Canada Gazette, Part I, Volume 146, Number 18: New Classes of Practitioners Regulations

May 5, 2012

Statutory authority

Controlled Drugs and Substances Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issue

At present, only practitioners defined as doctors of medicine, dentists and doctors of veterinary medicine under the Controlled Drugs and Substances Act are authorized to prescribe, administer and provide controlled substances when treating patients. With the evolution of the health care system in Canada in recent years, however, the range of categories of health professionals involved in providing health care services involving controlled substances has expanded. In some cases, these categories of health professionals are authorized under provincial or territorial legislation to prescribe controlled substances, but are not authorized to do so under the Controlled Drugs and Substances Act and its regulations. As a result of this inconsistency, midwives, nurse practitioners and podiatrists have been unable to provide health care services involving the provision of treatment with controlled substances in accordance with their full provincial or territorial scope of practice. There is thus a need to align to the extent possible the federal and provincial or territorial authority to prescribe, administer and provide controlled substances for these health professionals.

Objectives

The Controlled Drugs and Substances Act defines a practitioner as “a person who is registered and entitled under the laws of a province to practice in that province the profession of medicine, dentistry or veterinary medicine and includes any other person or class of persons prescribed as a practitioner”. The word “prescribed” means in this context prescribed by regulation.

The purpose of this regulatory initiative is to prescribe, by regulation, midwives, nurse practitioners and podiatrists as practitioners under the Controlled Drugs and Substances Act so that they would be authorized to conduct activities (e.g. prescribing, administering and providing) with controlled substances provided they are already authorized to do so within their scope of practice as set out in provincial or territorial legislation or regulation. In so doing, Health Canada strives to support flexibility and timeliness in health care service delivery. The proposed NCPR would only affect health professionals in provinces and territories where they are regulated and authorized to prescribe controlled substances. The proposed Regulations have also been designed with maximum flexibility so as to address situations where provincial or territorial authorization for midwives, nurse practitioners and podiatrists to prescribe controlled substances may be granted in the future.

These Regulations are needed because the Controlled Drugs and Substances Act prohibits any person from conducting activities with controlled substances unless authorized by regulation. Under the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations, only practitioners (defined under the Act as doctors of medicine, dentists and doctors of veterinary medicine) are authorized to prescribe, administer and provide controlled substances when treating their patients.

While midwives, nurse practitioners and podiatrists do not currently fall within the definition for practitioner under the Act, these categories of health professionals have nevertheless been authorized to prescribe controlled substances under provincial and territorial legislation in a number of jurisdictions. An overview of their authorization (which varies by jurisdiction) is provided below.

Midwives

Midwives are specialists in normal childbirths, providing care through early pregnancy to birth and six weeks postpartum to women and their infants. The profession of midwifery is regulated in all provinces and territories except Nunavut, Prince Edward Island and Yukon. While regulated midwives are permitted to prescribe medications in all jurisdictions except Newfoundland and Labrador, only midwives in British Columbia, Manitoba, Nova Scotia and Quebec are currently authorized to prescribe medications containing controlled substances under existing provincial and territorial legislation. Currently there are about 900 midwives in Canada.

Midwives work autonomously within a scope of practice as set out in provincial and territorial legislation, collaborating with other health care providers as needed. While there are differences among the provinces and territories in how midwifery is regulated, the basic model of midwifery practice is the same across all jurisdictions in Canada.

Nurse practitioners

Nurse practitioners are registered nurses who achieve additional competencies, usually through graduate nursing education, combined with substantial clinical experience. Legislation authorizing nurse practitioners to autonomously diagnose and treat health conditions and prescribe medications has been enacted in all provinces and territories except the Yukon. Regulated nurse practitioners in all jurisdictions except New Brunswick, Nova Scotia, Northwest Territories and Nunavut are allowed to prescribe medications containing controlled substances. Currently there are approximately 2 500 nurse practitioners in Canada.

Podiatrists

Podiatrists are health professionals specialized in the diagnosis and treatment of disorders and diseases affecting the foot, ankle and lower legs. There are two groups of podiatrists practising in Canada: doctors of podiatric medicine (DPM) and podiatrists/ chiropodists. There are close to 300 health professionals in each group and they are represented by two separate national associations. Regulated in British Columbia, Alberta, Ontario and Quebec, DPMs receive education at accredited colleges of podiatric medicine in the United States or at the Université du Québec à Trois-Rivières and are authorized to practise the profession of podiatry in those provinces with surgical and prescribing (where this includes medications containing controlled substances) privilege. Podiatrists/chiropodists (non-DPMs) are currently regulated in Saskatchewan, Manitoba, Ontario and New Brunswick. These podiatrists/chiropodists are not authorized under provincial and territorial legislation to prescribe medications containing controlled substances at present.

