FDA outlines details of surveys into physical differences in generics

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FDA outlines details of surveys into physical differences in generics

INICIO/Directrices | Posted 26/06/2015 0 Post your comment

The US Food and Drug Administration (FDA) in a Federal Register notice published on 14 May 2015 has outlined how it will carry out pharmacist and patient surveys into how changes in the physical characteristics of generics pills affect patients’ perceptions.

While generics are required to be pharmaceutically equivalent and bioequivalent to the brand-name drug, generics made by different manufacturers may differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance, e.g. colour, shape or size of pills.

Since patients may receive generics from different manufacturers when refilling their prescriptions, FDA is concerned that changes in the appearance of their drugs may cause ‘patient confusion and concerns about the safety and effectiveness’ of the generics.

The agency is therefore carrying out a national survey of pharmacists about their experiences with dispensing generics pills that differ in appearance from previous refills of the same medication and dosage level, e.g. when pharmacies switch generic suppliers.

FDA will send out 2,161 questionnaires to pharmacists in order to obtain the 1,000 responses required for adequate statistical power. The pharmacists will be asked about the frequency with which their pharmacy changes suppliers that lead to variations in the appearance of the generic drugs that they dispense, as well as strategies they use with patients to address the transition to pills that have a different appearance, e.g. alert stickers on pill bottles, verbal warnings and other strategies. They will also be asked about patient responses to changes in pill appearance, including what types of appearance changes seem to affect patients most often (shape/colour/size), how often patients report confusion about pill appearance, and how often patients ultimately refuse to accept the new product.

FDA will also survey patients using two different methodologies. The first is a telephone survey of patients who are 50 years and older and who take one or more generics for at least one of the following chronic conditions: epilepsy, diabetes, hypertension, hyperlipidaemia, depression and HIV.

For the second patient survey, patients will be selected from a proprietary research database of commercially insured patients containing medical and pharmacy claims linked to health insurance enrolment information. A nationally representative sample of patients with at least one chronic condition and who experienced a change in physical appearance of a generic pill will be identified by the research team using medical and pharmacy claims data.

Both patient surveys will consist of questions covering topics similar to those asked in the survey of pharmacists and is intended to provide answers to the same topic areas from patients’ perspectives. As before, topic areas will include beliefs about generic drugs, outcomes related to changes in generics pill appearance, and strategies used by pharmacists or doctors to alert patients to the possibility of changes in appearance.

The results from the surveys are intended to provide additional information that may help guide regulatory policy or pharmacy business practices. FDA published its draft guidance for industry on the size, shape and other physical attributes of generics for comment in December 2013 [1].

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: Federal Register, FDA