The Official Publication Of The Florida Pharmacy Association SEPT. 2020
Non-adherence of Antiretroviral Therapy Among Hispanic-Americans Living with HIV
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VOL. 83 | NO. 9 SEPTEMBER 2020 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION
Features
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Non-adherence of Antiretroviral Therapy Among Hispanic-Americans Living with HIV
5 Executive Insight 13 News Briefs
12
October is American Pharmacists Month
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FDA’s Bad Ad Program Teaches Providers to Look for Misleading Advertising
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3 Barriers to Effective Patient Counseling in the Community Pharmacy Setting
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Feds Issue Guidance on COVID-19 Vaccines
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Acella Issues Voluntary Recall of Two Lots of Thyroid Medication
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Pharmacists: Visible and Yet Invisible
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FPA Calendar 2020
OCTOBER
NOVEMBER
1-2
Midyear Nuclear Conference webinar
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3-4
Midyear Clinical Conference webinar
14 - 15 FPA Committees, Councils and Board meeting
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Southeastern Officers Virtual Conference
26 - 27 Thanksgiving FPA Office Closed
13 - 14 Board of Pharmacy Meeting via conference call 17-21 NCPA Annual Meeting Nashville, Tennessee
Veterans Day FPA Office Closed
DECEMBER 25-28 Christmas Holiday FPA Office Closed
Mission Statements: Florida Pharmacy Today Journal The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.
Florida Pharmacy Today Board of Directors
FOR A COMPLETE CALENDAR OF EVENTS GO TO WWW.FLORIDAPHARMACY.ORG
Events calendar subject to change
CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours’ LIVE continuing education as part of the required 30 hours’ general education needed every license renewal period. There is a two-hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. Pharmacists and pharmacy technicians must also complete a one-hour Florida Board approved continuing education on human trafficking by Jan. 1, 2021. Pharmacists should have satisfied all continuing education requirements for this biennial period by Sept. 30, 2021, or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by Dec. 31, 2020. For the Pharmacy Technician Certification Board application, exam information and study materials, please contact the FPA office. For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.floridapharmacy.org CONTACTS FPA — Michael Jackson (850) 222-2400
FSHP — Tamekia Bennett (850) 906-9333 UF — Emely McKitrick (352) 273-5169
FAMU — Leola Cleveland (850) 599-3301 NSU — Carsten Evans (954) 262-1300
The mission of the Florida Pharmacy Today Board of Directors is to serve in an advisory capacity to the managing editor and executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the Journal in its goal of self-support.
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Note: The views of the authors do not necessarily represent the views or opinions of the Florida Pharmacy Association, Florida Pharmacy Today or any related entities.
DISCLAIMER Articles in this publication are designed to provide accurate and authoritative information with respect to the subject matter covered. This information is provided with the understanding that neither Florida Pharmacy Today nor the Florida Pharmacy Association is engaged in rendering legal or other professional services through this publication. If expert assistance or legal advice is required, the services of a competent professional should be sought. The use of all medications or other pharmaceutical products should be used according to the recommendations of the manufacturers. Information provided by the maker of the product should always be consulted before use.
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FLORIDA PHARMACY TODAY
EMAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com
Executive Insight BY MICHAEL JACKSON, RPH MICHAEL JACKSON, BPHARM, EVP & CEO, FLORIDA PHARMACY ASSOCIATION
D
Fixing a Broken PBM Marketplace
uring the 2020 legislative session, the Florida Pharmacy Association along with a coalition of a number of pharmacy stakeholder entities, got heavily engaged in awareness of problems within the pharmacy benefit manager marketplace. There is no need to pour a lot of ink on this article describing the nature of the problem because much has been made available to our readers for many years. Annually, we march on the Florida Capitol and also travel to Washington, D.C., to try to convince policy makers to do something about this nightmare we are living in. DIR fees, network exclusion, unfair audits, onerous contract terms, mail order restrictions and preferential reimbursement are just a small list of the disruptions in the market. These issues affect pharmacy businesses we work in whether you own it or are employed by it. In the first three months of this year, the FPA working with the National Alliance of State Pharmacy Associations and American Pharmacy Cooperative Inc., commissioned a massive educational campaign to shine the light on PBMs. We got in front of the news media (both radio and television) and blew up social media with real, hard evidence that was discovered from a study of more than 350 million prescription drug claims in the Medicaid program.1 We can’t stop talking about the findings of this study because it was so obvious that something needs to be done. We understand that the Agency for Health Care Administration, the agency that is over Florida Medicaid, is about to release its own analysis of the Medicaid program as this article is be-
ing prepared for the Journal. We wait with guarded interest to see what those findings will be. During the 2019 House of Delegates meeting, a resolution was adopted asking that the FPA call on the governor, Florida’s attorney general, the state legislature and the insurance commissioner to mandate and ensure that compensation for pharmacists and
There is no need to pour a lot of ink on this article describing the nature of the problem because much has been made available to our readers for many years. pharmacy services who meet network qualifications be consistent and equal among providers. Prior to and during the 2020 session, we knocked on all those doors and exposed the critical issues related to PBMs. The adopted resolution above is a fair question to ask of any benefits manager, payer or governmental entity. If given the same qualifications, licensure and credentials, why is reimbursement
