Importation of US-Labelled Ketamine Hydrochloride for Injection due to Potential Shortage of Canadian-labelled Ketamine

Starting date:
May 6, 2020
Posting date:
May 6, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging, Product Safety, Supply, Important Safety Information
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-72987

Last updated:

Audience

Healthcare professionals including pharmacists, intensivists, anesthesiologists, critical care physicians, emergency physicians, dental surgeons and those involved with administering anesthesia or intubating patients.

Key messages

  • There is an unprecedented demand for ketamine hydrochloride injection in Canada as a result of the COVID-19 pandemic.
  • Ketamine hydrochloride is a rapid-acting, nonbarbiturate general anesthetic for intravenous and intramuscular administration. Given the medical necessity of ketamine in Canada, Health Canada has added US-labelled Ketamine Hydrochloride 500 mg/5 mL (100 mg/mL concentration) to the List of Drugs for Exceptional Importation and Sale.
  • Special attention is required to ensure correct patient dosing. US-labelled Ketamine Hydrochloride Injection (100 mg/mL) contains 10 times or 2 times higher concentration compared to Canadian-labelled ketamine hydrochloride injection products (10 mg/mL or 50 mg/mL, respectively).
  • Healthcare professionals are advised that:
    • Dosing calculations need to be modified to reflect the higher ketamine concentration (100 mg/mL)
    • This new concentration should be added to drug databases and other relevant systems as required
  • The 100 mg/mL concentration of ketamine should not be injected intravenously without proper dilution. It is recommended that the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water, to make its concentration to 50 mg/mL.
  • Healthcare professionals should visit Pfizer’s web site to access the US Prescribing Information, including additional dilution instructions.

    

Issue

There is an unprecedented demand for ketamine hydrochloride injection, in Canada as a result of the COVID-19 pandemic. Given the medical necessity of this product, Health Canada has added US-labelled Ketamine Hydrochloride 500 mg/5 mL (100 mg/mL concentration) in a 5 mL vial to the List of Drugs for Exceptional Importation and Sale in accordance with the Interim Order.

Ketamine hydrochloride is a rapid-acting, nonbarbiturate general anesthetic and the 100 mg/mL concentration 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 in Canada.

Products affected

Ketamine Hydrochloride Injection, USP (US Labelled)
500 mg/5 mL (100 mg/mL) in a 5 mL fliptop multi-dose vial format
Lot 10325DD

Background information

Indications and usage for Ketamine Hydrochloride Injection, USP, 500 mg/mL (100 mg/mL) are as follows:

  • Ketamine hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
  • Ketamine hydrochloride injection is best suited for short procedures, but it can be used, with additional doses, for longer procedures.
  • Ketamine hydrochloride injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.
  • Ketamine hydrochloride injection is indicated to supplement low-potency agents, such as nitrous oxide.

For information on appropriate use including dosage, dilution and administration, please refer to Ketamine Hydrochloride Injection, US Prescribing Information.

Who is affected

Information for healthcare professionals

In Canada, ketamine hydrochloride injection products are approved at concentrations of 10 mg/mL or 50 mg/mL. The Ketamine Hydrochloride imported from the US is a higher concentration, 500 mg/5 mL (100 mg/mL), which represents 10 times or 2 times higher concentration respectively compared to the concentration of Canadian marketed ketamine injectable products. Ketamine Hydrochloride Injection, USP, imported from the US should not be injected intravenously without proper dilution. The difference in the concentration of the foreign ketamine product may increase the risk of the wrong dose being administered and lead to overdoses.

The US-labelled ketamine hydrochloride injection is a higher concentration than the currently marketed ketamine products in Canada therefore:

  • Dosing calculations need to be modified to reflect the higher ketamine concentration (100 mg/mL)
  • This new concentration should be added to drug databases and other relevant systems as required
  • It is recommended that the 100 mg/mL US product be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water, to make it a 50 mg/mL concentration. Refer to the US Prescribing Information for additional dilution instructions.  Once diluted, this drug product can be used as other Ketamine Hydrochloride products on the Canadian market. For complete product information, please refer to Ketamine Hydrochloride Injection Prescribing Information.
     
  • Institutions should confirm that barcode systems provide correct information when the product is scanned. The barcode may not be appropriately recognized by scanning systems used in Canada.
     
  • Institutions should take extra care in the preparation and administration of this product.

Please see Appendix A for images of US-Labelled Ketamine Hydrochloride Injection.

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 Ketamine Hydrochloride Injection, USP to this list, which permits the importation and sale of US-labelled Ketamine Hydrochloride Injection.

Health Canada has worked with Pfizer Canada ULC to prepare this alert for Ketamine Hydrochloride. 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 healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Ketamine Hydrochloride 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:

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Enforcement Branch
E-mail: hc.hpce-cpsal.sc@canada.ca

Sincerely,

Original signed by

Vratislav Hadrava M.D., Ph.D.
Vice President & Medical Director
Pfizer Canada ULC

Images

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