Undoubtedly, COVID-19 has affected how health professionals practice. Pharmacists across the country are not only experiencing changes in how they practice (for example, accepting emailed prescriptions, where appropriate) but the scope of their practice as well. The latter change is not permanent, although the disruptions in practice may be felt long after the COVID-19 emergency subsides.
On March 19, 2020, Health Canada issued a short-term section 56(1) exemption under the Controlled Drugs and Substances Act (CDSA) that would authorize pharmacists to prescribe, sell, or provide controlled substances in limited circumstances, or transfer prescriptions for controlled substances (the CDSA Exemption).
The CDSA Exemption was issued in the public interest to ensure Canadian patients have access to controlled substances for medical treatments while they adhere to social distancing guidance from public health officials, or self-isolate if needed. For now, the CDSA Exemption is to expire on September 30, 2020, or earlier if revoked or replaced. Health Canada has stated it would consider issuing a new exemption if the current CDSA Exemption expires, but is still necessary.
The CDSA Exemption is subject to provincial laws and regulations. Our discussion is limited to those practicing in Ontario.
The Council of the Ontario College of Pharmacists met on March 23, 2020, to develop and unanimously approve amendments to regulations under the Pharmacy Act. For example, typically, section 36(2) of the General Regulation(O Reg. 202/94) prohibits pharmacists from renewing and adapting prescriptions for controlled substances. Without amendments, this section prevented pharmacists from implementing the various components of the CDSA Exemption.
The College submitted proposed amendments to the Ministry of Health and requested expedited approval to allow pharmacists to implement the various practice activities defined in the CDSA Exemption as quickly as possible. Understandably, the urgency in adapting responses to a state of emergency meant that the College was waiving its usual practice of holding a 60-day public consultation before submission.
On April 7, 2020, changes to the General Regulationcame into force.
Accordingly, pharmacists are now authorized to:
In addition to:
The changes to the General Regulations will automatically be revoked on April 7, 2022 (two years after coming into force). Of course, if Health Canada revokes the current CDSA Exemption or it expires, the changes to allow pharmacists to renew and adapt prescriptions for controlled substances will also expire.
Pharmacists will need to be diligent if they engage in these actions to ensure both patient safety and compliance with the CDSA Exemption. For example, in adapting a prescription for a controlled substance, a pharmacist can not make therapeutic substitutions, wherein the pharmacist would substitute a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent. A pharmacist may, however, change the prescribed dose, regime, or dosage form of the original prescribed controlled substance.
Additionally, the College expects pharmacists to collaborate with the prescriber or primary care provider before adapting or renewing prescriptions for controlled substances. If collaboration is not possible, pharmacists may adapt or renew the prescription and notify the prescriber within a ‘reasonable period of time.’ Reasonable period of time is undefined. The College urges its members to use their professional judgement to promote safe and optimal use of controlled substances while ensuring continuity of care and access. To this end, pharmacists should consider providing the patient with an up-to-date prescription history from the pharmacy, which will allow for continuity of care and a complete patient record moving forward. The College also recommends providing a copy of the prescription, clearly marked as such. While this is acceptable, it carries an increased risk of tampering, which should be avoided.
Pharmacists should be aware that they cannot delegate any of the above-described acts to others. The CDSA Exemption applies to pharmacists only. Only a pharmacist may adapt, renew, or transfer a prescription for a controlled substance. Pharmacy interns and registered pharmacy students are not named in the CDSA Exemption. Additionally, pharmacy technicians are not exempted and cannot transfer prescriptions for controlled substances.
To enable patients who are self-isolating access to prescriptions they may need, the CDSA Exemption allows pharmacy personnel or other persons to deliver a controlled substance on behalf of a pharmacist. The delivery person must have a copy of the CDSA Exemption in their possession while transporting any controlled substances. They must also have a note, in writing, from the pharmacist identifying the name of the individual effecting the delivery, the name and quantity of the controlled substance to be delivered, and the place of delivery. As with regular prescription deliveries, accurate delivery records must be kept.NOTE: A blog post is never a substitute for legal advice specific to your circumstances, particularly when surrounding circumstances are changing rapidly.
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