Single ingredient codeine downscheduled


Single ingredient codeine medicines are set to be downscheduled across the Tasman

New Zealand’s Medicines Classification Committee (MCC) has decided to downschedule single ingredient codeine medicines and upschedule all codeine combination medicines to prescription only.

Kiwis have until 31 January 2020 to implement the changes.

The MCC had been considering reclassifying codeine for some time, discussing the matter in May 2017 and deferring its decision to discuss again at its November 2017 meeting. It has now released the minutes of this meeting.

The MCC’s final decision was:

  • That, from 31 January 2020, all codeine in combination medicines, both analgesics and those used for cough and colds, should be reclassified to prescription medicines.
  • That, from 31 January 2020, medicines containing codeine as the only active ingredient should be reclassified from prescription to restricted medicine; for oral use in adults and children over 12 years of age in medicines containing not more than 15 mg per solid dosage unit with a maximum daily dose not exceeding 90 mg of codeine for use as an analgesic and when sold in a pack of not more three days’ supply.

After the May meeting, the MCC had set out three questions, which the health sector would need to answer to allow codeine to continue to be available without prescription:

  1. What education and continuing professional development would be provided to health professionals regarding the sale and prescription of codeine to minimise the risk of misuse and addiction in consumers?
  2. How will the sector fill the data gap with respect to over-the-counter codeine use?
  3. How will the sector track the sale of codeine in pharmacy in order to better identify consumers with additional needs for pain management and / or addiction problems?

Twelve comments were received, most of which opposed a reclassification of codeine that would reduce direct access through a pharmacist.

The MCC also decided that monitoring the sale of codeine was essential, no matter what classification the products are given. It recommended that it advocate the national monitoring of all codeine products, restricted and prescription.

“Medsafe and the Ministry of Health should explore how the Committee could advocate a monitoring system which would build on existing systems,” it said.

When making its decision to downschedule single-ingredient codeine products from prescription to restricted, the MCC said that it had considered the “pain relief gap” which would be created by making combination products prescription only.

“The Committee therefore suggested that it would be useful for medicines containing codeine as the only active ingredient to be available from a pharmacist for the emergency management of acute pain,” it noted.

“Concerns were raised regarding diagnostic accuracy if a patient presented in a pharmacy. However, there was general acknowledgement that codeine has a legitimate place as a step 2 analgesic in the World Health Organisations’ three-step pain ladder for adults.

“The Committee did not consider that there was a need for a cough and cold medicine containing codeine because of the evidence of toxicity and a risk of abuse associated with combination medicines.”

Read the full decision here.

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