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.
The past several weeks have been a challenging time for everyone. Health professionals have been bombarded with Emergency Orders and other pronouncements that can be confusing and at times seem contradictory.
With the rules and restrictions changing so rapidly, it is advisable to keep an eye on the website, social media feeds, and other communications from your respective regulatory College for your College’s interpretation and position on what you should and should not be doing during the pandemic. While the Emergency Orders and pronouncements apply to a broad spectrum of health professionals, individual Colleges can provide guidance and interpretation about how those orders and pronouncements relate to your specific profession.
But what if you’re still unsure about whether you can provide a particular service to a specific patient/client; or some other aspect of your professional obligations at this uncertain time?
Earlier this year, Wise Health Law succeeded on a motion for summary judgment in a dental malpractice case on the basis that the limitation period had expired before the Statement of Claim was issued. The (unreported) decision was delivered orally on the day of the motion.
In part, the plaintiff argued that she did not discover her claim until the Royal College of Dental Surgeons of Ontario (the “RCDSO” or “College”) rendered its decision, as she did not know if the defendant was negligent when she complained to the RCDSO, but merely had a “suspicion”.
In the midst of COVID-19, the proceedings of many health colleges, and consequently of the health professionals they regulate, have been in limbo while everyone finds a way forward.
On March 25, 2020, the Ontario government enacted the Hearings in Tribunal Proceedings (Temporary Measures) Act, 2020 (the “Act”) to help the process along.
The Act empowers statutory tribunals with more discretion over how proceedings before them are held.