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A new prescription for empirical ethics research in pharmacy: a critical review of the literature

A new prescription for empirical ethics research in pharmacy: a critical review of the literature
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  doi: 10.1136/jme.2005.015297 2007 33: 82-86 J Med Ethics  R J Cooper, P Bissell and J Wingfield in pharmacy: a critical review of the literatureA new prescription for empirical ethics research Updated information and services can be found at: These include:  References Article cited in: This article cites 29 articles, 3 of which can be accessed free at: serviceEmail alerting the top right corner of the online article.Receive free email alerts when new articles cite this article. Sign up in the box at Notes To order reprints of this article go to: go to: Journal of Medical Ethics  To subscribe to group.bmj.comon December 2, 2009 - Published by  jme.bmj.comDownloaded from   CLINICAL ETHICS  A new prescription for empirical ethics research in pharmacy:a critical review of the literature R J Cooper, P Bissell, J Wingfield ...................................................................................................................................  J Med Ethics 2007; 33 :82–86. doi: 10.1136/jme.2005.015297  Empirical ethics research is increasingly valued in bioethics andhealthcare more generally, but there remain as yet under-researched areas such as pharmacy, despite the increasingly  visible attempts by the profession to embrace additional rolesbeyond the supply of medicines. A descriptive and criticalreview of the extant empirical pharmacy ethics literature isprovided here. A chronological change from quantitative toqualitative approaches is highlighted in this review, as well asdiffering theoretical approaches such as cognitive moraldevelopment and the four principles of biomedical ethics.Research with pharmacy student cohorts is common, as isrepresentation from American pharmacists. Many examples of ethical problems are identified, as well as commercial and legalinfluences on ethical understanding and decision making. In thispaper, it is argued that as pharmacy seeks to developadditional roles with concomitant ethical responsibilities, a new prescription is needed for empirical ethics research inpharmacy—one that embraces an agenda of systematicresearch using a plurality of methodological and theoreticalapproaches to better explore this under-researched discipline. .............................................................................See end of article for authors’ affiliations........................Correspondence to:R J Cooper, Centre for Pharmacy, Health andSociety, The University of Nottingham, University Park, Nottingham NG7 2RD, UK; Received22 November 2005Revised 22 February 2006 Accepted 28 March 2006........................ T his paper reviews the literature at the con-fluence of two ethical subjects—one increas-ingly valued and researched and the other stillrelatively unexplored. Regarding the first, the useof empirical ethics data and research methodsfrom the social sciences has gained respectabilityand value both in the applied philosophical field of bioethics and also in health services researchgenerally. 1–3 Increasingly, empirical research isbelieved to be important in mapping out theethical terrain of healthcare and there is a hopethat closer integration of empirical and normativeethical study may be achieved, setting asidetraditional differences that srcinated in the ‘‘is–ought’’ debate. 4  As for the unexplored subjects,although many empirical, and indeed normative,ethical studies have been undertaken in the highdrama concerns of medicine and the pioneeringtechnologies of reproductive and genetic medicine,other areas of healthcare such as pharmacy havebeen relatively neglected. As Brazier 5 notes,‘‘…philosophers, social scientists and academiclawyers continue to demonstrate a worryingtendency to concentrate almost exclusively onethical dilemmas of high drama and low incidence[…] The daily round of the pharmacist in hospitalor the community simply lacks that drama’’(p xxii). Community pharmacists, in particular,represent a point of access for patients andcustomers to many services associated with med-icines and healthcare advice. At the same time,their roles are changing, and the traditionalactivities of medicine preparation, dispensing andover-the-counter sales have been augmented bymany additional services. In England, for example,community pharmacists have a new contract withthe National Health Service and are being encour-aged to undertake supplementary prescribing,drug use reviews, near-patient diagnostic testing,and the sale of an increasing number of de-regulated, former prescription-only medicines suchas emergency hormonal contraception and statins. 