Modernizing Canadian Pharmacists’ Scope of Practice for Controlled Drugs and Substances
Zahava R.S. Rosenberg-Yunger, MA, PhD i
Lisa D. Bishop, BScPharm, PharmD ii
Shelita Dattani, BScPharm, PharmD iii
Canadian Health Policy, June 2021. ISSN 2562-9492 www.canadianhealthpolicy.com
ABSTRACT
Community pharmacies in Canada and globally were considered an essential service and remained open during the COVID-19 pandemic. Although pharmacists continued to provide medications to their patients, a gap was evident in their ability to ensure continuity of their patients’ opioid regimen in the absence of an active prescription or the inability to contact the prescriber. Recognizing this care gap, in March 2020 Health Canada issued a short-term subsection 56(1) class exemption under Health Canada’s Controlled Drugs and Substances Act (CDSA) and its Regulations authorizing pharmacists to independently manage controlled substances. This exemption is temporary and is due to expire on September 30, 2021. The four authorities of the CDSA exemptions permit pharmacists to extend prescriptions, transfer prescriptions to other pharmacists, receive verbal orders, and allow other pharmacy employees to deliver prescriptions of controlled substances to patients. A discussion about making the CDSA exemptions permanent are presented here. While these considerations are specific to the Canadian context, they have implications to similar healthcare systems considering optimizing pharmacists’ scope of practice in helping to address the opioid crisis.
AUTHOR AFFILIATIONS
i Adjunct Professor, Ted Rogers School of Management, Health Services Management, Ryerson University.
ii Associate Professor, School of Pharmacy, Memorial University of Newfoundland.
iii Vice-President, Pharmacy Affairs, Neighborhood Pharmacy Association of Canada.
SUBMISSION: May 19, 2021 | PUBLICATION: June 8, 2021
DISCLOSURE: Dr. Lisa Bishop received honoraria to present the findings of this research at national events and conferences (2020, 2021) and she also served as an expert witness to provide expert opinion evidence for fentanyl (2018). Dr. Rosenberg-Yunger was a consultant for the Canadian Pharmacists Association (CPhA) during the time the qualitative study was conducted. Dr. Shelita Dattani was a staff member at CPhA at the time the qualitative study was conducted and serves on the advisory board for EBSI (Emergent Biosolutions).
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Introduction
Opioids are drugs that are often used to treat acute and chronic pain. (International Narcotics Control Board, 2015) They can also cause complications including respiratory depression, overdose, and addiction. The non-medical use of opioids is a global challenge and in 2017 approximately a half million deaths worldwide were attributed to drug use, of which more than 70% were related to opioids. (World Health Organization, 2020) The opioid crisis continues during the COVID-19 pandemic and both the USA and Canada have reported increases in overdose deaths during this time. (Centers for Disease Control and Prevention [CDC], 2020b; Public Health Agency of Canada [PHAC], 2021) In the USA, apparent synthetic opioid-related deaths increased by 38.4% in the 12-months ending May 2020 as compared to the previous year. (CDC, 2020a) In Canada, there was a 74% increase in opioid-toxicity deaths in the first 6-months of the pandemic compared to the previous 6-months. (PHAC, 2021)
Community pharmacies in Canada and globally were considered an essential service and remained open during the COVID-19 pandemic. (Gregory & Austin, 2020) Although pharmacists continued to provide medications to their patients, a gap was evident in their ability to ensure continuity of their patients’ opioid regimen in the absence of an active prescription or the inability to contact the prescriber.
Recognizing this care gap, in March 2020 Health Canada issued a short-term subsection 56(1) class exemption under Health Canada’s Controlled Drugs and Substances Act (CDSA) and its Regulations authorizing pharmacists to independently manage controlled substances. (Health Canada, 2020) This exemption is temporary and is due to expire on September 30, 2021. The four authorities of the CDSA exemptions permit pharmacists to extend prescriptions, transfer prescriptions to other pharmacists, receive verbal orders, and allow other pharmacy employees to deliver prescriptions of controlled substances to patients.
