On Dec. 31, my wife and I will welcome the new year by throwing away $668.80 worth of unused medication.
We won't be celebrating. We'll grit our teeth and try not to think about the months of phone calls to find someone, anyone, anywhere, who could benefit from the respiratory drug left behind when my wife's mother died in June at the age of 95. Then we'll carry the six never-opened boxes -- each containing 12 foil pouches of 5 individually packaged doses that expire on the last day of the year -- and dump them into the trash. Maybe, if I'm still feeling as discouraged as I do right now, I will raise a glass to the forces of inertia that favor waste and thwart creative thinking.
I apologize for that bit of sarcasm, but I come by it honestly. In the past six months, I have learned a lot about how different states' policies, some of which date back to the days when pharmaceutical packaging was primitive, have continued to hold sway long past their own expiration dates. I understand that it's difficult to ensure that medication, once it has left a pharmacy's control, has been stored properly and therefore is still safe and effective. I now know the Food and Drug Administration is worried that unused drugs can be diverted to a thriving underground market. And I suspect that there's probably no way to overcome fears that I might have left the medication in the back seat of my car on a hot summer's day.
But that doesn't explain why many nursing homes and long-term care facilities -- licensed institutions where drugs must be maintained safely so they can be dispensed to patients -- are destroying leftover medications worth tens of millions of dollars a year. In some states, it's a custom. In others, it's the law.
I can't be more precise about the volume because no one has come up with precise figures. One study, published in 2000 by researchers at Oklahoma State University, estimated that the nation's nursing homes alone account for between $73 million and $378 million worth of discarded drugs. That's a huge range. And the people I've contacted -- including regulators, nursing home officials, physicians and lawmakers in states that have tried to addressed this issue -- say the higher figure is probably too low.
At a time when prescription drug costs threaten the federal Medicare budget, state Medicaid programs and the pocketbooks of senior citizens, it's hard to believe that we're flushing so much money down the toilet. That's not just another tired cliche, by the way: In many states, including Maryland (where I live), that's exactly how most nursing homes destroy medication after someone has died or their prescription has changed.
Some states allow, under tight restrictions, some "re-use" of leftover medication within a nursing home or a hospital. A handful have passed or considered legislation in the past few years that permits nursing homes -- under stringent safeguards -- to return medication to the originating pharmacies for "re-direction" to indigent patients. But they are the exception. They should be the rule.
I suspect that, once you hear the story, you will recognize the plot. You see, there's nothing unique about what we experienced. After my wife's mother died, we were left with a three-month supply of a respiratory medication that had arrived at her suburban Baltimore house two days before her death. She suffered from emphysema, the result of six decades of smoking. In the final year of her life, she strapped a mask to her face as often as six times a day to inhale a medication that helped her breathe better.
As someone with a lifelong habit of searching the refrigerator for leftovers and buying used furniture, I felt a duty to find out if the medication could have a second life. I began my quest with low expectations. Once, a few years ago, a doctor had prescribed the wrong dosage of a drug that my son was taking. I didn't realize it, however, until I got home. When I went back to the pharmacy, I was told to discard the whole bottle. As galling as that was, it was understandable: The medication was in pill form, 30 doses counted out by hand and dispensed in an unsealed container. In these days of risk aversion and liability lawsuits, there was no way I could persuade the pharmacist that someone hadn't tampered with it during the half-hour that it had been in my possession.
But my mother-in-law's medication presented a wholly different case. It was still in its original packaging, untouched by human hands. Each foil pouch contained sealed "unit dose" vials of DuoNeb, a solution of albuterol sulfate and ipratropium bromide that works to prevent bronchospasms. The foil packs included specific instructions: The medication must be stored at temperatures between 36 degrees and 77 degrees Fahrenheit (a big margin for error) and it must be protected from light (easily accomplished by keeping it in the foil pack).
At each treatment, an aide would twist off the top of the vial and squirt the 3 milliliters of DuoNeb into a cup attached to a machine known as a nebulizer. The machine would convert the liquid into a mist that my mother-in-law would take into her damaged lungs.
About 2.8 million Americans have been diagnosed with emphysema, according to American Lung Association statistics. Chronic obstructive lung disease, which includes emphysema, is the fourth-leading cause of death in the United States. Surely, I thought, another emphysema sufferer could use this medication. And surely someone can. But as I have learned, there is no mechanism to make the connection -- at least, none that I could find after several weeks of effort.
I called the dispensing pharmacy. No help. I called several local agencies that serve the medical needs of the uninsured. No suggestions. I called several international relief agencies, thinking they might have more flexibility. No interest.
I called the local chapter of an organization that works on issues related to asthma, hoping that someone there might have a brighter idea than I did. This time, I found a sympathetic ear. "It's a real waste, isn't it?" said Mary Jo Harris of the Asthma and Allergy Foundation of America. "We hear about this all the time." But, she said, Maryland law prohibits such re-use. She promised, though, that she would ask several physicians and pharmacists if they had any ideas.
