Impact of findings on practice

  • There are significant differences in the level of agreement with 14 out of 43 items on our survey questionnaire (economic aspects [four statements], pharmaceutical care, code of ethics, evaluation, clinical research [two statements each] and training and education, dispensing medications [one statement each].

  • There are no guidelines about the importance that should be given to professional ethical thinking in pharmacy curricula. Our study highlights ethical thinking from Quebec pharmacy residents and French pharmacy interns and their background exposure to professional ethical thinking.

Introduction

The origins of ethics go back at least 2500 years to Hippocrates. The Hippocratic tradition was dominant for two millennia until the middle of the twentieth century with emerging concepts like patient self-determination, informed consent, clinical bioethics, life cycle and economic choices, etc. [1]. Ethics was integrated into healthcare practices first through academic medical curricula (Salerne [750], Bologna [1123], Oxford [1167], Paris [1215], etc.) [2]. In North America, the first medical code of ethics was adopted by the American Medical Association in 1847 [3]. The first pharmaceutical code of ethics was adopted by the American Pharmaceutical Association in 1848 [4]. In 2011, most pharmacy associations adopted a code ethics and most state pharmacy acts embedded ethical rules within their legislative framework applicable to pharmacy practice [5].

There are a limited number of publications on pharmacy ethics in the scientific literature. A comparative PubMed search on Feb 20, 2011, using a combination of pharmacy AND ethics as keywords provided 1,146 citations, while a combination of medicine AND ethics as keywords provided 37,021 citations.

Wingfield et al. [6] published a review paper on ethical issues in pharmacy practice from 1990 to 2002. They noted that there is little research in this area, with almost none addressing fundamental philosophical issues or values for pharmacy ethics. Furthermore, there is no dedicated journal and most material relating to pharmacy ethics takes the form of codes or pronouncements from professional bodies, opinions or reflections in textbooks and debates in letters and articles.

Latif [7] suggested that there is a link between moral reasoning scores, social desirability and patient-care performance scores. His work has suggested that theoretical exposure to ethical dilemmas is important and should be implemented early on in pharmacy curricula.

Cooper et al. reviewed the literature about empirical ethics research in pharmacy. They suggested that as pharmacy seeks to develop additional roles with concomitant ethical responsibilities, a “new prescription is needed for empirical ethics research in pharmacy-one that embraces an agenda of systematic research using a plurality of methodological and theoretical approaches to better explore this under-researched discipline.”[8] Among the studies included in their review, many relied on situation scenarios involving ethical dilemmas and independent questions on various ethical issues. They reported two types of tests that have been used and validated in the literature, namely the Defining Issues Tests (DIT) and the Moral Judgment Interview [9]. Chaar [10] described a different psychometric measure based on the theory of cognitive moral development (Professional Ethics in Pharmacy tool). Most studies have suggested that moral reasoning in professional ethics in pharmacy is a developmental process.

At the CHU Sainte-Justine over the last decade we have conducted a number of comparative studies on different aspects of pharmacy practice in Quebec and France in relation to among other things organization, dispensing, compounding and clinical pharmacy services [11–15]. Discussions between pharmacy residents in Quebec and pharmacy interns in France led us to identify potential differences in the perception of ethics in pharmacy practice.

Materials and methods

Objectives

The main objective of this pilot study is to compare the professional ethical thinking of Quebec pharmacy residents and French pharmacy interns. The secondary objective is to compare the professional ethical thinking of Quebec pharmacy residents and first year French pharmacy interns.

Main outcome measure

For this study, professional ethical thinking was defined as the level of agreement/disagreement with statements about pharmacy ethics/dilemmas.

Questionnaire

This is a cross-sectional, descriptive, web-based survey. A review of the literature on pharmacy ethics and existing studies on the ethical thinking of pharmacy students and pharmacists allowed us to develop a two-part questionnaire. Eight key themes about pharmacy ethics were identified. The first part of the questionnaire consisted of 16 demographic questions (sex, age, status, country, pharmacy career path, previous exposure to theoretical and practical pharmacy ethics topics). The second part of the questionnaire included 43 statements based on eight ethical themes (training and education, clinical research, advertising and marketing, evaluation, dispensing medications, pharmaceutical care/clinical pharmacy, economic aspects, and code of ethics). For each statement, the respondents were asked to indicate their level of agreement/disagreement based on a 4-item Likert scale (totally agree, partly agree, partly disagree and totally agree). All the statements were formulated toward a positive wording (i.e., an expected ethical behavior based on current literature and pharmacy codes of ethics). A translation of the 43 statements on the questionnaire is presented in “Appendix”, as the questionnaire used for the study was administered in French. A pre-test questionnaire was administered to a total of ten pharmacists and pharmacy residents/interns from France and Quebec for statement clarification. Ten items were modified following the pre-test. The questionnaire was then published on SurveyMonkey (http://www.surveymonkey.com/) between April 5 and May 26, 2008. Respondents were contacted by email on April 5, 2008 with one reminder sent at the end of April 2008. The responses provided were anonymous.

