Section 56 Exemptions for Providing Controlled Substances to Community Health Facilities
In 2018, Health Canada introduced a pair of subsection 56(1) class exemptions to the Controlled Drugs and Substances Act, one for nurses providing health care at a community health facility, and one for the person in charge of a hospital and/or pharmacist who supplies controlled substances to a community health facility:
Under the s.56 exemptions, pharmacists are permitted to provide certain controlled substances to a community health facility, subject to the terms and conditions of the exemption. The exemptions also provide nurses with the authority to possess, sell, provide, administer, transport, send and deliver certain controlled substances in the course of providing health care services to patients in community health facilities, subject to the terms and conditions of the exemption. For more information on which settings the exemptions apply to, see the FAQs below.
When performing activities permitted under the s.56 exemptions, pharmacists must adhere to the terms and conditions in the exemptions, and all applicable College bylaws, standards of practice, and professional practice policies. When providing patient-specific drugs to a community health facility, requirements include (but are not limited to) the following:
- For drugs in the Controlled Prescription Program (CPP), the prescription is received on the prescription form approved by both the board and the College of Physicians and Surgeons of British Columbia per the Pharmacy Operations and Drug Scheduling Act (PODSA) Bylaws s.19(6).
- For drugs in the CPP, the prescription form is signed by the patient or the patient’s representative upon receipt of the dispensed drug as per the PODSA Bylaws s.19(6).
- The Community Pharmacy Standards of Practice, including assessing the prescription for appropriateness and completeness, reviewing the patient’s personal health information in PharmaNet, preparing and labelling the drug pursuant to each individual prescription, and consulting with the patient or patient’s representative at the time of dispensing.
- Prescription information is entered and recorded in PharmaNet at the time of dispensing and the patient record is kept current as per the PODSA bylaws s.35(1).
Where a pharmacist provides a patient’s prescription for a controlled substance to a community health facility (where the terms and conditions of the exemptions are met), a nurse working at the community health facility may sign the CPP form and receive the pharmacist-patient representative consultation, if authorized by the patient.
Note: At this time, providing patient-specific oral opioid agonist treatment (OAT) prescriptions to a community health facility does not meet the requirements in Professional Practice Policy 66-Opioid Agonist Treatment and associated Policy Guides (PPP-66). For more information on this, see the FAQ below.
The information provided here and in the FAQs is intended to guide pharmacy practice. Other health professionals should consult with Health Canada, their regulatory College and employer on their roles and responsibilities when handling controlled substances.
- In what settings do these s.56 exemptions apply?
The exemptions define several terms, including the meanings of community health facility, controlled substance, health care service provider, nurse, and pharmacist. This means that the exemptions are specific to certain types of community health facilities, controlled substances, health care service providers, nurses, and pharmacists, etc., as defined in the exemptions. The exemptions only apply if the terms and conditions of the exemptions are met.
For the terms and conditions, see the exemptions:
- Can a pharmacist provide patient-specific injectable opioid agonist treatment (iOAT) prescriptions to a community health facility?
The BCCSU’s Guidance for Injectable Opioid Agonist Treatment (iOAT) for Opioid Use Disorder outlines three models of care for the provision of iOAT in British Columbia:
- A comprehensive and dedicated supervised iOAT program
- Integrated or embedded supervised iOAT program
- Emerging Model: Pharmacy-based supervised iOAT program
Currently, the College has a policy in place for the pharmacy-based supervised iOAT program model (Professional Practice Policy 67- Injectable Opioid Agonist Treatment and Policy Guide), but does not have iOAT policies in place for the comprehensive and dedicated supervised iOAT program model, nor the integrated or embedded supervised iOAT program model.
Pharmacists may provide patient-specific iOAT prescriptions to iOAT programs at community health facilities, where the terms and conditions of the s. 56 exemptions are met, and are required to follow all the applicable College bylaws, standards of practice, and professional practice policies. This includes ensuring that drugs are dispensed pursuant to a prescription, consulting with the patient or patient’s representative at the time of dispensing, and ensuring all necessary documentation and record-keeping is completed, etc.
- Can a pharmacist provide patient-specific oral opioid agonist treatment prescriptions to a community health facility?
Currently, the College’s Opioid Agonist Treatment (OAT) Policy Guides for buprenorphine/naloxone maintenance treatment, methadone maintenance treatment, and slow release oral morphine maintenance treatment require that a pharmacist must be present to witness the release of these oral OAT prescriptions to a patient. A pharmacist must also reconcile and notify prescribers of missed doses and ensure the accuracy of the PharmaNet record. Providing patient-specific oral OAT prescriptions to a community health facility doesn’t meet the requirements in PPP-66.
For more information on the requirements included in PPP-66, see:
The College’s policy on delivery of oral OAT allows pharmacists to deliver OAT directly to a patient at their location. Temporary COVID-19 amendments were made to this policy, allowing a pharmacist to authorize a regulated health professional, with the appropriate scope and competence, or a pharmacy employee to deliver the dose to a patient at their location, and witness the dose on the pharmacist’s behalf (see Professional Practice Policy 71- Delivery of Opioid Agonist Treatment for more information). The temporary policy amendments are not intended to address alternate practice models as OAT prescriptions must always be delivered directly to the patient and cannot be left with any other person.
The expectation is that pharmacists will practice in compliance with their legislative requirements, including the principles outlined in PPP-66. The College recognizes that new pharmacy practice models involving multidisciplinary care are emerging, and that pharmacy practice is not always ‘black and white’. Pharmacists must use sound professional judgment to ensure patients receive safe and accessible treatment, while also ensuring that their decisions are made in the best interest of the patient and with appropriate collaboration, notification, and documentation. While proper documentation is always important, complete and thorough documentation of the decision-making process, therapeutic rationale, and plan for follow-up is particularly crucial when navigating ‘the grey’.