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Study Highlights Debate Over Drug Expiration Dates

December 18, 2006

FORT LAUDERDALE, Fla. – If Jane Kreimer’s medicines were library books, she’d be fined for late returns. Her sleeping pills expired in 2000. Her pain pills and excess-fluid pills expired in 2004.

But the Fort Lauderdale retiree said she hasn’t replaced them, because a doctor told her to save the money and take the out-of-date drugs as long as they did the job. “They’re still working,” Kreimer said. “What a terrible waste it is for people to throw drugs away. I bet they’re making millions, if not billions, from people throwing out perfectly good medication.”

A growing body of studies and experts back her, asserting that many medicines remain safe, effective and stable for years beyond government-approved expiration dates set by drugmakers and pharmacists.

The leading evidence comes from a U.S. Food and Drug Administration program that tests drugs for the military. The results through July 2006: 88 percent of tested medicines remained potent for at least a year past expiration, some for up to 14 years.

Many officials from the FDA, drug industry and research community agree that certain medications, such as aspirin, may remain good well past expiration.

Even so, some of those experts discourage taking expired drugs, saying they are not a sure thing. The military stores drugs under ideal cool and dry conditions, these experts say, but consumers may not, creating a risk that old drugs will lose potency.

“After the manufacturer’s expiration, don’t use it, no matter what the government says,” said Skip Lenz, owner of Skip’s Pharmacy in Boca Raton, Fla. “Beyond that, it’s a crapshoot.”

The controversy has waged for more than a decade, dragging Florida drug chains into court and pushing the state to alter its pharmacy rules.

Expiration dates are set by the manufacturer and approved by the FDA based on company tests of a drug. The company guarantees the product will be at least 90 percent potent until the expiration date. Most drugs get a one- or two-year life.

Drugmakers can ask to extend the expiration if they test the drug further. But companies seldom do, industry officials said, because the tests take money and time, and do not lead to extra sales.

So, while aspirin is marked to expire in two or three years, Bayer has found its pills to be 100 percent potent after four years, said Dr. Jens Carstensen, a retired pharmacy professor in Wisconsin who wrote textbooks on drug shelf life. He tested five-year-old aspirin and found it to be “excellent.”

Ormond Beach, Fla., pharmacist Gerald Murphy, who has made the issue a crusade, said companies lowball expiration dates so consumers buy new drugs.

“We should tell people to throw away a $300 bottle of pills because of a marketing scheme?” Murphy said. “Even the manufacturers don’t know when their drugs expire. Here’s the government sanctioning a big lie.”

A spokesman for the pharmaceutical industry denied that drugmakers set expirations to boost sales. The dates must be conservative to ensure drugs work no matter how they are stored, said Alan Goldhammer, vice president for the trade group Pharmaceutical Research and Manufacturers of America.

Many consumers keep their drugs in the bathroom, exposed to heat and humidity that degrade drugs, Goldhammer said.

“I don’t think money is the consideration at all,” he said. “(Drugs) could still be good after the date but there’s no guarantee.”

The FDA does not make manufacturers test drugs for a longer time to find the true life span, because its priority is safety and effectiveness, not saving money for consumers, an agency spokeswoman said.

Certain drugs _ nitroglycerin for heart disease, liquid antibiotics and others _ are prone to degrade fast and must be watched, experts said.

Yet research shows many last for years:

The FDA Shelf Life Extension Program has tested hundreds of drugs for the U.S. military since 1985 and found that, on average, they were good for 5 { years after expiration. The program saved $296 million on drug replacements in 2005 alone, the FDA said.

Anesthetic lidocaine was found to be good past the expiration despite being stored for two years in an Oman warehouse at up to 135 degrees. Antibiotic ciprofloxacin marked to expire in three years was still good after 13. Cyanide antidote sodium thiosulfate was still good after 16 years.

The findings are clouded, the FDA says, because a few batches of long-lived drugs degraded before expiration.

Flu drugs amantadine and rimantadine stored for 25 years under household conditions proved to be fully effective, doctors said in a 1998 study in Antiviral Research.

The asthma drug theophylline proved to be 90 percent potent after 35 years, doctors said in a 2002 study in Human & Experimental Toxicology.

A Massachussetts Institute of Technology researcher, Moshe Alamaro, insists expiration dates are inaccurate, and is lobbying for state approval to collect unopened, expired medicine for the uninsured. Alamaro said supporters may follow suit in other states.

In general, pharmacy experts consider a medicine good at 90 percent potency, but author Carstensen said some drugs _ such as painkillers, cold remedies and others that simply relieve symptoms _ work fine at 85 percent or less. He said he eased a migraine with a drug six years old.

Yet he and others urge caution, saying consumers cannot tell which drugs were stored well enough to be good after expiration.

Some pharmacy specialists call for the FDA or drug companies to test drugs for longer periods, to possibly set longer expirations to benefit consumers, insurers and tax-supported Medicare and Medicaid.

“With medicines being so high, it would be nice if the government would pay for a study. It could save millions or billions,” said Dr. Jay Pomerantz, a Harvard professor who favors recycling expired drugs.

The industry calls the idea a non-starter. Why would a company spend time and money testing a drug’s shelf life when its patent expires after a number of years, Goldhammer said. Most medicines, he added, are given in quantities that should be taken fully to treat the illness, with no leftovers.

Some drug experts argue that aged drugs can break down into harmful byproducts, citing a 1963 study on a death from old tetracycline. But the editor of Harvard Health Letter wrote in 2003 that the old study is in dispute and that cases of old drugs causing harm are “virtually unknown.”

Manufacturer expirations are not the only source of controversy. About 17 states require pharmacists to put a one-year date on a prescription if the pills were removed from a factory container _ even if the official expiration is later _ on the theory that medicine may degrade in drugstore vials. The one-year date is backed by influential U.S. Pharmacopeia, which sets standards for the drug industry.

Florida’s pharmacy board had imposed the one-year rule for years until critics complained. In 2004, the board let pharmacists decide between one year and the factory date. Yet many of Florida’s 22,500 pharmacists don’t know of the change or use computers still programmed for one-year labels, said Paul Elias, owner of the Prescription Pad and president of the Broward Pharmacy Association.

The state pharmacy board doesn’t track pharmacists’ labeling and takes no position on expiration dates, board Director Rebecca Poston said.

Florida’s biggest drug chains, Walgreens and CVS, follow the one-year rule unless pills are in a factory package, company spokespersons said _ and they have been sued.

A 2004 class-action suit in Chicago’s Cook County calls Walgreens’ policy deceptive, said Ben Barnow, an attorney who filed it. A similar suit against CVS was dismissed but another is pending.

Clearly, the issue of expiration dates is far from settled.

“Each drug has to be looked at individually,” said Larry Sasich, a pharmacy professor and consultant for Public Citizen Health Research Group. “It sounds like it should be simple, but it’s not.”




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