Three years ago, Irit and Ehud awoke to the sound of cries from their baby son in the night. He had suddenly developed an ear infection, not a rarity at that age. Irit ran to the fridge only to discover that their only bottle of paracetamol syrup had expired a month ago. Unwilling to risk giving him an expired drug and unable to ease his pain through the night and see his regular doctor in the morning, they decided to go to the nearest emergency room.
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Parents typically won’t feed their children expired food either, even though the probability that it went bad on exactly that date is low. Regarding drugs, we fear that after their expiry date, at best they won’t work and at worst, could do us harm.
But unlike food, which really will go bad within days or weeks of its use-by date, a combined program of the United States Department of Defense and the Food and Drug Administration determined in 2012 that drugs can remain effective long beyond their stated shelf lives. The American Army, and Israel’s emergency storehouses, even adopted these findings and extend the lifetime of drugs, according to certain rules.
The drugs market in Israel, including in hospitals, prescription drugs and over-the-counter, is $2 billion a year, of which 10% is nonprescription. Expiry dates are based on stability tests carried out by the drug companies. They place samples of the drugs in a room with controlled storage conditions, and remove samples of these samples every few months for testing. The tests include high temperatures, damp conditions and shaking.
The general world standard for drug shelf life is five years. An Israeli drug company executive told TheMarker that his company sets it at three for unknown drugs until they have more information on it indicating otherwise. Asked why the five-year standard, he shrugged that he didn’t know.
The five-year standard is historic and has been in place for decades. Israel adopted European regulation on the subject, which is five years.
“For 90% of the drugs tested by the U.S. army, shelf lives could be extended by 15 to 60 months,” says Eli Srebrnik, head pharmacist of the “Friends for Health” free pharmacy project, which helps patients obtain drugs and medical equipment. “That is the absolute minimum. There are claims in the professional literature that shelf life could be extended to 28 and even 40 years.”
The Shelf Life Extension Program aims to extend the shelf lives of drugs held in U.S. federal reserves. The program rechecks the safety and stability of drugs held in controlled storage conditions over lengths of time. In many cases, drugs remained efficacious years after their stated expiry dates.
The program, driven by research, was launched in 1986. In fact, not only have its results been known for years – the IDF has been doing that very thing for decades. For instance, in the midst of the 1991 Gulf War, citizens complained that they’d been given expired atropine injectors. The IDF unequivocally made it clear that atropine is good for a large number of years, well beyond the five-year expiry date stamped on the package. In an article in Haaretz, the army’s chief medical officer, Brigadier General Prof. Yehuda Danon, said, “the effective date of the syringe is not five years. Atropine administered by syringe is good for a large number of years, and the last inspection in January extended the shelf life of syringes made in 1983 for another year, until the beginning of 1992.”
Even then, what deteriorates in the syringes isn’t the active drug but usually the spring and automatic mechanism, Danon added. Tests include drug efficacy and the syringe’s sterility, and their ability to withstand temperatures of 0 to 60 degrees Celsius.
“We just received a shipment of atropine syringes from Germany made in 1974 and 1975, and approved them for use,” he adds.
The army has been extending the shelf life of drugs for its emergency reserves since the 1960s, including drugs to treat traumatic wounds. The IDF program is based on several fundamentals: independent research by the R&D division of the medical equipment and pharmacology department, relevant professional literature, a large IDF database on drug stability going back decades, periodic monitoring and testing of drugs, and the Medical Corps lab. The chief medical officer supervises the validity testing process.
The IDF won’t provide exact figures on the economy achieved by extending drug shelf lives, but does admit it’s millions of shekels a year.
The Health Ministry instituted a shelf life extension program of its own in 2010 for the national emergency reserves. It won’t discuss figures either, but Eyal Schwartzberg, director of the Department of Pharmacology at the Health Ministry, estimates the savings at hundreds of millions a year.
