Drug diversion

This lesson is supported by

Drug diversion

INTRODUCTION particularly opioids and benzodiazepines, in disciplinary and/or other legal actions The risks associated with drug diver- provides the pharmacist with a focus on against him or her. These may include, sion from a pharmacy and the obligations targeted products for diversion.1 for example, suspension or loss of a phar- of the pharmacist to reduce drug diversion In April 2011, the Obama administra- macist’s license; loss of a pharmacy Drug often are underappreciated. Despite the tion issued a report entitled “Epidemic: Enforcement Agency registration number; fact that prescription drug abuse is now Responding to America’s Prescription criminal liability, such as sentencing to jail the fastest-growing drug problem in the Drug Abuse Crisis.”3 The report drew atten- time; and a variety of civil actions, includ- United States (more prevalent than illegal tion to the country’s epidemic of prescrip- ing monetary fines. “street” drugs, such as cocaine and mari- tion drug abuse and called for increased This continuing education lesson high- juana)1, pharmacists often are hesitant to education, tracking and monitoring; proper lights the trends in prescription drug diver- address the need to increase protections medication disposal; and enforcement. sion from inside retail pharmacies. The against diversion of prescription drug The plan the administration set forth to lesson addresses specific methods of internal products from within the pharmacy. address the crisis focused on measures to drug diversion and strategies to be imple- The public harm associated with drug combat external drug diversion (e.g., doc- mented by the pharmacist to protect against abuse continues to make headlines and tor shopping, fraudulent prescriptions and drug diversion. The initial sections of this receive significant media attention.2 As a the like). However, the internal diversion of lesson provide an overview of drug abuse result, pharmacists should expect increased prescription drugs is another form of diver- trends and a review of the laws and regu- focus and attention regarding their role in sion requiring the heightened awareness lations around controlled substances. The preventing drug diversion and curbing pre- of pharmacists. Pharmacists, in particular responsibilities of the pharmacist are dis- scription drug abuse. Pharmacists should pharmacists in charge, are responsible for cussed, including (1) identifying the dangers be aware of drug abuse trends in order to both securing controlled substances within associated with drug diversion, (2) prevent- reduce the diversion of prescription drug the pharmacy and overseeing the actions of ing drug diversion through the identifica- products from pharmacies. The trend of technicians working in the pharmacy. Fail- tion of common diversion scenarios and (3) increased abuse of prescription drugs, ure by the pharmacist to do so can result reporting drug diversion occurrences.

By Jill N. Link, PharmD, JD, Intellectual Property Law Learning Objectives This lesson is free of charge to Target pharmacists. at McKee, Voorhees & Sease PLC Upon completion of this program, the pharmacist should be able to: Author Disclosures 1. Identify trends in prescription drug diversion, as well Jill N. Link does not have any actual or potential as the most commonly diverted drugs. conflicts of interest in relation to this lesson. 2. Describe potential methods of internal drug diversion. 3. Specify strategies that can be implemented to help Universal Program Number: 401-000-11-304-H04-P reduce drug diversion. Activity type: Knowledge-based 4. Recall pharmacists’ responsibilities regarding Initial release date: August 1, 2011 protecting against and reporting drug diversion as Planned expiration date: August 1, 2014 outlined in the Drug Enforcement Agency (DEA) Code This program is worth two contact hours (0.2 CEUs). of Federal Regulations and DEA Pharmacist’s Manual. Drug Store News is accredited by the Accreditation 5. Explain how to handle potential drug diversion Council for Pharmacy Education as a provider of Target Audience scenarios appropriately. continuing pharmacy education. Pharmacists in community-based practice. To obtain credit: A minimum test score of 70% is Copyright ©2011 by Lebhar-Friedman Inc. Program Goal needed to obtain a statement of credit. Submit your All rights reserved. To improve pharmacists’ awareness of methods of answers online at www.cedrugstorenews.com, and prescription drug diversion and steps to take to help receive your statement of credit in your CE account safeguard against diversion, as well as procedures to folder immediately. Questions regarding statements follow if suspected or actual diversion occurs. of credit and other customer service issues should be directed to Angela Sims at (800) 933-9666. cedrugstorenews.com Drug diversion August 2011 • 1 Drug diversion

OVERVIEW OF DRUG ABUSE TRENDS TABLE 1 TO IDENTIFY DRUG DIVERSION TARGETS Classes of abused prescription drugs1 FROM RETAIL PHARMACY The abuse of prescription drugs has become a cultural phenomenon.4 As dis- cussed in this lesson, prescription drug STIMULANTS abuse includes the use of medications 14% that have not been prescribed or taking SEDATIVES & medications for reasons and/or in dosages TRANQUILIZERS other than as prescribed. Despite increased 27% media attention paid to the abuse of pre- scription drugs, many health profession- als, including pharmacists, retain the misconception that drug abuse predomi- nates within the illegal drug markets. This OPIOIDS dangerous misconception impedes phar- 59% macists’ ability to perform their key role in preventing drug diversion to decrease pre- scription drugs available for such abuse. Nonmedical use of prescription drugs is the fastest-growing drug problem in the United States.5 The 2009 National Sur- vey on Drug Use and Health released in September 2010 estimated that more than are the increases in opioid analgesic unin- the most commonly abused classes of pre- 50 million Americans misuse or abuse tentional overdose deaths (reported by the scription drugs to be psychotherapeutics prescription drugs (likely an underesti- CDC in July 2010), which have surpassed (including opioid pain relievers, tranquil- mation), representing an 80% increase in both heroin and cocaine poisonings each izers, stimulants and sedatives).1 prescription drug abuse between 2002 and year since 2000.8 As shown in Table 1, the most commonly 2009.6 The increasing percentage of the In addition to increased mortality, the abused class of prescription drug is opioids population abusing prescription drugs health risks associated with the abuse of (i.e., for treatment of pain), followed by represents a significant shift over the past prescription drugs can be just as danger- sedatives and tranquilizers, also known 10 years, coinciding with the gradual ous as those associated with the abuse of as central nervous system depressants decline in the abuse of illegal street drugs, illegal drugs.10 There is little doubt that (i.e., for anxiety and sleep disorders), and including cocaine, marijuana and her- risks of addiction present significant health stimulants (i.e., for attention-deficit/hyper- oin, which previously topped the list of concerns, in addition to other health con- activity disorder and narcolepsy).1,15 The most commonly abused drugs.4 Various cerns associated with the abuse of prescrip- increase in abuse of those classes of drugs sources suggest that prescription drug tion drugs. Increased reports of driving represents a significant increase in preva- abuse (most often involving sedatives, and operating heavy machinery under the lence compared with the 1999 data, when opiates and stimulants) is more common influence of prescription drugs, namely only a few classes of prescription drugs than the abuse of illegal street drugs.7 opioids, represent a significant danger.11 were represented in the top 20 most com- The increased abuse of prescription The pharmacist is directed to additional monly abused drugs, with benzodiazepines drugs has further coincided with increased resources for further general information representing the only class of prescription health risks and mortality. Abuse of pre- on the dangers associated with prescrip- drug in the top five most commonly abused scription drugs ranked as the second- tion drug abuse.12 drugs.16 Today, almost one-third of new leading cause of death between 1999 and The National Institute on Drug Abuse drug abusers report having an initial expe- 2007 (exceeded only by motor vehicle acci- (NIDA) conducts research identifying the rience with a prescription drug (almost 20% dents).8 Centers for Disease Control and most commonly abused categories of drugs, identify abuse of an opioid).17 Prevention (CDC) statistics estimated an including prescription drugs.13,14 The 2009 Opioids represent the most commonly increased rate of unintentional drug over- National Survey on Drug Use and Health abused class of prescription drug. Among dose deaths of nearly 70% between 1999 and quantified more current statistics regard- the opioids, those most commonly abused 2004, with more current figures expected to ing the prevalence of prescription drug include hydrocodone (Vicodin®, Lortab®) show further increases.9 Equally troubling abuse, as summarized in Table 1, showing and oxycodone (OxyContin®). Significant

