Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Fentanyl Transdermal Systems - New Changes to the Dose Conversion Guidelines - For Health Care Professionals

Starting date:
March 8, 2010
Posting date:
March 10, 2010
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-170002268

This is duplicated text of a letter from Janssen-Ortho Inc., Cobalt Pharmaceuticals Inc., Teva Canada Limited, Ranbaxy Pharmaceuticals Canada Inc., ratiopharm inc., Sandoz Canada Inc. and Pharmascience Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Fentanyl
Transdermal Systems

March 8, 2010

Dear Health Care Professional,

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 60mg/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 Health Care 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

Table 1.1Table 1.1 footnote 1: Dose Conversion Guidelines
To be used to convert from current opioid analgesic to the Fentanyl Transdermal Systems (FTS)
Current Analgesic Daily Dosage (mg/d)

Table 1.1 footnotes

Table 1.1 footnote 1

Table 1.1 should not be used to convert from DURAGESIC and other FTS to other therapies because this conversion to Duragesic and other FTS is conservative. Use of Table 1.1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible (see Dosage and Administration, Safe Use of Tables 1.1, and 1.2).

Return to table 1.1 footnote 1 referrer

Table 1.1 footnote 2

NA (not applicable) reflects insufficient data available for guidance. If needed, prescribers should make these conversions very carefully and conservatively.

Return to table 1.1 footnote 2 referrer

Table 1.1 footnote 3

The conversion ratio of parenteral hydromorphone to oral hydromorphone of 1:2 is based on clinical experience in patients with chronic pain. Reference: Parenteral Drug Therapy Manual, Vancouver General Hospital, Pharmaceutical Sciences Clinical Services. 2006.

Return to table 1.1 footnote 3 referrer

Oral morphine 60-134 135-179 180-224 225-269 270-314 315-359 360-404
IM/IV morphine (based on a 1:3 IM/IV:PO ratio) 20-44 45-60 61-75 76-90 NATable 1.1 footnote 2 NATable 1.1 footnote 2 NATable 1.1 footnote 2
Oral oxycodone 30-66 67-90 91-112 113-134 135-157 158-179 180-202
Oral codeine 150-447 448-597 598-747 748-897 898-1047 1048-1197 1198-1347
Oral hydromorphone 8-16 17-22 23-28 29-33 34-39 40-45 46-51
IV hydromorphoneTable 1.1 footnote 3 4.0-8.4 8.5-11.4 11.5-14.4 14.5-16.5 16.6- 19.5 19.6-22.5 22.6-25.5
  ↓↓ ↓↓ ↓↓ ↓↓ ↓↓ ↓↓ ↓↓
Recommended Fentanyl Transdermal System (FTS) Dose 25 mcg/h 37 mcg/h 50 mcg/h 62 mcg/h 75 mcg/h 87 mcg/h 100 mcg/h

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.