Testing program finds drugs outlast label expiration date
Government tests have found that some drugs stay fresh for years past their label expiration dates, enabling the military to save millions on replacing expired drugs, according to a report in today's Pittsburgh Post-Gazette.
The Shelf Life Extension Program (SLEP) found that drugs can stay safe and effective long after the manufacturer's expiration date if properly stored in the original container. Run by the FDA for the Defense Department, the program has saved the military millions of dollars on replacement of "expired" drugs.
In one instance, the Pentagon spent about $350,000 on testing of supposedly expired drugs and avoided needlessly discarding about $33 million worth of medicine, the Post-Gazette report said.
The newspaper report said that shelf-life program found that drug manufacturers use conservative expiration dates.
About 85 percent of the Pentagon's drug stockpile remained good after the expiration date and the shelf-life program extended their expiration dates by an average of 57 months, according to the FDA. Among them were everyday antibiotics like tetracycline and penicillin; tranquilizer Valium and the ulcer drug Tagamet. One batch of antibiotic Cipro was good 13 years after the expiration date.
"The actual shelf life of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer's container, which could result in the unnecessary waste, higher pharmaceutical costs and possibly reduced access to necessary drugs for some patients," The American Medical Association's (AMA) Council on Scientific Affairs said in a statement.
There are wider implications as well, according to the article, since some international aid agencies and foreign countries refuse donations of desperately needed drugs for AIDS and other serious diseases if the medication is expired or nearing the expiration date.
The AMA called on the Pharmaceutical Research and Manufacturers of America to determine whether increasing expiration dates would save money and involve any risks for patients.
Dr. Alan Goldhammer, vice president for regulatory affairs at PhRMA told the Post-Gazette he could not easily determine whether the association carried through on the recommendation. He disputed any implication that the pharmaceutical industry uses conservative expiration dating to increase sales by making consumers discard good medication.
"Companies choose a conservative approach so that patients will receive drugs that are safe, pure and potent under the condition of storage, " Goldhammer told the Post-Gazette.