Regulations Amending the Narcotic Control Regulations and the New Classes of Practitioners Regulations (Diacetylmorphine (Heroin) and Methadone): SOR/2018-37
Canada Gazette, Part II: Volume 152, Number 6
March 7, 2018
CONTROLLED DRUGS AND SUBSTANCES ACT
P.C. 2018-199 March 6, 2018
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1)footnote a of the Controlled Drugs and Substances Act footnote b, makes the annexed Regulations Amending the Narcotic Control Regulations and the New Classes of Practitioners Regulations (Diacetylmorphine (Heroin) and Methadone).
Regulations Amending the Narcotic Control Regulations and the New Classes of Practitioners Regulations (Diacetylmorphine (Heroin) and Methadone)
Narcotic Control Regulations
1 The portion of paragraph 3(1)(d) of the Narcotic Control Regulations footnote 1 before subparagraph (i) is replaced by the following:
- (d) has obtained the narcotic for his or her own use
2 (1) The portion of subsection 24(2) of the Regulations before paragraph (a) is replaced by the following:
(2) Subject to section 25, a licensed dealer may sell or provide any narcotic other than diacetylmorphine (heroin) to
(2) Subsection 24(3) of the Regulations is repealed.
(3) Paragraph 24(4)(c) of the Regulations is replaced by the following:
- (c) a practitioner of medicine or a nurse practitioner;
- (c.1) if practising in a hospital that provides care or treatment to persons, a practitioner of dentistry;
- (c.2) a pharmacist; or
3 (1) The portion of subsection 27(1) of the Regulations before paragraph (a) is replaced by the following:
27 (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer’s licence, sell or provide a narcotic under subsection 24(2), (4) or (5) if the licensed dealer has, on the premises specified in the licence, received
(2) The portion of subsection 27(2) of the Regulations before paragraph (a) is replaced by the following:
(2) A licensed dealer who has received an order referred to in paragraph (1)(a) may sell or provide a narcotic under subsection 24(2), (4) or (5) if
(3) Subparagraph 27(2)(a)(i) of the Regulations is replaced by the following:
- (i) if the narcotic is to be sold or provided to a person referred to in paragraph 24(2)(a), (b), (c) or (e) or 24(4)(a) or (d) or subsection 24(5), by that person, or
(4) Subsection 27(3.1) of the Regulations is repealed.
4 (1) Subsection 31(2) of the Regulations is replaced by the following:
(2) A pharmacist may sell or provide a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to a person
- (a) if the person is exempted under section 56 of the Act with respect to the possession of that narcotic;
- (b) except in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner and the signature of the practitioner, if not known to the pharmacist, has been verified by the pharmacist; or
- (c) in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner of medicine or a nurse practitioner and the signature of the practitioner, if not known to the pharmacist, has been verified by the pharmacist.
(2) Subsection 31(3) of the Regulations is replaced by the following:
(3) A pharmacist may sell or provide methadone to the following persons, in addition to the persons referred to in subsection (2):
- (a) a licensed dealer;
- (b) another pharmacist;
- (c) a hospital employee; or
- (d) a practitioner.
5 Subsection 35(1) of the Regulations is amended by striking out
“or” at the end of paragraph (a) and by replacing paragraph (b) with the following:
- (b) except in the case of diacetylmorphine (heroin), a practitioner who is authorized by the person in charge of the hospital to sign the order; or
- (c) in the case of diacetylmorphine (heroin), a practitioner of medicine or dentistry or a nurse practitioner who is authorized by the person in charge of the hospital to sign the order.
6 (1) The portion of subsection 53(2) of the Regulations before paragraph (a) is replaced by the following:
(2) Subject to subsection 53(4), a practitioner may administer a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to a person or animal, or prescribe, sell or provide it for a person or animal, if
(2) Subsections 53(3) and (4) of the Regulations are replaced by the following:
(4) A practitioner of dentistry or veterinary medicine shall not administer diacetylmorphine (heroin) to an animal or to a person who is not an in-patient or out-patient of a hospital providing care or treatment to persons, and shall not prescribe, sell or provide diacetylmorphine (heroin) for an animal or such a person.
