19 be resistant to potential benefits of this Imdevimab imdevimab 1.2 gm agent alone no longer that are determined to be that are determined to be (2) Patients with mild (3) Are on chronic bamlanivimab alone. administered together outweigh the known and high risk for progression to high risk for progression to to moderate oxygen therapy due severe COVID-19 and/or severe COVID-19 and/or via IV infusion as a potential risks for its COVID-19 who to underlying non- authorized use. hospitalization. hospitalization. single dose. are hospitalized for COVID-19-related a reason other comorbidity *SARS-CoV-2 vaccination should be deferred for > 90 days in people who have received anti-SARS-CoV-2 mAb than COVID-19.
www.fda.gov/news‐events/press‐announcements/coronavirus‐covid‐19‐update‐fda‐revokes‐emergency‐use‐authorization‐monoclonal‐antibody‐bamlanivimab accessed April 20, 2021 *No dosage adjustments are required for body weight, renal impairment, or mild hepatic impairment COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021. 23 24 www.fda.gov/news‐events/press‐announcements/coronavirus‐covid‐19‐update‐fda‐revokes‐emergency‐use‐authorization‐monoclonal‐antibody‐bamlanivimab accessed April 20, 2021 COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021.
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EUA MONOCLONAL MONOCLONAL ANTIBODY ANTIBODIES FOR COVID-19: ADVERSE EVENTS NOMENCLATURE
International Nonproprietary Names (INN) for monoclonal antibodies (mAb) consist of: 1. Prefix – random and distinctive 2. Substem A - which indicates the target (molecule, cell and organ) class of the mAb 3. Substem B - whichAs New indicatesmAb names are the created after species on whichmid-2017 the substem immunoglobulin B has been eliminated. is based 4. Stem (suffix) – always mAb
Parren PW et al. MABS 2017;9(6) 898‐906 JAMA. 2021;325(7):632-644. doi:10.1001/jama.2021.0202 25 WHO INN Working Doc. 17.416, May 2017 26
Q-Rx MONOCLONAL ANTIBODY COVID-19 MONOCLONAL NOMENCLATURE ANTIBODY NOMENCLATURE
mAb names created before the mAb Name Prefix Substem A = Suffix mid-2017 will not Ta r ge t be altered. (viral antigen) Bamlanivimab Bamlani- Etesevimab Etese- -vi- mab Casirivimab Casiri- Imdevimab Imde-
Lexicomp 2021 © 2021 UpToDate, Inc. accessed April 20, 2021 27 28
Presented at the Great Lakes Infectious Diseases Conference March 7, 2020 Presented at the Great Lakes Infectious Diseases Conference March 7, 2020
Repurposing: Use of Investigational agents Approved Therapies for Oseltamivir used in the treatment Remdesivir FDA approves or baloxavir Oct. 22, 2020 Treatment of COVID-19 of COVID-19
Nitazoxanide Tocilizumab Favipiravir Azvudine Approved Invest. Randomized controlled Therapies RCT are underway in the Therapy trials (RCTs) underway in U.S. for: the U.S. for: (1) Remdesivir (1) Hydroxychloroquine (2) Convalescent plasma (HCQ) Chloroquine/ Lopinavir/ (3) Vaccines Convalescent Vaccine FDA EUA (2) Tocilizumab HCQ ritonavir plasma Devolopment 3 vaccines
del Rio C., Malani P. JAMA 2020 published online Feb. 28, 2020 Lu H. Bioscience trends 2020 online access Feb. 20, 2020 Paules CI, Maston HD, Fauci AS. JAMA 2020 published online Jan. 23, 2020 https://apps.who.int/iris/bitstream/handle/10665/330680/WHO-HEO-RDBlueprint%28nCoV%29-2020.1-eng.pdf?ua=1
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Q-PT
ANTIVIRAL THERAPY FOR COVID-19: REMDESIVIR (VEKLURY) (GS-5734) REMDESIVIR (VEKLURY) (GS-5734)
WHO recommends against the use of remdesivir WHO Solidarity trial Nov 20, 2020 Oct 15, 2020
Aleissa MM et al. Antimicrob Agents Chemo 2021 doi: 10.1128/AAC.01814‐20 https://www.vekluryhcp.com/about/ Accessed March 21, 2021 https://www.who.int/news‐room/feature‐stories/detail/who‐recommends‐against‐the‐use‐of‐remdesivir‐in‐covid‐19‐patients Accessed March 21, 2021 31 32
(GS-5734): REMDESIVIR (VEKLURY) REMDESIVIR (VEKLURY) (GS-5734) CRITERIA FOR USE
Currently only drug or antiviral agent approved by the FDA for treatment of COVID-19 P'kinetics Complete first pass metabolism - not suitable for oral Requiring* administration increased oxygen Remdesivir t ~ 1 hour, active triphosphate metabolite t ~ 35 supplementation 1/2 1/2 Requiring minimal hours oxygen add dexamethasone Hospitalized supplementation Steady state achieved in 5 days without a loading dose (LD (SpO2 < 94% on recommended) PLUS room air) Lab confirmed OR Protein binding - 12.1%, rapid distribution to most tissues SARS-CoV-2 (+) by PCR PLUS Poor water solubility - solubilized by SBECD for IV administration
* Not approved in patients requiring mechanical ventilation Lexicomp: Lexi‐Drugs 2021 Accessed April 18, 2021 Aleissa MM et al Antimcro Ag Chemo 2021 e01814‐20 https://www.covid19treatmentguidelines.nih.gov/therapeutic‐management/ accessed May 9, 2021 33 34
(GS-5734): REMDESIVIR (VEKLURY) (GS-5734) REMDESIVIR (VEKLURY) ADVERSE EVENTS
