America's Community Pharmacists, Including the Owners of More Than 22,000 Independent Community Pharmacies

America’s November 2015 PHARMACIST THE VOICE OF THE COMMUNITY PHARMACIST

+ Taking the Initiative + Congessional Summer School + Pharmacy Quality Measures + Diabetes Education

Cold and ﬂ u season is here. Remind your patients to double check their medicine labels so they don’t double up on medicines that contain acetaminophen. Acetaminophen is found in more than 600 different prescription and over-the-counter medicines, including many for cold and ﬂ u. It is safe and effective when used as directed, but taking more than directed is an overdose and can lead to liver damage.

Order free patient education materials to display and distribute in your pharmacy at

National Community Pharmacists Association is a founding member of the Acetaminophen Awareness Coalition. MedSafe is an a ordable and easy-to-operate unused medication collection and disposal program for registered collectors. MedSafe meets the DEA requirements for collecting ultimate user controlled substances (Schedules II-V). The MedSafe system consists of a secure Collection Receptacle with removable Inner Liners. Inner Liners include prepaid return transportation via common carrier and disposal by incineration. Special Pricing for NCPA Members Call 1-800-772-5657

Collection Receptacles are available in two sizes (38-Gallon and 18-Gallon) to meet the needs of retail pharmacies and long-term care facilities. The 38-Gallon Collection Receptacle was designed primarily for use in retail pharmacies with the smaller 18-Gallon designed for use in long-term care facilities. Retail pharmacies may opt for the smaller 18-Gallon Collection Receptacle if oor space is a concern.

Inner Liners are contracted with multiple service schedule options, which may be changed once during contracted period if needed. Inner Liner service frequency is based upon volume of ultimate user medications collected in a given period. A large retail pharmacy in an urban area may opt for monthly service frequency while a smaller pharmacy in a rural area may opt for quarterly service. Similarly, retail pharmacies that are collectors for long-term care facilities may select service frequencies based on number of beds or patients serviced in a location. Lower patient occupancy will require an infrequent service schedule while a facility with 100+ beds lled may require service every other week.

Example System Con gurations Collection Type Service Frequency Receptacle MedSafe System Features LTCF (25 beds) 18-Gallon Quarterly • 16-Gauge Stainless Steel Construction LTCF (50 beds) 18-Gallon Bi-Monthly • Three security locks with one-way medicine drop LTCF (100 beds) 18-Gallon Bi-Weekly • Removable Inner Liners with serialized tracking • Prepaid return transportation of Inner Liners Pharmacy (rural) 38-Gallon Quarterly Pharmacy (urban • Proper disposal of returned medications 38-Gallon Monthly open 4 days a week) 800.772.5657 / www.sharpsinc.com Pharmacy (urban 38-Gallon Bi-Weekly Compliance, Inc. © 2015 Sharps Compliance, Inc. All rights reserved. open 7 days a week) November 2015

MedSafe is an a ordable and easy-to-operate unused medication contents collection and disposal program for registered collectors. MedSafe meets the DEA requirements for collecting ultimate user controlled substances (Schedules II-V). The MedSafe system FEATURES consists of a secure Collection Receptacle with removable Inner Liners. Inner Liners include prepaid return transportation via THIS MONTH’S cover FEATURE common carrier and disposal by incineration. Fighting the Good Fight on Capitol Hill...... 18 by Michael F. Conlan Special Pricing for NCPA’s Legislative/Legal Defense Fund gives community pharmacy a NCPA Members seat at the table. Caption: Our opponents outspend us 20-to-1, but community Call 1-800-772-5657 pharmacy keeps fighting. CVS Caremark, Express Scripts, and the trade association for the pharmacy benefit manager/ mail order industry, the Pharmaceutical Care Management Association, have spent more than $87 million lobbying Congress and federal agencies in the past six years, according to public records complied by the Center for Responsive Politics. CVS Caremark was by far the biggest influence seeker, Collection Receptacles are available in two sizes accounting for some $64 million of the total. By contrast, NCPA (38-Gallon and 18-Gallon) to meet the needs of spent $4.5 million for lobbying in 2010–15. “While we may never retail pharmacies and long-term care facilities. be able to outspend our deep-pocketed corporate opponents, The 38-Gallon Collection Receptacle was designed our true wealth is measured in the value of our membership,” primarily for use in retail pharmacies with the smaller said NCPA CEO B. Douglas Hoey, Pharmacist, MBA. “Their 18-Gallon designed for use in long-term care facilities. enduring bonds with their patients and their communities give Retail pharmacies may opt for the smaller 18-Gallon Collection Receptacle if oor space is a concern. us at least a fighting chance to get our grassroots message of 22 fairness for all across to legislators, policymakers, and regulators Inner Liners are contracted with multiple service in Washington, D.C. But in all honesty, we could do more for schedule options, which may be changed once community pharmacy if we had more money. Sad perhaps, but during contracted period if needed. true.” Inner Liner service frequency is based upon volume of ultimate user medications collected in a given period. A large retail pharmacy in an urban area may opt for monthly service frequency while a smaller pharmacy Taking the Initiative...... 22 in a rural area may opt for quarterly service. Similarly, by Chris Linville retail pharmacies that are collectors for long-term The pharmacy model is broken and Jasper Drugs is fixing it. care facilities may select service frequencies based on number of beds or patients serviced in a location. Congressional Summer School...... 30 Lower patient occupancy will require an infrequent by Michael Rule service schedule while a facility with 100+ beds lled may require service every other week. Community pharmacists hope educating lawmakers on issues will translate into support on Capitol Hill.

Example System Con gurations Pharmacy Quality Measures...... 34 by Laura Bergs, PharmD Collection 30 Type Service Frequency Receptacle An FAQ on proportion of days covered with sulfonylureas. MedSafe System Features LTCF (25 beds) 18-Gallon Quarterly Diabetes Education—The Pharmacist’s Role...... 36 • 16-Gauge Stainless Steel Construction LTCF (50 beds) 18-Gallon Bi-Monthly Letters to the editor—If you would like to comment on an article, email NCPA at [email protected]. Your by Alissa R. Segal, PharmD, CDE, CDTC, FCCP • Three security locks with one-way medicine drop LTCF (100 beds) 18-Gallon Bi-Weekly • Removable Inner Liners with serialized tracking letter may be posted on the NCPA website and edited Community pharmacists can empower and encourage patients • Prepaid return transportation of Inner Liners Pharmacy (rural) 38-Gallon Quarterly for length and clarity. to manage all aspects of their condition. Pharmacy (urban • Proper disposal of returned medications 38-Gallon Monthly open 4 days a week) 800.772.5657 / www.sharpsinc.com Pharmacy (urban 38-Gallon Bi-Weekly © 2015 Sharps Compliance, Inc. All rights reserved. Compliance, Inc. open 7 days a week) www.americaspharmacist.net 5 TAP OUR APP Download “NCPA Mobile” Today!

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Or simply scan the QR code above. AMERICA’S PHARMACIST VOLUME 137, NO. 11 (ISSN 1093-5401, USPS 535-410) is published monthly by the National Community Pharmacists Association, 100 Daingerfield Road, Alexandria, VA 22314. © 2015 NCPA. All rights reserved.

Ask Your Family Pharmacist®

POSTMASTER—Send address changes to: America’s Pharmacist, DEPARTMENTS Circulation Dept., 100 Daingerfield Road, Alexandria, VA 22314; 703-683-8200; [email protected]. Periodical postage paid at Alexandria, VA, and other mailing offices. Printed in the USA. Up Front...... 8 FOR MEMBERSHIP INFORMATION, email ncpamembership@ by B. Douglas Hoey, Pharmacist, MBA ncpanet.org. For other information go to www.ncpanet.org. Community pharmacists can make specialty special. AMERICA’S PHARMACIST ONLINE Read the dynamic edition of America’s Newswire...... 10 Pharmacist and search its archive of past issues online or on mobile devices at www.americaspharmacist.net. “Go green” and decide not to receive a mailed copy of America’s Adherence—It Only Takes A Minute...... 12 Pharmacist. You’ll still have access to all the editorial content by Michelle Roberts of the printed edition at your fingertips wherever you are. Have you tested your blood sugar today?

Board of Directors Medication Safety...... 14 PRESIDENT Bradley J. Arthur, Buffalo, N.Y. What’s your name and when were you born? Always verify names and birthdays. PRESIDENT-ELECT DeAnn M. Mullins, Lynn Haven, Fla. CHAIRMAN David M. Smith, Indiana, Penn. Bill Osborn, Miami, Okla. Pharmacy Law...... 16 Brian Caswell, Baxter Springs, Kan. by Jeffrey S. Baird, Esq. Michele Belcher, Grants Pass, Ore. Hugh Chancy, Hahira, Ga. Frequently asked questions regarding compounding pharmacies. Jeff Carson, San Antonio, Texas IMMEDIATE PAST PRESIDENT John T. Sherrer, Marietta, Ga. CEO B. Douglas Hoey, Alexandria, Va. Continuing Education...... 41 by Ashley Firm, PharmD; and Caitlin Bertrand, PharmD Officers The community pharmacist’s guide to pain management. FIRST VICE PRESIDENT Lea Wolsoncroft, Birmingham, Ala. SECOND VICE PRESIDENT Jeff Harrell, Ilwaco, Wash. THIRD VICE PRESIDENT Kristen Riddle, Conway, Ark. Reader Resources...... 55 FOURTH VICE PRESIDENT Christian Tadrus, Columbia, Mo. FIFTH VICE PRESIDENT Justin Wilson, Midwest City, Okla. NCPA activities and our advertisers. Magazine Staff Front-End Overhaul EDITOR AND VP, PUBLICATIONS Michael F. Conlan, ...... 56 [email protected] by Gabe Trahan MANAGING EDITOR Chris Linville Grab your green highlighter for diabetes support. CONTRIBUTING WRITERS Jeffrey S. Baird, Bill G. Felkey, Mark Jacobs, Bruce Kneeland CREATIVE DIRECTOR Robert E. Lewis DESIGN MANAGER Marianela Guinand SENIOR DIRECTOR, BUSINESS DEVELOPMENT Nina Dadgar, [email protected] DIRECTOR, MARKETING COMMUNICATIONS Stephanie DuBois DIRECTOR, MEMBERSHIP Stacey Loflin, [email protected]

The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 22,000 independent community pharmacies. Together they represent an $81.4 billion health care marketplace and employ more than 314,000 individuals on a full or part-time basis. To learn more, go to www.ncpanet.org, visit facebook.com/commpharmacy, or follow NCPA on Twitter @Commpharmacy.

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www.americaspharmacist.net 7 UP FRONT

Community Pharmacists Can Make Specialty Special

Earlier this year, NCPA sponsored The forum started with a keynote with assurances that the provid- a very informative forum on the address by Dan Mendelson, CEO of ers can meet their expectations. burgeoning area of specialty pharma- Avalere Health; then moved to the 7. Manufacturers and payers should ceuticals. I’ve written about it before patient experience with Liz Helms, include community pharmacies in Executive Update, but the topic is CEO of California Chronic Care in their specialty pharmacy plans. so important I think it bears repeating Coalition; followed by a session on 8. Specialty pharmacy is not a de- and remembering. building an independent specialty fined class of products but rather pharmacy; panels on models that products and services managed The forum illustrated the changing work and a stakeholder discussion; as a formulary tier by payers and landscape of the specialty market- and then time for networking among often with controlled distribution place and explored the intersection the 140 attendees. by manufacturers. of specialty medications, community 9. Specialty pharmacy is a signifi- pharmacy, and patient care. Stake- I am indebted to my friend Marsha cant part of the market today and holders from across the industry K. Millonig, MBA, BPharm, president will be even more important in learned how community pharmacy & CEO, Catalyst Enterprises, LLC, for the future. can help contribute to success in this providing these top 10 takeaways from 10. Community pharmacies must space, improve patient outcomes, and our Specialty Forum. market their capabilities to local help control overall health care costs. providers. 1. An increasing number of community pharmacies have the The forum surely demonstrated that “Patients should be capabilities to provide specialty specialty pharmacy is no longer an allowed to utilize pharmacy services. "around the corner" issue for NCPA, 2. Community pharmacists under- but a "here and now" one. A New York a qualified spe- stand this isn't business as usual, Times article this summer on special- and want to earn the specialty ty pharmacies prompted me to sub- cialty pharmacy of business. mit a letter to the editor that I closed their choice—be it 3. Patients want easy access and by saying, "Patients should be allowed care from their chosen providers. to utilize a qualified specialty pharma- a local one or mail 4. Community pharmacy is well cy of their choice—be it a local one positioned for the patient-centric or mail order." NCPA is committed to order.” practice required for specialty ensuring that is the case. ■ pharmacy services. This forum helped demonstrate and 5. There are multiple models for Best, showcase various models your col- community pharmacists to care leagues are using right now to meet for their specialty patients from the requirements of these varied and building capacity internally to valuable medications. The sessions partnering with others. sparked lively question and answer 6. Accreditation of pharmacies B. Douglas Hoey, Pharmacist, MBA discussions that allowed attendees to offering specialty pharmacy NCPA Chief Executive Officer learn from their peers' experiences. services serves to provide payers

8 America’s PHARMACIST | November 2015 Connect with NCPA Online!

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NCPA

Patient Charge Accounts What can be done Q: Is it okay to allow a patient to carry a balance about DIR fees? month after month on a charge account?

A: Not collecting on patient charge accounts may be con- DeAnn Mullins, president-elect sidered to be waiving of copays. Recently, Pharmacy Audit Mullins Pharmacy, Lynn Haven, Fla. Assistance Service analysts have become aware that many PBMs have included in their provider manual that We are already having to run a business under blinded pharmacies should be collecting all copays. PBMs have contracts. Not only have we lost the ability to forecast also started to include request for proof of copay collec- the long-term financial effects of our contracts, we can't tion for prescription items during onsite and desk audits. even see losses that are happening at the point of sale. NCPA has made DIR (direct and indirect remuneration) This is from a recent CVS Caremark audit notice: “Ex- fees a top priority. At last month’s Annual Convention, amples of acceptable evidence of copayment collection we adopted a policy resolution resolving to pursue solu- include credit card receipts, cash receipts and POS tions. We have been talking with Medicare about this receipts with transaction numbers. Invoices to patients for several years, since Part D is where DIRs got their that still show balances on an account do not constitute start. The government has proposed requiring PBMs to acceptable evidence of copayment collection and further estimate DIRs at point of sale—a position we support. documentation will be requested.” That Part D guidance is not yet finalized. We have a fact sheet on our website to inform members about DIRs. To To protect your pharmacy from audit recoupments, PAAS rec- restate the obvious, read all your contracts carefully. If ommends that you collect 100 percent of all patient copays. you have delegated the contracting process, make sure The routine waiving of or not collecting copays is “steering” you understand what’s in them. ■ and a serious violation of the anti-kickback statute.

By Mark Jacobs, RPh, PAAS National, the Pharmacy Audit Assis- tance Service. For more information, call 888-870-7227 toll-free, or visit www.paasnational.com. ADVOCACY ALERT

Independent • During Congress’ summer recess, NCPA mem- Pharmacy bers participated in roundtable discussions with 12 Today lawmakers in their district offices and another 13 lawmakers accepted invitations to tour NCPA-member Average Independent’s Numbers $3.6M pharmacies to get a first-hand look at the challenges Source: 2015 NCPA Digest, sponsored by Sales/location and rewards of independent community pharmacy Cardinal Health practice. (See p. 30.) • Pharmacy champion Rep. Doug Collins (R-Ga.) raised NCPA’s concerns about PBMs at a House subcommittee hearing on consolidation in the health care 61,568 market. On his YouTube channel, Collins posted a vid- 23% eo of his questioning witnesses that he titled, “Collins Prescriptions/year Gross margin calls out PBMs on anti-competitive actions.”

