Testing Tribulations

When I was an internal medicine resident, one of my staff attending’s, Dr. Charles Reasner, used to ask, “What is the indication for ordering a TSH?” This is a test of thyroid function (thyroid stimulating hormone), and he was asking what reasons should one order the test. His answer was to order it if you think about it. An overactive (hyperthyroidism) or under-active¬† (hypothyroidism) thyroid can cause many different kinds of symptoms, treatment is relatively easy, and the test is inexpensive. Thus he said if it occurred to you to order the test, then you should do so.

Unfortunately the Centers for Medicare & Medicaid Services (CMS)does not allow us to order tests based on intuition, even though numerous studies have shown that people often make their best decisions based on reasons they can’t explain. When a quarterback such as Peyton Manning throws a football to a receiver, he first has to make the decision what to do very quickly, while a 300 pound lineman is bearing down on him. Based on prior experience he can quickly survey the field and make a decision where to throw the ball before he could make a decision based on a logical analysis. He might not be able to explain exactly why he did something, but his skill and training contributed to making the right decision seemingly without thinking.

When physicians order a test, we have to associate a diagnosis. Presumably the main purpose is to prevent wasting money for ordering tests. Although there is no benefit in ordering a PSA test for a diagnosis of glaucoma, for example, this only catches errors in the test ordered or diagnoses associated, which probably doesn’t happen often. It’s a real problem though for ordering a vitamin D level.

Medicare no longer covers a screening test for vitamin D, even though perhaps 85% of patients in the United States are deficient, treatment is cheap, and it probably saves money in the long run. Once a patient is diagnosed with osteoporosis then a level is covered, but that’s too late. Plus in men a screening bone density test is not covered, so it’s a Catch-22 situation.

At least if not that expensive, physicians should be able to order labs because they think of them. Insurance companies and the government should trust our intuition.

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.