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Ministry Status: Routine Monitoring and Engagement

Ontario Health Insurance Plan

OHIP Bulletins

Physician Services InfoBulletins

To:  Prescribers with the Authority to Prescribe Controlled Drugs

Published by:   Ontario Public Drug Programs

Date Issued:  July 19, 2016

Corresponding Bulletin Reference Number:  4675

Re:   Important Notice Regarding Changes to the Ontario Drug Benefit (ODB) Program Funding of Opioid Medications

PDF Version Portable Document Format

Questions & Answers

1.  What changes to funding of opioid medications will take place with the January 2017 Ontario Drug Benefit (ODB) Formulary/Comparative Drug Index update?

Effective with the January 2017 ODB Formulary update, the following changes to funding of opioid medications will be made:

  • Higher strengths of long-acting opioids will be de-listed from the ODB Formulary:
    • Morphine 200 mg tablets;
    • Hydromorphone 24 mg and 30 mg capsules;
    • Fentanyl 75 mcg/hr and 100 mcg/hr patches; and
  • Meperidine 50 mg tablets will be de-listed from the ODB Formulary.

For the list of affected products to be removed from the ODB Formulary (by Drug Identification Number [DIN]), please consult Table 1 below.

Table 1: Products that will be de-listed from the ODB Formulary effective with the January 2017 Formulary update
Drug Name Drug Identification Number (DIN) Manufacturer
MS Contin 200 mg SR Tab 02014327 Purdue Pharma
Novo-morphine SR 200 mg 02302802 Novopharm
M-Eslon 200 mg ER Cap 02177757 Ethypharm Inc.
Hydromorph Contin 24 mg 02125382 Purdue Pharma
Hydromorph Contin 30 mg 02125390 Purdue Pharma
Fentanyl transdermal patch 75 mcg 02314657 Apotex
Fentanyl transdermal patch 75 mcg 02386887 Cobalt
Fentanyl transdermal patch 75 mcg 02396734 Mylan
Fentanyl transdermal patch 75 mcg 02341409 Pharmascience
Fentanyl transdermal patch 75 mcg 02330148 Ranbaxy
Fentanyl transdermal patch 75 mcg 02327155 Sandoz
Fentanyl transdermal patch 75 mcg 02282976 Teva
Fentanyl transdermal patch 100 mcg 02314665 Apotex
Fentanyl transdermal patch 100 mcg 02386895 Cobalt
Fentanyl transdermal patch 100 mcg 02396742 Mylan
Fentanyl transdermal patch 100 mcg 02341417 Pharmascience
Fentanyl transdermal patch 100 mcg 02330156 Ranbaxy
Fentanyl transdermal patch 100 mcg 02327163 Sandoz
Fentanyl transdermal patch 100 mcg 02282894 Teva
Demerol 50 mg tab 02138018 Sanofi Aventis Pharma

2.  Why is the ministry making these changes?

The inappropriate use, abuse, and diversion of prescription narcotics has emerged as an imminent public health and safety issue in Canada and other jurisdictions around the world. After the transition from OxyContin as a Limited Use benefit to OxyNEO reimbursement through the ODB program's Exceptional Access Program (EAP), the ministry made a commitment to review the funding status of the other opioid medications and make changes as necessary to improve and encourage appropriate prescribing.

For this purpose, a Pain Medication Formulary Review Subcommittee (the Pain Subcommittee) was convened to conduct a class review of narcotic medications prescribed for pain management. Members included clinical experts in pain, addiction, palliative care, clinical pharmacology, internal medicine, family practice, and pharmacy.

Based on extensive discussions with the Pain Subcommittee as well as further consideration of their recommendations by Ontario's expert advisory committee, the Committee to Evaluate Drugs (CED), and a detailed analysis of opioid utilization trends, the ministry will implement the above changes, effective with the January 2017 ODB Formulary update.

These changes are designed to encourage the appropriate use of opioids, improve patient care and help address the growing problem of opioid addiction in Ontario. The subcommittee indicated that lower opioid doses may improve patient outcomes. Since many patients on high doses may be considered ‘opioid failures’, tapering or withdrawing opioid treatment may result in improved mood, pain and function, with less sedation, fatigue, constipation, etc. For a complete summary of the rationale behind these changes, please refer to Table 2 below.

Table 2: Pain subcommittee rationale for pain medication review recommendations
Drug Name/ Type Recommendation Rationale
Higher-strengths of long-acting opioids De-list High-dose opioid prescribing is defined as any dose exceeding the equivalent of morphine 200 mg/day by the 2010 Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-cancer Pain.

This dose is the "watchful dose" above which there is little evidence to demonstrate improved pain management while being strongly associated with adverse events, addiction and opioid-related mortality. The subcommittee recommended that all high-dose formulations of long-acting opioids be delisted. This is consistent with the decision not to fund the high dose strengths (60 mg and 80 mg) of OxyNEO.
Demerol (meperidine) De-list Meperidine is a very old drug that is currently listed on the ODB Formulary as a Limited Use benefit, "Limited to 2 weeks supply for acute pain." It is not indicated for chronic pain and long-term use is contraindicated. Meperidine is associated with significant neurotoxicities (metabolized to normeperidine which is a neurotoxin), especially in patients with reduced renal function. Its addiction potential is similar to other opioids.

Given the many treatment alternatives that have now become available for acute pain management and the safety concerns with long-term use of meperidine, the subcommittee concluded that there is no therapeutic role for meperidine.

3.  Will the products that are being delisted from the ODB Formulary be eligible for reimbursement through the Exceptional Access Program or Compassionate Review Policy?

No – there will be no consideration of delisted products under the EAP or through the Compassionate Review Policy (CRP). The notification of these changes is being made 6 months in advance of implementation, to provide adequate time for patients to consult with their physicians regarding required changes to their drug therapy. Physicians should initiate this discussion as soon as possible with any patients affected by these changes.

4.  What is the Exceptional Access Program?

The EAP facilitates patient access in exceptional circumstances to drugs not listed on the Formulary which may be at higher risk of inappropriate utilization, be less cost-effective, and/or which should only be considered where formulary drugs were ineffective, not tolerated, or where no listed alternative was available. To apply through the EAP, a physician must submit a request documenting complete and relevant medical information to the ministry, and provide the clinical rationale for requesting the unlisted drug and reasons why covered benefits are not suitable. All requests are reviewed according to the guidelines and criteria approved through an established process involving experts and expert committee evaluations and approved by the Executive Officer. For more information about the EAP, please visit the ministry website.

5.  Where can I find information to support tapering and/or transitioning patients from the high-dose opioids that will be delisted from the ODB Formulary?

Physicians should consult available resources for support in transitioning and/or tapering patients, where required. One such resource is the 2010 Canadian Guidelines for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain.

6.  Who can I contact if I have additional questions?

If you require further clarification or have questions regarding this matter, please send your question(s) to PublicDrugPrgrms.moh@ontario.ca or call the telephone numbers provided below.

For Health Care Providers and the Public:

Please call ServiceOntario
Infoline at 1-866-532-3161
TTY 1-800-387-5559
In Toronto, at TTY 416-327-4282

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For More Information

Call ServiceOntario, Infoline at:
1-866-532-3161 (Toll-free)
In Toronto, (416) 314-5518
TTY 1-800-387-5559.
In Toronto, TTY 416-327-4282
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