In order to align the regulatory requirements of midwives, nurse practitioners and podiatrists handling controlled substances under both federal and provincial and territorial legislative frameworks, Health Canada decided to develop the New Classes of Practitioners Regulations, a regulatory framework that would prescribe these health professionals as practitioners under the CDSA, thus authorizing them to conduct activities with controlled substances when providing treatment to their patients.

Description

The NCPR, as proposed herein, contain the following components:

Definitions

Among other things, these Regulations would define who is considered to fall into the three new classes of practitioners.

New classes of practitioners prescribed

In accordance with the definition for practitioner in subsection 2(1) of the Controlled Drugs and Substances Act, the NCPR would prescribe midwives, nurse practitioners and podiatrists as practitioners.

Permitted activities

The NCPR would authorize affected health professionals to prescribe, administer and provide controlled substances, with certain exclusions, in accordance with the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations, provided they are allowed to do so within their scope of practice set out in provincial and territorial legislation.

Exclusions of controlled substances

The following exclusions of controlled substances would apply to each new class of practitioners respectively:

1. — for midwives and podiatrists: heroin, cannabis, opium, coca, methadone, buprenorphine, amphetamine, benzphetamine, methamphetamine, phenmetrazine, phendimetrazine and anabolic steroids; and
2. — for nurse practitioners: heroin, cannabis, opium, coca and anabolic steroids (except testosterone).

The above-noted exclusions of controlled substances were chosen based on the risk of diversion and/or abuse associated with the different substances, specific regulatory requirements in the Narcotic Control Regulations, Part G of the Food and Drug Regulations and the Marihuana Medical Access Regulations, and the scopes of practice of affected health professionals. For example, nurse practitioners are often involved in treating transgender sex reassignment patients, thus require the authority to prescribe testosterone.

Inconsistency with other regulations

As outlined in the proposed NCPR, these Regulations would prevail in the event of any inconsistency between these Regulations and the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations.

Similar to the NCPR prepublished in 2007, the revised Regulations contain consequential amendments to certain provisions in the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations and Part G of the Food and Drug Regulations. These provisions relate to the handling of controlled substances by practitioners, pharmacists and licensed dealers. Among other things, the consequential amendments clarify that unlike doctors of medicine, doctors of veterinary medicine and dentists, new classes of practitioners would not be able to designate an agent to handle controlled substances on their behalf, according to relevant provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations.

Furthermore, the proposed NCPR will serve as a vehicle to amend section G.04.001 of Part G of the Food and Drug Regulations by the deletion of subparagraph G.04.001(4)(a)(iii). This provision refers to the medical condition “mental retardation (minimal brain dysfunction)” in the context of the use of a designated drug (as defined earlier in the provision). The use of this terminology is inconsistent with the spirit of the United Nations Convention on the Rights of Persons with Disabilities, to which Canada is a signatory. Health Canada has elected to delete rather than replace this term because the Department is not aware that any of the designated drugs referred to in the provision are approved for sale in Canada for use in the treatment of “mental retardation.”

Overall, the proposed Regulations focus on prescribing midwives, nurse practitioners and podiatrists as practitioners as defined in the Controlled Drugs and Substances Act and would authorize them to conduct activities with controlled substances in accordance with provisions of the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations, with the exclusion of certain controlled substances. Affected health professionals would also have to comply with requirements set out in these regulations for practitioners with respect to keeping records on controlled substances prescribed, received or provided; ensuring proper security of controlled substances and the required records; and reporting on loss or theft of controlled substances within a specific timeframe to law enforcement and Health Canada.

Under the proposed NCPR, midwives, nurse practitioners and podiatrists who are already authorized to prescribe controlled substances within their scope of practice as set out in provincial and territorial legislation would be able to fully practise their profession by treating their patients with medications containing controlled substances, as needed. For those who are not currently allowed to prescribe controlled substances at the provincial or territorial level, the NCPR would not affect their practice unless the provincial or territorial legislation regulating their scope of practice is amended in the future to authorize them to prescribe controlled substances when treating patients.

