Complementary and Alternative Health Care and Natural Health Products Standards

Transcription

1 Standards Complementary and Alternative Health Care and Natural Health Products Standards Month Year

2 NATURAL HEALTH PRODUCTS i Approved by the College and Association of Registered Nurses of Alberta () Provincial Council, Month Year. Permission to reproduce this documents is granted. Please recognize. College and Association of Registered Nurses of Alberta St NW Edmonton, AB T5M 4A6 Phone: (in Edmonton) or (Canada-wide) Fax: practice@nurses.ab.ca Website:

3 NATURAL PRODUCTS 1 Table of Contents INTRODUCTION... 2 COMPLEMENTARY AND ALTERNATIVE HEALTH CARE... 3 NATURAL HEALTH PRODUCTS... 3 COMPLEMENTARY AND ALTERNATIVE HEALTH CARE AND NATURAL HEALTH PRODUCTS INITIATED BY CLIENTS... 5 COMPLEMENTARY AND ALTERNATIVE HEALTH CARE RESEARCH... 5 AUTHORITY TO PROVIDE COMPLEMENTARY AND ALTERNATIVE HEALTH CARE... 6 USE OF TITLE... 7 RECOGNITION OF NURSING PRACTICE... 7 FOR COMPLEMENTARY AND ALTERNATIVE HEALTH CARE AND NATURAL HEALTH PRODUCTS IN NURSING PRACTICE... 8 CONCLUSION REFERENCES APPENDIX A: GUIDELINES FOR DETERMINING IF A SPECIFIC INTERVENTION SHOULD BECOME A PART OF REGISTERED NURSING PRACTICE... 14

4 NATURAL PRODUCTS 2 Introduction Regulated members 1 in all areas of practice have encountered situations, questions or concerns related to complementary and alternative health care (CAHC) and natural health products (NHPs). Over the past years, there has been an increasing number of Canadians requesting the use of CAHC and NHPs. When completing a comprehensive health assessment, it is important for regulated members to assess and document the client s use of CAHC and/or NHPs. Many regulated members are interested in using CAHC and NHPs in their practice because of their emphasis on a holistic and natural approach to care. This holistic approach to care focuses on the mind-body-spirit connection. Florence Nightingale believed that nursing is putting us in the best possible conditions for Nature to restore or to preserve health to prevent or to cure disease or injury (Nightingale, 1954, p. 334). It was her belief that individuals are central to their own healing. The purpose of the Complementary and Alternative Health Care, and Natural Health Products Standards is to outline the expectations for regulated members: who have clients who wish to or are using CAHC and/or NHPs, who have clients who wish to or are using CAHC, and/or who recommend or provide advice on natural health products and their use. Regardless of the practice setting, the practice of all regulated members is grounded in the Canadian Nurses Association (CNA) Code of Ethics for Registered Nurses (2017) and the College and Association of Registered Nurses of Alberta () Practice Standards for Regulated Members (2013). Other documents provide direction and guide practice, for example: Documentation Standards for Regulated Members (2013) Medication Guidelines (2015) 1 The term regulated members includes RNs, NPs, CGNs, GNs, GNPs and courtesy permit holders.

5 NATURAL PRODUCTS 3 Health Professions Act: Standards for the Performance of Restricted Activities (2005) Scope of Practice for Registered Nurses (2011) Complementary and Alternative Health Care CAHC is an umbrella term used to describe numerous individual therapies and health care approaches that are often considered non-mainstream or non-conventional practices. It is important to note that some therapies that may be considered CAHC within the Canadian health care context are thought of as conventional medicine in other cultures (Smith & Simpson, 2003). The two terms, complementary and alternative, are often used interchangeably but they are different: Complementary - a non-mainstream practice used together with conventional medicine. Alternative - a non-mainstream practice used in place of conventional medicine (NCCIH, 2017). A third term, integrative health care, involves bringing conventional and complementary approaches together in a coordinated way. CAHC and NHPs may be a component of treatment plans for pain management, relief of symptoms in cancer patients and survivors, and promotion of healthy behaviors (NCCIH, 2017). Natural Health Products Seventy-one per cent of Canadians use NHPs. NHPs is a general term used to describe a variety of products. NHPs are used by Canadians to restore or maintain good health. They are naturally occurring substances which are mostly made from plants, but can also be made from other sources such as animals, microorganisms and marine sources. NHPs include: vitamins and minerals herbal remedies

6 NATURAL PRODUCTS 4 homeopathic medicines traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines probiotics products such as amino acids and essential fatty acids certain antiperspirants, shampoos and mouthwashes (Health Canada, 2016a) The Natural Health Products Regulations federal regulation governs the use NHPs. The regulations came into force in 2004 to ensure Canadians have access to NHPs that are safe, effective and of high quality. Any person or company that manufactures, packages, labels, and/or imports NHPs for commercial sale in Canada must meet the licensing requirements set out in the regulations. To obtain a license, applicants provide detailed information to Health Canada, e.g., medicinal ingredients, source, dose, potency, nonmedicinal ingredients, and recommended use(s). Once the product is approved by Health Canada, it is issued an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) which will be printed on the product label (Health Canada, 2016b). The label must include the following: product name product license number quantity of product in the bottle complete list of medicinal and non-medicinal ingredients recommended use (including purpose or health claim, route of administration and dose) any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product any special storage conditions (Health Canada, 2016b) Product labelling ensures easy recognition of the product for purposes of reporting adverse effects. It is important the client knows to inform their health care practitioner of any adverse reactions not only to determine next steps, but also so, the product can be reported to Health Canada. Reporting adverse reactions allows Health Canada to

7 NATURAL PRODUCTS 5 identify rare or serious adverse reactions, change the product safety information, issue public warnings and advisories, and/or remove unsafe products from the Canadian market. Complementary and Alternative Health Care and Natural Health Products Initiated by Clients The ease of access to information, particularly through the internet and technology, has led to clients actively increasing the management of their own health. Many are searching for therapies that will relieve the symptoms of chronic or acute illness. Others have cultural practices and values that are different from conventional Canadian health care where it is common practice for these therapies to be sought out and used. In situations where clients want to explore or have made a personal decision to initiate CAHC and/or self-select NHPs, the regulated member must: be non-judgmental in supporting the client s exploration of the therapies; recognize the client s autonomy in decision-making; assess the use of CAHC and/or NHPs in the client s care; when possible, assist the client to find accurate, reliable sources of information on CAHC therapies, NHPs and conventional treatment in order that the choices made by the client are informed choices; provide information on potential risks, benefits, costs and limitations of the therapy, the federal NHP regulation and/or referral to other health care providers; and encourage clients to inform all health-care providers, including primary care providers such as physicians and NPs, of the CAHC they are engaged in and NHPs they are using. Complementary and Alternative Health Care Research Research on CAHC therapies can be challenging for various reasons. Many CAHC therapies lack scientific evidence on efficacy and safety. However, some are thought to

8 NATURAL PRODUCTS 6 be effective due to observed positive outcomes. Some CAHC therapies do have scientific evidence which has been published in professional and nursing medical journals. There is also current research to support various nutritional practices that prevent the development of certain diseases (Potter, et al., 2014). Research into complementary and alternative health care is important to: understand how they work and confirm safety to use; determine if they interact with conventional medicine and how they interact; verify whether specific therapies are effective; test them against accepted treatments to determine results; learn if they improve quality of life; and examine cost effectiveness (Cancer Research UK, 2014). Any drug that is used to treat or cure health concerns needs to be developed and tested in laboratories before they are approved for clinical trials on people. This includes herbs, vitamins, minerals and any other substances. Authority to Provide Complementary and Alternative Health Care Often a CAHC practitioner is a member of a regulated profession. However, many therapies that fall under CAHC including aromatherapy, craniosacral therapy, Ayurvedic medicine, iridology, therapeutic touch, and Reiki are performed by a variety of individuals who may or may not be regulated health professionals. Regulated health professionals are governed by a professional college, meet minimum requirements to practice, and are subject to formal mechanisms to be held accountable for their practice. Unregulated providers may or may not have met a minimal educational standard to practice and are not accountable to a regulatory body that can assess and determine the appropriateness of practice. A regulated member has the authority to provide CAHC therapy if: 1. the therapy is within the scope of nursing practice (refer to Scope of Nursing for Registered Nurses, 2011) and professional legislation and regulation,

9 NATURAL PRODUCTS 7 including restricted activities authorization (refer to document Health Professions Act: Standards for Registered Nurses in the Performance of Restricted Activities, 2005); and 2. there are policies and procedures in place in the practice setting that support the use of the therapy as part of a client s individualized plan of care. The process outlined in the document Health Professions Act: Standards for Registered Nurses in the Performance of Restricted Activities (2005) can be used by regulated members to determine if specific CAHC therapies or NHPs would be appropriate as an adjunct to nursing practice in a particular setting (see Appendix A). Use of Title Registered nurses and nurse practitioners cannot use the title RN or NP in association with the endorsement or promotion of products or services. Endorsement of a product or service occurs when a nurse uses their credentials to lend credibility to a commercial product or service. The endorsement of a product or service without providing information about other options could be misleading to the public and may be considered a conflict of interest (, 2010). The use of the protected titles of registered nurse or RN and nurse practitioner or NP is authorized in the Registered Nurses Profession Regulation (2005). Registered nurses and nurse practitioners may use the title RN or NP with the promotion of their nursing practice. Using the title RN or NP in marketing approved professional services helps the consumer make an informed decision when choosing a health service provider. Recognition of Nursing Practice Nurses who are requesting to use CAHC therapies or as a self-employed practice must submit documentation for consideration of recognition of their nursing practice. Nurses are required to explain how the CAHC therapy fits into the following areas of nursing practice (as outlined in Schedule 24 of the Health Professions Act): Assist individuals, families, groups, and communities to achieve their optimal physical, emotional, mental, and spiritual health and well-being.

10 NATURAL PRODUCTS 8 Assess, diagnose and provide treatment and interventions and make referrals. Prevent or treat injury and illness. Teach, counsel and advocate to enhance health and well-being. Coordinate, supervise, monitor, and evaluate the provision of health services. Teach nursing theory and practice. Manage, administer, and allocate resources related to health services. Engage in research related to health and practice of nursing. Provide restricted activities authorized by. Standards for Complementary and Alternative Health Care and Natural Health Products in Nursing Practice The following standards and criteria identify the expectations for regulated members in the provision of care that includes CAHC and NHPs. The criteria illustrate how the standard must be met. All criteria must be met to achieve the standard. The criteria are not written in order of importance. Standard 1: The regulated member is responsible and accountable for their nursing practice related to CAHC and NHPs. Criteria 1.1 The regulated member must have the necessary competence (knowledge, skill, judgment, and attitudes) to provide the CAHC therapy in a safe, competent, and ethical manner. 1.2 The regulated member must follow employer policy related to CAHC therapies and NHP use (Employer policy might include identification of required education

11 NATURAL PRODUCTS 9 and competencies, experience, informed consent, documentation and supervision requirements.). 1.3 Regulated members only administer or recommend NHPs that are approved by Health Canada. The Natural Health Products Regulations, federal regulation governs the use NHPs. Any person or company that manufactures, packages, labels, and/or imports NHPs for commercial sale in Canada must meet the licensing requirements set out in the regulations. 1.4 NHPs that are administered must have an eight-digit product license number that is preceded by the letters NPN. Homeopathic medicines will have the eight-digit number preceded by the letters DIN-HM. Once a product is approved by Health Canada, it is issued an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) which will be printed on the product label. This labelling ensures easy recognition of the product for purposes of reporting adverse effects (Health Canada, 2016b). 1.5 The regulated member collaborates with primary care providers and/or other health care professionals as appropriate and where necessary. 1.6 The regulated member reports adverse effects of NHPs to Health Canada. Standard 2: Regulated members acquire and apply knowledge and skills of CAHC and NHPs to provide nursing care that is safe, competent, and evidenceinformed. Criteria 2.1 The regulated member must successfully complete appropriate educational or certificate programs to prepare themselves to provide the CAHC therapy. 2.2 The regulated member must use their knowledge and critical judgment to identify risks and expected outcomes, and to determine if the therapy is appropriate to the client situation.

