Prescription management by pharmacists with controlled substances under the Controlled Drugs and Substances Act and its regulations

Context

Pharmacists are medication experts and play a significant role in monitoring patients and medication to ensure safe and optimal use while contributing to outcome-focussed patient care. With the goal of supporting better medication management and protecting the health and safety of Canadians, Health Canada has developed the following related to prescribing activities with substances regulated under the Narcotic Control Regulations (NCR), the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) and the Food and Drug Regulations – Part G (FDR - Part G).

Scope^{Footnote 1}

Information in this document applies to pharmacists who are registered and entitled to practice pharmacy under the laws of their province or territory and are entitled to conduct activities with controlled substances.

While this document does not constitute legal advice as to the scope of the Controlled Drugs and Substances Act (CDSA) and its regulations, it is Health Canada’s interpretation of the legislation and regulations through which guidance is provided to pharmacists and provincial regulators.

Activities permitted

Regulations under the CDSA state that a pharmacist is authorized to sell or provide a controlled substance to a person if they have received a prescription or a written order from a practitioner.

While these regulations do not permit pharmacists to prescribe, other related activities that are included in the meaning of sell or provide are permitted as long as the quantity dispensed does not exceed the amount originally authorized. These activities include, but are not limited to:

• Adjusting the formulation: adjusting the dosage form in which the drug is prescribed;
  • e.g., change from pill to liquid formulations;
• Adjusting the dose and regimen: a structured plan that specifies the frequency in which a dose of medication should be ingested;
  • e.g., change from 20mg per day for 5 weeks to 10mg per day for 10 weeks
• De-prescribing: the planned and supervised process of reducing or stopping a medication;
• Part-filling: dispensing a quantity of a medication which is less than the total amount of the drug specified by a practitioner;
  • For greater clarity, this includes part-fills requested by a patient, when a pharmacy is dealing with an inventory shortage or other situations where the nature of the part fill is a matter of discussion between the pharmacist and patient.

This information is intended to clarify prescribing-related activities pharmacists are permitted to conduct under the CDSA and its regulations.

Pharmacists conducting any of these activities must ensure that their actions do not restrict patients’ access to their needed prescriptions and that they continue to work closely with the prescribing practitioner with a view to optimizing patients’ health care.

Additional requirements

Please note that there may be additional federal, provincial/territorial and municipal laws, regulations, and scope of practice considerations that must be complied with in addition to those under the CDSA and its regulations.

For any questions, please do not hesitate to contact csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca.

Related links

• Subsection 56(1) Class Exemption
• Subsection 56(1) Class Exemption– Frequently asked questions