Interim Policy for Methadone
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March 16, 2006
Advisory Notice: Methadone Maintenance Treatment (MMT)

Dear Pharmacist:

On March 15, 2006, Health Canada advised the Ontario College of Pharmacists of its support for the new "Ontario College of Pharmacists Interim Policy for the Provision of Methadone in Ontario" (see below) by granting pharmacists in Ontario an exemption under federal legislation that permits implementation of the new policy.

The interim policy was developed in collaboration with the College of Physicians and Surgeons of Ontario and in consultation with Health Canada with the view to permit a methadone maintenance treatment (MMT) model in Ontario that meets the needs of MMT patients, many of whom have expressed their views and concerns to the College in the past several weeks regarding their ongoing treatment.

Pharmacists are still required to dispense methadone, pursuant to a written prescription from an exempted physician, in individually labeled and fully diluted daily doses in an accredited pharmacy. The new exemption will now permit the pharmacist to transfer custody of such doses in a secure manner to a physician or their delegate (qualified person) provided that physician has applied for and been granted a new exemption by the College of Physicians and Surgeons of Ontario.

Be advised that you must, before transferring custody of such doses to any physician or delegate, confirm with the College of Physicians and Surgeons (at 416-967-2661) that the receiving physician has been granted the appropriate exemption. Any breach by a pharmacist or pharmacy of this or any other College policy with respect to the provision of methadone may be characterized as an act of professional misconduct and, further, may result in the revocation or amendment of the exemption issued by Health Canada under the Controlled Drug and Substances Act (CDSA) which is required to implement the Interim Policy. Over the next three months, our two Colleges will be collaborating on the development of a joint policy to ensure adequate accountability within this non-traditional approach to the provision of methadone while engaging in a process to review the Interim Policy.

As well, the Ontario College of Pharmacists and the College of Physicians and Surgeons of Ontario are issuing to pharmacists and physicians involved in the provision of methadone a document outlining Fundamental Assumptions relating to methadone provision (below). The document sets out the expectations of both Colleges for this area of practice.

Should you have any questions respecting the new policy, please contact the Professional Practice Programs area at 416-962-4861, ext. 236.

Yours truly,
Deanna L. Williams, R.Ph., B.Sc.Phm., CAE Registrar

Ontario College of Pharmacists
College of Physicians and Surgeons of Ontario Fundamental Assumptions around the Provision of Methadone
  • The ideal model for methadone maintenance treatment must provide for the integration of the patient, physician and pharmacist within the community to provide local and accessible solutions for patients requiring methadone maintenance treatment for opioid dependence.
  • The pharmacist practices in accordance with the provisions of the Drug and Pharmacies Regulations Act (DPRA), the standards of practice of the profession of pharmacy, the Code of Ethics for Pharmacists and the policies and guidelines of the Ontario College of Pharmacists (OCP); and federal legislation, in particular the Controlled Drugs and Substances Act (CDSA) and the Narcotic Control Regulations.
  • The physician practices in accordance with the College of Physicians and Surgeons of Ontario (CPSO) policies and guidelines and meets the requirements of other relevant legislation for the prescribing, dispensing and storage of methadone in Ontario.
  • Pharmacists are authorized by legislation to be custodians of methadone; they are responsible for the integrity of the drug until such time as they have dispensed directly to the patient or transferred its custody to a physician with an exemption under s.56 of the CDSA (an "Exempted Physician") or his/her delegate, as defined by the CPSO policy on Methadone Administration for Methadone Maintenance Treatment of Opioid Dependence (a "Delegate").
  • When the provision of methadone has been entrusted to a "delegate", the accountability and responsibility for the administration of methadone doses rests with the physician.
  • The pharmacist optimizes the drug therapy of the patient and establishes a therapeutic pharmacist-patient relationship with all patients for whom s/he dispenses drugs.
  • The pharmacist must be responsive to prescribed changes in the patient's methadone treatment and able to provide methadone in a timely manner.
  • The pharmacist and the physician play an important and complimentary role in the interdisciplinary model of methadone maintenance treatment. This includes joint development of written policies and procedures to ensure continuity of patient care and secure custody and storage of methadone.
  • The pharmacist, physician and his/her delegate must take all reasonable steps that are necessary to protect any quantities of methadone on the premises or under their control against theft or loss.
Interim Policy for the Provision of Methadone in Ontario

