Drug shortages: Can we resolve that problem?

Abstract

Although drug shortages have been an issue for several years, based on the unavailability of a number of drugs, 2012 has been the worst year for drug shortages in recent memory. The results of the national survey by Hall et al. published in this issue of the Journal highlight that fact. This increase in drug shortages is due in no small part to the unplanned partial closure of the Sandoz plant (Boucherville, QC, Canada) in early February 2012 and the downstream consequences of such a closure. It would be easy to blame Sandoz for all the problems relating to their poorly planned decision, but there are many factors that help explain why we are in such a difficult situation today. Recent publications have summarized some of the causes of drug shortages, not only in Canada but also in the United-States and Europe. Issues regarding the availability of raw material, especially when obtained outside of North America, can cause disruptions in the manufacturing process. At the manufacturing level, there are problems such as surge capacity limitations, inspection failures, outdated equipment, and voluntary recalls for batches not meeting the standards of good manufacturing practices. When the American Food and Drug Agency tightens the regulatory requirements for drug manufacturing plants that distribute to the USA, such regulations affect Canada when the same plant produces drugs for our market. Business and market factors also affect the vulnerability of the system. Having more and more generic drugs produced by only one manufacturer (also called ‘‘sole source’’ drugs) in Canada decreases alternate options when the manufacturer faces a drug shortage. Large contracts with group purchasing organizations (GPO) also reduce the incentive for other manufacturers to continue producing a drug that has not won an award with the GPO. The Canadian government is also changing some of its regulatory requirements, which is slowing down the approval of manufacturing changes requested by drug companies. The result is a longer time needed to implement improvements and potentially being unable to meet current demand. There are many drugs on the lists of drug shortages in Canada and the USA. On February 24, 2013, the drug shortage section of the Web site for the American Society of Health-System Pharmacists (ASHP) listed 238 drugs that were affected by a shortage. On the same date, the Canadian Web site www.drugshortages.ca listed 282 formulations. These lists are getting longer every year, yet no clear strategy is in place to help reduce or eliminate them. At the Drug Shortages Summit in November 2010, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the ASHP, and the Institute for Safe Medication Practices met to discuss different aspects of the problem and to develop an action plan. The following top three drug shortage difficulties were identified: the absence of information on the duration of a specific shortage, the lack of advance warning of an impending problem, and the absence of information on the cause of the shortage. In Canada, the Sandoz partial closure has put pressure on the provincial and federal governments to improve our regulatory system relating to drug approval. It has also shone the spotlight on an issue that has been growing in recent years but, until recently, was not publicly known. The survey by Hall et al. is significant for the fact that it measured, quite by chance, the impact of the Sandoz partial closure in the early days of the shortage crisis in February M. Bedard, PharmD, RPh (&) Department of Pharmacy, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada e-mail: mbedard@toh.on.ca