Int J Clin Pharm (2012) 34:6371 DOI 10.

1007/s11096-011-9586-y

RESEARCH ARTICLE

Pharmacists attitudes towards an evidence-based approach for over-the-counter medication

Lezley-Anne Hanna Carmel M. Hughes

Received: 15 July 2011 / Accepted: 7 November 2011 / Published online: 23 November 2011 Springer Science+Business Media B.V. 2011

Abstract Background With increasing deregulation of prescription-only medicines and drive for self-care, pharmacists have greater scope to manage more conditions. This brings added responsibility to be competent healthcare professionals who deliver high quality evidence-based patient care. Objective This study sought to establish pharmacists attitudes towards an evidence based approach for over-the-counter medication. Setting Pharmacists working in community pharmacies across Northern Ireland. Method Following ethical approval, a pre-piloted, self-completed questionnaire was distributed to all community pharmacies in Northern Ireland (n = 529) in September 2008. The development of the questionnaire was largely informed by the ndings of a previous qualitative study. It consisted of six sections (mainly closed questions) covering factors that inuence decisions regarding over-thecounter medication, recently deregulated prescription-only medicines, medications that lack evidence of effectiveness, knowledge of evidence-based practice, evidence-based practice with over-the-counter medication and demographic information. On receipt of questionnaires, responses to the closed questions were imported into SPSS (version 17.0) for analysis which largely took the form of descriptive statistics. Chi-square and the MannWhitney U test were used for association between responses and demographic information with an a priori level of less than 0.05 (P \ 0.05) set as signicant. Main outcome measure Pharmacists attitudes and opinions in relation to decision making about over-the-counter medication and evidence of effectiveness were measured. Results A 39.5% (209/529) response rate was achieved. Most pharmacists [191/208
L.-A. Hanna (&) C. M. Hughes School of Pharmacy, Queens University, Belfast, UK e-mail: l.hanna@qub.ac.uk

(91.8%)] strongly agreed or agreed that safety was the over-riding concern when dealing with over-the-counter medication. While 88.3% (181/205) strongly agreed or agreed that they were familiar with the concept of evidence-based practice, only 38.0% (78/205) strongly agreed or agreed they knew how to critically appraise research papers. Furthermore, less than a quarter [49/205 (23.9%)] appeared to be familiar with the work of the Cochrane Collaboration. Most [188/207 (90.8%)] strongly agreed or agreed that regardless of evidence of effectiveness, cough medicines were an important management option. Conclusion Safety was the primary concern when making decisions about over-the counter medicines. Pharmacists lacked knowledge of evidence-based practice and considered medicines which lacked evidence of effectiveness to have an important role in self-care. These factors present barriers to the widespread implementation of evidence-based practice. Keywords Effectiveness Evidence based practice Non-prescription medication Northern Ireland Over-the-counter medication Pharmacy

Impact of ndings on practice Learning needs exist for community pharmacists in Northern Ireland in relation to evidence-based practice and complementary medicines. Systematic reviews (for example, Cochrane Reviews) and evidence-based guidelines should be utilised in decision-making about over-the-counter medicines. While individual pharmacists must take responsibility for adhering to ethical guidance, further support is required from professional and educational bodies in

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Northern Ireland to ensure an evidence-based approach is routinely implemented when pharmacists are making decisions about over-the-counter medicines.

Introduction The drive to promote self-care [14] has implications for various health care professions, including community pharmacy. In the United Kingdom (UK), as the over-thecounter (OTC) market continues to expand with more prescription only medicines (POMs) being deregulated for both acute and long-term conditions [1, 2] pharmacists have, on the one hand, greater scope to manage more conditions but on the other, added responsibility to demonstrate they are competent healthcare professionals who deliver high quality evidence-based patient care. Evidencebased practice involves systematically reviewing, appraising and applying clinical research ndings to aid the delivery of optimum clinical care to patients [5]. Additional factors such as clinical expertise, cost and patients values are also important in the decision-making process [6]. Ethical guidance outlines that the care, well-being and safety of patients should be at the centre of everyday professional practice and of prime concern and pharmacists are advised to keep knowledge and skills up to date, evidence-based, [7].Therefore, it is imperative that pharmacists can recognise symptoms of various conditions and provide advice to patients on appropriate management strategies. As there is limited literature on what pharmacists consider when making decisions about OTC medicines, an initial qualitative study was conducted [8]. The key ndings suggested that safety was the overarching factor when making decisions, whilst evidence of effectiveness was of secondary importance. Overall, an evidence-based approach was not implemented by the pharmacists. Aim of the study This current study sought to establish views on evidence of effectiveness; a secondary aim was to enhance the ndings of previous qualitative research [8] as quantitative research can enhance the validity and expand the breadth and scope of research [9].

