Exploring consumer and pharmacist views on the professional role of the pharmacist with respect to natural health products: a study of focus groups

Background Natural health products (NHPs) such as herbs, vitamins and homeopathic medicines, are currently available for sale in most Canadian pharmacies. However, most pharmacists report that they have limited knowledge about these products which have been regulated in Canada as a specific sub-category of drugs. In this paper, consumers' and practicing pharmacists' perceptions of pharmacists' professional responsibilities with respect to NHPs are examined. Methods A total of 16 focus groups were conducted with consumers (n = 50) and pharmacists (n = 47) from four different cities across Canada (Vancouver, Edmonton, Toronto, and Halifax). Results In this paper, we illustrate the ways in which pharmacists' professional responsibilities are impacted by changing consumer needs. Many consumers in the study utilized a wide range of information resources that may or may not have included pharmacists. Nevertheless, the majority of consumers and pharmacists agreed that pharmacists should be knowledgeable about NHPs and felt that pharmacists should be able to manage drug-NHPs interactions as well as identify and evaluate the variety of information available to help consumers make informed decisions. Conclusion This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.


Background
Natural health products such as herbs, vitamins and homeopathic products are a growing Canadian product category worth over $400 million annually [1] and are widely available in Canadian pharmacies. Since pharmacists are readily accessible to consumers at the point where they are making decisions about purchasing NHPs, pharmacists are potentially in a good position to provide consumers with evidence-based information about NHPs, especially regarding potential interactions with conventional medications [2]. Pharmacists have the knowledge and experience to help consumers determine when selfmedication is appropriate and when the expertise of another health care provider is needed [2]. However, it is not clear that consumers want this kind of advice. With greater access to health-related information, consumers have become more literate, better educated, and increasingly capable of making their own decisions regarding their health care [3][4][5]. The current situation is the focus of our paper: with NHPs widely available and with engaged and informed consumers demanding access to them, what is the role of pharmacists regarding NHPs? In this paper, we seek to understand how pharmacists' professional responsibilities with respect to NHPs are influenced by consumers who have access to increasing amounts of health information.

Natural health products in pharmacy practice
Self-medication with natural health products (NHPs), such as herbal medicines and other supplements, has become very popular among Canadians. Based on data from the 2005 Baseline Natural Health Products Survey conducted by Health Canada, seven in ten Canadians have used a NHP at some time in their lives. A majority agree that NHPs can be used to maintain or promote health or to treat illness (68%) [6]. Fewer agree that NHPs are better than conventional medicines (43%) [6]. NHPs are used to treat an existing health condition or in an attempt to prevent illness and often consumed in tandem with conventional medicines [7].
In Canada, NHPs have been governed by the Natural Health Products Regulations since January 2004. Under the Regulations, a NHP is defined as a product found in nature that is "manufactured, sold or represented for use in: (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; (b) restoring or correcting organic functions in humans; or (c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health" [8] (p. 1573). Products that fall within this category include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines (e.g., traditional Chinese medicines), probiotics, amino acids, and essential fatty acids.
Tobacco, marijuana and biologics (e.g., blood-based products, insulin) are excluded. By definition, to be considered a NHP, a product must be safe for sale over-thecounter (OTC) and thus be available for self-care and selfselection [8]. More importantly, NHPs are classified as "drugs" at the level of the Federal Food and Drugs Act, which would appear to make them part of the pharmacist's professional scope of practice [8].
Much of the research on NHPs and pharmacy practice to date has focused on describing pharmacists' attitudes towards, and personal use of, NHPs. A systematic review found that Canadian and U.S. pharmacists do not perceive their knowledge of NHPs to be adequate and that a majority of pharmacists would like to receive additional training on NHPs, especially in the areas of interactions, side effects/adverse events, patient counseling, therapeutic uses, and dosing [9]. This is largely the result of the limited NHP-related curriculum in many pharmacy schools until very recently [10]. In addition, survey data reviewed indicate that pharmacists do not routinely document, monitor, or inquire about patients' use of NHPs despite receiving questions about NHPs from patients and other health care providers [9]. Although these surveys provide some description of how pharmacists behave with respect to NHPs, they do not provide any insight into what pharmacists should do or what factors influence how pharmacists' professional responsibilities are determined.