Study population

The pilot study was designed for Quebec hospital pharmacy residents and French pharmacy interns. In Quebec, the hospital residency program is 16 months long and leads to a post-graduate diploma including 4 months of courses and 12 months of rotations within a hospital. In France, the internship program lasts 4 years and leads to a post-graduate diploma with hospital, industry and biology career path options including courses and internships. The invitation to participate in the study was sent by email to all 2008 Quebec pharmacy residents (n = 55) through elected resident representatives from both faculties of pharmacy. The invitation to participate in the study was sent by email to a contact person at the Syndicat des internes en pharmacie des hôpitaux d’Ile-de-France (SIPHIF—http://www.siphif.org), who then relayed the invitation to SIPHIF members. We estimated the annual total number of pharmacy interns in France to be around 1,800 [16].

Statistical analysis

For demographic data analysis, Student t tests were used for quantitative variables and Chi-square tests were used for qualitative variables. Chi-square and bilateral Fisher’s exact tests were used to compare the level of agreement (agree vs. disagree) with each statement between both groups. A secondary analysis was conducted between first year French interns and Quebec residents. A value of P < 0.05 was considered statistically significant.

Results

All the responses were received electronically between April 5 and 18, 2008. Two hundred and forty-nine respondents completed the web-based questionnaire on SurveyMonkey (Quebec pharmacy residents: n = 50 and French pharmacy interns: n = 199). The distribution of French pharmacy interns throughout their curriculum was the following: 1st year (n = 54), 2nd year (n = 43), 3rd year (n = 44) and 4th year (n = 58). Of the 249 completed questionnaires, 208 were usable for analysis (n = 50 from Quebec and n = 158 from France). Excluded questionnaires all came from French respondents, since they did not complete the second part of the questionnaire. The response rate was 91% for Quebec respondents and it was estimated to be 11% for French respondents, as we could not confirm the absolute number of French interns reached by email at that time. The respondents’ profiles and demographic data are shown in Table 1.

Table 1 Demographic profile of the 208 respondents to the Ethics Questionnaire
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There were statistically significant differences between the two groups in terms of age (on average, French interns are older than Quebec residents, t-test P < 0.001) and sex (there are proportionately fewer women respondents in France than in Quebec, t-test P = 0.005). Also, the career orientation was different between both groups since there are at least three career paths in France versus a single dominant one in Quebec.

There were statistically significant differences between the two groups in terms of exposure to ethics during academic training and experiential practice with a proportionately higher number of Quebec respondents being exposed to ethics in most proposed choices (four out of five academic training themes, five out of five experiential practice themes, Table 1 for P-value details). Furthermore, Quebec respondents declared a significantly higher number of hours of exposure to courses related to pharmaceutical ethics during their academic curriculum (37.9 vs. 13.5 h, t-test P < 0.001).

We compared the overall level of agreement (agree vs. disagree) with each statement on pharmacy ethics between French pharmacy interns and Quebec pharmacy residents. There were no significant differences between Quebec pharmacy residents and French pharmacy interns for 29 out of 43 items (67%). However, there were significant statistical differences between both groups for 14 statements (3, 7, 13, 19, 20, 26, 30, 35, 36, 39, 40, 41, 42, 43) out of 43 (33%) as reported in Table 2. The differences were related to the following themes: economic aspects (four statements), pharmaceutical care aspects, code of ethics aspects, evaluation aspects, clinical research aspects (two statements each) and training and education aspects, dispensing medications aspects (one statement each). We also compared the level of agreement with each statement between the two groups of first year pharmacy respondents, as reported in Table 3. There were significant statistical differences between the two groups for 11 statements (26%), with only two out of 11 statements being different (18, 31) from those reported in the overall comparison.

