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versión On-line ISSN 1886-3655
Pharmacy Practice (Internet) v.6 n.1 Redondela jan.-mar. 2008
Pharmacists and Natural Health Products: A systematic analysis of professional responsibilities in Canada
Jennifer FARRELL, Nola M. RIES, Heather BOON.
Natural health products such as herbs, vitamins and homeopathic medicines are widely available in Canadian pharmacies.
Key words: Natural health products. Practice Guidelines as Topic. Pharmacists. Canada.
Los productos sanitarios naturales, tales como las plantas medicinales las vitaminas y los medicamentos homeopáticos están ampliamente disponibles en las farmacias canadienses.
Palabras clave: Productos sanitarios naturales. Guías de práctica como asunto. Farmacéuticos. Canadá.
Jennifer FARRELL. Faculty of Arts, University of Ottawa, Ottawa, Ontario (Canada).
Nola M. RIES. Health Law Institute, University of Alberta, Edmonton, Alberta (Canada).
Heather BOON. Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario (Canada).
Over half of Canadians aged 18 or older visit a pharmacy during any given week.1 A recent survey indicates that 71% have taken natural health products such as herbs, vitamins or homeopathic remedies and many take them on a daily or weekly basis.2 Various factors drive consumer demand for natural health products, including individual frustrations with conventional treatments, desire for greater autonomy and empowerment regarding health care choices, chronic health issues, and cultural influences.3-6 Natural health products are defined by Health Canada to include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, amino acids, and essential fatty acids sold over-the-counter (OTC) to consumers. The intent of the regulations is that a product should only be a natural health product if it is considered safe for consumer selection. Products from natural sources that are categorized as not safe for self-selection are to be regulated as drugs in Canada.7
Although natural health products are routinely available without prescription, that does not mean they are completely safe for all individuals. Some have known side effects, particularly for children, pregnant or breastfeeding women, seniors, those living with a serious disease, or surgical patients.8 Concurrent use of natural health products and prescription drugs is common 32% of Canadians reported such use in a 2004 survey9 and raises concern about adverse drug interactions. Almost half of all pharmacists responding to a 2006 survey reported they had identified a potential NHP-drug interaction in the past, but only two of these were reported to Health Canada.10 This suggests these kinds of interactions occur, but are often undetected by federal tracking systems.
Pharmacists are increasingly identified as the most suitable health care professional to counsel consumers about natural health products by offering evidence-based information to ensure safe product selection.11,12 Pharmacists report increasing frequency of patients seeking NHP advice. In a 1996 study, pharmacists reported that they gave advice on herbal remedies an average of two times each week; four years later, their counselling activities rose to an average of seven times per week.13 The National Drug Scheduling Advisory Committee (NDSAC) of Canadas National Association of Pharmacy Regulatory Authorities (NAPRA) identified natural health products as a growing force in the future direction of Canadian healthcare.14 They note that the Natural Health Products Regulations confer new legitimacy on natural health products and intensify pressure on pharmacists to be knowledgeable sources of information on these products. NDSAC also observes that many consumers have a thirst for health information which creates a greater need for pharmacists to be capable of advising consumers who are inundated with health information from a wide range of sources of varying credibility. According to Health Canadas consumer survey, pharmacies are the preferred venue for obtaining information on natural health products in comparison to other sources such as Health Canada's website and publications.2 However, the growth in information sources, especially Internet sources, suggests consumers depend less on healthcare practitioners for information.15 Kwan argues that pharmacists are taking on more of a consultant role as they help consumers interpret information about natural health products from a wide variety of sources.12
Kwan et al. note there is high agreement among pharmacists that they have professional responsibilities in regard to natural health products and, as drug experts, they are fittingly responsible for the safe usage of natural health products.12 Another commentator notes that pharmacists have a professional responsibility to advise patients about potentially harmful aspects of herbal remedies, including possible interactions or contraindications with synthetic medications and/or current disease states. To do otherwise could leave patients at risk for major problems and jeopardize the public trust accorded to pharmacists.16 Pharmacy regulatory bodies across Canada have adopted standards of practice and ethical mandates that require pharmacists to be knowledgeable about natural health products and counsel patients about benefits and risks of NHP use. Through public messaging, these professional organizations increasingly emphasize the role of pharmacists in advising patients about natural health products and hold out pharmacists as experts in this area. There is a clear expectation that pharmacists will have requisite knowledge to counsel patients, even though few in the profession report confidence in this area.12 These emerging professional responsibilities emphasize the need for pharmacy education to ensure pharmacists have capacity to meet evolving standards of practice.17 In light of burgeoning consumer interest in, and use of, natural health products, the objective of this paper is to provide a systematic analysis of emerging professional responsibilities of Canadian pharmacists in counselling patients about natural health products.
