Drug shortages in health care institutions: perspectives in early 2014.

Abstract

The year 2012 was marked by an unprecedented number of drug shortages in Canada. This crisis was due in particular to the publication, in November 2011, of a warning letter from the US Food and Drug Administration (FDA) to Novartis International AG for its Boucherville plant, which was managed by Sandoz Canada.1,2 Although Sandoz was not the only drug manufacturer with shortages for some products, the wide range of single-source generic parenteral products affected by this crisis led to a high level of uncertainty in the Canadian health care sector. Since the publication of our most recent analysis of the Canadian drug shortage situation,3 the FDA has issued at least one other warning letter, this time to Apotex, a Canadian generic manufacturer.4 In 2012, our research group evaluated the impact of drug shortages in 5 Quebec teaching hospitals and highlighted administrative costs of at least Can$0.5 million to manage these shortages, mainly at the level of individual pharmacies.5 Barthelemy and others6 also published a case study of the management of drug shortages in hospitals, illustrating the challenges for pharmacists and the risks for patients. In response to this crisis, many stakeholders (including the Standing Committee on Health, the Royal College of Physicians and Surgeons of Canada, the Ordre des pharmaciens du Quebec, the Canadian Pharmacists Association, and the group purchasing organization SigmaSante) came together in 2012 and made a set of recommendations to various levels of government, buying groups, supply chains, the pharmaceutical industry, and individual pharmacists.7 Surprisingly, only one-third of the 30 recommendations had been implemented 1 year later.7 In June 2013, a Member of Parliament from the New Democratic Party of Canada proposed a private member’s bill on the mandatory disclosure of drug shortages in Canada,8 but this bill was defeated at second reading in February 2014. In September 2013, Health Canada published a drug-shortage protocol and tool kit, based on the work of the Multi-Stakeholder Steering Committee on Drug Shortages.9 In its Appendix B, the protocol establishes a guide for drug-shortage notification and communication and lists the key relevant fields to be completed by drug manufacturers in the Canadian drug shortage database (www.drugshortages.ca). Pharmacists and various stakeholders, such as the Canadian Society of Hospital Pharmacists and group purchasing organizations, found this database to be incomplete and requested the addition of key data (e.g., number of similar commercialized products, links to other relevant information sources). Disappointingly, it took more than 24 months after initial consultations for these key data to be added as fields on the website for complete update by the manufacturers. Before then, these key data were available only on a website known as “FridayPM”. The FridayPM website, a voluntary, pharmacistinitiated tool launched in early 2011, was closed in August 2014, as drug manufacturers are now allowed by some group purchasing organizations to declare their drug shortages only on the Canad ian drug shortage platform.