The patient as consumer
The perspective of the consumer is important to consider when exploring pharmacists' responsibilities in relation to NHPs. An analysis of patients' perceived needs regarding information about NHPs brings into focus the inadequacy of the traditional paternalistic view of the 'patient' as occupying a subject position and demonstrating dependency and unquestioning compliance with medical expertise [11]. Instead, we argue that the majority of consumers interested in NHPs are best understood through the concept of the 'new consumer'. For several decades, the social science and marketing literature have described the existence and influence of "new consumers" [5,12].
New consumers are defined as being information strong, information seeking, and increasingly demanding [4,5]. Compared to 20-30 years ago, current consumers are more literate, better educated, and have more information resources at their disposal [5]. For example, the majority of Canadians are heavy Internet users (56% report being online seven or more hours per week) with researching medical information being one of their most popular Internet activities [13]. Linked to this is the established trend where expert knowledge in areas such as medicine and science is no longer simply accepted on face value. Expert knowledge is now open to skepticism and to chal-lenge on the part of lay people due to an increasing public awareness of the uncertainties that arise from applying group results from clinical trials to individual patients and increasing range of medical care options [14,15].
Much emphasis has been placed in recent literature on the impact of consumerism on the roles and status of healthcare professions in society [15][16][17][18][19][20][21]. Eysenbach and Jadad, in their discussion of consumers' increasing access to Internet based resources and the consequences for patient choice, propose a changing role for health professionals [17]. Specifically, they profile a shift from an information 'filter' role of the professional to a 'consumer as partner' model of practitioner-patient relations. In other words, the practitioner and the patient engage in a model of decision making that is more equitable in terms of power relations. Similarly, Fournier argues that the diffusion of professional knowledge to the consumer has eroded the boundary between professionals and clients/lay persons [18]. However, she concludes that the boundary is not eliminated but rather, it is shifted with professions having the capacity to redefine their boundaries as they adapt to changes. Several empirical studies that explored the impact of consumerism on the patient-provider relationship found the situation to be very complex, in that a continual tension exists between seeking dependency and wanting autonomy, which constrains the patient-provider relationship from moving too far in the direction of consumerism [15,[19][20][21]. Although previous literature has provided valuable insights into the impact of consumerism on the roles and status of healthcare professions, only a few studies have investigated how consumer behaviors might be relevant to pharmacy practice [3,5,11].
Most notably, Traulsen and Noerreslet found an increase in 'new consumers' in Danish community pharmacies [5]. The new consumers of medicines actively seek information on side effects, the efficacy and price of products; and in general no longer blindly accept the authority of the pharmacy staff. Seen in light of the theory of risk, the authors concluded that new consumers' behavior is an attempt to minimize the risk of pharmaceuticals, which they have learned about from the media and Internet sources [5]. Hibbert, Bissell, and Ward considered how the presence of new consumers has affected the professional role and status of the community pharmacist in relation to the sale of over-the-counter medicines [11]. They found that consumerism represents a significant challenge to medicine surveillance and professional work in the community pharmacy [11].
Here we investigate how consumers shape pharmacists' responsibilities with respect to NHPs. In the analysis to follow, we use data from focus groups of pharmacists and consumers to explore consumers' and pharmacists' per-ceptions of the professional responsibilities of the pharmacist with respect to NHPs. Doing so allows us to compare the views of the two groups and to illustrate the ways in which pharmacists' professional responsibilities are influenced by changing consumer patterns.

