Expiry date
The 2015 commentary in Mayo Clinic Proceedings, “Extending Shelf Life Just Makes Sense,” suggested that drug makers could be required to set a preliminary expiration date and then update it after long-term testing. An independent organization could also do testing similar to that done by the FDA extension program or data from the extension program could be applied to properly stored medications1
The United States’ Center for Drug Evaluation and Research officially recommends that drugs past their expiration date be disposed. It has been argued that this practice is wasteful, since consumers and medical facilities are encouraged to purchase fresh medication to replace their expired products, also resulting in additional profits for pharmaceutical firms.
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According to the Food and Drug Administration (FDA) study gets to the heart of medicine expiration and safety. Updated: August 13, 2017, it turns out that the expiration date on a drug does stand for something, but probably not what you think it does. Since a law was passed in 1979, drug manufacturers are required to stamp an expiration date on their products. This is the date at which the manufacturer can still guarantee the full potency and safety of the drug.
Medical authorities state that expired medicine is safe to take, even those that expired years ago. It’s true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date. Excluding nitroglycerin, insulin, and liquid antibiotics, most medications are as long-lasting as the ones tested by the military. Placing a medication in a cool place, such as a refrigerator, will help a drug remain potent for many years.
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Solid dosage forms, such as tablets and capsules, appear to be most stable past their expiration date. Drugs that exist in solution or as a reconstituted suspension, and that require refrigeration (such as amoxicillin suspension), may not have the required potency if used when outdated. Loss of potency can be a major health concern, especially when treating an infection with an antibiotic. In addition, antibiotic resistance may occur with sub-potent medications. Drugs that exist in solution, especially injectable drugs, should be discarded if the product forms a precipitant or looks cloudy or discolored.
A study by Khanchandani on efficacy, safety concern and disposal practices followed for expired drug preparations among medical personnel, found that 89.39% had knowledge that expiry date depends on both manufacturing and storing condition. Ninety one percent subject responded correctly that the drug should be best stored in cool dry and dark places. During the study they found out that majority consider expired drug use is not safe but 89.39% subject were aware about not using insulin, liquid antibiotic, nitroglycerin after expiry. The testing conducted by the US FDA ultimately covered more than 100 drugs prescription and OTC drugs. The result showed that about 90% were safe and effective as long as 15 years past their original expiration date. Loel Dawis, expiration date chief said that with a handful of exception notably nitroglycerin, Insulin and Liquid antibiotic most drugs are probably as durable as the agency tested.4.
A study done by Simons on outdated EpiPen and EpiPen Jr auto injectors: past their prime, noted that, drugs differ in terms of their forms, dosage, and stability. Usually, drugs in liquid forms (e.g. solutions and suspensions) are not as stable as those in the solid forms (e.g. tablets and capsules). It has been reported that bioavailability of EpiPen® (epinephrine auto-injectors) were reduced when administered between 1 to 90 months after the labelled expiration date compared with those that were not yet expired5
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