12 NATURAL PRODUCTS The regulated member who administers or recommends NHPs must be aware of the intended effects, possible side effects and be prepared to provide care in relation to expected or unexpected effects of the NHP. 2.4 The regulated member documents nursing care related to CAHC therapies and NHPs. Documentation includes: nursing history and assessment of the use of CAHC and NHPs, discussion regarding the history of the condition, risks and benefits of conventional treatment, client or families decision not to proceed with conventional therapy, risks and benefits of a proposed CAHC therapy or NHP and families response to that, and planning, intervention and evaluation of care and the therapy. 2.5 The regulated member must use reliable sources of information and examine the evidence to determine that the therapy is safe and effective, including consultation with a pharmacist or other health care providers as necessary (all pharmacies are required to have the Natural and Non-prescription Health Products Directorate [NNHPD]). 2.6 The regulated member must be aware of the intended effects and possible side effects of CAHC therapies, their interactions with other therapies and be prepared to provide care in relation to any expected or unexpected effects of the therapy including plans for backup care if it is needed. Standard 3: The regulated member complies with the Code of Ethics adopted by the Council in accordance with Section 133 of the Health Professions Act and bylaws (, 2012) related to CAHC and NHPs. Criteria 3.1 The regulated member respects the client s right to choose their treatment.

13 NATURAL PRODUCTS The regulated member must recommend to their clients that they inform their other health-care providers of CAHC and/or NHPs they are using. 3.3 The regulated member must use current, updated, and unbiased resources to inform the client of potential benefits and risks, intended effects and possible side effects of the therapy and other available options. 3.4 The regulated member must obtain informed consent by the client as outlined in the InfoLAW from the Canadian Nurses Protective Society (CNPS, 1994; CNPS, 2009), as well as compliance with employer policy for consent. Conclusion As CAHC and use of NHPs increases, it is important for regulated members to have an understanding of these therapies and products. Clients have the right to make their own personal decisions related to their care. Regulated members provide appropriate information so choices and decisions are informed.

14 NATURAL PRODUCTS 12 References Canadian Nurses Association. (2017). Code of ethics for registered nurses. Ottawa, ON: Author. Cancer Research UK. (2014). About complementary and alternative therapy research. Retrieved from Canadian Nurses Protective Society. (1994). Consent to treatment: The role of the nurse. Ottawa, ON: Author. Canadian Nurses Protective Society. (2009). Consent for the incapable adult. Ottawa, ON: Author. College and Association of Registered Nurses of Alberta. (2012) College and Association of Registered Nurses of Alberta bylaws. Edmonton, AB: Author. College and Association of Registered Nurses of Alberta. (2013). Practice standards for regulated members. Edmonton, AB: Author. College and Association of Registered Nurses of Alberta. (2010). Self-employment for nurses: Position statement and guidelines. Edmonton, AB: Author. Health Canada. (2016a). About natural health products. Retrieved from Health Canada. (2016b). About natural health product regulation in Canada. Retrieved from National Center for Complementary and Integrative Health. (2017). Complementary, alternative or integrative health: What s in a name? Retrieved from Nightingale, F. (1954). Nurses, training of and nursing the sick. In L.R. Seymer (Ed.), Selected writings of Florence Nightingale (pp ). New York: MacMillan. (Original work published 1882).