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TABLE 2 Examples of abused prescription drugs and “cocktails”19,20,21,22

Street Exemplary street Intended names prices Ingredients “high” Cocktail, Holy Trinity Varies as a result of Combination of: Exaggerated opioid effects; combination similar high to heroin Hydrocodone (Vicodin®, Lortab®, Lorcet®)

Carisoprodol (Soma®)

Alprazolam (Xanax®) Hillbilly Heroin, Oxy, OC, $6 to $10 per tablet Oxycodone (OxyContin®) Exaggerated opioid effects Oxycotton, Percs, Happy Pills, Vikes (Prices as high as $20 to $40 Hydrocodone (Vicodin®, per tablet for OxyContin®) Lortab®, Lorcet®)

Morphine (MS Contin®) Vitamin R, Rits, West $8 to $15 per tablet Methylphenidate (Ritalin®, Performance enhancer, Coast Concerta®, etc.) including improved memory and concentration to “gain Dextroamphetamine the edge” (Dexedrine®, Adderall®) Candy, Z-bar, Tranks $3 to $4-plus per tablet Alprazolam (Xanax®) or other Rapid onset and longer benzodiazepines duration DMX, CCC, Triple C, Varies Dextromethorphan Euphoria; visual and Skittles, Robo, Poor auditory hallucinations Man’s PCP

abuse of hydromorphone (Dilaudid®), acquired notoriety for producing a high amphetamines (Adderall®). Recent reports methadone, meperidine (Demerol®), pro- similar to morphine (it’s often referred show a staggering increase in abuse of meth- poxyphene (Darvon®) and diphenoxyl- to as the “Hillbilly Heroin”). In addition ylphenidate and other ADHD medications ate (Lomotil®) also is reported. It is clear to the abuse of individual prescription for “performance-enhancing” effects among that hydrocodone and oxycodone are the drugs, such as hydrocodone and oxyco- students believing that the use will increase most popular opioids among adolescents, done, abuse trends show increasing popu- GPAs and test scores.17 Additional informa- second in frequency of abuse only to mari- larity of “cocktails” of various prescription tion on prescription drugs of abuse, includ- juana.17 The increased use of opioids has drugs, including controlled substances. ing street names, the intended intoxication led to increased street prices for the drugs. Table 2 shows examples of drug cocktails, effects and potential health consequences, The price of hydrocodone (Vicodin®) along with the desired highs and examples is available for pharmacists through the ranges from $2 to $10 per tablet on the of street prices for the drugs, demonstrat- NIDA.23 street, making the 1,000-count bottle on ing the significant demand for the various Over-the-counter medications also the pharmacy shelf worth up to $10,000. CIII-CV drugs.19,20,21,22 commonly are abused and diverted, The consumption of hydrocodone has Among the depressants, benzodiaze- including cough and cold products con- been publicized widely within the United pines are by far the most commonly abused taining dextromethorphan.24 The abuse of States, with 2004 data indicating that the drugs, including diazepam (Valium®) and products containing dextromethorphan United States consumes 99% of the world’s alprazolam (Xanax®). Barbiturates, such as remains popular with adolescents, as they hydrocodone supply despite representing pentobarbital sodium (Nembutal®), also consume large quantities to obtain a high. only 4.5% of the world’s population.18 The are commonly abused depressants. The Because this lesson focuses on the abuse abuse of oxycodone (OxyContin®) also most commonly abused stimulants include and diversion of prescription drugs, phar- is well-documented, and the drug has methylphenidate (Ritalin®, Concerta®) and macists interested in learning more about

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the abuse of OTC drugs, especially by ado- tranquilizers where the traditional “drug hallucinogens, anabolic steroids and other lescents, are directed to the U.S. Depart- dealer” more often is involved.29 chemicals used in the production of con- ment of Health and Human Services, trolled substances). Substance Abuse and Mental Health Ser- PHARMACISTS’ RESPONSIBILITIES The CSA sets forth various degrees of vices Administration Web site.25 Pharmacists have a professional respon- control for all participants in the system, In addition to the shift towards abuse sibility to assist patients and the community including the manufacturer, distributor, of prescription drugs over street drugs, in the safe and effective use of prescrip- wholesaler, prescriber, pharmacy and on the “face” of the average prescription drug tion and OTC drug products. This profes- to the patient. The limited access to con- abuser may be unexpected to many phar- sional responsibility extends to protecting trolled substances under the CSA estab- macists — the average abuser is between patients from the dangers associated with lishes a majority of the safeguards against the ages of 18 and 25 years old.26,27 Research drug abuse and curbing drug diversion.30 diversion of these types of prescription through 2009 showed that over 16 million The increase in abuse and diversion of pre- drugs. However, the closed system of adolescent Americans had experimented scription drugs invokes a myriad of dan- distribution for controlled substances pri- with taking a prescription pain reliever, gers requiring the increased attention of marily focuses on safeguards up to the tranquilizer, stimulant or sedative.17 The pharmacists, as demonstrated by the fact point of dispensing by the pharmacist to 2010 survey by the NIDA concluded that that drug abuse is now the second-leading the patient. Once a controlled substance 2.7% of eighth graders, 7.7% of 10th graders, cause of accidental death in the United reaches the pharmacy, far fewer restric- and 8.0% of 12th graders had abused hydro- States.31 In certain areas of the country, tions (excluding CIIs) are in place as a codone and 2.1% of eighth graders, 4.6% of this risk is even greater. In an estimated 16 result of the need for the pharmacist to 10th graders and 5.1% of 12th graders had states, prescription drug overdoses have have access to the controlled substances abused oxycodone on at least one occasion become the leading cause of accidental for the dispensing/counseling process. within the prior year.17 These figures indi- death, surpassing motor vehicle accidents.32 The limited access to controlled sub- cate that nearly one in 12 high school seniors In addition to the professional respon- stances begins with registration require- have used hydrocodone and nearly one in 20 sibility of a pharmacist to protect patients ments, including DEA registration for all have used oxycodone for nonmedical pur- and ensure the safe and effective use of pre- parties handling controlled substances. poses, further illustrating the cultural phe- scription drug products, various authorities Pharmacists receive an exception to this nomenon of prescription drug abuse. mandate the responsibilities of the phar- registration requirement, wherein the Within this adolescent age group (par- macist through state and federal laws and registration obligation is limited to the ticularly ages 18 to 24), women appear regulations. The U.S. Department of Justice pharmacy or institution where the phar- more likely than men to abuse prescrip- and the Drug Enforcement Agency (DEA), macist is employed.35 tion drugs (as opposed to illegal drugs).26 specifically the DEA Office of Diversion The CSA also establishes record-keep- However, white men (of all age groups) Control, set forth various responsibilities ing requirements for tracking the trans- remain the overall largest demographic for health professionals, including phar- fer of controlled substances between of prescription drug abusers.26 And the macists, relating to the issues of drug abuse registered, legitimate users and a client adolescent and young adult demographic and drug diversion. These obligations are with a medical need for the controlled group is not alone; even younger chil- codified in the Code of Federal Regulations substance. In general, the transfer of con- dren, along with the middle-aged and the (CFR) and the Controlled Substance Act of trolled substances between registrants elderly, are affected by the phenomenon 1970 (CSA).33 In addition, the DEA Phar- requires a record of transfer containing of prescription drug abuse. macist’s Manual provides an informational the name of the controlled substance, The primary source or supply of the outline of the CSA for pharmacists.34 dosage, strength and number of units. prescription medications also is surpris- In addition, records of receipt at a phar- ing. Most adolescent users report obtain- Controlled Substance Act macy require notation of the containers ing prescription drugs for free from family The CSA is a federal law enforced by the received, date, name, address and DEA or friends.17 Youth are reporting the rela- DEA to establish a closed system of distri- registration of supplier, serving as a tive ease of obtaining prescription drugs bution for controlled substances. A closed record of receipt for CIII-CV products.36 in comparison with illegal drugs, with system ensures the security and account- The record-keeping requirements for an estimated 40% of 12th graders report- ability of a controlled substance from its CII products require use of the triplicate ing the ability to obtain painkillers eas- manufacturing to its consumption by an DEA form 222, wherein the controlled ily.28 In comparison, prescription drug intended party (i.e., the patient). The CSA is substances are shipped to the particular abuse among college-aged students and the government’s primary regulatory enact- address on the form obtained from the other young adults demonstrates higher ment aimed at fighting the abuse of drugs DEA, which serves as the only accept- use rates of stimulants (such as amphet- classified as controlled substances (includ- able record of the transfer.37 The optional amines and dextroamphetamine) and ing narcotics, stimulants, depressants, electronic ordering system known as the

