Mr. Hong Zhang
Regulatory Policy Division
Office of Controlled Substances
123 Slater Street, Room A310
Ottawa, ON K1A 1B9
June 4, 2012
Dear Mr. Zhang:
The Registered Nurses’ Association of Ontario (RNAO) is the professional association representing 33,000 registered nurses, nurse practitioners and nursing students in Ontario. We appreciate the opportunity to provide Health Canada with feedback on the pre-published New Classes of Practitioners Regulations (NCPR) that are poised to remove federal barriers preventing Nurse Practitioners (NPs) from prescribing controlled substances.
There are over 2,486 NPs improving access to health care for thousands of Canadians, representing a 120.2 per cent increase in the NP workforce between 2006-2010. Ontario alone holds almost 60 per cent of the nation’s NP workforce which equals over 1,482 NPs practicing in this province. It is important to highlight that this data is from 2010 and that further increases in the NP workforce are anticipated to be demonstrated in future data. Recently Ontario has authorized significant expansions to the scope of practice of NPs, including granting the authority to admit, treat, transfer and discharge hospital in-patients. Ontario has also been leading the way through significant expansions to the practice scope of the NP through the Regulated Health Professions Statute Law Amendment Act, 2009 to enhance access to quality health care for Ontarians. Therefore, it is timely for NPs to have access to prescribing controlled substances in Ontario, given the evolving role of the NP. RNAO understands that regulatory amendments would also be required at the provincial level. The College of Nurses of Ontario has indicated publicly that once the NCPR is published, they will work with Ontario’s Ministry of Health and Long-Term Care to amend regulations under Ontario’s Nursing Act, 1991. This is exciting news for both Ontario’s NPs and clients requiring controlled substances as part of their treatment plan.
RNAO is tremendously supportive of the enhancements made in the current version of the NCPR and consider this to be a significant step in the right direction when compared with the previous version pre-published in 2007. RNAO is particularly pleased to see that both methadone and buprenorphine are not listed as exclusions. Access to prescribing these medications, in combination with other measures, will allow NPs to provide a comprehensive treatment approach to the complex drug addiction challenges facing many communities in Ontario. Particular benefit will be felt in Ontario’s First Nations communities where addiction rates can be as high as 70 per cent. As addiction is a chronic condition requiring a multi-faceted treatment approach and given that NPs possess significant expertise in providing effective chronic disease management, restrictions experienced when NPs are unable to prescribe buprenorphine is a significant concern.
Publishing the NCPR and implementing the required regulations at the provincial level will allow Canadian NPs to join their international counterparts, such as NPs in the United States who are permitted by law in many states to prescribe controlled substances. Research has identified challenges encountered by NPs who are not authorized to prescribe controlled substances. For example, a study of long-term care pain management offered by NPs in Ontario’s long-term care sector found the inability to prescribe controlled substances restricted an NP’s ability to provide effective and efficient pain management. Expanding the authority of NPs to use their full knowledge, skill and judgment to benefit clients through increased access to medication, will have significant positive impacts on the health-care system.
RNAO agrees with the principle expressed in the NCPR that enabling NPs to prescribe controlled substances will enhance continuity of care and continuity of caregiver allowing for a more efficient and effective client experience throughout the health-care system. Therefore, RNAO is concerned that there are still restrictions being proposed on NP prescribing abilities through an exclusion list. The exclusions provided in the NCPR for NPs will represent access barriers in some practice settings, such as chronic disease management, palliative care, long-term care and NPs involved in harm reduction strategies. Furthermore, the exclusion rationales provided in the NCPR are related to the potential risk of diversion and abuse, regulatory requirements and scope of practice. RNAO feels that these rationales do not provide sufficient grounds, from either a client-centred care or health-system perspective, to justify restricting NPs prescribing abilities. Each of the three rationales will be examined below.