Methods
Two focus group discussions with consumers and two with practicing pharmacists were held in University meeting rooms in four different cities across Canada (Vancouver, Edmonton, Toronto, and Halifax) for a total of 16 focus groups. The research was conducted from May to November in 2006. Focus groups were chosen because they provide a forum for participants to discuss a wider range of ideas and issues than would arise in individual interviews [22]. They have also been shown to be an extremely useful tool, especially where researchers seek to access community and public views [23].
A recruitment agency was hired to recruit consumers for the focus groups using random digit dialing. Consumers with a range of age, education, and income were selected. Community pharmacies in Vancouver, Edmonton, Toronto, and Halifax were selected purposefully from the telephone book/Internet listings to recruit a mix of pharmacists practicing in a range of locations, including independent pharmacies, chain drug stores and hospital pharmacies across each city. A pharmacist-investigator contacted each pharmacy by telephone to recruit community pharmacists who met eligibility criteria. (Due to specific ethics requirement in Vancouver, each community pharmacy was faxed a study information sheet before the contact phone call.) In order to recruit both full-time and part-time pharmacists, pharmacies were contacted at different times of the day and at different days of the week.
Pharmacists were asked about their years of practice in order to obtain a group with different levels of experience. Hospital pharmacists were recruited by first e-mailing an information letter to the director of selected hospital pharmacies to request recommendations of pharmacists to contact. Each hospital pharmacist was then contacted individually by e-mail.
In total, 50 consumers and 47 pharmacists participated in the study. Please refer to Tables 1 and 2 for a summary of participants' demographics. All the focus groups were led by the same moderator whose main function was to keep the discussion on track, to encourage an open and relaxed discussion, and to probe into areas that needed clarification. The moderator was a pharmacy professor with no ties to community or hospital pharmacy. Current and potential professional (including legal and ethical) responsibilities of pharmacists with respect to NHPs were discussed in each group. See Appendix for specific questions.
The focus group discussions were recorded and transcribed verbatim. Qualitative content analysis was used to identify specific responsibilities for pharmacists with respect to NHPs. Qualitative content analysis involved analyzing the focus group transcripts by categorizing segments of the transcripts into topic areas called "themes" [24]. Each theme was then placed in a topic category based on its content. Large categories were further divided into sub-categories creating a tree-diagram. (See Figure 1 for the pharmacist coding tree.) Each transcript was coded independently by at least two members of the research team who met repeatedly to compare and discuss the coding until consensus was achieved. Computer software (NVivo 7, QSR International Pty. Ltd. © 1999-2006) was used to facilitate this process.
The identity of the participants has been kept confidential by the research team and participants of the groups were instructed not to disclose the identity of other participants and not to discuss anything that occurred during the focus group. All data related to the project has been stored in password projected files and will be destroyed after five years. This research was approved by the Health Sciences Research Ethics Board at the University of Toronto. In addition, ethical approval was provided by each of the Universities where data were collected: Dalhousie University, University of Alberta and University of British Columbia.

Results
A consistent pattern of responses emerged despite the geographical differences of the participants. Consumers and pharmacists agreed that there is a need for pharmacists to take on a consultative responsibility for NHPs, which takes into account the characteristics of the 'new consumer'. In particular, both agreed that this responsibility is especially important in terms of pharmacists' traditional responsibilities for ensuring patient safety from adverse events and drug interactions associated with NHPs. Not all consumers are information strong though, as we found some evidence for the continued existence of passive patients who rely on their pharmacists for information about NHPs.

