Fentanyl Transdermal Systems - New Changes to the Dose Conversion Guidelines - Notice to Hospitals

Notice to Hospitals

Health Canada Endorsed Important Safety Information on Fentanyl Transdermal Systems

March 8, 2010

To: Hospital Chief of Medical Staff

Please distribute to relevant Departments of Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Family Medicine, Nursing, Intensive Care and/or other Departments as required, and other involved professional staff and post this Notice in your institution.

Subject: New changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems

The manufacturers of Fentanyl Transdermal Systems (FTS) in collaboration with Health Canada wish to provide you with important new information regarding changes to the Dose Conversion Guidelines (Table 1.1) in the Dosage and Administration section of the Canadian Product Monographs for FTS.

• A 1:3 parenteral to oral morphine dose ratio replaces the previous 1:2 parenteral to oral morphine dose ratio, (e.g. 10 mg parenteral morphine = 30 mg oral morphine).
• The conversion doses of IV/IM morphine to Fentanyl Transdermal Systems for the 75, 87 and 100 mcg/hour patch strengths were revised to 'not applicable' to reflect the insufficiency of data available for guidance.
• The revised Dose Conversion Guidelines are provided below for your information and should be retained for future use. Changes have been highlighted for ease of reference.

Fentanyl, an opioid analgesic, is indicated for the management of persistent, moderate to severe chronic pain that cannot be managed by other means such as opioid combination products or immediate-release opioids. Fentanyl is to be used only in patients who require continuous around-the-clock opioid analgesia for an extended period of time and who are already receiving opioid therapy at a total daily dose of at least 60 mg/day oral Morphine Equivalents.

Changes to the Dose Conversion Guidelines reflect an update to the earlier changes outlined in the January 2009 Notice to Hospitals and Letter to Healthcare Professionals. It should be noted that all Dose Conversion Guidelines are approximations, and knowledge of the overall clinical condition of the patient is critical for the selection of doses.

The Dose Conversion Guidelines are to be used to convert adult patients from their current oral or parenteral opioid analgesic only to the fentanyl transdermal patch. The Dose Conversion Guidelines are unidirectional for use in chronic pain only. They should not be used to convert patients from FTS to other opioids, as this may result in overdose and toxicity.

Dosage Conversion Guidelines for Fentanyl Transdermal Systems

Manufacturers of all fentanyl transdermal patches are working with Health Canada to include this safety information in the Dosage and Administration section in all Canadian Product Monographs for Fentanyl Transdermal Systems:

• Duragesic^® (fentanyl transdermal system)
• Duragesic^® MAT (fentanyl transdermal system)
• Teva-fentanyl
• ratio-Fentanyl Transdermal System
• Ran-Fentanyl Transdermal System
• Ran-Fentanyl Matrix Patch
• CO Fentanyl
• PMS-Fentanyl MTX
• Sandoz Fentanyl MTX Patch

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving fentanyl transdermal systems should be reported to the manufacturers or Health Canada at the following addresses:

Janssen-Ortho Inc.

Drug Safety Department

19 Green Belt Drive

Toronto, Ontario M3C 1L9

Telephone: 1-800-567-3331

Fax: 1-866-767-5865

dsscan@joica.jnj.com

Cobalt Pharmaceuticals Inc.

6500 Kitimat Road

Mississauga, Ontario L5N 2B8

Telephone: 1-866-254-6111

Fax: 905-542-0478

Teva Canada Limited

Pharmacovigilance and Drug Safety

30 Novopharm Court

Toronto, Ontario M1B 2K9

Telephone: 416-291-8888 ext. 5005

Fax: 416-335-4472

E-mail: PhV@tevacanada.com

Ranbaxy Pharmaceuticals Canada Inc.

2680 Matheson Blvd. East, Suite 200

Mississauga, Ontario L4W 0A5

Telephone: 1-866-840-1340

Fax: 905-602-4216

ratiopharm inc.

17800 Lapointe

Mirabel, Quebec J7J 1P3

Telephone: 1-800-337-2584

Fax: 1-800-313-7673

www.ratiopharm.ca

E-mail: drugsafety@ratiopharm.ca

Sandoz Canada Inc.

145, Jules Leger

Boucherville (Qc) J4B 7K8

Telephone: 1-800-343-8839 ext. 4636

Fax : 450-641-6408

E-mail: drugsafety.canada@sandoz.com

Pharmascience Inc.

Medical Information Dept.

6111 Royalmount Ave., Suite #100

Montreal, Quebec H4P 2T4

Telephone: 514-344-0764 or 1-888-550-6060

Fax: 514-340-0164

E-mail: adr@pharmascience.com

Any suspected adverse reaction can also be reported to:

Canada Vigilance Program

Marketed Health Products Directorate

Health Canada

Address Locator: 0701D

Ottawa, Ontario, K1A 0K9

Telephone: 613-957-0337 or Fax: 613-957-0335

CanadaVigilance@hc-sc.gc.ca

To report an Adverse Reaction, consumers and health professionals may call toll free:

Telephone: 1-866-234-2345

Fax: 1-866-678-6789

Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

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

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Please contact the appropriate manufacturer with any questions or concerns.

Authorized by:

Janssen-Ortho Inc.

Cobalt Pharmaceuticals Inc.

Teva Canada Limited

Ranbaxy Pharmaceuticals Canada Inc.

ratiopharm inc.

Sandoz Canada Inc.

Pharmascience Inc.