Methadone Maintenance Treatment: What you need to know

January 1, 2014 The Tablet

As community pharmacies throughout BC now know, significant changes are being made to the standards and guidelines for delivering Methadone Maintenance Treatment (MMT) services.

In October 2012, Health Canada approved a new commercially available methadone 10 mg/ml solution (Methadose®) for sale in Canada (although British Columbia has been using a compounded methadone 1 mg/ml, it is currently the only province doing so).

With a new commercially available product now on the market and available for purchase by pharmacies, patient safety can be improved through a significant reduction in the risk of incorrect compounding. 

However, because the new Methadose® solution is 10 times the concentration of the compounded methadone 1 mg/ml solution, there is certainly a potential for measuring error in the early stages of the conversion period as pharmacists move their patients to the new product and adjust to the change. Pharmacists must ensure they talk to methadone patients about the upcoming transition and educate them on the new solution (a much smaller volume, but stronger).

The College of Pharmacists of BC collaborated with various working groups including the BC Pharmacy Association to identify areas within Professional Practice Policy 66 (PPP-66) Methadone Maintenance Treatment (MMT) and the Policy Guide that required significant changes due to the new methadone 10 mg/ml solution. The College has mandated the following timeline:

By February 1, 2014
All pharmacy managers, staff, relief pharmacists and pharmacy technicians employed in a community pharmacy that provides pharmacy services related to MMT must:

February 1, 2014 – February 28, 2014
During this transition period, pharmacists will be allowed to dispense both methadone 10 mg/ml solution (Methadose®) and compounded methadone 1 mg/ml. During this period, new MMT prescriptions must be written on the new form, and pharmacists must: 

  • transition their patients from 1 mg/ml to the commercially available 10 mg/ml methadone oral preparation
  • educate patients about safety concerns (e.g., 10 times concentration)
  • educate patients about appropriate security and storage (e.g., does not require refrigeration and must be stored securely because of increased strength), and
  • manage inventory, create plan and appropriately document methadone powder inventory. (Note that wholesalers will likely only accept returns of full, unopened bottles of powder. They cannot accept part bottles of any narcotic for return.) 

Documentation of the above must be available for review by College inspectors.

Effective March 1, 2014

  • All MMT prescriptions must be dispensed with the commercially available 10 mg/ml methadone oral preparation. 

In addition to the timeline, there are a few key points we’d like to highlight for members. 

  1.  As stated in principle 3.3.1 of the Policy Guide, when preparing a methadone prescription, “Methadone doses must be accurately measured in a calibrated device with an error rate of no greater than 0.1 ml.” We recognize that the volume dispensed will now be very small. You may need to buy specialized equipment in order to meet the 0.1 ml accuracy required by the College.
  2. Another key point is from principle 4.1.6 of the Policy Guide, which states that patients getting carries must receive each day in an individually labelled, separate bottle: “With respect to take-home doses the first dose, unless otherwise indicated in writing, must be a witnessed ingestion with all subsequent take-home doses dispensed in child-resistant containers … Each dose must be dispensed in an individual, appropriately sized, child-resistant container (bottle).”
  3. Note that the College will be strict on the requirement that as of February 1, 2014, any new MMT prescription must be written on the correct form. Please see principle 2.1.1 for more details on the new Methadone Maintenance Controlled Prescription form.
  4. As of February 1, 2014, the Professional Practice Policy-71: Delivery of Methadone for Maintenance also comes into effect, enforcing federal legislation that prohibits the delivery of methadone. PPP-71 also provides clarity for delivery under extraordinary circumstances, for example, if severe restrictions on mobility have been identified. Because of the new PPP-71, some pharmacies may have to adjust their hours of operations. If your pharmacy does not provide deliveries, you can refer the patient to another pharmacy (if the physician signs an exemption because of mobility). PPP-71 also enforces that pharmacists are responsible for secure transportation – direct from the dispensing pharmacy to patient – and must witness ingestion.

We know that many of our members are critical to maintaining patient care for those on methadone maintenance treatment, and will be affected by this transition to Methadose®. During this time, the Association aims to provide support to our members, and will continue to provide updates as more information is confirmed.

If you have any questions before you proceed with the changes, please contact the College of Pharmacists of BC. The full PPP-66, Policy Guide, and PPP-71 are available on the College’s website.

Because pharmacies may need to buy specialized equipment to meet the 0.1 ml accuracy required by the CPBC, the BCPhA has secured funding to help offset a portion of these costs. This grant has been made possible through a contribution by Mallinckrodt Canada ULC to the BCPhA’s Pharmacy Innovation Fund.
Details regarding the amount available for each pharmacy and the application process are being announced mid-December.

Frequently Asked Questions

Do the new policies apply to patients taking methadone for pain?
No. PPP-66 is specifically for Methadone Maintenance Treatment.

Is it now mandatory to lock up Methadose® (since it won’t be refrigerated)?
Store Methadose® as you would any other narcotic. The College is currently working with the Vancouver Police Department and a working group to review pharmacy security recommendations.

How do I ensure accuracy of dispensing?
Use a device that can provide an error rate of 0.1 ml or less.

What happens if there is a shortage?
As per the Policy Guide principle 6.3.1, Compounding in Exceptional Circumstances, the only situation that would constitute consideration of exceptional circumstances is when a commercially available 10 mg/ml oral preparation is not available.

Methadone for maintenance must be at the strength of 10 mg/ml to ensure minimization of errors.

A compounding log must be established to record when methadone solutions are prepared, how much was prepared, and who prepared the product.

What if a patient is allergic?
The patient’s physician may request an exemption from PharmaCare.

What do I need to know about the new form?
If not specified, the default is Daily Witnessed Ingestion (DWI), not carries.

Patients must sign the bottom of the form when receiving their first dose. 

This article is featured in The Tablet. The Tablet features pharmacy and industry news, profiles on B.C. pharmacists, information on research developments and new products.