CSHP Advises Health Canada on Heparin Shortage
On December 5th 2019, Health Canada made an announcement that will alleviate the premixed heparin shortage in Canada’s drug supply and help hospitals ensure an ongoing supply of the drug for patients.
In light of information provided by members of its Tier Assignment Committee (TAC), Health Canada considered the recent B. Braun premixed heparin shortage as a Tier 3 shortage, thus allowing the product to be imported to Canada as a medically necessary drug. Tier 3 shortages can potentially present the greatest impact on the Canadian drug supply and healthcare systems because of the scarcity/lack of alternative supplies, ingredients or therapies. The absence of therapeutic alternatives marketed in Canada and a manufacturer/importer’s inability to meet demand for the drug is the baseline criteria for a Tier 3 shortage.
The status of heparin had been in limbo after Health Canada cited a B. Braun manufacturing plant in 2018 as being non-GMP compliant. This temporary status put a halt on B. Braun’s ability to import any products manufactured at the plant into Canada which resulted in the shortage. At the time, Health Canada did not consider premixed heparin to be a medically necessary drug. The government pointed to the availability of other forms of heparin on the Canadian market, specifically 10,000 unit/mL vials that could be used to manufacture premixed heparin in-house.
In November 2019, the Tier Assessment Committee met to determine if Tier 3 status applied to the heparin drug shortage, and committee members, including the Canadian Society of Hospital Pharmacists’ (CSHP) Chief Pharmacy Officer, Christina Adams, gave their professional opinion on the situation. During the meeting, Adams and other members of the TAC explained the difficulties in manufacturing heparin in-house and how most hospitals would not be able to ramp up production at a moment’s notice, nor could many hospitals even safely compound the medication at all. Some of the risks associated with preparing this high-alert medication in-house were:
- staffing levels not adequate to meet demand;
- adequate and proper sterile preparation areas not available;
- risks with product manipulations;
- potential compounding and calculation errors;
- potential product selection errors; and
- potential labelling errors.
Health Canada considered the information, and also held a multi-stakeholder call with Fresenius Kabi, Pfizer, Baxter, and Sandoz to discuss availability of therapeutic alternatives Heparin and 5% Dextrose, and their ability to cope with an increase in demand.
It was determined that the heparin shortage would be considered a Tier 3 shortage. Subsequently, B. Braun was allowed to resume importing the product to Canada.
“It was important that CSHP was at the table for this decision,” said Adams. “Hospital pharmacists are on the front lines of premixed drug shortages and know the effect they have on patient care. I’m really pleased we could share our expertise so that suppliers could meet Canadian needs by bringing in necessary and appropriate medications for Canadian hospitals.”