6 In a recent review on the scope of the internationalethics literature on pharmacy, Wingfield et al 7 identified several concerns and omissions, includ-ing a preponderance of scenario-based studiesfrom pharmacy practice and a paucity of sub-stantive literature on ethics and values in phar-macy. Wingfield et al did provide an example of empirical ethics research but, because of specificsearch dates, omitted other relevant empiricalstudies. This paper aims to review the extantempirical ethics literature in pharmacy, heedingMarx’s 8 advice that ‘‘…we are not only creators of new knowledge, but protectors and transmitters of old knowledge […] Seek an appropriate balancebetween appreciation and advancement of theliterature’’ and also to identify opportunities forfurther research. Three key areas emerge from thereview. Firstly, earlier studies typically used ques-tionnaire-based quantitative methods but morerecently qualitative approaches have been adopted,using focus groups and semistructured interviews.Secondly, two dominant theories—principlism andcognitive moral development—are identified andexplored as approaches to grounding empiricalresearch in normative philosophical and alsopsychological theory, respectively. Thirdly, sampleshave often included students and Anglophone,especially American, pharmacists, and few studieshave focused on non-community pharmacy set-tings such as secondary hospital care. METHODS Our study included searches of several electronicdatabases, initially using combinations of thefollowing keywords: pharmacy, empirical, ethics,ethical, dilemma and pharmacist. Databasessearched were Medline, EMBASE, ISI Web of   Abbreviations: CMD, cognitive moral development; DIT,Defining Issues Test 82  group.bmj.comon December 2, 2009 - Published by  jme.bmj.comDownloaded from   Knowledge, SOSIG and BIOME. Hand searches were alsocarried out on specific journals such as The Pharmaceutical Journal , International Journal of Pharmacy Practice , Journal of  Medical Ethics and Journal of Business Ethics . Exclusion criteriaincluded pharmaceutical industry or exclusively educationalresearch, normative applied ethical discussions, and studies whose central aim was not related to ethical description orevaluation. Furthermore, an internet search using the abovekeywords was also undertaken using Google, in response to theEMPIRE project into empirical bioethics research, whichrecommended that ‘‘…it is also important to take into account‘grey’ literature such as reports, PhD theses, and government white/green papers’’( Part_A_final.pdf). Several additional studies, often conferencepresentations, were identified using this search method. Table 1gives details of the studies that were investigated. EMPIRICAL ETHICS RESEARCH IN PHARMACY  Results Having carried out searches in accordance with the method,several relevant studies were identified and are listed in table 1. Itshould benoted thattherelativelyprolific output ofLatifincludedthe repeated use of one dataset, reported in many publications.The number of distinct studies seems to be similar to otherrelatively under-researched areas of healthcare such as generalmedical practice, for example, where one literature reviewidentified only nine relevant empirical studies. 29 Followinganalysis of theidentified empirical pharmacy ethics studies,manyimportant themes emerged and these will now be considered inrelation to methodology, ethical theory and samples. Methodology and methods  A chronological change in research approach and method wasapparent over the 19-year period of identified empirical ethicsstudies. Many of the earlier studies used a questionnaire thatcontained hypothetical ethical scenarios from which respondentsselected options. This allowed statistical analysis of pharmacists’ethical problems and reasoning, whereas almost all later studiesadopted interview or focus group methods. Typical of the firstapproach was the earliest identified empirical ethics study, byLowenthal et al , that dealt with the attitudes of practising andstudent pharmacists to ethical dilemmas, with the aim of developing more appropriate undergraduate ethics teaching. A postal questionnaire was used, which included questions thatrequired a simple yes or no response to a variety of hypotheticaldilemmas—dilemmas srcinating from the authors’ experiencesor from the normative literature. The study concluded that there was broad attitudinal agreement among students and pharma-cists in relation to many of the dilemmas posed, but somedisagreements did occur. The choice of relevant vignettes orscenarios for questionnaires in empirical ethics research has been Table 1 Summary of empirical ethics studies in pharmacy  Study Sample Methodology Design Aims/results Lowenthal et al  , 9 Lowenthal 10 55 US pharmacists,165 US pharmacy studentsQuantitative Questionnaire Document pharmacy students’ attitudes to ethical dilemmas andcompare with pharmacists. Both have high levels of ethicalbehaviour.Dolinsky and Gottlieb 11 170 US pharmacy studentsQuantitative Questionnaire To identify pharmacy students’ descriptions of moral dilemmas anduse of moral development theory.Haddad 12 869 practising USpharmacistsQuantitative Postal questionnaire Compare incidence and difficulty of ethical problems and influencing variables.Latif and Berger  13 113 US pharmacists Quantitative DIT Psychometric Test Pharmacy students scored higher on moral reasoning thancommunity pharmacists.92 US studentsLatif  et al  14 114 US community pharmacistsQuantitative DIT Psychometric Test Community pharmacists’ moral reasoning and components of clinicalperformance.Latif  15 113 US community pharmacistsQuantitative DIT Ethical cognition, organisational reward systems and patient-focusedcare.Latif  16 113 US community pharmacistsQuantitative DIT Ethical cognition and selection-socialisation in retail pharmacy.Latif  17  114 US pharmacists Quantitative DIT Link between moral reasoning and patient care.Latif  18 Not stated Quantitative DIT A comparison of chain and independent pharmacists’ moralreasoning.Hibbert  et al  19 6 UK community pharmacistsQualitative SemistructuredinterviewsFour principles and practical ethical reasoning found. Legal,business, organisational concerns present.Range of dilemmas spontaneously identified.Latif  20 113 US community pharmacistsQuantitative DIT Psychometric Test (postal)Influence of pharmacists’ tenure on moral reasoning. Older pharmacists scored lower.Latif  21 69 Canadian and73US studentsQuantitative DIT Psychometric Test Assess moral reasoning of pharmacy students. Unexplained national variation.Elwell and Bailie 22 112 US pharmacy studentsQuantitative Questionnaire (3-point scale)Influence of class and clinical experience on ethical decisions was not relevant for five ethical scenarios. Wingfield et al  23 40 UK pharmacy studentsQualitative Focus group Perceptions of ethics among pharmacy students.Latif  24 1564 US pharmacy studentsQuantitative DIT Psychometric Test To measure and compare ethical reasoning of 1st-year and 3rd-year pharmacy students and geographical differences. Wingfield et al  25 11 UK community pharmacists (5 for focus group)Qualitative Focus group andsemistructuredinterviewsInfluence of company policy on ethical decision making. Policy created concern but also guided ethical thinking.Kalvemark  et al  26 5–7 Swedish hospitalpharmacists, dispensersQualitative Focus group Assess extent of moral distress in hospital doctors, nurses andpharmacists. Time/recourse constraints, rule breaking, professionalconflict cause pharmacy distress.Cooper  27  11 UK community pharmacistsQualitative Semistructuredinterviews Ability of pharmacists to resolve ethical problems varied. Legalcontrols, the commercial environment and professional isolationprecipitated a range of dilemmas.Chaar  et al  28 25 AustralianpharmacistsQualitative SemistructuredinterviewsCommon sense reasoning and best interests of patient identified ascentral. Legal and business dilemmas in community common.DIT, Defining Issues Test.  A new prescription for empirical ethics research in pharmacy 83  group.bmj.comon December 2, 2009 - Published by  jme.bmj.comDownloaded from   identified as a concern in the business and medical ethics fieldsand was also apparent in several of the pharmacy studiesidentified. 30 31 Haddad, 12 for example, argued that this was due tothe lack of available empirical examples of ethical problems and,using a questionnaire adapted from previous work on nursingethics, included 19 dilemmas that were selected on the basis of their frequency in the normative pharmacy ethics literature,rather than from practice. A free response section was includedfor pharmacists to provide their own examples, but the study didnot indicate whether this section was used. Despite quantitativestudies being particularly suited to statistical analysis of variablessuch as the frequency of ethical dilemmas, the study by Haddad was the only one to investigate this. It was reported that 58% of pharmacist respondents had encountered an ethical problem inthe last year but a third of pharmacists simply could not recall when they were last associated with an ethical dilemma.Quantitative and qualitative approaches have traditionallybeen considered to occupy distinct and separate epistemologicalterritory, with one privileged over the other. However, thisreview does not seek to perpetuate such a belief, but recognisesthat the choice of research approach should be determined bythe type of question being asked. The quantitative studiesidentified in this review, for example, often focused on specificquestions or sought to test hypotheses, whereas the qualitativestudies are more concerned with understanding and exploringissues in depth or