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Vol. 141, No. 26 — June 30, 2007
New Classes of Practitioners Regulations
Statutory authority
Controlled Drugs and Substances Act
Sponsoring department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Description
The purpose of this initiative is to introduce midwives, nurse practitioners, and doctors of podiatric medicine (DPMs) as practitioners under the Controlled Drugs and Substances Act (CDSA) by prescribing them as such in a new regulatory framework. In acknowledgment of recent changes to the scopes of practice of these three classes of health professionals, as expressed by some provincial/territorial governments, Health Canada is committed to removing the barriers to effective and timely access to controlled substances where and when needed. These Regulations will authorize midwives, nurse practitioners, and DPMs to possess, administer, prescribe, sell or provide and/or transport certain controlled substances, when these classes of professionals are authorized to prescribe drugs within their scope of professional practice under provincial/territorial law.
Legislative framework
The CDSA is the federal legislation which implements Canada's international obligations under the United Nations Drug Control Conventions, to which Canada is a signatory. The 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol (the 1961 Convention), and the 1971 Convention on Psychotropic Substances (the 1971 Convention) were enacted to ensure that the availability of narcotic drugs and psychotropic substances is limited to medical and scientific purposes. These substances can alter mental processes and may harm the health of an individual and society when diverted or misused.
The Narcotic Control Regulations (NCR), Part G of the Food and Drug Regulations (FDR), and the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) are regulations under the CDSA that govern specific activities of producers, distributors, importers, exporters, pharmacists, practitioners and hospitals relating to narcotics (e.g. morphine), controlled drugs (e.g. amphetamines), and benzodiazepines (e.g. diazepam), respectively. This system of control is intended to minimize diversion for illicit use without diminishing the medical and scientific usefulness of the substances, nor interfere with patient care.
Under the CDSA and its regulations, only practitioners can conduct certain activities with controlled substances, such as prescribing. The term practitioner is defined under the CDSA as meaning dentists and doctors of medicine and veterinary medicine and includes any other person or class of persons prescribed as a practitioner by regulation. The CDSA thus enables the granting of authorities to other health professionals that may have a requirement, within their respective scopes of practice, to conduct activities with certain controlled substances in a manner similar to dentists and doctors of medicine or veterinary medicine.
National and international perspectives
Globally, the delivery of health care has undergone significant changes due to a variety of interrelated factors, including for example, economic circumstances, a shortage of primary care physicians, and the lack of health services in under-serviced and rural areas. These facts, coupled with the increasing specialization and expanded scope of practice of midwives, DPMs and nurse practitioners, have made prescribing an essential component of medication management in the United Kingdom, the United States of America, Canada, New Zealand, Australia and Sweden. In the United States, the Drug Enforcement Administration registers multiple professions, including podiatrists as practitioners as well as nurse practitioners and midwives as mid-level practitioners having the authority to prescribe substances listed in their Controlled Substances Act.
Following the 2003 First Ministers Health Accord in which Canada's First Ministers agreed that the ultimate goal of primary health care reform is to provide all Canadians with access to an appropriate health care provider, 24 hours a day, 7 days a week, and further to requests from provincial/territorial governments and health professional associations, the Drug Strategy and Controlled Substances Programme (DSCSP) committed to ensuring that certain health professional groups be considered practitioners under the CDSA and its regulations. These Regulations will allow midwives, nurse practitioners, and DPMs to possess, administer, sell or provide, prescribe, and/or transport certain controlled substances, only if the authorization to prescribe controlled substances within the scope of their practice is permitted by provincial/ territorial law where they practice.
Policy framework
The policy implications of granting these authorities to nurse practitioners, midwives, and DPMs were explored provincially and with respect to future requests from other classes of health professionals seeking authorities under the CDSA. The "Policy Framework for Granting Authorities to Health Professionals other than Practitioners Under the CDSA" (the Policy) that was developed to address this issue outlines the conditions for granting authorities under the CDSA and, by consequence, the basic elements of the submission required by Health Canada to support its decision-making process.
To be eligible for consideration, the health profession must be regulated by a regulatory authority recognized under provincial/ territorial legislation, whose responsibility is to protect the public interest by licensing and monitoring individual health professionals and ensuring that the basic competencies of the profession are met. Regulatory authorities establish the scope of professional practice and ensure a high level of compliance by periodically assessing whether or not each member has and maintains the necessary competence and knowledge to safely conduct activities with controlled substances. Regulatory authorities also monitor the compliance of members and initiates corrective activities in response to non-professional conduct that may affect the health professional's ability to practice, including the activity of prescribing certain controlled substances.
In addition, the provincial/territorial ministries of Health must have been consulted and must not have put forward any significant objections which would indicate that granting authorities under the CDSA to the regulated health profession in question would present a significant risk to the health and safety of Canadians.
Once the eligibility criteria have been met, the health professional group must meet conditions aimed at mitigating the risk of diversion of a controlled substance, which include
- providing evidence of training, education, and/or maintenance of competencies;
- providing proof of existence of a mechanism to communicate to pharmacists and licensed dealers that a health professional has the authority to conduct activities with a controlled substance; and
- providing proof of existence of a mechanism to ensure compliance of health professionals with provincial legislation applicable to the regulated profession.