A discussion surrounding considerations of making the CDSA exemptions permanent are presented here. While these considerations are specific to the Canadian context, they have implications to similar healthcare systems considering optimizing pharmacists’ scope of practice in helping to address the opioid crisis.
Pharmacists’ Role as Opioid Stewards
Pharmacists are often underutilized healthcare professionals (HCPs) that have the knowledge and skills to provide optimal care for patients receiving opioids. (Compton, Jones, Stein, & Wargo, 2019; Reynolds, Causey, McKee, Reinstein, & Muzyk, 2017) Pharmacists have a role in providing opioid stewardship to their patients, which is centered on supporting and protecting patients’ health through interventions focused on improving, monitoring, and evaluating the optimal use of opioids. (Institute for Safe Medication Practices Canada, n.d.) Pharmacists are medication experts and are well positioned to provide such stewardship activities and help with the opioid crisis. (Brown, 2020; Compton et al, 2019; Murphy et al, 2018; Pringle, Cochran, & Aruru, 2019; Reynolds et al, 2017; Rosenberg-Yunger, Ellen, & Mickleborough, 2018; Suddaby, Morris, & Gray, 2019) They are trained to make recommendations about doses, deprescribe, suggest non-opioid options, as well as prevent, identify, and manage opioid use disorder (OUD). (Bach & Hartung, 2019; Bratberg et al, 2020; Agency for Healthcare Research and Quality, 2020; Suzuki et al, 2019; Wertheimer & Lai, 2020) They have a role in educating prescribers and patients about prescription opioids and harm reduction strategies. (Bach & Hartung, 2019; Bailey & Wermeling, 2014) Additionally, they can conduct opioid medication assessments which can lead to reduced dosages, changed medications, and improved patient pain scores. (Bhimji, Landry, & Jorgenson, 2020)
To date, the CDSA exemptions have facilitated pharmacists’ ability to help address the opioid crisis through optimal management of patients’ opioid medications. It assisted in the provision of continuity of care and ensured uninterrupted care, especially for our most vulnerable populations who may experience barriers in accessing care during COVID-19. (McMahon, Nadigel, Thompson, & Glazier, 2020)
Key Considerations for Policy Makers
Pharmacists have long standing relationships with patients and their families at the point of care and are responsible for providing timely access to appropriate care. Based on our qualitative study with Canadian pharmacists (L. Bishop, Rosenberg-Yunger, & Dattani, n.d.) and from the literature, several considerations emerged surrounding making the exemptions permanent in order to provide continuity of care and promote the optimal use of opioids. These considerations include equity and access to care and optimal delivery of care.
Equity And Access to Care
The exemptions have been beneficial in facilitating uninterrupted patient care, as they have enabled pharmacists to continue their patients’ opioid medications in times when patients were unable to access care. When patients were unable to reach their prescriber or were unable to travel to their pharmacy, the exemptions allowed pharmacists to take verbal orders, extend, renew, transfer, or deliver medication.
Prior to the exemptions, if the pharmacist could not reach the prescriber, which often occurs on weekends or evenings, typically the patient’s only options were to go to the emergency room or go without the medication. This has safety concerns, as stopping opioids abruptly can cause acute withdrawal or worsening pain and may result in patients seeking opioids from other sources. (US Food and Drug Administration, 2019)
However, inconsistencies exist in the legislative enactment of the exemptions across the provinces. Some provinces have utilized the full scope of the exemptions, while others were more restrictive [TABLE 1]. This resulted in inequitable care for patients depending on where they lived, and in many cases was a barrier to care. For example, in provinces where transfers were prohibited (MB, NU), when patients could not travel to their pharmacy due to the pandemic, the patient may have gone without their opioid medication. These inconsistencies in the scope of practice should be addressed to ensure equitable patient care for all.
The exemptions were particularly beneficial for patients receiving opioid agonist therapy (OAT) for OUD. OAT is the mainstay of treatment, with benefits such as reducing the use of other substances, reducing criminal activity, reducing transmission of infections, and protecting against overdose. (Bart, 2012; Canadian Research Initiative in Substance Misuse [CRISM], 2018) Patients who receive OAT require frequent monitoring and follow-up, often requiring daily or near daily dispenses and direct observation; missing a dose can cause withdrawal symptoms and destabilization, with patients potentially seeking drugs from other sources. (CRISM, 2018)
The pharmacist has a role in helping to reduce opioid-related harms, as they are often the HCP who the patient encounters most commonly. (Bach & Hartung, 2019) The exemptions have enabled patients to continue therapy in times when the prescriber could not be reached or they could not travel to the pharmacy. This continuity of care is crucial in a population who are at high risk of relapse and treatment failure.