Risk of Diversion and Abuse:
Under careful clinical supervision and a comprehensive treatment approach led by an NP, the risk of diversion and abuse of controlled substances would be comparable to the level of risk present when a physician would prescribe these medications. In fact, there are inconsistencies within the NCPR regarding abuse and diversion. For example, the NCPR identifies that “... while research on this issue is limited, there is little reason to believe that midwives, nurse practitioners and podiatrists are more likely than physicians to abuse prescribing privileges.” Regarding the risk of diversion, the NCPR identifies: “... the NCPR [provides] controls to mitigate the risk of diversion of controlled substances while ensuring that the new classes of practitioners can legitimately access these substances in the provision of health care services.” NPs possess the knowledge, skill and expertise to effectively assess the risk of diversion and are able to effectively monitor for indications of diversion throughout the course of treatment.
Additional Regulatory Amendments:
RNAO recognizes that removal of the current exclusions in the NCPR would require additional regulatory amendments to the Narcotic Control Regulations, the Food and Drug Regulations and the Marihuana Medical Access Regulations. RNAO strongly urges Health Canada not to position the need for additional regulatory amendments as a rationale that will inevitably reinforce access barriers for Canadians. RNAO feels that Health Canada possesses the capacity, authority and leadership to amend the required regulations and would be supported to do so from within the health-care community.
Scope of Practice:
As identified previously within this response, the scope of practice of the NP has dramatically broadened within Ontario at the recommendation of the Health Professional Regulatory Advisory Council and the College of Nurses of Ontario. NPs in Ontario are regulated health professionals that: possess university degrees (often at the graduate level), NP-specific certification and years of previous clinical experience as RNs. All NPs are subject to participation in a quality assurance program delivered annually by the College of Nurses of Ontario, including potential selection for a practice assessment. Therefore, controls are in place to monitor the effectiveness and safety of NP practice in Ontario. It is also important to highlight that by the end of 2012, thousands of Ontarians will be receiving care in 26 nurse practitioner-led clinics, which represent a North American first and position the NP as the leader of an interprofessional team of primary care professionals. An extensive cochrane review examined the ability of a nurse to provide a comparable level of care as a physician and concluded that: “... appropriately trained nurses can produce as high quality care as primary care doctors and achieve as good health outcomes for clients.” Therefore, NPs should not be subjected to exclusions that do not apply to other health-care professionals, such as physicians. Removing the exclusions in the NCPR would align with the significant evolution and establishment of the NP in Canada’s health-care system.
RNAO is also concerned that the current NCPR specifies that unlike physicians and veterinarians, NPs would not be permitted to designate an agent to handle controlled substances on their behalf. This restriction will present significant challenges for the many NPs who are providing invaluable care in the northern remote areas of Ontario and may require the transfer of controlled substances. For example, a NP may need to designate an agent to transfer a controlled substance from a hospital to a remote nursing station to care for an ill client. The current wording in the NCPR would prevent the NP from doing so, restricting equitable access to required medications.
RNAO is pleased to see that a performance measure and evaluation plan will be developed by Health Canada and would welcome opportunity to review and contribute to this plan. Given that the NCPR identifies little evidence to date regarding the cost effectiveness of enabling NPs to prescribe controlled substances, RNAO feels that this will be an important element to be built into the evaluation.
RNAO is also pleased to offer support to Canada’s midwives and podiatrists that are included within the NCPR. RNAO feels strongly that the full knowledge, skill and judgment of all members of the interprofessional team should be fully utilized to benefit the client.
In conclusion, RNAO is very pleased with the current version of the NCPR and urges Health Canada to act quickly in publishing and implementing the regulations with the following amendments:
• Removing the exclusion list for NPs; and
• Enabling NPs to designate an agent to handle controlled substances on their behalf.
Doing so will represent a significant step forward to creating equitable and coordinated access to quality health care for all Canadians.
Once again, RNAO extends its gratitude to Health Canada for the opportunity to offer this response and will be pleased to discuss and/or offer clarification to any of the points included.
Doris Grinspun, RN, MSN, PhD, LLD(hon), O.ONT.
Chief Executive Officer
Registered Nurses’ Association of Ontario