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Feds propose new drug regulations

Web posted on May 14, 2012

The Federal Government today proposed new regulations that aim to increase flexibility within the health care system and improve the timeliness of service delivery in Canada.

"These new regulations will improve flexibility within the health care system and the timeliness of service delivery in Canada," said the Honourable Leona Aglukkaq, Minister of Health. "They will promote better continuity of care by removing barriers to access to these medications, where and when they are needed."

Currently, the Controlled Drugs and Substances Act authorizes only medical doctors, dentists and veterinarians to conduct activities with controlled substances. The proposed New Classes of Practitioners Regulations (NCPR) would authorize these additional health professionals (midwives, nurse practitioners and podiatrists) to prescribe, administer and provide legal controlled substances such as codeine, fentanyl and diazepam to treat patients in provinces and territories where they are licensed to do so.

"Because of these new regulations, nurse practitioners will be able to efficiently deliver a more comprehensive level of quality care for which they are trained," said Judith Shamian, President, Canadian Nurses Association. "Nurse practitioners are poised and ready to deliver an advanced level of care that will reduce wait times and the burden on emergency departments. The time for transformation is now and governments are to be commended when they lead progressive changes such as this one, positively affecting millions of Canadians."

"The designation of midwives as practitioners under the Controlled Drugs and Substances Act is an important first step which we hope will ultimately facilitate midwives having the authority to prescribe a limited number of the appropriate medications for women in their care - namely medications for pain relief in labour and management of narcotic-induced depression in the neonate," said Kris Robinson, Chairperson of the Canadian Midwifery Regulators Consortium (CMRC).

Provincial and territorial governments are responsible for regulating health professionals, and have been consulted in the development of these proposed changes. By working closely with provinces and territories, the Harper Government is creating greater flexibility in the health care system by making it more convenient for patients to obtain the medications they need.

In summary, the proposed changes have the following effect:

Nurse Practitioners
Nurse practitioners are primary health professionals for many Canadians. Currently, even though some provincial and territorial governments have authorized nurse practitioners to prescribe medications containing controlled substances, the CDSA does not allow them to do so. This disconnect means that patients who would otherwise access complete health care through a nurse practitioner now have to visit a physician in order to access the medication they need, or wait until the nurse practitioner consults a physician who can prescribe the required medication. In this regard, the proposed NCPR would allow nurse practitioners to fully practice their profession by ordering, prescribing and administering medications containing controlled substances, with the following exclusions: heroin, cannabis, opium, coca, and anabolic steroids (except testosterone).

Midwives are specialists in normal childbirths, providing care through early pregnancy to birth and afterwards, to women and their infants. They may need to prescribe controlled substances to deal with pain during labour and after birth. Currently, midwives lack the authority to prescribe medications containing controlled substances. This has resulted in patients suffering from unnecessary pain during labour because midwives must refer their patients to a physician in order for them to obtain a prescription for these types of medications. Improved access to selected controlled substances would alleviate this situation and result in more effective health care service delivery and improved quality of patient care. The following exclusion of controlled substances would apply to midwives: heroin, cannabis, opium, coca, methadone, buprenorphine, amphetamine, benzphetamine, methamphetamine, phenmetrazine, phendimetrazine, and anabolic steroids.

Podiatrists are specialized in the diagnosis and treatment of illnesses and diseases affecting the foot, ankle and lower legs, and thus use medications containing controlled substances to sedate patients during foot surgery and in managing post-operative pain. While doctors of podiatric medicine (a subset of podiatrists) can prescribe benzodiazepines in accordance with a Section 56 exemption issued under the CDSA, the proposed regulations would now allow all podiatrists to prescribe a broader range of medications in order to provide appropriate care to their patients. This will result in more effective health care service delivery and improved patient comfort and well-being. The exclusions of controlled substances for this class of practitioner are: heroin, cannabis, opium, coca, methadone, buprenorphine, amphetamine, benzphetamine, methamphetamine, phenmetrazine, phendimetrazine, and anabolic steroids.


People are invited to view the proposed Regulations as published in the May 5, 2012 Canadian Gazette.

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice (Vol. 146, No. 18 - May 5, 2012), and be addressed to Hong Zhang, Regulatory Policy Division, Office of Controlled Substances, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, Address Locator: 3503D, Ottawa, Ontario K1A 0K9 (fax: 613-946-4224; or e-mail).

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