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has published various indicators that TABLE 3 help in determining whether a controlled 30,31 Potential indicators of forged or non-legitimate prescriptions substance prescription may be forged and/or issued for a non-legitimate medi- The following criteria may indicate that a prescription was cal purpose (Table 3).30,31 not issued for a legitimate medical purpose: The requirement of confirming a • The prescriber writes significantly more prescriptions (or in larger legitimate medical purpose obligates the quantities) compared with other practitioners in the area. pharmacist to dispense controlled sub- stances only for acceptable purposes. • The patient appears to be returning too frequently. A prescription that Here, the pharmacist must exercise should last for a month in legitimate use is being refilled on a biweekly, weekly or even a daily basis. sound professional judgment in deter- mining the legitimacy of the purpose for • The prescriber writes prescriptions for antagonistic drugs, such as the controlled substance. Many pharma- depressants and stimulants, at the same time. Drug abusers often cists are not aware that under the CSA, request prescriptions for “uppers” and “downers” at the same time. a legitimate purpose does not include dispensing a controlled substance to an • The patient presents prescriptions written in the names of other people. addict to avoid withdrawal (unless the • A number of people appear simultaneously, or within a short time, all patient is enrolled in a licensed treatment bearing similar prescriptions from the same physician. program).34 These distinctions under the CSA are important, as the act provides for • People who are not regular patrons or residents of the community show both civil and criminal liability for phar- up with prescriptions from the same physician. macists filling prescriptions not issued in 39 The following criteria may indicate a forged prescription: the course of professional treatment. The CSA establishes various additional • The prescription looks “too good.” The prescriber’s handwriting is too requirements for pharmacists and phar- legible. macies in the handling of controlled sub- stances. Further information is included • Quantities, directions or dosages differ from usual medical usage. in the discussion of the codification of the • The prescription does not comply with the acceptable standard CSA infra (CFR). abbreviations or appears to be textbook presentations. Pharmacist’s Manual • The prescription appears to be photocopied. The DEA publishes the Pharmacist’s Manual, a reference providing specific • Directions are written in full with no abbreviations. guidance and information on the require- • Prescription is written in different color inks or written in different ments of the CSA. The Pharmacist’s Man- handwriting. ual provides further guidance on how to implement the CSA regulations within a pharmacy. The manual is available online Controlled Substance Ordering System a prescription for a controlled substance and provides a thorough reference for also is available for a pharmacy’s order- (as state dispensing laws closely mirror understanding, implementing and com- ing of controlled substances, providing the CSA). The CSA requires: (1) a valid plying with the CSA.35 Pertinent sections an electronic equivalent with various prescription (2) issued for a legitimate of the Pharmacist’s Manual affecting a benefits (e.g., decreased turnaround time medical purpose.38 The requirement for pharmacist’s responsibility to protect and error rates in completing forms).34 a valid prescription obligates pharma- against drug diversion are set forth in These and other restrictions at the whole- cists to ensure the legality of a prescrip- Table 4. Pharmacists are encouraged to sale level significantly deter diversion tion, including being on the lookout for be familiar with at least these sections of because of the limited access and various fraudulent prescriptions (e.g., altered or the manual. Most states require that this accountability measures. However, there forged prescriptions, stolen prescription reference be available in a pharmacy’s remains significant diversion at the phar- pads, scanned duplicates of prescrip- reference library. macy level as a result of the more readily tions).34 Identifying fraudulent prescrip- In particular, the Pharmacist’s Man- available access to controlled substances. tions often is difficult, as technology has ual outlines the proper transfer and Most pharmacists are well aware of made counterfeiting techniques harder to disposal of controlled substances for the CSA’s requirements for dispensing detect.31 To assist pharmacists, the DEA compliance with the CSA (as outlined

