Pharmacy scope of practice and access to Opioid Agonist Therapies (OAT) in Canada after COVID-19

Pharmacy scope of practice and access to Opioid Agonist Therapies (OAT) in Canada after COVID-19

Sarah Lussier-Hoskyn, MA Economics, BPHA, affiliated scholar Canadian Health Policy Institute
Brett Skinner, PhD, CEO Canadian Health Policy Institute, Editor Canadian Health Policy Journal

ABSTRACT: Under the regulations contained in the federal Controlled Drugs and Substances Act (CDSA), prescribing, selling, distributing and other related activities involving drugs like opioids are only allowed for designated health professions. On March 19, 2020, Health Canada issued an exemption, temporarily expanding pharmacists’ scope of practice to include activities usually prohibited by the CDSA. The exemption was implemented partly to facilitate continuity of access to opioid agonist therapies (OAT) for people suffering from opioid use disorder (OUD) during the COVID-19 pandemic. This article discusses the implications of making the exemption permanent. We review the latest research and data on the health and economic costs associated with OUD, to clarify the magnitude of the problem and significance of expanding the scope of practice for pharmacists. We discuss the scope of practice issues for pharmacists related to improving patient access to OAT and offer policy recommendations.

SUBMITTED: October 7, 2021 | REVISED: November 11, 2021 | PUBLISHED: January 31, 2022

CONTRIBUTIONS: Lussier-Hoskyn conducted the scan of pharmacy scope of practice and co-authored the observations and policy recommendations. Skinner conducted supplementary research and co-authored the observations and policy recommendations.

DISCLOSURE: Development and Open Access for this paper was made possible by funding from Indivior Canada Ltd.

CITATION: Lussier-Hoskyn, Sarah; Skinner, Brett (2022). Pharmacy scope of practice and access to Opioid Agonist Therapies (OAT) in Canada after COVID-19. Canadian Health Policy, January 2022. ISSN 2562-9492 https://doi.org/10.54194/DIGR6414 www.canadianhealthpolicy.com.

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POLICY ISSUE

This paper briefly reviews the scope of practice for pharmacists in Canada before and during the COVID-19 coronavirus pandemic and discusses related issues regarding patient access to pharmaceutical treatments for opioid use disorder (OUD).

OPIOID USE DISORDER (OUD)

Opioid use disorder involves nonmedical use of and addiction to illicit drugs like heroin and prescription drugs like oxycodone, hydrocodone, hydromorphone, fentanyl, carfentanil, codeine, morphine, tramadol, etc. OUD was previously classified as opioid abuse, opioid dependence or opioid addiction.[1] The American Psychiatric Association currently describes OUD as:

“a problematic pattern of opioid use leading to problems or distress, with at least two of the following occurring within a 12-month period:

• Taking larger amounts or taking drugs over a longer period than intended.
• Persistent desire or unsuccessful efforts to cut down or control opioid use.
• Spending a great deal of time obtaining or using the opioid or recovering from its effects.
• Craving, or a strong desire or urge to use opioids
• Problems fulfilling obligations at work, school or home.
• Continued opioid use despite having recurring social or interpersonal problems.
• Giving up or reducing activities because of opioid use.
• Using opioids in physically hazardous situations.
• Continued opioid use despite ongoing physical or psychological problem likely to have been caused or worsened by opioids.
• Tolerance (i.e., need for increased amounts or diminished effect with continued use of the same amount)
• Experiencing withdrawal (opioid withdrawal syndrome) or taking opioids (or a closely related substance) to relieve or avoid withdrawal symptoms.” [2]

In chronic users, abruptly stopping the use of opioids leads to severe symptoms, including generalized pain, chills, cramps, diarrhea, dilated pupils, restlessness, anxiety, nausea, vomiting, insomnia, and very intense cravings, creating significant motivation to continue using opioids to prevent withdrawal.[3]

HEALTH AND ECONOMIC BURDEN

OUD is associated with significant rates of mortality, hospitalization, and utilization of emergency medical services. OUD is also associated with mental illness, family dysfunction, crime, economic productivity loss, and social intervention costs.[4]

The health and social problems associated with OUD were worsened by an increase in opioid use correlated with the COVID-19 global pandemic, and by the public health policy response to the crisis.[5] Stay-at-home orders, physical distancing and general fear of the virus made it more difficult to access a regular prescriber, usually a physician, and disrupted the continuity of treatment for OUD patients.