Category Dose Duration Comments Adults and Children Loading dose: 200mg IV 5 days or until hospital Infuse over 30-120 > 40kg infusion X 1 dose discharge which ever is minutes. Maintenance dose: first. 100mg IV infusion daily May be extended to 10 *Patients without days in certain substantial clinical Children 3.5 – Loading dose: 5mg/kg of patients*. improvement by day 5. < 40kg BW x 1 dose Maintenance dose: Formulations contain 2.5mg/kg IV infusion daily SBECD – clinical Renal impairment GFR > 30ml/min. – no adjustment significance is not GFR < 30ml/min. – mfg. does not recommend use certain. Hepatic impairment ALT > 10 times ULN - consider discontinuation ALT elevation AND signs or symptoms of liver inflammation – discontinue
Lexicomp: Lexi‐Drugs 2021 Accessed April 18, 2021 Aleissa MM et al Antimcro Ag Chemo 2021 e01814‐20 35 36 Goldman J et al N Engl J Med 2020 DOI: 10.1056/NEJMoa2015301
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Q-Rx INVESTIGATIONAL ANTIVIRALS INVESTIGATIONAL ANTIVIRALS COVID-19 TREATMENT COVID-19 TREATMENT
Azuvidine (FNC) PF-07321332 • 2 non-U.S. clinical trials identified • Broad spectrum dual targeting nucleoside-based antiviral agent It should be recognized • Investigational agent recently reported by Pfizer for outpatient oral therapy Favipiravir • Protease inhibitor • 48 clinical trials identified (2 U.S. trials) that antiviral drug • Synthetic prodrug, antiviral agent approved in Japan for emerging pandemic influenza infections development against other • Phase 1 clinical trials identifier NCT04756531 Molnupiravir PF-07304814 • 5 clinical trials identified (4 U.S. clinical trials) RNA respiratory viruses • Prodrug with active antiviral ribonucleoside analog has activity against number of RNA viruses including SAR-CoV-2 has resulted in very few • Investigational agent recently reported by Pfizer intravenously administered Umifenovir (Arbidol) agent • 12 non-U.S. clinical trials identified effective therapies. • Broad spectrum antiviral activity which could effectively inhibit the fusion of SAR-CoV-2 with host cells • 3CL protease inhibitor • Phase 1b clinical trials identifier NCT04535167
Coomes EA et al. J Antimicrob Chemother 2020 75:2013‐14 Srinivas P et al. Clev Clin J Med 2020 doi:10.3949.ccjm.87a.ccc030 Painter WP et al. Antimicrob Agents Chemother 2021 doi:10.1128/AAC.02428‐20 Clinicaltrials.gov accessed May 8, 2021 Huang F et al. Med Virol 2020 doi: 10.1002/jmv.26256 https://www.clinicaltrials.gov Accessed April 18, 2021 37 38
NIH GUIDELINES: PHARMACOLOGIC MANAGEMENT OF PATIENTS WITH COVID-19 BASED ON DISEASE SEVERITY
COVID‐19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID‐19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 25, 2021. 39 40
U.S. COVID-19 VACCINATION NUMBERS U.S. EUA COVID-19 VACCINES
Pfizer –BioNTech (BNT192b2) Two-dose schedule •EUA Dec. 11, 2020 Recommended interval: 21 days Efficacy: overall – 95% 7 days after 2nd •ACIP age > 12 years Earliest interval: 17 days from 1st dose Prevention severe infection: 89% •Platform mRNA vaccine Latest interval: 42 days from 1st dose Dose 30mcg/0.3ml
Moderna (mRNA-1273) Two-dose schedule •EUA Dec. 18, 2020 Recommended interval: 28 days Efficacy: overall – 94% 14 days after 2nd •ACIP age > 18 years Earliest interval: 24 days from 1st dose Prevention severe infection: 100% •Platform mRNA vaccine Latest interval: 42 days from 1st dose Dose 100mcg/0.5ml Pause initiated by the Janssen (Ad26.CoV2.S) Single dose FDA/CDC due to CVST (4/13/2021) •EUA Feb. 27, 2021 Efficacy: overall – 67% 14 days after 2nd •ACIP age > 18 years Prevention severe infection: 85% •Platform viral vector vaccine Dose 50 billion viral particles/0.5ml FDA/ACIP reinstated https://www.cdc.gov/coronavirus/2019‐ncov/covid‐ with new warning data/covidview/index.html accessed May 8, 2021 (4/23/2021) 41 42 https://s3.amazonaws.com/filehost.pharmacist.com/CDN/PDFS/COVID/APhACOVIDVaccineSummaryChart0321_web.pdf?AWSAccessKeyId=AKIAYICBVAN2V7IWVG4T&Expires=1618066630&Signature=LvNk1dVu3la1VPrS%2FT8Kdc3Bl4k%3D Accessed May 10,, 2021
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Q-PT COVID-19 VACCINES: ADVERSE EVENTS
Pfizer –BioNTech (BNT192b2)
•Injection site: pain, swelling, erythema •Systemic: fever, fatigue, headache, chills, myalgia, arthralgia – more common after 2nd dose •Anaphylaxis: 4.7 cases/million administered doses
Moderna (mRNA-1273)
•Injection site: pain, swelling, erythema •Systemic: fever, fatigue, headache, chills, myalgia, arthralgia – more common after 2nd dose •Anaphylaxis: 2.5 cases/million administered doses
Janssen (Ad26.CoV2.S)
•Injection site: pain, swelling, erythema •Systemic: headache, fatigue, muscle aches, nausea and fever •Anaphylaxis: reported in clinical studies, CVST 6/6,800,000 administered doses in the U.S.
https://s3.amazonaws.com/filehost.pharmacist.com/CDN/PDFS/COVID/APhACOVIDVaccineSummaryChart0321_web.pdf?AWSAccessKeyId=AKIAYICBVAN2V7IWVG4T&Expires=1618066630&Signature=LvNk1dVu3la1VPrS%2FT8Kdc3Bl4k%3D Accessed April 10, 2021
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ACIP meeting update accessed May 12, 2021 47 48
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CASE – 1 – CASE – 1 – DELAYED HYPERSENSITIVITY RXN. DELAYED HYPERSENSITIVITY RXN.
