Proposed Controlled Substances Regulations Changes

In July 2018, PTSA published a position paper on The Pharmacy Technician’s Role in the Handling of Controlled Substances to provide recommendations for the legislative changes necessary to support optimized pharmacy practice in the context of the procurement, receipt, preparation, provision, storage, destruction and related record keeping of narcotics, controlled drugs and targeted substances.

Health Canada has recognized that there are gaps in the regulatory framework and responded to feedback regarding changes required to regulations. In 2019, changes to provisions pertaining to licenses and permits were made. In June of this year, Health Canada initiated a consultation period on proposed Controlled Substances Regulations (CSR) that would consolidate 6 exemptions and 6 regulations including the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, Part G and J of the Food and Drug Regulations and the New Classes of Practitioners Regulations. The proposal reflects changes to allow pharmacy technicians to independently conduct activities with controlled substances, in a pharmacy setting, in line with our scope of practice. More information is available here: Canada Gazette, Part 1, Volume 158, Number 22: Controlled Substances Regulations

The authorized activities would include compounding, sending, delivering or transporting a controlled substance, transferring a prescription to a pharmacist or another pharmacy technician, or destroying a controlled substance on site. Like pharmacists, pharmacy technicians would assume the legal responsibility to comply with requirements on record-keeping and security for storage and during transportation. It is proposed that only pharmacists would be authorized to independently conduct the activities of selling and providing controlled substances (on the current understanding that overall oversight for these activities would rest with the pharmacist rather than the pharmacy technician). As part of the third phase of Health Canada’s work to modernize regulations, input is being sought to help identify any additional regulatory changes (beyond those already proposed in the draft CSR) that may be needed to reflect modern pharmacy practice.

During the townhall discussion at the Annual General Meeting earlier this month, members in attendance discussed what the changes will mean for pharmacy technician practice and identified areas that may still require feedback. It is unclear if the current proposed revisions will enable pharmacy technicians to place orders for controlled substances, which was noted as necessary to improve practice.

Feedback on the current consultation is due by December 1, 2024.

If you are interested in joining the advocacy committee to contribute to further review of the proposed legislative changes and providing feedback to Health Canada, please contact info@ptsa.ca.