Models for Dispensing of Methadone to Patients pursuant to a prescription by a Physician
1.The pharmacist dispenses methadone to patients in a pharmacy accredited by the Ontario College of Pharmacists (OCP) pursuant to the Drug and Pharmacies Regulations Act (DPRA) (a "Pharmacy"). The pharmacy may be physically located in the treatment location. If the pharmacy is not open seven days a week, pharmacists open the pharmacy for a restricted time or collaborate with a hospital or another pharmacy to provide weekend access to patients requiring daily doses. This is how the majority of methadone doses are being dispensed currently in Ontario and it is consistent with current guidelines.
2.The pharmacist provides individually labelled doses of methadone dispensed pursuant to a prescription and diluted in a vehicle which does not lend itself to injection (e.g. TangŪ), in a secure manner to a physician or his/her Delegate for (custody of and) administration to patients. This requires an exemption of s56 under the Controlled Drug and Substances Act (CDSA) for the pharmacist.
3.The pharmacist provides the individually labelled doses of methadone dispensed pursuant to a prescription and diluted in a vehicle which does not lend itself to injection (e.g. TangŪ), to the patient at the treatment location and observes the ingestion by the patient.

Criteria for Authorized Dispensing of Methadone by Pharmacists
1.The pharmacist receives a prescription written by an authorized prescriber.
2.The pharmacist establishes a relationship with the patient and determines eligibility for the patient to receive methadone prior to commencing methadone treatment. (Standards of Practice require pharmacists to dialogue with the patient on all initial
prescriptions.) The pharmacist is available to the patient and their health care providers for consultation on all medication therapy.
3.The pharmacist prepares the methadone in a manner and form required for dispensing to a patient, namely, diluted in a vehicle which does not lend itself to injection (e.g. TangŪ) and, more specifically, in accordance with the:
  1. prescriber's instructions
  2. standards of practice
  3. OCP policy on Methadone Maintenance Treatment
  4. Centre for Addiction and Mental Health guidelines
  5. Drug and Pharmacies Regulations Act and Regulations
  6. Narcotic Control Regulations
4.The pharmacist prepares the daily dose of methadone in a pharmacy as prescribed and then does one of the following:
  1. Observes the ingestion by the patient in the pharmacy.
  2. Observes the ingestion of the first dose of the maintenance prescription by the patient in the pharmacy and provides authorized carries to the patient.
  3. Transfers custody of the individually labelled doses of methadone dispensed pursuant to a prescription in a secure manner to a physician or his/her Delegate, who signs that they have received the doses of methadone. Unless directly handed by the pharmacist to the physician or his/her Delegate, the pharmacist must use a method of sending that involves a means of tracking and safekeeping of the package during transit (e.g. a chain-of-signatures).
  4. Takes the dose to the patient and observes the ingestion of the dose.
  5. Takes the doses to the patient and observes the ingestion of the first dose of the maintenance prescription by the patient and provides authorized carries.
5.The pharmacist documents in each patient record whether administration of the dose has been observed in the pharmacy, transferred to a physician or his/her Delegate for observation of the administration, or has been provided to the patient by the pharmacist at the treatment location and the pharmacist has observed the administration. Each patient record will be kept in such a way as to indicate clearly what has happened to the methadone so that it can be determined quickly for patient care purposes, and later for audit purposes.
6.Records of methadone ingestion must be maintained including the patient's name, daily dose, date, time and place where the administration was observed. The dispensing pharmacist must be provided with copies of such records daily.
7.Any new doses or changes of dose of methadone require a new prescription and must be dispensed by a pharmacist.
8.No alteration of the individually labelled doses of methadone, dispensed by the pharmacist shall be performed.
9.Unused individually labelled doses of methadone:
  1. Remain in the pharmacy and are managed in accordance with applicable law, standards of practice, and OCP policy (where the patient did not attend the pharmacy for his dose, or where the patient was clinically or behaviourally disqualified for the drink); or
  2. Are returned to the pharmacy by the physician or his/her Delegate, preferably on a daily basis, signed for upon receipt, entered into the appropriate record, and destroyed in the pharmacy in accordance with applicable law, standards of practice and OCP policy.
10.The pharmacist conducts a daily reconciliation of the methadone dispensed to and received from a treatment location, in such a manner that would allow for immediate detection of any losses or diverted quantities.