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above), including the use of a reverse distributor. In addition, the manual TABLE 4 establishes security requirements Exemplary sections of Drug Enforcement Agency within a pharmacy, including that a Pharmacist’s Manual affecting drug diversion prevention35 pharmacy not employ people having certain felony convictions in any posi- • Transfer or disposal of controlled substances (§IV) tion having access to the controlled sub- stances within the pharmacy, without • Security requirements (§V) 40 an exemption granted by the DEA. • Record-keeping requirements (§VI) Code of Federal Regulations • Inventory requirements (§VII) The DEA Office of Diversion Control’s • Ordering controlled substances (§VIII) authority is codified in the CFR Title 21, parts 1300-1399.41 Similar to the guidance • Valid prescription requirements (§IX) provided in the CSA and reiterated in • Dispensing requirements (§X) the Pharmacist’s Manual, the CFR pro- vides specific guidance on protecting CII drugs. However, the requirements for non-CII drugs are vague, requir- More specific guidance regarding the and laws. A pharmacist’s state licensure ing “effective controls and procedures reporting of diversion is set forth under and the pharmacy’s DEA registration to guard against theft and diversion of the CFR. There is an explicit requirement (required for a pharmacy to dispense controlled substances.”42 Therefore, in for any employee having knowledge of controlled substances) are dependent contrast to the explicit codified require- drug diversion from his or her employer upon the actions of both the pharmacy ments for protecting CII drugs, there are (pharmacy) by another employee to technicians and the pharmacists to com- fewer regulations controlling the protec- report the information to the employer.45 ply with the CSA and CFR. In addition, tion of CIII-CV drugs, as they are viewed There also are requirements for the criminal liability (including jail time), as presenting a less significant public regulated entity (pharmacy) to report along with civil monetary fines, can be risk. to the DEA any “unusual or excessive levied against pharmacists, depend- Similar to the requirements under loss or disappearance of a scheduled ing upon the actions of the pharmacist the CSA, parts 1305 (order forms), 1306 [product].”46 The initial notice of signifi- in failing to comply with the CSA and (prescriptions) and 1314 (retail sale and cant loss must be submitted to the DEA CFR. The pharmacist is therefore encour- dispensing of scheduled listed chemi- within 24 hours of the entity (pharmacy) aged to take additional steps to ensure cal products) provide similar guidance first becoming aware of the incident of the compliance of all people within the for preventing drug diversion. The diversion or loss. The pharmacist should pharmacy. And the pharmacist in charge requirements for retail pharmacy’s sale be well aware of these requirements, as has additional obligations to ensure of scheduled products place additional there are an estimated 6,500 pharmacy the various regulations and laws are security limitations on the scheduled thefts occurring annually in the United met by those within the pharmacy. As drug products. For example, the phar- States.47 Of those thefts, an estimated addressed in this lesson, an understand- macist must ensure that scheduled drug 50% result from employee diversion, ing of the specific methods of internal products are not accessible by clients meaning there’s a relatively high likeli- drug diversion will assist the pharma- prior to the sale (dispensing).43 The CFR hood that the pharmacist may need to cist in establishing further strategies to requires that the products be placed follow these reporting requirements at protect against drug diversion and better behind the counter and may include the some point. comply with the various regulations and use of a locked storage cabinet. The pharmacist is obligated to ensure laws discussed. The CFR provides additional diver- compliance with the various regulations In addition to the pharmacist’s sion security measures through its and laws discussed herein, including responsibilities under state and federal regulation of various employment mea- the CSA and CFR (both as outlined and laws, trends in curbing the epidemic of sures. The pharmacy is authorized to explained in the Pharmacist’s Manual). prescription drug abuse and drug diver- take “reasonable measures” to protect In addition to the pharmacist’s indi- sion suggest that state boards of phar- against employees presenting a risk for vidual compliance, the actions of those macy may weigh in on the matter. It is drug diversion, granting the pharmacy working under the pharmacist’s direc- conceivable that in the future, pharmacy broad discretion in implementing inter- tion, including interns and technicians, accreditations may further depend upon nal security procedures.44 also must comply with these regulations the specific measures for preventing

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and/or reporting drug diversion inci- of timely inventories, creates a break in patient of the pharmacy; however, the dents by pharmacies and pharmacists. the protocol of pharmacy operations such prescription may never be dispensed As a result, the pharmacist’s responsibil- that a pharmacy employee could remove (or sold). Instead the prescription may ity for the appropriate oversight of con- drug products from the pharmacy easily be taken by the pharmacy employee. trolled substances and other prescription without having an accurate inventory to Consider the scenario of a prescription drugs is expected to increase beyond the evidence the diversion of the product. that has already been filled and billed CSA, CFR and other state-specific laws In addition to inventorying drug for a legitimate patient but that can’t and regulations. products within the pharmacy, the ini- be located within the pharmacy. In the tial step of ordering the products pres- event the prescription has to be refilled, DRUG DIVERSION TECHNIQUES ents an opportunity for internal drug the pharmacist should look to see what Drug diversion has become an essen- diversion. For example, diversion may products went missing, as it is possible tial means to supply the demand for occur as a result of unauthorized peo- that the full prescription was taken by the abuse of prescription drugs. As a ple placing orders (including orders for a pharmacy member from the bins wait- result, pharmacies have become a target controlled substances). Orders may be ing for pickup, and then a new prescrip- for drug diversion, as they are an easily placed for excess quantities of the drug tion is refilled for the actual patient. identifiable part of the supply chain. The products, and in the event the same Alternatively, the pharmacy employee trends in abuse outlined in this lesson pharmacy employee conducts both the may actually dispense the prescription provide the pharmacist with informa- ordering (and acceptance of deliveries) to a “patient” who is in collusion with tion about targeted drugs and popula- and the inventorying, there is ample the employee to make the transaction tions of abusers who may seek to divert opportunity for discrepancies and falsi- appear legitimate. Such methods may be prescription and/or OTC medications fication of records. extremely difficult to detect. from a pharmacy. Diversion as a result of fraudulent There are various other mechanisms The diversion of prescription drugs may record keeping also can occur at the time of diversion from within the pharmacy. occur either internally (within a pharmacy) a drug product is disposed. People dis- For example, during the filling of a pre- or externally (outside the pharmacy or after posing of products from the pharmacy scription, a pharmacy employee may the dispensing of a prescription). Regard- may document a product as outdated remove dosages from the prescription less of the type of diversion, the methods or contaminated, requiring disposal, intentionally to “short fill” the prescrip- refer to the illegal removal of a prescription and then take the product rather than tion. As a result, a patient may receive 27 drug from its intended path beginning with actually disposing of it. Alternatively, tablets instead of 30, with the pharmacy a manufacturer and ending with the dis- another product could be substituted for employee pocketing the remaining three pensing to a patient. the product documented as disposed in tablets. Other diversion techniques may Internal diversion is the removal or an effort to divert the product. More bla- be employed to remove small or medium loss of prescription drug products from tant techniques also may be employed, quantities of drug products from within within the pharmacy. Internal diver- such as placing a bottle or other container the pharmacy consistently. For example, sion often results from various types of in the garbage with product remaining dosages may be placed into personal employee theft or pilferage, which is in the container and later retrieving the belongings, such as pockets or purses, made possible as a result of the signifi- remaining drug product from the gar- throughout an employee’s shift. Liquids cant access to prescription drug products bage. This especially holds true if a phar- may be poured into soda cans or water afforded to pharmacy employees or oth- macy member knows that he or she will bottles kept by the employee within the ers allowed in the pharmacy (whether be taking out the garbage at closing of the pharmacy. These diversion techniques authorized or not).11 Internal drug diver- pharmacy to a location where no one else create difficulty, as there usually are no sion techniques may occur during all would be able to see him or her take the means to track the diversion because no phases of pharmacy operations, includ- containers back out of the bag. retail transaction has occurred. ing the ordering, inventorying, disposal Internal diversion also can occur as a In addition, traditional theft and rob- and/or dispensing of medications. Inter- result of the fabrication of prescription bery of a pharmacy may be utilized to nal diversion usually involves a rela- orders and/or the reuse of prescriptions obtain larger quantities of drug prod- tively small group of potential suspects in order to fill excess prescriptions that ucts. Those employed within the phar- (depending upon the pharmacy size). appear legitimate. These diversion tech- macy have intimate knowledge of the The inventorying of prescription drugs niques may or may not involve collu- operation of the pharmacy and the lev- presents a unique opportunity for those sion with the patient and/or prescriber. els of security employed, providing a with access to the pharmacy to divert In particular, the reuse of prescrip- myriad of opportunities to breach the prescription drug products. Inaccurate tion orders gives the appearance that systems of security established. This or forged inventories, along with a lack a prescription is filled for a legitimate may include providing people outside

