New ACP Guideline Regarding Generic Drugs

Last week, The American College of Physicians released a new guideline addressing the use of generic medications.  The authors addressed 5 questions: 1) How commonly are brand-name medications used when a generic version is available? 2) How does the use of generic medications influence adherence?  3) What is the evidence that brand-name and generic medications have similar clinical effects? 4) What are the barriers to increasing the use of generic medications? 5) What strategies can be used to promote cost savings through greater generic medication use?

In response to the first question, the committee looked at several studies of Medicare beneficiaries which revealed that from one-fourth to more than one-third of the time, such patients were receiving brand-name drugs when identical generic versions were available.  It was recognized that in the VA system, with its central formulary, there is a much greater use of generics. However, it is also notable that physicians frequently choose newer, more expensive medications when older, similarly effective medications could be chosen – even when guidelines support the use of the less expensive drug – and that changing this behavior might result in greater savings than using identical generics.

Regarding adherence, there is evidence that use of generics is associated with greater adherence.  By extension, this would be expected to lead to cost savings because downstream costs are lower when adherence is higher.  The data is mainly observational; it is unlikely a randomized controlled trial will ever be done.

A long-standing concern has been that generics could be therapeutically inferior to their brand-name counterparts.  The FDA only requires bioequivalence, which is determined by looking at pharmacological parameters rather than therapeutic outcomes.  The debate over thyroid hormone is probably the best known controversy in this regard.  The committee reviewed evidence showing that, with a few exceptions, there is no reason to suspect inferior therapeutic performance.

Barriers to greater use of generics are discussed.  Most of the discussion centers on provider and patient preferences, driven by perceptions of efficacy or safety.  Some states prohibit automatic generic substitution, so the fact that providers often refer to medications, with available generics, by the trade name results in more brand-name prescriptions.  There is a brief discussion of the link between physician acceptance of industry gifts and likelihood of reporting the use of brand-names at a patient’s request.

The paper concludes by listing strategies for promoting more use of generics, which will be expected to result in cost savings.  Provider-level strategies include EMRs that provide formulary status of medications in CPOE and academic detailing (see my last blog post for a reference to this); it has not been determined if “gift bans” will positively affect prescribing behavior.  Patient-level interventions, such as education campaigns, have not been well-studied.  At the payer level, payment reform is expected to have the most dramatic impact on use of generics as a cost-containment strategy.

The recommended “best practice advice” is that clinicians should prescribe generic medications, if possible, rather than more expensive brand-name medications.  There is a table that summarizes the advice and opportunities to implement the strategy.  I urge you to review the guideline.

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