Eligible classes of health professionals
A number of provinces have adopted provincial legislation enabling health professionals other than physicians, dentists or veterinarians to prescribe drug products, such as those listed in Schedule F to the FDR; however, this authority does not carry over to controlled substances due to the limited definition of practitioner in the CDSA. At present, midwives, nurse practitioners and DPMs are not considered practitioners under the CDSA and, therefore, cannot prescribe nor can they administer, sell or provide controlled substances as practitioners. Over the past several years, Health Canada has received a number of requests from provincial Ministries of Health and the health professional associations representing midwives, nurse practitioners and DPMs requesting that Health Canada consider granting them prescriptive authority for controlled substances.
Midwives
Midwives are specialists in normal child births, providing 24-7 care through pregnancy, labour, birth and 6 weeks post partum. They work autonomously within a defined scope of practice, collaborating with other health care providers as needed. There are about 520 midwives in Canada, the majority working in the 6 jurisdictions where midwifery is regulated: Alberta, British Columbia, Manitoba, the Northwest Territories, Quebec, and Ontario. Legislation/regulation is being developed in the Yukon.
The Standards of Regulated Canadian Midwifery outline the model of care for regulated midwives throughout Canada. All provinces regulating midwifery accept a similar definition of the midwifery scope of practice. The Ontario legislation was the foundation upon which the regulated scope of practice is based, and this definition is as follows in the Ontario Midwifery Act, 1991 and the Regulated Health Professions Act, 1991:
"The practice of midwifery is the assessment and monitoring of women during pregnancy, labour and the post-partum period and of their newborn babies, the provisions of care during normal pregnancy, labour and the post-partum period and the conducting of spontaneous normal vaginal deliveries."
The Canadian Midwifery Regulators Consortium (CMRC) prepared the Canadian Competencies for Midwives in May 2005. This document was developed to provide a base for the development of national assessment processes and to provide information to internationally educated midwives about what Canadian midwives are expected to know and do. It outlines the knowledge and skills expected of an entry-level midwife in Canada. Some additional competency requirements can be found in provincial and territorial documents. The Canadian Midwifery Registration Examination (CMRE) is a national, written examination designed to assess applicants for midwifery registration to ensure that they meet entry-level competency standards set out in the Canadian Competencies for Midwives.
The Agreement on Mobility for Midwifery between the regulatory authorities of Alberta, British Columbia, Manitoba, the Northwest Territories, Quebec, and Ontario establishes the conditions under which a midwife who is registered in one province will have her qualifications recognized in another Canadian jurisdiction which is Party to the agreement. This agreement serves to standardize the requirements for registration and the competencies of the midwife profession across Canada.
All midwifery regulators agree with respect to the specific drugs that midwives should have the authority to prescribe and administer. The addition of controlled substances to the identified list of drugs has been requested in order to help improve the timeliness of services to women, increase patient safety, lessen the workload of other health professional team members, and support midwives and physicians working collaboratively.
Nurse practitioners
Nurse practitioners are registered nurses who achieve additional competencies, usually through graduate nursing education that has been consolidated through substantial clinical learning experiences. The 2005 Canadian Nurse Practitioner Core Competency Framework developed by the Canadian Nurses Association (CNA) defines the core competencies nurse practitioners are required to maintain in their practice.
The document entitled The Regulation and Supply of Nurse Practitioners in Canada: 2006 Update, developed by the Canadian Institute for Health Information and the CNA, defines a nurse practitioner as a "registered nurse with additional education in health assessment, diagnosis and management of illnesses and injuries, including ordering tests and prescribing drugs," who provides care in diverse health settings, from community clinics and health centres to hospitals, medical practices, nursing homes, and home care settings. The nurse practitioner's role "is not intended to replace any health care professional, but to address gaps in the health care system, increase existing services and add enhanced nursing expertise to multi disciplinary teams."
In all provinces and territories except the Yukon, legislation has been enacted granting additional authority through the regulatory authority for nurse practitioners to autonomously diagnose and treat health problems and prescribe drugs. Currently, the authority to prescribe drugs does not extend to controlled substances. In some provinces, nurse practitioners may have a different title. For example, in Ontario, nurse practitioners are referred to as Registered Nurses in the Extended Class, in Manitoba, as a Registered Nurse, Extended Practice and, in Quebec, as specialized nurse practitioners. As of 2005, there were 1 026 nurse practitioners working in Canada.
Doctors of podiatric medicine
DPMs are health professionals specialized in the diagnosis and treatment of disorders and diseases affecting the foot, ankle and the lower legs, such as foot deformities, ankle and foot injuries, infections, ingrown toenails and bunions as well as conditions like arch disorders, flat feet and athlete's foot. They are fully trained in medical and surgical techniques to diagnose and treat diseases, injuries and abnormalities of the feet and ankles through medical, surgical and bio-mechanical means. There are approximately 250 DPMs working in Canada.
DPMs are authorized to practice in the provinces of Alberta, British Columbia, Ontario and Quebec. It takes eight years of university level education to become a DPM; four years for the undergraduate degree followed by another four years of specialized podiatric medical education to obtain the Doctor of Podiatric Medicine degree. All students entering a College of Podiatric Medicine have a Bachelor of Science or higher degree and must achieve the required results in the Medical College Admission Test (MCAT). The podiatry curriculum spans four years at an accredited College of Podiatric Medicine in the United States, where students study courses in all basic medical sciences. The last two years of training include an emphasis on disorders affecting the foot and ankle and their various types of treatment. Students undergo clinical training in the university teaching hospitals. Once this education is completed the graduate obtains his or her Doctor of Podiatric Medicine degree and must pass Comprehensive Board exams as well as provincial licensing exams before being licensed to practice. Continuing education programs keep DPMs informed of new developments in podiatric medicine and foot surgery.