Mortality

According to the Public Health Agency of Canada (PHAC), the outbreak of the COVID-19 pandemic in January 2020 was associated with an increase in opioid toxicity deaths (CHART 1, TABLE 1). In 2020, across Canada 6,265 opioid toxicity deaths occurred, up from 3,658 in 2019 representing a 71% increase year over year. By contrast, opioid toxicity deaths numbered 4,391 in 2018, representing a decline of -17% over the 12 months from 2018 to 2019.[6]

Hospitalizations

The impact of COVID-19 on opioid related hospitalizations is also apparent in the data reported by PHAC. In 2020, 5,215 opioid-related hospitalizations occurred across Canada (excluding Quebec), representing a 16% year over year increase from 4,514 hospitalizations in 2019. Again, this reverses the previous year over year decline of -11% from the 5,052 hospitalizations that occurred in 2018.[7]

Emergency Medical Services

PHAC also reported 28,812 Emergency Medical Services (EMS) responses to suspected opioid-related overdoses based on available data from nine provinces and territories in 2020. Once again, the impact of COVID-19 can be seen. The year over year change was 36% from 2019 (21,138 responses) to 2020, compared to 3% from 2018 (20,488 responses) to 2019.[8]

Economic Cost

At a societal level the health-related economic costs associated with OUD are substantial. The most recent estimate of the economic cost of opioid use disorder was published by the Canadian Centre for Substance-Abuse and attributed CAN$3.5 billion in societal costs to OUD in 2014, counting related health care costs, lost productivity, and costs related to criminal justice.[9]

Other research from the United States suggests that this could be an underestimate of the costs associated with OUD. A recently published American study found that the overall estimated cost of opioid use disorder in the United States was US$1.02 trillion in 2017, with 85% of this burden from reduced quality of life from OUD and life lost to opioid overdose, while lost productivity was estimated at $100 billion, healthcare costs at $34.8 billion, and criminal justice costs at $14.8 billion. The estimate was based on data showing that there were 47,600 opioid overdose deaths and 2.13 million people with OUD in the United States in 2017.[10]

AVAILABLE TREATMENTS

Opioid Agonist Therapies (OAT)

OUD is treatable with orally administered opioid agonist therapies (OAT) like methadone, buprenorphine/naloxone, or buprenorphine, which work to prevent withdrawal and reduce cravings for opioid drugs for 24 to 36 hours without euphoric effects.[11] Buprenorphine is also available as an extended release injectable administered to the patient by a health professional once a month. The injection must be given to the patient subcutaneously because after injection it forms a solid mass that could be fatal if injected intravenously.[12]

Research has shown that these medications reduce overdose mortality for those with an opioid use disorder.[13]^, [14] There is also evidence that long-term treatment with opioid agonists for OUD improved health outcomes, versus a tapering approach, a detoxification model, and other short-term courses of therapy.[15] Injectable forms of OAT have a well-developed evidence base over many years supporting their use for people who have not responded to oral OAT options.[16]

Opioid Antagonists

Naloxone is an opioid antagonist that rapidly reverses opioid overdose by blocking the effects of other opioids. Naloxone can quickly restore normal breathing to a person if their breathing has slowed or stopped because of an opioid overdose. Naloxone is not a treatment for opioid use disorder. However, the drug is vital for the prevention of overdose fatality.[17]

PHARMACY SCOPE OF PRACTICE

Controlled Drugs and Substances Act (CDSA)

Access to OAT is affected by federal regulations under the Controlled Drugs and Substances Act (CDSA). In Canada, the provincial governments have exclusive legislative jurisdiction for regulating the scope of practice for health professionals. The federal government does not directly regulate the scope of practice for health professions, but indirectly affects scope of practice by regulating activities involving narcotics like opioids, including opioid agonists through its administration of the CDSA.