Table 2 Statements with a statistical difference in level of agreement between Quebec residents and french interns (all respondents)
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Table 3 Statements with a statistical difference in level of agreement between Quebec residents and French interns (only 1st year respondents)
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Discussion

Published data on the professional ethical thinking of pharmacy residents and interns remain limited. Our pilot study relies on two groups of pharmacy interns in France and residents in Quebec. Quebec pharmacy residents are on average 2 years younger than French pharmacy interns with a higher proportion of females and a shorter curriculum (16 months vs. 4 years). In addition, the French curriculum offers wider career opportunities (hospital, biology, industry and others), while the Quebec curriculum focuses solely on hospital practice. While there are significant demographic differences between the two groups, they both pursue post-graduate pharmacy training with either an important proportion (46% of French pharmacy interns) or a dominant proportion (94% of Quebec residents) following a hospital career path.

There are no significant differences between Quebec residents and French interns for 29 out of 43 items (67%). This is not surprising, since in modern countries pharmacy curricula and practices share many similarities.

However, there are significant differences in the level of agreement with 14 out 43 items surveyed by our questionnaire. Looking at the absolute difference between the proportion of Quebec and French respondents in agreement with each of the statements, it varies between minus 10 and plus 43 points (average 19 ± 14) for the 14 statements. In all cases but two, Quebec residents supported the proposed ethics statements to a higher extent than did French pharmacy interns. A sub-analysis of first year interns and residents gave similar results with a difference range of 0–45 points and an average difference of 21 ± 15. Latif suggested that ethical reasoning increases with age and that females have a higher moral reasoning score than do males [17, 18]. While proportionately there are more females in the Quebec resident group (85% in Quebec vs. 65% in France), which could explain their higher level of support for statements, they are on average 2 years younger than the French interns.

It is interesting to explore some of the differences in the level of agreement between the two groups. For instance, Quebec residents expressed higher support levels for a more distant relationship with the pharmaceutical industry (e.g., “Funding of recreational activities for students by the pharmaceutical industry or wholesale distributors must be prohibited” is supported by 64% of Quebec residents vs. 29% of French interns; “Presence of pharmaceutical representatives/visitors in healthcare hospitals must be prohibited” is supported by 50% of Quebec residents vs. 24% of French interns; “Financial kickbacks to pharmacists from the pharmaceutical industry that may influence the selection of one medication over another must be prohibited” is supported by 98% of Quebec residents vs. 84% of French interns; “Financial costs related to meals or entertainment offered by the pharmaceutical industry must be refused” is supported by 54% of Quebec residents vs. 44% French interns; “Financial costs related to transportation or lodging by the pharmaceutical industry within the context of continuing education activity must be refused” is supported by 62% of Quebec residents vs. 20% of French interns). In Canada over the last decade different events have contributed to the re-definition of relationships between the pharmaceutical industry and healthcare professionals (e.g., illegal or undeclared rebates given to retail pharmacists by the generic industry to pharmacists for product positioning, high marketing expenses from the brand industry to influence prescribers, below market conditions for physicians renting space to pharmacists, etc.) [19–22]. In response to these events, Quebec medical [23] and pharmaceutical [24] codes of ethics were revamped and a voluntary code of ethics was proposed by the association representing the Canadian brand industry (RxD) [25]. While French media were monitoring healthcare professional relationships as well, there were no such changes in the legal pharmacy environment in France or the applicable code of ethics [26]. However, French pharmacy interns expressed higher support for accountability in the pharmaceutical industry for vulnerable populations (e.g., “Pharmaceutical industry must be forced to conduct studies on vulnerable populations even if no market is deemed sufficiently profitable or important for the studies” is supported by 92% of French interns vs. 82% of Quebec residents). Many authors question pharmacist vs. pharmaceutical industry relationships [27–30].

Quebec residents have reported higher support for evidence-based practice (e.g., “Sale of natural health products in pharmacies must be prohibited when their safety and efficacy have not been demonstrated by a regulatory authority” is supported by 90% of Quebec residents vs. 70% of French interns; “Sale of homeopathic products in pharmacies must be prohibited when their safety and efficacy have not been demonstrated by a regulatory authority” is supported by 84% of Quebec residents vs. 41% of French interns). Evidence-based practice has been a key component of medicine and pharmacy curricula over the last decade in North America [31]. In Quebec, the pharmacy curriculum based on an entry-level Pharm. D. degree was completely redefined in 2008 largely on the basis of evidence-based pharmacotherapy [32]. While natural health products have had legal status in Canada since 2004 (note, however, that a significant number of natural health products had not yet been studied by the federal regulatory authority at the time of our pilot study), these products (e.g., natural health products and homeopathic remedies) are not reimbursed by public and private third party payers in Canada, while some of them are covered by public payers in France [33, 34]. Reimbursement can be perceived as state support for these products. There is also higher popular support for homeopathic remedies in France than in Canada. Natural health products and homeopathic remedies illustrate a potential ethical conflict for pharmacists, as their accessibility can be determined either by third party payers that count on evidence-based literature or by patient self-determination and beliefs in so-called non-medical treatment [35, 36].