7 (1) Subsection 65(2) of the Regulations is replaced by the following:
(2) On receipt of a prescription or a written order, signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer or diacetylmorphine (heroin) — to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal.
(2) Subsection 65(3) of the Regulations is replaced by the following:
(3) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to be provided, for emergency purposes, to a hospital employee or practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.
(3) Subsections 65(4) and (5) of the Regulations are replaced by the following:
(4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.
(4) Subsection 65(7) of the Regulations is replaced by the following:
(7) The person in charge of a hospital providing care or treatment to persons may permit diacetylmorphine (heroin) to be sold, provided or administered to a person under treatment as an in-patient or out-patient of the hospital on receipt of a prescription or a written order signed and dated by a practitioner of medicine or dentistry or a nurse practitioner.
New Classes of Practitioners Regulations
8 Paragraph 4(2)(b) of the New Classes of Practitioners Regulations footnote 2 is replaced by the following:
- (b) subitem 1(1) or 2(1) of the schedule to the Narcotic Control Regulations.
Coming into Force
9 These Regulations come into force on the 60th day after the day on which they are published in the Canada Gazette, Part II.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
There is a continuum of treatments for opioid use disorder. Opioid substitution treatment in the form of methadone or diacetylmorphine-assisted treatment are two key options along this continuum. However, Health Canada and its stakeholders have noted that the existence of certain specific and unique regulatory constraints imposed on methadone and diacetylmorphine (heroin) in the Narcotic Control Regulations (NCR) pose barriers to accessing treatment, thereby limiting access to an important health care service to help respond to the opioid crisis.
For example, for methadone, the existence of the requirement for practitioners to obtain an exemption under subsection 56(1) — hereafter section 56 — of the Controlled Drugs and Substances Act (CDSA) before they can prescribe and administer methadone creates barriers. Health Canada has heard that this requirement discourages many family physicians and general practitioners from applying for the exemption, thereby limiting the availability of methadone treatment. In addition, in a broad consultation on the section 56 exemption requirement, stakeholders indicated that removing the requirement would
“normalize” methadone treatment and help reduce the stigma associated with treatment for substance use disorders.
For diacetylmorphine, certain provisions in the Regulations have the effect of restricting its administration to hospital settings only. As a result, patients may have to go to a hospital, possibly several times a day, to receive this treatment. This limits access to diacetylmorphine-assisted treatment and places burden on patients.
These specific regulatory constraints also pose barriers to some of the community-based treatment models that are being considered in order to address the opioid crisis. Evidence indicates that any barrier to accessing treatment can deter patients suffering from opioid use disorder, and that providing quick, non-judgmental services where they are most needed is one key to success. footnote 3
Nurse practitioners play an important role in the health care system with respect to treating people with opioid use disorder. However, the New Classes of Practitioners Regulations (NCPR) do not allow nurse practitioners to conduct activities with diacetylmorphine. This has a negative impact on access to treatment, in particular in places where nurse practitioners are the only available health professionals.
Amendments to the NCR and the NCPR are necessary to remove undue barriers to methadone and diacetylmorphine and increase access to opioid substitution treatment.
The opioid crisis continues to be a national health concern in Canada. The number of overdoses and deaths caused by opioids has risen sharply and the crisis is worsening. Datafootnote 4 indicates that more than 2 800 apparent opioid-related deaths occurred in Canada in 2016. So far, early data released for 2017 shows a marked increase in these numbers.
- – On December 11, 2017, British Columbia posted data on all unintentional illicit drug overdose deaths in British Columbia (accidental and undetermined) that occurred between January 1, 2017, and October 31, 2017, inclusive. The data, which captured all drug overdose deaths, not just those related to opioids, showed that 1 208 deaths occurred from January to October 2017, compared with 683 during the same time period for 2016.
- – On November 27, 2017, Alberta released updated information about
“opioid misuse.”At that point in time, there had been 428 accidental drug overdose deaths related to an opioid, an increase of 40% over the same period in the previous year (2016) when there were 346 deaths.