Regulatory and non-regulatory options considered

As elaborated above, addressing the inconsistencies among federal, provincial and territorial legislation is key to supporting flexible and timely delivery of health care services involving affected health professionals. In accordance with section 56 of the Controlled Drugs and Substances Act, the Minister of Health may exempt any person or class of persons from the application of any provisions of the Act or its regulations for medical or scientific purposes, or in the public interest. While the issuance of such exemptions is a potential non-regulatory option, this approach was deemed inappropriate and inefficient as every single midwife, nurse practitioner or podiatrist would have to be exempted from the applicable prohibitions in order to be permitted to conduct activities with controlled substances. As a result, Health Canada examined the following three options:

Option 1: Amend the definition of “practitioner” in the Controlled Drugs and Substances Act to include new classes of practitioners

Although proceeding with a statutory amendment to change the definition of practitioner in the Act would be a viable way of authorizing the affected health professionals to conduct activities with controlled substances, Option 1 was not desirable since the current definition of practitioner in the Controlled Drugs and Substances Act already allows for the Governor in Council to prescribe by regulation a person or class of persons as a practitioner. In addition, employing this option would automatically and unilaterally extend all of the authorities of a practitioner as currently specified in relevant regulations to the new classes of practitioners. As a result, Health Canada would not have the flexibility to impose certain restrictions based on individual scopes of practice or risk of diversion to the illicit market.

Option 2: Develop new sections for the new classes of practitioners in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations

Option 2 was similarly rejected as provisions specific to each new class of practitioners would need to be added to each of the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations. This option would result in Health Canada having to amend three sets of regulations each time any changes need to be made to the provisions governing the activities of affected health professionals or if an additional category of health professionals were to be designated as practitioners under the Act in the future.

Option 3: Promulgate new regulations under the Act that would prescribe new classes of practitioners and stipulate which of the provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations are applicable

This option would provide clarity for stakeholders, in particular the affected health professionals, with respect to the permitted activities and exceptions, if any, under the federal regulatory framework. This approach would also allow Health Canada to designate, by way of amendment to the NCPR, additional classes of health professionals as practitioners in the future.

Following an analysis of the options above, Health Canada has determined that Option 3 would allow the objectives of this proposal to be realized in the most efficient manner possible.

Benefits and costs

In order to estimate the potential costs and benefits of the NCPR, Health Canada commissioned a literature review aimed at evaluating the potential implications of expanding the authority to prescribe, administer and provide controlled substances to midwives, nurse practitioners, and podiatrists. The literature review was focussed primarily on an examination of research on related experience in countries such as the United Kingdom, the United States, New Zealand, Australia and Sweden.

References for studies referred to below can be found in a summary of the literature review which is available upon request. It should be noted that much of this review examines the experience of health professionals in other countries whose health care systems often differ from the Canadian system. Moreover, many studies dealing with expanding authority to prescribe and administer medications do not necessarily focus specifically on medications containing controlled substances.

In this regard, while these studies offer valuable insight as to the potential impacts of the NCPR, care must be taken in making intercountry comparisons, or drawing conclusions as to specific benefits and costs in Canada.

Benefits

This regulatory initiative aims to support flexibility and timeliness of health care delivery in Canada for patients treated by a midwife, nurse practitioner or podiatrist. Under the proposed Regulations, these health professionals would have the authority to prescribe medications containing controlled substances to patients when allowed to do so under their scopes of practice as set out in provincial and territorial legislation, thereby no longer requiring another assessment by a doctor of medicine or a dentist. This may be important to a patient’s comfort and well-being in situations where timely treatment with a controlled substance is required.

Reducing unnecessary referrals would also increase the flexibility and timeliness of health care service delivery by affected health professionals. Patients would also benefit through a reduction in the time required to access medications containing controlled substances.

Studies from other countries including the United States, the United Kingdom and New Zealand suggest that the expansion of prescribing authority to nurses or midwives offers patients more timely access to the medical care they require. Moreover, studies indicate there is no significant difference in prescribing practice between these health professionals and physicians. Finally, while research on this issue is limited, there is little reason to believe that midwives, nurse practitioners and podiatrists are more likely than physicians to abuse prescribing privileges.

Costs

A review of existing research yielded little direct information on the cost-effectiveness of allowing midwives, nurse practitioners and podiatrists to prescribe controlled substances or to engage in related activities. In examining the impact of increasing the role and responsibilities of nurses, midwives, and similar groups in prescribing medication and delivering primary care, the literature suggests that such an expansion is unlikely to have a significant impact on the overall cost of service. In some instances, researchers have found that increased reliance on health professionals other than physicians may reduce the overall cost of service. The weight of evidence, however, is insufficient to conclude that implementation of the NCPR is likely to lead to significant cost savings to provincial and territorial health care systems.