To examine emerging professional responsibilities in the Canadian context, we systematically examined all legislation, codes of ethics, standards of practice and guidance documents that apply to the practice of pharmacy in each Canadian jurisdiction to identify if, and how, these instruments establish professional duties in regard to natural health products. Between May and August 2007 all Canadian laws that regulate the practice of pharmacy were identified from up-to-date publicly accessible statute databases or the QuickLaw legal database. In addition websites for all Canadian pharmacy regulatory and licensing authorities were searched for any additional policies related to natural health products. To supplement this systematic search, we also searched websites of organizations such as the National Association of Pharmacy Regulatory Authorities (NAPRA) to identify relevant instruments such as model standards of practice and policy statements. Key words used in all searches were: natural health products; herbal medicine; botanical medicine; homeopathy; vitamins, minerals; over-the-counter drugs/medicines/medications; non-prescription drugs/medicines/medications. After compiling these materials, they were analyzed by two authors (JF, NMR) using basic content analytic methods to identify provisions relevant to pharmacy practice and natural health products. The relevant provisions were then classified into key themes that focused on how, if at all, each legal or policy document referred to natural health products.
Pharmacy Regulation in Canada
In Canada, provincial and territorial governments have constitutional authority over the regulation of health care professions and each jurisdiction may, in turn, enact legislation to confer self-regulation powers on health professions.18 Self-regulating professions are governed by professional colleges that set standards to which their members must adhere. Pharmacy is a self-regulating profession across Canada and, in each jurisdiction, a provincial statute sets out the scope and standards of practice for pharmacists. Provincial pharmacy regulation statutes do not explicitly address professional obligations in regard to natural health products, although they typically state that the practice of pharmacy includes provision of non-prescription drugs and information related to drug use. (See e.g. Ontario Pharmacy Act, S.O. 1991, c. 36, s. 3).
Provincial Standards of Practice and Codes of Ethics
Provincial Colleges of Pharmacists enact bylaws and issue practice standards that further clarify professional roles and responsibilities. Key provisions from each Canadian jurisdiction are summarized in the Appendix to this article. In general, these documents frequently refer to pharmacists knowledge in regard to OTC products. For example, British Columbias Standards of Practice document states: [a]s experts on prescription and non-prescription medications, todays pharmacists are an integral part of our patients health care teams. Non-prescription pharmaceutical products are defined as non-prescription medications, nutrition supplements, health care devices, home care products and complementary and alternative medicines. Albertas new Standards of Practice state that, in making prescribing decisions and counselling patients, a pharmacist has a duty to consider appropriate information which includes other health care products, aids and devices or other products being used by the patient that might affect drug response. (See https://pharmacists.ab.ca/document_library/HPAstds.pdf) Health care products, aids and devices are defined in Albertas Pharmacy and Drug Regulation to include natural health products as they are defined in the Natural Health Products Regulation. Saskatchewans Standards of Practice require pharmacists to be accessible for consultation regarding non-prescription medication, and s/he should advise the patient on how, when and whether to take non-prescription medication .
According to Manitobas Standards of Practice, the pharmacist must provide patient counselling for any prescription or non-prescription medication. The pharmacist must also maintain patient profiles, making a reasonable effort to record information including non-prescription, herbal, and homeopathic drug use. (See Standard H. 1.34(f)) The document further states that patient counselling must include information about significant interactions with other drugs, non-prescription medication, natural health products, nutraceuticals and food. Ontarios Standards of Practice state that the pharmacist must record appropriate patient information, including known contraindications to prescription drugs, non-prescription drugs, natural health products, and complementary or alternative medicines. Another standard maintains that the pharmacist must be clearly identifiable and available, accessible, and approachable to consult with patients who wish to self-medicate with a non-prescription drug, a NHP, or a complementary or alternative medicine.
Both the Nova Scotia College of Pharmacists and the Prince Edward Island Pharmacy Board offer guidelines on natural health products. They state that their pharmacists shall have a general knowledge of natural health products, have a current and reliable reference, be satisfied that the product is approved for sale by Health Canada (Nova Scotia) or be safe (Prince Edward Island), and that when counselling the consumer, the pharmacist must be satisfied that the product will not interfere or interact with the consumers possible disease state and/or other conventional medications.
Provincial Codes of Ethics also establish professional conduct obligations for pharmacists. For instance, Codes of Ethics in Alberta, Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland and Labrador state that a pharmacist must hold the health and safety of each client to be the primary consideration. This principle recognizes that [p]harmacists have specialized knowledge about medicines, health related products, and medicinal and nonmedicinal therapies and are expected to use this knowledge to benefit their patients.
National Standards of Practice and Guidance Documents
Some provinces Nova Scotia, Prince Edward Island and Newfoundland and Labrador - adhere to NAPRAs Model Standards of Practice. While these standards are scheduled for review in fall 2007, the current version contains several references to natural health products. One of the model standards of professional competency is that a pharmacist must develop a professional relationship with the patient by, for example, offering assistance in selecting non-prescription drug therapy and natural health products. Another competency element holds that a pharmacist must develop therapeutic plans, which includes recommending therapeutic options and instructions for doses, scheduling and administration. On patient request, the pharmacist must provide accurate information regarding the efficacy, toxicity, side effects or interactions of natural health products. With respect to the professional competency of providing drug information, a pharmacist demonstrates advanced or exemplary practice skills if s/he [r]outinely and efficiently retrieve[s] the information necessary to provide recommendations about all drugs, including herbal and complementary medicines. (Model Standard 2.2)
NAPRA has also promulgated guidelines regarding alternative health products, stating that when pharmacists provide advice or sell alternative health products, the pharmacist must abide by their obligation to act in the patients best interest by ensuring the products are safe to use, free from product toxicity and not harmful to current disease states. The pharmacist must understand the indications for use, possible side effects and expected outcomes.19 NAPRA does, however, caution pharmacists about going too far. Pharmacists endorsements bestow professional credibility to health products, so promoting products with scant or no evidence-based data in support of their efficacy or safety raise concerns. NAPRA provides the following guidance on this situation: Product recommendations to individual patients based on the patients current health status are appropriate provided that the patient is informed about the absence of evidence-based product information, if that is the case. However, generalized product endorsements or testimonials are not appropriate.20
Messages to the Public
Messages of regulatory bodies aimed at the public also convey an expectation that pharmacists will take on new responsibilities in regard to natural health products. For example, the College of Pharmacists of British Columbia states that consumers should ask their pharmacist if their medication will be affected by vitamins or herbal supplements. They also claim that pharmacists are experts on all prescription and non-prescription medications. Other statements emphasizing pharmacists role include: Please tell your pharmacist about any non-prescription drugs you are taking. Many over-the-counter products including natural health products and herbal supplements may interact with your medication; Your pharmacist also knows a great deal about over the counter (non-prescription) drugs and natural health products; Please talk to your pharmacist when you buy natural health products or over-the-counter drugs; Many pharmacies offer several brands of natural health products.... Please ask your pharmacist to recommend which one is best for you.
The Alberta College of Pharmacists also presents their pharmacists as capable to consult on natural health products, stating they can provide advice on non-prescription drugs and natural health products and check that prescription medications will not interact adversely with natural health products. The Frequently Asked Questions section of the College website encourages patients to ask their pharmacist about natural health products: Please talk to your pharmacist. Too few patients take advantage of the pharmacist's knowledge and ask questions about non-prescription drugs and alternative therapies. Ontarios Standards of Practice recommend signage in pharmacies encouraging consumers to consult with a pharmacist about selecting non-prescription products.
The Canadian Pharmacists Association (CPhA) also sends an important message to pharmacists and the public. It states that pharmacists contribute to the health care system by providing non-prescription drugs and natural health products and help manage minor ailments by offering information to consumers on self-care and non-prescription medications.21 The CPhA tells the public that their pharmacist can help them choose non-prescription medicines or health care products and can provide information on vitamins and herbal remedies.22 The CPhA has published brochures for the public on natural health products, suggesting they inform their pharmacist of any herbal products they consume, that their pharmacist can help them choose a herbal or natural product and that their pharmacist can help you wade through all the pros and cons about the NHP youre considering to help you make the best choice for your health.23 The CPhA stresses that the public should buy their natural health products from a pharmacy rather than another source, since the pharmacy is the logical place to buy these products. Why? Because the pharmacy is where you buy medications. And herbal and natural health products are medications.24 The CphA also stresses that, given the dearth of scientific evidence surrounding natural health products, a consumer should consult their pharmacist for information on scientific evidence about the product, and whether other medications may adversely interact with the NHP the consumer is considering.24
The CPhA asserts that natural health products should be treated with the same respect shown to prescription medication and indicates pharmacists should have comprehensive knowledge, including information about the product, side effects, interactions with prescription and non-prescription medicine, impact on ongoing illnesses, and safe use during pregnancy.24 The CPhA summarizes their advice to the public in a position statement that recommends you always speak with your pharmacist before taking medications - including herbal and natural health products.25 Health Canada supports this position and advises consumers to minimize risks associated with NHP use by seeking advice from a health care professional such as a doctor, pharmacist, or complementary/alternative care provider.8 Further, in the Canadian Adverse Reaction Newsletter, Health Canada notes that health care professionals must be made aware if their patients are taking natural health products.26
National Drug Schedule Amendments
One regulatory factor that may affect pharmacists responsibilities is the status of natural health products in the National Drug Schedules (NDS). The NDS, which are accepted through most of Canada, maintain model conditions of sale of medicinal ingredients that are also captured by the Natural Health Products Regulations. The NDS categorizes drugs based on the level of pharmacist involvement required in their sale; however, in April 2006, NAPRA excluded all natural health products from the scope of the NDS because of differing requirements for acquiring market authorization for natural health products and for conventional pharmaceuticals. NAPRA also determined that the monitoring and enforcement of conditions for sale of natural health products were beyond the scope of the pharmacy regulatory authorities.27 Though changes to the NDS will likely not be made until all identified natural health products listed in the NDS have received a Natural Product Number (NPN) (or a DIN-HM for homeopathic medicines) and the supplemental framework establishing their conditions of sale has been produced by the Natural Health Products Directorate, the implications for patients, pharmacists, and other stakeholders are as yet unclear.28 NAPRA cautions that if scheduling changes are made to products currently listed on the NDS (Schedules I-III), there will be considerable confusion regarding the role of the pharmacist regarding their sale because it is technically still possible that a product regulated by Health Canada as a natural health product28 (i.e., deemed safe for self-care), may be require a prescription in a specific Canadian province due to the provincial drug schedules). Furthermore, each of the provincial governments and pharmacy regulatory bodies will have to decide whether to implement the changes made to the NDS. Despite this uncertainty over the NDS, pharmacists will maintain professional responsibilities in regard to NHP counselling as described in this paper.
Pharmacists must comply with legal and ethical obligations to avoid malpractice liability and disciplinary actions for failure to meet appropriate standards of professional conduct and patient care. Increasingly, these obligations as set out in standards of practice, codes of ethics and other instruments - include a responsibility to be knowledgeable about natural health products, counsel patients in regard to NHP selection and use, and, importantly, to protect patients from adverse interactions between natural health products and other drugs. These responsibilities are heightened as pharmacists gain expanded scopes of practice, including the power to prescribe, which reinforces obligations to seek information about patient NHP use to avoid harmful drug interactions.
Some instruments promulgated by professional bodies, such as guidance documents that recommend desirable practices but do not prescribe standards, may not go so far as to establish legally enforceable rules of conduct. These recommendations nonetheless may be used as evidence of an appropriate standard of practice in liability claims or professional discipline proceedings against pharmacists. Indeed, the registrar of the Nova Scotia College of Pharmacists has warned that pharmacists risk liability if they provide little to no patient counselling on non-prescription drug treatment.29
Natural health products are available for sale in a variety of locations outside pharmacies (e.g., health food stores, grocery stores) where patients may buy products from clerks with little or no training. Although a full discussion of the implications of allowing natural health products to be sold in such a wide range of retail settings is beyond the scope of this paper, it is important to note that pharmacists are held to standards regarding their professional responsibilities for natural health products that differ significantly from the general lack of standards for other retailers. This may have many implications. For example, consumers have little recourse if they follow ill-advised recommendations from retail clerks; however, as licensed health care practitioners, pharmacists are held to a higher standard regarding the advice they provide consumers.
Since January 1, 2004 natural health products such as herbs, vitamins and other supplements have been regulated in Canada as a subset of drugs under the Food and Drugs Act. Provinces and territories have been slow to develop policies and standards of practice documents that provide explicit guidance regarding pharmacists professional responsibilities with respect to natural health products. However, it is clear from this review that pharmacists have an obligation to be able to counsel patients about the natural health products they sell, especially about potential interactions with other drugs.
CONFLICT OF INTEREST
None declared. Funding support is acknowledged from the Advanced Foods and Materials Network (AFMNet), a Network of Centres of Excellence; the Canadian Institutes of Health Research; and the Ontario Ministry of Health and Longterm Care.
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