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Case Study 1

A pharmacy staffing two pharmacists and three technicians is routinely very busy. In an effort to facilitate more efficient practices, the pharmacist in charge has discussed with the other pharmacist ways to have the technicians begin working as soon as they arrive and before the actual opening of the pharmacy. This allows the technicians to be in the pharmacy even if the pharmacist may be in and out for administrative reasons prior to opening. In addition, the technicians assist with ordering and the acceptance of orders. Oftentimes, there simply is not enough time for the pharmacist in charge or pharmacist colleague to complete all of those tasks on his or her own. At the pharmacy, technicians routinely take the initiative to place and fill the orders for various prescription drug products, including controlled substances. One technician begins placing orders for additional bottles of alprazolam using the electronic ordering system. In addition, the same technician accepts the orders and restocks the bottles in the pharmacy. However, the technician routinely removes quantities of the alprazolam (often entire bottles), while not having to alter the documentation records for the amount of the controlled substance received in the shipments, as one of the pharmacists just signs the invoice after the alprazolam already has been placed on the shelf. As a result, the technician is able to divert relatively large quantities of the controlled substance from the pharmacy, with documented records showing that the pharmacist in charge and the other pharmacist were initialing the orders, creating significant liability for the pharmacist in charge.

Case discussion The pharmacy now is establishing revised controls to reduce the incidence and risks of internal drug diversion. In an effort to provide more limited access to controlled substances, the pharmacy’s opening and closing process has been changed. The pharmacist does not leave the pharmacy at any time when it’s closed and the technicians are still in the pharmacy. This ensures that the technicians are not in the pharmacy without supervision. While the pharmacists do take lunch, leaving the technicians alone in the pharmacy, this only occurs during operating hours, when others have the capability to see into the pharmacy. In addition, security cameras can be utilized if any concerns or doubts about internal diversion arise. In addition, the pharmacy is creating a system of “checks and balances” to ensure that the process of ordering controlled substances is not completed by any one individual (including a single pharmacist). A policy is created to ensure that a different person places the order, receives the order and shelves the order within the pharmacy. This is not done on a set rotational basis, as such a policy permits one person to know when and how to adjust to the schedule. The pharmacy also requires increased audits of all controlled substances to compare inventories against the purchase invoices for the controlled substances. And all the bottles for controlled substances now are placed with the invoice so the pharmacist who initials the inventory has an exact count of bottles. Additional safeguards soon will be implemented within the pharmacy, including a rule prohibiting pharmacy employees from keeping personal belongings on or near the counters (including purses, backpacks and other containers). A further store policy has been implemented to allow the pharmacist in charge to check the personal belongings of the employees at the beginning and end of a shift (including jackets, purses, etc.) to look for stolen drugs.

the pharmacy with sufficient knowledge robbery of a pharmacy and/or acquir- legitimate medical needs. As a result, to orchestrate a theft or robbery of the ing products from unauthorized Internet improved controls are necessary to reduce pharmacy. For example, a pharmacy sales or traditional drug dealing. Various internal diversion, and the pharmacist is employee may work in tangent with key identifiers for high-risk diversion sce- the key person to implement and oversee another employee of the store (outside narios for a pharmacist are identified in such controls. The pharmacist’s access to the pharmacy) and provide access codes Table 5.30 As the focus of this lesson is on prescription drug products and oversight to the pharmacy, along with instructions internal diversion of prescription drugs, of employees and pharmacy operations on where the desired prescription drug the pharmacist is directed to additional puts the pharmacist in the best position for products are located. resources for more information on exter- improving strategies to reduce diversion. External diversion involves the sourc- nal diversion methods.30 ing of prescription drugs through a vari- Reduction of internal diversion ety of mechanisms outside the pharmacy. STRATEGIES TO REDUCE Reducing internal diversion begins with Often, external diversion includes a vari- INTERNAL DRUG DIVERSION a pharmacist’s appreciation of the trends ety of patient pretenses, such as a patient’s Reducing drug diversion is a complex of the most commonly targeted drugs of use of a fraudulent and/or altered pre- endeavor, as neither the supply nor the abuse, along with the key demographics scription, doctor shopping, lack of a legiti- demand can ever be eliminated because for prescription drug abuse. An under- mate medical use, obtaining prescription it is essential to maintain access to pre- standing of the trends of prescription drug drugs from friends or relatives, theft or scription drug products for those with abuse will allow for the implementation of

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medications, rather than only CII medica- TABLE 5 tions. Enhanced security measures around High-risk drug diversion scenarios: patient characteristics30 CIII-CV medications are essential within the pharmacy, as the more relaxed stan- dards required under the CSA and state • Client requesting brand-name controlled substance regulations make these medications an • Prescription written with apparent irregularities easier target for internal drug diversion. Pharmacists should review their own cur- • Client’s lack of familiarity with the prescribing physician rent practices about who opens the CII • Client and/or prescribing physician from out of town cabinet, especially if the highly sought- after medications also are stored in this • Suspicious client demeanor (overly friendly, nervous or aberrant) area — leaving the cabinet unlocked when • Client trying to pay in cash instead of using insurance a product is out only provides greater temptation for internal diversion. • Client triggers “gut” instinct of pharmacist Record-keeping and inventory require- ments also can be enhanced to reduce internal diversion. Inventories upon the increased security measures for those most The prevention of unauthorized access transfer, disposal and/or dispensing of all commonly targeted drugs (opiates, includ- to the pharmacy is essential in the reduction controlled substances significantly would ing hydrocodone, oxycodone and metha- of internal diversion. Pharmacists and those decrease the opportunities for pharmacy done; stimulants, including amphetamine, working in the pharmacy do not have the employees to remove drugs without the dextroamphetamine and methylpheni- same physical restrictions limiting access detection of others in the pharmacy. In date; and sedatives and tranquilizers). to controlled substances and other targeted addition, the pharmacist should consider Although CII drugs may appear to be the prescription drug products, as access is an increasing the frequency of inventories, most likely target of diversion, this gener- essential element to dispensing such drugs. including requiring the perpetual inven- ally is not the case because of the estab- This is distinct from the limited access tory of non-CII drugs. This significantly lished precautions for monitoring (such as given to other DEA registrations, wherein would decrease the opportunities for tech- a perpetual inventory). As a result, more there may be extensive background and eli- nicians and other pharmacy employees to attention should be placed on the targeted gibility limitations and security measures remove drugs without prompt detection. diversion of CIII-CV drugs, which often (e.g., extensive vaults, alarms and even Some states recommend keeping perpet- can be taken between inventory periods caged security systems). As a result, any ual inventories of high-risk drugs, such with greater ease. The increased focus on person having access behind the counter as hydrocodone or alprazolam, to ensure CIII-CIVs is particularly important, as should be under direct supervision, and that accurate records are maintained.48 this is where both hydrocodone and ben- the “visits” should be kept to a minimum. Ensuring that the same person does not zodiazepines are classified — the most This includes all members of the pharmacy always conduct the inventories provides frequently targeted drugs for internal team, as well as those granted occasional further safeguards. diversion. access to the pharmacy (e.g., pharmacy Review of the pharmacy’s salvage In addition, a greater awareness as to maintenance, computer repair, store man- process also can be an efficient means those employed within the pharmacy, ager, other store team members, etc.). of reducing diversion. Oftentimes, the along with any people having access to the Changes to dispensing practices are pharmacy’s salvage bin is a staging area pharmacy, is required. This includes the recommended to reduce internal diver- for drug diversion. As with other control pharmacists, technicians, sales associates, sion. Further limitations on employee limitations, it is preferred that more than backup technicians and other store person- access to controlled substances are recom- one person oversees this process. For nel entering the pharmacy (e.g., for mainte- mended to provide additional safeguards. example, the same technician should not nance or garbage removal). No pharmacy Limited access to controlled substances be responsible for documenting damages personnel are immune to the risk of internal often is sacrificed for convenience, which or expired products, placing the con- drug diversion. A culture of responsibility is detrimental to the goals of deterring tainers in a salvage bin and then trans- and accountability for the security of the drug diversion. Controlled substances at porting the drugs for disposal or return. prescription drug products of the phar- highest risk of diversion (e.g., hydroco- Additional red flags within the salvage macy is essential. Commitment to standard done and benzodiazepines) also could be process should be monitored, includ- processes for monitoring and controlling stored under lock and key and require the ing the regular use of large amounts of the inventory within a pharmacy will assist supervision of a pharmacist to remove for a controlled substance requiring wasting in curbing internal diversion. dispensing. These should include CIII-CV of a portion of the controlled substance