Method Ethical approval for the study was obtained from the School of Pharmacy Ethical Committee. The context of the

study was pharmacists working in community pharmacies across Northern Ireland. Self-completed postal questionnaires were distributed to each registered community pharmacy; n = 529 [10, 11]. The questionnaire was piloted with 16 pharmacists (all with community pharmacy experience) within Queens University, Belfast (QUB) and minor amendments made prior to distribution. The content of the questionnaire was largely informed by the ndings of previous qualitative study [8]. Previous questionnaire studies investigating attitudes and knowledge of evidencebased practice with primary care professionals [1215] were also used. The questionnaire was internally reviewed for content validity by an expert in the eld and assessed for face validity by colleagues in QUB who were not part of the pilot or actual study. A copy of the questionnaire is available from the authors. The questionnaire began with straight forward statements relating to decision making, through to more challenging ones relating to evidencebased medicine [16]. Demographic information was collected last [17]. A cover letter (signed personally by the authors) was included providing an explanation of evidence-based practice. Pharmacists were reassured that responses were anonymous. The questionnaire consisted of 6 sections covering the following areas: factors that inuence decisions regarding OTC medication (Section A); recent deregulation (Section B); OTC medication that lacks evidence of effectiveness (Section C); evidence-based practice (Section D); evidence-based practice with OTC medication (Section E) and demographic information (Section F). All questions in Sections A to E were closed with one exception in Section B which was an open response. Attitudinal statements were measured using a ve-point Likert scale (strongly agree to strongly disagree). Each envelope was addressed to The Pharmacist (as no individual contact details were known) and included a prepaid envelope for returning the questionnaire [18]. The rst mailing occurred in September 2008 with a second 3 weeks later to enhance the response rate [18]. On receipt of questionnaires, responses were coded (assigned numerical values), except for the open responses, and entered into Microsoft Excel. The closed question responses were imported into SPSS (version 17.0) for analysis. Analyses largely took the form of descriptive statistics i.e. number, frequency or percentage as appropriate. Chi-square and the MannWhitney U test were used for association between responses and demographic information with an a priori level of less than 0.05 (P \ 0.05) set as signicant. Analyses were pre-specied and were largely driven by previous ndings in the literature [19 23]. The open response question was analysed using thematic analysis; responses were independently analysed by the authors.

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Results From the initial mailing (n = 529 pharmacies), 162 completed questionnaires were returned, yielding a response rate of 30.6%. Following the second mailing (n = 529 pharmacies), 47 additional questionnaires were returned. Assuming the questionnaire was completed once only, by one pharmacist associated with each pharmacy, this equated to a maximum response rate of 209/529 = 39.5%. Table 1 presents demographic information of pharmacists in the study in comparison to the community pharmacist population of Northern Ireland [Pharmaceutical Society of Northern Ireland (PSNI) Registrar Kerr, personal communication]. There were more female respondents than males in the study which was very similar to the distribution on the PSNI register. While the proportion of

employer pharmacists in the study was almost the same as the register, there was an over-representation of employees and an under-representation of locums in the study compared with the population (v2 = 32.320, df = 2, P \ 0.05). Most employee respondents worked for large multiple pharmacies; experience in community pharmacy ranged from \1 year to [20 years. Section A: decision-making about OTC medication The majority [191/208 (91.8%)] strongly agreed or agreed that safety was the over-riding concern when dealing with OTC medication. Male pharmacists were signicantly more likely to strongly agree or agree that they did not recommend OTC products that lacked evidence of effectiveness, compared with females [75.9% (60/

Table 1 Demographic information of pharmacists in this study compared to community pharmacists on the PSNI registera