Quebec residents showed stronger support for freedom of choice for patients and pharmacists based on their beliefs (e.g., “Pharmacists must be allowed to refuse to give emergency oral contraceptives if this practice goes against their personal or religious values” is supported by 28% of Quebec residents vs. 6% of French interns). A revised version of Quebec’s Code of Ethics of Pharmacists allows pharmacists to refuse emergency oral contraceptives, as long as they offer an alternative to the consulting woman (e.g., rapid consultation with a colleague) [24]. While oral emergency contraceptives were available without a physician’s order in France and Canada at the time of this study, pharmacists controlled dispensing modalities by usually keeping the drugs behind the counter. Such control theoretically allows pharmacists to refuse to dispense according to their beliefs. A higher support for refusal on the part of pharmacists in Quebec is probably linked to the allowance embedded in the code of ethics. In France, refusal of oral emergency medicine is prohibited in the Pharmacy Code of Ethics [37, 38].

Finally, Quebec pharmacy residents expressed a higher level of agreement with statements about denunciation of colleagues (e.g., “Colleagues who practice under the effect of illicit substances must be reported to their professional order” is supported by 100% of Quebec residents vs. 79% of French interns; “Colleagues who practice in an incompetent manner or dangerously must be systematically reported to their professional order” is supported by 100% of Quebec residents vs. 88% of French interns).

While it was not possible to conduct a predictive mathematical model to explain the professional ethical thinking of Quebec or French residents, we believe the higher exposure of Quebec residents to ethics during academic courses and experiential/practical training may have contributed to a higher level of agreement with some ethical statements. According to previous studies, numerous factors can influence the ethical thinking of pharmacy students (e.g. age, sex, family, religious and cultural background, pharmacy training with ethical exposure, ethical fiber of role models, etc.). While this pilot study was not designed to evaluate the contribution of these factors to the development of ethical thinking, it has shown varying levels of agreement among pharmacy residents or interns with 43 different items about ethics in pharmacy. Latif [39] has compared the level of moral development of American and Canadian pharmacy students. While he observed lower scores of moral reasoning with pharmacy students than with other student health professionals, he believed that several health professions have demonstrated that students’ moral reasoning can be significantly enhanced during professional education. Dunn et al. concluded that moral reasoning skills are both teachable and measurable and that ethical dilemma case discussions may enhance moral development [40].

There are no guidelines about the optimal weight given to content on pharmacy ethics in academic training. Exposure to pharmacy ethics content differs between the two countries (an average of 38 h in Quebec vs. 14 h in France). Bumgarner et al. [41] have indicated that pharmacy students should be taught and exposed to ethical dilemmas early on in their pharmacy education. Also, Latif [39] has described the usefulness and impact of teaching ethics to second year pharmacy students. While our pilot study does not capture the timing of students’ exposure to ethical thinking and does not evaluate if the relative exposure of both studied group is enough, we do believe it is an important topic to consider when pharmacy curricula gets reevaluated. Our pilot study may be used as a starting point for discussion between pharmacy residents and interns.

This pilot study has several limitations. While a first year analysis showed similar results in terms of differences in levels of agreement with ethical statements, a study including only hospital pharmacy interns or residents with a sufficient sample size would provide a better comparison. We did not use a validated tool to survey the moral reasoning of pharmacy students but rather surveyed the professional ethical thinking of pharmacy residents and interns. However, the questionnaire used was based on practical issues raised by similar pharmacy residents or interns and the questionnaire was pre-tested to reduce potential misinterpretations between the two French-speaking pharmacy populations. Also, respondents were not allowed a neutral choice (no opinion). The 4-item Likert scale forced the respondents to support or not support (either totally or partly) a given statement. We allowed multiple respondents from a single computer (e.g., a single individual could have responded more than once, although this seems improbable). This was done for a reason, as pharmacy interns and residents share limited access to personal computers and the Internet.

Conclusion

Published data on the professional ethical thinking of pharmacy residents and interns remain limited. There were no significant differences between Quebec residents and French interns for 29 out of 43 items. However, there were significant differences in their level of agreement with 14 out of 43 items surveyed by our questionnaire. The differences related to the following themes: economic aspects (four statements), pharmaceutical care, code of ethics, evaluation, clinical research (two statements each) and training and education, dispensing medications (one statement each). The same questionnaire could be administered to pharmacy residents or interns from other countries to detect cultural or academic differences.