Moral Medicine: A Modest Proposal on East Tennessee Medical News

Moral Medicine: A Modest Proposal

By: David Stevens, MD, MA (Bioethics)

The biggest issue in healthcare reform is escalating costs. Without something changing our growth curve, we will be spending one out of every five dollars in the country on healthcare in 2017, one out of four in 2025, and one out of two by 2050. Clearly, something must be done.

Many ideas on how to alter our stratospheric trajectory have been put on the table–tort reform, decreasing bureaucracy, regulating insurance companies, electronic medical records, etc. Let me add a rather modest proposal that I have not heard anyone mention so far that could significantly decrease wasteful spending.

Let’s just require the expiration date on each medication to be accurate.

Here is the scoop. Since 1979, the FDA has required expiration dates on prescription and over-the-counter medications so drug companies could give consumers and regulators confidence that their drugs were safe and effective until that date. Pharmaceutical manufactures analyze potency and quality and breakdown products of drugs on a certain date, usually two to three years after manufacturing, and give that assurance. Though no one says it, most patients assume that a drug is perfectly okay the day before the expiration date and dangerous or at least ineffective the day afterwards. Most dutifully discard, often into the water system, their out-of-date drugs.

Recently, a physician friend sent me an article entitled, “Do Medicines Really Expire?” It pointed out that drug companies arbitrarily pick their expiration dates. That date has nothing to do with a drop in potency or the degrading of an ingredient turning it into a dangerous byproduct. It has to do with marketing, new packaging, and profits. It is simple economics. If the patient keeps their Tylenol with a true expiration date in their medicine cabinet for 10 years, they are not going to the store to buy more.

I started to research this subject and found that way back in the mid-eighties, the Air Force had a large stockpile of drugs, so they petitioned the FDA to retest these drugs for quality and potency instead of discarding them. It was a prudent step, rather than incurring the very high cost of replacing them every 2-3 years. Working with the FDA, they tested over 100 different drugs. The results showed that 90% of their medications were safe and effective as far out as 15-years past their manufacturing date. The military started a shelf-life extension program of retesting drugs that is still active today and has saved enormous amounts of money. Shouldn’t our whole medical system do the same?

The Air Force had a good solution for their large stockpiles; but patients, or for that matter, neighborhood pharmacies, cannot afford to retest small drug quantities. There is a cheaper and more efficient solution than that. The FDA just needs to require drug companies to establish real and meaningful drug expiration dates on everything from over-the-counter antihistamines to antibiotics. The fact that my aspirin has lost 5% of its potency is not an indication it should be thrown away. If the drug in question is a life saving antibiotic for sepsis or nitroglycerin, then that 5% loss of potency may be significant.

Drug companies could easily develop an effectiveness curve and an honest expiration date for each drug. This effectiveness curve, developed under normal storage conditions, could then be made available to pharmacists and practitioners. Much more accurate expiration dates on each drug container would give consumers accurate information and inserts could instruct on good storage practices.

The result would be billions of dollars of savings on the $230 billion spent on prescription drugs each year in the U.S. with the added bonus of savings on over-the-counter medication expenditures.

A change in policy would also make drugs more available in developing countries. Most countries, following the U.S. and World Health Organization guidelines, now require medical and relief teams to bring in drugs that have at least a year expiration date. People suffer and some die for lack of simple medications that are unjustly branded as dangerous or ineffective when, in reality, they could still meet the needs of the poor.

This is a modest proposal and just a small part of solving the problem but add to it limiting direct-to-consumer marketing, drug detailing to doctors, and streamlining the cost of bringing new drugs to market, and it could have a great impact on medication costs. Perhaps we could approach the cost of medications in Europe, where they are 40% less than the U.S.

A billion here and a billion there and before you know it, you are talking about real money … and real healthcare reform!

David Stevens, MD, MA (Ethics), is CEO of the Christian Medical & Dental Associations. For more information, please visit their Web site at www.cmda.org