Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor
Drug shortages appear to have had an increasing impact on oncology practices in recent years. In 2009, a shortage of leucovorin was widely publicized, and the American Society of Clinical Oncology (ASCO) released a "Clinical Alert" that summarized the reasons for the shortage and offered some remedies1. ASCO reported that the shortage was due to manufacturing delays, and discussed using alternatives, such as levoleucovorin, oral leucovorin, and substituting capecitabine for fluorouracil/leucovorin combinations.
In a previous National Comprehensive Cancer Network® (NCCN®) eBulletin article, we described some survey data suggesting that most clinicians were able to meet their practice demands for the drug despite these shortages. However, cancer drug shortages are worsening, with 2010 being the worst year on record.2 According to the Food and Drug Administration’s (FDA) list of current shortages,3 the following drugs used in the treatment of cancer are currently in short supply:
According to the FDA, the reasons for these shortages are variable and include increased demand, manufacturing delays, and issues with raw materials. It’s important to note that most of the above products are generic, and therefore susceptible to shortages through manufacturer consolidations or business decisions to stop manufacturing the product.
To discuss and provide guidance on this issue, four professional organizations, the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), the American Society of Health-System Pharmacists (ASHP), and the Institute for Safe Medication Practices (ISMP) convened a Drug Shortages Summit on November 5, 2010.4 The discussion revolved around the causes and consequences of drug shortages, and recommendations were offered in four main categories of factors that contribute to drug shortages: 1) regulatory and legislative, 2) raw materials and manufacturing, 3) business and market, and 4) distribution. Next steps include the formation of working groups to create detailed action plans based on these recommendations. The full summary report of the Summit is available at: http://www.ashp.org/drugshortages/summitreport.
In the interim, the question remains regarding how institutions and oncology practices will cope with these shortages. ASHP has published guidelines on how to manage drug shortages in hospitals and health systems.5 Although these guidelines are geared toward the institutional setting, some of the strategies are also applicable toward oncology practices. In addition to assessing current inventory supplies and searching for alternative sources for the drug, clinicians should be prepared to use therapeutic alternatives.
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) can be a useful resource to determine alternative therapies. Depending on the clinical situation, alternatives with similar efficacy may be available for the aforementioned drugs in short supply. Unfortunately, alternative therapies may not always be available for certain patient groups. In these scenarios, ASHP recommends prioritizing the limited supply of drugs based on clear criteria developed by a multidisciplinary team. This strategy may be helpful if these shortages become long-term.
Of note, ASHP guidelines state that stockpiling drugs in anticipation of a shortage can worsen or create a shortage when one did not exist (i.e., by depleting the existing supply inventory). Additionally, stockpiling is expensive, and it is possible that the institution will be left with an excess of inventory if the shortage is not severe. As drug shortages become more prevalent, it is likely that regulatory and legislative changes will be necessary to provide long-term relief. The focus of this crisis should be on patient care and safety, and therefore communication and teamwork among health care providers and between clinicians and patients is essential and should be emphasized.
1Clinical Alert – Leucovorin Shortage. American Society of Clinical Oncology website. Available at: http://www.asco.org/ASCOv2/Department%20Content/Cancer%20Policy%20and%20Clinical%20Affairs/Downloads/Cancer%20Policy%20News/Cancer%20Policy%20Alert/Leucovorin%20Alert%208-5-2010.pdf. Accessed February 4, 2011.
2Traynor K. Drug Shortages Mount in 2010. Am J Health-Syst Pharm. 2010;67:1492-1494.
3 Current Drug Shortages. US Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm. Accessed February 1, 2011.
4 Summit Addresses Nation’s Drug Shortages Problems. American Society of Health-System Pharmacists website. Available at: http://www.ashp.org/import/news/pressreleases/pressrelease.aspx?id=605. Accessed February 2, 2011.
5 American Society of Health-System Pharmacists. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009;66:1399-406.