In terms of costs to Health Canada as a result of the implementation of these Regulations, it may incur marginal costs related to revoking or reinstating authorities for an individual practitioner to conduct activities with controlled substances granted under the proposed NCPR, which is the responsibility of the Minister of Health in accordance with provisions of the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations. Notices would need to be sent to pharmacists and licensed dealers using the processes currently in place for practitioners under the Controlled Drugs and Substances Act. As such revocations or reinstatements occur on an occasional basis only (roughly 25 cases per year at a cost of approximately $2,000 per case), the cost to Health Canada associated with the implementation of the proposed NCPR is expected to be minimal.

Implementation of the NCPR is also not expected to have extensive cost implications at the provincial and territorial level as the affected health professionals are already regulated under provincial and territorial legislation and provincial and territorial licensing authorities already have established mechanisms to monitor compliance with relevant legislation and regulations for these professionals. In addition, training with respect to prescribing practice is already a part of competency requirements for affected health professionals in jurisdictions where they are authorized to prescribe medications under the provincial and territorial legislation. There may be cost implications for provincial and territorial licensing authorities for nursing if they decide to establish a mechanism, similar to that set up by licensing authorities for medical doctors, to ensure the qualifications and compliance of nurse practitioners who request exemptions issued by the Minister of Health under section 56 of the Controlled Drugs and Substances Act with respect to handling methadone for the treatment of opioid dependence or pain (in accordance with subsection 53(3) of the Narcotic Control Regulations).

Rationale

As the federal department responsible for helping the people of Canada maintain and improve their health, Health Canada is committed to improving the lives of all of Canada’s people and to making this country’s population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system. One of the ways of achieving this goal is by supporting effective health care service delivery to Canadians through appropriate access to controlled substances by health professionals.

While the federal legislative framework regulates activities with controlled substances, provincial and territorial legislation regulates health professions and determines the specific scope of practice for each category of regulated health professionals. Such scope of practice covers a broad range of authorities including the authority to prescribe medications containing controlled substances. Given that the authority to handle controlled substances for health professionals is governed at the federal and provincial or territorial level, the proposed Regulations seek to align this authority to the extent possible for midwives, nurse practitioners and podiatrists so that they are able to fully provide appropriate health care services to patients, including prescribing controlled substances as required.

As the Controlled Drugs and Substances Act prohibits any person from conducting activities with controlled substances unless authorized by regulation, and only practitioners (defined as doctors of medicine, dentists and doctors of veterinary medicine) can conduct activities with controlled substances under the Act, developing a set of regulations to prescribe midwives, nurse practitioners and podiatrists as practitioners (in accordance with the definition of practitioner in the Act) has been determined by Health Canada to be the most effective solution to realize the objectives of the regulatory proposal.

The proposed NCPR would affect three classes of health professionals where they are already authorized to prescribe controlled substances under existing provincial or territorial legislation. As midwifery, nursing and podiatry are already regulated health professions in many jurisdictions, the implementation of the NCPR is not expected to impose a significant administrative burden on these health professionals and their licensing authorities since mechanisms for ensuring the competency of these health professionals and monitoring their compliance with relevant legislation, policies and guidelines already exist. In the jurisdictions where affected health professionals have yet to be regulated with respect to prescribing controlled substances, the NCPR would have no effect until the time when relevant provincial or territorial legislation is in place.

The proposed NCPR are in line with current international practices of allowing health professionals such as nurse practitioners to play a critical role in the provision of primary health care. Along with changes in the delivery of primary health care over the past decades, prescribing and administering medications has become an essential component of the expanded scopes of practice of midwives, nurse practitioners and podiatrists in countries such as the United Kingdom, the United States, New Zealand, Australia and Sweden. In the United States, for instance, the Drug Enforcement Administration registers multiple professions having the authority to prescribe controlled substances listed in the Controlled Substances Act; this includes registering podiatrists as practitioners, as well as recognizing other health professionals such as nurse practitioners and midwives who are registered at the state level to practice.

Moreover, as Canada is a signatory to the United Nations drug control treaties, namely the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971, the NCPR support the fulfillment of Canada’s treaty obligations to ensure that the availability of narcotic drugs and psychotropic substances is limited to medical and scientific purposes. By authorizing the affected health professionals to prescribe, administer and provide controlled substances in accordance with the conditions and requirements of the Controlled Drugs and Substances Act and its regulations, the NCPR provide controls to mitigate the risk of diversion of controlled substances while ensuring the new classes of practitioners can legitimately access these substances in the provision of health care services. The NCPR would thus support Canada’s compliance with the provisions of the United Nations drug control conventions.

Consultation

A notice to interested parties regarding a regulatory proposal to expand the authority to prescribe controlled substances to regulated health professionals other than practitioners of medicine, dentistry or veterinary medicine was published in the Canada Gazette, Part Ⅰ, in 2004, followed by consultations with self-identified interested groups from provincial and territorial governments, national associations of health professionals, and provincial and territorial licensing authorities, among others.

