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Although many pharmacies sell natural health products (NHPs), there is no clear definition as to the roles and responsibilities (if any) of pharmacists with respect to these products.
The purpose of this study was to explore pharmacy and stakeholder leaders’ perceptions of pharmacists’ professional NHP roles and responsibilities.
Semi-structured key informant interviews were conducted with pharmacy leaders (n= 17) and stakeholder (n=18) leaders representing consumers, complementary and alternative medicine practitioners, conventional healthcare practitioners, and industry across Canada.
Overwhelmingly all participants believed a main NHP responsibility for pharmacists was safety monitoring. One challenge identified in the interviews was pharmacists’ general lack of NHP knowledge. Stakeholder leaders did not expect pharmacists to be experts on NHPs, rather that pharmacists should have a basic level of knowledge about NHPs. Many pharmacy leaders appeared to be unfamiliar with current pharmacy policies and guidelines concerning NHPs.
Participants described pharmacists’ professional roles and responsibilities for NHPs as similar to those for over-the-counter drugs. More awareness of existing NHP-related pharmacy policies is needed. Pharmacy owners/managers should provide additional training to ensure front-line pharmacists have appropriate knowledge of NHPs sold in the pharmacy.
Over the past decade use of natural health products (NHPs) has dramatically increased in North America.1–3 Although NHPs can be purchased from a variety of sources such as health food stores and grocery stores, Canadians often purchase NHPs in pharmacies.1, 2 There is evidence to suggest that Canadian consumers are more likely to approach a pharmacist when seeking information about NHPs for the first time than any other health care professional (HCP).4 Due to widespread consumer use of NHPs, the availability of NHPs for self-selection in various retail locations, the claimed expertise of complementary and alternative medicine (CAM) practitioners with respect to NHPs and the possible influence of other conventional health care providers on NHP consumption, it is clear that non-pharmacist stakeholder input will be instrumental in determining the pharmacists’ roles and responsibilities (if any) with respect to NHPs. The objective of this study was to explore pharmacy leaders’ and stakeholder leaders’ perceptions of the professional roles and responsibilities of pharmacists in regards to NHPs. Stakeholder groups in this study included consumers groups, CAM practitioner associations, conventional HCP associations, and NHP industry groups.
In Canada, the federal government sets the legal framework for the regulation of NHPs, but it is the responsibility of the various provinces/territories to define the scope of practice responsibilities of pharmacists towards these products. According to the Canadian NHP Regulations, “NHPs are defined as: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicine, probiotics, amino acids and essential fatty acids”5 that are used for medicinal purposes and are safe for self-care.
Although their professional responsibilities vary among jurisdictions, all pharmacists have the responsibility to dispense prescription medications to consumers. However, pharmacy policy documents are not always clear with respect to NHPs. Among the pharmacy licensing authorities across Canada: six regions have policy wording that only refer to “drugs” in general; two regions’ policies refer to drugs and over-the-counter products (OTCs); and four regions have policies that refer to drugs, OTCs, and NHPs.6 According to the federal Food and Drugs Act, NHPs are technically considered a sub-class of drugs, and NHP regulations clearly state NHPs must be available without a prescription for self-care; thus, implying policy documents referring to drugs or OTCs should also apply to NHPs. However, the inconsistent use of terminology and lack of clear definitions in pharmacy policy documents has created a gap in defining practice responsibilities with respect to NHPs at the provincial/territorial level. Previous studies indicate pharmacists do not perceive NHPs to be the same as conventional medications and they are generally less knowledgeable about NHPs in comparison to conventional medications.7–11 Since NHPs are commonly sold in pharmacies, it is clear the pharmacist’s roles and responsibilities need to be more defined for these products. Our previous studies have investigated practicing pharmacists’ and lay consumers’ expectations of pharmacists.12 The purpose of this study was to explore the opinions of other stakeholder groups to assist in determining what is expected (or not) of pharmacists with regards to NHPs.
