Vol. 146, No. 24 — November 21, 2012

Registration

SOR/2012-230 November 1, 2012

CONTROLLED DRUGS AND SUBSTANCES ACT

New Classes of Practitioners Regulations

P.C. 2012-1448 November 1, 2012

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote a), makes the annexed New Classes of Practitioners Regulations.

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 the 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

• (a) is a registered nurse;
  
  
• (b) possesses additional educational preparation and experience related to health care;
  
  
• (c) can autonomously make diagnoses, order and interpret diagnostic tests, prescribe drugs and perform other specific procedures under the laws of a province; and
  
  
• (d) is practising their profession in accordance with, for example, the following provincial laws, as amended from time to time:
  • (i) the Extended Practice Regulation, Man. Reg. 43/2005, made under The Registered Nurses Act of Manitoba, C.C.S.M., c. R40,
    
    
  • (ii) Ontario Regulation 275/94, made under the Nursing Act, 1991 of Ontario, S.O. 1991, c. 32, or
    
    
  • (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 or chiropody and who is practising podiatry or chiropody 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:

• (a) midwives;
  
  
• (b) nurse practitioners; and
  
  
• (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

• (a) the definition “designated drug” in subsection G.04.001(1) of the Food and Drug Regulations;
  
  
• (b) item 1 of Part Ⅲ of the schedule to Part G of the Food and Drug Regulations; and
  
  
• (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

• (a) item 1 of Part Ⅲ of the schedule to Part G of the Food and Drug Regulations, except for subitem (40); and
  
  
• (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

• (a) a drug set out in the schedule to this Part, including a preparation; or
  
  
• (b) in respect of a midwife, nurse practitioner or podiatrist, a drug set out in the schedule to this Part, including a preparation, that the midwife, nurse practitioner or podiatrist 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. Paragraph G.02.001.2(2)(b) of the Regulations is replaced by the following:

• (b) shall either
  • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or
    
    
  • (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

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

• (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;

9. 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 the midwife, nurse practitioner or podiatrist 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.

10. (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:

• (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 sold or provided a controlled drug listed in Part Ⅱ or III of the schedule to this Part to a person referred to in any of paragraphs G.02.024(1)(b) to (d), shall immediately record

11. 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 the midwife, nurse practitioner or podiatrist 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.

12. (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 if 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.

13. 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

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

“narcotic” means

• (a) any substance set out in the schedule or anything that contains the substance, or
  
  
• (b) in respect of a midwife, nurse practitioner or podiatrist, any substance set out in the schedule, or anything that contains the substance, that the midwife, nurse practitioner or podiatrist 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)

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

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

• (b) shall either
  • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or
    
    
  • (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

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

• (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;
  

18. (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 the midwife, nurse practitioner or podiatrist 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:

• (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:

• (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

19. 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:

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

20. (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 the midwife, nurse practitioner or podiatrist 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:

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

21. Paragraph 36(1)(b) of the Regulations is replaced by the following:

• (b) there is legibly and conspicuously printed on the inner label and the outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations, a caution to the following effect:
  • “This preparation contains codeine and should not be administered to children except on the advice of a physician, dentist or 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

• (a) a controlled substance included in Schedule 1, or a product or compound that contains the controlled substance; or
  
  
• (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, that the midwife, nurse practitioner or podiatrist 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. Paragraph 19(2)(b) of the Regulations is replaced by the following:

• (b) either
  • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or
    
    
  • (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
    

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

• (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);
  

TRANSITIONAL PROVISIONS

Definition

28. (1) In this section, “former Regulations” means the Narcotic Control Regulations as they read immediately before the day on which these Regulations come into force.

Application

(2) This section applies to a preparation referred to in section 36 of the former Regulations.

Former Regulations — para. 36(1)(b)

(3) Despite these Regulations, if the main panel of the label of a preparation or any outer container of the preparation displays information in accordance with paragraph 36(1)(b) of the former Regulations, that paragraph continues to apply to the main panel of the label or any outer container during the period of six months after the day on which these Regulations are published in the Canada Gazette, Part Ⅱ.

COMING INTO FORCE

Publication

29.These Regulations come into force on 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.)

Executive summary

Issue

At present, only practitioners defined as doctors of medicine and dentists 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, categories of health professionals are authorized under P/T legislation, regulation or policy 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 P/T scope of practice. There is thus a need to align, to the extent possible, the federal and P/T 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” in this context means prescribed by regulation.

