FDA approves a generic drug as substitutable with the originator drug if it has proven to be ‘identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use’. FDA list approved generics in its Orange Book. Although approved generics have been demonstrated to have therapeutic equivalence some clinicians have questioned whether that equivalence extends to all patients and all clinical scenarios.

Figure 1: Pharmacist and prescriber opinions on generics

The author asked readers of Medscape to participate in a survey describing their experience with generics and their opinions on the appropriateness of their use.

Substitution
The results of the survey showed that over 80% of pharmacists who responded had been required to make a substitution for a generic drug. Only 28% reported, however, that they had an obligation to notify the prescriber of the substitution.

One pharmacist commented that a change from a brand-name drug to a generic drug was as often made because of patient requests as because of insurance requirements, with patients citing higher out-of-pocket costs for brand-name medications.

Safety
When questioned on the safety and effectiveness of generics most pharmacists (85%) agreed that they were as safe and effective as their brand-name counterparts. In contrast, only 55% of prescribers agreed. While over a quarter (27%) of prescribers thought that generics were not as safe and effective as their brand-name counterparts, only 5% of pharmacists believed this.

Cost
Most (80%) of the pharmacists surveyed agreed that generic drugs probably save money or reduce expenditures when they are used. However, 10% disagreed and 10% voiced no opinion.

Liability
Potential liability with the use of generics is a concern that has been expressed by both pharmacists and clinicians. In this survey, when clinicians were asked whether they believed that allowing the use of generic drugs for their patients increased their legal liability, opinions were split. Just over half (56%) of respondents did not feel at increased risk of liability, while a small percentage (12%) were concerned about increased legal liability. Almost a third (31%) of clinicians questioned had no opinion on whether prescribing generics increased their legal liability or not.

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