PE: The right upper extremity was erythematous had no CC: A 30 year old female noticed a large red area on the upper drainage or urticarial lesions. It was also indurated but not portion of her right arm at the site where she had been tender to the touch. This delayed injection site reaction was administered the mRNA COVID-19 vaccine (Moderna). reported to her primary care physician. Cellulitis of the area was ruled out. HPI: The vaccine was administered on 12/26/2020. Within 24-48 Assessment/Plan: Post COVID-19 vaccine delayed hours after the injection she had soreness at the injection site hypersensitivity reaction – no treatment was required, the and overall body fatigue. These symptoms resolved by progress of the area was evaluated and monitored frequently by 12/28/2000. On the evening of 1/3/2021 (8 days post an allergist. vaccination) she noticed a large area on the right upper Post vaccination follow-up: The erythematous/indurated area extremity being erythematous around the injection site but not began to improve on 1/8 and completely resolved within a two painful. days after that. She received the second dose of the mRNA vaccine 28 days Medication allergies: Cefeclor –hives on the trunk, ~ 25 years after the first dose, this was administered in the opposite arm. ago. This reaction took place 4 days after starting cefaclor. The Post administration she experienced minor local injection site medication was discontinued. pain and short lived systemic reactions of fever and chills. She did not experience any delayed local reactions after the second 51 52 dose.
CASE – 2 – RECIPIENT OF MULTIPLE COVID-19 VACCINES
• ZX is an 18 year old male, a student at an international music academy in a midwestern state, who recently traveled home for an end of semester vacation. While There were 343 unique reports of cutaneous at his Southeast Asian residence he received 2 doses of Corona Vac vaccine (Sinovac manifestations after Moderna (mRNA) vaccine Life Sciences). He tolerated the vaccine without any significant adverse events. including 267 reports after the first dose. • After his vacation break he traveled back to school to complete his senior year of high -Most common reactions were delayed school at the academy. In early April his school administration was offered the first large local reactions (median of 7 days). dose of an mRNA COVID-19 vaccine (Pfizer) for any eligible student. -Incidence with Moderna (mRNA) vaccine 0.8% • ZX attended the vaccine clinic on April 15th and registered to receive the first dose of Impressions: These reactions were not consider the vaccine. to be IgE mediated reactions. The reactions were considered not to be a contraindication to • The pharmacist administering the vaccine asked the required questions which included receive the second dose of the vaccine. if he had received any other COVID-19 vaccine previously. ZX informed the pharmacist that he did receive the vaccine as previously described. McMahon DE et al. J Am Acad Dermatol 2021 https://doi.org/10.1016/j.jaad.2021.03.092 53 54 Blumental KG et al. N Engl J Med 2021 DOI:10.1056/NEJMc2102131
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Q-Rx CASE – 2 CASE – 2 RECIPIENT OF MULTIPLE RECIPIENT OF MULTIPLE COVID-19 VACCINES COVID-19 VACCINES
Questions asked by the Corona Vac What would be your decision on administration of the first dose of the mRNA Pharmacist: vaccine (Pfizer) to this individual? 1. Why did he want the mRNA • Sinovac Life Science - Beijing, China vaccine within 2 months of • Inactivated vaccine, produced by Vero cells a) Administer the first dose of the vaccine as requested receiving the inactivated • Not FDA EUA vaccine from his native • 2 doses given 28 days apart b) Deny the vaccine for fear of significant and potentially serious adverse events country? • WHO has not currently authorized for emergency use c) Delay the administration of the vaccine until you inquire from infectious He stated that he was somewhat reluctant to receive the mRNA • Efficacy: Phase 3 trials conducted in Brazil had an diseases specialists on the availability for this individual vaccine in the U.S. but his parents efficacy rate of 50.4% in preventing severe and wanted him to receive it. mild COVID-19 infections d) Wait for the availability of a different platform COVID-19 vaccine (i.e. viral 2. What were his side effects vector) after receiving the inactivated vaccine? WHO.gov accessed May 8, 2021 He had some injection site pain and Zhang PY et al. The Lancet IDOI:https://doi.org/10.1016/S1473-3099(20)30843-4 some mild fatigue, both short lived. 55 56
CASE – 2 CASE – 2 RECIPIENT OF MULTIPLE RECIPIENT OF MULTIPLE COVID-19 VACCINES COVID-19 VACCINES
Organization Consulted Response Comments MDHHS Recommended to administer Consulted with them at the the first dose of the mRNA site of vaccine clinic, prior to vaccine. administration. Infectious Diseases Physician Recommended to administer Consulted within 2 days after Specialists (2) the first dose of the mRNA the administration of the vaccine. vaccine. CDC Approved to administer. See accompanying guidance WHO At the time of the vaccine administration the WHO had not authorized the vaccine for emergency use.