Michael Jackson, B.Pharm
and access so variable across pharmacy networks? If Pharmacy A can demonstrate exceptional outcomes and great care comparable to Pharmacy B, why is it that Pharmacy B gets better terms or is even admitted to a network when Pharmacy A may be excluded? Regardless of the outcome, no one can argue that change must happen. Health care cannot survive in this environment and the need for a new model should be the main topic of discussion. There are opportunities and challenges ahead of us. We are diving towards a general election this fall on Nov. 3. We just completed our state’s primary on Aug. 18 and know who the candidates will be. The November election will likely be the most polarized political campaign yet with candidates likely spending their resources swinging at each other. It is also an election year where most SEPTEMBER 2020
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FPA STAFF Executive Vice President/CEO Michael Jackson (850) 222-2400, ext. 200
Director of Continuing Education Tian Merren-Owens, ext. 120
Continuing Education Coordinator Stacey Brooks, ext. 210 Coordinator of Membership Christopher Heil, ext. 110
FLORIDA PHARMACY TODAY BOARD Chair............................... Carol Motycka, St. Augustine Vice Chair.........................Cristina Medina, Hollywood Treasurer.................................... Eric Jakab, Gainesville Secretary............................. Julie Burger, Pensacola Member.........................Michael Finnick, Jacksonville Member.............David Mackarey, Boynton Beach Member....................................... Matt Schneller, Tampa Member............................Teresa Tomerlin, Rockledge Member...................................... Greta Pelegrin, Hialeah Technician Member..........Julie Burger, Pensacola Executive Editor.......Michael Jackson, Tallahassee Managing Editor...................Dave Fiore, Tallahassee Journal Reviewer........................... Dr. Melissa Ruble Journal Reviewer....................................Dr. Angela Hill This is a peer-reviewed publication. . ©2020 FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board. FLORIDA PHARMACY TODAY, Annual subscription - United States and foreign, Individual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax. FLORIDA PHARMACY ASSOCIATION
610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web address: www.floridapharmacy.org.
Executive Insight, from Page 5
of the seats in the House and Senate are in play. The task before us is to navigate through the rhetoric and get candidates to reveal their positions on pharmacy issues. Now is the time to have that conversation with your local incumbent politicians and candidates while they are soliciting your support for their campaigns. The Florida Pharmacist Political Committee is actively engaged on this issue. There were nine campaigns watched during the primary supported by the FPPC, and 8 of the 9 won their races. It is always risky when participating in primary races because the outcomes are less predictable. When we do engage and pick the right horse, the candidate remembers and generally has more empathy to what policies may be needed that we put before them. As we get closer to the fall election, you will see candidates on street corners holding signs and participating in virtual and live town hall meetings. It is not unusual for me to see a candidate in my community and engage in conversations about the issues. Right now, they are open to hearing what you have to say. They will have no clue of what’s wrong until you take the time to talk with them. Let’s not wait until October or November to make that conversation happen. They should not get glassy-eyed or confused if you tell them what a PBM is. Would you like to find out who is running for office in your community? This web site link (https://dos.elections.myflorida.com/candidates/) lists all federal and state candidates by legislative district. Just take a peek at your voter registration card and it will tell you what district that you live in. Find your candidate and look them up. Don’t wait for them to call you. A connection that you make today will pay huge dividends for you in the future. 1. https://www.floridapharmacy.org/news/487161/Shining-the-Light-on-PBMs.htm
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Non-adherence of Antiretroviral Therapy Among Hispanic-Americans Living with HIV Authors:
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Antonio J. Carrion, PharmD, MPH, AAHIVP, CPh Associate Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tallahassee, FL 32307 Antonio.carrion@famu.edu Phone: (850) 412-7376
Fajr Hassan, PharmD, BCADM, CPh Director of Pharmacy Encompass Health Rehabilitation Hospital Tallahassee, FL 32308 fajr.hassan@encompasshealth.com Phone: (850) 656-4832
*Briana Journee, PharmD, MBA, AAHIVP, CPh (Corresponding Author) Assistant Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tallahassee, FL 32307 Briana.journee@famu.edu Phone: (850) 599-3687
Rashida Hudson, PharmD Clinical Pharmacist Encompass Health Rehabilitation Hospital Tallahassee, FL 32308 fajr.hassan@encompasshealth.com Phone: (850) 656-4832
Jovan D. Miles, PharmD, AAHIVP, CPh Assistant Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tallahassee, FL 32307 Jovan.miles@famu.edu Phone: (850) 599-3301
Brandi Bethune Doctor of Pharmacy Candidate, 2020 Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tallahassee, FL 32307 Email: brandi1.bethune@famu.edu Phone: (334) 669-1108
Michael D. Thompson, PharmD, AAHIVP Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tallahassee, FL 32307 Michael.thompson@famu.edu Phone: (850) 599-3301
Kimberly Mesumbe Doctor of Pharmacy Candidate, 2021 Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tallahassee, FL 32307 Email: kimberly1.mesumbe@famu.edu Phone: (470) 848-0291
FLORIDA PHARMACY TODAY
Key Words HIV, Hispanic-Americans, Hispanic, Latino, Latinx, Antiretroviral therapy (ART), Non-adherence
munication and relationships, medication side effects, and language barriers all account for a rise in antiretroviral medication non-adherence in this population.4
Disclosure The authors of this article report no financial or commercial relationships with any pharmaceutical or medical education companies.