As much as I would like someone to have my mother-in-law's DuoNeb, I know that wouldn't save the federal government much money. But the nursing home industry, which now cares for more than 1.5 million Americans older than 65, offers a huge opportunity to cut prescription drug costs, help indigent patients and prevent the waste of usable medication -- not to mention the waste of the staff time it takes to get rid of it
George Nikstaitis knows this firsthand. He has worked as director of nursing at several Maryland facilities, and it is his job to certify that all leftover medication is destroyed. He or his assistant personally supervise the weekly process, which has become more laborious because of the tamper-proof packaging that's now ubiquitous in nursing homes. Pills come in blister or bubble packs, each dose individually sealed in plastic and covered with foil, so someone has to punch out each pill before it can be flushed down the toilet.
Nikstaitis says he isn't worried about harming the water supply because he believes the dilution factor is large enough to prevent any problems. But not everyone is convinced of that, and some researchers believe that studies should be done. (Michael Lapolla, director of the Center for Health Policy Research at Oklahoma State University, said he knows a nursing home physician who quips, "I never go fishing the day after we dispose of our drugs.")
I asked Nikstaitis why the toilet is the preferred method of disposal. "I don't feel comfortable just putting it out back in a trash bag. There's powerful stuff, morphine and other narcotics. Anyone could get into it. I don't even feel comfortable putting it in that red biohazard bag. I'm legally responsible for destroying it, and once it goes in the bag, it's no longer in my control."
But he, too, thinks that there's something absurd about the current practice. "I've thrown away thousands and thousands of pills, and in my opinion -- and it is just my opinion -- they could be used. It is a waste."
In Charlottesville, there's a member of the Virginia House of Delegates who not only agrees, but has taken up the cause and done something about it. Mitch Van Yahres, a Democrat who has served in the House since 1981, was walking in his neighborhood when he ran into a constituent who works as a doctor in a nursing home. "He was upset about all this wasted medication," Van Yahres said. "He showed me a photo of a bucket with thousands of pills in it," all destined for destruction.
Van Yahres calls himself a "recycler, a re-user." It's probably relevant that his family owns a tree service and that Van Yahres is trained as an arborist. He sees the world as a place that renews itself yearly. In the 2002 session, he sponsored legislation that "permits" nursing homes to enter into voluntary agreements with pharmacists to return unused drugs, which could then be dispensed free to indigent patients under strict conditions. The initial opposition, he said, came mostly from regulators and pharmacists. The pharmaceutical industry had no major objections. The legislation passed, and the state is now drawing up regulations.
A handful of other states -- Oklahoma, Texas, Louisiana -- have taken small steps recently as well. Why? Because in 2000, after Oklahoma advocates had urged the American Medical Association to make new inquiries, the FDA "clarified" its policy.
The original three-paragraph statement, issued in 1980 and often cited as the main obstacle to action, said in part: "It could be a dangerous practice for pharmacists to accept and return to stock the unused portions of prescriptions that are returned by patrons, because he would no longer have any assurance of the strength, quality, purity or identity of the articles." Pharmacists call that language unambiguous.
In a Feb. 25, 2000, letter to the AMA, the FDA relented just enough to give the creative thinkers a chance. In a subsequent letter in August, the agency stressed that it still had concerns about safety, and about the "potential for drugs to be diverted and then sold [illegally] on the gray market." But if specific criteria were met -- primarily, if nursing homes could prove that they had handled the drugs properly and that the medication was in its unbroken, original packaging -- the FDA had no objection to allowing states to decide for themselves what to do.
That's a start, but it won't be enough by itself to overcome the nervousness of those who want a guarantee that nothing will go wrong. Lapolla, whose center has been instrumental in the Oklahoma effort, said: "I'd love to say that things are going great, but once state regulators got their hands on it, they scaled it back." The legislature approved only a pilot project in a few Tulsa County nursing homes, and in Lapolla's view, the small size of the project makes it more difficult to prove that the idea is cost-effective.
There are no villains in this story. That's what so frustrating. The FDA wants to protect patients and make sure that good intentions don't open a pipeline for the illegal diversion of drugs. The states want to make sure they have the resources to handle their oversight responsibilities. The pharmacists want to ensure that they don't become a conduit for medication that is no longer safe or effective. But it seems to me that if we can invent bubble packs in response to tampering, surely we can design a system to make use of medication that is perfectly good.
As for my mother-in-law's DuoNeb, I'm glad that the law doesn't require that we break open all 360 vials and dispose of the liquid through the method that George Nikstaitis uses once a week. So until the ball drops in Times Square and the expiration date passes, we have 360 doses looking for a good home. I'm not holding my breath.