David L. Girouard, MPH, R.Ph. [December 19 2012]
When you are ill and go to see a doctor, you may receive a prescription that you will take to a local pharmacy to get filled. We typically expect a medication to be available. In reality, there are shortages, on a national level, of varied medications in both retail and hospital settings.
Nationwide, there were more than 200 drug shortages in 2011 involving all kinds of medications. Most shortages affected medications used in hospitals but several also affected the retail pharmacy setting.
Typically, generic drugs are more prone to shortages for varied reasons. Intravenous medications require complex manufacturing processes and make up most of the shortages impacting hospitals. For example, a shortage of methotrexate, which is used to treat childhood leukemia reached a crisis level nationwide in early 2012. Propofol, a medication used for general anesthesia, has been in chronic shortage thus limiting treatment options in some hospitals and surgery centers. As part of its website, the FDA provides an online list of drug shortages.
There are varied causes of drug shortages. The FDA is responsible for ensuring pharmaceutical product safety and inspects manufacturers to verify they are employing good manufacturing practices. The FDA has dramatically increased such regulatory activity to maintain drug supply integrity. Manufacturers must respond to FDA warning letters and often need to shut down production lines. Typically there are few manufacturers of a generic drug and when one manufacturer shuts down production the others cannot meet demand. Other contributing factors to shortages include price controls on generic drugs, which tend to limit the number of manufacturers; and time it takes for approval to produce a generic drug.
When hospitals learn of a pending drug shortage they usually buy as much of the affected drug as possible to safeguard supply for their patients. Hospitals will also attempt to purchase drugs that may serve as alternatives to the drug in short supply. When use of an alternative drug is necessary, physicians, pharmacists and nurses work as a team to ensure the alternative drug is used in a safe and effective manner.
Toward helping resolve this nationwide issue, President Obama recently signed into law bill S. 3187, which is intended to address some root causes of drug shortages. While consumers may be impacted on the retail level, by having to check varied pharmacies to see if one has a needed medication in stock, they can also make a positive impact by voicing their concerns to their governmental representatives and support those working to alleviate the problem.
David Girouard is director of Pharmacy at The Hospital of Central Connecticut (HOCC). For referrals to HOCC physicians, please contact our free Need-A-Physician referral service by phone at 1-800-321-6244 or online, www.thocc.org.