December 2014, Vol 2, No 6 - The First Word
Donald J. Dietz, RPh, MS

The US Food and Drug Administration (FDA) is preparing to survey pharmacists and patients on variations in the physical characteristics of generic drugs and patient perceptions. This is important to retail pharmacy, since approximately 85% of all prescriptions dispensed are generic medications.1

When a generic drug is dispensed as a substitute for a brand medication, it is pharmaceutically equivalent (ie, same active ingredient, strength, dosage form, and route of administration) and bioequivalent. The FDA Orange Book assigns “A” ratings to products that are pharmaceutically equivalent, bioequivalent, and that can be substituted.2

Although the FDA validates bioequivalence of pharmaceutically equivalent products to determine the A rating, the physical appearance such as color, shape, or size of the tablet or capsule may vary. The concern is that changing the drug product appearance could lead to patient confusion and concern about product safety and efficacy.3

Supporting Evidence
A recent study has shown that patients are more likely to stop taking a generic medication when the physical appearance of the drug product changes, which can have a negative impact on patients’ health and lead to an increase in overall healthcare costs.4 In the study, which was published in Annals of Internal Medicine, Aaron S. Kesselheim, MD, JD, MPH, Associate Professor of Medicine at Harvard Medical School, Boston, MA, and colleagues followed patients who were discharged after myocardial infarction. The study evaluated patients between 2006 and 2011 treated with a generic β-blocker, angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or statin, and found that the odds of nonpersistence increased by 34% after a change in pill color, and 66% after a change in pill shape.

The survey of pharmacists and patients on the variations in the physical characteristics of generic drug pills and patients’ perceptions conducted by the FDA may enable them to investigate factors that explain the association between changes in pill appearance and nonadherence, including which factors could be modified to improve the safe and effective use of generic drugs.5

The Pharmacist’s Role
What can retail pharmacists do with this information? If you are one of the 2100 pharmacists who receive the survey, taking the time to complete and return it will help provide additional insight into the issue.

There has been an increasing trend of generic product shortages, price changes, and suppliers exiting the market that lead to changes in suppliers at retail pharmacies. Although the Kesselheim study was conducted from 2006 to 2011, I suspect the challenge of tablet and capsule color, shape, and size variations has increased in the past 3 years. If, as a pharmacist, your role involves choosing the generic drugs purchased at your pharmacy, continuity in pill characteristics may become a more important consideration if you have a choice in suppliers and there is minimal variation in purchase price.

When dispensing pharmacists encounter a change in the generic supplier of a product for a prescription refill, they follow their pharmacy guidelines for documenting the change in the pharmacy dispensing system. They also apply an auxiliary label to the vial, alerting the patient that the shape and/or color of the vial contents have changed, but the product is the same as previously received. This has been the baseline standard of practice for decades.

Flagging prescriptions with product appearance changes on the outside of the prescription bag is a simple solution to alert the technician or cashier that a pharmacist would like to explain changes in product color/shape to the patient or caregiver. Based on the study findings, it is important for pharmacists to personally counsel the patient or caregiver at prescription pickup that the prescription product appearance has changed, but that it is the same item as prescribed.

Although it will most likely be months before the FDA survey results are released, taking steps in your pharmacy to better communicate to patients when a change in product shape, size, or color occurs is a proactive, positive step that fosters patient engagement and may help increase patients remaining on the prescribed medication.

As always, I am interested in your views, and you can reach me at This email address is being protected from spambots. You need JavaScript enabled to view it..




References
  1. Fischer MA, Choudhry NK, Brill G, et al. Trouble getting started: predictors of primary medication nonadherence. Am J Med. 2011;124:1081. e9-22.
  2. US Food and Drug Administration. Orange Book preface. www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm. Updated March 14, 2014. Accessed November 15, 2014.
  3. US Department of Health & Human Services, US Food and Drug Administration, US Center for Drug Evaluation and Research. Guidance for industry: size, shape, and other physical attributes of generic tablets and capsules. www.fda.gov/downloads/drugs/guidancecompli anceregulatoryinformation/guidances/ucm377938.pdf. Published December 2013. Accessed November 15, 2014.
  4. Kesselheim A, Katsiaryna B, Jerry A, et al. Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case–control studies. Ann Intern Med. 2014;161:96-103.
  5. Federal Register. Agency information collection activities: proposed collection; comment request; survey of pharmacists and patients; variations in the physical characteristics of generic drug pills and patients’ perceptions. www.federalregister.gov/articles/2014/10/15/2014-24365/agency-information-collection-activities-proposed- collection-comment-request-survey-of-pharmacists. Published October 15, 2014. Accessed November 15, 2014.
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