- – On December 7, 2017, Ontario released updated data for opioid-related deaths from May to July 2017. There were 336 opioid-related deaths in that 3-month period, compared with 201 during the same time period in 2016, representing a 68% increase. From July to September 2017, there were 2 449 emergency department visits related to opioid overdoses, compared with 1 896 in the 3 months prior, representing a 29% increase.
In November 2016, the Government of Canada committed to a number of actions to address the opioid crisis, including supporting better treatment options for patients. Moreover, the Minister of Health’s mandate letter, released in October 2017, committed the Minister to use the government’s regulatory powers to ensure that interested communities do not face undue barriers in introducing effective programs and treatment options.
In Canada, methadone maintenance therapy is commonly used to treat opioid use disorder. Methadone is also used to treat pain. Methadone is controlled under the CDSA and activities with it are regulated by the NCR. The sale of methadone is also regulated under the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR).
Subsection 53(3) of the NCR requires practitioners to obtain an exemption under section 56 of the CDSA before they can prescribe, sell or provide or administer methadone. This exemption requirement is unique to methadone and does not apply to other opioids, including high-strength pain relievers such as controlled release oxycodone and fentanyl, or buprenorphine, which is also used to treat opioid use disorder. Furthermore, the NCR require a pharmacist to dispense methadone to patients pursuant to a prescription issued by a practitioner who has obtained an exemption as described above.
Depending on the province or territory, practitioners either apply for a section 56 exemption directly to Health Canada or apply via their respective licensing authority. In all cases but one, namely the use of methadone for pain management in Ontario, the provincial or territorial (P/T) licensing authority then makes a recommendation to Health Canada regarding the section 56 exemption issuance. Health Canada’s decision regarding the section 56 exemption application considers the recommendation of the respective P/T licensing authority. P/T professional licensing authorities for practitioners of medicine have different requirements that practitioners must meet at the P/T level. This can include the completion of practical mentored experience and training (a preceptorship) and a review of the practitioner’s prescribing profile. Health Canada has no additional requirements for practitioners in this regard.
As with other opioids, prescription diacetylmorphine has traditionally been used to treat pain. It is also used in various countries, including Switzerland, Germany, the Netherlands and Denmark, to treat the small percentage of patients with opioid dependence that have not responded to other treatment options. In Canada, diacetylmorphine was approved and available for sale until 1997, when the manufacturer discontinued selling the product in Canada. Diacetylmorphine has been used in Canadian clinical trials from 2005 to 2015 for opioid substitution therapy and was also obtained through the Special Access Programme for approximately 100 patients at the conclusion of a clinical trial.
Unlike other opioids, diacetylmorphine is subject to additional specific regulatory controls that have the effect of restricting its administration to hospital settings only. The NCR only authorize licensed dealers to sell or provide diacetylmorphine to a hospital employee, a practitioner of medicine or dentistry who is practising in a hospital, or a person who is exempted under section 56 of the CDSA with respect to its possession. Secondly, the NCR prohibit practitioners of medicine or dentistry from prescribing or providing diacetylmorphine, and from administering it to a person, unless they are an in-patient or out-patient of a hospital.
In Canada, diacetylmorphine is regulated under the FDA and the CDSA. Diacetylmorphine is not currently approved for sale on the Canadian market, but it has been authorized for sale in other countries, such as Switzerland, Germany, and the United Kingdom. Currently in Canada, diacetylmorphine is accessible under the FDA through the Special Access Program and, more recently, through the Importation of Drugs for an Urgent Public Health Need process. This new mechanism provides a population-based response to an exceptional public health crisis by allowing the importation and sale in Canada of foreign authorized drugs, such as diacetylmorphine, that have been added to the List of Drugs for an Urgent Public Health Need (the List). With three diacetylmorphine products currently on the List (British Columbia is the notifying jurisdiction), diacetylmorphine is allowed to be imported into Canada and used in British Columbia to help respond to the opioid crisis.
