Here’s what healthcare workers need to know about proposed changes to regulations around controlled substances

The federal government is proposing new Controlled Substances Regulations (CSR) to replace multiple regulations and six class exemptions. That would create one comprehensive regulatory framework for all controlled substances across Canada, lowering the administrative burden on practitioners and pharmacists and bringing more clarity to the rules. Pharmacists are a big part of this—and both the Canadian Pharmacists Association (CPhA) and the Ontario Pharmacists Association (OPA) have submitted responses to the act with suggested changes, including having pharmacists be classified as prescribers, and making the ability for pharmacists to adapt prescriptions for controlled substances permanent. Read: New prescribing rules for narcotics and controlled substances in ManitobaThe new Controlled Substances RegulationsThe Controlled Substances Regulations will replace the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, Parts G and J of the Food and Drug Regulations, and the New Classes of Practitioners Regulations. It would also encompass subsection 56(1) class exemptions. “The proposed CSR would also incorporate authorizations for pharmacists conducting certain activities currently permitted pursuant to certain subsection 56(1) class exemptions, such as extending a prescription issued by a practitioner, destroying a controlled substance on site or sending such products to a licensed dealer who is specialized in destruction,” the Controlled Substances Regulations says. Pharmacists would also be allowed to sell or provide controlled substances to another pharmacist to fill a prescription—making it easier to use central fill services for controlled substances.Read: A child patient is prescribed opioids: 7 ways to use them more safelyPharmacy technicians would also be able to do more: they would be able to independently compound, send, deliver and transport controlled substances, transfer prescriptions to pharmacists or pharmacy technicians and destroy controlled substances on site. Pharmacy technicians would also take on the legal responsibility around record-keeping and security for storage and during transportation, as pharmacists do. The Canadian Pharmacists Association's response The Canadian Pharmacists Association (CPhA) also submitted a response to the Controlled Substances Regulations to the government. Its primary recommendation is for the regulations to list pharmacists as practitioners. “That would give them prescribing authority,” says Joelle Walker, vice president of public and professional affairs at the CPhA. “It would provide better care for patients and help with people who might experience opioid addiction.” The prescriber list in CSR currently includes physicians, dentists, veterinarians, nurse practitioners, midwives and podiatrists. “By adding pharmacists as practitioners, they would be essentially removing barriers for the provinces to manage the practice of pharmacy,” Walker says. “Regardless of where one practices, pharmacists are all trained with the same level of education and should be able to practice; those provincial regulations are all evolving very quickly, but the federal overlay remains a bit of a barrier for pharmacists to practice.” Those changes would help pharmacists do more in many situations, the CPhA argues. That includes treating unattached patients; being able to initiate opioid agonist treatment, which is especially important given that it should be available within 48 hours; doing therapeutic substitution, which is increasingly important in cases of drug shortages; deprescribing; treating chronic pain; adjusting palliative care medications; and meeting patient needs during emergencies, like floods and fires. Read: A pharmacist-owner suspended for more than $200K in fictitious medication salesWalker points to the example of a pharmacist being able to substitute for another medication for ADHD to help a patient find the best medication for them without them having to go back and forth with a physician—which is particularly difficult for patients who don’t have a family doctor. The CPhA argues in the letter that pharmacists are well-equipped to take on this role. “Pharmacists are prescribers for all other classes of medication and have a very intimate knowledge of the role of narcotic, controlled and targeted substances in medication therapy management. Limiting pharmacists’ ability to prescribe is actually hindering patient care,” it says.And it points out that in some cases, medical directives are being used as a workaround to allow pharmacists to offer opioid-related care. “If a healthcare provider has a license, they should be able to own their actions and not use or rely on someone else’s license to govern their acts,” it says. The OPA responseThe Ontario Pharmacists Association also submitted comments and recommendations around this. The letter argues that all pharmacists should be permanently allowed to adapt prescriptions for controlled substances, which is now part of the temporary subsection 56 exemption for pharmacists. It also argues that the government should consider expanding the scope of practice for pharmacy technicians, allowing them to do things like accept verbal prescriptions.The OPA letter references a study on the impact of the subsection 56(1) class exemption that found Ontario pharmacists used the exemption but at low rates. The researchers concluded that the results “suggest an effective change to pharmacy practice as the low rates show pharmacists used the exemption as a last line of defense.” “Anecdotally, we have heard that in communities where access to care can be limited and challenging (e.g. rural communities), this scope has been most helpful to supporting continuity of and timely access to care for patients,” says Angeline Ng, vice-president of professional affairs at the Ontario Pharmacists Association. “There has also been positive feedback that the exemptions facilitated the pharmacist’s ability to provide opioid stewardship.”It agrees with the CPhA that the CSR should list pharmacists as practitioners. “This change is important not just for enabling pharmacists to adapt prescriptions for controlled substances but to futureproof the regulations as the scope of pharmacists continues to evolve,” says Angeline. Read: Ontario Pharmacists Association partners with Box Labs to offer pharmacies cloud-based tools

Here’s what healthcare workers need to know about proposed changes to regulations around controlled substances

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