The CDSA prohibits any activity involving controlled drugs and substances that is not specifically authorized in the regulations. For example, under the CDSA regulations, only designated professions or “practitioners” can prescribe controlled drugs and substances. Authorized practitioners include physicians, dentists and veterinarians. Nurse practitioners, midwives, and podiatrists are also authorized to prescribe controlled substances subject to the laws and regulations of the provinces or territories.

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 the regulations do not permit pharmacists to prescribe, they do allow pharmacists to adjust the dosage and form in which the drug is prescribed; de-prescribe, reduce or stop a medication; and partially fill prescriptions by dispensing a quantity of a medication which is less than the total amount of the drug specified by a practitioner.[18]^, [19]

The CDSA allows the Minister of Health to exempt any person or class of persons or any controlled substance from the application of all or any provisions of the Act or the regulations if the exemption is deemed necessary for a medical or scientific purpose or is otherwise in the public interest.

COVID-19 Pandemic

Following the World Health Organization’s declaration of a global pandemic in March 2020, the federal, provincial, and territorial governments recognized that regulatory restrictions on the scope of practice for pharmacists regarding prescribing and administering opioid agonists, were a potential barrier to accessing treatment for OUD patients. On March 19, 2020, Health Canada responded by issuing an exemption to the federal regulations to temporarily authorize an expanded scope of practice allowing pharmacists to:[20]

• Accept a verbal or faxed order from a prescriber for a controlled substance. The CDSA normally requires a written prescription order from a designated practitioner.
• Transfer a prescription for a narcotic or controlled drug to another pharmacist in the same province. The CDSA normally requires a new prescription when a patient switches pharmacies.
• Renew or extend a prescription for a controlled substance. The CDSA normally requires a new prescription from the original prescriber.
• Adapt prescription for controlled drug including dose, formulation, regimen. Normally pharmacists are not included among the designated health professionals authorized to adapt.
• Use pharmacy employees to deliver controlled substances to patients (at their homes or an alternate location). The CDSA normally prohibits non-pharmacists from delivering controlled drugs or substances on behalf of the pharmacy.

The CDSA exemption was initially set to expire October 2020 but was extended to September 2021, and then extended again to expire on September 30, 2026, or until such time as it is replaced by another exemption or revoked. The federal exemption is subject to provincial or territorial legislation and regulation regarding the scope of practice for pharmacists.

To maintain consistency with Health Canada’s temporary amendments to the CDSA, and to preserve continuity of care, most provinces and territories amended their regulations to expand the scope of practice for pharmacists regarding controlled drugs and substances, including OAT. In some provinces and territories, the exemption is in effect until the federal exemption is revoked or expires in September 2026. Ontario’s exemption expires on April 7, 2022, nearly 4.5 years before the CDSA is set to expire.[21]

Current Scope of Practice by Province

We conducted an independent environmental scan of the scope of practice for pharmacists in Canada current to August 2021 (APPENDIX 1-3). The results were generally consistent with information published by CPhA up to that date. While this paper was in review, the Canadian Pharmacists Association published updated summaries of the current (or pending regulatory changes) scope of practice for pharmacists by province and territory as of November 2021 (APPENDIX 4-6).[22] We subsequently updated our data and merged the two scans (TABLE 2).

Overall Scope

There are notable differences between provinces and territories. Overall, Alberta stands out as the province with the least restrictive scope of practice for pharmacists. The most restrictive jurisdictions include the three territories (Northwest, Yukon, and Nunavut) and the provinces of British Columbia and Ontario.

Initiate Prescription

Alberta is the only province where pharmacists are authorized to routinely and independently initiate or adapt a prescription for any Schedule 1 drug. Saskatchewan, Manitoba, New Brunswick, and Nova Scotia allow pharmacists similar authority to prescribe but only in a collaborative practice setting. Nine of the 10 provinces give pharmacists the routine authority to initiate a prescription for smoking cessation products, and for products to treat minor ailments. British Columbia is the exception. All 10 provinces currently (or pending legislation) authorize pharmacists to initiate a prescription in an emergency, except for controlled drugs. Prescriptive authority is severely restricted in all three territories.