New Classes of Practitioners Regulations (NCPR)
The NCPR designate midwives, nurse practitioners and podiatrists as practitioners defined in the CDSA. These Regulations authorize these practitioners to conduct activities with certain controlled substances in accordance with the NCR, Part G of the FDR and the Benzodiazepines and Other Targeted Substances Regulations, if they are allowed to prescribe those substances in their practice under the laws of the province in which they are registered and entitled to practise. Section 4 of the NCPR specifies particular controlled substances with which midwives, nurse practitioners and podiatrists cannot conduct activities under the CDSA regulations. For nurse practitioners, subsection 4(2) indicates that they cannot prescribe, sell, provide or administer diacetylmorphine, opium, coca leaves, and anabolic steroids, with the exception of testosterone.
The objective of these regulatory amendments is to ensure Canadians have greater access to a continuum of treatment options for opioid use disorder by amending certain provisions in the NCR and the NCPR so that
- with respect to methadone, practitioners of medicine, nurse practitioners, dentists and veterinarians can conduct activities with methadone without a section 56 exemption; and
- with respect to diacetylmorphine, practitioners of medicine and nurse practitioners can conduct activities with this substance either in or outside of a hospital setting.
In order to remove unnecessary regulatory barriers to access methadone and diacetylmorphine, as part of a comprehensive treatment plan, the Regulations Amending the Narcotic Control Regulations and the New Classes of Practitioners Regulations (Diacetylmorphine (Heroin) and Methadone) [hereafter
“the amending regulations”] make key amendments to certain provisions of the NCR and to one provision of the NCPR.
Amendments to the NCR with respect to methadone
The amending regulations make the following amendments to the NCR with respect to methadone:
- – Section 24 is amended to allow a licensed dealer to sell or provide methadone in a similar manner to other narcotics.
- – Section 27 is amended to facilitate the removal of additional requirements specific to methadone for a licensed dealer.
- – Subsections 31(2) and 31(3) are amended to align the authority of pharmacists to dispense methadone to its new status.
- – Section 53 is amended to allow a practitioner to prescribe, provide, or administer methadone like other narcotics, when treating their patients.
- – Subsection 65(3) is amended and subsection 65(5) is repealed as a consequence to the amendment made to section 53.
Amendments to the NCR with respect to diacetylmorphine
The amending regulations modify the following provisions of the NCR to allow practitioners of medicine and nurse practitioners to treat their patients with diacetylmorphine when practising their profession in or outside of a hospital:
- – Paragraph 24(4)(c) is amended to allow a licensed dealer to sell or provide diacetylmorphine to a pharmacist, practitioner of medicine or nurse practitioner. This way, a practitioner of medicine or nurse practitioner can provide treatment to their patients with diacetylmorphine in or outside of a hospital.
- – Subsection 31(2) is amended to align the authority of pharmacists to dispense medication containing diacetylmorphine with the fact that diacetylmorphine can now be sold, provided or prescribed by practitioners of medicine and nurse practitioners outside of a hospital.
- – Subsection 35(1) is amended to align provisions related to the provision of diacetylmorphine in a hospital setting with the fact that it may be sold, provided or prescribed in a hospital setting by practitioners of medicine, dentistry, and nurse practitioners.
- – Subsection 53(4) is amended by removing the reference to a practitioner of medicine. A practitioner of medicine can now prescribe, provide or administer diacetylmorphine when practising their profession, either in or outside of a hospital setting.
- – Subsection 65(4) is amended to permit the emergency sale or provision of diacetylmorphine to a pharmacist by the person in charge of a hospital.
- – Subsection 65(7) is amended by adding nurse practitioner to this provision. The NCR now allow a person in charge of a hospital to further authorize a nurse practitioner to prescribe, provide or administer diacetylmorphine to in-patients or out-patients of that hospital.
Amendment to the NCPR with respect to diacetylmorphine
The amending regulations modify paragraph 4(2)(b) of the NCPR by removing the reference of diacetylmorphine. As a result, subject to any provincial and regulatory limitations, nurse practitioners are allowed to prescribe, provide or administer diacetylmorphine in accordance with the NCR.
The amending regulations will result in a reduction in the administrative burden to businesses. The
“One-for-One” Rule applies and is an
“OUT” for the purpose of controlling administrative burden. The reduction in administrative burden cost will be banked, and the administrative credits used to offset administrative burden costs imposed by regulations implemented under the health portfolio.
