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 But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.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.

Prior Authorization – License to Kill (our time)

A patient of mine informed me that her insurance didn’t want to cover a medication, and preferred a similar generic medication, which she previously tried but did not tolerate. She asked me to Call Humana’s  pharmacy review board. I usually leave such things to my nurse, but called them myself. A voice recognition system asked me for the patient’s account number and date of birth. After providing these, I was connected to a human, who asked for the same information. When I pointed out that I had just supplied the information, she said it didn’t come through, but made no offer to investigate why not.

If their menu system is not capable of transmitting such information to the computer screen of the people working for them, then they should not ask for the information using the automated system in the first place. This was not a onetime glitch, but something the nurses in my office encounter regularly. Our time is valuable. It’s bad enough that we have to justify our prescriptions, but it’s disrespectful of our time when we have to repeat ourselves with patient identification information. We have better things to do with our time.

Before deciding to post this, I decided to call again and give them a chance to say they would try and improve things. First I went to their website and clicked the For Providers link. I didn’t want to have to register, so I clicked the Customer Support button. Next I clicked the Contact Humana button. At the top it said they welcomed email, but one had to register to send messages securely. So I called their phone number for providers. Someone answered and wanted my patients ID number and date of birth. I informed I just had a question about the pre-authorization process, and not about a particular patient. She said that was another department and she transferred me, but not before asking for my name and call back number (I gave her my name, but told her I didn’t want a call back).

The next person again asked for my name and call back number. I explained my concern about being asked for the same patient information more than once. “That’s the process we’re required to follow,” she replied. I asked if they were interested in improving how they do things and she repeated what she had said. I asked if I could talk to someone who could improve the process. She told me they don’t have such a person!

I hope Humana and other pharmacy benefit managers take note. It may be your job to save your customers money, but you don’t have to waste physician’s and their office staff’s time. I hope the cynical view, that you do on it purpose to discourage prior authorizations, is not true.