Semi-structured key informant interviews were conducted with pharmacy and stakeholder leaders selected using criterion-based purposive sampling.13, 14 A list was compiled of pharmacy leaders (defined as someone who is a president, dean, head, chair or director) from all known registered pharmacy schools, provincial pharmacy colleges, provincial and national pharmacy organizations; and major drug store chains in Canada. Similarly, a list of stakeholder leaders from Canadian consumer advocacy groups, CAM practitioner associations, conventional HCP organizations, and NHP industry groups was identified based on internet searches. Although not exhaustive, the list contained far more potential participants then was needed for the study. The only exclusion criterion identified was that consumer stakeholder leaders could not be licensed healthcare providers (e.g., physician, nurse, pharmacist, chiropractor, naturopathic practitioner) to obtain a true consumer “layman” perspective. Participants were chosen to ensure a range of different types of groups and geography (to ensure a range across Canada). A variety of national and provincial representatives was chosen when possible. At the conclusion of each interview, participants were asked if they could recommend other individuals (in their organizations or others) who may be able to provide additional insight into the professional roles and responsibilities of pharmacists with respect to NHPs (“snowball sampling”). This allowed for the identification of additional key informants and was a way to ensure that no one with important or unique knowledge in the area of study was omitted from participation inadvertently.
All interviews were conducted in English, audio-recorded and transcribed verbatim. All except 6 interviews were conducted in person. Interviews continued until saturation was reached for the key emergent themes.13 This protocol received ethics approval from the University of Toronto Health Sciences Research Ethics Board.
Content analysis was used to identify specific professional roles and responsibilities for pharmacists with respect to NHPs.15, 16 Initial categories were broad and focused on a range of relevant key issues identified for pharmacists with respect to NHPs. These were not identified a priori, but rather emerged from the data collected. Three team members participated in establishing preliminary coding categories, and later coded all transcripts individually and met regularly to come to consensus on any areas of disagreement. Analysis was performed throughout the data collection period to allow for adjustment to the interview guide and to address new issues or topics that emerged from early interviews. NVIVO computer software was used to facilitate the coordination of data for coding.17
A total of 35 key informant interviews were completed with individuals representing a variety of national and provincial groups across Canada (see Table 1). There was overwhelming support from all the pharmacy and stakeholder leaders that pharmacists have a role to play with respect to NHPs. See illustrative quotations in Table 2. One of the reasons many stakeholder leaders gave for supporting a NHP-related role for pharmacists was that high quality, objective information about the safety and efficacy of NHPs was not always easily accessible to consumers. Consumer group leaders mentioned their members often do not know where to find answers to their questions about NHPs. Industry leaders thought pharmacies would be a credible place for consumers to learn about NHP products and how to use them appropriately. Despite the widespread agreement that there was a role for pharmacists to play with respect to NHPs, there was less agreement on the scope of that role.
All participants agreed that pharmacists had a vital responsibility in the area of safety monitoring of adverse events, drug-NHP interactions, and contraindications for consumers; however, expectations about pharmacists’ knowledge of other aspects of NHPs were more mixed (see Table 2). Although all participants indicated pharmacists should have some NHP knowledge, the level of knowledge was not clearly defined. Some participants expressed the opinion that pharmacists should be able to counsel consumers about NHPs in a manner similar to what they currently do for all other OTC medications. This implies an expectation that pharmacists are knowledgeable about the range of NHPs available (at minimum in their stores). Others advocated pharmacists only needed, and realistically could only be expected to have, a more basic knowledge of NHPs. Exactly what this “basic” knowledge was or how it would be defined, was not clearly articulated. However, many participants indicated they expected pharmacists should know when and how to refer patients to other experts who could answer their questions about NHPs. For example, CAM leaders expected pharmacists to refer to CAM providers when consumers needed more in-depth counselling.
Despite the strong agreement that pharmacists had professional responsibilities related to NHPs, a number of challenges associated with meeting those responsibilities were identified. Many stakeholders identified a lack of available information about the safety and effectiveness of NHPs in general as being the main concern (see Table 2). Some thought that it was not a lack of evidence that limited pharmacists’ ability to counsel patients about NHPs, but rather that pharmacists did not know about the evidence that does exist. There was general agreement across all participants that pharmacists should receive more education about NHPs in order to adequately assist the consumer in making decisions. All pharmacy and stakeholder leaders indicated if pharmacists chose to sell NHPs then they had an ethical responsibility to be able to counsel consumers on all the NHPs carried in the pharmacy (see Table 2).
