https://www.propublica.org/article/the-myth-of-drug-expiration-dates
The Myth of Drug Expiration Dates â?" ProPublica
The box of prescription drugs had been forgotten in a back closet of a
retail pharmacy for so long that some of the pills predated the 1969 moon
landing. Most were 30 to 40 years past their expiration dates â?" possibly
toxic, probably worthless.
But to Lee Cantrell, who helps run the California Poison Control System, the
cache was an opportunity to answer an enduring question about the actual
shelf life of drugs: Could these drugs from the bell-bottom era still be
potent?
Cantrell called Roy Gerona, a University of California, San Francisco,
researcher who specializes in analyzing chemicals. Gerona had grown up in
the Philippines and had seen people recover from sickness by taking expired
drugs with no apparent ill effects.
â?oThis was very cool,â? Gerona says. â?oWho gets the chance of analyzing
drugs that have been in storage for more than 30 years?â?
The age of the drugs might have been bizarre, but the question the
researchers wanted to answer wasnâ?Tt. Pharmacies across the country â?" in
major medical centers and in neighborhood strip malls â?" routinely toss out
tons of scarce and potentially valuable prescription drugs when they hit
their expiration dates.
Gerona and Cantrell, a pharmacist and toxicologist, knew that the term
â?oexpiration dateâ? was a misnomer. The dates on drug labels are simply
the point up to which the Food and Drug Administration and pharmaceutical
companies guarantee their effectiveness, typically at two or three years.
But the dates donâ?Tt necessarily mean theyâ?Tre ineffective immediately
after they â?oexpireâ? â?" just that thereâ?Ts no incentive for drugmakers
to study whether they could still be usable.
ProPublica has been researching why the U.S. health care system is the most
expensive in the world. One answer, broadly, is waste â?" some of it buried
in practices that the medical establishment and the rest of us take for
granted. Â Weâ?Tve documented how hospitals often discard pricey new
supplies, how nursing homes trash valuable medications after patients pass
away or move out, and how drug companies create expensive combinations of
cheap drugs. Experts estimate such squandering eats up about $765 billion a
year â?" as much as a quarter of all the countryâ?Ts health care spending.
... long article ...
The 2015 commentary in Mayo Clinic Proceedings, called â?oExtending Shelf
Life Just Makes Sense,â? also suggested that drugmakers 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 medications.
ProPublica asked the FDA whether it could expand its extension program, or
something like it, to hospital pharmacies, where drugs are stored in stable
conditions similar to the national stockpile.
â?oThe Agency does not have a position on the concept you have proposed,â?
an official wrote back in an email.
Whatever the solution, the drug industry will need to be spurred in order to
change, says Hussain, the former FDA scientist. â?oThe FDA will have to take
the lead for a solution to emerge,â? he says. â?oWe are throwing away
products that are certainly stable, and we need to do something about it.â?