Medication Adherence Maintaining an appropriate therapeutic schedule of antiretroviral medications can be a challenge, which impacts a patient’s adherence to antiretroviral therapy. Adherence to a pharmaceutical drug regimen is generally characterized as the extent to which patients properly take their medications as prescribed by their health care providers5. To achieve optimal efficacy, antiretroviral medication regimens require an extremely high rate of adherence (90-95 percent or better adherence to doses) to achieve an undetectable plasma HIV ribonucleic acid (RNA) level, to suppress the virus, and boost the CD4 cell count for long-term benefits.5 Common reasons associated with non-adherence include forgetfulness (i.e. elderly), priorities, decision to omit doses (self-dosing), lack of information or patient education and emotional factors. Furthermore, social factors, stereotypes, poor family relationships and language barriers that contribute to misunderstanding medication instructions can influence adherence to treatment. 6 Many people with HIV/AIDS may be on regimens that require them to take five or more pills per day at various dosing intervals, which can also contribute to none adherence.6 Additionally, certain types of antiretrovirals (i.e. protease inhibitors), have food restrictions or requirements due to the drug’s mechanism of action that can be burdensome to patients.7
Introduction Since 2006, Hispanic or Latinx Americans have continued to be the leading and fastest growing ethnic minority group in the United States.1 The Hispanic/Latinx community includes people of either Cuban, Mexican, Puerto Rican, South American, Central American or other Spanish culture or origin, regardless of race.1 From 2000 to 2007, they accounted for nearly half of the nation’s population growth.1 As of 2018, there are approximately 59.9 million Hispanics living in the United States. Although they only comprise 18.3 percent of the U.S. population, Hispanics represent about 27 percent of all HIV/AIDS cases nationwide.2 The incidence of new HIV infections within the Hispanic population can be attributed to an influx of immigration, meager access to care, lack of health literacy/education, intravenous drug usage and an increasing number of men who have sex with men (MSM) population.3 Because HIV attacks CD4 cells and depletes the immune system, life-long treatment with highly active antiretroviral medications should be introduced to suppress viral progression and control the activity of the disease. Different factors act as obstacles to treatment adherence in the Hispanic population. There is also a a high level of stigma. Some of these inhibiting factors include cultural stressors that make them more apprehensive to seek or maintain treatment adherence.4 Inadequate social support, quality of patient-provider com-
Social Support The social support network is a vital part to a patient adhering to their medication regimen. Social networks can involve the absence or presence of support from family or friends, certain levels and type of support, satisfaction with
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social functioning, and assessments of support received relative to what is needed.8 The depiction of social support has been identified as a strong and consistent predictor of successful adherence management in those living with HIV/ AIDS.8 A few elements that can improve support are encouragement, information, listening, understanding from family and friends and perceived interpersonal manner and conduct of health care providers.8 There have been instances, however, where those who are single, live alone and have a smaller household were associated with greater adherence. Moreover, satisfaction with support from a partner was associated with medication adherence but that broader support from friends and family was not. Overall, social support is key in achieving and maintaining antiretroviral medication adherence. Patient-Provider Relationship A sound physician-patient relationship is critical to Hispanics learning how to accept and settle into treatment requirements. The strong rapport enables the provider to understand the patient better and establish the necessary lifestyle changes that will promote constant adherence to treatment.9 The engagement between the patient and provider will allow respect to be garnered, access to health care that involves the patient in decision-making (information sharing), and medical support from the provider on the patient’s behalf.10 Hispanics that were engaged in their health care proved to have greater adherence to their medication regimens than those clients who were less engaged and were less likely to follow provider advice.9 Patients with lesser quality relationships with their providers had a deleterious effect on the attitudes of patients, ultimately impeding adherence.10 The patient-provider collaboration can lead to lifestyle-tailored (individualized) regimens that enhance adherence and the patients’ willingness to continue therapy longitudinally.10 10