Adapt Prescription

Alberta and Nova Scotia are the only provinces to allow pharmacists to independently adapt prescriptions for Schedule 1 drugs. Five of the 10 provinces with the exceptions of British Columbia, Ontario, Quebec, Prince Edward Island, and Newfoundland and Labrador permit pharmacists to adapt Schedule 1 prescriptions only in a collaborative practice setting. Eight of the 10 provinces allow pharmacists to make therapeutic substitutions, with the exceptions of Manitoba and Ontario. All 10 provinces allow Schedule 1 adaptation authority in an emergency; and permit adaptation of the formulation, dose and regimen; and permit renewal or extension of a prescription for continuity of care. Eight of 10 provinces authorize pharmacists to administer any drug or vaccine by injection. In British Columbia this authority is pending legislation. Ontario is the exception, and only permits pharmacists to administer vaccines by injection. Injection authority is permitted in the Yukon but is restricted in Northwest Territories and Nunavut.

Injection Authority

Lab Tests

Seven of 10 provinces authorize pharmacists to order and interpret lab tests. The exceptions are British Columbia, Ontario, and Newfoundland and Labrador. Northwest, Yukon and Nunavut territories also restrict pharmacists from ordering lab tests.

CDSA Exemptions

As of November 2021, four of 10 provinces (Ontario, Quebec, New Brunswick, Nova Scotia) had fully implemented all provisions of the CDSA exemptions.[23] The remaining six provinces had partially implemented the CDSA exemptions. Northwest and Yukon territories partially implemented the CDSA, while Nunavut did not implement any of the CDSA exemptions.

Naloxone

Five of 10 provinces (Alberta, Ontario, Quebec, New Brunswick, and Nova Scotia) and two of three territories (Northwest and Yukon territories) currently (November 2021) allow/utilize pharmacies to offer publicly funded access to naloxone for all OUD patients. The other jurisdictions in Canada make naloxone available for free through pharmacies only under restricted eligibility conditions, or only have naloxone available for purchase at pharmacies.[24]

POST COVID-19 POLICY DISCUSSION

The CPhA and Ontario Pharmacists Association (OPA) have called on the federal and provincial governments to make the CDSA exemptions permanent, and to expand the scope of practice to include the administration of all injectable drugs.[25]^, [26] Researchers have also called for similar changes to the scope of practice for pharmacists.[27]

While the COVID-19 coronavirus pandemic is still far from over, it is worth considering now what the policy direction should be regarding the evolving scope of practice for pharmacists and opioids. The health and economic costs associated with untreated opioid use disorder are significant. Policies that facilitate patient access to opioid agonist treatments have potential to improve the quality of life for patients suffering opioid use disorder, which could produce significant societal benefits. Policies that increase the availability of opioid antagonists could reduce mortality from overdose.

Community-based pharmacies are well positioned to provide accessible localized services to OUD patients. There are more than 44,000 pharmacists in Canada, representing a substantial untapped healthcare workforce that could be enlisted to provide OUD services on a national scale (TABLE 3). However, federal and provincial regulations restricting the scope of practice for pharmacists create unnecessary barriers to access. Several remedial policies are discussed below.

Make the CDSA Exemptions Permanent

The federal, provincial, and territorial governments should permanently expand the scope of practice for pharmacists to include the temporary authorizations granted by the CDSA exemption. There is currently no evidence to suggest that there were any negative outcomes associated with the expanded scope of practice for pharmacists under the temporary exemptions of the CDSA, while there is some evidence that the CDSA exemptions were associated with positive outcomes regarding access to opioid agonist therapies.