Emergency reserves yes, citizens no
Yet when it comes to the general population, the Health Ministry behaves with extreme caution. It is meticulous at collecting and destroying expired drugs from health institutions, but extends the shelf life of the emergency reserves and the army’s stocks.
“Why shouldn’t it be done routinely?” Srebrnik asks. “I say it categorically: This thing is based on science. We are talking about drugs about which we know exactly what the active ingredient is, and routine testing shows it remains stable.”
Several leading figures in the medical establishment agree with Srebrnik.
“I worked in R&D and one thing I know today is that drugs don’t expire so fast,” says Howard Rice, former chairman of the Pharmaceutical Association of Israel.
Some studies showed there are drugs that only lost 10% of their efficacy after 40 years, he says, and of all the ones tested, only two dropped below acceptable efficacy. “Yet despite these findings, only armies extend drug shelf life,” Rice says.
Why doesn’t it happen in the civilian drug sphere?
“The drug companies tell the government it could be hazardous. Nobody is willing to take the risk, because the drug companies would get sued. It’s also a financial matter, of course. Studies testing drugs 20 years after their expiry dates found in 12 out of 14 cases, or 93%, that they were still usable, the active ingredient was still there. It’s completely clear that with findings like these, the drug companies would collapse.”
Yoel Lifschitz, former deputy director general of the Health Ministry, argues on the other hand that the present system works. “You can’t translate shelf-life extension to the civilian market,” he says, “only the shelf life of drugs held in appropriate storage conditions over the long term, meaning under controlled temperature and after stability tests, and with the acquiescence of the drug companies and their full scientific support. You can’t ensure proper storage conditions in people’s homes, where the temperature isn’t fixed. Even if they store a drug in the fridge, they open and close it dozens of times a day, and if they forget it in the car the active ingredient will break down fast. Also, most people store their drugs in the kitchen or bathroom, both sources of moisture and heat. This is not a risk that can be taken.”
The drugs in the emergency storage are important, expensive ones, Lifschitz continues. “Nobody keeps a drug costing 100,000 shekels on a shelf in the home. Aspirin or ointments are trivial – you won’t keep that at home for more than three years anyway.”
But the data argue otherwise. Dr.Gilad Golub, CEO of Environmental Services Company, a government body that handles hazardous waste in Ramat Hovav, says that thousands of tons of drugs are destroyed each year, crushed and burned.
OTC drugs usually have a shelf life of five years, points out Miki Ofer, former chairman of the Pharmaceutical Society of Israel. Some drugs to treat chronic conditions last three to five years, but get used and replaced on a monthly basis, and OTC drugs get bought when the household runs out, so there’s no savings involved, he argues.
“Hospital inventories aren’t of a significant scale like the national emergency reserve, and are managed so not many expired drugs remain,” he says.
Schwartzburg explains the Health Ministry’s perspective: “When developing analytical methods to extend shelf life, you’re undertaking a great deal of responsibility and have to check the methods carefully to assure the quality and safety of the drugs. The issue is a little different with the emergency reserves because it’s a national reserve, the quantities are huge, not one drug or two, to defend against plagues, and biological and chemical weapons. Logic says that to utilize the nation’s resources maximally without injuring people, one should check a certain number of items in the inventory the state undertakes the responsibility and the manufacturer is not involved any more.”
Isn’t it in the national interest to extend drug lifetimes in the civilian market too?
“The professional elements at the Health Ministry don’t think so, because there isn’t a lot of waste,” says Schwartzburg. “With the national reserve, beyond the heavy costs of new procurement, sometimes it’s impossible to buy enough supply for the whole nation the cost-benefit doesn’t work in favor of the Shelf Life Extension Program for civilian drugs.”
Rice believes that positions on this, and on the risk entailed for the public, would change if the ministry started thinking like the army, where to save money. People should keep their drugs in a cool, dry place, such as the fridge, where most would last a nice long time.