CDC.gov COVID‐19 accessed May 1, 2021
• The student was given the mRNA vaccine at the time he had first visited the 57 58 vaccination site. CDC.gov COVID‐19 accessed May 1, 2021
CASE – 2 RECIPIENT OF MULTIPLE KEY POINTS COVID-19 VACCINES
• ZX returned to the C0VID-19 vaccine clinic on May 6th (3 weeks after the first • Both SARS-CoV-2 and COVID-19 continue to evolve dose). • Variants of SARS-CoV-2 may determine the effectiveness of the • The pharmacist was again able to discuss with him the results of his inquiry of current vaccines and monoclonal antibodies the different organizations. • At this time antivirals are not able to effectively eradicate SARS- • ZX explained the side effects after first dose were mild: CoV-2 • Injection site pain and mild fatigue • Pharmacists will continue to be play a major role as frontline • He was given the second dose of the mRNA vaccine. healthcare professionals on the assault of this virus • There is HOPE FOR RECOVERY
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THANK YOU
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11 COVID‐19 Seminar May 25, 2021
Innate Immune Defenses
COVID‐19 First lines of defense Vaccines Constitutive expression Non‐specific Dr. Clifton Franklund No (very little) immunological memory Department of Biological Receptors are somatically encoded (no recombination) Sciences Myeloid cell lines (neutrophils and macrophage) Ferris State University
68TH ANNUAL PHARMACY SPRING SEMINARMay 25, 2021 4
Toll‐Like Receptors
A Brief Road Map Pattern recognition
1) Antiviral Immune Defenses External or Internal 2) What Exactly is SARS‐CoV‐2? Pathogens 3) COVID‐19 Vaccine Strategies 4) Genetic Variants of SARS‐CoV‐2 5) Current COVID‐19 Data 6) Future Implications
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Antiviral Toll‐Like Receptors Immune Pattern recognition Defenses Multiple signaling cascades “If you know neither the Culminate in localization and enemy nor yourself, you activation or regulatory proteins will succumb in every battle.” Cytokines produced and released ‐ Sun Tzu, The Art of War Interferons
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Dr. Clifton Franklund 1 COVID‐19 Seminar May 25, 2021
Adaptive Immune Defenses Exogenous Antigen Presentation
Second and third lines of defense Inducible expression Immunological memory Highly specific Receptors formed through somatic recombination Lymphoid cells lines (B‐ and T‐cells)
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Antigen Recognition by Lymphocytes T‐Cell Differentiation
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Endogenous Antigen Presentation SARS‐CoV‐2 “If you know yourself but not the enemy, for every victory gained you will also suffer a defeat.” ‐ Sun Tzu, The Art of War
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Dr. Clifton Franklund 2 COVID‐19 Seminar May 25, 2021
SARS‐CoV‐2 Virion Spike Protein Domains
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SARS‐CoV‐2 Spike Protein Structure
Trimeric structure
Receptor binding site is sequestered
Released by protease action (like furin)
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SARS‐CoV‐2 Infectious Cycle SARS‐CoV‐2 Spike Protein Function
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Dr. Clifton Franklund 3 COVID‐19 Seminar May 25, 2021
Adenovirus Vaccines COVID‐19 Vaccines Spike gene cloned into a vector as DNA Viral infections introduce gene “If you know the enemy and know yourself, you Gene expressed by host cell need not fear the result Spike protein process and presented of a hundred battles.” ‐ Sun Tzu, The Art of War
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Current Slate of Vaccines SARS‐CoV‐2 Genetic Pfizer‐BioNTech (mRNA) USA Moderna (mRNA) USA Variants Johnson & Johnson (Adenovirus) USA “This preservation of Oxford‐AstraZeneca (Adenovirus) EU favorable variations and the destruction of Novavax (Protein adjuvant) Clinical trials injurious variations, I call Sputnik V (Adenovirus) Russian Natural Selection, or the BBIBP‐CorV (Inactivated virus) Clinical trials Argentina Survival of the Fittest.” BBV152 or Covaxin (Inactivated virus) Clinical trials India ‐ Charles Darwin
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mRNA Vaccines COVID‐19 Genetic Variants
Spike gene encased in lipid vesicle as mRNA
Internalized and expressed by cells
Antigen processing and presentation
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Dr. Clifton Franklund 4 COVID‐19 Seminar May 25, 2021
Efficacy by severity of COVID-19 Vaccine Hospitalization or Mild or moderate Severe Selective Advantages death Moderna ≈94% (89–97%) ≈100% ≈100% Mutations that affect receptor binding Pfizer–BioNTech ≈95% (90–98%) Not reported Not reported Mutations that affect spike conformation Oxford– ≈76% (68–82%) ≈100% ≈100% Mutations that alter antibody neutralization AstraZeneca
BBIBP‐CorV ≈79% ≈100% ≈100%
Novavax ≈89% (75–95%) ≈100% ≈100%
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Future Current Data Implications
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Lessons from Super Bowl 50 The Future
Statistic Carolina Panthers Denver Broncos Prospect for genetic variants First downs 21 11 Vaccine adaptations Total yards 315 194 Societal impacts Third down conversion 3/15 1/14 Attitudes regarding vaccines Time of possession 32:47 27:13 Role of pharmacists in healthcare Score 10 24
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Dr. Clifton Franklund 5 COVID‐19 Seminar May 25, 2021
Thank You!
Questions? Comments? Discussion?