Proposed regulatory framework
The proposed requirements for new classes of practitioners (designated practitioners) closely follow those currently in place for practitioners under the BOTSR, as well as the NCR, and Part G of the FDR. These regulatory frameworks include provisions authorizing classes of health professionals to possess, administer, prescribe, sell or provide and transport certain controlled substances and include provisions for record keeping, loss/theft reporting, and security. Many of these provisions are duplicated in the proposed Regulations, and some have been modified to expand upon their intent and provide clarity to the health professional groups involved. The choice to develop a new set of regulations, instead of adding to current regulations, is the most efficient and effective way to address the requests of the three health professional groups concerned.
The proposed regulatory framework differs from existing regulatory frameworks with regards to
(a) Definitions
The new classes of practitioners, namely the nurse practitioners, DPMs, and midwives, will be defined as designated practitioners.
(b) Registration number
Designated practitioners will have to include their provincial registration number on all prescriptions that they issue. Pharmacists can use this number to identify the health professional who has issued the prescription, without having to rely on a signature alone.
(c) Records
Designated practitioners will be required to keep records of all controlled substances that are received, sold, or provided.
(d) Security
Specific provisions to ensure the security of controlled substances while being stored or during transport will be added.
(e) Schedules of substances
Three schedules will be introduced. Each one will contain a list of substances specific to midwives, nurse practitioners, or DPMs respectively.
Consequential amendments
A number of consequential amendments to the NCR, BOTSR, and Part G of the FDR were identified during the development of the proposed New Classes of Practitioners Regulations (NCPR). In particular, a definition for the health professionals who are designated as practitioners (designated practitioners) will be included in each set of regulations to introduce them as practitioners who are authorized to conduct activities with controlled substances. The definition for the controlled substance in question (be it a targeted substance, narcotic, or controlled drug) will also be modified to provide greater clarity with respect to the controlled substances that a designated practitioner can possess, administer, prescribe, sell or provide, and transport.
In addition, a number of provisions from current regulations are duplicated in the NCPR. These sections include provisions with respect to practitioners, the issuance of notices by the Minister to revoke the prescribing privileges of a particular health professional, and security requirements. A consequential amendment will exclude designated practitioners from the provisions that have been duplicated in the NCPR.
Also, the regulations will be modified to clarify that designated practitioners cannot be a qualified person in charge (QPIC) or an alternate qualified person in charge (AQPIC) solely by virtue of being a designated practitioner. Designated practitioners can, however, be QPICs or AQPICs if they meet the qualifications as specified in the applicable regulations.
Finally, a consequential amendment will also be made to establish consistency across the regulations with respect to the definitions of "hospital" and "pharmacist." A definition has been added to the BOTSR for "common-law partner," and the notion of child in paragraph 79(4)(c) of the BOTSR is enlarged to include "child adopted in fact." This is in response to the Modernization of Benefits and Obligations Act, S.C. 2000, c. 12.
Alternatives
While federal legislation has, for the most part, limited the authority to administer and prescribe controlled substances to the more traditional prescribing professions, e.g. dentists and doctors of medicine or veterinary medicine, primary health care reform at the provincial level has resulted in increasing pressure on the Government of Canada to recognize the broadened scopes of practice of other regulated health professionals, and to remove barriers to effective and timely access to controlled substances where and when needed.
Health Canada considered a number of alternatives in deciding how to address this issue:
| Option 1 |
Amend the definition of "practitioner" in the CDSA to include midwives, nurse practitioners, and DPMs. |
| Option 2 |
Develop new sections and schedules for midwives, nurse practitioners, and DPMs in the NCR, the BOTSR, and Part G of the FDR. |
| Option 3 |
Promulgate new regulations under the CDSA that prescribe new classes of practitioners and authorize them to conduct certain activities with specific controlled substances. |
Although proceeding with a statutory amendment to change the definition of "practitioner" in the CDSA (Option 1) would explicitly define the classes of health professionals that have been granted authorities to conduct activities with controlled substances, this alternative would also automatically extend all of the authorities of a practitioner as currently defined in the CDSA to each new class of health professional that is seeking those authorities, and this may not be desired given the limited scopes of practice of some classes of health professionals. This option was also discarded because it would require parliamentary approval, and the definition of practitioner in the CDSA already contains a mechanism for designating practitioners through regulation.
In Option 2, provisions and schedules specific to designated practitioners would need to be added to each of the NCR, the BOTSR, and Part G of the FDR. While this may be less time-intensive than changing the definition of "practitioner" under the CDSA, this option was discarded as it will result in Health Canada having to amend three sets of regulations each time an additional class of health professional is to be granted authorities under the CDSA. In addition, designated practitioners would have to refer to multiple sets of regulations in order to ensure compliance with all relevant provisions. The additional schedules required to be added to existing regulations could cause confusion among health professionals, licensed dealers, and other stakeholders.
Option 3 is therefore the preferred option in that it allows Health Canada to respond to the requests from health professional associations and/or provincial/territorial governments in the clearest way possible. A single new set of regulations provides ease of reference for stakeholders and facilitates amendments to add new classes of practitioners.
Benefits and costs
Benefits
This regulatory initiative aims to improve the timeliness of health care delivery in Canada and to promote continuity of care and flexibility in that patients being treated by a nurse practitioner, DPM, or midwife can now be treated with certain drugs containing controlled substances without having to be assessed by another health care provider who has the authority to write the necessary prescription. This may be important to a patient's comfort and well-being in situations where immediate treatment with a controlled substance is required.
By proceeding with this new set of regulations under the CDSA, Health Canada is responding to the requests from midwifery, nursing, and DPM professional associations, and certain provincial/territorial ministries of Health. The proposed Regulations aim to facilitate health care at the provincial level by enabling health care providers who have been granted prescriptive authority by their province to provide certain controlled substances to their patients when required, for the medical condition being treated.
Costs
The provincial/territorial regulatory authorities will be responsible for ensuring that health professionals meet the required minimum levels of qualification, education, and competency. Regulatory authorities also have the responsibility to ensure that their health professionals meet and maintain compliance with all relevant provincial/territorial legislation. As the regulatory authorities in the provinces where midwives, nurse practitioners, and DPMs are regulated and they already have the mechanisms in place to achieve this, the costs to this sector are expected to be minimal.
Health Canada may incur costs to issue notices to revoke and reinstate authorities granted under the proposed Regulations. These notices are required to be sent to pharmacists and licensed dealers using established processes currently in place for dentists and doctors of medicine and veterinary medicine.
Given that Health Canada processes approximately 25 notifications per year at an average cost of $49,706.47, excluding the salary costs of the personnel involved, it is estimated that Health Canada would only need to issue one more notice per year at an average cost of $1,988. Therefore, the cost to Health Canada associated with the proposed Regulations is expected to be relatively minimal.
Should the numbers of nurse practitioners, DPMs, and midwives grow dramatically in the future, or should new classes of designated practitioners be included in the regulations, the costs associated with the proposed regulatory framework will need to be reassessed.
Consultation
The decision of the federal government to expand authorities under the CDSA to health professionals other than dentists and doctors of medicine or veterinary medicine was based on consultation among provincial/territorial regulatory authorities of those classes of health professionals requesting these authorities.
A notice to interested parties was published in the Canada Gazette, Part I, on March 13, 2004. Of the 39 responses received, 31 were supportive of the initiative and 8 expressed concerns. The concerns expressed were as follows:
- profession-specific guidelines for permissible prescribing of controlled substances should be developed with input from medical associations;
- appropriate standards are developed and maintained for prescribing that include intensive training, rigorous credentialing, quality assurance protocols and ongoing monitoring of the effect of this measure on patients' health and safety;
- that physicians, dentists and veterinarians receive appropriate scientific training in the diagnosis, pharmacology and therapeutics and that any evaluation of the training and regulations for potential "new prescribers" must weigh the benefit of this training against the desire of these groups to be able to prescribe; and
- the ability to diagnose and a broad-based understanding of pharmacology and therapeutics are required to ensure safe prescribing.
The criteria outlined in the Policy were designed to address these concerns. The Policy explains the requirement for minimum levels of training, education, and competency and for having both a communication and compliance mechanism in place. In particular, the Policy emphasizes that it is the responsibility of the provinces along with the regulatory authorities to ensure that the minimum levels of training, credentialing, and quality assurance exist and are applied.
A few health professionals were not supportive of the initiative, given that there is already an issue with prescription drug abuse and misuse. For this reason, conditions to mitigate the risk of misuse or diversion were developed as part of the Policy and must be met by each class of health professional seeking authorities under the CDSA.
Initial work on this regulatory project was completed further to a series of meetings that took place with individual stakeholder groups throughout 2004 and 2005. Three conference calls, one with each proposed new class of practitioner, were also held in May 2004.
Health Canada then established an Advisory Committee, consisting primarily of representatives of national health professional associations, provincial/territorial governments and regulatory authorities. At its first meeting in 2005, the Committee met to confirm underlying principles on which the policy framework regarding the authority to prescribe controlled substances would be developed.
A draft policy framework was then circulated to Advisory Committee members, who were invited to review and send their preliminary comments to the Drug Strategy and Controlled Substances Programme, Health Canada, with a view to having further discussion at the next meeting of the Advisory Committee in 2006. The draft policy framework was finalized following this meeting and redistributed to members for their information.
Compliance and enforcement
Provincial/territorial regulatory authorities currently have disciplinary mechanisms in place to ensure that their regulated health professionals are acting in the public interest and are compliant with the relevant legislation. This means having a mechanism in place to revoke, suspend or otherwise amend a licence or registration issued to a regulated health professional and to report to Health Canada any situations which may require federal intervention to remove the authorities provided under the CDSA and its regulations that have been granted to an individual health professional.
Health Canada's compliance and enforcement strategy will be modelled on the existing strategy in place for dentists and doctors of medicine or veterinary medicine. If Health Canada determines, pursuant to the applicable provision of the regulations, that the authorities granted under the CDSA to an individual health professional are to be revoked or reinstated, it will communicate this information via a notice to pharmacists and to licensed dealers.
As with the other regulatory frameworks under the CDSA, the proposed framework includes provisions to enable the inspection of a designated practitioner's records, and provisions regarding loss and theft reporting.
Contact
Erin Kingdom
Telephone: 613-948-8948
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 60 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 Erin Kingdom, Drug Strategy and Controlled Substances Programme, Department of Health, Address Locator 3503A, Ottawa, Ontario K1A 1B9 (fax: 613-946-4224; email:
OCS_Policy_and_Regulatory_Affairs@hc-sc.gc.ca).