contextually. The chronological variation inresearch approach is nonetheless apparent and appears to haveprecluded study designs that triangulate and combine meth-ods. 33 More recent research has tended to use qualitativeapproaches such as semistructured interviews or focus groups.In the earliest identified study of this type, by Hibbert et al , 19 theauthors used interviews to identify and explore the types of dilemma encountered by community pharmacists and to gainan understanding of pharmacists’ ethical awareness. The studyfound a diversity of ethical influences on pharmacists,including business values, ethical codes, organisational valuesand ethical reasoning, which corresponded to many ethicalprinciples and also common sense. The qualitative studiesidentified often offered a complex pattern of ethical pharmacypractice. The study by Cooper, for example, found that a varietyof dilemmas and approaches to ethical reasoning were apparentamong pharmacists—evidenced often by intuitive reasoningand examples that corresponded to a model of ethical decisionmaking that included identifying an ethical problem, usingethical reasoning and also making an ethical decision. 34 However, pharmacists’ ability to resolve ethical problems variedand factors such as legal concerns, a sense of professional andethical isolation and the commercial environment seemed to beinimical to developing ethical competency. As well as semi-structured interview methods, some later qualitative studiesadopted focus group methods, with the advantage of allowingdata to be gathered quickly and easily, and using the interactiveaspects common to focus group studies. Ethical theory  In addition to methodological differences between the studiesidentified, many distinct theoretical approaches were also foundinrelationtoethics,ofbothanormativeandapsychologicalkind.For example, although the study by Hibbert et al 19 sought toexplore the diversity of ethical understanding, the subsequentanalysis of interview data included a comparison of pharmacists’reasoningtoonlyone particular, albeitpopular,normativeethicaltheory.Othervalues wereconsidered,but thetheoretical basis fordetermining evidence of ethical understanding was based on theprinciples of biomedical ethics developed by Beauchampand Childress. 35 The study identified examples of each princi-ple—autonomy, beneficence, non-maleficence and justice—although the authors recognised the implied nature of suchinferences and noted that pharmacists did not mention theseprinciples explicitly. The study offered no support for theassumption that the four-principles approach should be theapproach for ethical judgement except by reference to secondarytexts. 35  A similar approach was favoured by Chaar et al , 28  whoagain, despite recognising the range of available ethical theories,gave primacy to the four principles. In our study, no evidence of  justice or non-maleficence was found, but patients’ best interests were identified as being influential. Although based on theprinciples of biomedical ethics, neither study considered one of the central aspects of the theory—the process ofspecification andbalancing of the principles. As Beauchamp and Childress makeclear in their work, it isnot simply the recitation ofthe principles,perse,butratherthecoherentistreasoninginselectingaprincipleinaparticularhealthcaresituationthatcharacterisestheirtheory,in a manner similar to Rawls’s 36 reflective equilibrium. Bothstudies found, however, that a range of value sets and commonsense appeared to be ethically influential for pharmacists.In contrast with the normative ethical four-principles theoryused by Hibbert et al , 19 a psychological theory was used in theempirical pharmacy ethics studies by Dolinsky and Gottlieb 11 and also Latif  13 . This related to cognitive moral development(CMD), and these studies offer relatively detailed accounts of the theory, identifying the work of Piaget, 37 Kohlberg, 38 andRest and Narvaez 39 in the theory’s development. CMD isconcerned with the progression of people through variousmental stages of moral development over time, and Kohlbergidentified three levels of moral development (and twosubstages of each level) relating to reasoning that could bedistinguished as (1) pre-conventional and involving reasoningrelated to external punishment (stage one) or egoistic self-interest (stage two); (2) conventional and appealing toreasoning that considers our immediate peers (stage three)and then broader social implications and laws (stage four); (3)post-conventional and applying principled reasoning thatrecognises the social contract (stage five); and (4) universalethical principles (stage six). The CMD theory has been usedextensively in many healthcare settings, and is claimed to have validity in relation to predicting better clinical or professionalbehaviour. 40 41 The attraction of the theory for empiricalpharmacy research according to Latif  13 is that CMD may beregarded as a conceptual tool or skill and that ‘‘…individuals with more advanced moral reasoning skills are often better ableto make sense of and resolve difficult moral and socialdilemmas’’ (p 167). However, Dolinsky and Gottlieb argue thatCMD may also be useful in clarifying and developing moralunderstanding and that the authors use CMD in differing ways.For Dolinsky and Gottlieb, CMD is primarily an analytical tool,to ascribe developmental stages to the responses that pharmacystudents provided about ethical dilemmas, in a similar way tothat used by Kohlberg (who developed a moral judgementinterview that required participants to provide reasoned butopen responses to hypothetical questions that were subse-quently stage coded); for Latif, the CMD theory is used in apsychometric form called the Defining Issues Test (DIT)developed by Rest. 39 Using a self-completion questionnaireformat, Rest sought to make identifying moral reasoning botheasier and faster to administer, and to provide less potentialresearcher bias by non-interpretative, pre-coded responses tothe dilemmas posed. The DIT is manifestly quantitative innature and often uses a calculation that assesses the percentageof principled responses chosen over six (but possibly three)hypothetical dilemmas—what is called the P% score. Incontrast with Kohlberg’s claim that people reason progressivelyhigher, Rest allows for reasoning across stages, and isconcerned with recognition and rating of pre-coded reasoningas opposed to Kohlberg’s focus upon self-generated responses. 84 Cooper, Bissell, Wingfield  group.bmj.comon December 2, 2009 - Published by  jme.bmj.comDownloaded from   However, no mention is made of such theoretical differences byLatif.The substantive content of Latif’s work has been covered insome detail by Wingfield et al, 7 but across several publicationshe uses CMD and specifically the DIT instrument to explore thecommunity pharmacy environment and consider what may beresponsible for what he describes as the relatively low levels of moral reasoning of practising pharmacists. Following thisinitial finding, many subsequent hypotheses were consideredin further publications, including whether community phar-macists’ level of moral reasoning would be, variously, positivelycorrelated to their clinical skills, or related to owner oremployee status and number of years practised. The study byDolinsky and Gottlieb 11 appeared to offer evidence of principled,stage-six reasoning, although the lack of empirical data tosupport such a stage has raised concerns about this aspect of Kohlberg’s theory. 42 Latif does recognise several challenges toCMD, and in particular identifies Gilligan’s criticism of Kohlberg’s theory that justice-based reasoning neglects alter-native moral approaches such as an ethics of care. Latif explored evidence of specific gender differences, and foundthat female pharmacists obtained ‘‘higher’’ DIT scores,although Gilligan 43 has subsequently argued that an ethics of care represents simply a different, and not necessarily female, voice. Latif also identifies several implications of CMD in his work: (1) an economic saving could be made if pharmacistsdevelop more advanced moral reasoning skills; (2) that moralreasoning be tested in the pharmacist recruitment process of organisations; and (3) that litigation against pharmacists maydecrease in relation to the level of moral reasoning. Samples Having identified methodological and theoretical differences inthe empirical pharmacy ethics literature, another relevant theme was the types of respondents or samples used in the variousstudies.As table 1 indicates,differencesinthe samples relating tonationalityandstudentcohorts areapparent.Manyofthestudiesidentified used American pharmacists and despite more recentstudies including UK, Swedish and Australian pharmacists, thereis under-representation in many areas of the world, which maylimit the scope of our comprehension of empirical ethical issuesacross different healthcare systems and cultures. In addition, fewstudies focused specifically on the hospital pharmacy setting, andalthoughHaddad 12 andChaar et al 28 sampledpharmacistsfromallareasofpharmacypractice,includingacademia,onlythestudybyKalvemark et al 26 focusedonthehospitalenvironment. Itwasalsothe only study to include pharmacy dispensers and assistants.More apparent was the use of student cohorts in the studiesidentified, either solely or in comparison with practisingpharmacists. This may be explained by the fact that manystudies set out to inform the teaching of ethics at theundergraduate level. Indeed, even studies that sought toexplore practising pharmacists’ understanding of ethics, suchas the study by Hibbert et al , also aimed to be of use in theundergraduate pharmacy curriculum (Hibbert