You awaken at 2am with a splitting headache, and, knowing that ibuprofen has helped in the past, you go to the medicine chest.  Alas, the medication expired one month prior.  Should you dispose of the remaining pills and go to a 24 hour pharmacy to get a new batch?  Or just take the expired pills and hope they work, without doing you any harm?

Some Facts

It turns out there is a considerable literature on the subject of expired drugs.  In 1979 Congress passed a law that required pharmaceutical manufacturers to put expiration dates on all medications, including over-the-counter remedies.  These dates mark the time up to which the manufacturers can guarantee full potency and safety.  Pharmacies and hospitals are therefore required to dispose of all medications that have remained on the shelf past their expiration dates–no matter how expensive or vital the drugs may be. The federal government does not comply with this rule, so that Medicare, Medicaid, and the Veterans Administration have considerable stockpiles of “expired” drugs.

At the request of the Department of Defense, the Food and Drug Administration (FDA) conducted a study on the viability of drugs after expiration dates.  This was no trivial undertaking: the DOD maintains a stockpile of drugs worth $13.6 billion.  The research showed that 90 % of 100 drugs tested were still effective for 15 years after their “expiration” dates.  Not automatically disposing of outdated drugs saves over two billion dollars per year. 

Role of Drug Companies

Do drug companies “game” the expiration date?  There is mixed opinion on this issue.  Clearly, companies benefit from the rule to throw away drugs at the expiration dates, as this necessitates more sales.  On the other hand, the companies say that they want to provide drugs that confer full benefit for the purchasers.  I have found no articles that investigate this matter, but I ask the following question: would pharmaceutical executives prefer that people throw away half a bottle of, say, Ibuprofen, and buy another bottle, or use up what remains of “expired” medications? 

Scientific means are available to test the potency of drugs.  In fact, some health economists advocate that drug manufacturers be compelled to update their expiration dates, and keep the ones on the market that are still good.  This proposal has gained no traction in our feckless Congress.  

Safety and Recommendations

What about safety?  No poison control center, federal, state, or local, has documented a case of harm resulting from the ingestion of outdated drugs.  

Some experts, quoted in Harvard Health Publishing, provide the following advice.  Use of medications beyond their expiration dates is safe, but with marginal diminishing efficacy the longer they are taken from their expiration date. So… if you use drugs for arthritis, you might well use them past their expiration date.  On the other hand, if you have a rip roaring cellulitis (this is a skin infection that gets out of control that requires antibiotics) from a minor cut, you may want to be sure that your antibiotic is fully potent.

Another consideration is storage.  Ironically, the medicine chest is the worst place to store drugs, as heat and humidity are the suboptimal environments to store drugs.  A cool environment such as a refrigerator is recommended.

Savings

By law, hospitals and pharmacies discard $765 billion worth of drugs each year.  The total amount of expenditure on healthcare in the United States in 2021 was $4.3 trillion, indicating that 18% of our nation’s heallthcare expenditure is wasted on disposal of drugs that are effective. The Biden Administration will soon begin to negotiate drug prices for government sponsored healthcare.  This has been controversial, and I don’t know how impactful the negotiations will be.  On the other hand, there appears to be some low-hanging fruit that could be harvested at great savings with some simple changes in regulation of the pharmaceutical industry. 

NOTE: Studies alluded to in the above refer to “solid” dosage forms (tablets and capsules), not liquids, creams or ointments.  Also, nitroglycerin, insulin, vaccines and others do degrade with time.  Regardless, nothing in this blog entry should be construed as a recommendation on handling a personal supply of drugs.