Initiate Prescriptions for OATA recent study compared the timeliness of patient access to OAT during the COVID-19 pandemic, in 14 US states and 3 Canadian provinces (Alberta, British Columbia, and Ontario) with the highest rates of opioid overdose deaths. The US jurisdictions tended to restrict distribution and administration of OAT to a limited number of authorized clinical settings, whereas the Canadian jurisdictions adopted an open access approach, and reduced regulatory restrictions on the scope of practice for pharmacists in response to the overdose epidemic. Delays in access were found to be less likely in Canada.[28]

There are sound reasons for regulating and restricting the authority to initiate a prescription for opioids, given the potential for serious harm, and the documented problems with the diversion of the supply of prescription opioid products from medical to non-medical use.[29] To reduce opportunities for diversion, governments should adopt and maintain containment strategies that limit the authority to prescribe opioids for pain management.

However, this should not apply to opioid agonist therapies, ­which have great potential to reduce the harms associated with opioid use disorder. It is counterproductive to prohibit pharmacists from initiating a prescription for opioid agonist therapies when a physician is unavailable. Federal, provincial and territorial governments should further expand pharmacists’ scope of practice to include the authority to initiate a prescription for opioid agonist therapy, perhaps with a requirement to inform the patient’s physician prescriber within a reasonable timeframe.

There is precedent at the provincial level for including additional health professions under regulations authorizing prescribing authority for OAT. British Columbia recently expanded the scope of practice to allow Registered Nurses (RNs) and Registered Psychiatric Nurses (RPNs) to prescribe some opioid agonist treatments (OAT) to treat substance use conditions.[30]

Administer Drugs by Injection

Provincial/Territorial governments should also lift restrictions on pharmacists administering drugs by injection. A recent survey of access to injectable forms of opioid agonist therapy in British Columbia, Alberta and Ontario concluded that there is an urgent need to scale up injectable forms of OAT using diverse service delivery models that respond to local contexts and client needs.[31] Pharmacists offer health care services in local settings and are therefore well positioned to meet the needs of patients requiring injectable forms of OAT. Experience with pilot projects in the United Kingdom’s National Health Service show that permitting pharmacists to administer injectable OAT is feasible.[32]

There is also a consensus among the provinces regarding pharmacists’ general authority to administer non-controlled drugs by injection. Nine of the 10 provinces permit pharmacists injection authority for all drugs and vaccines, except for controlled drugs. Ontario is currently the only province to prohibit general injection authority. However, the province allows pharmacists the authority to inject COVID-19 vaccines during the pandemic. Expanding the scope of practice to include the authority to administer injectable forms of OAT is a sensible next step but it should be conditional on certified training in subcutaneous injection.

Order Lab Tests

From a patient health perspective, there appears to be no justification for restricting pharmacists from having the authority to order and interpret lab tests. Currently, seven of 10 provinces permit pharmacists to order and interpret lab tests, the exceptions are British Columbia, Ontario, and Newfoundland and Labrador. However, British Columbia, Ontario, Newfoundland and Labrador, allow pharmacists to conduct COVID-19 testing during the pandemic. This should be expanded. Authority to order lab work could be limited to specified relevant markers in blood and urine analyses.

Naloxone Access

Timely access and administration are key factors for the effectiveness of opioid antagonists like naloxone. Pharmacies are well placed in the community as local distribution points and could improve the time to access naloxone when needed. Federal, provincial, and territorial governments should provide publicly funded access to naloxone for all OUD patients utilizing pharmacies as part of the distribution system.

CONCLUSION

OUD is a significant health and social problem in Canada, associated with high rates of mortality, hospitalization, and utilization of emergency medical services, and associated economic costs. OUD is treatable with opioid agonist therapies, which research has shown reduce overdose mortality for those with an opioid use disorder. Federal, provincial, and territorial regulatory restrictions on the scope of practice for pharmacists regarding prescribing and administering opioid agonists, are a barrier to accessing treatment for OUD patients. The CDSA exemptions issued by Health Canada temporarily alleviated some of the barriers to access created by scope of practice restrictions. This paper discussed several policy options for improving access to OAT, focused on expanding the scope of practice for pharmacists by making the CDSA exemptions permanent, and establishing authority to initiate prescriptions for OAT, administer injectable forms of OAT, and order OUD-related lab tests. This paper also discussed the importance of improving access to opioid antagonists. Public funding and distribution through pharmacies could be a solution.

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