10 America’s PHARMACIST | November 2015 Whether you’re looking to buy, grow, train, certify, or sell, you can find what you need at NCPA’s online store at www.ncpanet.org.

NCPA’s comprehensive library of business tools and educational materials include a variety of how-to guides, manuals, certificate programs, CDs, and digests, distinctive to the needs of current and future independent pharmacy owners. And NCPA members receive a discount of 10% or more on most items, including best-selling titles Buying A Pharmacy, CARE Quality Assurance Operations Manual; Effective Pharmacy Management; Profit Mastery; Survival Spanish for Pharmacists; Employee Policy and Procedures; Selling A Pharmacy; and more!

For more information or to join NCPA before you buy, visit www.ncpanet.org or call 1-800-544-7447 ADHERENCE IT ONLY TAKES A MINUTE

Have You Tested Your Blood Sugar Today?

by Michelle Roberts

Pharmacists have all heard patients challenges of SMBG. One of the in treatment in terms familiar to the say it: ultimate goals of any diabetes patient. It allows the clinicians working regimen is to ensure normoglycemic on their care to see in “real time” the “I felt fine so I didn’t test my blood control for the patient. Advantages of effects of their medications, as well as sugar today.” SMBG include detection of asymp- their diet. Patients testing their blood tomatic hypoglycemia, which could glucose first thing in the morning are Often, diabetes patients starting be harmful if left untreated. It can measuring their fasting glucose levels, a new medication regimen do not also identify hyperglycemic spells, indicating if their basal insulin (such as understand the importance of testing which may result in an increased risk Lantus or Levemir) is working correctly, their blood glucose even when they for cardiovascular events. Further while testing the blood glucose two feel fine physically. But from a clinical benefits of SMBG include enabling hours after meals can gauge if their standpoint, pharmacists recognize patients to learn the effects of food, bolus insulin (for example Humalog) is this isn’t acceptable or beneficial for exercise, and medications on their dosed appropriately. the patient. A recent study published blood glucose levels, which pro- in the American Diabetes Association motes self-care. One of the best ways to ensure Diabetes Care magazine identified a adherence to a new and sometimes positive correlation between adher- frightening regimen is to educate ence to frequent self-monitoring …it’s important and support patients. A disease state blood glucose (SMBG) checks and a such as diabetes requires therapeu- decreased HbA1c, reflecting glyce- to stress to pa- tic and pharmacologic interventions mic control over the previous three tients why that in- to develop a healthy, balanced life. months. Pharmacists are in a rare The consequences of non-adherence position to empower patients in the formation is valu- to monitoring blood glucose are beginning and throughout transi- directly related to the difficulty for tions of their disease state, often able in treatment clinicians trying to create a stable dispensing patients their first blood in terms familiar medication regimen for patients glucose monitor or filling their new with diabetes. With this in mind, prescription for insulin. This creates a to the patient. pharmacists are able to educate their wonderful counseling opportunity for patients on the importance of meet- pharmacists to discuss not only the ing their glycemic targets through importance of SMBG, but also provide There are challenges associated with adjusting their diet, exercise, and counseling on adherence to their new SMBG that allow patients to justify pharmacologic therapies. ■ insulin regimen. non-adherence. Testing blood glucose multiple times a day can become a bur- Michelle Roberts is a 2016 PharmD can- Identifying goals of diabetes mon- den, but it’s important to stress to pa- didate at the Lipscomb University College itoring is vital in overcoming the tients why that information is valuable of Pharmacy.

12 America’s PHARMACIST | November 2015 Help Improve Your Patients’ Diabetes Care Develop a New Niche & for Your Pharmacy

Establishing an accredited diabetes education program in your pharmacy can be both a rewarding and profitable niche for your patients and your business. 2016 Program Dates: Learn how to expand your role in diabetes self- Mar. 31-Apr. 1–Kansas City, Mo. management education/training (DSME/T) and access a path for reimbursement from the Centers for Medicare & Medicaid Services (CMS) through our Diabetes Accreditation Standards-Practical Applications (DASPA) program. www.ncpanet.org/daspa

This comprehensive, day-and-a-half-long program will cover topics such as case management, marketing, billing, accreditation, and documentation for DSME/T. The program includes both an online and live component and introduces pharmacists to the American Association of Diabetes Educators accreditation process. MEDICATION SAFETY

What’s Your Name and When Were You Born? Always Verify Names and Birthdays

We continue to receive reports of AUVI-Q POST INJECTION wrong patient errors occurring in TICKING SOUND ambulatory practice settings. In the There’s something important to latest case, a clinic pharmacy received know about the AUVI-Q auto-injector prescriptions for hydrochlorothiazide, (EPINEPHrine injection), which uses DIOVAN (valsartan), and NEXIUM digital voice instructions to “talk” peo- (esomeprazole) for a patient. The ple through the injection process. The clinic’s clinical staff recorded the date device has LED light cues that flash that the cover needs to be replaced or of birth for a different patient, but one green during injection and red after the device will emit a ticking sound as who happened to have the same first the device has been used. Prior to in- the battery dies. and last name as the intended patient, jection, Auvi-Q must be removed from on the prescriptions before sending its case and the needle guard must be STANDARDIZED CONCENTRA- them to the clinic’s pharmacy. As a pulled off (view the Auvi-Q demonstra- TIONS FOR PEDIATRIC ORAL result, the pharmacy entered the three tion at www.auvi-q.com/auvi-q-demo). LIQUIDS prescriptions into the wrong patient’s The device will make a distinct click Few would disagree that standardizing profile. Luckily, the prescriptions were and hiss sound when activated. the concentrations of drugs has enor- actually dispensed to the correct mous potential for increasing safety, patient. It appears that neither the clin- According to the package insert, the especially in pediatric care. Standardiza- ic’s clinical staff nor the clinic pharma- base that houses the needle will lock tion limits the risk of variation, especial- cy staff verified the date of birth of the in place after injection so it can’t be ly when children are transitioned from patient actually seen prior to dispens- reused. The voice instruction system hospital to home or have prescriptions ing the prescriptions. It is critical that will continue to remind the user that filled at different pharmacies. A state- each time a patient encounter takes the Auvi-Q has been used, and its LED wide initiative in Michigan, led by the place that staff asks for and verifies lights will continue to blink red until the University of Michigan, has accom- the patient’s name and date of birth. cover is put back on or until the battery plished standardizing drug concentra- eventually runs out. If the cover is not tions for more than 100 pediatric liquid replaced on the device, the electronic medications (www.mipedscompounds. It is critical that voice speaker makes a “ticking” sound org). With a grant from the Food and as the battery drains and can’t fully Drug Administration (FDA) Safe Use each time a pa- power the device. This sound might Initiative, the University of Michigan tient encounter alarm someone who thinks the ticking team collaborated with health care noise is associated with a possible providers to determine standard con- takes place that calamitous event. Emergency depart- centrations for a range of medications. ment staff alerted us to this recently This was accomplished by assessing staff asks for and after the family of a patient who used the concentrations that pharmacies verifies the pa- an Auvi-Q auto-injector brought it in were compounding and determining without the case. Staff later heard a whether the concentration would meet tient’s name and ticking sound coming from a needle the needs of the majority of patients. disposal box where the device had been date of birth. discarded. Educate staff and patients Continued on page 55 

14 America’s PHARMACIST | November 2015 SMARTER DECONGESTANTS

Many responsible pharmacies have already started to help reduce meth production in their communities byMAKE removing single-ingredient SAFER pseudoephedrine (PSE) COMMUNITIES. products from their stores and replacing them with Nexafed. Why? Only Nexafed works just like Sudafed® and has meth-deterring Impede® technology, which makes it unsuitable for meth production.1 So, this cold and ﬂ u season, be part of the solution—not the problem. Recommend Nexafed instead. Learn more at Nexafed.com

Sudafed® is a registered trademark of Johnson & Johnson. Reference: 1. Brzeczko AW, Leech R, Stark JG. The advent of a new pseudoephedrine product to combat methamphetamine abuse. U.S. News & World Report Survey of Pharmacist Recommendations. Am J Drug Alcohol Abuse. 2013;39(5):284-290. Pharmacy Times: Abuse Deterrent Oral Decongestants, June 2015. © 2015 Acura Pharmaceuticals, Inc. All rights reserved. 15NEX015.3.2

15NEX015_3_2-Rsp-Ad-NCPA-Nov15-M.indd 1 10/5/15 3:28 PM PHARMACY LAW

Frequently Asked Questions Regarding Compounding Pharmacies

by Jeffrey S. Baird, Esq.

If the physician has specified the base to be used, the pharmacy should either dispense that base or contact the physician and obtain a new prescription for a different base.

Q: How legal is 72-hour office dispensing, otherwise known as a “starter pack?” I have always been told an office can legally dispense a small 72-hour supply, and then the remaining month supply can be shipped from the pharmacy. Is this legal?

Over the past several years, there has been a steady growth in the number of A: The answer depends on the facts pharmacies that compound. This is due to a number of factors, including the and state law. For example, state law recognition by physicians of the clinical benefits of medications compounded may allow a physician to dispense a specifically for a particular patient. As compounding proliferates, a number of limited emergency supply when the legal issues arise. Part one of this article in the September 2015 America’s Phar- patient cannot make it to a pharmacy. macist discussed a number of important “frequently asked questions” pertain- This should not be a problem with ing to compounding operations. Part two discusses additional FAQs. commercially available drugs that the

16 America’s PHARMACIST | November 2015 physician has in stock. State law will Q: There are insurance policies govern whether or not this is permis- being set up specifically to pay the sible, but without a patient specific high copays resulting from the sale prescription, I believe it is unlikely. of expensive pain gels. Is this legal, and if so, where do I go about Q: Sales reps are often searching finding a company to do this? and finding clinical information on the Internet. They often desire to A: The legality of such arrangements pass that information on to a phy- will depend on state law in the state sician. Is this acceptable or should where the program is offered. Many that type of information only come times, state law may require that from the pharmacist? the companies offering the program also have to register as an insurance A: I recommend that, at a minimum, agency with the state department of the pharmacy review and approve insurance before being able to offer any information before a sales rep such a discount program. METH LAB provides it to a physician. The clinical information that the sales rep finds Q: If a physician specifically writes, may or may not reflect the practices for example, lipoderm as the base INCIDENTS of the pharmacy. Additionally, you and the pharmacy makes the for- want to be careful about represent- mulation with a different base with- ing that a compounded medication out notating same, is that legal? are DOWN is safe or efficacious for a particular condition. A: The pharmacy should only dis- 50% in W.V. pense what the physician has written After most Q: I know of pharmacies that in the prescription. If the physician pharmacies in West are blatantly offering money to has specified the base to be used, Virginia switched physicians and their staffs for the pharmacy should either dispense to meth-resistant referrals. Please tell us how to that base or contact the physician respond when a physician asks for and obtain a new prescription for a products, including the same thing from my pharmacy. different base. Nexafed in 2014, Where do I report this activity if it meth lab incidents does not stop? Q: Please go over the responsi- dropped by 50%.1 bilities of a pharmacy regarding A: You should tell the physician or information being delivered by staff member that paying for re- their 1099 independent contractor ferrals is a violation of the federal marketing reps. anti-kickback statute and is a felony. The pharmacy, the physician, and A: The pharmacy is ultimately respon- the physician staff member can be sible for information disseminated prosecuted. Most states also have a by its marketing reps, regardless of state statute that prohibits offering or whether they are W2 employees or receiving remuneration for referrals. 1099 independent contractors. For this Additionally, this type of activity is reason, the pharmacy should review frequently included as unprofessional and approve all information being conduct under state licensing laws. provided by its reps to ensure that it By engaging in this conduct, the accurately reflects the operations of physician or staff member is risking the pharmacy, and does not indicate significant sanctions. If you need to that the drugs compounded by the report the activity, you should report pharmacy are safe or efficacious for the conduct to the Office of Inspector any particular condition. Reference: 1. Data on ﬁ le, Acura Pharmaceuticals, General (OIG) and/or the state attor- Inc., Palatine, IL. ney general’s office. Continued on page 55  © 2015 Acura Pharmaceuticals, Inc. All rights reserved. 15NEX015.3.2 www.americaspharmacist.net Fighting the Good Fight on Capitol Hill

NCPA’s Legislative/ Legal Defense Fund gives community pharmacy a seat at the table by Michael F. Conlan Our opponents outspend us 20-to-1, but community pharmacy keeps fighting. CVS Caremark, Express Scripts, and the trade association for the pharmacy benefit manager/ mail order industry, the Pharmaceutical Care Management Association, have spent more than $87 million lobbying Congress and federal agencies in the past six years, according to public records complied by the Center for Responsive Politics. CVS Caremark was by far the biggest influence seeker, accounting for some $64 million of the total.

By contrast, NCPA spent $4.5 million for lobbying in 2010–15.

“While we may never be able to outspend our deep-pocketed corporate opponents, our true wealth is measured in the value of our membership,” said NCPA CEO B. Douglas Hoey, Pharmacist, MBA. “Their enduring bonds with their patients and their communities give us at least a fighting chance to get our grassroots message of fairness for all across to legislators, policymakers, and regulators in Washington, D.C. But in all honesty, we could do more for community pharmacy if we had more money. Sad perhaps, but true.”

Differences Between the NCPA PAC and LDF The NCPA PAC is the political action committee for NCPA. It makes political contributions to qualified federal candidates. The NCPA LDF (legislative/legal defense fund) is a special fund to help offset the costs of lobbying, grassroots, and legal activities. More information about both the NCPA PAC and LDF can be found on the NCPA website. National Community Pharmacists Association LDF The Legislative/Legal Defense Fund: Defending Community Pharmacy

Running an effective legislative and regulatory program can be quite costly. A fully-funded Government Affairs operation is necessary to keep $1.7 Million the tide turning in our favor and can cost over $3 million a year. total receipts in FY 2014

The health care industry alone NCPA $1.8M What is the spends $450+ million EXPRESS $2.2M SCRIPTS annually on lobbying. money used PCMA (PBM Despite being outspent, NCPA and TRADE ASSOC.) $3.8M for/what does the grassroots efforts of members CVS $14.7M the LDF do? HEALTH stopped giant PBM initiatives.

Litigation is time-consuming, expensive, and without guarantees—but sometimes necessary. This year, the NCPALDF helped the Iowa Pharmacy Association by supporting the Iowa attorney general’s defense of the state’s MAC transparency law in the face of a federal court challenge by the PBM industry. The defense was successful—a notable win for community pharmacy. The NCPALDF also is backing the Arkansas Pharmacy Association and the state in their defense of Arkansas’ MAC law.

NCPA’s Legislative/Legal Defense Fund (LDF) funds level. (The figures in this article report on only federal lobbying national and state government affairs and legal advo- efforts, not those conducted in states.) NCPA needs a healthy cacy on behalf of independent community pharmacists LDF to stay in the game and fight back where necessary. everywhere. (The LDF is not the same as the NCPA Political Action Committee.) Running an effective legisla- Community pharmacy is subject to pervasive federal tive, regulatory and legal program can be quite costly. A regulation. The government plays the leading role in fully-funded government affairs operation is necessary to reimbursement policy for Medicare and Medicaid patients. keep the tide turning in our favor and can cost more than These two programs collectively account for 51 percent of $3 million a year. Litigation is also expensive and time and all prescription drugs dispensed by independent com- resource-consuming. munity pharmacies, according to the 2015 NCPA Digest, sponsored by Cardinal Health. That means, on average, The health care industry alone spends $450+ million annual- half of your business is directly impacted by government ly—more than any other sector—in its efforts to influence Con- programs. This is a huge and growing impact on our pro- gress and federal agencies. Millions more are spent at the state fession and our business and if we don’t have a seat at the

20 America’s PHARMACIST | November 2015 Community pharmacy is subject to pervasive federal regulation. The LDF The government funds plays the leading role in reimbursement policy for Medicare our national and state government and Medicaid patients. affairs activities on your behalf.

