They say the only thing certain in life is death and taxes. That is true, but we like to believe other things are ‘certain’ too – like McDonalds will always have fries, the Labor Day MDA telethon will always have Jerry Lewis and hospitals will always have drugs. Well, I don’t know where Jerry went, and now, unfortunately, too many of us are finding out hospitals don’t always have the drugs we need.
It’s a rude awakening – but an all too familiar reality these days – when you discover your treatment is not available due to a drug shortage. The majority of medications affected by the shortage are injected generic drugs — ones that not only treat cancers, but drugs that can actually cure diseases such as Hodgkin’s, testicular cancer and leukemia. The drug shortage has not only compromised patient care, but also led to increased drug prices as hospitals are forced to purchase their drugs from the ‘gray markets’ at huge markups (a markup, on average, of 650%).
Possible Causes of Drug Shortages
The shortages can be attributed to several factors, the most prevalent being quality and manufacturing issues. As medications come off their patent and become ‘generic’, the original company that developed the drug usually exits production. How come? If there is not a profit, Big Pharma manufacturers won’t make a drug. This leads to a smaller manufacturers taking over production, often in an older facilities where the potential for contamination is higher. Once there is a breach in quality at a plant, all production is halted until the quality problem is resolved. Once one manufacturing plant is shut down, the others cannot keep up with the demand, resulting in a shortage. Further complicating the issue is the fact prices drop exorbitantly once a medication is off patent, (why this is, is an entire blog on its own) resulting in fewer companies producing the product. With fewer manufactures, potential shortages are possible. Today only 6 manufacturers make a majority of injected drugs. That’s not a lot, when you consider the demand.
Last week the White House issued an executive order to the FDA to reduce drug shortages by broadening it’s reporting of potential drug shortages (now it is only mandatory for a sole manufacturer of a drug), accelerating application of drug production changes, and providing the Justice Department with information on possible collusion or price gouging. This is a good start, and it did alleviate the need to wait for Congress to act on similar legislation requiring FDA notification of pending drug shortages. However, all three mandates are a call to action ‘after’ the fact. In other words, the shortage has already happened, or is pending.
I would propose the administration consider the added value of a mandated pedigree documentation program. In such a program, a program that documents drug production and distribution from raw materials to Walgreens, it would be obvious where there are insufficiencies. It would be capable of alerting the FDA of raw material shortages, thefts, hoarding and even facilitate verification of other market problems such as rebate and insurance company overpayment.
Other solutions being considered are incentives for manufacturers, a national stockpile of cancer drugs (much like the Center for Disease Control does now with antibiotics and antidotes in case of terrorist attack) and allowing drugs in short supply to be imported in limited amounts. All good ideas also, but if we had transparency throughout the supply chain we could avert many of these problems. If we can’t count on anything but death and taxes, we should at least be ‘pretty certain’ about our medicine. Don’t you think? Or should I be worried about my fries too?