The amending regulations remove the administrative burden imposed on regulated health practitioners by no longer requiring a section 56 exemption in order for them to treat patients with methadone. As a result, the time it takes preparing and submitting an exemption request will no longer be spent.
For the purpose of the
“One-for-One” Rule, practitioners of medicine are the only businesses that will see a decrease in the administrative burden and their associated costs. In 2016, there were about 2 120 exemption requests made to Health Canada (excluding those that fall under the class exemption issued in 2016) by or on behalf of practitioners of medicine. Historical data (from 2012 to 2016) on section 56 exemption requests indicate that the number of these requests increased on average by 3.7% on an annual basis. It is assumed that in the absence of the amending regulations, this trend would have continued into the future. Once the amending regulations come into force, these exemptions will no longer be required, and the associated administrative burden in terms of time spent going through the exemption process will be avoided. The exemption application is not cumbersome and it does not take a significant amount of time for practitioners of medicine to complete the form. Consulted practitioners of medicine indicated that on average, a maximum of 10 minutes are spent preparing a request. Given the number of requests that will no longer be submitted, it is then estimated that a total of 4 500 hours over 10 years, which would have been spent filling out these applications, will be saved. A cost of $74.60 per hour (in 2012 dollars and adjusted for overhead) is used to calculate the savings associated with the administrative burden reduction.
In accordance with the Red Tape Reduction Regulations, the reduction in the administrative burden cost to practitioners of medicine was estimated over 10 years (2018 to 2027) and discounted to 2012 using a 7% discount rate. The reduction in administrative burden cost is estimated to be $153,945 or an annualized saving of $21,920 (in 2012 dollars).
Small business lens
The amending regulations will not result in any cost increase to the small businesses. As a result, the small business lens does not apply.
Methadone — The Canadian Research Initiative in Substance Misuse (CRISM) was contracted by Health Canada to conduct a national consultation on the section 56 exemption requirement for methadone prescribing and issue a report detailing their findings. Participants in this process included clinical leaders and other health service providers; representatives from provincial/territorial regulatory bodies, provincial and federal governments and regional health authorities; and people with lived experience of substance use (including family members).
Key results of the consultation indicate that the majority of respondents felt that the section 56 exemption posed a barrier or obstacle to treatment. In addition, while the section 56 exemption requirement was not identified as the most significant obstacle, almost 70% of participants felt that removing the exemption requirement would be a beneficial step in expanding access to methadone treatment.
While the removal of the section 56 exemption requirement was highly supported in the CRISM consultation, some concerns were raised regarding the potential for the removal to lead to increased diversion, inappropriate prescribing and resulting harm to patients, lower quality care for patients and providers not adhering to guidelines and standards of practice for methadone treatment. During this consultation, respondents did indicate, however, that these concerns would be mitigated if P/T regulatory bodies maintained training and oversight. In this regard, most P/Ts indicated that they would retain their existing processes for practitioners. Overall, the majority of them indicated during the CRISM consultations that they supported, or were neutral in regard to, the removal of the exemption requirement.
During the CRISM consultation, some stakeholders in Ontario stated that the College of Physicians and Surgeons of Ontario (CPSO) may have difficulty enforcing the educational requirements and would need to establish new mechanisms to regulate methadone prescribing. While the CPSO did not express opposition to repealing the exemption requirement during subsequent discussions with Health Canada, it did note that the development of the above noted mechanisms would benefit from the sharing of best practices and related information.
In light of the above-noted concerns, Health Canada is ensuring that all provincial and territorial licensing authorities have a sufficient transition period to adjust their processes (in light of the removal of the section 56 requirement) by including a 60-day coming-into-force period for the amending regulations.
Diacetylmorphine — On November 11, 2017, Health Canada posted a Notice to Interested Parties regarding potential amendments related to diacetylmorphine in Canada Gazette, Part I, initiating a 60-day consultation period. While the majority of respondents supported the proposal, several of them noted that in order to achieve the longer-term objective of reducing the incidence of opioid use disorder in Canada, greater access to diacetylmorphine-assisted treatment should be viewed as one component of a comprehensive treatment plan that included wraparound services, such as primary healthcare and counselling services. These amending regulations are enabling and do not preclude offering other comprehensive services as part of the healthcare continuum.