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when a smaller dose is available that would generate less waste. In addition, Case Study 2 any increase in damaged or broken vials, spills, etc., requiring the discarding of A pharmacist receives an oral prescription for a CIV. The prescription is received controlled substances should be moni- from a practitioner’s office that the pharmacist is not familiar with, and the number on caller ID has been blocked. The pharmacist determines that the tored. There should always be appropri- legitimacy of this prescription order should be confirmed prior to dispensing to ate witness documentation for any waste the patient. or discarding of a controlled substance, and the witness actually should see the Case discussion discarding of the product. The pharmacist should verify all prescriber information, including calling the A review of the existing security mea- prescriber’s office back and verifying the DEA registration number. Just calling sures within the pharmacy in terms of the number provided without verifying the DEA registration number is not storage and access may identify the need enough. Fraud groups have set up operations that include phone numbers that are directed back to them or a partner and not the true physician’s office. Any for adding security cameras, mirrors or person answering the call-back number should be asked a variety of questions other means of ensuring that pharmacy to ensure the legitimacy of the prescriber and the DEA registration number. If the technicians or those having access to the pharmacist is still in doubt over the legitimacy of the prescriber, the pharmacist pharmacy do not remove drug products should use the Internet to find the actual number of the prescriber and compare through the various techniques discussed it with the information provided from the oral prescription. in this lesson. Other measures may Prior to dispensing the prescription, the pharmacist also should verify the include storing the personal belongings of patient’s information. The pharmacist also may request that the patient confirm the identity of the prescribing physician. The pharmacist is encouraged to pay pharmacy employees (e.g., purses, coats) particular attention to the patient for any additional suspicious behavior and in an appropriately defined area that is should not dispense the prescription if the legitimacy of the prescription and its not accessible during the work shift and/ medical use are not confirmed. or having a pharmacy manager inspect these items before the end of a shift to ensure that no theft has taken place. In addition, an overall increase in the of drug abuse trends. The pharmacist provide for methods of professional and vigilance to what is happening within the should continue to verify all suspicious law enforcement intervention. A phar- pharmacy is a critical element of reducing prescriptions and client behavior vigi- macist’s participation in such programs drug diversion. The pharmacist should lantly before dispensing a prescription. often requires reporting certain dispens- be aware of the behavior of technicians, In addition, patient education regarding ing information, such as patient name, interns and other pharmacists to identify the proper usage of medications and the date and quantity of the drug dispensed, signs of potential misuse or abuse of drug dangers of drug misuse and abuse (includ- refills, practitioner and dispenser infor- products, which might indicate the per- ing allowing others to use one’s medica- mation. All programs require the track- son also is diverting drugs from the phar- tion) should be included in discussions ing of information related to CII drugs. macy. For example, employees exhibiting with patients. Drug utilization review and However, programs differ on the require- sluggish behavior or indications of sleep medication therapy management services ments with regard to CIII-CV drugs. As disturbances, frequent flu-like symp- also should be tools utilized by the phar- the design and requirements of your state toms, bloodshot eyes, changes in mood macist to assess whether drug abuse and/ programs may differ, pharmacists are or mental state, or indications they need or diversion is occurring. directed to the DEA for further informa- treatment by drugs or have exaggerated tion on state requirements.50 medical problems may be signals that the Participation in prescription drug person is at risk and in need of additional monitoring programs Reporting drug diversion monitoring or intervention. Each of these National and/or local prescription In the event of an actual drug diversion are ways the pharmacist can take a proac- drug monitoring program (PDMP) partic- occurrence, check with your organiza- tive role in identifying signs of potential ipation may provide further opportunities tion for specific reporting obligations and drug diversion from the pharmacy rather to minimize the diversion of prescription protocol (including reporting the loss to than looking the other way. drugs. Both national and local PDMPs the DEA Office of Diversion Control and have been formed to try to detect suspi- local law enforcement). The reporting of Reduction of external diversion cious patterns of drug use, particularly issues through appropriate law enforce- The reduction of external diversion also controlled substance use.49 PDMPs seek ment, regulatory and compliance chan- is a responsibility of the pharmacist and to identify prescribers and patients at nels not only will assist with compliance requires the pharmacist’s understanding risk for both addiction and diversion and with applicable laws, but also will assist

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in establishing additional safeguards for have a professional responsibility, along measures be taken to protect the ordering, preventing future drug diversion. with legal obligations, to both deter and inventorying, disposal and dispensing of report incidences of drug diversion from controlled substances. These and other reg- CONCLUSION the pharmacy. These professional responsi- ulated efforts will assist in preventing drug Pharmacists’ understanding of their bilities obligate the pharmacist to be aware diversion. However, additional security responsibilities to protect against drug of potential scenarios for possible drug measures and pharmacist awareness are diversion should be heightened after review diversion. In addition, the CSA and other required to curb the incidence of internal of this lesson. It is clear that pharmacists regulations require that certain security pharmacy diversion.

Practice points

1. Pharmacists must understand the trends in drug abuse to identify targeted prescription drugs for diversion from the pharmacy. 2. The pharmacist is responsible for the activities of all people within the pharmacy, including technicians and interns. 3. Increased vigilance is required for CIII-CV drugs in the pharmacy. 4. Increased diligence is needed in enforcing all corporate policies and procedures around controlled substance security. 5. Personal belongings in the pharmacy need to be screened carefully to prevent diversion.