That means, on average,

Why should of your I contribute 51% business to the LDF?

NCPA needs a healthy is directly impacted by what the LDF to fight back. government does or doesn’t do.

If you have any questions or want to learn more about the NCPA LDF, please contact Kendal Miller at [email protected] or 703.838.2695

table, we put both at risk. “There’s an old saying in Wash- If you would like to contribute to the NCPA LDF, fill out the ington: ‘If you’re not at the table, you’re probably on the convenient, safe, and postage-free mailer in this issue of menu,’” says Steven Pfister, NCPA senior vice president, America’s Pharmacist. You don’t have to be a member of government affairs. “A strong LDF gets us to the table.” NCPA to contribute. You can also contribute: • By check, payable to "NCPALDF" at 100 Daingerfield We are fighting on the legislative and legal fronts the Road, Alexandria, VA 22314 PBM abuses that you and your patients face daily. NCPA • By calling NCPA with your credit card information toll- is the only group in our nation’s capital looking out for the free at 800-544-7447 unique needs of independent pharmacy owners. As this • By faxing your completed contribution form to 703- article illustrates, the PBMs spend millions of dollars for 683-3619. (We urge you to select the convenient option well-financed and very slick government affairs opera- of automatic monthly contributions.) tions. To help you and your business succeed, we need • By downloading a copy of the Contribution Form your support to make sure we can remain effective. • By filling out our Online Contribution Form.

Unlike PAC donations, where only personal funds can be Help us continue to fight the good fight on your behalf. contributed, both personal and corporate funds may be Make a contribution today. ■ legally contributed to the LDF without limits. Some percentage of corporate funds may be tax deductible as a business Michael F. Conlan is editor of America’s Pharmacist. expense under the laws of your state. Ask your accountant if you are unsure. www.americaspharmacist.net 21 Taking theInitiative

22 America’s PHARMACIST | November 2015 The pharmacy model is broken and Jasper Drugs is fixing it

by Chris Linville

Jack Dunn, RPh, isn’t the type of person to be easily satisfied, or ever be ac- cused of being complacent. When somebody recently told him that he had a great store, Dunn disagreed, saying, “I don’t have a great store; I’ve got a good store that’s going to be great.”

Whatever adjective Dunn uses to describe his pharmacy, Jasper Drugs and Gifts (www.jasperdrugs.com), has been a landmark location in north Geor- gia for 63 years, when his father Lee established the business. Jack grew up helping out in the pharmacy, and returned to work there after graduating from the Mercer School of Pharmacy in 1978. In the late 1990s Lee passed the leadership reins to Jack. Since that time, Dunn has expanded the pharmacy and services, with offerings including compounding, medication therapy management, medication synchronization, immunizations, diabetes products and education (including shoes and fittings), weight management, blood pressure control, smoking cessation, and natural medications. The pharmacy also provides long-term care services to several assisted living facilities and nursing homes.

“I’ve always wanted to help people,” he says. “It’s been great for me in my life, following my father’s footsteps, learning the trade, and doing the right things.”

For Dunn, maintaining the status quo is not acceptable.

“We’re taking the initiative,” he says. “I had a meeting with my staff recently and I told them the model of the pharmacy is broken. And were going to change that. And they were on board. They know what direction we are going. We’re trying to move forward and prepare for what’s going to occur and what should occur. I’m not going to sit here and think I know everything. I learn something everywhere I go. So you put those improvements into practice and move forward. Those people who just sit there aren’t going to be there much longer, so that’s the way www.americaspharmacist.net 23 than this,” and decided to go in an- lived here and drove back and forth other direction. He attended a junior to the Lockheed plane manufacturing college for a while and told his father plant in Marietta [20 miles north of that pharmacy looked like a good idea Atlanta]. A lot of businesspeople were after all. also moving into the area to get away from the hustle and bustle of the “Needless to say, I had to start picking metro area. up courses here and there, so the rest is history,” Dunn says. “I had to take “It was astounding what happened I look at it. I’m all about getting ready some courses to get into pharmacy when we expanded. There were so for the future, and counting and pour- school at Mercer, and fortunately was many people coming in the store, ing is not the future.” able to get in.” (He met his wife Terry, bringing prescription bottles from also a pharmacist, at Mercer, and his other pharmacies. They said they It’s this attitude that has drawn son also graduated from there with a appreciated what we’re doing for the accolades and respect from Dunn’s pharmacy degree.) community. I was overwhelmed.” peers, and his efforts on behalf of the profession were honored last year In 1972, the pharmacy had remodeled, The pharmacy has 12 on staff, with a when he was named the 2014 recipi- going from 2,500 square feet to 5,500 few part-timers. It’s dispenses some ent of the NCPA Willard B. Simmons square feet. By 1999, demographic 500 prescriptions on a typical Monday, Independent Pharmacist of the Year trends prompted another expansion, and about 300 the other days of the at the 116th Annual NCPA Convention this time bumping the space to 11,000 week. A second location was opened and Trade Exposition in Austin, Texas. square feet. six years ago in Marble Hill, Ga. It is More recently, he won a Next Genera- a 750-square-foot apothecary-style tion Pharmacist Award in the provid- “At that time we didn’t have any chains pharmacy inside of a grocery store. ing patient care category. The awards up here,” Dunn says. “We had a Big B, Dunn’s wife manages that facility with program was established through a us and one other independent. I was two technicians. partnership between Parata Systems just trying to be prepared. I foresaw and Pharmacy Times. a population migration from Atlanta Dunn says that Jasper Drugs’ phi- [60 miles south] to north Georgia, as losophy is to “try to look at things “It’s been quite a ride, and I’m very a four-lane highway was being built. and address issues that affect our fortunate,” he says. In north Georgia, we knew movement community. We were one of the first was coming this way. A lot of people pharmacies here to do immunizations. PHARMACY NOT A GIVEN Dunn, 61, was born and raised in Jasper, Ga., where his father opened the pharmacy in July 1952. Jasper is a town of about 3,000 residents, and the surrounding county (Pickens) has a population of some 20,000. Dunn says that despite his father being in the profession, pharmacy was not an automatic decision for him. In fact, he told his father, “I’ll never be a pharmacist.” Dunn was a good athlete growing up, and was an all-state linebacker in high school, graduating in 1972. He thought he might become a football coach. Dunn initially went to a college in North Carolina where he walked on to the football team.

After a half year playing football, Dunn said to himself, “There’s more to life

24 America’s PHARMACIST | November 2015 “I've always wanted to help people,” he says. “It’s been great for me in my life, following my father’s footsteps, learning the trade, and doing the right things.”

www.americaspharmacist.net 25 I do two diabetes education programs people, and he’ll conduct extra classes he needed to do, how to test, how a month. One was for a senior citizens depending on demand. Dunn uses a to eat, how to count carbs, how to center here in town, and one was here PowerPoint presentation through the exercise. Within 2-1/2 weeks he had in the store. We also do Medicare en- Creative Pharmacist program (www. lost 10 pounds, and his A1C went from rollment. I was astounded when Medi- creativepharmacist.com) created by 7.3 to 6.6. So when you can get those care Part D started. I went to Atlanta David Pope, PharmD, CDM, CDE. “I’ve kind of results, that’s what we need to and met with the woman who was done quite well with it,” he says. be doing.” overseeing the whole Southeast [Al- abama, Florida, Georgia, Tennessee, BETTER CALL GABE the Carolinas], and we were the only …every six Dunn is not one to sit still. He says pharmacy trying to figure out what years or so he’ll that every six years or so he’ll do Medicare Part D was going to be. I something to the store, usually chang- learned how to talk to people about do something to ing the color scheme and moving Medicare Part D, and made sure they things around. This became more had the right policy in front of them the store, usually of a necessity than a choice when so they weren’t getting ripped off. We changing the color representatives from McKesson (his started doing enrollments in our store wholesaler) came in and noticed that then, and we still do that today.” scheme and mov- his shopping patterns weren’t good.

Dunn is particularly proud of the phar- ing things around. “They said that we have a beautiful macy’s efforts to help patients with looking store, but people are coming diabetes. About five years ago at an Dunn’s focus on personalized diabetes in and going out the same way,” Dunn NCPA convention he bought a prod- care is illustrated in a story he shared says. “So we changed some shopping uct called iStep, which helps identify about a patient he met who had just patterns, and that was prior to going arch type, foot size, and pressure been diagnosed with the disease. “We to Austin [for the 2014 NCPA conven- points. He gets referrals from a couple talked to him about diabetes education]. I told my staff that people were of podiatrists in the area. The pharma- tion, so we set up a time to meet with going to be coming in and saying, cy has three staff people certified to him,” he says. “I told him he needed ‘Who is this Jack Dunn who’s won assist patients with diabetic shoes. to have his family with him, because this national award,’ so we have to get this is a family disease and everybody prepared. We started on a Monday Dunn also teaches a diabetes class in needs to know what is going on. So moving things around, and finished on the pharmacy’s education room. The he brought his wife in and we spent Friday before leaving for convention. It classes have a capacity for about 12 about 40 minutes talking about what completed the transformation.”

26 America’s PHARMACIST | November 2015 Staying Connected

Jack Dunn, RPh, isn’t the type to sit on the sidelines and watch Pharmacy’s been good to you, hasn’t it?” To which his father the world go by. And with so much happening in community replied affirmatively. Dunn then continued, saying, “Pharmacy’s pharmacy, the owner of Jasper Drugs and Gifts in Jasper, Ga., been good to me and my wife, and it’s time to put something doesn’t understand why others would do so either. back into it.” And with that, his father gave his support.

“There are some people that I know [independent pharmacists] After deciding to run, Dunn was fortunate enough to win. Under and they never go to meetings,” he says. “I don’t know where the GPhA leadership structure, Dunn actually first served a they get their information. I just don’t understand people doing one-year term as second vice president, before moving on to those kind of things. We have to understand that the world is one-year terms as first vice president, president-elect, president, changing really fast, and we have to come to grips with that.” and chairman of the board, respectively.

As for himself, Dunn says, “I’m going to try and go to every “I would not trade anything for my run for the presidency of the meeting that I can. I tell my wife, ‘This is where I learn things.’ GPhA,” he says. “The relationships I developed, the pharmacists A lot of people go to see sights, and I do some of that, but the that I met, have brought new perspectives about pharmacy and main reason I’m going to a meeting is to learn something. my world.” That’s just what I do, regardless of the organization.” Dunn likes to reference a comment from hockey great Wayne Dunn has always been involved, and has gravitated toward Gretzky as an analogy for his profession. leadership roles, a trait he credits to his parents, saying, “They brought me up in the correct way.” In high school he “Wayne Gretzky once said, ‘I skate to where the puck is going to was president of his senior class and the student council, be, not to where it has been. A good hockey player plays where along with being captain of the football team. In college he the puck is. A great hockey player plays where the puck is going was his fraternity’s president and he was vice president of to be.’ As pharmacists, we need to heed that advice. Some of his senior class in pharmacy school at Mercer. Immediately us are skating with the puck. We need to skate where the puck after graduating in 1978, he joined NCPA and GPhA (Georgia is going. We need to look forward and establish new growth in Pharmacy Association) and has remained a member of both different areas within our stores to provide additional areas for ever since. In the 1980s he became region president for GPhA in improvement for patient involvement and patient care.” north Georgia and won an award for being outstanding region president. He was asked to run for state president, but declined A particular passion for Dunn is serving as a mentor for youth because at the time he had children in school and didn’t want in the community. He says pharmacy has given him a lot, and to spend time away from them. A number of years later, in 2007, he is at a stage in his life where he wants to give back. Recently several buddies approached him and asked if he would consider he was speaking to students at a local school. Dunn mentioned again, and this time he decided to do so. the two national awards that he has won in the last years, not to brag, but to tell them that if a small-town person like himself “I spoke to my wife [Terry], and she knew it was something I can rise from small-town roots to win national awards, that the always wanted to do,” he says. “I spoke to my staff, and they were sky is the limit if you work hard and apply yourself. supportive, and then I spoke to my dad [Lee], who had reservations. “I just see so much potential in young people,” Dunn says, “Son, I don’t know if you want to do this, it’s going to take away and his message is, “Don’t let anyone tell you that you can’t from your business, you’re going to be gone, and you’re going do something.” to lose this much money,” Dunn says his father told him. Dunn responded by saying, “Let me ask you a question.

www.americaspharmacist.net 27 But Dunn wanted to build on those As for the main shopping area, Dunn control unit, they don’t leave the store efforts. He has known Gabe Trahan, says that Trahan gave him a to-do list, without being shown how to use it,” he NCPA’s senior director of store oper- and he and his staff promptly went says. “If a doctor writes a prescription ations and marketing, for a number to work. for a compound, I am going to tell the of years. He was aware of Trahan’s patient what the compound is doing, reputation helping other pharmacies “You can imagine what kind of job and why it’s doing what it is doing. If improve their appearance, become that is with 5,500 square feet,” he I need to spend 20 minutes with the more customer friendly, and increase says. “We completed five sections patient to explain everything, I’ll do it. sales. So Dunn set up an appointment of relocating merchandise and I’m just about giving information.” with Trahan to visit his pharmacy and bringing them up-to-date because provide an honest assessment with a we were doing a promotional sale Dunn says he always tries to delve fresh set of eyes. and it wasn’t doing what I thought deeper when it comes to finding it was going to do. What we had solutions. He explained the story of a “I love what Gabe does,” Dunn says. been doing is taking all of this patient who had plantar fasciitis in her “He came and looked at things from extra merchandise, putting it in our foot, and had went to three doctors a different perspective. When you categories which weren’t selling to with no relief before coming to Jasper walk in your store every day, you have begin with, and had been marking Drugs, where she received a com- blinders on. You can overlook things it down. So we went through each pounded medication. (In fact, as part and not know it. You think you know category, brought merchandise up- of his patient education and market- what you are doing, but if you don’t to-date, and within four months we ing efforts, Dunn says a video was look at every detail, then you are completed the improvements that made about this particular situation.) standing still. For people who don’t Gabe had suggested.” Dunn says think this improves your outlook, and that the pharmacy now has a better “There’s a lot of people out there just improve your pharmacy, you need product and traffic flow, making it a making compounds and giving it to to open that door and go through it. more enjoyable, easier, and efficient people and saying to put it on the If you are just sitting there and not shopping experience for customers. arch,” he says. “But that’s not where doing anything, you aren’t improving the pain is originating, so I showed the quality of life for the patients you Some changes had already been her three areas where to put the are taking care of. My store isn’t going in the works. Dunn says that a cream, and she came in two days later to be one of those.” couple of years ago the business hugging me and saying ‘thank you,’ had pharmacy and gift items in the because it worked.” Dunn says that Trahan “went through same section on both sides of the the store and said we need to look at store. It was then decided to divide Dunn says he is hoping to get more categories and what categories we it up – 5,500 for pharmacy and 5,500 into wound and neuropathic pain think we need to be moving into, so for gifts. Gifts are now displayed in compounding. He’s attended several we gave him some ideas of categories the pharmacy’s Clock Tower Gifts PCCA conferences to learn more, and we were considering. He knew I was & Boutique section, with offerings he says that segment has “taken off.” high on vitamins and nutrition and from higher-end brands such as Vera had an area adapted for that, and he Bradley and Pandora. “I haven’t pushed compounding as knew that we were doing MTM and much as I wanted to,” he says. “I want diabetes education, weight loss, and CORE SERVICE AREAS to market and promote that area. smoking cessation.” Dunn sees compounding, nutrition We’ve been doing well with compound- and vitamins, MTM, diabetes care, ing, but we’re about to do a lot better.” Near a checkout area is open space and weight and blood pressure con- where customers can ask general trol as the primary areas where he is MEASURING INVESTMENT questions of staff. Right near that is focusing and where he will continue to When asked how he measures return a private, sound-proof consultation do so. The key is to find the best ways on investment, Dunn says, “The bot- room where patients can talk to phar- to get optimum results in those areas. tom line is not going to be done today, macists in confidence. Also, another Customer care is certainly a tried and it’s going to be done for tomorrow, room was created and is primarily true method to achieve adjectives. because the world is going to change. used for classes in diabetes educa- Of course if I had to sell today I’m not tion, weight loss, smoking cessation “I’ll say this, when anybody buys a going to get the investment that I think and the like. blood pressure unit, or a sugar diabetes it’s worth to me. But if I keep going in

28 America’s PHARMACIST | November 2015 the direction that I see, going from a A To-Do List Quickly Becomes a Done List good store to a great store, then yes, When Jack Dunn, RPh, owner of Jasper Drug and Gift in Jasper, Ga., was looking for help my investment is going to improve.” in improving the overall look and flow of his retail section to make it better organized, he called Gabe Trahan, NCPA senior director of store operations and marketing. The following Dunn again stresses that being static are Trahan’s observations of his visit. is not acceptable. It’s about antici- pating trends, sensing a need, and When I met with Jack, I learned a valuable lesson. That lesson was don’t try to keep up providing a service. with Jack Dunn. He will leave you in the dust. I’m not sure he even sleeps.