As the opioid crisis in Canada continues, there is an urgent public health need to increase access to known effective opioid substitution treatments. Both methadone and diacetylmorphine-assisted treatments are two such treatments.
By removing the above-noted regulatory constraints, these amending regulations ensure that Canadians have greater access to a continuum of opioid substitution treatment options.
In addition, these amending regulations support federal actions on opioids and are consistent with commitments outlined in the October 4, 2017, Minister of Health mandate letter commitment to
“use the government’s regulatory powers to ensure that interested communities do not face undue barriers in introducing effective opioid substitution programs and treatment options” and the federal government’s commitments under the November 2016
Costs and benefits
Since the amending regulations do not result in any new or expanded requirements, there is no incremental cost imposed on affected stakeholders.
Patients, certain healthcare practitioners (e.g. practitioners of medicine, nurse practitioners), pharmacies, healthcare facilities and the federal government will benefit from the amending regulations. More specifically, these benefits will accrue to
- patients — who will be able to access treatment without experiencing some of the delays and barriers currently caused by regulatory impediments;
- practitioners — who will be enabled to more easily prescribe these substances to their patients and more specifically, in the case of methadone, they will no longer need an exemption under section 56 of the CDSA in order to prescribe; and
- government, practitioners and their regulatory bodies — who will see a decrease in administrative and other burden due to the removal of these regulatory requirements.
The amending regulations, in addition to other unquantified benefits, will result in cost savings valued at $565,170 over 10 years (present value), or $80,470 (annualized). These benefits are discussed below. All the estimates (in 2012 dollars) were done for 10 years (2018 to 2027) and discounted to 2018 using a 7% discount rate.
Benefits to patients
Methadone — Patients will benefit from the amending regulations because any delay in receiving their treatment that is attributable to exemption processing and pharmacy checking (i.e. practitioners waiting to either receive an exemption or for their exemption to be renewed and pharmacists checking with Health Canada to confirm that the prescribing practitioner has the required exemption) is eliminated. The amending regulations remove the current federal regulatory barrier to treatment, and will facilitate patients in receiving their treatment in a more timely fashion, and ultimately contribute to reducing the potential health risks. For certain pain patients who may be treated with methadone, this will reduce unnecessary prolonged pain and suffering that would have resulted from the delay in providing their treating practitioners with an exemption.
Diacetylmorphine — The amending regulations will allow for the prescribing, provision, and administration of diacetylmorphine outside of a hospital setting by certain classes of practitioners. This will remove a barrier to treatment because patients will be able to go to locations that are more convenient for them to get the treatment and will no longer be required to make multiple trips a day to a hospital while having to balance these trips with daily responsibilities. Further, it is believed that this added flexibility in establishing community-based treatment options will help remove the stigma faced by patients undergoing this treatment.
Benefits to practitioners
Methadone — The amending regulations will enable more practitioners to prescribe methadone to their patients in a timely manner, without having to go through the process of getting an exemption under section 56 of the CDSA. For currently exempted practitioners of medicine, they will no longer need to renew their exemptions when they expire in order to continue to prescribe, and practitioners of medicine not currently exempted will be able to do so without facing a regulatory barrier. These regulatory changes will result in a reduction of burden on these practitioners of medicine, but they will still have to meet all other applicable requirements of the NCR, as well as the requirements established by the relevant jurisdictions or licensing authority governing their practice when dealing with controlled substances. P/Ts have indicated that their requirements for methadone prescribing are likely to remain. For other practitioners such as nurse practitioners, no tangible incremental benefits are expected, as no exemption requests for this class of practitioners were received in the past, and the likelihood of receiving such requests in the future, absent the amending regulations, are considered negligible.
As discussed in the
“One-for-One” Rule section above, 4 500 hours, which would have been spent by practitioners of medicine filling out these applications over the period 2018 to 2027, will be saved. Applying the hourly cost to prepare an exemption request to the number of hours saved and discounted to 2018 using a 7% discount rate, the amending regulations will save these practitioners of medicine $231,030 in administrative burden costs.
