Although we used to have any drug we needed at our fingertips (regulatory interference notwithstanding) today we don’t. So, what has changed? Have they run out of the rare “zine” compound that is needed to make Compazine, or the “tron” in ondansetron? Hardly! We can only order what the pharmaceutical companies are willing and able to produce.
In the Journal of the American Medical Association, January, 2012, Gehrett published an interesting article about the drug shortage. To no one’s surprise, the shortages are strongly related to financial incentives of the pharmaceutical companies. Although some chemotherapeutic agents have also fallen in short supply, the drugs experiencing national shortages are usually low-cost agents such as metoclopramide, prochlorperazine, morphine sulfate and even ondansetron. The shortages are often with injectables that require more effort to produce, as quality assurance mechanisms for injectable drugs are often more involved, and expensive, than orally delivered medications. Generic drugs (off patent) that are expensive to produce, but inexpensive to purchase are most likely to make the shortage list.
Unfortunately, patients are the most likely to be harmed by these shortages as free enterprise influences what drugs are to be produced. Common medications for acute migraine management, including prochlorperazine and metoclopramide, are rarely available anymore. This results in substandard management of migraine sufferers. In addition, benzodiazepines, such as diazepam (Valium) and lorazepam (Ativan) are also becoming scarce. In some cases, the unavailability of these drugs leaves clinicians with no suitable substitute, forcing the provider to use a substandard treatment.
I know we live in a capitalist society, and I’m fine with that. It’s usually a good thing. However, when financial motivation is allowed to impact drug availability, we all suffer. Driving the market by advertising, drug reps, doughnuts, pens and fancy brochures is one thing. Influencing our prescribing patterns by way of production levels – or a lack thereof – is something quite different.
Drug shortages are not a new problem, but they do seem to be getting worse. In 2005, the Center for Drug Evaluation and Research reported 62 drug shortages. There were 157 (72 injectables) in 2009, 178 (132 injectables) in 2010 and somewhere between 200 and 300 for 2011.
So, who’s to blame? From my perspective, the burden lies on the pharmaceutical industry and the Federal government. However, to be fair, this is a complex, multifactorial problem with no easy fix on the horizon. Although some drugs are produced by multiple manufacturers and at multiple sites, they’re often supplied by a single vendor. In addition, foreign countries supply 80% of the components needed for drug manufacturing, and many drugs have limited shelf lives. The propofol shortage a couple of years ago was actually due to quality control and not due to low production levels. Two of the three manufacturers had their supplies recalled due to contamination from bacteria and particulate matter. So, there are legitimate shortages that are, perhaps, out of the drug companies’ control. However, many are due to a lack of financial incentive for their production and distribution. Plain and simply, drugs without a return on investment take a back seat to those that cost more. With benefits managers contracting for volume discounts (lowering the selling price) and Medicare rates equaling the selling price plus 6%, the financial incentive for generic, injectable drugs is almost non-existent.
The government has fallen short with respect to policing the pharmaceutical industry and ensuring production of the drugs our ED patients need. If a drug company is the sole producer of a drug or they are producing a “medically necessary product” (whatever that means), they are required to report their intention to discontinue production to the FDA. Otherwise, reporting of product discontinuation or anticipated shortages are only subject to voluntary reporting. Given advance notice, the FDA has proven success in averting or limiting some shortages. The FDA averted 38 shortages in 2010 and 99 shortages in 2011 when advance notice was provided. Fortunately, the FDA is working toward managing these shortages and avoiding them. In October of 2011, an executive order was signed by President Obama, providing the FDA with expanded authority. This new power will require adequate, advance reporting of shortages. In addition, this may include fast tracking new manufacturing sites. This process currently takes approximately three years. Although this is a good start, our troubles are far from over. The medication crisis is in the hands of the Federal government and the pharmaceutical industry. And that just doesn’t sound like a winning combination.
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written by jon , April 09, 2012