“We saw that we can make some On the last night of my visit, I left Jack a to-do list. Before boarding the plane the next money doing MTM,” he says, citing morning, Jack texted me saying that three of the items on the list were complete. And an example. “We were one of the first just a few days after my visit he already had a contractor in the store, building a new people in Jasper, Georgia, and maybe patient consulting room. all of north Georgia, to do synchronization. We were doing that five years In my opinion, what makes Jack so successful is his energy and that he has no sacred ago, and nobody else was doing it. At cows. As long as you spell things out and it makes sense, he is fully open to change. the time I knew that this was coming For example, I asked him to move his collegiate gift wear off a wall, remove a platform and we were just getting prepared for (no easy feat) and cut the collegiate section in half. Normally that kind of suggestion it. We didn’t jump into it as much as doesn’t go over well. He looked at the section, took a look at sales numbers, and the we are now, but we were making small wall came down. steps. My clinical pharmacist did 13 MTMs the other day. A few days later The other key to Jack’s success is the people in town love him. I sat with him at the she did 30, and then she had 50. She local diner. People constantly came to the table to say hi, shake his hand or give him a came to me and said, ‘What is it with hug. I just ate my lunch and watched; Jack didn’t eat. I’m not sure he eats either. this? Why am I getting so many?’ I told her that nobody else was doing it so we had to do it.” they come in we review everything to you. We’re a team of pharmacists with them. They don’t have to call across the United States, and we have Dunn says that Jasper Pharmacy their doctor as we do that for them. Ev- to keep fighting and keep pushing. also has about 250 people in its erything is ready for them, so all they That’s what it’s all about.” ■ synchronization program, including have to do is pick it up. This allows us many LTC patients. Patients come in to reduce our inventory, and they are Chris Linville is managing editor of once a month to pick up all of their receiving their medications in a timely America’s Pharmacist. medications and are notified three and organized way.” days in advance. For example, Dunn he says that if a patient is sched- Drawing on his sports background, uled to come in on a Tuesday, he or Dunn has a collection of quotes that someone else on staff will call that he likes to cite that he thinks applies to person the preceding Friday. The day his business. One in particular is from each patient is scheduled to visit is Herb Brooks, coach of the 1980 U.S. noted on a calendar. When a patient Olympic hockey team, which over- is called, it is also an opportunity came huge odds in beating the Soviet to ask how he or she is doing, and Union on its way to the gold medal. if they are taking any OTC medica- Brooks said, “I’m not looking for the tions such as aspirins or laxatives. best people. I’m looking for the right Pharmacy staff will also call the people.” That comment is a favorite patient’s physician to ask if there are because its stresses people coming any changes in their overall prescrip- together and working as a team. tion, dosages, anything else in their medication regimen. “I just want people to know that as pharmacists we need to step up to the “We try to make it as easy as we can plate.” Dunn says. “When you went to for the patients,” Dunn says. “When pharmacy school, nothing was handed www.americaspharmacist.net 29 Congressional SummerSchool Community pharmacists hope educating lawmakers on issues will translate into support on Capitol Hill by Michael Rule

NCPA encouraged independent pharmacists to use the an- Similarly, in North Carolina, independent pharmacists nual August congressional work period this year to express and representatives from the North Carolina Associa- support for “Any Willing Pharmacy" legislation (H.R. 793/S. tion of Pharmacists and the Association of Community 1190, the Ensuring Seniors Access to Local Pharmacies Pharmacists met with Rep. Renee Ellmers (R), a mem- Act) and a MAC transparency bill (H.R. 244), and provided ber of E&C. Following this meeting she cosponsored tips and resources to simplify the process of doing so. We H.R. 244. were pleased that many NCPA members heeded this call to action and interacted directly with their legislators. Independent pharmacists in North Dakota were particularly active in August and were able to meet with their During the five-week period, some independent pharma- entire congressional delegation: Rep. Kevin Cramer cists had the opportunity to meet with their congressional (R), another W&M member, and Sens. John Hoeven (R) representative face-to-face at the lawmaker's district and Heidi Heitkamp (D) during the recess period. All office. Several of these representatives sit on key commit- members of the North Dakota delegation had previously tees with jurisdiction over legislation relating to indepen- cosponsored their respective provider status bills, and dent community pharmacy such as the House Energy and these meetings provided an opportunity to discuss MAC Commerce (E&C) and the House Ways and Means (W&M) and any willing pharmacy legislation, among other phar- committees. NCPA staff was on hand to participate in macy-related issues. several of these meetings as well. Finally, in Pennsylvania, representatives from NCPA, the The traditional summer break kicked off with pharmacists Pennsylvania Pharmacists Association, and a contingent in Georgia meeting with Rep. Tom Price (R), the chairman of independent pharmacists met with Rep. Tom Marino (R), of the House Budget Committee who also serves on chairman of the House Judiciary Subcommittee on Regu- W&M. The meeting was well attended, and included par- latory Reform, Commercial and Antitrust Law. Marino is a ticipation from then-NCPA President John Sherrer, NCPA longtime supporter of independent community pharmacy, Senior Vice President of Government Affairs Steve Pfister, having keynoted NCPA's Legislative Conference in 2013 and Greg Reybold from the Georgia Pharmacy Associa- and as a current cosponsored H.R. 793. The meeting was tion. It provided an opportunity to speak with Price about an occasion to continue the dialogue with him on these NCPA priority legislation including provider status under critical issues. Medicare Part B (H.R. 592/S. 314). These are just a few examples of the opportunities inde- In Kansas, NCPA Vice President of Government Affairs pendent pharmacists had to meet with their legislators in a Mike Tomberlin joined Pete Stern with the Kansas In- roundtable setting to promote important legislative initiatives. dependent Pharmacy Services Corporation and local constituents in meeting with Rep. Lynn Jenkins (R), also a While these roundtable events were an effective means to W&M member. Participants had an opportunity to applaud discuss policy, an equally important method is for mem- her support of H.R. 592 and to encourage her to support bers of Congress to visit independent pharmacies and H.R. 244 and H.R. 793. get a first-hand look at the operations of one of their most www.americaspharmacist.net 31 A B

E D

(Photo A) From left to right: Steve Pfister, Thomas Sherrer, John Sherrer, Rep. Tom Price, Jennifer Shannon, Mac McCord, Ira Katz, and Greg Reybold. (Photo B) From left to right: David Olig, Mike Schwab, Terry Kristensen, Rep. Kevin Cramer, Tony Welder, and Mark Hardy. (Photo C) Rep. David Loebsack (third from left) visits Towncrest Pharmacy in Iowa City, Iowa. (Photo D) From left to right: Pete Stern, Rep. Lynn Jenkins, Jody Reel, and Mike Tomberlin. (Photo E) From left to right: Prescott Godwin, Mike James, Rep. Renee Ellmers, Paige Houston, Fred Eckel, and Bill Rustin. Additional photos of the pharmacy visits and roundtables are available on the NCPA Facebook page.

important local small businesses. A few such examples In addition to these in-person meetings, countless phar- were previously highlighted, but there were many others macists took the time to make phone calls or send emails during the month. to their members of Congress to ask support for these critical issues. NCPA is thankful to all of our members Rep. Gus Bilirakis (R-Fla.) toured Hoye's Pharmacy in Tam- who took the time to voice support whether in person or pa. Bilirakis is a member of E&C and the visit allowed him through other means and is grateful to all the members of to learn more about challenges faced by compounding Congress who took the time to tour a pharmacy or to meet pharmacies as well as the need for H.R. 244 and H.R. 793. with their constituent independent pharmacists. It also provided an opportunity for him to learn about the prescription drug monitoring programs. While August is an opportune time to engage, grassroots advocacy is a year-round effort. We encourage all inde- In Iowa, Rep. Dave Loebsack (D), who also serves on E&C pendent pharmacists to make use of the grassroots toolkit and is an original cosponsor of H.R. 244, toured Towncrest and other upcoming recess or weekend opportunities to Pharmacy in Iowa City. Loebsack is a longtime support- continue to advocate for these important issues. ■ er of independent community pharmacy and this visit allowed him to learn more about other issues that impact Michael Rule is NCPA’s associate director of public affairs these small business providers. and grassroots.

32 America’s PHARMACIST | November 2015 PHARMACY QUALITY MEASURES

An FAQ on Proportion of Days Covered With Sulfonylureas

by Laura Bergs, PharmD

WHERE DOES THIS MEASURE pharmacy will increase your pharma- Additionally, any barriers to adherence FIT INTO THE OVERALL MEDI- cy’s appeal to be included in these can be identified and resolved. For ex- CARE PART D STAR RATINGS? plans, and increasing the PDC of ample, if your patients are less adher- Sulfonylureas are one of the four drug sulfonylureas is one of those opportu- ent because they have transportation classes found classified under the nities for improvement. barriers in getting to the pharmacy to Oral Diabetes Medication Adherence pick up their prescription on time, and Measure, which is one of five Medicare WHAT IMPACT DOES THIS HAVE your pharmacy offers delivery, you can Part D Star Ratings measures that ON PATIENT SAFETY? offer that service to the patient to help relate to pharmacy and medications. Sulfonylureas are oral agents used in improve adherence. Patients may also diabetes patients to help control their need to be reminded of symptoms WHAT DOES THIS MEASURE blood sugar levels. They have been of hypoglycemia such as shakiness, ANALYZE? shown to lower a patient’s A1C by dizziness, sweating, and irritability. If a It analyzes the percentage of patients about 1.0–1.25 percentage points. As patient’s adherence improves and they age 18 and over who meet the propor- a patient’s adherence decreases, the start experiencing these symptoms, tion of days covered (PDC) thresh- benefit of sulfonylureas on lowering a their dose may need to be lowered. As old of 80 percent for sulfonylureas patient’s A1C decreases as well. When an added bonus, these MTM pro- (such as glimepiride, glipizide, and a patient’s high blood sugars go un- grams may offer reimbursement for glyburide). PDC is used to estimate treated for long periods of time, it can completed cases. It also helps to find adherence among these patients, lead to neuropathy, kidney damage, ways to add convenience to medi- in that a PDC closer to 100 percent retinopathy (which can lead to blind- cation regimens wherever possible, means better adherence. A PDC of ness), foot problems due to damaged especially for patients on multiple at least 80 percent indicates high nerves, and blood flow (which can medications, and programs such as adherence because patients have lead to amputation), and infections. NCPA’s Simplify My Meds® allow your filled their prescriptions often enough Conversely, overuse of sulfonylureas pharmacy to help with that. ■ to cover 80 percent of the days that (indicated by a PDC of greater than they should be taking the medication, 100 percent) puts a patient at risk for Laura Bergs, PharmD, is a 2015 graduate which would be 24 days in a 30-day hypoglycemia. Strict adherence to of the University of Oklahoma College period, or 72 days in a 90-day period. diabetes medications such as sulfo- of Pharmacy. Combination drugs including sulfony- nylureas can help keep sugars under lureas (such as glimepiride/pioglita- control and prevent these issues. zone or glyburide/metformin) are also included in this measure. WHAT CAN I DO IMPROVE PER- FORMANCE IN MY PHARMACY? WHAT IMPACT CAN THIS HAVE MTM programs such as Mirixa® ON MY PHARMACY? and OutcomesMTM® allow pharma- Medicare Advantage plans and cists to identify patients who have a Medicare prescription drug plans low PDC of sulfonylureas. Patients are incentivized to maintain high star identified may need help understand- ratings with bonus payments for doing ing why they are on the medication, so. Finding areas of improvement to help identifying hypoglycemia, and obtain a status as a high-performing the consequences of non-adherence. www.americaspharmacist.net 33 PATIENT CALL TO ACTION! YOUR PATIENTS HAVE A STORY TO TELL! ASK THEM TM TO SHARE IT THROUGH FIGHT4RX !

Your patients know firsthand the valuable role you play in their health care. Their voices are critically important to policymakers in understanding that role and the services you provide to the community. Ask your patients to stay informed on issues affecting their pharmacy choice by signing up for a bimonthly newsletter and action alerts from Fight4Rx. Simply have them fill out the form below and return it to NCPA, or register online at www.Fight4Rx.org.

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NAME National Community Pharmacists Association Attn: Michael Rule PHARMACY 100 Daingerfield Road Alexandria, VA 22314 ADDRESS 703-683-3619 fax

CITY/STATE/ZIP

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Thank you for your participation! PATIENT CALL TO ACTION! YOUR PATIENTS HAVE A STORY TO TELL! ASK THEM TM TO SHARE IT THROUGH FIGHT4RX !

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Fight4Rx Patient Newsletter Form Complete this form online at www.Fight4Rx.org or mail to:

NAME National Community Pharmacists Association Attn: Michael Rule PHARMACY 100 Daingerfield Road Alexandria, VA 22314 ADDRESS 703-683-3619 fax

CITY/STATE/ZIP

PHONE FAX E-MAIL

Any data you provide herein is confidential and will never be sold to a third party.