Diacetylmorphine — Once the amending regulations come into force, practitioners of medicine and nurse practitioners working outside of a hospital will be able to prescribe diacetylmorphine to their patients either for pain management or as part of a comprehensive treatment plan for opioid use disorder. The amending regulations will further improve their flexibility in administering the medication they deem most effective to treat their patient’s condition.
Benefits to provincial/territorial healthcare systems
Diacetylmorphine — Provinces and territories, where diacetylmorphine-assisted therapy is available and currently provided through hospitals, may see cost savings associated with providing this healthcare service. As the amending regulations will allow diacetylmorphine-assisted therapy to be provided in other approved specialized healthcare facilities, patients who can take advantage of this option will go to these facilities instead. It is expected that the cost associated with providing healthcare in such facilities are considerably less compared to a hospital. As a result, certain provinces or territories will see an overall decrease in the cost strictly associated with this kind of treatment. Due to the unavailability of data, it is not possible to estimate the potential savings, although it is considered significant.
Benefits to pharmacies and regulatory bodies
Methadone — Currently, before dispensing methadone, pharmacies check with Health Canada and get confirmation that the prescribing practitioner of medicine has a valid section 56 exemption. Internal data indicates that Health Canada receives on average 43 enquiries per day from pharmacies. The interaction between Health Canada and the pharmacy takes five minutes on average to complete. However, it might take additional time for pharmacies to initiate the process. This additional length of time is not known, but it is reasonable to assume that the total length of time it takes pharmacies on a per request basis likely exceeds the average five minutes. For the purpose of this analysis, however, it is assumed that at least five minutes are spent by pharmacies getting the confirmation from Health Canada. Once the amending regulations come into force, pharmacies will not need to perform this check and will save at least 892 hours per year. Assuming an average wage rate of $53.32 per hour for pharmacists (in 2012 dollars and adjusted for overhead), this burden reduction translates into a cost saving of $334,140 over 10 years (present value). This is a lower bound estimate as it is possible that pharmacies spend more than five minutes confirming that a prescribing practitioner of medicine is in possession of a section 56 exemption.
Similarly, licensing authorities (e.g. colleges of physicians and surgeons) may see a reduction in the burden associated with processing an application from practitioners of medicine and submitting a recommendation to Health Canada. As mentioned above, the CRISM report states that most P/Ts would likely maintain their existing processes for practitioners of medicine, as such, the monitoring could be rolled into their established practitioner of medicine monitoring and training requirements. For all exemptions, a certain amount of processing time is spent by licensing authorities to provide a recommendation to Health Canada with respect to granting the exemption. Communications with a licensing authority indicate that about 40 minutes are spent on such an exercise. Given this processing time, 17 995 hours over 10 years will be saved by licensing authority for no longer having to undertake this activity.
Benefits to the federal government
Methadone — The amending regulations will also create benefit for the federal government. Health Canada will no longer have to process applications for section 56 exemptions for methadone. On a yearly basis, 3 280 hours are spent on processing exemptions for methadone as well as related activities. The amending regulations will benefit Health Canada as the time spent on these methadone-related activities will be reallocated to other activities, including improving the operational efficiency of the controlled substances program.
Other benefits — In addition, the amending regulations with respect to both methadone and diacetylmorphine will help the Minister deliver on her commitment to remove barriers to treatment at the federal level as one of the actions to address the unprecedented opioid crisis currently occurring in Canada.
Implementation, enforcement and service standards
Coming into force
These amending regulations come into force 60 days after the publication in the Canada Gazette, Part II. As part of the implementation of the amending regulations, Health Canada will notify provincial and territorial partners and stakeholders of the changes to NCR and the NCPR. Information will also be provided on Health Canada’s website.
As the amending regulations remove restrictions for accessing methadone and diacetylmorphine, no specific enforcement activities will be required. However, federal, provincial and local law enforcement agencies will continue to take enforcement action in response to contraventions of the CDSA and its regulations. Under the CDSA, a range of penalties apply to offences associated with methadone and diacetylmorphine. For certain offences associated with these substances, listed in Schedule I of the CDSA, there is a maximum penalty of life imprisonment (mandatory minimum penalties of one, two or three years may apply if certain conditions are met).
There are no service standards associated with the amending regulations.
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