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Adverse Drug Effects Treatment with antiretrovirals is associated with a number of adverse effects that have short-term and long-term consequences. Adverse effects can include nausea, skin reactions, diarrhea, lipodystrophy, hepatic toxicity, bone marrow suppression, hyperlipidemia, skin problems. These are closely associated with missing antiretroviral medications.11 Women and men are similar in their overall reports of adverse effects, and the Latinx community reports more adverse effects to ARVs than white or African American patients.6 Non-adherence also increased when health care professionals responded negatively to patient complaints about medication side effects.8 When providers dismissed or minimized such side effects, some participants reported discontinuing their regimen.9 When health care professionals reacted in a caring way to their patients’ disclosure of adherence problems and helped them solve such problems, overall the patients’ adherence improved. 10 Language Barrier Communication plays the most prevalent role in how we interact with each other on a daily basis. Language barriers can cause significant problems for patients such as hindering them from communicating with their physician, comprehending medical regimen information and adherence. Spanish-speaking Latinos are significantly more dissatisfied with their medical care because they did not comprehend their physician’s or pharmacy’s instructions that were written in English. Most patients have a difficult time understanding the provider’s medication administration instructions and will, therefore, force the use of a translator. Health care providers may sometimes provide translators, while others complained that they were not readily available or, if available, did not
A SOUND PHYSICIAN-PATIENT RELATIONSHIP IS CRITICAL TO HISPANICS LEARNING HOW TO ACCEPT AND SETTLE INTO TREATMENT REQUIREMENTS. THE STRONG RAPPORT ENABLES THE PROVIDER TO UNDERSTAND THE PATIENT BETTER AND ESTABLISH THE NECESSARY LIFESTYLE CHANGES THAT WILL PROMOTE CONSTANT ADHERENCE TO TREATMENT. translate accurately and adequately enough for principal communication.4 Since health care providers who speak Spanish are scarce, trained translators need to be readily available for HIV-infected Spanish-speaking patients in order to ensure accurate information conveyed to the patient by the provider.9 Because communication between Latinx HIV-positive patients and health care providers is a significant obstacle, understanding and overcoming the linguistic barriers is critical in managing disparities in health care.4 Conclusion In 2017, HIV/AIDS was among the leading causes of death among Hispanic/Latinx men and women aged 25-44.12 Greater acclimation into U.S. culture has both positive and negative effects on the health behaviors of Hispanics/Latinx.3 The countless barriers to ARV therapy adherence that face monolingual HIV patients are the same as those found in non-Latinx/Hispanic English-speaking patients.4 The management of medication adherence is more complex by the thought of multiple, overlapping factors that impact adherence. In providing social support, loved ones can remind those infected to take their medication, take command of the dosing interval and offer appropriate nutritional support by providing meals. Emotional or informational support from friends and family, quality of patient-provider relationships, side effects of antiretroviral medications and communications barriers are noteworthy in regard to adherence behaviors in Spanish-speaking Latinos receiving antiretroviral medications.4 A focus on enhancing health literacy and maximizing communications with health care providers is particularly essential in those communities where HIV infection rates are increasing, affecting individuals’ ability to adapt to rigorous medication therapy plans and regimens.9 However, to develop appropriate intervention programs for HIV-infected patients, the barriers to adherence must be understood and curtailed.5 In all, empowering patients to take ownership of their therapy can significantly improve medication adherence among Hispanic-Americans and will inevitably benefit the fight in this epidemic. References
1. Bureau USC. Hispanic Heritage Month 2019. The United States Census Bureau. https://www.census.gov/newsroom/factsfor-features/2019/hispanic-heritage-month.html. Published October 9, 2019. Accessed July 21, 2020. 2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2018 (Updated); vol.31. http://www.cdc.gov/hiv/ library/reports/hiv-surveillance.html. Published May 2020.
