Drugs

Doctors, Health Systems Should Test Generics: Article

Physicians and health systems can take steps to identify substandard generic medicines and minimize the risk to patients from them. That’s the view of two authors of a Health Affairs article.

“Because generic drugs sold in the U.S. must be FDA-approved,” the authors write, “healthcare providers and patients assume that they are safe and effective. There is growing evidence that this confidence may be misplaced. In fact, quality issues are the precipitating factor in more than 60% of generic drug shortages.”

The article describes several of the generic drug quality and safety issues that have arisen in the last few years and the impact globalization of generic drug production has had on FDA’s ability to protect the public.

The authors say that America is highly reliant on other countries for its generic drugs and the ingredients and raw materials needed to make them. “Unfortunately,” they say, “offshoring generic drug production made FDA plant inspections more difficult, particularly in India and China.”

The paper suggests three steps doctors and health systems can take to minimize the risk to patients:

if patients say their generic drug is not working properly, doctors should not dismiss the concern;
promptly reporting patient complaints to FDA’s MedWatch program may reveal patterns that indicate a problem; and
rather than wait for FDA and Congress to act, health systems can do batch testing to assess the quality of some of their generic drugs.

“Testing generic drugs to confirm that they contain the appropriate amount of active pharmaceutical ingredient, dissolve at the proper rate, and are contaminant-free would be worth the modest cost,” the authors conclude. “Focusing on drug quality as well as price might even bring a larger share of production closer to home, where FDA can rigorously inspect facilities. This could reduce the risk of drug shortages.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

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