The proposed NCPR were subsequently prepublished in the Canada Gazette, Part Ⅰ, on June 30, 2007 (www.gazette.gc.ca/rp-pr/p1/2007/2007-06-30/pdf/g1-14126.pdf), followed by a 60-day comment period. These proposed Regulations set out a framework within which midwives, nurse practitioners and podiatrists would be permitted to conduct activities with controlled substances under certain circumstances. The proposed Regulations contained the following key elements:

• Definitions for new classes of practitioners and other related definitions;
• Permitted activities (possessing, transporting, administering, providing and selling), provided these practitioners were authorized under provincial or territorial legislation to prescribe controlled substances for treating patients;
• Requirements for new classes of practitioners with respect to record-keeping, security, reporting on loss or theft, and communication to the Minister of Health of required information;
• Limitations for licensed dealers and pharmacists concerning the supply of controlled substances to new classes of practitioners;
• Schedules listing the controlled substances that each new class of practitioners could prescribe; and
• The authority for the Minister of Health with respect to revocation and reinstatement of practitioners’ privileges for handling controlled substances.

The proposed Regulations also specified consequential amendments to relevant provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations.

During the comment period, 33 comments were received. Additional comments were also received by Health Canada after that period. While most comments supported the development of the proposed Regulations, some groups representing physicians opposed this regulatory proposal, citing concerns of insufficient knowledge and experience of the affected health professionals in handling controlled substances when providing treatment to patients. Furthermore, provincial and territorial ministries of health and key stakeholder groups raised significant concerns regarding certain provisions of the proposed NCPR such as the proposed drug schedules setting out specific controlled substances with which each new class of practitioners can conduct activities, the proposed definitions for nurse practitioner and doctor of podiatric medicine, and the proposed requirements for practitioners regarding record-keeping, security and reporting on loss or theft.

To address these concerns, Health Canada launched a new round of consultations with provincial and territorial ministries of health in July 2009. In January 2011, Health Canada and all provincial and territorial ministries of health agreed on the following revisions to the original proposal:

• Revision of the proposed definition for nurse practitioner to reflect the common competencies possessed by all nurse practitioners;
• Revision of the proposed definition for doctor of podiatric medicine to cover both doctors of podiatric medicine and podiatrists (to ensure the latter are covered under the NCPR should they be authorized in the future under provincial or territorial legislation to handle controlled substances under their scope of practice);
• Deletion of provisions with respect to record-keeping, security, reporting on loss or theft (as related provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations would apply under the revised proposal);
• Reference to the permitted activities for practitioners specified in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations; and
• Replacement of previously proposed schedules of substances with the schedules to the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations with the aforementioned exclusions of controlled substances with which various classes of new practitioners are not authorized to conduct activities.

Health Canada has subsequently shared the proposed changes with key stakeholder groups, including the Canadian Nurses Association, the Canadian Midwifery Regulators Consortium, the Canadian Podiatric Medical Association, and the Canada Federation of Podiatric Medicine. All of these groups were supportive of the revised proposal.

Implementation, enforcement and service standards

Monitoring the overall practice of the affected health professionals is the responsibility of provincial and territorial jurisdictions, and respective provincial and territorial licensing authorities already have mechanisms in place to ensure that these health professionals comply with relevant legislation. These mechanisms include components such as the issuance, suspension and revocation of licence or registration, ensuring appropriate competencies, and monitoring compliance with any particular conditions or requirements. As required under the federal regulatory framework, provincial and territorial licensing authorities would also assume the responsibility of communicating to Health Canada occurrences which may result in the suspension or revocation of certain authorities under the Controlled Drugs and Substances Act and its regulations.

Health Canada would then, in accordance with relevant provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations, suspend or revoke the prescribing authority for the named individual, and communicate its action in this regard to relevant provincial or territorial licensing authorities, pharmacists and licensed dealers.

To complement the proposed NCPR, Health Canada has established a process outlining the manner in which Health Canada would consider amending the NCPR in order to designate additional classes of health professionals as practitioners in the future. The framework for this process stipulates principles for designating additional classes of health professionals as practitioners under the NCPR, specifies roles and responsibilities of parties involved, and delineates the steps of the designation procedure. Within this context, it should be noted that only proposals submitted by provincial or territorial ministries of health for the inclusion of an additional category of health professionals in these Regulations would be considered by Health Canada.