The purpose of this regulatory initiative is to designate by regulation midwives, nurse practitioners and podiatrists as practitioners under the Controlled Drugs and Substances Act so that they are authorized to conduct activities, e.g. prescribing, administering and providing, with controlled substances provided they are also authorized to do so within their scope of practice as set out in P/T legislation, regulation or policy. In so doing, Health Canada strives to support flexibility and timeliness in health care service delivery. The NCPR would only affect health professionals in provinces and territories where they are regulated and authorized to prescribe controlled substances. That said, these Regulations have been designed with maximum flexibility so as to address situations where P/T 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 (specifically doctors of medicine and dentists) 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 P/T legislation, regulation or policy in a number of jurisdictions. An overview of their authorization (which varies by jurisdiction) is provided below.

Midwives

Midwives are specialists in childbirth, providing care to women and their infants from early pregnancy through six weeks postpartum. 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 P/T legislation, regulation or policy. Currently, there are about 900 midwives in Canada.

Midwives work autonomously within a scope of practice as set out in P/T legislation, regulation or policy, collaborating with other health care providers as needed. While there are differences between 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 and regulation authorizing nurse practitioners to autonomously diagnose/treat health conditions and prescribe medications has been enacted in all provinces/territories except the Yukon. Regulated nurse practitioners in all jurisdictions except New Brunswick, Nova Scotia and Nunavut are allowed to prescribe medications containing controlled substances. Currently, there are over 3 000 nurse practitioners in Canada.

Podiatrists

Podiatrists are health professionals specialized in the diagnosis and treatment of disorders and diseases affecting the foot, ankle and the lower legs. There are two groups of podiatrists practising in Canada: doctors of podiatric medicine (DPMs) and podiatrists/ chiropodists. There are about 300 DPMs and approximately 700 podiatrists/chiropodists in Canada. 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 privileges. However, podiatrists/ chiropodists (non-DPMs) are currently regulated in Saskatchewan, Manitoba, Ontario and New Brunswick. While these podiatrists/chiropodists have surgical and prescribing privileges in some jurisdictions, they are not yet authorized under P/T legislation/regulation to prescribe medications containing controlled substances.

Description

The NCPR contain the following components:

Definitions

Among other things, these Regulations 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 designate midwives, nurse practitioners and podiatrists as practitioners.

Permitted activities

The NCPR authorize affected health professionals to, with certain exclusions, prescribe, administer and provide controlled substances 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 P/T legislation, regulation or policy.

Exclusions of controlled substances

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

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

The above-noted exclusions of controlled substances were decided 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 attached to their use, and the scopes of practice of affected health professionals. For example, nurse practitioners are often involved in treating transgender sex reassignment patients and thus require the authority to prescribe testosterone.

Overall, these Regulations focus on designating midwives, nurse practitioners and podiatrists as practitioners as defined in the Controlled Drugs and Substances Act and authorizing 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 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 NCPR, midwives, nurse practitioners and podiatrists who are already authorized to prescribe controlled substances within their scope of practice as set out in P/T legislation, regulation or policy are 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 P/T level, the NCPR will not affect their practice unless the P/T legislation, regulation or policy outlining their scope of practice is amended in the future to authorize them to prescribe controlled substances when treating patients.

The NCPR will also serve as a vehicle to amend section G.04.001 of Part G of the Food and Drug Regulations by deleting 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). As 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 it is not aware of any of the designated drugs referred to in the provision being approved for sale in Canada for use in the treatment of “mental retardation.”

Relationship to other regulations under the Controlled Drugs and Substances Act

As outlined in the NCPR, these Regulations 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.

These Regulations also contain consequential amendments related to the handling of controlled substances by practitioners, pharmacists and licensed dealers to certain provisions in the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations and Part G of the Food and Drug Regulations.

Lastly, subsection 16(2) of the NCPR repeals subsection 3(3) of the Narcotic Control Regulations. This provision, which pertains to persons seeking narcotics or prescription for narcotics from practitioners, is being repealed as it is deemed redundant in light of subsection 4(2) of the Controlled Drugs and Substances Act.

Regulatory and non-regulatory options considered

Option 1: Authorize midwives, nurse practitioners and podiatrists to prescribe, administer and provide controlled substances via a class exemption in accordance with section 56 of the Controlled Drugs and Substances Act.

Section 56 of the Controlled Drugs and Substances Act authorizes the Minister of Health to exempt any person or a 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, in the case of individual exemptions, every individual 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. For class exemptions, it would need to be determined, on a case-by-case basis, who is a member of that class.

Option 2: Amend the definition of “practitioner” in the Controlled Drugs and Substances Act to include the individual classes of practitioners being designated under the NCPR.

