Drug shortages in anesthesia and perioperative medicine: Canada needs a better supply system

Abstract

On February 15, 2012, Sandoz Canada notified pharmacies across Canada that it would be reducing the manufacturing capacity of its pharmaceutical manufacturing plant in Boucherville, Quebec while undertaking intensified remediation efforts. The company announced that it was taking these steps as a result of an inspection by the United States Food and Drug Administration (FDA) and a warning letter sent by the FDA in November 2011. Sandoz Canada also served notice that it would be discontinuing certain (unspecified) intravenous products in conjunction with this closure. The anticipated duration of the reduction in services is unknown, but it could likely be more than 18 months. On March 4, 2012, a fire in the boiler room of the Boucherville plant further reduced the plant capacity, and as a result, injectable drugs were being produced in limited amounts. Sandoz Canada supplies 80% of the market for generic injectable drugs in Canada, including many used in the delivery of anesthesia, critical care, and pain medicine. As a consequence of the tight supply chain between the manufacturer and hospital pharmacies, elective surgery cancellations were being reported almost immediately following the announcement. Physicians across Canada are stunned by this sequence of events and its considerable negative impact on the delivery of anesthesia and critical care medicine in Canada. Several factors must be considered to understand what has led to these events. First, as regards the actions by Sandoz, according to the news release cited above, Sandoz Canada had been duly notified of the FDA report and its recommendation of November 2011. Despite receiving this notification, Sandoz did not notify Canadian doctors of its decision to reduce drug production prior to the actual rampdown of production at the Boucherville plant. Even if we consider the time the company needed to evaluate the intensified remediation measures required at the Boucherville plant, the time lag suggests that alternative suppliers could have been notified and drug production could have been augmented at other facilities. Apparently, these steps could not be taken because the key stakeholders were not informed of the decision to reduce drug production until February 2012. While this decision may have made good business sense (as it served to protect the market share until the very last moment), it has exposed the Canadian population to the vagaries of an overly tight drug supply chain R. Hall, MD Dalhousie University and the Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada