Information Update - Health Canada provides information on shortage of injectable sodium bicarbonate products in Canada

Starting date:

June 17, 2017

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Supply

Audience:

General Public

Identification number:

RA-63654

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  Media enquiries
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  Public enquiries

June 17, 2017

For immediate release

OTTAWA – Health Canada is informing Canadians of the current shortage of injectable sodium bicarbonate product in Canada. Sodium bicarbonate is used in the treatment of a wide range of ‎conditions including metabolic acidosis (buildup of acid in the blood), in open heart surgery, as an antidote to certain poisons, in cases of organ failure, and in some types of cancer chemotherapy. It is administered by health care professionals, usually in a health setting.

On June 14, 2017, Pfizer Canada informed Health Canada that it was voluntarily recalling two lots of 8.4% sodium bicarbonate injection, USP, 50 mL vials, because of possible microbial contamination in the manufacturing process. While Pfizer estimates that the likelihood of contaminated product reaching the patient is low, the risk was sufficient to recall all vials from these two lots. The recall does not affect the pre-filled syringe format.

The global supply of the vials has been tight since late May due to manufacturing delays. The recall means that the product is now in shortage in Canada and around the world.

There are two injectable sodium bicarbonate drugs authorized in Canada, both supplied by Pfizer: vial format and pre-filled syringes.

Pfizer has informed Health Canada that it will be issuing an updated communication to customers about the recall and supply situation early next week. Information is also available on DrugShortagesCanada.ca. Health care professionals can also contact the company directly.

The health and safety of Canadians is Health Canada’s first priority. We recognize that these products can play a critical role in patient care. We are working closely with the company, the provinces and territories as well as other partners and stakeholders to reduce the impact of the shortage on Canadian patients. We are gathering information about the supply situation and possible mitigation strategies, including alternative sources of supply. Locating alternative supply may be challenging in an international shortage situation. We are in contact with the U.S. Food and Drug Administration regarding the shortage experienced in its jurisdiction and to share information on possible risk mitigation measures. We are also monitoring the recall.

Pfizer has advised Health Canada that it is implementing a strict allocation strategy to prioritize the available supply of pre-filled syringes, which can be used as an alternative to the vials. The company has reported that additional supply of the pre-filled syringes is anticipated in late July or the first week of August. Until the supply situation is resolved, Pfizer has asked hospitals to restrict their inventory and future orders to life-saving procedures and critical emergency use only.

Patients with questions or concerns about the shortage should speak to their health care professional, and are encouraged to report health product adverse events or complaints to Health Canada.

Addressing drug shortages is a multi-stakeholder responsibility requiring collaborative action from provinces and territories, manufacturers, distributors, practitioners, and the federal government. Health Canada works closely and collaboratively with these stakeholders to prevent drug shortages wherever possible, mitigate the effects of national drug shortages when they occur, and help to keep Canadians informed of the details and status of shortages so that they have sufficient time to adapt. We will continue to monitor this situation closely and work within the health system to minimize its effects on patient care.

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