Although proceeding with a statutory amendment to change the definition for practitioner in the Act would be a viable way of authorizing the affected health professionals to conduct activities with controlled substances, Option 2 was not desirable since the current definition for 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 extend all of the authorities of a practitioner as currently specified in relevant regulations to the new classes of practitioners unilaterally. 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. Furthermore, amending the definition would require legislative change and further legislative changes would be needed every time that Health Canada wanted to designate a new class of health professionals as a practitioner under the Controlled Drugs and Substances Act.

Option 3: Develop new provisions relating to 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 3 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 professional were to be designated as practitioners under the Act in the future.

Option 4: Promulgate new regulations under the Act that would prescribe new classes of practitioners and stipulate the applicable provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations.

This option would provide the most clarity for stakeholders, in particular the affected health professionals with respect to both permitted activities and exceptions where applicable. This approach would also require Health Canada to amend one set of regulations if it had the need to designate additional classes of health professionals as practitioners in the future.

Following an analysis of the options above, Health Canada has determined that Option 4 would enable 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 of America, 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 focus specifically on medications containing controlled substances.

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 Regulations, these health professionals 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 P/T legislation, regulation or policy, 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 efficiency in the health care system, as patients would not have to see a second health professional before accessing medications containing controlled substances.

Studies from other countries, including the United States of America, 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 evidence 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 actually 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 for P/T governments.

The costs to Health Canada as a result of the implementation of these Regulations are likely to be marginal as they relate primarily to the costs associated with revoking or reinstating the authority for an individual practitioner to conduct activities with controlled substances, 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 will need to be sent to pharmacists and licensed dealers using the processes currently in place for practitioners under the Controlled Drugs and Substances Act. At present, such revocations or reinstatements occur on an occasional basis only: roughly 25 cases per year at a cost of approximately $2,000 per case.

Implementation of the NCPR is also not expected to have extensive cost implications at the P/T level as the affected health professionals are already regulated under P/T legislation/ regulation and P/T licensing authorities already have established mechanisms to monitor their compliance with relevant legislation and regulations. 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 P/T legislation/regulation. There may be cost implications for P/T licensing authorities if they decide to establish additional mechanisms specifically for monitoring the prescribing practices of specific classes of practitioners with respect to certain controlled substances.

The consequential amendments to Part G of the Food and Drug Regulations, the Benzodiazepines and Other Targeted Substances Regulations, and the Narcotic Control Regulations are not expected to result in any notable burden for affected stakeholders. Although the amendment to paragraph 36(1)(b) of the Narcotic Control Regulations will require drug manufacturers to re-label certain drug products containing a low dose of codeine to include a caution to the effect that said product “should not be administered to children except on the advice of a physician, dentist or nurse practitioner,” the NCPR provides a six-month transition period for this consequential amendment so that drug manufacturers will not have to incur any additional costs associated with the re-labelling of affected product stock.

Rationale

While the federal government is responsible for regulating activities with controlled substances, P/T governments are responsible for regulating health professions and determining the specific scope of practice for each category of regulated health professionals. Such scopes of practice cover a broad range of authorities including the authority to prescribe medications containing controlled substances. Given this split authority regarding the handling of controlled substances, these Regulations seek to align the federal and P/T authorities for midwives, nurse practitioners and podiatrists, thereby allowing them to work in accordance with their full scope of practice.

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 veterinarian medicine) can conduct activities with controlled substances under the Act, developing a set of regulations to prescribe midwives, nurse practitioners and podiatrists as practitioners has been determined by Health Canada to be the most effective solution to realize the objectives of the regulatory proposal.

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/regulation, policies and guidelines already exist. The NCPR will have no effect in the jurisdictions where affected health professionals are not yet authorized to prescribe controlled substances.

The 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 of America, New Zealand, Australia and Sweden. In the United States of America, for instance, the Drug Enforcement Administration registers multiple professions having the authority to prescribe controlled substances listed in the Controlled Substances Act, including podiatrists, nurse practitioners and midwives.

Moreover, as 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 by ensuring that narcotic drugs and psychotropic substances are available for legitimate medical and scientific purposes while limiting their risk of diversion to the illicit market. 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 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. This was followed by consultations with self-identified representatives from P/T governments, national associations of health professionals, and P/T licensing authorities.

The original 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. 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 P/T legislation, regulation, or policy 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
• 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.

While most of the comments received during the comment period were supportive, 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, P/T 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 P/T ministries of health in July 2009. Based on outcomes of the consultations, Health Canada made fundamental changes to the original proposed NCPR and a new set of draft regulations was prepublished in the Canada Gazette, Part Ⅰ, on May 5, 2012 (www.gazette.gc.ca/rp-pr/p1/2012/2012-05-05/pdf/g1-14618.pdf).

