Importation of US-Labelled Pancuronium Bromide Injection Due to Shortage of Neuromuscular Blocker Products
- Starting date:
- April 29, 2020
- Posting date:
- April 29, 2020
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Labelling and Packaging, Important Safety Information
- Audience:
- Healthcare Professionals, Hospitals
- Identification number:
- RA-72911
Last updated: 2020-04-29
Audience
Healthcare professionals including pharmacists, anesthesiologists, critical care physicians, emergency physicians and those involved with administering anesthesia or intubating patients.
Key messages
- There is an unprecedented demand and shortage of neuromuscular blocker (NMB) products in Canada as a result of the COVID-19 pandemic.
- Pancuronium Bromide Injection, USP is a non-depolarizing NMB agent that is not currently authorized for use in Canada; however, Health Canada has permitted the exceptional importation and sale of this US-labelled product to mitigate shortages of NMB products in Canada.
- US-labelled Pancuronium Bromide Injection, USP DOES NOT HAVE a distinctive red ferrule (metal seal on vial) with white lettering: "WARNING: PARALYZING AGENT" OR "PARALYZING AGENT" (see Appendix A).
- Healthcare professionals should be aware of the potential risk of errors resulting from inadvertent selection and administration of NMB, resulting in serious harm to patients.
- Proper selection of intended product must be confirmed to avoid confusion with other injectable solutions.
Issue
There is an unprecedented demand and shortage of neuromuscular blocker (NMB) products in Canada as a result of the COVID-19 pandemic.
Pancuronium Bromide Injection, USP is a non-depolarizing NMB agent that is not authorized for use in Canada; however, Health Canada has permitted the exceptional importation and sale of this US-labelled product to mitigate shortages of NMB products in Canada.
Products affected
Pancuronium Bromide Injection, USP (US-Labelled)
1 mg/mL Solution for Injection
Background information
Pancuronium bromide is indicated in the United States as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
For information on appropriate use of pancuronium bromide including dosage and administration, please refer to the US Pancuronium Bromide Prescribing Information.
Who is affected
Information for healthcare professionals
This drug should be administered by appropriately trained healthcare professionals familiar with its actions, characteristics, and hazards.
In Canada, neuromuscular blockers are commonly supplied with a distinctive red ferrule (metal seal on vial) with white lettering: "Warning: Paralyzing Agent" or "Paralyzing Agent". Canadian healthcare professionals who administer NMBs are accustomed to this labelling and packaging practice, which has been adopted by industry as a strategy to readily identify NMBs so that they are not confused with other products.
Foreign NMB products may have ferrules that aren’t red. This is the case for US-labelled Pancuronium Bromide Injection, USP (see Appendix A). This non-standard labelling and packaging may increase the risk of errors in which NMBs are inadvertently selected and administered to patients.
Health Canada is aware of domestic and international reports of NMB mix-ups causing serious harm including death; some of these errors are related to differences in the labelling and packaging of these products.
Proper selection of intended product must be confirmed to avoid confusion with other injectable solutions.
For complete product information, please refer to the US Pancuronium Bromide Prescribing Information.
Action taken by Health Canada
The Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. Drugs included on the List of Drugs for Exceptional Importation and Sale referenced in the Interim Order are eligible for the exceptional importation and sale provisions provided for in the Interim Order. Health Canada has added Pancuronium Bromide Injection, USP to this list, which permits the importation and sale of US-labelled Pancuronium Bromide Injection.
Health Canada has worked with Pfizer Canada ULC to prepare this alert for Pancuronium Bromide. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect⢠e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Pancuronium Bromide Injection should be reported to Pfizer Canada ULC or Health Canada.
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
To correct your mailing address or fax number, contact Pfizer Canada ULC.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
⢠Calling toll-free at 1-866-234-2345; or
⢠Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Product Directorate
E-mail: hc.mhpd-dpsc.sc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Sincerely,
Original signed by
Vratislav Hadrava M.D., Ph.D.
Vice President & Medical Director
Pfizer Canada ULC
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