Increasing Support For Generic Drugs And Therapeutic Substitution

–But some physicians, perhaps influenced by industry, remain skeptical.

Generic drugs and therapeutic substitution (replacing a drug without a generic equivalent with a different but closely related drug in the same general class) are two key ingredients in most recipes to hold down health care costs. Now a package of articles and commentary in JAMA Internal Medicine highlights the considerable progress and remaining weaknesses in this crucially important area.

One study found that therapeutic substitution could have saved as much as $73 billion between 2010 and 2012. The cost to patients in out-of-pocket expenses was $25 billion. The investigators found that the biggest excess costs occurred with statins, atypical antipsychotics, proton pump inhibitors, SSRIs, and ACE inhibitors.

In an accompanying editorial Joe Ross (Yale University) notes that in some cases there may be good reasons to use a branded drug. However, “drug companies often market their new brand-name medications as having special benefits over existing competitors, even when these benefits have not been substantiated in randomized clinical trials.”

In a second paper researchers surveyed physicians and found broad but by no means universal acceptance of generic drugs. 91% agreed that Americans spend too much money on prescription drugs and 85% said generic drugs should be used more often. But about 10% expressed concerns that generic drugs were not as effective or safe as brand name drugs. Physicians were more likely to be skeptical about generics if they learned about a new generic drug from a pharmaceutical sales representative. Another study found that as physicians received more money from industry they were more likely to prescribe a brand-name statin instead of a generic statin.

In an accompanying editorial, Joshua Sharfstein and Jeremy Greene write that generic drugs today account for 88% of all prescriptions filled in pharmacies and “have assumed a central role in the delivery of high-quality, low-cost health care.”

The JAMA Internal Medicine articles, they write, “underscore the importance of affirmatively teaching clinicians and patients about the history and structure of the generic industry, the meaning of bioequivalence standards, and the current availability of generic drugs. Physicians and other prescribers should understand, for example, that patients are more likely to take a generic medication that they can afford compared with a me-too medication that offers no additional benefit.”

One way to increase the rate of prescribing for generics is to make it easier to do so on electronic health records (EHR). Yet another study in JAMA Internal Medicine reported a 23% increase in the generic prescribing rate simply by changing the defaults in the EHR. Importantly, in the case of levothyroxine, where there is a legitimate question about generic equivalence, the opt-out rate for a generic was significantly higher than for other drugs.

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