D, personalcommunication, 2004). Although most studies valued theethical views of students by virtue of their not being practisingpharmacists, students in the study by Dolinsky and Gottlieb 11 appeared to be used as proxies in relation to ethical dilemmas.Students were asked to describe two dilemmas that includedaltruism and self-interest but these could be drawn from eitherfirst-person experience or what students recalled about thedilemmas of other pharmacists. The authors concede that‘‘…the inferred reasons for actions probably tells us more aboutthe pharmacy student doing the inferring than about the levelof moral judgment of the pharmacist’’ (p 57). By contrast, andmore transparently, the aim of the study by Wingfield et al thatincluded pharmacy students was simply to determine theirperceptions of pharmacy ethics, and they concluded thatexposure to practice (as students progress through the four- year UK course) led to an increased awareness and under-standing of ethical issues. 23 Despite the direct pedagogical aimsof some studies, it may also be argued that student cohorts areused partly because they represent an easier research group torecruit and investigate, and are, in effect, a convenience sample.They are usually logistically, financially and temporally easier,as they may be closer to the researcher on campus, require lessremuneration (if any) for participating, and also have perhapsmore time to spare in comparison with practising pharmacists. Dilemmas and themes Having so far offered a critical review of the empirical ethicsliterature in pharmacy in terms of methodology, theory andsampling, the actual results of these studies and advances inknowledge that they have generated must not be ignored. What was evident from many of the studies was that the pharmacyenvironment seemed to be important in terms of shaping thetypes of ethical dilemmas or problems encountered and alsorelevant in terms of influencing the ethical reasoning of thepharmacist. This appeared to be especially important forcommunity pharmacy, and Chaar et al noted that problemsoccurred more often in the community setting than in otherareas of pharmacy practice. Haddad similarly identified moreethical problems in the community setting but also found thatactual work experience shaped pharmacists ethically. Bycontrast, Latif’s work repeatedly suggested that the communitypharmacy environment was detrimental to moral reasoning—pharmacists who had remained in practice longer tended tohave lower moral reasoning scores and there were also somedifferences between scores for independent pharmacists andthose who were employees; pharmacy students, who had notbeen exposed to the community pharmacy environment, alsoscored higher. However, the qualitative studies in this literaturereview provide a more complex picture of ethical influence. Forexample, Wingfield et al 25 found that although business andcommercial values led to ethical issues such as controllingprofit and customer pressure, company and organisationalpolicies were also helpful in terms of dealing with ethicallyproblematic issues and in ‘‘guiding their thinking in difficultareas such as supply of emergency hormonal contraception’’.The pharmacists interviewed by Hibbert et al appeared to beeven more variously influenced—by self-interest, commercialand organisational values, and also legal concerns. The studyalso offered a considerable number of pharmacist-generatedethical concerns that provide a wealth of information about UK community pharmacy and that, for example, pharmacists oftenhave to deal with patient representatives and encounterconfidentiality issues; regulations relating to emergency sup-plies and controlled drugs lead to conflicts between benefitingthe patient and complying with legal requirements; supplyingsyringes to addicts to prevent health risks must be balanced bya concern about theft from the pharmacy; and that the code of ethics was not often referred to. The study by Cooper identifiedsimilar concerns among UK pharmacists, along with additionalcommercial ethical dilemmas relating to charging for mon-itored dosage systems, branded medicine substitution, pressureto link-sell medicines, concern for customer poverty and sellingconfectionery. In the study by Kalvemark et al , 26 Swedishpharmacists appeared to experience moral stress from issuesthat were related to time pressures in a hospital dispensary andto staff shortages. Similar concerns emerged in the study byHibbert et al , in that pharmacists expressed concern aboutchallenging prescribing doctors because of the perception of professional hierarchy and also having to balance breaking aregulation to benefit a patient.  A new prescription for empirical ethics research in pharmacy 85  group.bmj.comon December 2, 2009 - Published by  jme.bmj.comDownloaded from 
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