Importation of Spanish-Labelled Salbutamol Aldo-Union inhalers due to Shortage of Canadian-Labelled Salbutamol

Starting date:
May 19, 2020
Posting date:
May 19, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety, Supply, Important Safety Information
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-73143

Last updated:

Audiences

Healthcare professionals including General Practitioners, Allergists, Pulmonologists, Respiratory disease specialists, Emergency physicians, Pharmacists

Key messages

  • There is an increased demand and shortage of salbutamol metered-dose inhalers (MDIs) in Canada due to the COVID-19 pandemic.
  • Given the medical necessity of salbutamol, Health Canada has added Spanish-labelled Salbutamol Aldo-Union metered-dose aerosol (100 mcg salbutamol /metered dose) to the List of Drugs for Exceptional Importation and Sale.
  • The Spanish-labelled salbutamol inhalers have the same active ingredient and strength as salbutamol inhalers on the Canadian market and are used in a comparable way.
  • While the label text of the imported salbutamol is in Spanish, a sticker will be added to the carton label including the distributor name (JAMP Pharma Corporation), contact information and unique bar code.
  • Healthcare professionals are advised that the preparation for use instructions for the Spanish-labelled salbutamol inhaler differ from those for Canadian inhalers. Before using the Spanish-labelled salbutamol inhaler for the first time, or if the product has not been used for several days or more, 1 spray should be released into the air away from the face to ensure it is working properly.
  • For salbutamol prescribing information, healthcare professionals should consult the product monographs for salbutamol inhalers on the Canadian market, available on Health Canada’s Web site

    

Issue

There is an increased demand for salbutamol metered-dose inhalers (MDIs) due to the COVID-19 pandemic, which has led to some manufacturers reporting shortages and limited supply of this product in Canada. 

Given the medical necessity of salbutamol, Health Canada has added Spanish-labelled Salbutamol Aldo-Union to the List of Drugs for Exceptional Importation and Sale

Products affected

Salbutamol Aldo-Union (Spanish labelled)
Salbutamol sulfate metered-dose aerosol
100 mcg salbutamol per actuation

Background information

In Canada, salbutamol sulfate inhalation aerosol is indicated in adults and children 4 years and older for:

  • the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in patients in whom reversible bronchospasm is a complicating factor.
  • the prevention of exercise-induced bronchospasm.

Who is affected

Information for patients

Manufacturers have reported salbutamol shortages because of an increase in demand related to the current COVID-19 pandemic. Some patients will receive the Spanish-labelled salbutamol inhaler, which is being imported into Canada to help alleviate the shortage. Both Canadian and Spanish-labelled salbutamol inhalers are used in a comparable way. At this time, to manage and conserve supply, most patients should receive only one inhaler at a time when they go to refill their prescription.

Patients should contact their healthcare professional for more information.

Information for healthcare professionals

The Spanish-labelled salbutamol inhaler has the same active ingredient and concentration as salbutamol inhalers on the Canadian market, and is used in a comparable way.

Healthcare professionals are advised that the preparation for use instructions for the Spanish-labelled salbutamol inhaler may differ from those for the Canadian inhalers. Before using the Spanish-labelled salbutamol inhaler for the first time, or if it has not been used for several days or more, 1 spray should be released into the air away from the face to ensure it is working properly.

Pharmacists and other healthcare professionals should:

  • Inform patients that they are receiving a Spanish-labelled product.
  • Print this communication and make it available to patients and caregivers upon dispensing the Spanish-labelled product.
  • Review the preparation for use instructions for the Spanish-labelled inhaler with the patient when dispensing this product.
  • Remind patients to continue to follow the same routine cleaning instructions as with the Canadian product.
  • Supply only one inhaler at a time when patients go to refill their prescription, to manage and conserve supply.
  • Consult the product monographs for salbutamol inhalers on the Canadian market, available on Heath Canada’s Web site for salbutamol prescribing information.

While the label text of the imported salbutamol is in Spanish, a sticker will be added to the carton label including the distributor name: JAMP Pharma Corporation, phone number, website and unique bar code.

Please see Appendix A for images of Spanish-labelled salbutamol product.

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 Spanish-labelled Salbutamol Aldo-Union to this list, which permits its importation and sale.

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 our website and 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 Salbutamol from Aldo-Union should be reported to JAMP Pharma Corporation or Health Canada.

JAMP Pharma Corporation
1310, Nobel,
Boucherville
QC J4B 5H3
Email: medinfo@jamppharma.com
Telephone: 1-866-399-9091
Fax: 1-866-399-9092

To correct your mailing address or fax number, contact JAMP Pharma Corporation.

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:

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

Original signed by

Patrizia Franco
Senior Director, Regulatory Affairs
JAMP Pharma Corporation

Images

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