Accessed July 21, 2020. 3. Espinoza L, Hall HI, Hu X. Increases in HIV Diagnoses at the U.S.-Mexico Border, 2003-2006. AIDS Education and Prevention. 2009;21 (Suppl B): 19-33. 4. Murphy DA, Roberts KJ, Hoffman D, Molina A, Lu MC. Barriers and successful strategies to antiretroviral adherence among HIV-infected monolingual Spanishspeaking patients. AIDS Care. 2003;15(2):217-230. doi:10.1080/0954012031000068362 5. Cardarelli R, Weis S, Adams E, et al. General health status and adherence to antiretroviral therapy. J Int Assoc Physicians AIDS Care (Chic). 2008;7(3):123-129. doi:10.1177/1545109708318526 6. Berg KM, Demas PA, Howard AA, Schoenbaum EE, Gourevitch MN, Arnsten JH. Gender differences in factors associated with adherence to antiretroviral therapy. J Gen Intern Med. 2004;19(11):1111-1117. doi:10.1111/j.15251497.2004.30445x 7. Demmer C. Attitudes toward HIV protease inhibitors and medication adherence in an inner city HIV population. AIDS Patient Care STDS. 2003;17(11):575-580. doi:10.1089/108729103322555962 8. Power, R., Koopman, C., Volk, J., Israilski, D. M., Stone, L., Chesney, M. A., et al. (2003). Social support, substance use, and denial in relationship to antiretroviral treatment adherence among HIV-infected persons. AIDS Patient Care and STDS, 17, 245-252. 9. Effects of a treatment adherence enhancement program on health literacy, patient-provider relationships, and adherence to HAART among low-income HIV-positive Spanish-speaking Latinos. AIDS Patient Care STDS. 2005;19(11):745-759. doi:10.1089/apc.2005.19.745 10. Schneider, J., Kaplan, S. H., Greenfield, S., Li, W., & Wilson, I. B. (2004). Better physician patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. Journal of General Internal Medicine, 19, 1096-1103. 11. Johnson MO, Charlebois E, Morin SF, et al. Perceived adverse effects of antiretroviral therapy. Journal of pain and symptom management. 2005;29(2):193–205 12. Heron M. Deaths: Leading causes for 2017. National Vital Statistics Reports; vol 68 no 6. Hyattsville, MD: National Center for Health Statistics. 2019. 13. Rachel Power, Cheryl Koopman, Jonathan Volk, Dennis M. Israelski, Louisa Stone, Margaret A. Chesney, and David Spiegel. AIDS Patient Care and STDs. May 2003.245-252. http://doi.org/10.1089/108729103321655890 14. Priest JL, Burton T, Blauer-Peterson C, Andrade K, Oglesby A. Clinical characteristics and treatment patterns among US patients with HIV. Am J Manag Care. 2019;25(12):580-586.
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October is American Pharmacists Month The American Pharmacists Association celebrates the accomplishments of pharmacists year-round, but it launched American Pharmacists Month in 2004 to recognize pharmacists’ contributions to health care and all they do for their communities. While the whole month is dedicated to pharmacists, there are two special days. National Women Pharmacists Day is Oct. 12 and #RxTechDay is Oct. 15.
Community Activities Here are some things you can do to promote American Pharmacists Month in your community. ■ Get a proclamation from your legislator designating October as American Pharmacists Month. While you’re at it, host a visit for your legislator and give them a full view of the contemporary roles of pharmacists. ■ Engage the public and increase your visibility. Make sure everyone knows about pharmacists’ contributions to health care. ■ Create a medication information and education display for your local library, YMCA or other suitable community site. ■ Promote health and wellness in your community by hosting vaccination clinics, medication check-ups and disease screenings. ■ Give educational talks and presentations to civic, neighborhood and church groups. Consider distributing patient education brochures and small giveaways. ■ Conduct OTC tours geared to the needs of a group, like parents of young children, older adults, athletes and others. Help each group understand how to select appropriate products for conditions most likely to affect them. Emphasize the importance of reading product labels, knowing the active ingredients in certain medications and consulting the pharmacist when questions arise. ■ Provide Medicare counseling to seniors in your community. List your event in the local newspaper or send the information to a television or radio station. 12
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Schools and Colleges of Pharmacy ■ Coordinate patient care and community outreach projects such as free health screenings that offer medication checkups or consider other community education events for area businesses and civic organizations. ■ Connect with your state pharmacy associations. Look for ways to participate and make suggestions for additional events. ■ Hold a celebratory lunch for student pharmacists. Invite an honored local practitioner to discuss the importance of leadership and professionalism in pharmacy. Find more information at the American Pharmacists Month website at pharmacistsmonth.com.
Florida Pharmacy Today is accepting original submissions of 1,500-2,600 words for the peer review process. You may wish to contact the editor, Dave Fiore, at dave@fiorecommunications.com regarding topic.
FDA’s Bad Ad Program Teaches Providers to Look for Misleading Advertising Source: FDA
Health care providers are bombarded with prescription drug promotions and information. The Bad Ad Program is designed to help providers recognize potentially false or misleading prescription drug promotion. It’s run by the FDA’s Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research. The program also offers continuing education courses to help providers recognize potentially false or misleading prescription drug information. The Bad Ad Course is a one hour, self-paced training that includes modules on the program itself, the science of influence, oversight of prescription drug promotion, common prescription drug promotion issues, real life scenarios and reporting issues.
Bad Ads Case Studies are based on actual warning and untitled letters issued by the ODPD to companies regarding alleged false or misleading prescription drug promotion. These case studies include alleged violative promotional material, the warning or untitled letter issued, prescribing information, and a facilitator guide that can be used to lead group discussion. To report potentially false or misleading prescription drug promotion, email BadAd@fda.gov or call (855) RX-BADAD. You can also write the program at Bad Ad Program, FDA/ CDER/OPDP, 5901-B Ammendale Road, Beltsville MD 207051266.