Thank you for your participation! Diabetes Education –the Pharmacist’s Role

36 America’s PHARMACIST | November 2015 Community pharmacists can empower and encourage patients to manage all aspects of their condition by Alissa R. Segal, PharmD, CDE, CDTC, FCCP

It’s well known that diabetes and prediabetes continue to pharmacists are successfully educating patients with rise to alarming proportions in the United States and across diabetes, allowing them to be empowered and encouraged the globe. According to the Centers for Disease Control and when it comes to handling all aspects of their condition. Prevention, at least 29.1 million people—nearly 10 percent of the U.S. population—live with diabetes, and nearly 86 million For people living with diabetes, the management of the adults—one in three—have prediabetes. With roughly $322 bil- disease and its impact on their lives is often difficult and lion dollars spent annually in health care costs and lost wages, complex. Living with diabetes or prediabetes can affect diabetes and prediabetes prevention and care have become many aspects of a person’s daily activities, including (but one of the country’s most expensive health care missions. As not limited to) choice of foods, quantity and frequency of the number of people with diabetes rises, the personal and medications necessary, and the ability to work. Standard financial impacts of the disease grow exponentially. activities, such as taking a vacation, eating at a restau- rant, or having a modest medical procedure require more Education about diabetes is essential. In fact, a recent study thought, education, and care coordination. Patients and from the Journal of the American Medical Association indicat- their families continually search for ways to make managed that as awareness and education has grown, instances ing diabetes simpler and less burdensome. of diabetes in the U.S. may be leveling off. While diabetes education programs and relationships with diabetes educa- This article will discuss the many ways in which pharmacists tors and other health care practitioners are essential, phar- are primed to encourage diabetes education and can help pa- macists in particular are uniquely positioned to help lead the tients devise a personalized strategy for managing their disease. charge in diabetes education and prevention efforts. BROAD UNDERSTANDING OF COMPLEX MEDICA- WHY PHARMACISTS? TIONS AND TREATMENT OPTIONS In today’s environment, providing the best care to a person Diabetes management often requires multiple medications living with diabetes involves ongoing collaboration between for both glycemic management and prevention (or treat- a team of different health care professionals. Because of ment) of complications, monitoring of blood glucose levels their access to patients, their in-depth training in pharma- and other indicators, and modifications to a patient’s life- ceuticals, and their place within the health care paradigm, style. The treatment plan for each individual is unique and www.americaspharmacist.net 37 dependent on a number of medical and personal factors. COMPREHENSIVE PATIENT- Pharmacy is the only profession with a primary focus on PHARMACIST RELATIONSHIP the medication aspect of managing diabetes, the mixing The existing relationship between patient and pharmacist of various pharmaceuticals and their potential side effects, opens important doors for diabetes education, particularly and the complex treatment options that are specific to the with community pharmacists who have frequent, direct individual’s plan of care. Their deep understanding of the access to patients and their caregivers. Because patients ways in which medications react within the body and their often see the same pharmacist, community pharmacists interactions with other treatments make pharmacists an know them, their families, their stories, their struggles, and essential resource for both providers and patients. their needs. They can reinforce the importance of taking medications consistently and in a timely fashion, and can Pharmacists can also help tailor individual medical therapy help ensure patients understand the reasons behind cer- interventions. Depending on known allergies, side effects, tain therapies and proper administration technique for any financial restrictions, health beliefs, and daily activities, that are not solid, oral dosage forms some treatment regimens will be more relevant than others. For instance, if patients are having trouble remember- Pharmacists should ask patients to demonstrate their blood ing to monitor glucose levels and take their insulin before a glucose testing and drug administration technique and meal, pharmacists can offer helpful suggestions, such as coach as needed to improve. Are they rotating the location placing a pen needle in the sections of a pillbox containing for insulin injections? Are they on more than one injectable, medications taken prior to a meal, or identifying an injec- and do they understand the subtleties of various injectables, tion assistance tool, if necessary. Tailoring treatments is such as GLP-1 agonists versus insulin (long- and/or rapid-act- an important aspect of educating patients—knowing that ing) versus PCSK9 inhibitors? Are they holding their breath there is often more than one right answer can help empow- with inhaled insulin and replacing the inhaler every 15 days? er patients and maximize success along the way. Pharmacists can review a patient’s existing “routine” and offer suggestions for better outcomes. Maintaining an on- Finally, many pharmacists provide medication therapy going relationship with a patient offers the chance to repeat management for chronic diseases and conditions that education, reinforce best practices, and identify opportunities co-exist with diabetes, such as hypertension, high blood for adjustment as the disease progresses, or as necessary pressure, asthma, and dyslipidemia. As diabetes treat- with health or cognitive changes. Diabetes management can ments become more pharmacologically diverse, phar- be overwhelming. Patients may need reminders, for instance, macists have the opportunity to demonstrate to patients, to use alcohol swabs or wash their hands before they check providers, and other members of the health care team that their blood glucose. These little mistakes often can have big they have the expertise to manage a comprehensive diabe- impacts, and small suggestions or tweaks in their technique tes plan, going beyond the traditional medication role. can improve efficiency and accuracy.

38 America’s PHARMACIST | November 2015 For the patient, pharmacists to a pharmacist offers the opportunity to ask medication questions, inquire about potential side effects, or find out if often represent an important an OTC medication might interact with a pharmaceutical. Patients view pharmacists as nearly always available, par- conduit to other providers, ticularly with the introduction of 24-hour pharmacies and completing the dialogue, coor- patient areas for private dialogue. dinating care, and monitoring Not only is it simpler to visit with a pharmacist, but patients can talk to pharmacists virtually anywhere. For instance, adherence to medications and if a patient is on vacation and has a question about how a treatment procedures. standard OTC anti-nausea treatment might interact with one of her current drug therapies, she doesn’t need to be at her local pharmacy to ask. Patients have access to pharmacists’ Additionally, ongoing relationships between patients and expertise regardless of where they are. There is often a local pharmacists promote closeness and encourages important pharmacist nearby who can assist and answer questions. conversations that may be necessary to achieve the best outcomes, particularly when other health care providers A CRUCIAL LINK BETWEEN PATIENT, may be harder to reach or seen at less frequent intervals. HEALTH CARE TEAM Patients report viewing pharmacists as a trusted resource Successful diabetes management relies on a wide array of and may have an easier time—and more opportunity—to health care experts and organizations, including physicians, discuss any new treatment challenges, changes, or side ef- nurses, dietitians, mental health providers, social workers, fects. A pharmacist also has the benefit of seeing patients diabetes educators, and even insurance companies, all collab- in a functional space and can take note of questionable orating to provide medical care, medication management, and behaviors that may necessitate monitoring and treatment education. For the patient, pharmacists often represent an adjustment, such as tremors, shaking hands, swelling, ap- important conduit to other providers, completing the dialogue, parent confusion, or changes in speech or body language. coordinating care, and monitoring adherence to medications and treatment procedures. For instance, a pharmacist may But the relationship aspect is not only relevant to commu- inquire about a lack of—or excessive—refills and can report nity pharmacists. Pharmacists that are part of a patient’s such findings to a provider with new dosage suggestions. direct team care or who work in an institutional or health system setting can also contribute to the care of patients What can pharmacists do to help better educate patients? with diabetes to assist in achievement of the best possible There are several simple, tangible things pharmacists can do to outcomes. Inpatient pharmacists can help manage glyce- encourage diabetes education within their own practices. You mic alterations that occur with acute illnesses and their are likely already doing some of these on several levels and all treatment, adjust regimens around surgical procedures and tactics can help continue education efforts in important ways. the varying dietary intake that occur during hospitalizations, and provide discharge education to help prevent re-hospi- Empower Your Patients talizations. Ambulatory care pharmacists can work directly Gone are the days of physician-only directives; patients with providers and patients within outpatient clinics to help must take an active role in their therapy. Empowering individualize treatment regimens, adjust and monitor those patients is essential for successful diabetes self-manage- regimens, and educate both patients and providers regard- ment. Because their lifestyle, actions, and choices have the ing current and new pharmaceutical modalities. most important impacts on their health, patients must be involved and educated participants in their diabetes man- INSTANT ACCESS agement. Encourage them to take charge of their therapy Aside from the inherent relationship-building benefits, and learn their options. Suggest resources that may be of from the patient’s perspective, pharmacists also have the value to where they are in their personal journey, such as important advantage of instant access, opening doors for through the American Diabetes Association, an accredited immediate educational opportunities when other health diabetes self-management education/training (DSME/T) professionals may not be so readily available. For those program, or other local community resources. with diabetes, maintaining an open and ongoing dialogue with providers is an extremely important part of manag- Encourage Dialogue ing their disease—however, making appointments and Don’t wait for your patients to come to you with questions. traveling to them are not simple tasks. Having quick access Proactively inquire about how their therapy is going, espe- www.americaspharmacist.net 39 cially if they are on new medication or have undergone any a DSME/T program is another option to reach patients with recent medical procedures. Similarly, if you see something diabetes and provide revenue to the pharmacy. Accred- questionable or concerning, bring it to light. They may not ited programs can enroll in Medicare Part B and bill for even realize there is a potential issue looming. Through on- group, and in some cases, individual training. Information going discussion, you can monitor how they are handling on program accreditation standards is available from the their diabetes management and therapy methods and offer American Association of Diabetes Educator or NCPA’s suggestions for improving their experience. Diabetes Accreditation Standards – Practical Applications course (www.ncpanet.org/daspa). Stay Educated Remain up-to-date on your skills and expertise through NEED FOR MORE EDUCATION relevant credentialing organizations and continuing educa- As advancements in technology, medications, and com- tion programs. Professional credentialing programs, such prehensive diabetes management tools grow, so does as the Certified Diabetes Educator (CDE) offered through the need for greater patient education. While we may not the National Certification Board for Diabetes Educators, know what the future holds in the way of diabetes research enhance credibility, reinforce knowledge and ability, and and care, it’s clear that individualized patient education serve as a valuable professional development tool. A CDE is essential for empowering patients and helping them in particular has the ability to help arm a patient with the make informed decisions along the way. Accessible and knowledge and tools to manage and improve health, em- trusted by people at all stages in their personal diabetes powering the individual and engaging them in the process. path, opportunities abound for pharmacists to educate and Often the best way to educate others is by remaining the empower the growing number of people with diabetes. ■ consummate student. Certification also provides credibility with providers and superiors and can open doors to Alissa R. Segal, PharmD, CDE, CDTC, FCCP, is associate new areas of diabetes management, including billing for professor of pharmacy practice, and MCPHS University/clinical medication therapy management. Facility accreditation for pharmacist, Joslin Diabetes Center. CONTINUING EDUCATION

The Community Pharmacist’s Guide to Pain Management by Ashley Firm, PharmD; and Caitlin Bertrand, PharmD

Nov. 2, 2015 (expires Nov. 2, 2018) Activity Type: Application-based To earn continuing education credit: ACPE Program 0207-0000-15-011-H01-P; 0207-0000-15-011-H01-T

Upon successful completion of this article, the pharmacist should be able to: 1. Explain realistic and obtainable goals of pain management therapy. 2. Design appropriate pain regimens for the treatment of chronic nonmalignant pain. 3. Discuss alternatives to decrease the use of high risk pain medication in patients older than 65 years. 4. Design alternative therapy options for patients utilizing greater than 120 morphine equivalents daily without a cancer diagnosis. 5. Discuss recommended safe and proper drug disposal to patients with unwanted medications.

Upon successful completion of this article, the pharmacy technician should be able to: FREE ONLINE CE. To take advantage 1. Discuss goals of pain management therapy. of free continuing pharmacy educa- 2. List newly approved analgesic drugs and their drug class. tion (CPE) for this program, pharma- 3. Discuss recommended safe and proper drug disposal to patients with cists and pharmacy technicians must unwanted medications. achieve a passing score of 70% on the online continuing education quiz for the program. If a passing score is not achieved, one free reexamination is permitted. To take this test, go to www.pharmacistelink.com and click on the CE tab. Click on the CE Center, which will take you to the online activities that are available. If you have not registered with Pharmacist eLink, you must do so before being able to access the CE Center. You will receive immediate online test results and credits will be posted to CPE Monitor NCPA® is accredited by the Accreditation Council for Pharmacy Education as a provider of within six weeks. To obtain your CPE continuing pharmacy education. NCPA has assigned 1.5 contact hours (0.15 CEU) of continuing education credit to this article. Eligibility to receive continuing education credit for this article Monitor e-Profile ID, please go to expires three years from the month published. www.cpemonitor.com to register.

www.americaspharmacist.net 41 INTRODUCTION As more than 100 million Americans suffer from chronic pain, it has emerged as the most common cause of long-term disability. Almost 80 percent of patients who experience chronic pain report their pain prevents them Moderate to severe pain from performing activities of daily living (ADLs). As pain management has evolved to become a common aspect in health care, pain is viewed as the fifth vital sign. It is without question that pain is an ailment that health care providers encounter each day, and the impact of pain on the economic health care system continues to grow. Pain is defined as an unpleasant sensory or emotion- al experience associated with actual or potential tissue damage or described in terms of such damage. There are several different types of pain including nociceptive and neuropathic. Nociceptive pain is further categorized as somatic pain caused by injury to body tissue that is well defined and localized, or visceral pain caused by injury to the viscera that is poorly localized due to being mediated Image courtesy of UpToDate by stretch receptors. Neuropathic pain follows the nervous system and can be due to damage to a peripheral nerve (peripheral neuropathy), autonomic change (sympathet- plus pharmacotherapy, sham acupuncture plus pharma- ically mediated pain), or from abnormal central nervous cotherapy and pharmacotherapy alone. The acupuncture system activity (central pain). Examples of peripheral plus pharmacotherapy group shows statistically significant neuropathy, sympathetically mediated pain, and central improvement in the Western Ontario and McMaster Univer- pain are diabetic neuropathy, sympathetic dystrophy, and sities index, which assesses pain, stiffness and physical phantom limb pain, respectively. The American College of function in patients with osteoarthritis. Suggesting alter- Rheumatology defines chronic pain as pain lasting longer natives or adjuncts to pain medication, such as exercise than three months. and physical therapy can be of great benefit to patients, The approach for the treatment of pain, or pain man- and community pharmacists can recommend appropriate agement, should be a multidisciplinary team approach options for patients when necessary. utilizing nonpharmacologic and pharmacologic options. Many pharmacologic options exist for the treatment The Institute of Medicine’s 2011 Report on relieving pain of pain with an outline of escalation from over-the-count- in America emphasized the need to change the patient er options to high dose opioid therapy using the World and provider’s view of pain. This includes viewing pain as Health Organization (WHO) Pain Ladder. Although orig- a public health challenge and tailoring pain care to each inally designed for relief from cancer pain, the step-wise patient’s experiences. While customizing pain manage- approach has been used for relief of chronic non-cancer ment for each individual patient, the patient’s expectations pain as well. The pain ladder suggests using non-opioids of pain reduction should not be to become 100 percent and adjuvants initially including non-steroidal anti-inflam- pain free, as most clinical trials suggest a 33-50 percent matory drugs (NSAIDs), acetaminophen, skeletal muscle reduction in pain as a reasonable standard to determine if relaxants, and topical agents. If the pain worsens or a regimen is effective. Communicating this information to remains after use of the above agents, continuation onto patients is helpful in establishing realistic treatment goals opioid therapy is recommended. and reduce unnecessary dose escalations. Starting with step one, the use of pharmacologic op- Non-pharmacologic options should be considered tions focuses on non-opioids such as NSAIDs or acetamin- with any pain management plan, including relaxation, ophen. In addition to the direct pain relievers listed in the aerobic exercise, physical therapy, electric stimulation, and ladder, adjuvant agents such as skeletal muscle relaxants acupuncture. A meta-analysis of 40 systematic reviews and topical analgesics could also be considered at this comparing a variety of nonpharmacologic options such as step to enhance analgesic effects and reduce other symp- acupuncture, back schools, and exercise therapy showed toms associated with chronic pain. benefit in reducing pain compared to placebo, sham ther- While all NSAIDs carry black box warnings for gas- apy or no treatment. A randomized study of 120 patients trointestinal bleeds and cardiovascular adverse events, with osteoarthritis of the knee compared acupuncture there are preferred NSAIDs to help decrease the risk of a

