Addressing drug shortages
Impact of CYP3A4 pathway
What actions are being taken in regard to current shortages of chemotherapeutic agents? — Carol J. DeVore, RN, BSN, OCN
Shortages of medications used in oncology are becoming increasingly common.1 In response to the growing public awareness of this issue, two bills were introduced in Congress in 2011. These bills will require manufacturers to submit notification to the Food and Drug Administration (FDA) 6 months prior to a discontinuation or an interruption of distribution that may lead to a drug shortage, as well as require the Government Accountability Office (GAO) to study the causes of drug shortages.
Representatives from oncology organizations such as the American Society of Clinical Oncology (ASCO) have testified before Congress to highlight the need for action. These organizations also suggested using incentives to increase production of generic chemotherapy medications.
On October 31, 2011, President Obama signed an executive order directing the FDA to take multiple actions to mitigate drug shortages, including broaden the reporting of potential shortages, expedite review of new manufacturing sites and drug suppliers to prevent shortages, and work with the Department of Justice to investigate whether shortages have led to price gouging or illegal stockpiling of medications.2 The White House also encouraged Congress to pass pending legislation to further strengthen the FDA's ability to prevent shortages of prescription drugs.
Information on shortages of individual medications is available from the FDA and the American Society of Health-System Pharmacists (ASHP). The ASHP website includes links to information on both current and resolved drug shortages as well as those drugs no longer available.ONA
REFERENCES
1. Tobin J. Understanding and managing drug shortages in oncology. Oncology Nurse Advisor. 2011;2(3):24-29, 37. http://www.oncologynurseadvisor.com/understanding-and-managing-drug-shortages-in-oncology/article/203077/. Accessed October 26, 2011.
2. White House Office of the Press Secretary. We can't wait: Obama Administration takes action to reduce prescription drug shortages, fight price gouging. http://www.whitehouse.gov/the-press-office/2011/10/31/we-can-t-wait-obama-administration-takes-action-reduce-prescription-drug. Accessed November 15, 2011.
Lisa Thompson is assistant professor, Department of Clinical Pharmacy, University of Colorado Denver School of Pharmacy, Aurora, Colorado.