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Dr. Clifton Franklund 6 Pandemic Fatigue: The Psychosocial Impacts of COVID-19 Ferris State University College of Pharmacy 68th Spring Seminar May 25th, 2021 Giulia Barlow, PharmD, BCPS, BCPP
Outline 1. COVID-19 Pandemic-Related Stressors 2. Building Resilience a. Build Connections b. Prioritize Wellness and Self-care c. Embrace Healthy Thoughts d. Find Purpose 3. Resilience and Well-Being Resources a. Resilience Resources b. Self-Assessment Question c. Support Hotlines d. Support Directories 4. The Racial Pandemic a. Bias and Racism Definition b. COVID-19 Pandemic + Racial Pandemic Stressors c. Examples of Implicit Bias in Healthcare d. Self-Assessment Question e. Eliminating Implicit Bias in Patient Care
Key Points: ● The pandemic has caused unprecedented amounts of stress and uncertainty that continues to negatively impact the well-being of healthcare workers worldwide. ● Building resilience is an evidence-based approach to better adapt and overcome adversity. Anyone can develop resilience through awareness and behavioral modifications- it takes time and intentionality. ● The pandemic has highlighted racial equalities, implicit bias, and systemic racism in the healthcare system. Do you part! Educate yourself and others on how healthcare providers can consciously avoid race-based biases when providing patient care.
References: 1. Elbeddini, A., Wen, C.X., Tayefehchamani, Y. et al. Mental health issues impacting pharmacists during COVID-19. J of Pharm Policy and Pract 13, 46 (2020). https://doi.org/10.1186/s40545-020-00252-0. 2. Lai J, Ma S, Wang Y, et al. Factors associated with mental health outcomes among health care workers exposed to coronavirus disease 2019. JAMA Netw Open 2020;3:e203976. 3. Min L, et al. The psychological and mental impact of coronavirus disease 2019 (COVID-19) on medical staff and general public – A systematic review and meta-analysis. 4. Luo M, Guo L, Yu M, Jiang W, Wang H. The psychological and mental impact of coronavirus disease 2019 (COVID-19) on medical staff and general public - A systematic review and meta-analysis. Psychiatry Res (2020) 291:113190. doi: 10.1016/j.psychres.2020.113190. 5. American Psychological Association. Building your resilience. http://www.apa.org/topics/resilience. Accessed April 22, 2021. 6. Joyce S, Shand F, Tighe J, et al. Road to resilience: a systematic review and meta-analysis of resilience training programmes and interventions. BMJ Open 2018;8:e017858. doi: 10.1136/bmjopen-2017-017858. 7. Bias and Well-Meaning People. National Center for Cultural Competence. https://nccc.georgetown.edu/bias/module-3/references.php. Accessed April 22, 2021. 8. Vyas, D. et al. Hidden in Plain Sight--Reconsidering the Use of Race Correction in Clinical Algorithms. N Engl J Med 2020; 383:874-882. 9. Edgoose J, et al. How to Identify, Understand, and Unlearn Implicit Bias in Patient Care.Fam Pract Manag. 2019 Jul-Aug;26(4):29-33.
5/24/2021
LEARNING OBJECTIVES PITFALLS IN ESTIMATING Review the underlying rationale for estimating and measuring kidney function. KIDNEY Review the most common equations used to estimate FUNCTION creatinine clearance and GFR. Describe the pitfalls and challenges of drug dosing in kidney disease.
CHRONIC KIDNEY DISEASE BY THE NUMBERS KIDNEY FUNCTION ESTIMATION VS. • Kidney diseases are the ninth leading cause of MEASUREMENT 9th death in the United States.
• About 37 million US adults are estimated to have Measuring Kidney Function Estimating Kidney Function 37 million CKD and most are undiagnosed. Measured Creatinine Clearance (24hr) Estimated Creatinine Clearance (eCrCL) 40% • 40% of people with severely reduced kidney function Measure GFR directly Cockcroft Gault Equation are not aware of having CKD. Inulin Estimated Glomerular Filtration Rate (eGFR) 75% • In the United States, diabetes and high blood Iothamate pressure are the leading causes of kidney failure, MDRD representing about 3 out of 4 new cases. Iohexol CKD-EPI Used for Clinical Research/Trials $150 Billion • In 2018, treating Medicare beneficiaries with CKD Designed to stratify CKD into stages for cost over $81.8 billion, and treating people with Not routinely used in practice settings population health studies ESRD cost an additional $36.6 billion. https://www.cdc.gov/kidneydisease/index.html
EQUATIONS FOR ESTIMATING KIDNEY FUNCTION Name Equation Estimate of: RENAL DOSE ADJUSTMENTS Creatine Clearance Cockcroft-Gault = (eCLcr) Knowledge of kidney function is important for dosage of medications that are excreted by the kidneys (usually > 30% eliminated by kidneys). 175 GFR MDRD = (eGFR) Food and Drug Administration (FDA)-approved drug-labeling guides provide adjustments of drug dosages for patients with impaired kidney function.
CKD-EPI = GFR On these labels, serum creatinine; measured creatinine clearance (CrCl); or, (eGFR) most commonly, estimated creatinine clearance using the Cockcroft-Gault Where: is 0.7 for females and 0.9 for males; α is ‐0.329 for females and ‐0.411 for males; min indicates the minimum of Scr/ or 1; max equation (eCrCl) are used to estimate kidney function. indicates the maximum of Scr/ or 1.