Characteristics Genderb Male Female Missing response(s) Community pharmacy experience \1 year C1 to \5 years C5 to \10 years C10 to \15 years C15 to \20 years C20 years Missing response(s) Employment statusb Employer Employee Self-employed locum Missing response(s) Type of pharmacy worked in Small multiple (\5 pharmacies) Intermediate multiple (520 pharmacies) Large multiple ([20 pharmacies) Independent Various Missing response(s) Postgraduate qualications No postgraduate qualications Diploma/certicate MSc/PhD (in formulation area) Supplementary prescriber Supplementary and Independent prescriber Missing response(s)

Study: n (%)

PSNI: n (%)

79 (37.8%) 129 (61.7%) 1 (0.5%) 11 (5.3%) 63 (30.1%) 46 (22.0%) 29 (13.9%) 20 (9.6%) 35 (16.7%) 5 (2.4%) 38 (18.2%) 163 (78.0%) 6 (2.9%) 2 (1.0%) 47 (22.5%) 20 (9.6%) 82 (39.2%) 55 (26.3%) 3 (1.5%) 2 (1.0%) 192 (91.7%) 10 (4.8%) 3 (1.4%) 1 (0.5%) 2 (1.0%) 1 (0.5%)

567 (40.1%) 846 (60.0%) a a a a a a a 220 (15.6%) 937 (66.3%) 256 (18.1%) a a a a a a a a a 10 (0.7%) 12 (0.8%) a

Data reects the community pharmacist demographic prole in 20092010 Chi-square tests were run comparing the study sample and the PSNI register for these parameters. A signicant difference was found between the two groups in the employment status parameter (v2 = 32.320, df = 2, P \ 0.05) a = unknown
b

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79) of males in comparison to 60.2% (77/128) of females; z = 2.748, P \ 0.05]. Almost three-quarters of respondents [150/208 (72.1%)] strongly agreed or agreed that the placebo effect played an important role with OTC medication and 86.5% (180/208) strongly agreed or agreed that it was important to portray OTC products in a positive way, focussing on potential benets. Most respondents [169/207 (81.6%)] strongly agreed or agreed that their role with OTC medication was to allow the patient to make an informed choice. Pharmacists were also asked to rank ve factors (patient choice, effectiveness of product, cost of product, popularity of product and safety) in order of importance, giving 1 for the most important through to 5 for the least important. Safety was ranked as the most important factor (i.e. ranked 1) by the majority of respondents [67.6% (138/204)], followed by effectiveness of product [36.8% (75/204)], then patient choice and cost of product and nally popularity of product. Employers were signicantly more likely to rank cost a 1 or 20 compared to employee pharmacists [8.1% (3/37) of employers in comparison to 1.9% (3/159) of employees; z = 1.976, P \ 0.05]. The nal part related to determining effectiveness and pharmacists were given 11 options and asked to select all that applied. The options and responses are illustrated in Fig. 1; there were 2 responses missing (n = 207).

Section B: recently deregulated medicines (from POM status) Pharmacists were asked to consider various medicines and rate how often they recommended each. A 1 was used if they never recommended the medication through to 5 if they recommended it most of the time in daily practice (see Fig. 2). Pharmacists were asked to consider the products they would never recommend and explain why. Their reasons centred on cost considerations (for all products) safety concerns (naproxen, omeprazole, simvastatin and sumatriptan) and effectiveness (of amorolne, omeprazole and simvastatin). There was 1 response missing for the statements about amorolne and simvastatin; 3 missing for omeprazole and naproxen; 4 missing for penciclovir. Sections C (i) complementary medicines (for example, homeopathy, herbal, aromatherapy and Bach Flower remedies) and C (ii) cough medicines Pharmacists with postgraduate qualications were signicantly more likely to strongly agree or agree that they felt condent advising people on complementary medicine compared to those with no postgraduate qualications [62.5% (10/16) of respondents with postgraduate qualications in comparison to 30.5% (58/190) of those with no

Fig. 1 Methods by which community pharmacists determined product effectiveness

From the opti ions given, please tick the box(es) that apply. I determine that a produ uct works (is effec ctive) from:

100

80

Percentage of respondents

60

40

20

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Int J Clin Pharm (2012) 34:6371 Fig. 2 Community pharmacists views on recently deregulated products rated in relation to how often they are recommended in daily practice

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1. O Over the past few years many products have been deregulated from m prescription only y to pharmacy st tatus. sider the following treatment options and rate how oft ten you recommen nd them in your daily practice. Use 1 for Cons oduct you never re ct you recommend d most of the time. a pro ecommend, through to 5 for a produc

80

Percentage of respondents

60

40

20
1 (Never recommend) 3 5 (Recommend most of the time)

postgraduate qualications; z = 2.181, P \ 0.05]. Overall, 33.8% (70/207) strongly agreed or agreed that they were adequately trained to provide advice on complementary medicines. Only 9.2% (19/207) of respondents strongly agreed or agreed that complementary medicines should not be available through community pharmacies. With OTC cough medicines, employers were signicantly more likely to disagree or strongly disagree that cough medicines were an unnecessary expense for patients in comparison to employee pharmacists [83.8%
Fig. 3 A comparison of responses in relation to questions on complementary and cough medication

(31/37) of employers compared to 59.3% (96/162) of employees; z = 2.452, P \ 0.05]. Figure 3 illustrates the comparison of responses to various statements. Section D: knowledge of evidence-based practice Most [181/205 (88.3%)] strongly agreed or agreed that they were familiar with the concept of evidence-based practice; there was a greater level of agreement from pharmacists with postgraduate qualications compared to

i. I am awar re that the evidenc ce of effectiveness for the medication n is weak. ii. Regardless of evidence, the e medication still has a role to play in n self-care. iii. The popu cation is largely due to the placebo e effect. ularity of the medic iv. Pharmaci inf formation to allow patients to make an informed choic ce. ists must provide evidence-based e v. It is an et cation that lacks ev vidence of effectiveness. thical dilemma to provide the medic

Percentage of respondenets 'strongly agreeing' or 'agreeing'

Complementary medicines 100

Cough medicines

80

60

40

20

0 i ii iii iv v

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those with none (z = 3.150, P \ 0.05). However, only 37.1% (76/205) of respondents strongly agreed or agreed that they knew how to perform a comprehensive literature review and 38.0% (78/205) strongly agreed or agreed that they knew how to critically appraise research papers. Less than one quarter of pharmacists [49/205 (23.9%)] strongly agreed or agreed that they were familiar with the work of the Cochrane Collaboration. Only a minority [30/204 (14.7%)] strongly agreed or agreed that they performed literature reviews as a routine part of practice. Even fewer [16/205 (7.8%)] strongly agreed or agreed that they critically appraised research papers as a routine part of practice. While 84.4% (173/205) of the respondents strongly agreed or agreed that evidencebased practice improved the quality of patient care, 62.9% (129/205) strongly agreed or agreed that evidence-based practice was more difcult for community pharmacists to implement than other healthcare professionals. Section E: evidence-based practice with OTC medication A minority [39/206 (18.9%)] strongly agreed or agreed that there was adequate evidence-based information available relating to OTC medication. Additionally, most [175/206 (85.0%)] strongly agreed or agreed that it would be helpful to have evidence-based OTC guidelines. Over three-quarters [158/205 (77.1%)] strongly agreed or agreed that one reason why evidence-based practice was difcult to implement with OTC medication was due to product advertising. Most [172/206 (83.5%)] strongly agreed or agreed that evidence-based practice was easier to implement when responding to symptoms rather than when dealing with specic product requests. Pharmacists with postgraduate qualications were signicantly more likely to strongly disagree or disagree that patient choice was more important than evidence of effectiveness when dealing with product requests compared with respondents who had no postgraduate qualications [75.0% (12/16) of pharmacists with postgraduate qualications in comparison to 39.2% (74/189) of those with no postgraduate qualications; z = 2.786, P \ 0.05].

Discussion Safety was considered to be the most important factor for community pharmacists when making decisions about OTC medications; product effectiveness was deemed to be less important. The questionnaire study highlighted many views in relation to evidence of effectiveness and exposed potential barriers to the implementation of an evidencebased approach in practice.

