By Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor
Recent news is plentiful with stories about how local hospitals and physician practices are struggling to provide their patients with drugs they critically need in today’s climate of drug shortages. In a previous eBulletin article, we described some ways to cope with the ever-expanding list of drugs that are in short supply. According to the FDA Drug Shortages website, three additional drugs (daunorubicin, thiotepa, and vincristine) have been added to the list of injectable drugs that are in short supply and used for the active treatment of cancer since that article was written. The shortage resolved for one drug previously on the list, which is carmustine. The list of oncology drugs currently experiencing a shortage stands as follows:
As you can see, many of the drugs on this list are critical pieces of well-established chemotherapy regimens. In the short term, the US Food and Drug Administration (FDA) has some ability to help resolve some shortages. However, this ability is somewhat limited, especially if the cause of the shortage is due to circumstances beyond their control. Nonetheless, the FDA may be able to expedite the review of submissions by manufactures for a new product or manufacturing change that, if approved, may help to increase the supply of the drug that is currently experiencing a shortage. Additionally, the FDA works with manufacturers to identify sources of raw material or encourage others to increase production of the drug. Lastly, the FDA can utilize enforcement discretion to temporarily allow the importation of a drug from other countries, although the FDA has maintained that this practice is rare.1 Interestingly, it appears that the FDA is considering allowing the importation of certain oncology products (e.g., cytarabine, thiotepa).2, 3
Recently, legislation that may offer some long-term relief to this crisis was introduced to Congress. The “Preserving Access to Life Saving Medications Act (S. 296)” proposes to establish an early warning system so that manufacturers must report to the US Food and Drug Administration (FDA) on conditions that would likely result in a drug shortage. It also would provide the FDA with the power to impose financial penalties for manufacturers who fail to comply with this reporting.
As more drugs are added to the list of those in short supply, there is growing concern among the public regarding how patients are affected by these shortages. Hopefully, the actions of the FDA and Congress will relieve some of these problems and we will again see an adequate supply of these important medications.
1 Jensen V, Kimzey LM, Goldberger MJ. FDA’s role in responding to drug shortages. Am J Health-Syst Pharm. 2002;59:1423-5.
2 Adienne Pharma & Biotech. Urgent - Thiotepa Update. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM251666.pdf. Accessed May 26, 2011.
3 Dooreen JC. Shortage Worsens of Leukemia Drug. The Wall Street Journal. April 14, 2011. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM251666.pdf. Accessed May 26, 2011.