Ottawa, June 14, 2007
MARY O'NEILL
Assistant Clerk of the Privy Council
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NEW CLASSES OF PRACTITIONERS REGULATIONS |
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INTERPRETATION |
| Definitions |
1. The following definitions apply in these
Regulations. |
"Act"
« Loi » |
"Act" means the Controlled Drugs and Substances Act. |
"common-law partner"
« conjoint de fait » |
"common-law partner", in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year. |
"designated drug offence"
« infraction désignée en matière de drogue » |
"designated drug offence" means
(a) an offence against section 39, 44.2, 44.3, 48, 50.2 or 50.3 of the Food and Drugs Act,
as those provisions read immediately before May 14, 1997;
(b) an offence against section 4, 5, 6, 19.1 or 19.2 of the Narcotic Control Act, as those provisions read immediately before May 14, 1997;
(c) an offence under Part I of the Act, except subsection 4(1), and an offence against section 46 of the Act; or
(d) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (c). |
"designated practitioner"
« praticien désigné » |
"designated practitioner" means a doctor of podiatric medicine, a midwife or a nurse practitioner. |
"doctor of podiatric medicine"
« docteur en médecine podiatrique » |
"doctor of podiatric medicine" means a person who
(a) is authorized under the laws of a province to engage in the practice of podiatry and is practising podiatry in the province;
(b) has received the degree of doctor of podiatric medicine granted by an institution recognized, in that regard, by the province; and
(c) has, in accordance with the specifications of the province, successfully completed the certification examinations and met the residency requirements, pertaining to that degree. |
"hospital"
« hôpital » |
"hospital" means a facility that
(a) is licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons; or
(b) is owned or operated by the government of Canada or of a province and provides health
services. |
"licensed dealer"
« distributeur autorisé » |
"licensed dealer" means a licensed dealer as defined in subsection 1(1) of the Benzodiazepines and Other Targeted Substances Regulations, subsection G.01.001(1) of the Food and Drug
Regulations or section 2 of the Narcotic Control Regulations who sells or provides a listed
substance. |
"listed substance"
« substance inscrite » |
"listed substance" means a substance having a
drug identification number issued under section C.01.014.2 of the Food and Drug Regulations that
(a) in respect of a doctor of podiatric medicine, is included in Schedule 1 or any thing that contains the substance;
(b) in respect of a midwife, is included in Schedule 2 or any thing that contains the substance; and
(c) in respect of a nurse practitioner, is included in Schedule 3 or any thing that contains the substance; |
"midwife"
« sage-femme » |
"midwife" means a person who
(a) is authorized under the laws of a province to practice midwifery; and
(b) is practising midwifery in that province. |
"nurse practitioner"
« infirmier praticien » |
"nurse practitioner" means a person who is authorized under the laws of a province to practise as a nurse practitioner and is practising as a nurse practitioner in that province and, for greater certainty, includes
(a) in respect of the Province of Manitoba, a person who is a registered nurse (extended practice) as defined in section 1 of the Extended Practice Regulation made under The Registered Nurses Act (Manitoba);
(b) in respect of the Province of Ontario, a person who is a registered nurse in the extended class as defined in section 0.1 of Ontario Regulation 275/94 made under the Nursing Act, 1991 (Ontario); and
(c) in respect of the Province of Quebec, a person who is a nurse practitioner specializing in neonatology, nephrology or cardiology as provided for in section 3 of 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. |
"pharmacist"
« pharmacien » |
"pharmacist" means an individual who
(a) is registered or otherwise authorized under the laws of a province to practise pharmacy; and
(b) is practising pharmacy in that province. |
"prescription"
« ordonnance » |
"prescription" means, in respect of a listed substance, an authorization from a designated practitioner stating that a specific amount of the
listed substance may be sold or provided to the individual under the practitioner's care named in the authorization. |
"proper name"
« nom propre » |
"proper name", in relation to a listed substance, means the name internationally recognized for the substance or the name assigned to the substance in the latest edition of any generally recognized pharmacopoeia or compendium of drugs. |
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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) doctors of podiatric medicine;
(b) midwives; and
(c) nurse practitioners. |
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PERMITTED ACTIVITIES |
| Possession |
3. (1) Subject to subsection (2), a designated practitioner may possess a listed substance. |
| Requirements |
(2) The designated practitioner must
(a) be permitted to prescribe the listed substance in their practice under the laws of the province in which the practitioner is authorized to practise;
(b) have obtained the substance
(i) in the case of a doctor of podiatric medicine, in accordance with the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations,
(ii) in the case of a midwife, in accordance with the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations, and
(iii) in the case of a nurse practitioner, in accordance with the Benzodiazepines and Other Targeted Substances Regulations, Part G of the Food and Drug Regulations or the Narcotic Control Regulations;
(c) require the substance for their practice; and
(d) possess the substance in the province in which they are authorized to practise. |
| Transportation |
4. A designated practitioner may transport a listed substance for a purpose related to their practice. |
| Other activities |
5. A designated practitioner may administer a listed substance to a person under the professional care of the practitioner and may sell or provide a listed substance to or for the person, only if
(a) the practitioner is permitted to prescribe the substance in their practice under the laws of the province in which the practitioner is authorized to practise; and
(b) the listed substance is required for the condition for which the person is receiving treatment. |
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INFORMATION |
| Registration number |
6. When issuing a prescription or order for a listed substance, a designated practitioner shall
(a) in the case of a written prescription or order, include, on the prescription or order, the registration number or other unique identifier provided by their provincial professional licensing authority; and
(b) in the case of a verbal prescription or order, give, to the person who takes the prescription or order, the registration number or other unique identifier. |
| Records |
7. (1) A designated practitioner shall keep a record of the following information:
(a) the brand name or, if one does not exist, the proper name, the quantity and strength per unit of a listed substance received from a licensed dealer, pharmacist or hospital as well as the date of receipt and the name and address of the licensed dealer, pharmacist or hospital who sold or provided the listed substance; and
(b) in the case of a listed substance sold or provided to a person, the brand name or, if one does not exist, the proper name, the quantity and strength per unit of the substance, the date on which the substance was sold or provided and the name and address of the person. |
| Provision |
(2) The practitioner shall keep the records at a place and in a form and manner that permits an inspector to examine them and make copies and,
on request, shall provide any of the records to an inspector. |
| Retention |
(3) The practitioner shall keep a record referred to in subsection (1) for at least two years from the date it is made or revised. |
| Communication on request |
8. A designated practitioner shall
(a) provide to the Minister, on request, any information respecting the use by the practitioner of listed substances received, including the administering, selling or providing of them to a
person;
(b) provide to the Minister, on request, a copy of any record the practitioner is required to keep under section 7; and
(c) permit, on request, an inspector to check all stocks of listed substances in the practitioner's possession. |
| Communication to the provincial authority |
9. (1) The Minister may provide, in writing, to the professional licensing authority for the province in which the practitioner is authorized to practise, any factual information about the practitioner that has been obtained under the Act or these Regulations, if
(a) the authority submits to the Minister a written request that sets out the name and address of the practitioner, a description of the information being sought and a statement that the information is required for the purpose of assisting an official investigation by the authority; or
(b) the Minister has reasonable grounds to believe that the practitioner has
(i) contravened a rule of conduct established by the authority,
(ii) been found guilty in a court of law of a designated drug offence or of a contravention of these Regulations, or
(iii) done any act that contravenes a provision of these Regulations. |
| Communication to another provincial authority |
(2) The Minister may provide, in writing, to the professional licensing authority for another province, any factual information about the practitioner that has been obtained under the Act or these Regulations, if the Minister receives from the authority
(a) a written request for information that states the name and address of the practitioner and a description of the information being sought; and
(b) documentation that shows that the practitioner has applied to the authority to practise in that province. |
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SECURITY
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| Reasonable steps |
10. (1) A designated practitioner shall take reasonable steps to ensure the security of listed substances in their possession and, in particular, shall
(a) store listed substances in a secure area that is accessible only by the practitioner and persons authorized by the practitioner to have access;
(b) take reasonable steps to ensure the security of listed substances during transport; and
(c) report to the Minister the loss or theft of a listed substance within 10 days after the practitioner's discovery of the loss or theft. |
| Follow up |
(2) A designated practitioner who has been issued an identifying code referred to in subsections G.02.025(5) and (6) of the Food and Drug
Regulations or subsections 27(6) and (7) of the Narcotic Control Regulations must
(a) take any steps that are necessary to ensure the security of the code; and
(b) report to the Minister, not later than 10 days after discovery, any loss or theft of the code, a machine that is capable of producing the code or a document that discloses the code. |
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LIMITATIONS |
| Licensed dealers |
11. No licensed dealer shall sell or provide a listed substance to a designated practitioner named in a notice issued by the Minister under subsection 14(1) unless they have received a notice of retraction in respect of the designated practitioner issued under section 15. |
| Pharmacists |
12. No pharmacist shall, unless the pharmacy in which they work has received a notice of retraction issued under section 15 in respect of the designated practitioner,
(a) sell or provide a listed substance to a designated practitioner named in a notice issued by the Minister under subsection 14(1); or
(b) fill a prescription or order for a listed substance issued by a designated practitioner named in a notice issued by the Minister under subsection 14(1). |
| Request by designated practitioner |
13. A designated practitioner who does not wish to receive or have possession of listed substances may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under subsection 14(1), advising them of one or both of the following requirements:
(a) recipients of the notice must not sell or provide a listed substance to the practitioner; or
(b) pharmacists practising in the notified pharmacies must not fill a prescription or order for a listed substance issued by the practitioner. |
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NOTICE FROM MINISTER |
| Notice |
14. (1) In the circumstances set out in subsection (2), the Minister must issue a notice to the recipients specified in subsection (3) advising them of one or both of the following requirements:
(a) licensed dealers and pharmacists working in the notified pharmacies must not sell or provide
a listed substance to the designated practitioner named in the notice; or
(b) pharmacists working in the notified pharmacies must not fill a prescription or order for a listed substance from the designated practitioner named in the notice. |
| Cases of issuance |
(2) The notice must be issued if the designated practitioner has
(a) made a request to the Minister in accordance with section 13 to issue the notice;
(b) been found, by the professional licensing authority for the province in which the practitioner is authorized to practise, to have contravened a rule of conduct established by the authority and the authority has requested the Minister in writing to issue the notice; or
(c) been found guilty in a court of law of a
designated drug offence or of an offence under these Regulations. |
| Recipients |
(3) The notice must be issued to
(a) all licensed dealers;
(b) all pharmacies within the province in which the designated practitioner is authorized to
practise;
(c) the professional licensing authority for the province in which the practitioner is authorized to practise;
(d) any interested professional licensing authority in another province; and
(e) any pharmacies in an adjacent province in which a prescription or order from the practitioner may be filled. |
| Other cases |