Cockcroft, D.W. and M.H. Gault. Prediction of creatinine clearance from serum creatinine. Nephron. 1976. 16(1):31-41. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet Dowling, T. C., Matzke, G. R., Murphy, J. E., & Burckart, G. J.(2010). Evaluation of Renal Drug Dosing: Prescribing Information and Clinical Pharmacist in Renal Disease Study Group. Ann Intern Med 1999;130(6):461-70. Approaches. Pharmacotherapy, 30(8),776-786, DOI: 10.1592/phco.30.8.776. Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate (CKD-EPI Collaboration). Ann Intern Med 2009;150(9):604-12. 5
1 5/24/2021
EXAMPLE OF RENAL
Toxicity Concentration Range DRUG DOSING IN FDA PACKAGE Drug Concentration INSERT (mg/L)
NEURONTIN (Gabapentin)
Day of Dosing
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf
EXAMPLE OF RENAL PITFALL #1: BEWARE OF DRUG DOSING IN SUBSTITUTING eGFR EQUATIONS IN FDA PACKAGE PLACE OF CG EQUATION FOR RENAL INSERT DRUG DOSING
NEURONTIN (Gabapentin)
10 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf
MDRD AND CKD-EPI OVERESTIMATE KIDNEY MDRD AND CKD-EPI OVERESTIMATE FUNCTION IN OBESITY (BMI ≥ 30 KG/M2) KIDNEY FUNCTION IN ELDERLY (AGE > 70)
* * *** p < 0.001 vs. mCLCr; p < 0.001 vs. CG
* *
* p < 0.001 vs. CG-CrCL
Dowling TC, Wang ES, Ferrucci L, Sorkin JD. Glomerular filtration rate equations overestimate creatinine clearance in older individuals enrolled in the Baltimore Higdon EA, Kimmons LA, Duhart B, Hudson JQ. Disagreement in Estimates of Kidney Function for Drug Dosing in Obese Inpatients. J Pharm Pract 2019 Feb;32(1):41-47. Longitudinal Study on Aging: impact on renal drug dosing. Pharmacotherapy 2013 Sep;33(9):912-21. 12
2 5/24/2021
ROUNDING UP SERUM CREATININE TO 1.0 PITFALL #2: AVOID “ROUNDING UP” LEADS TO UNDERESTIMATION OF mCLCR SERUM CREATINE TO 1.0 MG/DL
*** p < 0.001 vs. mCLCr; p < 0.001 vs. CG
Dowling TC, Wang ES, Ferrucci L, Sorkin JD. Glomerular filtration rate equations overestimate creatinine clearance in older individuals enrolled in the Baltimore 13 Longitudinal Study on Aging: impact on renal drug dosing. Pharmacotherapy 2013 Sep;33(9):912-21.
DOES YOUR INSTITUTION REPORT eGFR PITFALL #3: KNOW WHICH KIDNEY FUNCTION AND/OR eCLcr? (CAN BE CONFUSING) ESTIMATES ARE REPORTED IN ELECTRONIC HEALTH RECORD (EHR) Spectrum Health – reports both MDRD eGFR and CG eCLcr MDRD eGFR eGFR >60 mL/min reported as “> 60 mL/min” eGFR< 60 mL/min reported as actual value, ie “32 mL/min” CG eCLcr Most EHRs report MDRD eGFR Requires separate manual calculation of CG eCLcr
VARIATIONS IN REPORTING OF KIDNEY FUNCTION IN ELECTRONIC HEALTH RECORD (EHR) SUMMARY
Some institutions are making their own modifications to eGFR Important to recognize Chronic Kidney Disease and need for renal equations in EHR dose adjustments. Example: Mount Sinai Hospital The differences between eGFR (MDRD, CKD-EPI) and Creatinine Report CKD-EPI eGFR (but remove race indicator) Clearance (Cockcroft-Gault) can be significant. “What we are saying is that race is not Identify which kidney estimation method is used at your institution biological,it is not found in the kidney, and interpret with caution. and therefore it should be removed from the equation for kidney function.”
Kirk Campbell, MD https://reports.mountsinai.org/article/neph2021-07-egfr-and-race#content Associate Professor of Medicine (Nephrology)
3 5/24/2021
ASSESSMENT QUESTION #1 ASSESSMENT QUESTION #2
Which of the following equations were designed to estimate The package insert includes instructions for calculating renal dose creatinine clearance (eCLCr)? adjustments, as approved by: A. MDRD A. ASHP B. CKD‐EPI B. MSHP C. Cockcroft‐Gault C. ACCP D.All of the above D. FDA
4 5/20/2021
Objectives
• Explain marketplace changes necessitating practice transformation • Explain the differences between traditional community practice and clinical community practice in today’s environment The Future Pharmacy: CPESN • Outline practice transformation strategies Identify payment for Perspectives on Practice Innovation service opportunities nationwide
Troy Trygstad PharmD MBA PhD VP of Provider and Pharmacy Partnerships, CCNC Executive Director, CPESN USA May 25th, 2021
#ACTforPharmacy | www.actforpharmacy.com
Commonly Held Pharmacy Myth #1: Community Pharmacies Business and Practice Myths are Expensive to Operate
(persistent and pervasive, but largely (Pharmacies get unfairly pulled into the vortex unfounded) of “runaway drug costs”)
Keeping 65k Pharmacies Open is Not Expensive Myth #2: Community Pharmacy Labor Markets are Isolated and Self‐Contained (This line of thinking defies empirical evidence from many other industries)
1 5/20/2021
The Proverbial Balloon Squeeze Myth #3: “Provider Status” will Is There a Limit on… https://welovelocalgovernment.wordpress.c om/2011/07/04/squeezing‐the‐balloon/ obviate the need to sustain
177k Pharmacists needing Non‐ Community Pharmacy Jobs 177k Pharmacists losing Community community pharmacy practice. + Pharmacy Jobs* 84k Existing Hospital* & 61k “Other” Setting Jobs* Filled for Non‐Community Pharmacists (…on the contrary, maybe it’s the solution to sustaining Community Pharmacy)
… Non‐Community Pharmacy Jobs?