42 America’s PHARMACIST | November 2015 Table 1.

Medications Oral Dose Equivalent Duration Half-Life Total Daily Dose=120 Morphine Equivalents

Codeine 200 mg 4-6 hours 3 hours 800 mg

Fentanyl Transdermal= 12.5mcg/ 50 mcg/hour hour

Hydrocodone 30 mg 4-8 hours 4 hours 120 mg

Hydromorphone 7.5 mg 4-5 hours 3-4 hours 30 mg

Meperidine 300 mg 2-4 hours 3-4 hours 1,200 mg

Morphine 30 mg 2-4 hours 3-4 hours 120 mg

Oxycodone 20 mg 4-6 hours 4 hours 80 mg

Oxymorphone 10 mg 3-6 hours 8 hours 40 mg

Tramadol 150 mg 9 hours 6-8 hours 600 mg

*Adapted from Pharmacist’s Letter August 2012 and Washington State Agency Medical Director Guideline. particular event. For example, naproxen is the preferred abuse, such as those with a personal or family history of NSAID for patients with cardiovascular disease because it substance abuse, should be evaluated by a mental health does not appear to increase the risk of major cardiovascu- or addiction specialist to determine if opioid therapy is lar events, supported by a meta-analysis of more than 750 appropriate for them. trials comparing NSAIDs to either placebo or head-to-head Once it has been determined opioid treatment is an with another NSAID. The vascular risks of ibuprofen and appropriate option for a patient, the patient should be high-dose diclofenac were found to be comparable to COX- prescribed a low dose, immediate release opioid therapy 2 inhibitors. to be used as needed with dose titrations occurring only A meta-analysis of 32 controlled trials and 13 cohort after an improvement in daily activities is observed. If the trials from 1985 to 2003 evaluated the risk of developing patient is using the immediate release product at each gastrointestinal adverse events on NSAID therapy. The risk available dose time, conversion to a long acting opioid may of developing gastrointestinal complications was highest be considered. With each dose titration or addition of ther- with indomethacin, followed by naproxen, diclofenac, apy, total daily morphine equivalents should be calculated piroxicam, ibuprofen, and meloxicam. The average duration to verify the 120 morphine equivalents per day threshold of treatment before developing symptomatic gastrointesti- has not been exceeded without demonstration of clear nal events was 84 days, but could be observed as early as benefit of therapy. The total morphine equivalents should seven days with indomethacin. be calculated to include all long acting and short acting If treatment with step one therapies is unsuccessful at oral, transdermal, intravenous and intramuscular opioid obtaining adequate pain reduction, progression to step two therapy. This threshold was outlined by the Washington with opioid therapy is warranted. The evidence supporting State Agency Medical Director’s Group as the point where the use of opioids for acute pain and cancer pain is well es- the risk of overdose dramatically increases and extreme tablished but the use of opioids for chronic nonmalignant caution should be used when exceeding this threshold. pain is not as strong. A systematic review in 2014 of 39 The occurrence of adverse events should be evaluated studies found patients treated with opioids for chronic pain at each follow up encounter and after any dose escalations found no benefit but did find an increased risk of dose-de- to re-evaluate the risks and benefits of continuing opioid pendent harm, such as overdose. therapy. Adverse events to specifically inquire about include Opioid therapy for chronic pain should be initiated only constipation, somnolence or mental clouding, and nausea in carefully selected patients, after assessing the benefits or vomiting. Any allergic reactions experienced by the pa- of therapy versus the risks of adverse effects and the pos- tient should be addressed and managed at each encounter. sibility of addiction and/or dependence. Guidelines from One of the first adverse effects to be addressed is the American Pain Society and the American Academy distinguishing an allergic reaction to opioid therapy from of Pain Medicine recommend patients at high risk for a pseudo allergy. Pseudo allergies are adverse effects that www.americaspharmacist.net 43 mimic an allergic reaction: pruritus, hives, flushing, sweat- A common adverse effect of pain medication that ing, or mild hypotension. These reactions may be related to should be addressed is constipation. It is known that the mechanism of action of the medication, as is the case opioids can cause constipation via several mechanisms: with codeine, which causes a histamine release. This can reduced peristalsis in the small intestine and colon, result in a rash and pruritus, which may be treated with an increased anal sphincter tone and increased water and antihistamine. Pseudo allergic reactions may be treated if electrolyte absorption. Due to the multiple contributing fac- another opioid is not appropriate for the patient. True aller- tors to constipation, a multidrug bowel regimen is logical gies include skin reactions other than those listed above, to prevent opioid-induced constipation. Although patients severe hypotension, swelling of lips, tongue, face or mouth, may prevent constipation with adequate hydration and and difficulties breathing, speaking, or swallowing. increased intake of fruits and vegetables for dietary fiber, Community pharmacists may be consulted by patients of advanced age, those with with poor diet, those prescribers on navigating a complicated patient allergy taking other constipating medications or patients with profile and choosing another opioid with no cross-re- hypercalcemia may need pharmacologic treatment. All pa- action with their allergy. Cross-sensitivity does not exist tients receiving opioid therapy should be counseled to ex- between all opioids; it is based on the structure of the pect and manage constipation, even if they were previously opioid. When a true allergy or intolerable pseudo allergy or are currently being treated with opioid therapy because presents, rotation to a different opioid structure can help some patients experience constipation but are unaware provide relief from pain without the risk of adverse events. it is caused by their opioid medication. Pharmacists are Morphine, hydromorphone, oxycodone, hydrocodone and a valuable resource to these patients by providing proper codeine are all phenathrenes, while fentanyl and meper- counseling and recommending an appropriate bowel idine are phenylpiperidines and methadone is the only regimen as an adjunct to their pain management regimen. diphenylheptane. Cross sensitivity reactions will occur Recommended pharmacotherapy to treat opioid-induced between opioids with the same structure but not across constipation includes a stool softener and cathartic agent different structures. (docusate sodium 100 mg twice daily and two tablets of

Table 2. Medications Recommendation Alternative

Meperidine Avoid Mild-moderate pain: Acetaminophen, short May cause neurotoxicity; not an effective course oral NSAID (ibuprofen, naproxen, analgesic at common doses. meloxicam), topical NSAID

Non-selective NSAIDs (examples) Avoid chronic use unless no other Moderate-severe pain: hydrocodone/ Aspirin >325 mg alternatives exist. acetaminophen or oxycodone/ Diclofenac (oral) acetaminophen Etodolac If chronic use is necessary, use of Ibuprofen gastrointestinal protective agent is Meloxicam recommended, such as a proton-pump Naproxen inhibitor or misoprostol. Sulindac

Indomethacin Avoid Mild-moderate pain: Acetaminophen, short Ketorolac High risk of gastrointestinal bleeding course oral NSAID (ibuprofen, naproxen, meloxicam), topical NSAID

Moderate-severe pain: hydrocodone/ acetaminophen or oxycodone/ acetaminophen

Skeletal Muscle Relaxants (examples) Avoid Baclofen Carisoprodol Poorly tolerated by the elderly due to Tizanidine Cyclobenzaprine anticholinergic effects Metaxalone Methocarbamol

44 America’s PHARMACIST | November 2015 senna at bedtime) or daily administration of an osmotic extra layer of surveillance beyond the NABP InterConnect, laxative such as polyethylene glycol. an integrated system of prescription monitoring programs Opioids typically cause sedation but can also cause by analyzing the prescribing and dispensing of opioid medi- mental clouding, a state where the patient is confused cations and providing post-market surveillance for govern- about their surroundings. This can be expected with the ini- ment regulation and pharmaceutical companies. tiation or titration of opioid therapy, but symptoms should In response to the changes in medication misuse, decrease over a few days to weeks. If symptoms, often along with the reduction of acetaminophen maximum observed as inattention, fatigue or delirium, persist beyond per-unit dose and the rescheduling of hydrocodone as a a few weeks or decrease quality of life, the opioid regimen Schedule II medication, two new single-entity, extended-re- should be evaluated. If pain is well-controlled, consider a lease hydrocodone products have recently come to market. 25 percent dose reduction; if pain is not well-controlled, Zohydro ER is an extended-release, twice daily hy- try opioid rotation with another opioid. If dose reduction or drocodone capsule indicated for pain management of opioid rotation is not possible, off-label use of stimulants severe pain requiring long term, around the clock opioid like modafinil or methylphenidate may be considered to treatment. Zohydro ER is not indicated for as needed pain help with sedation. A thorough medication review should management or for short term use. Zohydro ER is available be conducted when initiating opioid therapy to identify in six strengths ranging from 10 mg capsules to 50 mg other prescription and over-the-counter medications which capsules. If converting from immediate release hydroco- may contribute to sedation, dizziness and drowsiness. done-acetaminophen combination to Zohydro ER, the total Nausea and vomiting secondary to opioid use are ad- daily hydrocodone dose should be divided to the twice daily verse effects that affect quality of life and may cause addi- Zohydro ER equivalent. If the patient’s total daily dose of tional pain from movements associated with vomiting. They hydrocodone falls between two Zohydro ER strengths, the are mediated by several mechanisms such as a direct effect lower strength should be prescribed and the dose titrated on the chemoreceptor trigger zone, enhanced vestibular to desired effect. A conversion table is available in the sensitivity and delayed gastric emptying. Although this is prescribing information for conversion from other opioids. unpleasant for the patient upon therapy initiation, tolerance If titration is required, dose escalation should not exceed develops quickly and persistent symptoms are infrequent. 10 mg per dose every 5-7 days. When initially released, Gradual titration may help to avoid the development of Zohydro ER did not contain any abuse deterrent properties. nausea. If nausea does persist, opioid rotation or an alter- In October 2014, the makers of Zohydro ER announced native administration route may help to reduce symptoms. the development of an abuse deterrent formula to deter Patients may obtain relief using dopamine antagonists such crushing for intranasal or intravenous use by using Bead- as promethazine or serotonin receptor antagonists such as Tek technology, which forms a viscous gel when snorted or ondansetron, however long-term use of serotonin receptor mixed with solvents. The newer formulation was released antagonists may cause additional constipation. to pharmacies in May 2015. Hysingla ER is an extended-release, once-daily hydroco- NEW THERAPY UPDATES done tablet with abuse deterrent properties to deter crush- Opioids ing of tablets for intranasal or intravenous use by forming Pharmacologic options for the management of pain a viscous gel. Hysingla ER is also indicated for severe pain continue to evolve, with manufacturers working to provide requiring long-term, around the clock opioid treatment and products with fewer side effects to reduce harmful events is also not indicated for as needed or short term pain relief. and greater narcotic abuse deterrents to reduce the risk of Hysingla ER is available in seven doses ranging from 20 misuse. In addition to the abuse deterrent formulations of mg to 120 mg to allow for customization for each patient. the long acting opioids Opana ER (oxymorphone), Exalgo When converting from other oral hydrocodone regimens, (hydromorphone), and Oxycontin (oxycodone) discussed calculate the patient’s total daily dose of hydrocodone and in “A Review of Abuse-Deterrent Opioids for Chronic convert to once daily Hysingla ER as a one-to-one ratio. If Nonmalignant Pain” in the July 2012 issue of Pharmacy converting from another opioid to Hysingla ER, a conver- and Therapeutics, manufacturers continue to work to stay sion table is provided in the prescribing information. It is ahead of the latest trends in medication manipulation and recommended to underestimate the patient’s dose and misuse. Information on the latest trends and patterns in provide immediate release opioids for breakthrough pain prescription medication use is monitored by the National and titrate to an effective dose. Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) and continually updated to allow providers, Non Opioids pharmacists and manufacturers to remain informed on Two NSAIDs that have gone off patent were approved by medication misuse. This subscription service provides an the Food and Drug Administration recently in formula- www.americaspharmacist.net 45 tions with a feature that provides similar efficacy from a find the best alternative therapy for pain management in smaller dose, though it is unknown whether this reduces older adults without causing unwanted and potentially incidence of adverse events. Zorvolex (diclofendac) and dangerous adverse effects. Reducing the use of high risk Tivorbex (indomethacin) are capsule preparations created medications in the elderly will not only help patients, but with SoluMatrix Fine Particle Technology, which allows for will also help the pharmacy have an objective metric that it a lower overall NSAID dose with similar efficacy as high is providing high quality care. dose NSAIDs. Zorvolex is low-dose diclofenac indicated for the treatment of osteoarthritis pain. It is available as 18 mg SAFE STORAGE AND DISPOSAL and 35 mg capsules and dosed three times a day. Tivorbex News headlines and reports of disciplinary action from is low-dose indomethacin indicated for the treatment of state boards taken against licensed health care profession- mild to moderate acute pain in adults. It is available in 20 als document the persistent demand for diverted controlled mg and 40 mg capsules, 20 percent lower than current substances. Diversion by doctors and other prescribers, indomethacin products on the marker, and is dosed two to nurses, pharmacists, pharmacy and medical technicians, three times a day. home health workers, family members, and visitors happens when medications are stolen or illegally sold from ROLE OF PHARMACISTS hospitals, pharmacies, or patients. As theft continues to be Community pharmacists can play a role in pain manage- a threat to adequate pain management, safe storage is an ment by collaborating with local physicians, nurses, nurse important part of patient education when initiating opioid practitioners, and physician assistants. Establishing open therapy. Counseling tips for patients new to opioid therapy lines of communication with these health care providers include not sharing their medical information with friends helps to ensure the safety of mutual patients regarding and family to prevent being targeted, maintaining an inven- controlled substance medications. In addition to informing tory of medication to detect theft, and only carrying a small providers about drug interactions, dosing concerns, or pos- amount of medication when traveling. sible misuse of prescriptions, pharmacists can help local Patients should regularly clean out their medication prescribers to stay up to date on new updates of therapy cabinet to dispose of medications no longer needed. The or new laws and policies concerning controlled substance Drug Enforcement Administration (DEA) has finalized rules prescriptions such as the expansion of naloxone distribu- governing the disposal of controlled substances by its tion. A good working relationship with local providers will registrants and consumers. These regulations permit au- also help to ensure better reception of recommendations. thorized manufacturers, distributors, reverse distributors, The next few sections describe a few of the issues that are and retail pharmacies to voluntarily administer mail-back ripe for pharmacist-prescriber collaboration. programs and maintain collection receptacles. In addition, the finalized rule expands the authority of authorized hos- High Risk Medications pitals/clinics and retail pharmacies to voluntarily maintain All opioid medications should be considered “high risk” collection receptacles at long-term care facilities. Some from the aspect of dispensing due to the potential for state laws prohibit the establishment of such collection harm including abuse, misuse, and overdose. In addition sites when not located in a law enforcement center. In to specific opioids, other pain medications have been July 2015, the DEA announced the Take Back Days would identified by the American Geriatric Society (AGS) as high resume in September 2015, although the press release did risk medications to be avoided in the elderly. The AGS pub- not mention a reason for reinstating the program. lishes the Beers Criteria to identify medications with a high The FDA offers instructions for certain medications probability of adverse events in the elderly using a system- (basically anything containing an opioid analgesic) to atic review. Of the medications identified by the AGS Beers be flushed once no longer needed and proper disposal Criteria, a portion are incorporated into the list maintained in household trash when authorized collection sites are by the National Committee for Quality Assurance (NCQA) not available. The FDA-recommended disposal methods which is the reference for the “High Risk Medication” include removing the label or blackening out personal measure that is once again set to be part of the Medicare information, emptying the medication into a sealable Part D Star Rating System in the 2016 plan year. Phar- container and mixing with an undesirable substance such macists can have an impact on preventing initiation or as kitty litter, used coffee grounds, or dirt. Pharmacists encouraging discontinuation of high risk medications by can provide education to patients in need of disposing regularly screening new prescriptions, and by completing unwanted medications, both controlled and non-controlled medication therapy management (MTM) cases assigned by substances. It is important that patients are aware of how OutcomesMTM and Mirixa. While performing this service, to safely dispose of medications as it can be a hazard to pharmacists can consult both patients and physicians to other family members, especially children and pets. Sever-

