Expired drugs: To take or not to take

Abstract

Expiry dates on the medications and vitamins are a conservative estimate by the manufacturers to ensure quality, say some studies. In many instances, medicines past their expiry date are safe but may not be as effective or potent SHOULD we discard all medicines from our home medicine kit that have passed their expiry date and replace them? If someone is administered an expired medicine, is he/ she going to suffer a serious side effect? If someone is having a sudden and severe neck or back pain during midnight, and the only painkiller available in the medicine kit is past its expiry date, should the patient take it or keep on suffering? Most of us may have faced these dilemmas at one time or other. But the question is that what happens to the potency and safety of the drugs that have passed their expiry dates. The website of Harvard Medical School (HMS) Family Health Guide says that the expiration dates on the medications and vitamins are a conservative estimate by the manufacturers to ensure quality. In most instances, expired medications are safe but may not be as effective or potent once past their expiry date. FDA ruling Before 1979, it was not mandatory for drug manufacturers to mention the expiration date on the products. For the first time in 1979, the Food and Drug Administration (FDA), US, made it necessary under the law for all drug manufacturers to mention the date up to which the full potency and safety of the drug was certified. This resulted into the start of a new era of discarding drugs that had passed the date of expiry mentioned on their packing. Thus it caused huge losses to the bulk purchasers of the drugs, especially in government health departments and the US Army, forcing them to replace the unused expired drugs with a fresh stock. In 1985, this loss was noticed by the US Army authorities when they were faced with the task of destroying and replacing the stockpiled expired drugs worth more than a billion dollars. This triggered the process of testing the efficacy and safety of the expired drugs. The task of testing was assigned to the FDA by the US Army. Accordingly, the FDA tested more than a hundred prescriptions and over-the-counter medications and observed that 90 per cent of the expired drugs were still safe and potent; the oldest drug tested had expired 15 years back at the time of testing. The study pointed out that the expiry date did not really indicate a point at which the medication was no longer effective or had become unsafe to use. This report was published in the Wall Street Journal (March 29, 2000), which was reported by Laurie P. Cohen. At present, there is a programme being run jointly by the Department of Defence and the FDA, US, known as "Shelf Life Extension Program" (SLEP) that is meant to defer drug replacement costs for date-sensitive stockpiles of