Like all studies, this one has some limitations. A relatively small number of pharmacy and stakeholder leaders were interviewed. However, by including participants from both national and provincial organizations, conducting interviews until saturation was reached in the participants’ responses, as well as analyzing the data and modifying the interview guide as new concepts arose, it is unlikely more interviews would have generated different results. It would have been ideal to interview a participant from each province or territory. However, it is unlikely this significantly influenced the results because nearly half of the participants were national representatives and their responses did not differ substantially from the provincial participants.
There was strong agreement by nearly all the pharmacy and stakeholder leaders that pharmacists have a responsibility to monitor NHPs for safety, for example identifying and preventing adverse events and drug interactions. All the leaders expected pharmacists to have a basic level of knowledge of NHPs sold in their stores (although the concept of “basic” knowledge was not clearly defined by anyone), and the ability to locate additional information if necessary. Many pharmacy and stakeholder leaders noted pharmacists should be able to counsel about NHPs in the same manner as they currently do for all other OTCs. The literature indicates there is strong support for these responsibilities among practising pharmacists.7, 8, 18, 19 This agreement is important because it suggests that it will be easier to implement pharmacy NHP-related standards of practice and educational standards if these are aligned with both stakeholder and pharmacist expectations.
Most stakeholders noted there were limits to pharmacists’ knowledge of these products; however, there was little agreement on who were the experts to whom pharmacists could refer patients. Similarly, a review of the literature does not provide a clear answer as to who is considered to be an “expert” on NHPs. Biomedical literature tends to identify physicians and occasionally pharmacists as the “experts” to help patients make decisions about NHP therapy options based on scientific information.20 At the same time, the literature also points out that physicians, not unlike pharmacists, rarely can credibly claim “expertise” in this area due to their general lack of knowledge of NHPs, or exposure to only brief NHP-training sessions.21 In a recent Canadian survey, consumers ranked pharmacists a close second behind physicians when asked who they completely trust for NHP information.1 Since pharmacists are well trained in regards to prescription and OTC medication, it has been argued that pharmacists are well placed to effectively monitor drug-NHP interactions.11, 22–25 In contrast, CAM practitioners are typically identified as “experts” in the CAM literature.26–28 Studies on HCPs’ attitudes, knowledge, and practices towards NHPs generally contain caveats that physicians and pharmacists may not have enough knowledge to answer patient questions about NHPs; however, the literature does not generally identify any other expert options.7, 8, 10, 23, 29
Our results highlight a professional and ethical dilemma faced by pharmacists when they work in a store that offers NHPs for sale and they do not have enough knowledge to answer questions about them. Thus they are generating revenue from (and some might argue meeting consumer demand for) products they cannot ensure are safe and effective for their patients. With many NHPs lacking sufficient evidence to support safety and effectiveness, pharmacists are having to “balance their obligations to make a living, with their professional duties as providers of advice and support to optimise the use of medicines”.30 For some NHPs there is little information available in terms of research for pharmacists to be able to look up or even counsel on these products. Since NHPs are available for self-medication it is more important than ever for pharmacists to be informed about these products in order to counsel consumers. The findings of our study stress the need for minimum NHP education standards if pharmacists hope to take on roles such as NHP information providers and safety monitors for NHPs as part of providing pharmaceutical care.
There is agreement among a wide range of participants that NHPs are part of the pharmacists’ scope of practice. Generally all the leaders reported the main roles of the pharmacist were as “information provider” and “safety monitor” for consumers and the health care team, and refer to other experts if necessary. In order to assume professional responsibilities towards NHPs, minimum NHP education standards and examination content need to be established such that pharmacists have a baseline level of knowledge for these products. Pharmacy owners/managers must be more accountable in ensuring front-line pharmacists have appropriate knowledge of NHPs sold in the pharmacy by providing training to their employees.
Thanks to all the individuals who generously donated their time to participate in this study. The study was funded by the Canadian Institutes of Health Research (CIHR grant #PHE – 78700) and the Advanced Foods and Materials Network (AFMNet). H. Boon is funded by a CIHR New Investigator salary award and K. Hirschkorn is funded by a CIHR Post-doctoral salary award.
Shade Olatunde, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Heather Boon, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Kristine Hirschkorn, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Sandy Welsh, Department of Sociology, Faculty of Arts and Sciences, University of Toronto, Toronto, Ontario, Canada.
Jana Bajcar, Leslie Dan Faculty of Pharmacy and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.