Performance measurement and evaluation

In accordance with the Cabinet Directive on Streamlining Regulation, Health Canada will, in collaboration with key partners and stakeholders, such as provincial and territorial ministries of heath and relevant licensing authorities, and national associations representing affected health professionals, develop and finalize a performance measurement and evaluation plan to assess the implementation of the NCPR with a view to ensuring that the Regulations support more flexible and timely health care service delivery.

This plan will clearly specify the methods selected to measure the impacts of the NCPR, relevant measures and indicators, and roles and responsibilities of all parties involved. A performance measurement and evaluation plan will be finalized in the months ahead and will be available upon request from Health Canada.

Contact

Mr. Hong Zhang
Regulatory Policy Division
Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
123 Slater Street, Room A310
Ottawa, Ontario
K1A 1B9
Telephone: 613-948-7792
Fax: 613-946-4224
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@ hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote a), proposes to make the annexed New Classes of Practitioners Regulations.

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be addressed to Hong Zhang, Regulatory Policy Division, Office of Controlled Substances, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, Address Locator: 3503D, Ottawa, Ontario K1A 0K9 (fax: 613-946-4224; email: OCS_regulatorypolicy-BSC_ politiquereglementaire@hc-sc.gc.ca).

Ottawa, April 26, 2012

JURICA ČAPKUN
Assistant Clerk of the Privy Council

NEW CLASSES OF PRACTITIONERS REGULATIONS

INTERPRETATION

Definitions

1. The following definitions apply in these Regulations.

“Act”
« Loi »

“Act” means the Controlled Drugs and Substances Act.

“listed substance”
« substance inscrite »

“listed substance” means a substance set out in Schedule 1 to the Benzodiazepines and Other Targeted Substances Regulations, the schedule to Part G of the Food and Drug Regulations or the schedule to the Narcotic Control Regulations, and includes anything that contains that substance.

“midwife”
« sage-femme »

“midwife” means a person who is registered and entitled under the laws of a province to practise midwifery and who is practising midwifery in that province.

“nurse practitioner”
« infirmier praticien »

“nurse practitioner” means a person who is registered and entitled under the laws of a province to practise as a nurse practitioner or an equivalent designation and who is practising as a nurse practitioner or an equivalent designation in that province. For the purpose of this definition, a designation is equivalent when it designates a person who

1. (a) is a registered nurse;
2. (b) possesses additional health care related educational preparation and experience;
3. (c) can autonomously diagnose, order and interpret diagnostic tests, prescribe drugs and perform other specific procedures under the laws of a province; and
4. (d) is authorized to practise, for example, under the following provincial laws, as amended from time to time:
   
   1. (i) the Extended Practice Regulation, Man. Reg. 43/2005, made under The Registered Nurses Act of Manitoba, C.C.S.M., c. R40,
   2. (ii) Ontario Regulation 275/94, made under the Nursing Act, 1991 of Ontario, S.O. 1991, c. 32, or
   3. (iii) the Regulation respecting Ordre des infirmières et infirmiers du Québec classes of specialities related to the performance of acts contemplated in section 36.1 of the Nurses Act, R.R.Q., c. I-8, r. 8, made under the Nurses Act of Quebec, R.S.Q., c. I-8.
      

“podiatrist”
« podiatre »

“podiatrist” means a person who is registered and entitled under the laws of a province to practise podiatry and who is practising podiatry in that province.

NEW CLASSES OF PRACTITIONERS PRESCRIBED

Classes

2. For the purpose of the definition “practitioner” in subsection 2(1) of the Act, the following classes of persons are prescribed:

1. (a) midwives;
2. (b) nurse practitioners; and
3. (c) podiatrists.

PERMITTED ACTIVITIES AND EXCLUSIONS

Permitted activities

3. Subject to section 4, a midwife, nurse practitioner or podiatrist, as a practitioner, may prescribe or possess a listed substance, or conduct an activity with a listed substance, in accordance with the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations or the Narcotic Control Regulations if they are permitted to prescribe, in their practice under the laws of the province in which they are registered and entitled to practise, that substance.

Exclusions — midwife or podiatrist

4. (1) In respect of a midwife or podiatrist, a listed substance excludes a substance set out in

1. (a) the definition “designated drug” in subsection G.04.001(1) of the Food and Drug Regulations;
2. (b) item 1 of Part Ⅲ of the schedule to Part G of the Food and Drug Regulations; and
3. (c) any of subitems 1(1) and (10), 2(1), 5(4), 10(1) and 17(2) of the schedule to the Narcotic Control Regulations.

