The new regulations:

• Prevent long-acting oxycodone products from being funded under the Ontario Public Drug Programs and/or designated as an interchangeable product, unless specific conditions are met. 
• Require a manufacturer of a long-acting oxycodone product to provide evidence satisfactory to the Ministry that the oxycodone product is manufactured in such a way to make it more difficult to alter, break, crush, chew, dissolve or otherwise manipulate; or less effective and less likely to be misused or abused, in the event that the product is altered, broken, crushed, chewed, dissolved, or otherwise manipulated.

Yes, generic long-acting oxycodone products may be made available to patients in Ontario under certain circumstances, if authorized by a prescriber.

However, generic long-acting oxycodone products that do not satisfy the regulatory requirements under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act will not be available for public funding. They also cannot be substituted by a pharmacist if the prescription is written for "OxyNEO" or "OxyContin" without first contacting the prescriber.

Long-acting oxycodone products that satisfies the regulatory requirements under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act will be considered for public funding and/or designation as an interchangeable product.

Currently, only OxyNEO will be reimbursed for Ontario Drug Benefit recipients. OxyNEO will be funded through the Exceptional Access Program (EAP) for treatment of chronic pain in patients who cannot tolerate treatment with another listed long-acting opioid and through the Facilitated Access to Palliative Care Drugs mechanism for the treatment of cancer-related pain, or pain in patients receiving end-of-life palliative care based on the funding criteria.

A patient who wishes to pay for a prescription for generic long-acting oxycodone or has a private insurance coverage will be able to obtain the product if authorized by a prescriber.  However, if a prescriber writes a prescription for "OxyContin" or "OxyNEO", a pharmacist cannot substitute the generic long-acting oxycodone product without first contacting the prescriber.

OxyNEO and OxyContin are two different brand names of the active ingredient oxycodone, which is indicated for the relief of moderate to severe pain requiring the continuous use of an opioid analgesic preparation for several days or more.

Although the active ingredients are the same, the OxyNEO tablet is manufactured differently than the OxyContin tablet.  OxyNEO is reported to be more tamper-resistant.than OxyContin because the tablet is more difficult to crush.  In addition, if OxyNEO is crushed and added to water, it results in the formation of a thick gel-like substance.

Patients are encouraged to speak with their primary health care provider on whether or not OxyNEO is an appropriate option to manage their pain.

Recent studies suggest that increased rates of opioid prescribing, particularly involving long acting oxycodone have contributed significantly to opioid-related harms, including hundreds of deaths in Ontario. Issues identified in these studies include excessive prescribing, increasing misuse, diversion of drugs away from intended medical purposes, increases in addiction, and increases in opioid-related deaths.

Ontario has the highest rate of opioid use in Canada. Between 1991 and 2009, the number of prescriptions in Ontario for oxycodone drugs rose by 900 per cent. Each year in Ontario, between 300 and 400 people die from overdoses involving prescription opioids.  While there are several factors that may contribute to death (in particular, high doses of opioids and use with alcohol or other depressant-type drugs), the opioid most commonly found on post-mortem analyses in recent years is oxycodone.  In addition, compared to other opioids available in Ontario, a disproportionate number of patients taking long-acting oxycodone receive doses in excess of national guidelines.

The ministry initiated a third party review of the Ontario Drug Benefit (ODB) claims data to look at the use of oxycodone long acting tablets.  The results of the study were concerning because of the high number of patients who are:

• started on long acting oxycodone after only trying short acting narcotics; or
• are being started on long acting oxycodone as an initial treatment

The current funding criteria require patients to start on another long acting opioid first before starting on long acting oxycodone due to concerns about appropriate use.

The ministry aims to increase the extent to which long acting oxycodone is prescribed in line with these criteria, while ensuring continued access to the drug for patients who require this as an option for managing their pain.  OxyNEO will be funded through the Exceptional Access Program (EAP) and through the Facilitated Access to Palliative Care Drugs mechanism based on the funding criteria.

These changes are based on recommendations from Ontario’s Committee to Evaluate Drugs, as well as extensive discussions with practicing pain specialists, addiction experts and other health care providers, and are designed to balance appropriate use, patient care and the growing problem of opioid addiction in Ontario.

The ministry anticipates that taking steps to change the funding status of oxycodone long acting tablets will serve to improve the quality and value of the overall health and safety of patients and the public.