During the 30-day comment period, 126 comments were received from stakeholders.

While the majority of stakeholders were of the view that enabling affected health professionals (particularly nurse practitioners) to prescribe, administer and provide controlled substances would be beneficial to patients in terms of timely health care service delivery, a few concerns were raised with regard to specific provisions in the proposed Regulations. Based on a review and analysis of comments received, and subsequent follow-up consultations with P/T ministries of health, Health Canada made minor modifications to the proposed Regulations.

Firstly, several stakeholders objected to proposed consequential amendments to provisions in the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations and the Narcotic Control Regulations. These amendments would prohibit a person from possessing controlled substances as the agent of a midwife, nurse practitioner or podiatrist. Stakeholders argued that an affected health professional in a clinic where he or she is the lead practitioner may need to delegate a staff member as an “agent” to carry out certain activities such as administering medications to patients or transporting medications between locations. Based on consultations with representatives of P/T ministries of health and key stakeholders, Health Canada has decided to remove the proposed consequential amendments, thus allowing new classes of practitioners to use an agent as required.

Secondly, a consequential amendment to paragraph 36(1)(b) of the Narcotic Control Regulations has also been made in response to concerns raised by provincial/territorial ministries of health. This provision specified that the label of certain preparations containing codeine must indicate that they should not be administered to children except on the advice of a physician or dentist. P/T ministries of health have commented that excluding nurse practitioners from advising on the administration of these preparations constitutes an unnecessary barrier to these health professionals. Consequently, this provision has been amended to include a reference to nurse practitioners.

Thirdly, the definition of podiatrist in the New Classes of Practitioners Regulations has been modified to ensure that it also encompasses chiropodists practicing in Ontario.

Aside from the above noted changes based on comments received by Health Canada, some stakeholders expressed their concerns about the knowledge and experience of affected health professionals in dealing with controlled substances and the increased risk of diversion/misuse of controlled substances. Although Health Canada appreciates these concerns, it does not view them as a barrier to proceeding with the Regulations, given that it is P/T ministries of health that are responsible for setting education and competency requirements for affected health professionals.

Another stakeholder group expressed a preference for a regulatory framework that authorizes other health professionals to conduct activities with controlled substances within a practice environment in which physicians assume the leading role and provide necessary expertise in guiding the prescribing practices of other health professionals. Health Canada has not addressed this suggestion in the final Regulations as the scope of practice and conduct of affected health professionals are governed at the P/T level.

Lastly, Health Canada received several submissions from groups representing pharmacists, physician assistants and optometrists expressing interest in being designated as a practitioner under the proposed NCPR. However, these health professionals have not yet been authorized to prescribe medications containing controlled substances at the P/T level, and consequently cannot be designated as new classes of practitioners at this point in time.

That said, Health Canada acknowledges that the process for designating additional classes of health professionals as practitioners in the future may not have been made clear sufficiently to stakeholders. In the interest of clarity, Health Canada has established the “Framework for Designating Additional Classes of Practitioner under the New Classes of Practitioners Regulations.” This document sets out the principles for designating in the future additional classes of health professionals as practitioners under the NCPR, specifies the 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 P/T ministries of health for the inclusion of an additional category of health professionals in these Regulations would be considered by Health Canada. This document is available on the Health Canada Web site at www.hc-sc.gc.ca/hc-ps/substancontrol/ pol/pol-docs/classes-categories-eng.php.

Implementation, enforcement and service standards

Monitoring the overall practice of the affected health professionals is the responsibility of P/T jurisdictions, and respective P/T licensing authorities already have mechanisms in place to ensure that these health professionals comply with relevant legislation/regulation. 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, P/T licensing authorities would also assume the responsibility of communication to Health Canada of situations that 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 P/T licensing authorities, pharmacists and licensed dealers.

Performance measurement and evaluation

In accordance with the Cabinet Directive on Streamlining Regulation, Health Canada has, in collaboration with key partners and stakeholders, i.e. P/T ministries of health and relevant licensing authorities, developed a Performance Measurement and Evaluation Plan to assess the implementation of the NCPR in the short to long term.

This plan specifies the methods selected to measure the impact of the NCPR on the health care system, relevant measures and indicators, and the roles and responsibilities of all parties involved. This Performance Measurement and Evaluation Plan is available upon request.

Contact

Mr. 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 1B9
Telephone: 613-948-7792
Fax: 613-946-4224
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca

Footnote a
S.C. 1996, c. 19

Footnote 1
C.R.C., c. 870

Footnote 2
C.R.C., c. 1041

Footnote 3
SOR/2000-217; SOR/2003-38