News in Brief from the FPA Board Recommends HB389 Rules The Florida Board of Pharmacy Rules Committee and full board met to review and recommend for adoption of draft rules related to HB389. This legislation, signed into law by Gov. Ron DeSantis, allows pharmacists to initiate, modify or discontinue prescription drug therapy for patients with certain chronic diseases in collaboration with licensed Florida physicians. The legislation also allows pharmacists to test and treat patients with certain non-chronic conditions. The draft rules require 20 hours of certificate training for chronic diseases and 20 hours for non-chronic conditions. Eight hours of that training must be in a live or a live video teleconference. A new chapter is being created that helps to implement HB389. Rules are being developed under 64B16-31. Find a Vaccine with Website The VaccineFinder website helps people find providers who offer seasonal influenza vaccination and routine adult and child vaccination (www.vaccinefinder.org). VaccineFinder relies on partnerships with vaccination
providers to report accurate and up-to-date information about vaccination services. The HealthMap Computational Epidemiology Lab maintains VaccineFinder in partnership with the Center for Disease Control and Prevention. VaccineFinder’s goal is to make it simple for people to find a nearby location to receive a vaccination. Pharmacies should consider registering on this site. DHHS Moves to Expand Immunizations Last month, The Department of Health and Human Services announced as a declaration under the Public Readiness and Emergency Preparedness Act to expand immunization services for children. This included working to allow pharmacists to provide these services. More 22 states allow pharmacists to immunize children, however Florida laws do not permit this. While we believe that this action by HHS supersedes state laws, we are in communication with the Department of Health to clarify that Florida pharmacists can provide these services. HHS has provided a toolkit that can be used to advocate for childhood vaccinations. SEPTEMBER 2020
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3 Barriers to Effective Patient Counseling in the Community Pharmacy Setting By: Leeandrea Jones, Pharm.D. Candidate 2021
The profession of pharmacy is in the midst of significant transitions. It is possible that, over the next few years, the traditional community pharmacist will become extinct due to numerous factors. The growth of internet pharmacies, along with advances in technology, poses possible threats to the profession. With the large use Leeandrea Jones of technology in pharmacies, including electronic patient profiles, electronic pill counters, robotic prescription filling and more, one may question the need for pharmacists today. The answer to that question is simple. Although technological advances aid pharmacists in numerous ways and provide many benefits to the profession, it simply cannot replace the personalized relationship and trust that is built between a pharmacist and patient during a face-to-face consultation. Throughout my didactic portion of pharmacy school, the importance of patient counseling was drilled into the heads of my classmates and I. We are trained to understand and know that this is one of the most important duties of a pharmacist. What good is it to dispense the appropriate inhaler to manage a patient’s asthma if he or she is unclear on how 14
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to use it correctly, right? Pharmacists have the ability to directly affect patient health outcomes by providing education on medication and encouraging compliance to therapy. This process not only helps avoid medication errors but also improves health outcomes and the patient satisfaction. During my introductory pharmacy practice experiences and advanced pharmacy practice experiences community rotations, I was surprised to observe how difficult it was for pharmacists to provide quality medication counseling to patients. I had been informed that the community pharmacy setting was extremely fast paced and busy, but did not come to terms with what that truly meant until I was in the midst of what felt like organized chaos. There are numerous barriers that prevent pharmacists from providing quality patient counseling, some more difficult to overcome than others. The following three barriers pose as potential challenges, but can provide great satisfaction if overcame. Embarrassed Patients When it comes to managing a patient’s health, there are numerous reasons a patient may feel embarrassed. Whether it is a young woman receiving medication for a sexually transmitted disease, an elderly man receiving medication for erec-
tile dysfunction or any other similar scenario, the last thing certain patients would like to do is discuss their medication and particular situation with a pharmacist. Embarrassment can keep a patient from seeking medical treatment and proper advisement on their condition or medication. In certain situations, some patients may have questions about their therapy, but feel the question is silly or is uncomfortable interrupting a busy pharmacist or technician. Making the first move by asking if they have any questions in regards to their medication or simply expressing your willingness to discuss the patient’s therapy with them can go a long way. In addition, having a designated area in the pharmacy where private consultations are held can possibly put the patient’s anxiety at ease. This area should provide enough privacy that allows patients to speak openly without fear of being interrupted or overheard. Pharmacists should also display empathy when providing patient counseling. It is important to reassure patients that they should not feel embarrassed and you are here to help. Constant Multitasking In the community pharmacy setting, it can be easy for pharmacists and staff members to feel overwhelmed. Between processing and dispensing prescriptions, checking the phone for voicemails, assisting with the front desk and drive through, managing the staff, performing immunizations and so many other tasks, there is barely enough time for the pharmacist to take a five-minute restroom break, let alone spend time with a patient to counsel on the correct use of their medication. When the pharmacy