Yes.  There are several opioid and non-opioid products that are available on the Formulary.  Some of these options are noted below:

Non-opioid:

• Acetaminophen
• non-steroidal anti-inflammatory products (e.g., ibuprofen, naproxen and many others)

Short acting opioid products or combination products:

• acetaminophen with codeine
• oxycodone preparations with acetaminophen or ASA
• short acting codeine products
• short acting morphine products (also hydromorphone)

Long acting opioid products:

• long acting codeine
• long acting morphine
• long acting hydromorphone, fentanyl patches

The changes will affect Ontario Drug Benefit (ODB) recipients as follows:

• For existing ODB recipients currently receiving OxyContin (i.e. current formulation of oxycodone):
  • ODB recipients who have had a claim submitted to the ODB program for OxyContin within the past six (6) months will receive automatic coverage for OxyContin for a one (1) month period from February 29, 2012 to April 2, 2012, subject to availability of supply at the pharmacies.
  • After April 2, 2012, if your doctor determines that OxyNEO is appropriate, you will continue to receive automatic coverage for OxyNEO (10mg, 15mg, 20mg, 30mg, 40mg and 80mg) for a period of one year.  This coverage will end on February 28, 2013.
  • If coverage for OxyNEO is required beyond February 28, 2013, your physician must apply for an EAP approval.
• For all other ODB recipients requiring OxyNEO (i.e. new formulation of oxycodone effective March 1, 2012), the following process will apply:
  • for patients with chronic pain, OxyNEO (10mg, 15mg, 20mg, 30mg and 40mg tablets) will be considered through the EAP according to specific criteria.
  • for cancer patients or palliative care patients, OxyNEO (10mg, 15mg, 20mg, 30mg, 40mg and 80mg tablets) will be considered for funding according to the specific criteria through the Palliative Care Facilitated Access List for whom the prescriber is registered.  If the prescriber is not registered on the Palliative Care Facilitated Access List, a request for funding of OxyNEO must be made through the EAP process.

It is important to talk to your health care professional about the EAP criteria and to determine which of the above situations may apply.

Narcotics/opioids have several dose-dependent side effects that must be considered when starting and adjusting therapy.  As a result, many guidelines make reference to the term “watchful dose”.  Doses above the watchful dose are likely to result in an increased risk of side effects, including addiction and death, and the guidelines should be consulted when prescribing these products.  Since each opioid has different levels of potency, the term “morphine equivalent” is used to compare the effects of the various products using a common standard.  For example, oxycodone is 1.5 to 2 times more potent than morphine on a mg to mg basis.

The "watchful dose" recommended in the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain is 200mg/day morphine equivalent.  The guideline states that: “the potential for adverse psychological and physical effects, the potential for misuse, and questionable efficacy are all factors that should be considered in limiting the dose and increasing the frequency of follow-up visits. Some studies reported safety concerns or questionable efficacy of higher daily doses of opioids.” (http://nationalpaincentre.mcmaster.ca/opioid)

As part of the review for OxyNEO, the Committee to Evaluate Drugs (CED) noted that the 60mg and 80mg strengths, when used twice daily, would approach or exceed this watchful dose.  Because of these concerns and the availability of alternative opioids, the CED recommended that the 60mg and 80mg strengths of OxyNEO not be funded for chronic non-cancer pain.

The Exceptional Access Program (EAP) facilitates patient access in exceptional circumstances to drugs not listed on the ODB Formulary or where Formulary drugs are ineffective, not tolerated, or where no Formulary listed alternative are 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 recommended by the ministry’s expert advisory committee, the Committee to Evaluate Drugs, and approved by the Executive Officer, and include a thorough assessment of the patient’s specific case and clinical circumstances, as provided by the physician, as well as the available scientific evidence.

Due to the volume of requests that the ministry receives, an EAP approval may take up to approximately three months from the date of the application request.  You are encouraged to discuss treatment options that best suit your need with your doctor.

No.  The changes apply only to eligible ODB recipients receiving drug coverage under the Ontario Public Drug Programs.

No. The manufacturer is removing the brand OxyContin from the Canadian market and it will no longer be available.  However, the manufacturer is introducing a new brand OxyNEO, containing the same active ingredient. Please speak with your doctor about your treatment options, and whether or not OxyNEO would be suitable for you.

You are encouraged to speak with your primary health care provider about your treatment options.

If you have a general question on this issue, please send your question(s) to PublicDrugPrgrms.moh@ontario.ca , or call ServiceOntario at 1-866-532-3161 (TTY 1-800-387-5559, or in Toronto, TTY 416-327-4282).