46 America’s PHARMACIST | November 2015 al options available for pharmacies to offer to patients for Regulators and lawyers are taking a greater interest home use include pre-paid mail away packages or home in the extent to which pharmacists and prescribers may deactivation kits. In addition to home disposal options, be liable for misused and diverted prescription drugs. pharmacies may now explore reverse distributor options The Code of Federal Regulations, Title 21, section 1306.04 when allowable by their state and local regulations to states: “a prescription for a controlled substance must collect and dispose of returned medications. By providing be issued for a legitimate medical purpose by an individ- a safe way to dispose of these medications, pharmacists ual practitioner in the usual course of their professional can prevent an accidental overdoses. practice, and the pharmacist possesses a corresponding responsibility to ensure the prescription is used legiti- PREVENTING DIVERSION mately.” A violation of this section is no longer based on In 2012, it was estimated 2.1 million people in the United the pharmacist knowing it is not for legitimate medical States were suffering from substance use disorder related practice, but should have known. to opioids. In 2008, there were 14,800 deaths due to over- One of the earliest examples of the assertion in respon- dose, with prescription pain medications being responsi- sibility is USA vs. East Main Street Pharmacy in 2010. The ble for nearly three out of four overdoses. The number of DEA’s Show Cause Order alleged the pharmacist should patients with substance use disorders is only expected have known the prescriptions were not for legitimate to rise as more prescriptions are written for opioids each medical practice due to a number of red flags, including year. Opioid use disorders are broken down into three dispensing combinations of “cocktail” prescriptions, early categories: misuse of prescribed opioid medications, use refills, and high doses without individualization of dosing. of diverted opioid medications, and use of illicitly obtained Another example of violation of the code is USA vs. heroin. As patients with legitimate diagnoses warranting Nick Tran, RPh, for filling prescriptions faxed from a medi- opioid therapy are not immune from opioid use disorders, cal center without any question of their validity despite the caution should be used with all opioid prescriptions to same medication being filled at multiple pharmacies in ensure safe and proper use by the patient. the area. Tran’s pharmacy accounted for the dispensing of When speaking of prescription diversion, many phar- 98 percent of the medical center’s controlled substances, macists think of altered or forged prescriptions. One of increasing its dispensing of controlled prescriptions from the quickest ways to alter a prescription is the addition of a few hundred to several thousand. Tran was sentenced to a digit to the quantity or strength to change the dispensed 10 years in prison after he was found guilty for dispensing quantity or strength to a higher amount. Pharmacists and prescriptions outside of his scope of practice. pharmacy technicians can identify this red flag in prescrip- More recently, the state Supreme Court of West Virgin- tions altered in this fashion by comparing the quantity ia ruled patients addicted to controlled substances could prescribed to the directions and prescriber’s specialty. file lawsuits against the prescribers and pharmacists who For example, a prescription written by an emergency contributed to their addiction. The plaintiffs in the eight department provider for an opioid four times a day seems lawsuits against the four physicians and three pharmacies more logical to be written for a quantity of 20 for a five-day claimed their addiction resulted in their criminal abuse of supply as opposed to a quantity of 120 for a 30-day supply. and criminal activity to obtain the controlled substances. Additional evidence of an altered prescription include signs This ruling provides the strongest highlight of the respon- of rinsing, or removing previous ink by rinsing the prescrip- sibility to dispense the prescribed medication correctly tion with acetone or xylene, such as the use of different ink only after analyzing the drug therapy for safe, effective and on different parts of the prescription, or a “water” line on appropriate use. the prescription where the rinsing occurred. As the pharmacist’s duty to determine the medical An important tool for prescribers and pharmacies to legitimacy of prescriptions is put in the spotlight, what are use against unauthorized changes to a written prescrip- the warning signs or red flags of illegitimate medical use? tion is e-prescribing. It insures that no one other than the In an effort to help educate pharmacists to identify warning prescriber or pharmacy has access to the prescription to signs of diversion and abuse, the National Association of copy or alter it. E-prescribing of controlled substances is Boards of Pharmacy (NABP) and Anti-Diversion Industry permitted in all 50 states and as of August 2015, every state Working Group (ADIWG) have released a video titled “Red permits prescriptions for Schedule II-V drugs to be sent Flags” and is available to view in the pharmacist’s section electronically. Pharmacy vendors report that they have of NABP’s AwareRx.com prescription safety website (www. met security requirements to receive e-prescriptions for awarerx.org/pharmacists). controlled substances and the upcoming deadline in New Red flags of prescription drug abuse include groups York state to send all prescriptions electronically is putting of patients presenting with similar prescriptions from the pressure on prescriber software vendors. same office, prescriptions from distant locations, high dose www.americaspharmacist.net 47 or ongoing pain medications from a provider not specialized providers altered their prescribing for patients receiving in pain, using street slang for medication names, request- multiple narcotics at the same time. Of the 41 percent, 61 ing early refills, or willingness to pay cash for opioids de- percent prescribed no narcotics or fewer than anticipated. spite prescription insurance coverage. Additional warning • In California, 74 percent of physicians who responded to signs include prescriptions for drug cocktails of an opioid the survey indicated they had altered their prescribing + a benzodiazepine + a muscle relaxant, which are used practices as a result of using the PDMP. together to intensify the effect of the medications. Hydroco- • Doctor shopping in Florida decreased 51 percent after done, alprazolam, and carisoprodol are known as the “trio” the creation of the PDMP. or “trinity”; when oxycodone is included with alprazolam and carisoprodol, it is described as the “holy trinity.” However, not all PDMP systems are connected, so pa- Doctor shopping or pharmacy shopping is another red tients may visit multiple providers and multiple pharmacies flag for prescription misuse and diversion. When claims for in neighboring states without being flagged to a pharma- identical or similar medications are adjudicated to prescrip- cist when dispensing. Within the United States, 29 PDMPs tion insurance, the insurance may reject the claim for refill are actively sharing data and four others are in the process too soon. Detecting multiple prescriptions for similar medi- of establishing data sharing, connected states are listed cations filled at multiple pharmacies becomes more difficult on NABP’s PMP InterConnect webpage (www.nabp.net/ as patients become more sophisticated and track their refill programs/pmp-interconnect/nabp-pmp-interconnect). Until dates, request similar but not identical prescriptions, or pay all systems are connected and actively sharing data, phar- cash to prevent insurance rejections. Pharmacists who have macists should consider registering for PDMP programs in access to a prescription drug monitoring program (PDMP) nearby bordering states and verifying patient activity with to monitor patient activity at other pharmacies should utilize each system prior to dispensing. it. If it is discovered a patient is using multiple pharmacies to fill narcotic prescriptions, an open dialogue with the PAIN CONTRACTS patient is necessary to determine the reasoning for using Pain contracts (also described as opioid contracts or opioid multiple pharmacies. Similarly, if the patient is using several treatment agreements) are agreements entered into by the prescribers to receive controlled substances, pharmacists patient and provider when entering a pain management should make the prescribers aware of the situation. It should program. The contracts serve several purposes: provid- be stressed to patients to use one pharmacy, or one phar- ing the patient with information about the risks of opioid macy chain with networked dispensing records, to decrease therapies, outlining monitoring procedures to ensure the likelihood of missed drug interactions, duplications in proper opioid use, restricting the obtaining of opioids from therapy or other dangerous prescription cocktails. multiple providers, and allowing for more complete management of the patient’s pain. Aspects of pain contracts PRESCRIPTION DRUG MONITORING PROGRAM may include provisions for monitoring such as medication Each state, except for Missouri, has established a PDMP counts, urine drug screens, and scheduled office visits to to collect prescription dispensing data from pharmacies detect improper medication usage, including overuse and at regular intervals every 7-30 days. Each individual PDMP diversion. The contract may also require the use of one determines what drug schedules are reported from only pharmacy to assist in the monitoring for opioids from one schedule II to schedule II-V. Information sent to the pro- provider. Pharmacists should be aware of the multitude gram includes patient name and date of birth, medication of non-controlled medications that can result in a positive name and strength, quantity, day supply, prescriber, and urine drug screen, such as quetiapine, diphenhydramine, dispensing pharmacy. Pharmacists, prescribers, and law and ibuprofen. The false positives occur due to the similar enforcement agencies may request access to the program shape between these medications and the shape of the to perform a patient search. Because all information is pro- opioid the urine screen is detecting. vided to the program, regardless of payment method, pa- Pain contracts may be perceived by some patients tients are no longer able to “beat the system” by receiving as a lack of trust or limitations preventing adequate pain prescriptions from different prescribers, filling at different control. These negative perceptions should be discussed pharmacies, and paying cash to avoid any insurance flags. with the patient with the goal by all parties to optimize pain Dozens of studies have reviewed the use of the PDMP management in a safe manner. While the many stipula- programs to determine their efficacy in reducing medications in pain contracts can seem restrictive to the patient’s tion diversion, and a complete review of evidence is avail- autonomy, a systematic review of four observational able on the PDMP Center of Excellence Briefing of PDMP studies found a modest decrease of 7-23 percent in opioid Excellence. Highlights of the report include: misuse when a pain contract was implemented, compared • In Ohio emergency departments, 41 percent of medical to a control group with no contract.

48 America’s PHARMACIST | November 2015 ROLE OF NALOXONE control of their own treatment. Motivational interviewing Due to the increasing number of opioid related deaths in is based on three key elements for success: collaboration the United States, the DEA has become very strict in mon- with the patient, evoking or drawing out the patient’s ideas itoring the Controlled Substance Act (CSA) in regard to about change, and emphasizing the patient’s autonomy not only pharmacists and pharmacies, but also physicians and decision making power in health care decisions. When and drug wholesalers. Along with the previously mentioned interviewing patients, asking questions regarding how cases of pharmacists being responsible for adverse events, they feel about a particular treatment option, or request- physicians have also taken precautions when prescribing permission to contact their prescriber for changes to ing opioid pain medications to decrease their liability. In therapy allow patients to believe they are an active part of some areas, prescribers of opioid therapy have prescribed their treatment plan. naloxone for patients to use in the case of an accidental “Change talk” are statements made by patients revealing overdose. As of July 2015, 40 states and the District of consideration of, motivation for, or commitment to change, Columbia have amended their legislation to allow for easier and should be a factor considered in driving pain man- access to naloxone, with some states allowing access to agement therapy. With change talk, pharmacists can gain naloxone in a pharmacy without a prescription or removing a better understanding of how likely a patient is to follow fear of criminal charges from those requesting assistance through with changes using several types of questions to for a person experiencing a drug overdose. Several states, elicit six different types of change talk. The different types of including New Mexico, Washington, California and Rhode change talk include statements about a desire for change, Island, currently have collaborative practice agreements in capability for change, reasons for change, feeling obliged to place allowing pharmacists to prescribe naloxone kits to change, commitment to change or actions taken. The first patients to use in case of overdose. four provide insight on the desire to commit change, or pre- Community pharmacists should be familiar with the commitment to change, but no action to change behaviors. different delivery devices and instructions for use as many The last two are the action phase of change and should be patients, family, friends, and caregivers have no previous the ultimate goal of discussing change talk. experience with naloxone products and will require edu- Using the patient’s own desires and motivation for cation on proper use and administration in the event of an change can assist in the development of SMART (specif- overdose emergency. The most common packaging of nal- ic, measureable, attainable, realistic and timely) goals to oxone for administration by the patient in the community convert precommitment talk to action. These goals can be is an auto injector, available under the brand name EVZIO, related to several aspects of pain management: incorpora- intramuscular or subcutaneous injection. In July 2015, FDA tion of non-pharmacologic options into therapeutic plan, accepted a new drug application for a naloxone nasal spray decrease in use of as needed medication to decrease ad- product, and is still considering the application at the time verse effects, or other goals important to the patient. Phar- this article was printed. Each time a pharmacist dispenses macists can use the patient-developed SMART goals to one of these naloxone products, the pharmacist should help track improvement in the control of pain and decrease provide counseling to the patient and their friends and fam- reliance on pain medications to perform daily activities. ily members. Due to the nature of an overdose, it is unlikely As pharmacists are the last line of defense before a the patient will be the one administering the medication, medication reaches a patient, it is critical that pharmacists so others who have close contact with the patient should remain updated on the current trends of pain medica- be prepared to administer naloxone in case of emergency. tion use and misuse. It is the pharmacist’s responsibility The EVZIO system is designed to be administered by those to ensure that patients are receiving safe and effective without training by providing visual and voice instructions dosages of pain medications to avoid accidental overdoses. to aid in proper administration. Each prescription should be carefully analyzed for potential dangers, even if it is the same dosing as previous prescrip- MOTIVATIONAL INTERVIEWING tions. Factors to consider when reviewing the prescription Pharmacists are uniquely positioned to provide counsel- include adverse events, development of tolerance, inade- ing for pain management expectations and the patient’s quate pain relief, and misuse of medication. When filling goals of therapy at the point of dispensing each month. prescriptions, technicians and pharmacists should pay During the patient encounter, patient autonomy should close attention to early refills and start a dialogue with be emphasized and the patients should be included in patients if they are requesting early refills frequently, as this their decision making. A pharmacist may place the focus may be a sign of inadequate pain relief, misuse, or abuse. of pain management on patients discussing their goals of In either case, patients should be counseled on the impor- therapy, concerns about cost or adverse effects or relief tance of following the prescriber’s directions, the dangers experienced with current regimen to place patients in of not taking their medication as prescribed, and to speak www.americaspharmacist.net 49 CE QUIZ

to their prescriber about changing their regimen if their Continuing Education Quiz pain is not currently controlled. Select the correct answer. Common adverse effects pharmacists should screen for at each dispensing include constipation, dizziness, and 1. When counseling patients on new pain medication, falls. This is especially important in the elderly population, what is a realistic goal related to controlling their pain? as older adults are more susceptible to experiencing ad- a. With proper pain management regimens, including verse effects and could develop new adverse effects while nonpharmacologic options, their pain should be on a stable regimen due to changes in renal or hepatic reduced by 75-100 percent. function. If patients are experiencing adverse effects, b. Pain medication regimens reduce pain by 33-50 pharmacists should make appropriate recommendations percent alone, but increases to 50-80 percent when for both nonpharmacologic and pharmacologic therapy. Ed- nonpharmacologic options are added. ucating patients on what is considered a true drug allergy c. Optimal use of nonpharmacologic and pharmacologic should be included in counseling regarding adverse effects. pain management options will lead to a pain reduc- Overall, by taking an active role in pain management, tion of 33-50 percent. community pharmacists can help patients to receive d. Although no pain management regimen will reduce adequate pain control while eliminating undesirable and pain to 100 percent pain free, patients should expect potentially dangerous side effects. By educating patients their pain to significantly reduce to greater than 50 on side effects, proper medication disposal, and proper percent relief when starting opioid therapy. usage of pain medications, along with working with local physicians, pharmacists can be a great benefit in the 2. Which of the following is not considered a suspicious practice of pain management. ■ activity when a patient requesting a prescription fills by the National Association of Boards of Pharmacy and Ashley Firm, PharmD, is clinical pharmacy coordinator at Asti’s Anti-Diversion Industry Working Group’s video? South Hills Pharmacy in Pittsburgh. Caitlin Bertrand, PharmD, a. Using brand names when referring to a medication in completed a PGY1 community residency with South Carolina conversation with the pharmacist College of Pharmacy and Barney’s Pharmacy in Augusta, Ga. b. Requesting early refills on skeletal muscle relaxants She is a registered pharmacist in Louisiana and practices as a c. Prescriptions from offices far away from pharmacy community pharmacist. location d. Multiple patients presenting with similar prescriptions from the same provider

3. Which of the following is an example of a pseudoaller- gy and can be treated with an antihistamine? a. Difficulty swallowing b. Hives c. Face swelling d. Severe hypotension

4. If a patient is allergic to Tylenol #3, which of the following pain medications could possibly have cross reactivity and should be avoided if possible? a. Percocet b. Norco c. MS Contin d. All of the above

Editor’s Note: For the list of references used in this article, please contact America’s Pharmacist Managing Editor Chris Linville at 703-838-2680, or at [email protected].