Exclusions — nurse practitioner

(2) In respect of a nurse practitioner, a listed substance excludes a substance set out in

1. (a) item 1 of Part Ⅲ of the schedule to Part G of the Food and Drug Regulations, except for subitem (40); and
2. (b) any of subitems 1(1) and (10), 2(1) and 17(2) of the schedule to the Narcotic Control Regulations.

INCONSISTENCY WITH OTHER REGULATIONS

Inconsistency

5. In the event of any inconsistency between these Regulations and the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations or the Narcotic Control Regulations, these Regulations prevail to the extent of the inconsistency.

CONSEQUENTIAL AMENDMENTS

FOOD AND DRUG REGULATIONS

6. (1) The definition “controlled drug” in subsection G.01.001(1) of the Food and Drug Regulations (see footnote 1) is replaced by the following:

“controlled drug” means

1. (a) a drug set out in the schedule to this Part and includes a preparation; or
2. (b) in respect of a midwife, nurse practitioner or podiatrist, a drug set out in the schedule to this Part, including a preparation, which any of these practitioners may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations; (drogue contrôlée)

(2) Subsection G.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

“midwife” has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (sage-femme)

“nurse practitioner” has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (infirmier praticien)

“podiatrist” has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (podiatre)

7. Section G.01.002 of the Regulations is amended by adding the following after subsection (2):

(2.1) Subsection (2) does not apply to a person who is acting as the agent for a midwife, nurse practitioner or podiatrist.

8. Paragraph G.02.001.2(2)(b) of the Regulations is replaced by the following:

1. (b) shall either
   
   1. (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or
   2. (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and
      

9. Paragraph G.02.003(3)(e) of the Regulations is replaced by the following:

1. (e) if the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge is not a pharmacist or a practitioner of medicine, dentistry or veterinary medicine registered with a provincial professional licensing authority, a copy of the person’s degree required under subparagraph G.02.001.2(2)(b)(ii) and a copy of the course transcript for that degree;

10. Section G.02.024 of the Regulations is renumbered as subsection G.02.024(1) and is amended by adding the following:

(2) For the purpose of subsection (1), for greater certainty, a licensed dealer may sell or provide a controlled drug to a midwife, nurse practitioner or podiatrist only if such a practitioner is permitted to prescribe or possess the controlled drug, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

11. (1) The portion of subsection G.02.025(1) of the Regulations before paragraph (a) is replaced by the following:

G.02.025. (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 controlled drug to a person as permitted under section G.02.024 if

(2) The portion of subsection G.02.025(2) of the Regulations before paragraph (b) is replaced by the following:

(2) A licensed dealer who has received an order referred to in subparagraph (1)(b)(i) and verified the signature on the order may sell or provide a controlled drug to a person as permitted under section G.02.024, if the order is signed and dated by one of the following persons:

1. (a) if the controlled drug is to be sold or provided to a person referred to in paragraph G.02.024(1)(a), (b), (c) or (f), by that person; or

(3) The portion of subsection G.02.025(4) of the Regulations before paragraph (a) is replaced by the following:

(4) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii), and has provided a controlled drug listed in Part Ⅱ or III of the schedule to this Part to a person referred to in paragraphs G.02.024(1)(b) to (d), shall immediately record

12. Section G.03.003 of the Regulations is renumbered as subsection G.03.003(1) and is amended by adding the following:

(2) For the purpose of subsection (1), for greater certainty, a pharmacist may sell or provide a controlled drug to a midwife, nurse practitioner or podiatrist only if such a practitioner is permitted to prescribe or possess the controlled drug, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

13. (1) The portion of subsection G.04.001(4) of the Regulations before paragraph (a) is replaced by the following:

(4) A practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner may administer a designated drug to an animal or a person who is a patient under their professional treatment where the designated drug is for the treatment of any of the following conditions:

(2) Subparagraph G.04.001(4)(a)(iii) of the Regulations is repealed.

14. Section G.07.001 of the Regulations is amended by adding the following after subsection (2):

(3) Subsection (2) does not apply to a nurse practitioner.

NARCOTIC CONTROL REGULATIONS

15. (1) The definition “narcotic” in section 2 of the Narcotic Control Regulations (see footnote 2) is replaced by the following:

“narcotic” means

1. (a) any substance set out in the schedule or anything that contains the substance, or
2. (b) in respect of a midwife, nurse practitioner or podiatrist, any substance set out in the schedule, or anything that contains the substance, which any of these practitioners may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations; (stupéfiant)

(2) Section 2 of the Regulations is amended by adding the following in alphabetical order:

“midwife” has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (sage-femme)

“nurse practitioner” has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (infirmier praticien)

“podiatrist” has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (podiatre)

16. (1) Section 3 of the Regulations is amended by adding the following after subsection (2.1):

(2.2) Subsection (2) does not apply to a person who is acting as the agent for a midwife, nurse practitioner or podiatrist.