1. Substance Abuse and Mental Health Services Administration (SAMHSA) National Survey on Drug Use and Health. “Results from the 2009 National Survey on Drug Use and Health (NSDUH).” Available at: http://oas.samhsa.gov/NSDUH/2k9NSDUH/2k9ResultsP.pdf. Accessed May 29, 2011. 2. Statement Of The National Association of Chain Drug Stores For U.S. House of Representatives Energy and Commerce Committee Commerce, Manufacturing, and Trade Subcommittee Hearing. “Warning: The Growing Danger of Prescription Drug Diversion.” April 14, 2011. Available at: http://www.nacds.org/user-assets/pdfs/2011/newsrelease/4_14_SubcommStatement.pdf. Accessed April 23, 2011. 3. White House Drug Policy Report. “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” Available at: http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf. Accessed April 29, 2011. 4. McCarthy, M. Prescription Drug Abuse Up Sharply in the USA. Lancet. 2007; 369:1505-1506. 5. Office of National Drug Control Policy. “Prescription Drug Facts and Figures.” Available at: http://www.whitehousedrugpolicy.gov/drugfact/prescrptn_drgs/rx_ff.html. Accessed April 20, 2011. 6. Substance Abuse and Mental Health Administration (SAMHSA). National Survey on Drug Use and Health. Available at: http://www.oas.samhsa.gov/nsduhLatest.htm. Accessed May 30, 2011. 7. National Institute of Drug Abuse. Research Report Series - Prescription Drugs: Abuse and Addiction. Available at: http://www.drugabuse.gov/ResearchReports/Prescription/prescription2.html. Accessed April 20, 2011. 8. Office of National Drug Control Policy. Prescription Drug Abuse. Available at: http://www.whitehousedrugpolicy.gov/prescriptiondrugs. Accessed July 3, 2011. 9. Centers for Disease Control (CDC). Unintentional Poisoning Deaths (U.S.) MMWR Morb Mortal Wkly Rep. 2007;56:93-96. 10. National Institute on Drug Abuse (NIDA) Research Reports. “Prescription Drugs: Abuse and Addiction.” Available at: http://www.nida.nih.gov/ResearchReports/Prescription/Prescription.html. Accessed April 20, 2011. 11. Burke, J. “An Inside Job: Drug Diversion in the Pharmacy” Parts 1 and 2. June-July 2003. Available at: http://www.pharmacytimes.com/publications/issue/2003/2003-06/2003-06-7240 and http://www.pharmacytimes.com/ publications/issue/2003/2003-07/2003-07-7318. Accessed May 30, 2011. 12. Iowa Substance Abuse Information Center. Prescription and Over-the-Counter Drug Information. Available at: www.DrugFreeInfo.org. Accessed April 20, 2011. 13. National Institute on Drug Abuse (NIDA). “Commonly Abused Drug Chart” Available at: http://www.drugabuse.gov/DrugPages/ DrugsofAbuse.html. Accessed May 30, 2011. 14. National Institute on Drug Abuse (NIDA). “Prescription Drug Abuse Chart” Available at: http://www.drugabuse.gov/DrugPages/ PrescripDrugsChart.html. Accessed April 20, 2011. 15. Manchikanti, L, et al. Therapeutic Use, Abuse, and Nonmedical Use of Opioids: A Ten-Year Perspective. Pain Physician. 13:401- 435. 2010. 16. Drug Abuse Warning Network (DAWN). “Annual Medical Examiner Data 1999.” Table 2.06A. Available at: http://www.oas.samhsa.gov/99me_annual.pdf. Accessed June 2, 2011. 17. University of Michigan Institute for Social Research. “Monitoring the Future: National Results of Adolescent Drug Use.” Available at: http://www.monitoringthefuture.org/pubs/ monographs/overview2009.pdf. Accessed May 30, 2011. 18. Kuehn, B. Opioid Prescriptions Soar. JAMA, 2007; 297(3):249-51. 19. Rannazzisi, J. DEA office of Diversion Control. U.S. Department of Education Office of Safe and Drug Free Schools Presentation. “The National Pharmaceutical Situation Report.” August 2009. 20. Enforcement Agency (DEA) Office of Diversion Control. Drugs and Chemicals of Concern. Available at: http://www.deadiversion.usdoj.gov/drugs_concern.htm. Accessed July 3, 2011. 21. National Institute on Drug Abuse (NIDA). NIDA for Teens. Available at: http://teens.drugabuse.gov. Accessed July 3, 2011. 22. Prescription for Peril: How Insurance Fraud Finances Theft and Abuse of Addictive Prescription Drugs. December 2007. Available at: http://www.insurancefraud.org/downloads/drugDiversion.pdf. Accessed July 3, 2011. 23. National Institute on Drug Abuse (NIDA). “Selected Prescription Drugs with Potential for Abuse.” Available at: http://www.whitehousedrugpolicy.gov/drugfact/prescrptn_drgs/rx_ff.html. Accessed May 30, 2011. 24. Drug Enforcement Agency (DEA) Office of Diversion Control. Drugs and Chemicals of Concern: Dextromethorphan. Available at: http://www.deadiversion.usdoj.gov/drugs_concern/dextro_m/ dextro_m.htm. Accessed May 30, 2011. 25. Substance Abuse and Mental Health Services Administration (SAMHSA). “Non-Medical use and Abuse: Prescription-type and Over-the- Counter Drugs.” Available at: http://www.oas.samhsa.gov/prescription.htm. Accessed April 20, 2011. 26. Zickler P. NIDA Scientific Panel Reports on Prescription Drug Misuse and Abuse. NIDA Notes. 2001;16(3). 27. Johnston, LD, et al. Monitoring the Future. National Results on Adolescent Drug Use: Overview of Key Findings, 2007. NIH publication 08-6418 (National Institute on Drug Abuse). 28. Office of National Drug Control Policy. The Abuse of Prescription and Over-the-Counter Drugs. September 2007. Available at: www.theantidrug. com/pdfs/resources/teen-rx/Prescription_Abuse_brochure.pdf. Accessed May 30, 2011. 29. Johnston, LD, et al. Monitoring the Future. National Survey Results on Drug Use, 1975- 2007: Volume II, College Students and Adults Ages 19-45. NIH publication 08-6418B (National Institute on Drug Abuse). 30. Drug Enforcement Agency (DEA). “A Pharmacist’s Manual: An Information Outline of the Controlled Substances Act. Appendix D – Pharmacist’s Guide to Prescription Fraud” Revised 2010. Available at: http://www.deadiversion.usdoj.gov/pubs/ manuals/pharm2/pharm_manual.pdf. Accessed April 28, 2011. 31. U.S. Department of Justice: National Drug Intelligence Center. “National Drug Threat Assessment 2009.” Available at: www.usdoj.gov/ndic/pubs31/31379/index.htm. Accessed May 29, 2011. See also National Association of Drug Diversion Investigators. Available at: http://naddi.associationdatabase. com. Accessed May 29, 2011. 32. Senate Judiciary Committee, Subcommittee on Crime and Terrorism. “Responding to the Prescription Drug Epidemic: Strategies for Reducing Abuse, Misuse, Diversion, and Fraud.” Webcast of May 24, 2011 Hearing. Available at: http://judiciary.senate.gov/hearings/hearing.cfm?id=e655f9e2809e5476862f735da16cf3a9. Accessed May 26, 2011. 33. Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. Controlled Substances Act, 21 U.S.C. § 801 et seq (2002). 34. Drug Enforcement Agency (DEA). “A Pharmacist’s Manual: An Information Outline of the Controlled Substances Act.” Revised 2010. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/ pharm2/pharm_manual.pdf. Accessed April 28, 2011. 35. 21 C.F.R. § 1301.13(d). 36. 21 C.F.R. § 1304.22(c). 37. 21 C.F.R. § 1305.11. 38. 21 C.F.R. § 1306.04(a)). 39. 21 U.S.C. § 842 (2002). 40. 21 C.F.R. §§ 1301.76(a), 1307.03; Drug Enforcement Agency (DEA). “A Pharmacist’s Manual: An Information Outline of the Controlled Substances Act.” p. 15. Revised 2010. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf. Accessed April 28, 2011. 41. Title 21 C.F.R., Parts 1300-139 (updated April 1, 2010). Available at: http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html. Accessed April 20, 2011. 42. 21 C.F.R. § 1301.71. 43. 21 C.F.R. § 1314.25. 44. 21 C.F.R. §1314.50. 45. 21 C.F.R. § 1301.91. 46. 21 C.F.R. § 1314.15. 47. Joranson DE, et al. Wanted: A Public Health Approach to Prescription Opioid Abuse and Diversion. Pharmacoepidemiol Drug Saf. 2006;15:632-634. 48. Bureau of Narcotic Enforcement New York State Department of Health. “A Pharmacist’s Guide to Controlled Substance Diversion.” Available at: http://www.nyhealth.gov/ publications/1059.pdf. Accessed June 2, 2011. 49. Burke, J. “RX Abuse 2011 – Moving Forward.” February 2011. Available at: http://www.pharmacytimes.com/publications/issue/2011/ February2011/DrugDiversion-0211. Accessed May 25, 2011. 50. Drug Enforcement Agency. “State Prescription Drug Monitoring Programs.” Updated July 2010. Available at: http:// www.deadiversion.usdoj.gov/faq/rx_monitor. Accessed May 30, 2011.