(4) The Minister may issue the notice to the recipients specified in subsection (3), if the Minister, on reasonable grounds, believes that the designated practitioner
(a) has contravened a provision of the Act or the regulations;
(b) has, on more than one occasion, self-administered a listed substance under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted practice for the practitioner's area of practice;
(c) has, on more than one occasion, prescribed, provided or administered a listed substance to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted practice for the practitioner's area of practice; or
(d) is unable to account for a quantity of listed substance for which the practitioner was responsible under these Regulations. |
| Measures before issuance |
(5) In the circumstances described in subsection (4), the Minister must not issue the notice until the Minister has
(a) consulted with the professional licensing authority for the province in which the practitioner is authorized to practise;
(b) given the designated practitioner an opportunity to present reasons why the notice should not be issued; and
(c) considered the compliance history of the
designated practitioner in respect of the Act and the regulations and whether the actions of the practitioner pose a significant security, public health or safety hazard, including the risk of the listed substance being diverted to an illicit market or use. |
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RETRACTION |
| Notice |
15. The Minister must provide a notice of retraction to the recipients who were sent a notice under subsection 14(1), in respect of the designated practitioner named in the notice, if
(a) in the circumstance described in paragraph 14(2)(a), the requirements set out in paragraph (b) have been met and one year has elapsed since the notice was sent by the Minister; or
(b) in the circumstance described in any of paragraphs 14(2)(b) and (c) and subsection (4), the practitioner has
(i) requested in writing that a retraction of the notice be issued, and
(ii) provided a letter from the professional licensing authority for the province in which the practitioner is authorized to practise, in which the authority consents to the retraction of the notice. |
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CONSEQUENTIAL AMENDMENTS |
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FOOD AND DRUG REGULATIONS |
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16. (1) The definitions "controlled drug", "hospital" and "pharmacist" in subsection G.01.001(1) of the Food and Drug Regulations (see footnote 1) are replaced by the following: |
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"controlled drug" means
(a) a drug set out in the schedule to this Part and includes a preparation, or
(b) in respect of a designated practitioner, a drug set out in the schedule to this Part that is a listed substance in respect of the practitioner according to the definition "listed substance" in section 1 of the New Classes of Practitioners Regulations and includes a preparation; (drogue contrôlée)
"hospital" means a facility that
(a) is licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons or animals, or
(b) is owned or operated by the government of Canada or of a province and provides health services; (hôpital)
"pharmacist" means an individual who
(a) is registered or otherwise entitled under the laws of a province to practise pharmacy, and
(b) is practising pharmacy in that province; (pharmacien) |
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(2) Subsection G.01.001(1) of the Regulations is amended by adding the following in alphabetical order:
"designated practitioner" has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (praticien désigné) |
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17. The Regulations are amended by adding the following before section G.04.001: |
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G.04.0001. This Division does not apply to
designated practitioners. |
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18. The Regulations are amended by replacing the word "practitioner" with the words "practitioner — other than a designated practitioner — " wherever it occurs in the following provisions:
(a) subparagraph G.01.002(1)(a)(iii);
(b) paragraphs G.01.002(1)(b) and (c); and
(c) paragraph G.02.001.2(2)(b). |
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NARCOTIC CONTROL REGULATIONS |
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19. (1) The definitions "hospital", "narcotic" and "pharmacist" in section 2 of the Narcotic Control Regulations (see footnote 2) are replaced by the following: |
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"hospital" means a facility that
(a) is licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons or animals, or
(b) is owned or operated by the government of Canada or of a province and provides health services; (hôpital) |
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"narcotic" means
(a) any substance set out in the schedule or anything that contains the substance, or
(b) in respect of a designated practitioner, a substance set out in the schedule that is a listed substance in respect of the practitioner according to the definition "listed substance" in
section 1 of the New Classes of Practitioners Regulations and includes anything that contains the substance; (stupéfiant) |
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"pharmacist" means an individual who
(a) is registered or otherwise authorized under the laws of a province to practise pharmacy, and
(b) is practising pharmacy in that province; (pharmacien) |
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(2) Section 2 of the Regulations is amended by adding the following in alphabetical order:
"designated practitioner" has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (praticien désigné) |
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20. The Regulations are amended by adding the following before section 53: |
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52. Sections 53 to 60 do not apply to designated practitioners. |
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21. The Regulations are amended by replacing the word "practitioner" with the words "practitioner — other than a designated practitioner — " wherever it occurs in the following provisions:
(a) subparagraph 3(1)(a)(iii);
(b) paragraphs 3(1)(b) and (c);
(c) paragraph 8.3(2)(b);
(d) paragraph 24(3)(c);
(e) paragraph 24(4)(b);
(f) paragraph 31(3)(c); and
(g) subsection 65(7). |
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BENZODIAZEPINES AND OTHER TARGETED SUBSTANCES REGULATIONS |
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22. (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 designated practitioner, a controlled substance included in Schedule 1 that is a listed substance in respect of the practitioner according to the definition "listed substance" in section 1 of the New Classes of Practitioners Regulations or a product or compound that contains the controlled substance. |
