* In test, some 50-year-old drugs still potent
* One trial saves $13 to $94 for every $1 in testing
* Should manufacturers do longer drug stability tests?
By Frederik Joelving
NEW YORK, Oct 8 (Reuters Health) - A few old boxes ofmedicine in the back of a pharmacy got poison control expert LeeCantrell thinking.
With dozens of drugs in short supply in the United Statesand a bloated national health bill, what if expired medicationswere still effective? What if instead of throwing out the drugs,patients and pharmacists could keep them on the shelves forseveral more years?
So Cantrell and his colleagues went about testing thecontents of those boxes, which had expired 28 to 40 yearsearlier. Out of the 14 compounds they analyzed, 12 stillfulfilled government requirements for potency, according to theteam's report, published on Monday in the Archives of InternalMedicine. For the full study, see
"The vast majority of the samples tested contained at leasttheir stated potency and therefore their active ingredient wouldstill be viable," said Cantrell, director of the CaliforniaPoison Control System, San Diego Division, and a professor ofclinical pharmacy at University of California, San Francisco.
"At least some of them, 50 years and they are still potent!"he told Reuters Health.
The boxed drugs included the narcotic painkillershydrocodone and codeine as well as the sedatives pentobarbitaland butalbital. Aspirin and amphetamine were the only two drugsthat appeared to have degraded to less than 90 percent of theirdeclared amount, the minimum accepted by the U.S. Food and DrugAdministration.
According to the report, drug shelf lives usually rangebetween one and five years from production. But that's anarbitrary expiration set by the manufacturer, said Cantrell,because the FDA doesn't require companies to determine how longthe medicine retains its potency.
"If manufacturers were required to do longer-term stabilitytests, it could be an enormous cost-saver for consumers," hesaid, adding that it could also "be an answer to some of theworld's drug shortages."
Americans spend more than $300 billion on drugs every year.Cantrell said it is unclear how much medicine is thrown outbecause it's too old, but suggested it would be an "enormousamount."
Officials at the FDA and the National Institutes of Healthwere not available for immediate comment.
DON'T TRY THIS AT HOME
The new study did not examine the safety of the old drugs,which had been kept in sealed containers in a controlledenvironment.
"When the average reader reads this, the take-home messageis not, 'Your expired medications are safe to take,'" warnedCantrell.
Still, he said, to his knowledge there has only been onereport of a drug that became toxic after it had expired, andthat was due to an inert ingredient in one particularmanufacturer's formulation.
"Beyond that there has never been a well-documented case ofany expired medication that became toxic," Cantrell said.
Since 1986, the FDA has been testing drugs stockpiled by themilitary to check their stability under the so-called Shelf LifeExtension Program. Many of those drugs have had their originalexpiration dates extended by several years and that has savedbetween $13 and $94 for every $1 spent on testing, according torecent research.
He also said that if shelf lives were to be extended, thatwould slow down the product turnover at pharmacies across theglobe, cutting manufacturer revenues.
"I know that big industry doesn't want to hear that,"Cantrell said.
Cantrell said his report had been rejected by a number ofmajor medical journals and that the one that finally publishedit had removed references to drug shortages.
The Pharmaceutical Research and Manufacturers of America,the industry's main trade group, said they were still reviewingthe new study and could not comment yet.
(Editing by Ivan Oransky, Michele Gershberg and CynthiaOsterman)
Keywords: USA HEALTH/DRUGS