(2) Subsection 3(3) of the Regulations is repealed.

17. Paragraph 8.3(2)(b) of the Regulations is replaced by the following:

1. (b) shall either
   
   1. (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or
   2. (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and
      

18. Paragraph 9(3)(e) of the Regulations is replaced by the following:

1. (e) if the proposed qualified person in charge or, if applicable, the proposed alternate qualified person in charge is not a pharmacist or a practitioner of medicine, dentistry or veterinary medicine registered with a provincial professional licensing authority, a copy of the person’s degree required under subparagraph 8.3(2)(b)(ii) and a copy of the course transcript for that degree;

19. (1) Section 24 of the Regulations is amended by adding the following after subsection (2):

(2.1) For the purpose of subsection (2), for greater certainty, a licensed dealer may sell or provide a narcotic to a midwife, nurse practitioner or podiatrist only if such a practitioner is permitted to prescribe or possess the narcotic, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

(2) Paragraph 24(3)(c) of the Regulations is replaced by the following:

1. (c) a hospital employee;
   
   (c.1) if practising in a hospital, a practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner;

(3) Paragraph 24(4)(b) of the Regulations is replaced by the following:

1. (b) a hospital employee, where that hospital provides care or treatment to persons;
   
   (b.1) if practising in a hospital, a practitioner of medicine or dentistry, where that hospital provides care or treatment to persons; or

20. Subsection 27(3.1) of the Regulations is replaced by the following:

(3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in paragraph (1)(b) may provide methadone to the following persons, if the order has been placed by a practitioner exempted under section 56 of the Act with respect to methadone:

1. (a) a hospital employee; or
2. (b) if practising in a hospital, a practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner.

21. (1) Subsection 31(1) of the Regulations is replaced by the following:

31. (1) No pharmacist shall sell or provide narcotics except in accordance with subsections (2), (2.1) and ( 3) and sections 34 to 36.

(2) Section 31 of the Regulations is amended by adding the following after subsection (2):

(2.1) For the purpose of subsection (2), for greater certainty, a pharmacist may sell or provide a narcotic to a midwife, nurse practitioner or podiatrist only if such a practitioner is permitted to prescribe or possess the narcotic, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

(3) Paragraph 31(3)(c) of the Regulations is replaced by the following:

1. (c) a hospital employee;
   
   (c.1) if practising in a hospital, a practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner;

22. Subsection 53(4) of the Regulations is replaced by the following:

(4) A practitioner of medicine, 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.

23. 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.

24. Section 73 of the Regulations is amended by adding the following after subsection (2):

(3) Subsection (2) does not apply to a nurse practitioner.

BENZODIAZEPINES AND OTHER TARGETED SUBSTANCES REGULATIONS

25. (1) The definition “targeted substance” in subsection 1(1) of the Benzodiazepines and Other Targeted Substances Regulations (see footnote 3) is replaced by the following:

“targeted substance”
« substance ciblée »

“targeted substance” means

1. (a) a controlled substance included in Schedule 1, or a product or compound that contains the controlled substance; or
2. (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance included in Schedule 1, or a product or compound that contains the controlled substance, which any of these practitioners may prescribe, possess or conduct an activity with, in accordance with section 3 of the New Classes of Practitioners Regulations.

(2) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

“midwife”
« sage-femme »

“midwife” has the same meaning as in section 1 of the New Classes of Practitioners Regulations.

“nurse practitioner”
« infirmier praticien »

“nurse practitioner” has the same meaning as in section 1 of the New Classes of Practitioners Regulations.

“podiatrist”
« podiatre »

“podiatrist” has the same meaning as in section 1 of the New Classes of Practitioners Regulations.

26. Section 4 of the Regulations is amended by adding the following after subsection (3):

Exception

(3.1) Subsection (3) does not apply to a person who is an employee of or is acting as the agent for a midwife, nurse practitioner or podiatrist.

27. Paragraph 19(2)(b) of the Regulations is replaced by the following:

1. (b) either
   
   1. (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or
   2. (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and
      

28. Paragraph 20(3)(e) of the Regulations is replaced by the following:

1. (e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner of medicine, dentistry or veterinary medicine authorized or entitled to practise by a provincial professional licensing authority, a copy of the person’s degree referred to in subparagraph 19(2)(b)(ii);

COMING INTO FORCE

Registration

29. These Regulations come into force on the day on which they are registered.

[18-1-o]