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(2) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order: |
"common-law partner"
« conjoint de fait » |
"common-law partner", in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year. |
"designated practitioner"
« praticien désigné » |
"designated practitioner" has the same meaning as in section 1 of the New Classes of Practitioners Regulations. |
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23. (1) Section 7 of the Regulations is amended by adding the following after subsection (1): |
| Designated practitioners |
(1.1) The security requirements applicable to a designated practitioner are those established by the New Classes of Practitioners Regulations. |
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(2) Paragraph 7(2)(b) of the English version of the Regulations is replaced by the following:
(b) report to the Minister, not later than 10 days after discovery, any loss or theft of the code, a machine that is capable of producing the code or a document that discloses the code. |
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24. The Regulations are amended by adding the following before section 58: |
| Designated practitioners |
57.1 This Part does not apply to designated
practitioners. |
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25. Paragraph 60(1)(d) of the Regulations is replaced by the following:
(d) in the case of an emergency supply referred to in subsection 59(1), the name of the administering agent, the location of the emergency supply, the name, quantity and strength per unit of each targeted substance, the date of all transactions related to that emergency supply and the name and address of the individual to whom the targeted substance was administered. |
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26. The Regulations are amended by adding the following before section 79: |
| Designated practitioners |
78.1 This Part does not apply to designated
practitioners. |
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27. Paragraph 79(4)(c) of the Regulations is replaced by the following:
(c) has, on more than one occasion, prescribed, provided or administered a targeted substance to a person who is a spouse, common-law partner, parent or child of the pharmacist or practitioner, including a child adopted in fact, contrary to accepted pharmaceutical, medical, dental or veterinary practice; or |
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28. The Regulations are amended by replacing the words "a practitioner" with the words "a practitioner — other than a designated practitioner — " wherever they occur in the following provisions:
(a) subparagraph 4(2)(a)(iii);
(b) paragraphs 4(2)(b) and (c);
(c) paragraph 7(1)(c); and
(d) paragraph 19(2)(b). |
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COMING INTO FORCE |
| Registration |
29. These Regulations come into force on the day on which they are registered. |
SCHEDULE 1
(Section 1 and Subsection 3(1))
LISTED SUBSTANCES — DOCTORS OF PODIATRIC MEDICINE
| 1. |
Codeine (methylmorphine) |
| 2. |
Morphine (7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol) |
| 3. |
Hydromorphone (dihydromorphinone) |
| 4. |
Oxycodone (dihydrohydroxycodeinone) |
| 5. |
Pethidine (ethyl 1-methyl-4-phenylpiperidine-4-carboxylate) |
| 6. |
Dextropropoxyphene ([S-(R*,S*)]-α-[2-(dimethylamino)-1-methylethyl]-a-phenylbenzeneethanol, propanoate ester) |
| 7. |
Pentazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol) |
| 8. |
Alprazolam (8-chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-a][1,4] benzodiazepine) |
| 9. |
Bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1, 4-benzodiazepin-2-one) |
| 10. |
Clonazepam (5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one) |
| 11. |
Diazepam (7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one) |
| 12. |
Lorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one) |
| 13. |
Midazolam (8-chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine) |
| 14. |
Nitrazepam (1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one) |
| 15. |
Oxazepam (7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one) |
SCHEDULE 2
(Section 1 and Subsection 3(1))
LISTED SUBSTANCES — MIDWIVES
| 1. |
Codeine (methylmorphine) |
| 2. |
Morphine (7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol) |
| 3. |
Hydromorphone (dihydromorphinone) |
| 4. |
Oxycodone (dihydrohydroxycodeinone) |
| 5. |
Pethidine (ethyl 1-methyl-4-phenylpiperidine-4-carboxylate) |
| 6. |
Lorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one) |
| 7. |
Oxazepam (7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one) |
SCHEDULE 3
(Section 1 and Subsection 3(1))
LISTED SUBSTANCES — NURSE PRACTITIONERS
| 1. |
Codeine (methylmorphine) |
| 2. |
Morphine (7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol) |
| 3. |
Hydrocodone (dihydrocodeinone) |
| 4. |
Hydromorphone (dihydromorphinone) |
| 5. |
Oxycodone (dihydrohydroxycodeinone) |
| 6. |
Diphenoxylate (ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate) |
| 7. |
Pethidine (ethyl 1-methyl-4-phenylpiperidine-4-carboxylate) |
| 8. |
Dextropropoxyphene ([S-(R*,S*)]-α-[2-(dimethylamino)-1-methylethyl]-a-phenylbenzeneethanol, propanoate ester) |
| 9. |
Pentazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol) |
| 10. |
Cannabidiol (2-[3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) |
| 11. |
Nabilone ((±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one) |
| 12. |
Tetrahydrocannabinol (tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol) |
| 13. |
Amphetamine (α-methylbenzeneethanamine) |
| 14. |
Dexamphetamine (d-α-methylbenzeneethanamine) |
| 15. |
Methylphenidate (α-phenyl-2-piperidineacetic acid methyl ester) |
| 16. |
Butalbital (5-allyl-5-isobutylbarbituric acid) |
| 17. |
Phenobarbital (5-ethyl-5-phenylbarbituric acid) |
| 18. |
Alprazolam (8-chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-a][1,4] benzodiazepine) |
| 19. |
Bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepin-2-one) |
| 20. |
Chlordiazepoxide (7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide) |
| 21. |
Clobazam (7-chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4(3H,5H)-dione) |
| 22. |
Clonazepam (5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one) |
| 23. |
Clorazepate (7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1H-1,4-benzodiazepine-3-carboxylic acid) |
| 24. |
Diazepam (7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one) |
| 25. |
Flurazepam (7-chloro-1-[2-(diethylamino) ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one) |
| 26. |
Lorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one) |
| 27. |
Midazolam (8-chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine) |
| 28. |
Nitrazepam (1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one) |
| 29. |
Oxazepam (7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one) |
| 30. |
Temazepam (7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one) |
| 31. |
Triazolam (8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine) |
[26-1-o]
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
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