Canadian healthcare providers’ access to critical – and often life saving – medications may be severely hindered by a recent announcement that there is expected to be a long-standing supply disruption of several of products made by generic drug manufacturer, Sandoz Canada.
As a result, Medbuy, Canada’s longest-standing national healthcare group purchasing organization, which sources pharmaceuticals for many health facilities and authorities across the country, has been actively working with its membership and industry peers to share information regarding the affected products. This includes a recently launched web portal, so Members have any-time, on-demand access to the latest information.
“This is not an issue specific to one province, organization or individual,” says Medbuy’s Richard Jones, a long-time hospital pharmacist and vice president overseeing pharmacy sourcing and patient safety initiatives. “This drug supply issue is unprecedented in its scope – this is why we recommended from the outset that Canada’s GPOs work together cooperatively with Sandoz and regulatory bodies to share accurate information with our respective Members in a timely, consistent, concise and coordinated fashion.”
Jones says that information sharing is Medbuy’s primary focus as it allows hospitals to plan effectively in order to respond quickly. “Our collective commitment is to the patient first and to do what we can to stay on top of the issue. This ensures the right information is communicated throughout our membership and the industry…and thereby minimizing the impact of any supply shortage on patient outcomes.”
The Sandoz supply shortage stems from a U.S. Food and Drug Administration citation in November 2011 on operations at the drug manufacturer’s Boucherville, Quebec plant in addition to two others based in the United States. In response, Sandoz’s parent company Novartis AG, based in Switzerland, has supported an internal plan to scale back or stop production of all products at the plant, affecting the more than 260 products, including those not a part of the FDA citation. This includes generic injectable drugs such as morphine, hydromorphone, fentanyl, gentamycin, tobramycin, midazolam, heparin, isoproterenol, ondansetron, etc.
These products – used for surgery, treatment of infection and sedation that enables other procedures – will be available to hospitals in limited quantities. Hospitals are not alone in grappling with the issue as palliative care patients in long-term care, who rely on access to some of these medications, will also be affected. Moreover, some of these medications are also included in mandatory supplies for emergency medical services across the country.
The vast majority of the products from this plant are sterile injectables of which more than 140 are sole source to Canada, meaning no other manufacturer is available. The situation was further complicated by a recent fire at the plant, which is the only manufacturing site in Canada for these injectable drugs. In addition, for many of the affected products, Sandoz enjoys significant majority of the market share leaving other potential producers with little lead time and limited capacity to respond to potential large-scale demand.
“This is why it’s imperative that we continue to work collaboratively with our Members and industry groups, as well as maintain regular communication with Health Canada and provincial authorities, to minimize any effect on the safety of Canadian patients. We must also advocate for concrete steps to be taken that ensure a stable supply for the country,” notes Jones. “While some shortages have been reported, many hospitals have been able to confirm inventory, balance current supply with patient needs and work to identify therapeutic alternatives where available. It’s important that we continue to share information for these efforts in the coming weeks, while also looking for a longer-term solution.”
In a letter sent to Health Canada earlier this week, two of Canada’s largest GPOs (Medbuy and Sigma Santé) asked the government agency responsible for drug regulation and approval to not only undertake a review of Novartis AG’s response, but also permit products that meet therapeutic quality control requirements to be sold in Canada while Sandoz continues to resolve issues related to the FDA citation. The federal government should also expedite processes to enable products to be made available in Canada in response to this situation.
In the meantime, Medbuy is continuing to work with its Members and GPO peers in assisting hospital pharmacies to figure out how to best handle any shortages as well as serving as an information resource. We are also cooperating with several drug information services so acceptable therapeutic alternatives can be identified.
For more information please contact:
Vice President, Clinical Services, Patient Safety and Business Development
Tel: 519-652-1688 ext. 162