*https://www.bls.gov/ooh/healthcare/pharmacists.htm#tab‐3
Primary Care is Changing Personnel… Primary Care is Changing Too…
Primary Care Version of “Pharmacy Mail Order” is here…
Median PA Pay = $112,260 NP Pay = $109,820, Median Graduate Nursing Debt = $55,000
https://www.aacnnursing.org/Portals/42/Policy/PDF/2016‐Student‐ AACN 2017 Graduate Nursing Student Loan Survey Debt‐Glance.pdf
Outlook for Pharmacist Jobs is Not So Good What makes us different?
Median Graduate Pharmacist Debt = $142,800, New Graduates Each Year = ~14,000
2 5/20/2021
65k Potential Practice Sites…. Myth #4: Lack of Clinical Competence is an Absolute Barrier to Community Pharmacy Sustainability *Medicaid recipients with Multiple Co‐Morbidities * (Generalists versus Specialists tension exists across health professions) *Pharmacy visits outnumbered Clinic Visits 13 to 7 in Medicare population Lucas A. Berenbrok, PharmD, MS; Nico Gabriel, MA; Kim C. Coley, PharmD; et al
More than 2/3 of RxClinic Profit Margin is from Services RxClinic Community Pharmacy Results Myth #5: Community Pharmacists’ Lack of Focus Health Care Service Delivery is by Choice (Don’t Blame the Victim!)
Sinclair J, Bentley OS, Abubakar A, Rhodes LA, Marciniak MW, Impact of Pharmacists in Improving Quality Measures that Affect Physician Payment, Journal of the American Pharmacists Association (2019), doi: https://doi.org/10.1016/j.japh.2019.03.013.
What if Pharmacies Got Paid to Build Bridges?
What Used to Be is No Longer
(the pharmacy landscape is changing more quickly than most realize)
3 5/20/2021
What Used to Be… Is Now..
• RPh Shortage • RPh Glut • Healthy Product Margin • Little or No Product margin What Does a “Future Pharmacy” • No Rx Value Based Contracting • Emerging VBC Marketplace Look like? • No In‐Workflow Documentation • 18 Systems eCare Plan Capable • Pharmacy Services Taboo • Pharmacy Services Preferred (well, it looks largely the same, but it operates quite differently)
What does the “Future Pharmacy” look like? • The Appointment Based Model (ABM) is core to service What Does a delivery “Future Pharmacy” • Need ability to proactively Look like? prepare for patients for non‐ acute services • COVID‐19 Testing and Mass Immunizations are prompting pharmacies to adopt scheduling utilities (aka early Practice Management Systems
What does the What does the “Future Pharmacy” “Future Pharmacy” look like? look like? • Pharmacists can’t do it by • Chronic disease requires themselves! (just like follow up and monitoring physicians with PCMH) • This is where community pharmacies’ greatest • 70‐90% of the tasks potential lies required can and should be • Alongside public health taken on by non‐pharmacist staff • IMZ • Screenings • Get rid of the term “technician”!
4 5/20/2021
What does the What does the “Future Pharmacy” “Future Pharmacy” look like? look like?
• If you can’t measure it, • Talk to any pharmacy that is you can’t manage it. still doing well in 2020 and they have complex patients. • If you can’t report it, it didn’t happen. • They didn’t get those patients without knowing and • We must find an efficient serving care‐team members. and non‐imposing ways to document. • They didn’t keep those patients without good service.
What does the “Future Pharmacy” look like? • The ultimate motivator – payment. What Does Victory Look Like? • Payment = Sustainability • Yet it isn’t as simple as the opportunity to get paid. (For all of us ‐ #onepharmacycommunity) • Transformation also requires a different way of business modeling on services (both investments and returns).
Scaled, Measurable, Scaled, Measurable, and Meaningful and Meaningful
CPESN Pharmacies that Vaccinate
CPESN Pharmacies with CLIA Waiver CPESN Pharmacies in Designated Rural Areas 2 3 9 0
5 5/20/2021
Scaled, Measurable, and Meaningful Scaled, Measurable, and Meaningful
What if....? • 2,500 Pharmacies took 10 blood pressures a day? In 2020, • That’s nearly 10 Million blood pressures a year. Size and • What if.... Half of them were out of range? Coverage • And half of those could be fixed by coaching... Matter. • And the other half given a regimen change... • Would millions more patients in range change the game?
3 1
Scaled, Measurable, and Meaningful Meaningful: Example Real World VBC Contracts
• HEDIS: Healthcare Effectiveness Data and Information Set
Meaningful: Example Real World VBC Contracts
How Do We Get There?