When respondents were asked how they determined product effectiveness, feedback (from patients and other colleagues) and personal use were more frequently reported than clinical trial data which echoes the ndings of other studies [24, 25] and adds credence to the ndings of the previous qualitative study [8]. This further suggests that an evidence-based approach is not utilized. Interestingly, a greater proportion of the pharmacists with no postgraduate qualications thought that patient choice was more important than evidence of effectiveness. However, as only sixteen respondents reported having postgraduate qualications, further research is required before meaningful conclusions can be drawn. Additionally, product cost was shown to have a significantly greater inuence on employer pharmacists than their employee counterparts. The greater weight of economic factors (for example, prot) on employers OTC product selection in comparison to other pharmacists was reported in an earlier postal questionnaire study with pharmacists in Great Britain [20] but was not apparent with the previous qualitative research [8]. However, for the purposes of comparisons, it should also be noted that pharmacist respondents in our questionnaire study were not asked questions that directly related to prot with OTC medicines. The majority of pharmacists did not recommend many of the recently deregulated products (particularly simvastatin) routinely in practice. Their reasons (cost, lack of evidence of effectiveness and safety concerns) have been discussed by other community pharmacists in Great Britain in relation to OTC simvastatin and omeprazole [26, 27] and by the participants in the previous qualitative study [8]. However, pharmacists were more enthusiastic about OTC chloramphenicol, which may add weight to the concerns proposed by the medical profession surrounding its deregulation [28]. Despite evidence that topical chloramphenicol should be reserved for use when symptoms do not resolve [29], it appeared that these community pharmacists were routinely recommending it. As reported previously by doctors [12, 14], the majority of pharmacists considered that evidence-based practice improved the quality of patient care. However, while almost 90% of the respondents appeared familiar with the concept of evidence-based practice, under 40% strongly agreed or agreed that they knew how to perform a literature review or critically appraise papers. Other studies found that doctors only had a partial understanding of technical terminology used in evidence-based medicine [12, 30, 31] whilst nurses reported research papers to be too statistical and complex [32]. For respondents who knew how to perform critical literature reviews or critically appraise the literature, these skills were not being utilised in practice. This reects the ndings of other research [33]:

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acquiring a knowledge of evidence-based medicine does not always result in a change of behaviour in practice. However, difculty obtaining papers relating to OTC medication (as reported by many respondents) may partially explain why literature reviews and critical appraisals were limited. Over 83% of respondents reported that evidence-based practice was easier to implement when responding to symptoms rather than when dealing with product requests. Indeed, when a patient asks for a specic product, they may have previously found it to be effective. Therefore, it may be perceived as irrelevant to be informed that it lacks evidence of effectiveness. Furthermore, over 60% of pharmacists strongly agreed or agreed that evidencebased practice was more difcult for community pharmacists than other healthcare professionals. Various reasons could explain this. Firstly, many OTC products lack evidence of effectiveness [3436]. Advertising creates awareness and high expectations of particular products. In a recent qualitative study in Australia, many of the pharmacists perceived that direct-to-consumer advertising of non-prescription medicines inuenced consumers to oppose professional advice which led to a sense of disempowerment [37]. Moreover, the community pharmacy is different from a doctors surgery in terms of allocated time with individual patients and access to medical records. Possibly the biggest barrier to an evidence-based approach with OTC medicines was that most pharmacists considered that medicines lacking in evidence of effectiveness had a role to play in self-care. This was also reported in the qualitative study [8]. Having less ethical concerns with cough medicine and thinking that they have a greater role to play in self-care than complementary medicines may be because they are widely used and probably prescribed by doctors on more occasions than complementary medicines; pharmacists are not the only healthcare professional to endorse their use. Additionally, many respondents thought that complementary medicines should be available through community pharmacies. Similarly, the UK Department of Health recently defended its views on homeopathy by saying that patients should be able to make informed choices about their treatments, and doctors should be able to prescribe whatever treatment they deem to be most appropriate [38]. Indeed, while many respondents in this study agreed that their role was to enable the patient to make an informed choice, the quality of the information provided remains questionable. Pharmacists deemed it important to portray OTC products in a positive way and thought the placebo effect was benecial. Additionally, as two-thirds reported a lack of condence advising on complementary products, there appear to be learning needs in relation to complementary medicines which has been reported elsewhere [39]. Finally, it should