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Learning Assessment

Successful completion of “Drug 3. The Code of Federal Regulations The following scenario is provided diversion” (lesson 401-000-11-304-H04-P) codifies the following requirements for Questions 6 to 9 below. is worth two contact hours of credit. To for non-CII drugs: answer questions, visit our Web site a. Effective controls and A pharmacist in charge oversees at www.cedrugstorenews.com. procedures to guard against three pharmacists (as well as a theft and diversion variety of PRN pharmacists who 1. Which of the following statements b. Locked in a storage cabinet prior frequently fill in shifts as needed) regarding the Controlled Substances to dispensing and five technicians. Although the Act is true? c. Use of DEA 222 forms pharmacist in charge has known a. The federal law establishes a (and equivalent electronic many of the pharmacy employees closed system for controlled prescribing system) for years, the PRN pharmacists substances up to the point of d. Perpetual inventories and two of the technicians are new a wholesaler or manufacturer members of the pharmacy team, and selling the controlled substance 4. The classes of prescription drugs the pharmacist in charge has not to a pharmacy. most commonly abused include: had an opportunity to work closely b. A pharmacy DEA registration for a. Tranquilizers, opioids with them. There was a break- handling controlled substances and steroids in at the pharmacy a few months may be revoked as a result of b. Opioids, sedatives and earlier, and security measures a pharmacist’s or technician’s tranquilizers, and stimulants were enhanced to minimize access failure to comply with the c. Opioids, stimulants and steroids to the pharmacy to any people Controlled Substances Act. d. Opioids, stimulants and other than the pharmacists and c. Pharmacists have increased benzodiazepines technicians. Since the break-in, the regulation under the closed pharmacist in charge has monitored system of the Controlled 5. Death from prescription drug the controlled substances in the Substances Act as a result of the overdose: pharmacy more vigilantly and has direct contact with the intended a. Is more common than deaths noticed an increase in discrepancies party (i.e., the patient). attributed to overdose of heroin in controlled substance inventories, d. Pharmacists are exempt from and cocaine combined particularly hydrocodone and the requirements of the b. Rarely occurs as an accidental alprazolam. The other pharmacists Controlled Substances Act cause of death also have informed the pharmacist because they do not have a c. Is the second-leading cause in charge of incidents when filled DEA registration number. of accidental death in the prescriptions have had to be United States refilled as a result of the 2. A controlled substance prescription d. Has not been documented prescription being misplaced under federal law (Controlled prior to dispensing to the patient. Substances Act) must be a valid However, no other “suspicious prescription issued for a legitimate behavior” has been identified. medical purpose. Which of the following is an indicator of a 6. The pharmacist in charge should forged prescription and/or a non- consider whether which of the legitimate purpose? following methods of internal a. The prescription is written diversion is occurring within for antagonistic drugs at the the pharmacy: same time. a. Employee theft b. Directions are written in full with b. Forged inventories, including no abbreviations. orders, disposals/wastes c. The prescription appears to be and transfers a photocopy. c. Short filling prescriptions d. All of the above d. All of the above

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Learning Assessment

7. Which statement is false based upon 9. Which statement regarding internal the scenario? drug diversion according to the a. The pharmacist in charge has an scenario is true? ethical and legal obligation to a. Each member of the pharmacy establish safeguards and controls team is solely responsible for his to prevent drug diversion. or her actions, and pharmacists b. To ensure controlled substance are not responsible for the actions inventories are accurate, only the of technicians. pharmacist in charge should be b. Failure of the pharmacist in allowed to place orders, accept charge to supervise employees orders, stock all controlled and implement securities against substances and inventory internal diversion may result in controlled substances. loss of license and/or other board c. The pharmacist in charge of pharmacy or legal action. should implement a perpetual c. As a result of the robbery from inventory for the hydrocodone the pharmacy, it is expected that and alprazolam. inventories will be inaccurate d. The increase in the number of for a period of time until the pharmacists working at the complete extent of the theft has pharmacy, along with the new been identified. hiring of technicians, should d. All of the above trigger the pharmacist in charge to be more vigilant of the behaviors 10. Methods of reducing diversion with and work tactics of the employees improved record keeping can be to monitor for employee theft. achieved by the following: a. Inventorying only CII drugs 8. Methods of reducing internal b. Increasing the frequency of diversion according to the scenario inventories, including may include: non-CII drugs a. Increased supervision of any new c. Maintaining perpetual inventories member of the pharmacy team of CII drugs and considering whether the d. Using the same pharmacy employee fits within recognized personnel to inventory to demographics for current trends maintain consistency of drug abuse and diversion b. Increased scrutiny and awareness of employee behavior, including occasional double checks on filled prescriptions for hydrocodone and alprazolam (e.g., ensuring no undercounting or “shorting” of prescriptions) c. Perpetual inventories for targeted CIII-CV drugs, including hydrocodone and alprazolam d. All of the above

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