50 America’s PHARMACIST | November 2015 CE QUIZ

5. Which of the following is considered a Food and Drug Ad- 11. Which of the following is an appropriate recommenda- ministration recommended method for drug disposal? tion to prevent opioid induced constipation? a. Flushing all prescription medications, other than hor- a. Increase fluid intake to maintain adequate hydration. monal products, down the toilet b. Increase fruits and vegetables in diet. b. Removing label and mixing medication with kitty litter or c. Add docusate and senna to medication regimen. used coffee grounds. d. All of the above. c. Blacking out personal information on the label and throwing medication in the trash 12. Which abuse deterrent feature is used in the formula- d. Placing medication in garbage disposal with used coffee tion of two recently approved long-acting opioids? grounds a. Crushed tablet forms a viscous gel in most liquids. b. Tablet is indestructible outside duodenal pH. 6. Which of the following combinations of medications is a c. Capsule contains a radioluminescent dye pack. possible warning sign for prescription drug abuse? d. None of the above a. Zohydro, Motrin, Skelaxin b. Vicodin, Ativan, Naprosyn 13. Which of the following NSAIDs has the lowest risk c. Percocet, Xanax, Soma of cardiovascular events and is the preferred NSAID in d. Norco, Valium, Ambien patients with cardiovascular disease? a. Ibuprofen 7. According to the American College of Rheumatology, b. Meloxicam patients are considered to have chronic pain when their c. Naproxen pain lasts longer than ______. d. Diclofenac a. 30 days b. 60 days 14. How many total morphine equivalents should not be c. 90 days exceeded per day to avoid the risk of opioid overdose? d. 180 days a. 100 b. 120 8. Which of the following is not considered a high risk c. 150 medication by the Beer’s Criteria and has a lower risk of d. 200 adverse effects in adults greater than 65 years of age? a. Meperidine 15. Which of the following is a correct mechanism of ac- b. Cyclobenzaprine tion for opioid induced nausea and vomiting? c. Baclofen a. Indirect effect on chemoreceptor trigger zone d. Indomethacin b. Enhanced vestibular sensitivity c. Rapid gastric emptying 9. Phantom limb pain is an example of ______pain. d. Stimulation of 5-HT3 receptors a. Peripheral neuropathy b. Nociceptive pain 16. Fine particle formulations of diclofenac and indometha- c. Central pain cin offer which advantage over generic NSAIDs? d. Somatic pain a. Once daily dosing b. Superior efficacy compared to other NSAIDs due to once 10. According to the World Health Organization (WHO) daily dosing and increased drug exposure Pain Ladder, which of the following is not true regarding c. Lower overall systemic drug exposure therapy for pain management? d. Lower risk of adverse events a. Patients can begin with opioid therapy at first presen- e. C and D tation of pain if the pain is ranked a 10 out of 10 on the pain scale. b. Step 1 therapy options include acetaminophen and NSAIDs. c. Adjuvants such as skeletal muscle relaxants and topical agents can be used to enhance analgesic effects. d. Opioid therapy is recommended only when patients do not receive adequate relief with Step 1 therapies.

www.americaspharmacist.net 51 CE QUIZ

17. A patient presents to your pharmacy with new prescriptions 19. Which is an incorrect statement about the use of nalox- for Oxycontin 40 mg twice daily and Roxicodone 5 mg every one for opioid overdose? six hours as needed. The patient and prescriber are familiar to a. Naloxone should only be administered by trained health- your pharmacy and you believe the patient to be using the med- care professionals. ication legitimately. What is the morphine equivalent (MEQ) of b. Naloxone is available for dispensing with a pharmacist this regimen and proper action by the pharmacist? written order in 40 states and the District of Columbia. a. 100 MEQ, the patient should be counseled on proper use c. Naloxone is available in an intranasal delivery system of his as needed Roxicodone under the brand name EVZIO. b. 120 MEQ, the patient is over the recommended limit d. Naloxone administration technique should be taught to and the pharmacist should contact the prescriber for a the patient and friends and family of the patient in case decrease in dosage of emergency. c. 150 MEQ, the patient is over the recommended limit and the pharmacist should contact the prescriber for a 20. Which of the following is an example of a SMART goal decrease in dosage related to pain management? d. 150 MEQ, the pharmacist should counsel a. Decrease use of as needed oxycodone from four to three the patient on signs of drug overdose and develop an tablets daily by next month. appropriate action plan if an overdose is suspected b. Increase physical therapy exercises by next week. c. Decrease use of long acting hydrocodone products. 18. Which of the following is an appropriate manage- d. Decrease use of as needed oxycodone ment of a patient new to opioid therapy who complains of products to three tablets. confusion regarding his surroundings and an inability to complete daily activities? a. Continue opioid therapy at a higher dose to decrease time to tolerance. b. Discontinue opioid therapy until symptoms clear and restart opioid titration. c. Rotate opioid with a non-opioid until symptoms resolve d. Decrease the opioid dose by 25 percent and continue to monitor symptoms.

52 America’s PHARMACIST | November 2015 National Community Pharmacists Association Foundation www.ncpafoundation.org

INTRODUCING THE Pharmacy Disaster Support Center ENROLL TODAY!

Independent community pharmacy owners now have a new integrated resource for consolidating their disaster preparedness, response, and recovery procedures. This integration will result in a faster business recovery after calamity.

The Pharmacy Disaster Support Center was created with the goal of helping pharmacy owners minimize business interruption from a natural disaster or other adverse event. The center is supported by the National Community Pharmacists Association Foundation and Pharmacists Mutual Insurance Company.

Why participate? Enrollees of the Pharmacy Disaster Support Center will benefit from a streamlined communication process during the chaotic aftermath of a calamity and appreciate having a centralized hub for insurance and vendor contacts. What’s more, the non-financial business data collected during the enrollment process will help in the coordination of assistance that’s specific to your unique business operation needs.

Are you open for business? Should we come to work today? Can my business bounce back?

These are some of the questions your customers, employees, and you will ask if the unthinkable happens. We want you to plan ahead so you can respond: “Yes, Yes, Yes!”

Visit www.rxdisaster.com or email [email protected] for more details about this exciting new program designed for owners aiming to strengthen their business-continuity procedures. PCCA will match designated National Community Pharmacists Association pre-convention program registrations at the 2015 NCPA Annual Convention and individual donations made to the NCPA Foundation through year end—up to a combined total of $50,000.

Donor support helps the NCPA Foundation DONATION preserve the legacy of independent pharmacy through scholarships to pharmacy students, research/programs to improve the success of independent pharmacy and patient care, community health awareness DONATE VIA programs, and disaster aid to community pharmacy owners. The Foundation was established in 1953 and is a non-profit 501(c)(3) organization. Contributions are TEXT tax-deductible as charitable donations to the extent permitted under federal tax law. Visit www.ncpafoundation.org.

NCPA Foundation: Donation Form ❏ Credit Card ❏ AMERICAN EXPRESS ❏ DISCOVER ❏ MASTERCARD ❏ VISA TODAY'S DATE CARD NUMBER EXP. DATE (MM/YY) SEC. CODE NAME NAME ON CARD (PRINT) PHARMACY/COMPANY NAME SIGNATURE TODAY’S DATE ADDRESS 3 Ways to Give CITY STATE ZIP 1. Text using mobile device: 52014/@ncpaf#pcca Text to the above number. In the text message field, enter @ncpaf#pcca, press PHONE the space key, and then type the donation amount. For example, to make a $200 donation enter @ncpaf#pcca 200. (You’ll quickly receive a text response Donation to complete the process and can choose to make a one-time, monthly, or ❏ $1,000 ❏ $500 ❏ $250 ❏ $150 Other $ annual donation.)

Payment 2. Visit the donation page of www.ncpafoundation.org ❏ Check Enclosed is my check payable to the NCPA Foundation for $ 3. Complete and return this form  Continued from page 14 Reader Resources They also required that the compounded formulations be NCPA activities and our advertisers supported by published literature. Consumer Healthcare Products Association 3 The proposed standard concentrations have been EPIC Inside Front Cover endorsed by Michigan Academy of Physician Assistants, HBS 40 Michigan Health & Hospital Association, Michigan Phar- Live Oak Bank Back Cover macists Association, Michigan Osteopathic Association, MedSafe 4 and the Michigan State Medical Society. We urge pre- Nexafed 15, 17 scribers and pharmacists to review the list and consider PRS 1 adopting the proposed concentrations if possible. Your PRS 2 efforts can help reduce the risk of medication errors when treating pediatric patients. ■ NCPA DASPA 13 This article is from the Institute for Safe Medication Practices Fight4Rx 34-35 (ISMP). The reports described were received through the USP– NCPA Bookstore 11 ISMP Medication Errors Reporting Program. Errors, near misses, NCPA Foundation Match 54 or hazardous conditions may be reported on the ISMP website NCPA Mobile 6 at www.ismp.org. ISMP can be reached at 215-947-7797 or NCPA Social Media 9 [email protected]. Multiple Locations Conference Inside Back Cover Pharmacy Disaster Support Center 53

 Continued from page 17 including licensure laws, in the states have similar self-referral prohibition into which it is shipping. statutes. ■ Q: Please explain the reasons you would recommend using a Q: If you know that a pharma- Jeffrey S. Baird, Esq. is chairman of the W2 employee marketing rep over cy does not have a license in a Health Care Group at Brown & Fortunato, a 1099 independent contract mar- particular state (that requires a P.C., a law firm based in Amarillo, Texas. keting rep. license in that state) but is still He represents pharmacies, infusion shipping in to that state, what companies, home medical equipment A: If a marketing rep is generating would you do? companies and other health care provid- patients who are covered by a gov- ers throughout the United States. Baird ernment health care program, then A: Contact the state board of phar- is board certified in health law by the the rep cannot be paid commissions macy for that state and report the Texas Board of Legal Specialization. He if he is a 1099 independent contrac- pharmacy. can be reached at (806) 345-6320, or tor. The reason for this is because [email protected]. the federal anti-kickback statute Q: We are seeing more physicians prohibits paying compensation to a setting up compounding pharmacies person who refers (or arranges for in their practices. What are the rules, the referral of) a patient covered by if any, about physician ownership a government health care program. and self-referring? The anti-kickback statute provides an exception for commission pay- A: The federal Stark law prohibits a ments to a bona fide part-time or physician from referring a Medicare full-time employee. or Medicaid patient to a pharmacy for outpatient prescription drugs if Q: What is your opinion of a phar- the physician or his/her immediate macy shipping across state lines? family member has an ownership or compensation arrangement with A: It is permissible as long as the the pharmacy, unless one of the pharmacy is complying with state law, Stark exceptions is met. Some states www.americaspharmacist.net 55 FRONT-END OVERHAUL

Grab Your Green Highlighter for Diabetes Support

by Gabe Trahan

A green highlighter just might become Friendly Store! Look for the green to help these individuals take great your best marketing tool—one that stripe for sugar-free products.” These care of their feet. Place a sample of a will make many current and soon-to- signs can be 5 x 7 inches and should diabetic shoe on your pharmacy count- be new customers happy. be posted in any section in which a er. I can tell you from experience that green stripe appears. Add to your not everyone who lives with diabetes is The number of individuals with diabe- offerings by researching and stocking aware there are shoes to offer comfort tes is undeniably on the rise—half of other lines that offer sugar-free prod- and safety for diabetic feet. Also con- the U.S. population is either pre-dia- ucts. Do not limit your selection to sider giving out a pair of diabetic socks betes or has diabetes, according to health related items—people with dia- to 30 of your diabetes customers. This the Journal of the American Medical betes will appreciate quality sugar-free may cost you as much as $300, but Association. Now is the time to make chocolates, drinks, and snacks. I can’t think of a better way to spend it easier for these customers to shop $300 to market your services and do a your store. Start reading the backs of Mark the shelf tag good deed. Do it this month. everything on your OTC shelves that customers ingest or put on or near of each sugar-free Sign ideas for your diabetic shoe their mouths, and look for the words section or displays: “sugar-free.” Do not confuse the words item with a green “Safety and Comfort for Diabetics and “sugar-free” and “no sugar added” highlighter. Anyone Else Who Loves Their Feet” as being the same. They are not. Nor “Comfort and Safety for the Diabetic Sole” does “organic” or “all-natural” mean Use your digital or marquee exteri- “Let Our Certified Shoe Fitter Help You sugar-free. Here are a few items where or sign to promote your extensive Find the Perfect Shoe for Your Feet” you can start your hunt: selected inventory: “Now Stocking Over 200 SKUs of Tums, Robitussin, liquid chil- Sugar-Free Items!” Be sure to include Good luck and happy counting. ■ dren’s Advil, Cepacol, Halls, Ricola, this information in your media market- Orajel, and MiraLAX. Scope out the ing as well. With a green highlighter Gabe Trahan is NCPA's senior director mouthwash, antacid, laxative, and and a little bit of time, your store can of store operations and marketing. Gabe vitamin sections. The more sugar-free be branded as a Diabetes Support uses 30 years of front-end merchandis- items you find, the better! (Note: If Center. The chains may have a few ing experience to help NCPA members there is any doubt as to whether or not more sugar-free items than you, but increase store traffic and improve profits. a product is sugar-free, either contact remember: it’s not how many you Visit www.ncpanet.org/feo to watch vid- the manufacturer or skip it.) After you have, it’s how many you took the time eos, read tips, and view galleries of photo have thoroughly checked your OTC to count. Having 300 sugar-free items examples by Gabe. Follow him on Twitter offerings, count your findings—it may and not telling anyone is nearly the @NCPAGabe for additional tips. be in the hundreds! Remember, each same as having none. flavor of Halls’ sugar-free lozenges is counted as one, and so on. Once you are done counting your sugar-free items, take time to do research. Mark the shelf tag of each sugar-free Find a multivitamin that you feel com- item with a green highlighter. Next, fortable in specifically recommending create signs that read, “Diabetes - to your diabetes patients, and be ready

56 America’s PHARMACIST | November 2015 MULTIPLE LOCATIONS CONFERENCE | FEBRUARY 10 –14, 2016 Fort Myers FLORIDA

NCPA MULTIPLE LOCATIONS PHARMACY CONFERENCE Continuing education, networking, exhibitors, and much more… Hyatt Coconut Point | www.ncpanet.org/multiplelocations When you’re ready to acquire a pharmacy, we’ll handle the financing.

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Jimmy Neil Mike Bollinger 910.212.4951 910.212.4953 [email protected] [email protected]