grows overwhelmingly busy, it is important for pharmacists to remember that they are a part of a team. In many cases, the productivity in a work day is largely dependent on how smoothly the team operates. Effective delegation is crucial when working in a busy pharmacy. It reduces the workload on the pharmacist, providing the opportunity to spend more time counseling patients, while also providing your employees with more responsibility, showing that you trust them. In addition, recognizing and utilizing the skills and strengths of your employees fosters an environment where the best of everyone is given. These changes will be extremely important when new Board of Pharmacy rules take effect that allow pharmacists to manage chronic and non-chronic diseases. When that happens, expect the role of the pharmacist to be significantly increase in patient care. Performance Metrics Many pharmacists working for large chain pharmacies complain about the struggles to meet corporate pharmacy metrics while performing the many task required of a pharmacist. According to a New York Times article, large chain pharmacy companies were found to be aggressive in imposing performance metrics while simultaneously attaching bonuses to achieving them.1 Nearly every task performed in the pharmacy is tracked, analyzed and used to evaluate employ-
ees. This includes phone calls to patients, phone hold time, how often a pharmacist makes a correction to a prescription a technician entered, the time it takes to fill a prescription, the number of vaccines administered, the number of customers signing up for 90-day supplies of medication, to name a few. While representatives from large chain pharmacies may argue that performance metrics are in place to enhance patient care, one can argue that metrics place unnecessary pressure on pharmacy staff that can jeopardize patient care. In addition, the continuous downsizing of staff has contributed to chaotic work environments. Pharmacists should never feel forced to choose between meeting certain standards or targets over taking the time to provide quality counseling to a patient. It is imperative to remember that productivity and profit does not come before patient care. Ensuring patient safety, providing education and advocating for patients must remain a top priority that should not be jeopardized by meeting certain performance metrics. While it is not uncommon for patients to look up information regarding their medication on the internet or read the information listed on the package label, these practices may not be enough for patients to fully understand their therapy. A patient’s knowledge of why they are taking their medications and the consequences of nonadherence is critical to achieving the best possible health outcomes. Barriers to providing quality patient counseling can pose as potential threats to a patient’s health and safety. The lack of time available to spend with patients along with an environment that fuels the possibility of medication errors is frightening. One of the main responsibilities of a pharmacist is to ensure a patient’s safety and wellness. It is incredibly difficult for an overworked, distracted pharmacist to fulfill this responsibility in a chaotic environment that places meeting certain performance metrics above anything else. Pharmacists must collectively advocate for the well-being of themselves and their patients, without fear of being ignored or replaced by someone who is willing to work in a dangerous environment for less pay. Change will not come from being quiet or complacent. By identifying potential barriers to providing quality medication counseling to patients, strategies can be implemented to overcome them, leading to better patient health outcomes. It is recognized that in the world of business and industry that productivity, efficiency and proficiency are critical to the profitability of services provided. These principles are expected in the production of tangible products. These general core business measures should not be a substitute for quality, safety and best practices in the provision of patient care. References:
1. 1. Gabler, E., 2020. How Chaos At Chain Pharmacies Is Putting Patients At Risk. [online] Nytimes.com. Available at: <https:// www.nytimes.com/2020/01/31/health/pharmacistsmedication-errors.html> [Accessed 22 September 2020].
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Feds Issue Guidance on COVID-19 Vaccines Source: U.S. Department of Health and Human Services
The Department of Health and Human Services authorized state-licensed pharmacists to order and administer COVID-19 vaccines when they become available. The guidance, issued Sept. 9 under the Public Readiness and Emergency Preparedness Act, also authorizes pharmacy interns to administer the vaccines when supervised by a qualified pharmacist. “This action builds upon our Administration’s progress toward delivering a safe, effective, and widely available vaccine by 2021,” said Assistant Secretary for Health ADM Brett P. Giroir, M.D. “Allowing pharmacists to order and administer COVID-19 vaccines will greatly expand convenient access for the American people.” Pharmacists and interns can administer the vaccines to people over the age of 3, subject to certain requirements. ■ The vaccine administered must be FDA-authorized or FDA-licensed. ■ The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ COVID-19 vaccine recommendation. ■ The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education, including hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions. 16
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Pharmacy interns must complete an ACPE-approved practical training program. The licensed pharmacist and pharmacy intern must have a current basic CPR certificate. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements for their jurisdiction, including reviewing the vaccine registry or other records prior to administering a vaccine. The licensed pharmacist must, if the patient is 18 or younger, inform the patient and their adult caregiver of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. The licensed pharmacist or intern must comply with requirements or conditions of use as set forth in the Centers for Disease Control and Prevention COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccines.