15 NATURAL PRODUCTS 13 Potter, P. A., Perry, A. G., Ross-Kerr, J. C., Wood, M. J., Astie, B. J., & Duggleby, W., (Eds.). (2014). Canadian fundamentals of nursing (5th ed.). Toronto, ON: Mosby.Elsevier. Registered Nurses Profession Regulation, Alta. Reg. 232/2005. Smith, M. J., & Simpson, J. E. (2003, November). Alternative practices and products: A survival guide. Health Policy Research Bulletin, 2003(7), 3-5.

16 NATURAL PRODUCTS 14 Appendix A: Guidelines for Determining if a Specific Intervention Should Become a Part of Registered Nursing Practice From the document Health Professions Act: Standards for Registered Nurses in the Performance of Restricted Activities (2005): A number of health professionals may be authorized to perform a specific restricted activity. Factors influencing which health professional will perform the restricted activity intervention in a given situation include: authorization by the professional s regulatory college to perform the restricted activity needs of the client context of care including the acuity/stability/complexity of the client service delivery model knowledge and competency of the health-care professional availability of health professionals in the practice setting continuity of care within the setting The practice of registered nurses (RNs), like that of other health-care professionals, is constantly evolving. In the assessment of client care and nursing practice, employers and RNs may identify interventions/tasks within a restricted activity authorized for RNs that they are not currently performing. Assessment of the clinical situation may indicate that it would be reasonable for an RN to perform that restricted activity intervention. The following guidelines have been identified to provide assistance to administrators, managers and RNs in determining if interventions within a restricted activity category should be incorporated as a part of RNs practice in that particular practice setting.

17 NATURAL PRODUCTS 15 Guideline 1 Assessment of Client Need, Intent and Purpose of the Restricted Activity Intervention The determination of whether or not an RN performs a specific intervention/task within a restricted activity category must be mutually agreed upon between RNs and other health-care professionals in the practice setting. The determination should be supported by institutional policy, be the same on any shift and driven by the needs of the client, not by the desire for convenience of health-care professionals. For example, the RN may be the only available provider in a practice setting during the night shift who has a competency in a particular restricted activity intervention. If the RN is not allowed to perform this intervention on a day shift, they should not be allowed to perform it on nights. Additionally, if the person was not competent to provide the intervention, it does not matter if they are the only available provider they must not perform the activity. Guideline 2 Knowledge and Skill to Perform the Restricted Activity Intervention Safely The responsibility for attaining and maintaining competence in the restricted activity intervention is held jointly by RNs and their employers. One of the important factors to consider when decisions are made as to whether or not a particular restricted activity intervention should become a part of nursing practice is the opportunity to maintain competence. The RN is expected to: identify his/her own learning needs with respect to the restricted activity intervention, practise only within his/her areas of competence, and utilize available educational resources to attain and maintain competency in the activity.

18 NATURAL PRODUCTS 16 Employers have the responsibility to: provide orientation and staff development programs based on identified learning needs related to the goals of the organization, and ensure the provision of the necessary resources for RNs to attain and maintain competency in the restricted activity interventions required by the needs of clients in the practice setting. RNs and employers share responsibility for collaborating on the ongoing evaluation of the need for and the performance of all interventions, including the competence of the practitioners involved. Employers will need to strive for consistent methods to evaluate RN competence. Guideline 3 Identification and Establishment of Policies and Procedures to Facilitate Safe and Competent Performance of the Activity The development and implementation of evidence-based policies and procedures is critical to support safe and competent performance of restricted activity interventions. As part of this process, there must be mutual agreement by the professionals involved in the practice setting that this intervention will become a part of nursing practice. In any practice setting, RNs have both the right and the professional obligation to question policies and procedures inconsistent with therapeutic client outcomes, current practices, and safety standards. Accordingly, where the performance of a particular restricted activity intervention in a specific practice setting is not consistent with therapeutic client outcomes, current practices, and/or safety standards, RNs have the professional responsibility to refuse the acceptance of such a restricted activity intervention, and to communicate their concern to the employer. Employers have the responsibility to address the concerns outlined with respect to the proposed restricted activity intervention. In such instances, the particular restricted activity intervention should only be incorporated as a part of registered nursing practice when all concerns of the parties affected have been satisfactorily addressed.