be noted that within the last year, the PSNI has provided guidance for pharmacists in relation to homeopathy. They state that opinion on the evidence base for the efcacy of homeopathic products remains divided and advise pharmacists to inform patients purchasing homeopathic products that this is the case [40]. More males strongly agreed or agreed that they did not recommend OTC products that lack evidence of effectiveness compared with female pharmacists. Similarly, Kurtz et al. [22] reported that female doctors were more likely to talk to their patients about complementary medicines. Conversely, the ndings may be related to assertiveness or not criticising the patients choice. Hall and Roter [41] concluded that patients were more assertive towards female doctors and tended to interrupt them more. Other research found that male doctors were more assertive when communicating with patients [42] and female doctors were more likely to avoid being critical of a patient [43]. Less than one quarter of pharmacists strongly agreed or agreed that they were familiar with the work of the Cochrane Collaboration which mirrored previous ndings [15]. Given time pressures in a community pharmacy, promoting the use of these reviews and other evidencebased summaries to inform decision-making with OTC medicines may be more appropriate than trying to teach all pharmacists how to conduct literature searches or critically appraise papers. However, complications arise when systematic reviews conclude that there is a lack of evidence. In those situations, it would be helpful if best practice guidelines were available. The ndings need to be contextualised against the low response rate achieved when considering generalisability. Additionally, as the study was only conducted with pharmacists in Northern Ireland, this further limits the generalisability of the ndings. Questionnaires were addressed to The Pharmacist and as there was an under-representation of locum pharmacists in the sample, it is possible that they left the questionnaire aside for the regular pharmacist to complete. The low response rate obtained raises the possibility of non-respondent bias. It is possible that non-respondent pharmacists did not consider research on evidence of effectiveness with OTC medication to be important. Indeed, a self-completed postal questionnaire conducted in Illinois assessing pharmacists attitudes toward evidence-based medicine only achieved a response rate of 17.2% [15]. Finally, although comparisons were made between pharmacists who had postgraduate qualications and those who had none, these qualications were diverse and only applied to a minority of respondents. Therefore, we are unable to conclude if this factor was important. Nevertheless, the respondents in the study were broad in terms of their characteristics. The gender distribution

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closely reected the prole of pharmacists on the register. Respondents worked in various community pharmacy settings and had an extensive range of experience. Similarities were also noted between this work and other studies documented in the literature [12, 14, 15, 20, 26, 27] and the qualitative study [8] which further enhanced the validity. Additionally, it is anticipated that this work will have international relevance, given that implementing an evidence-based approach is an ethical obligation for pharmacists in various countries [44, 45] and is not unique to those practising in Northern Ireland. Moreover, as a greater emphasis continues to be placed on self-care, the global OTC medicines market will continue to expand. With a wider range of products available, and a more diverse range of conditions to manage, pharmacists must be able to demonstrate that they are competent healthcare professionals who deliver a high quality evidence-based service in all areas of their practice.

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Conclusion Safety was the over-riding consideration when making decisions about OTC medicines. An evidence-based approach was not readily adopted by most community pharmacist respondents. Indeed, many respondents reported a lack of knowledge of how to perform comprehensive literature reviews, critically appraise research papers and were not familiar with the work of the Cochrane Collaboration. Furthermore, the majority of the pharmacists thought that medicines lacking evidence of effectiveness had an important role to play in self-care. This mindset presents one of the biggest challenges for implementing an evidence-based approach with OTC medicines. In light of these ndings, the authors consider that there needs to be a greater emphasis placed on the importance of evidence-based practice from various organisational bodies in Northern Ireland otherwise it may appear to be little more than a theoretical requirement. Additionally, as there are currently no stand-alone courses on evidence-based medicine available, the authors suggest that such courses should be made available and their impact on practice evaluated through future research.
Acknowledgments The authors wish to thank the pharmacists who participated in this study. Funding The corresponding author was supported by payment of academic fees from the Northern Ireland Centre for Pharmacy Learning and Development and Queens University Staff Training and Development Unit. Neither organisation had any involvement in the design of the study, data collection or interpretation and writing of the manuscript. Conicts of interest The authors have no conicts of interest.

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