Important Safety Information - Importation of Teva UK-labelled Salamol CFC-Free (Salbutamol Sulfate) Inhaler due to Shortage

Starting date:
May 13, 2020
Posting date:
May 13, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Supply, Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-73095

Last updated:

Audience

Healthcare professionals including pharmacists, and primary care, hospital and long term care physicians and nurses

Key messages

  • There is an increased demand and shortage of salbutamol inhalers in Canada due to the COVID-19 pandemic.
  • Health Canada is allowing the importation of a limited supply of Teva’s UK-labelled salbutamol inhaler (100 mcg per metered dose) to help alleviate the current shortage of this product.
  • The UK-labelled salbutamol inhalers have the same active ingredient and are identical in concentration as salbutamol inhalers on the Canadian market, and are used in a comparable way.
  • Healthcare professionals are advised that the preparation for use instructions for the UK-labelled salbutamol inhaler differ from those for the Canadian inhalers. To ensure that it is working properly, the UK-labelled inhaler requires 2 sprays to be released into the air before using it for the first time, or if it has not been used for 5 days or more.
  • Healthcare professionals are also advised to follow Canadian dosing recommendations when using, prescribing, or dispensing UK-labelled salbutamol inhaler for children 4–11 years of age: maximum 4 sprays (400 mcg salbutamol) per day. The maximum recommended daily dosage on the UK-labelled salbutamol inhaler indicates 8 sprays per day.
  • Pharmacists and other healthcare professionals are reminded to:
    • Inform patients that they are receiving a UK-labelled product, which delivers the same labelled dose of the same active ingredient as the Canadian product.
    • Print this communication and make it available to patients and caregivers upon dispensing the UK-labelled product.
    • Review the preparation for use instructions for the UK-labelled inhaler with the patient when dispensing this product and advise to follow the UK-labelled instructions for inhaler preparation.
    • Remind caregivers to follow the Canadian labelled maximum recommended daily dose for children 4-11 years of age: maximum 4 sprays (400 mcg salbutamol) per day.
    • Supply only one inhaler at a time when patients refill their prescription, to manage and conserve supply.
    • Consult the Canadian product monograph for other prescribing information as well as important safety information on salbutamol inhalers at Health Canada's Drug Product Database.

   

Issue

Increased demand for salbutamol inhalers due to the COVID-19 pandemic has led to reported shortages and limited supply of this product in Canada.

In consultation with Health Canada and stakeholders, and given the medical necessity of salbutamol in Canada, limited stock of Teva’s UK-labelled salbutamol inhaler (100 mcg per metered dose) has been imported to help alleviate the current shortage in Canada. Health Canada has expressed no objection to this importation.

Products affected

UK-labelled product: Salamol CFC-Free (Salbutamol Sulfate Pressurised Inhalation Suspension) 100 mcg salbutamol per metered dose, manufactured by IVAX Pharmaceuticals Ireland (Teva Pharmaceutical Industries)

The UK-labelled product identifier is PL 00530/0555.

Background information

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

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

Increased demand for salbutamol inhalers due to the COVID-19 pandemic has led to reported shortages and limited supply of this product in Canada.

Who is affected

Information for consumers

Salbutamol is used in adults and children 4 years of age and older to relieve and prevent bronchospasm (a sudden worsening of shortness of breath and wheezing) due to bronchial asthma, chronic bronchitis or other chronic lung disorders and to prevent bronchospasm caused by exercise.

Some manufacturers have reported shortages of this product on Drug Shortages Canada because of an increase in demand, and given the medical necessity of salbutamol, related to the current COVID-19 pandemic. At this time, to manage and conserve supply, most patients will receive only one inhaler at a time when they go to refill their prescription.

Health Canada has permitted the exceptional importation of UK-labelled salbutamol to help alleviate the shortage. Both Canadian and UK-labelled salbutamol inhalers are used in a comparable way. Preparation for use instructions for the UK-labelled inhaler are different from the Canadian inhaler. Before using the UK-labelled inhaler for the first time, or if it has not been used for 5 days or more, release 2 sprays into the air to ensure it is working properly. Follow Canadian dosing recommendations when using UK-labelled salbutamol inhaler for children 4–11 years of age: maximum 4 sprays (400 mcg salbutamol) per day. The maximum recommended daily dosage on the UK-labelled salbutamol inhaler indicates 8 sprays per day.

Patients should contact their healthcare professional for more details on this new safety information.

Information for healthcare professionals

The UK-labelled salbutamol inhalers have the same active ingredient and are identical in concentration as salbutamol inhalers on the Canadian market, and are used in a comparable way. Healthcare professionals are advised that the preparation for use instructions for the UK-labelled salbutamol inhaler may differ from those for the Canadian inhalers. Before using the UK-labelled salbutamol inhaler for the first time, or if it has not been used for 5 days or more, 2 sprays should be released into the air to ensure it is working properly.

Healthcare professionals are also advised to follow Canadian dosing recommendations when using, prescribing, or dispensing UK-labelled salbutamol inhaler for children 4–11 years of age: maximum 4 sprays (400 mcg salbutamol) per day. The maximum recommended daily dosage on the UK-labelled salbutamol inhaler indicates 8 sprays per day.

Pharmacists and other healthcare professionals are reminded to:

  • Inform patients that they are receiving a UK-labelled product.
  • Print this communication and make it available to patients and caregivers upon dispensing the UK-labelled product.
  • Review the preparation for use instructions for the UK-labelled inhaler with the patient when dispensing this product.
  • Remind caregivers that the maximum recommended daily dose is 4 sprays for children 4-11 years of age. 
  • Supply only one inhaler at a time when patients go to refill their prescription, to manage and conserve supply.
  • Consult the Canadian product monograph for prescribing information as well as important safety information on salbutamol inhalers at Health Canada's Drug Product Database.

Action taken by Health Canada

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 will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare providers and consumers reporting adverse reactions and medical device incidents. Any adverse reaction in patients receiving Salamol CFC-Free should be reported to Teva Canada Limited or Health Canada.

Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Telephone:
1-800-268-4127, Option 3
Email: PhV@tevacanada.com
Fax: 1-416-335-4472

To correct your mailing address or fax number, contact Teva Canada Limited.

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

Original signed by

Didier Reymond, MD
Country Medical Director
Teva Canada