Acella Issues Voluntary Recall of Two Lots of Thyroid Medication Source: FDA
RECALL Acella Pharmaceuticals announced Sept. 17 that it was voluntarily recalling one lot of 15mg and one lot of 120mg NP Thyroid, Thyroid Tablets, USP (levothyroxine, T4, and liothyronine, T3). These products are packed in 100-count bottles. Testing has found these lots to be subpotent. Patients being treated for hypothyroidism who receive the subpotent medication may experience signs and symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland or unexplained weight gain or difficulty losing weight. There is a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism, including early miscarriage, fetal hyperthyroidism or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism my occur. ■ ■
Patients who are taking NP Thyroid from the recalled lots should not discontinue use without contacting their health care provider for guidance. Consumers with questions can email Acella at recall@acellapharma.com or call (888) 2802044, Monday-Friday, 8 a.m. to 5 p.m. Eastern. If consumers are experiencing any problems with these drugs, they should contact their health care provider. Report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program.
Affected NDCs, lot numbers and expiration dates are: NP Thyroid 15, Thyroid Tablets, USP, ¼ grain (15mg): NDC 42192-327-01. Lot M327E19-1. Expires October 2020. NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120mg): NDC 42192-328-01. Lot M328F19-3. Expires November 2020.
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Pharmacists: Visible and Yet Invisible By William Garst, Consultant Pharmacist Pharmacists are the most visible and accessible health professionals. We see them every day in community pharmacies filling prescriptions, counseling patients about prescription and over-the-counter medications, administering immunizations, conferring with providers and working with insurance companies on the patient’s behalf. They William Garst are very approachable when questions need to be answered, and all this without an appointment. However, pharmacists are also involved in health care in ways not as visible as in community pharmacies. Pharmacists are an integral part of hospital care. Did you know that every order a provider writes for an patient in the hospital must be verified by a pharmacist, as appropriate? This involves checking allergies, drug interactions, routes of administration and appropriateness per guidelines for therapy. The pharmacist sometimes must make arrangements for the delivery of unique medications in special situations. For instance, if a patient has a rare blood disorder and a particular medication needs to be obtained, the pharmacist will make the arrangements for shipping and delivery. In addition to these activities, pharmacists also monitor storage conditions for all the medications in the hospital, especially the refrigerated medications or the ones that need to remain frozen. When temperatures are out of range, the pharmacist is responsible for relocating the medications to proper storage conditions. Another important function of the pharmacist is the monitoring of controlled drug usage. The pharmacist must be involved in resolving discrepancies when they occur, in the number of doses of a controlled drug that are supposed to be on the unit and what is actually on the unit. All discrepancies must be resolved to make sure that controlled substances are not being diverted. When discrepancies are not resolved, the pharmacist must report these occurrences to the hospital administration for further investigation. Hospital pharmacists are involved in a process called medication reconciliation. When a patient is admitted to a hospital, the patient’s medication list needs to be clarified and double-checked to make sure the list is appropriate and accurate. This same procedure is done when a patient is discharged from a hospital. Patients are given a list of their medication regimen and told of any changes that have been made. They are made aware of any new medications added to their regimen and any changes in dosage. The patient is told to take this list to their primary care provider. May I add here that this list should be shown to the community pharmacist, so they know of the changes that have been made. Monitoring laboratory results of patients taking medications that affect their blood coagulation or blood sugars is an18
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other important function of the pharmacist. They ensure the results are acted on if the laboratory results are out of range. Another of the more important functions of pharmacists in hospitals in the monitoring of antibiotic usage, called antibiotic stewardship. In fact, some large hospitals have pharmacists dedicated to monitoring antibiotic usage and conferring with providers on the most appropriate antibiotic therapy. This pharmacist, called an infectious disease pharmacist, reviews laboratory results of antibiotic levels and recommends dosage adjustments. Also, large hospitals have pharmacists dedicated to the oncology unit, who are responsible for the correct ordering and preparation of the oncology regimen medications and scheduling. In addition, the pharmacist monitors the oncology patient’s laboratory values because oncology therapy can affect a patient’s blood values, and alerts the provider when values are out of range. Many emergency departments have pharmacists dedicated to their service to assist in the management of patients. These pharmacists participate in cardio-pulmonary resuscitation and assist in complicated medication management issues in emergency departments. In addition to the role’s pharmacists play in hospital care, there are a few more that need mentioning. They are very much involved with patients who need parenteral nutrition, which is given to patients who cannot use their gastrointestinal tract for a period of time and must be fed intravenously. Another area that is emerging is the appropriate management of pain in hospital patients, so pain is addressed and the risk of addiction is lowered. Of course, the pharmacist is still responsible for the medication distribution system that involves correct charging for medications, timely delivery to nursing units and the compounding of sterile products for intravenous administration.
“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”
WE ARE. We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. Our Pharmacy Quality Commitment (PQC) program: • • • •
Helps you implement and maintain a continuous quality improvement program Offers federal protection for your patient safety data and your quality improvement work Assists with quality assurance requirements found in network contracts, Medicare Part D, and state regulations Provides tools, training and support to keep your pharmacy running efficiently and your patients safe
Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION SEPTEMBER 2020
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Pharmacy Insurance
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