Drug Shortages and the Joint Commission Stance

Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.

Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.

I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.

So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.

Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.

Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.

Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.

A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.

The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.

I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.

About Daniel Ginsberg, MD, FACP

I'm an internal medicine physician and have avidly applied computers to medicine since 1986, when I wrote my first medically oriented computer programs. So yes, that means I'm at least 35-years-old!
This entry was posted in Business of Medicine, Government, Legal, Pharmaceuticals and tagged , , , , , . Bookmark the permalink.

One Response to Drug Shortages and the Joint Commission Stance

  1. Tricia says:

    SLEP programme appears an excellent and rational approach. The financial costs worldwide of disposing of ‘ out of date’ meds must be phenomenol , but the health costs perhaps more. Probably better an out of date regulated med than an ‘ in date’ cheaper copy version of questionable pharmacological content.

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