Consumers and NHPs
Consumers in this study generally did not rely on pharmacists for information about NHPs. Many consumers displayed characteristics of the 'new consumer'. They perceived themselves as being capable of making their own decisions regarding the use of NHPs and utilized a wide range of information resources (that may or may not include pharmacists) to make those decisions.
The majority of consumers in our study believed that they were well informed prior to coming to the pharmacy. Many found information from the Internet, friends or family, newspapers, magazines, books, health food stores,

The Pharmacist as an NHP "consultant"
Despite the fact that most consumers do not rely on pharmacists for NHP-related advice, the majority of both consumers and pharmacists agreed that pharmacists need to be knowledgeable about NHPs. Our participants suggested that pharmacists could adopt a consultative role to help consumers identify and assess the range of information available, but not necessarily make the final decision for them regarding use.
Pharmacist coding tree Figure 1 Pharmacist coding tree Overall, the majority of consumers and pharmacists agreed that pharmacists should be knowledgeable about NHPs and could adopt a consultative or advisory role to help consumers identify and assess the range of information available about a particular NHP.

Ensuring patient safety
Although pharmacists recognized the need to respect consumers' expertise and knowledge regarding NHPs, they also placed a great emphasis on their responsibility as pharmacists to ensure patient safety. When asked about their first priority with respect to patient care, the majority of pharmacists clearly identified patient safety, especially with respect to potential drug-herb interactions. This was also identified as a topic that generated many patient questions: My first priority is making sure that whatever they are using is not interacting or we are watching for side effects, it is not going to affect their sugars; it is not going to cause any type of unfortunate effect... my first priority as a pharmacist is their safety. -Edmonton pharmacist Consumers also agreed that pharmacists are in the best position to manage potential drug-NHPs interactions and to ensure the safe use of NHPs because they have expertise in conventional medications: I know the pharmacy here, the pharmacists they have sitting rooms, a little room, and if they give you a prescription that you haven't had before they bring you in and sit you down and discuss it with you, and he's got, you  When dispensing prescriptions, some pharmacists are proactive and ask for information about NHP use. This allows the pharmacist to check for possible interactions so that they can intervene to protect the consumer. Pharmacists are very unlikely to actively recommend an NHP if a consumer does not first express interest in taking it: I ask the patient what kind of herbal product they are on and then I would check the drug interaction, whether they agree with the prescription medication. This I would do, but as far as recommendation, I wait for the customer to ask me, rather then recommend an herb to them. -Vancouver pharmacist However, the amount of input a pharmacist can have is ultimately determined by the patient because NHPs are available for self-selection. Thus, consumers may purchase these products without seeking the advice of a pharmacist. More importantly, NHPs are available for sale in a range of retail locations (i.e. health food stores, grocery stores). Consequently, checking for potential drug-NHP interactions is difficult or all but precluded, if the consumer does not approach the pharmacist.
The problem generally though is people shop at different places. So you know I buy this in here and this in there and I am not telling people when I am buying it; unless somebody points it out to me, I don't know that there is an interaction. -Toronto consumer I think people just grab them and go. -Edmonton pharmacist Overall, pharmacists tended to place a great emphasis on ensuring patient safety in terms of their responsibility. In contrast, most consumers emphasized the importance of making their own decisions, while acknowledging that pharmacists could play an important role in helping them to make choices that would not result in harm.

Consumers as patients
Although many of our participants fit the descriptions of the "new consumer" in the literature, some clearly wanted more of a partnership model of relationship with their pharmacists. What appears to differentiate these consumers is their view of a longer-term relationship between 'patients' and pharmacists: [Jay] said the relationship between the pharmacist and the "client" and [Jen] has said the relationship between the pharmacist and "customer"; and to me, I don't want to be a "client". I mean, I know that I am, but I don't want my pharmacist to see me as a "client" or a "customer". I want them to see me more like a "patient" as opposed to a revenue source. In the context of NHPs, the relationship between a consumer and the pharmacist matters. The degree of involvement a pharmacist has in the NHP decision-making process is ultimately controlled by the consumer. But since NHPs are sold in pharmacies, both consumers and pharmacists agreed that pharmacists have a responsibility to provide basic advice about NHPs, especially regarding their safety.