(community pharmacy practice transformation starts with markets and scalability)
6 5/20/2021
Scaled, Measurable, and Meaningful
COVID‐19 Effects…
• Public awareness and expectations of pharmacies changed • POCT becoming more prominent This should be the focus of our investment of time, • Scheduling utilities adopted energy and funding • Services dollars begin to generate more total margin than product sales
Serving their communities…
#ACTforPharmacy | www.actforpharmacy.com | [email protected]
7 5/20/2021
Objectives
1. Review recent therapy advances since the publication of the Pharmacotherapy Update: most recent heart failure guideline focused update 2. Discuss strategies for addressing social determinants of health Heart Failure in heart failure Kyle J. Schmidt, PharmD, BCCCP 3. Describe anticipated novel pharmacotherapy options for heart Assistant Professor of Pharmacy Practice failure Ferris State University College of Pharmacy [email protected]
I do not have any relevant financial relationship with any commercial interests
ACC Expert ACC/AHA/HFSA Consensus Focused Update Decision Pathway (2017) (2021)
European Society Established Drugs, New Tricks of Cardiology (2019)
ARNI Update PIONEER-HF
Initial indication chronic heart failure HFrEF with elevated NT-proBNP or BNP with acute decompensated heart failure PIONEER-HF: acute decompensated heart failure Randomized patients to sacubitril-valsartan versus enalapril
8 week total duration
Primary outcome: change in NT-proBNP
1 5/20/2021
PIONEER-HF PIONEER-HF Exploratory Efficacy (No difference….except) Target doses achieved in Change in NT‐proBNP 55-60% of patients • Rehospitalization rates lower in ARNI group (8% vs 13.8%)
‐46.7% ARNI Secondary Safety (No different) vs ‐25.3% ARB • Worsening renal function • Hyperkalemia •Symptomatic hypotension
EMPA-REG OUTCOME SGLT-2 Inhibitors EMPEROR - Reduced DAPA-HF EMPEROR – Preserved PRESERVED – HF
DAPA-HF 41.8% diabetic DAPA-HF Primary composite outcome Dapagliflozin 10 mg daily vs placebo in HFrEF 92,373 vs 2,371) •16.3% vs 21.2%, HR 0.74 (0.65‐0.85) • Primarily driven by decrease in worsening heart failure Not dependent on presence of diabetes
Composite of worsening heart failure or Cardiovascular death or heart failure hospitalization death from cardiovascular causes •16.1% vs 20.9%, HR 0.75 (0.65 to 0.85) Approximately 2 years of follow-up • Cardiovascular death alone •9.6% vs 11.5%, HR 0.82 (0.69 to 0.98)
2 5/20/2021
EMPEROR-Reduced Empagliflozin 10 mg daily vs placebo in HFrEF (1,863 v 1,867)
Not dependent on presence of diabetes
Cardiovascular death or heart failure hospitalization
Approximately 2 years of follow-up
EMPEROR-Reduced 49.8% diabetic Primary composite outcome
• 19.4% vs 24.7%, HR 0.75 (0.65‐0.86) • Primarily driven by reduction in hospitalizations
Mean slope of eGFR change
• ‐0.55 vs ‐2.28, HR 0.7 (0.58‐0.85) •Noted to significantly decrease composite renal outcome (HD, transplant, sustained reduction in GFR)
Time to all-cause death (n=8,474) True across some • HR 0.87 [95% CI 0.77-0.98] subgroups Cardiovascular death •Diabetes • HR 0.86 [95% CI 0.76-0.98] • Treatment with ARNI • Baseline eGFR Heterogeneity not significant
3 5/20/2021
Estimated Completion April 2021
Estimated Completion Addressing Barriers to Care June 2021
“…logical to assume that below-target doses Barriers of multiple classes of goal directed medical therapy are likely more effective in Cost of therapy reducing risk than large doses of 1 or 2 agents” Limited ability for office visits (and therapy optimization)
“…decrease in eGFR of >30% or the Medication non-adherence development of hyperkalemia should alert the clinician that reduction in doses may be necessary…”
Improving Adherence - Highlights
Motivational interviewing, patient’s perspective
Proactively discuss out-of-pocket costs
Simplify regimens when possible
4 5/20/2021
Perfection is the enemy of progress
Accept incremental steps toward an end goal as success • Don’t have to hit a home run every time
Focus on known risk factors • Smoking, diet, activity “Circumstances in which people are born, grow up, live, work, and age…and the systems put in place to offer health care and Maintain empathy and sensitivity to effects of poverty services to a community”
Collaborate with Adopt assessment community Assessing Social Determinants of Health tool as routine partners Accountable Health Communities Social Needs Screening Tool Routinely collect and Establish Social Deprivation Index utilize data needed for interprofessional assessments teams
Functional Health Patterns Framework Utilize clinical triggers Explore to notify providers of nontraditional roles SDOH challenges to focus on SDOH
Omecamtiv mecarbil
Current therapies aim to increase cardiac myocyte intracellular calcium – increase heart rate, myocardial oxygen consumption
Cardiac myosin activator – increased contractility without Novel Therapies increasing energy consumption (increased efficiency)
5 5/20/2021
Omecamtiv mecarbil
ATOMIC‐HF PK, PD, dose ranging
COSMIC‐HF PK, PD, dose ranging
GALACTIC‐HF Phase 3 clinical trial
Median follow up 22 GALACTIC-HF GALACTIC-HF months Primary composite outcome Symptomatic HFrEF (<35%) • 37% vs 39.1%, HR 0.92 (0.86‐0.99) • Primarily driven by reduction in hospitalizations Placebo controlled
Secondary outcomes First heart-failure event or death from CV causes •No significant difference in cardiovascular death, change in symptom scores, first hospitalization for HF or death from any cause 8,256 patients in total
Verquvo (vericiguat)
FDA approved Jan 2021 • Symptomatic HF (EF <45%)
Soluble guanylate cyclase stimulator smooth muscle relaxation and vasodilation
6 5/20/2021
Median follow up 10.8 VICTORIA VICTORIA months Primary composite outcome HFrEF (<45%) • 33.6% vs 37.8%, HR 0.90 (0.82‐0.98) Placebo controlled • Primarily driven by reduction in hospitalizations
Death from CV causes or first hospitalization for heart failure Secondary outcomes •Less total hospitalizations for heart failure 5,050 patients in enrolled
Bottom Line
Don’t get lost chasing perfection with patients
Very promising results with SGLT2 inhibitors, regardless of diabetes status
Potential for novel therapies in the pipeline
Expect to see more from sacubitril-valsartan
Pharmacotherapy Update: Heart Failure Kyle J. Schmidt, PharmD, BCCCP Assistant Professor of Pharmacy Practice Ferris State University College of Pharmacy [email protected]
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