Additionally, permitting limited prescribing of OAT for pharmacists would help further increase accessibility in situations where patients are in need of OAT and initiating therapy falls outside the scope of what the exemptions currently allow. (Health Canada, 2020)
Pharmacists also have an important role in optimizing opioid therapy for chronic pain patients. (Murphy, Chang, Dattani, & Sproule, 2019) As outlined in the 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain, pharmacists have a role on the interprofessional team in optimizing patients’ pain management including opioid tapering. (Murphy et al, 2019; Busse et al, 2017) With the exemptions permitting pharmacists to independently manage opioid therapy, it allows them to have a greater role in optimizing patients’ pain therapy. Evidence supports the benefit that pharmacists-led medication assessments can provide in opioid deprescribing, and it is anticipated that the benefit would increase when given the opportunity to have a greater role in opioid stewardship. (Bhimji et al, 2020)
Optimal Provision of Patient Care
Optimal provision of patient care can be facilitated by the exemptions, which is a key consideration in making the exemptions permanent. This includes permitting pharmacists to work to their full scope, providing adequate resources to support pharmacists in their scope, as well as raising patients’ and HCPs’ awareness of the role pharmacists can play in opioid stewardship.
Sufficient resources are needed to facilitate pharmacists’ ability to provide optimal care. Currently, remuneration models for pharmacies are primarily based on medication dispensing, with inconsistent remuneration for other clinically-based services. (Raiche et al, 2020; Canadian Pharmacists Association [CPhA], 2016) For example, when a pharmacist extends or adapts a prescription, the pharmacists may not be remunerated for their time to conduct the patient assessment, to extend or adapt the prescription, or to perform any of the opioid scope related activities. This is unfortunate, as evidence supports the economic value that the pharmacist can provide to the healthcare system. (Gagnon-Arpin, Dobrescu, Sutherland, Stonebridge, & Dinh, 2017) In order to provide the resources in the delivery of optimal patient care, governments and insurance providers should establish consistent remuneration policies.
Finally, to increase the uptake of pharmacists’ expanded services, there must be awareness by patients, HCPs, and pharmacists themselves around the opioid stewardship services that are available. Many pharmacists expressed a need for more training in pain and OUD management. (L. Bishop et al, n.d.; Compton, Jones, Stein, & Wargo, 2019; Fleming et al, 2014) Consistent and accessible training and educational resources for pharmacists around expanded scope in the area of opioid stewardship would facilitate uptake and comfort in their ability to provide opioid stewardship. (Compton et al, 2019; Eukel, Skoy, Werremeyer, Burck, & Strand, 2019) Communication to patients regarding pharmacist expanded services could improve awareness and expectations for pharmacist-provided care as well as increase patient-initiated interactions between pharmacists and their patients. (Bishop et al, 2015; Kelly, Young, Phillips, & Clark, 2014; CPhA, 2015) Increasing other HCPs’ awareness of the pharmacist’s role in opioid stewardship can improve interprofessional collaboration, reduce scope misconceptions, and help optimize patient care.
Recommendations
The Canadian government has recognized the potential negative impact of the COVID-19 pandemic on the opioid crisis and subsequently temporarily enacted the CDSA exemptions to address some of the gaps in care patients were experiencing. Pharmacists’ initial experiences have demonstrated that the exemptions have not only promoted their ability to provide opioid stewardship activities but also supported their ability to positively affect patient care during a time when access was limited. The exemptions have increased the ability of the pharmacist to address care gaps and have promoted more equitable patient access to care. Given these exemptions are temporary, further consideration for permanent and consistent implementation of the CDSA exemptions is necessary. Moreover, consideration should be given to modernizing the act and permitting limited prescribing of OAT.
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