Discussion
The findings presented in this paper demonstrate that both consumers' and pharmacists' perceptions of the professional responsibilities of the pharmacist with respect to NHPs are affected by the changing behaviour of consumers. Many consumers in the focus groups perceived themselves as being capable of making their own decisions regarding the use of NHPs and utilized a wide range of information resources that may or may not include pharmacists. However, some consumers preferred to adopt a more traditional patient role, seeking a partnership with a particular pharmacist that has earned the consumer's trust.
Both consumers and pharmacists in the study suggested that pharmacists could adopt a consultative role to help consumers integrate different sources of information, but not necessarily make the decision for them about the use of NHPs. The consultative role appears similar to the interpretive or informed choice decision making model [17,25]. In this model, the professional supplies the consumer with relevant information and helps to elucidate and articulate the consumer's values, but does not participate directly in decision making [17,25]. The deliberative or shared decision making model, which researchers and pharmacy leaders advocate to be the best, describes consumers and professionals as active participants in the decision making process with two-way exchange of information and working as partners or friends [17,25,26]. The key difference between the interpretive and deliberative models is that in the interpretive model, the professional does not participate in decision making but in the deliberative model, s/he does. The propensity towards the interpretive, as opposed to the deliberative model, can be understood in the context that NHPs are primarily intended for self-medication by consumers and so it is ultimately the consumers' decision whether or not they choose to use them. One could also argue that in reality, it is the consumer that makes the final decision regarding use of all treatments (including over-the counter products and prescription drug therapy). The data we describe suggest that this is explicitly acknowledged when consumers and pharmacists are discussing NHP use.
Pharmacists in the study tended to place an emphasis on ensuring patient safety, especially with respect to potential drug-NHP interactions, as their first priority in patient care. Most said they would wait for the consumer to take the initiative to ask them for a recommendation about NHPs. Since pharmacists have traditionally taken on the role of gatekeepers in protecting the public from dangerous medicines [27], the 'safety role' can be conceptualized as an extension of this traditional role. In the original paternalistic description of patient-professional interactions, the professional ensures that patients receive the interventions that best promote their health and wellbeing and adopts the role of main supplier of knowledge [17,25]. What is different in our case is that although most pharmacists were concerned with making sure the products are safe for consumers, they do not perceive themselves to be the main purveyors of information on NHPs. In this context, it is important that pharmacists ask consumers about their NHP use when dispensing prescription medicine so pharmacists can check for interactions.
The 'new consumer' is not a ubiquitous actor, but rather one that emerges more strongly in some contexts than others. For example, the consultative role of pharmacists reflects the impact of the new consumer but where safety considerations emerge, a more traditional paternalistic role of the pharmacist was supported by both consumers and pharmacists in the focus groups. This highlights the tension between seeking dependency and wanting autonomy that exists in the "new consumer" literature [15,20,21]. Even the most information-strong consumer may not have access to detailed information about specific NHP-drug interactions. A minimum responsibility for pharmacists appears to be providing information about NHPs that may interact with prescription drugs. In addition, the consultative role of the pharmacist may come into play as consumers try to sort through large volumes of often conflicting information (and sometimes mis-information) available from a multitude of sources including the Internet.
Like all studies, this one has its limitations. Focus group data is not designed to be generalizable. However, the fact that the themes described in this study were consistent across four geographically disparate Canadian cities suggests that the findings may be applicable to urban areas. It is not clear if Canadians in rural areas, French-speaking Canadians or populations from other countries would express similar opinions.

Conclusion
In conclusion, when studying the development of professional roles in health care, it is important to consider the consumer perspective and the impact of consumerism on the requirement for health services. Our analysis of consumer and pharmacist focus groups suggests that consumers contribute to shaping the pharmacists' role by using the pharmacist as a consultant and looking to the pharmacist for help with the management of drug-NHPs interactions.

List of abbreviations
CAM: complementary and alternative medicine; NHP: natural health product; OTC: over-the-counter.
In Closing Do you have any advice to give to the profession of pharmacy in regards to what their professional responsibilities for NHPs should be?