Report Explores Drug Shortage Causes, Impact, and Proposed Solutions

October 21, 2011 10:38 am

A report on the growing shortage of life-saving cancer drugs, presents some possible reasons for shortages, the impact of the problem, and solutions being explored, and stresses that regulators and lawmakers have not identified the cause of the shortage. According to the report from Reuters, many patients must use drugs other than the one recommended for their diagnosis and some must delay treatment. Food and Drug Administration (FDA) reports over 200 medication shortages in 2011, compared with 56 shortages reported in 2006. “Sterile injectables such as the cancer drugs, make up the lion's share and accounted for 132 out of 178 shortages in 2010,” Reuters notes. Peter Lurie, a senior adviser in the FDA Office of the Commissioner, told Reuters that "There appear to be multiple factors that are playing in it and it's very difficult to identify which one is most important." Sandra Kweder, deputy director of the FDA's Office of New Drugs indicates that over half of immediate shortages in 2010 were due to product quality and "significant" manufacturing problems such as metal shavings found in vials or fungal contamination.

Another possible reason for shortages is lack of incentive for manufacturers to produce generic drugs, Reuters reports. In addition to the impact on patient treatment, “gray market” distributors exploit shortages, selling drugs to hospitals at increased prices, as described in a recent Institute for Safe Medication Practices safety alert. Proposed solutions include:

• creating a national stockpile for emergency injectables
• offering tax incentives for manufacturers of low-cost but life-saving products
• introducing a bill that would require manufacturers to inform FDA of anticipated shortages

The International Monetary Fund and the US Department of Health and Human Services are both investigating the issue, and a Government Accountability Office report will be released in November 2011.