ethics applied to pharmacy practice

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10 Pharmacy World & Science Volume 22 Nr. 1 2000 Article Introduction Many of us use the word ethics or the idea ethics whenever we are in a position to reflect on conflicting interests of individuals, groups or systems. In private, professional or in public life, choices whether explicit- ly stated or not are to be made at various occasions. Today’s practice of pharmacy will reveal these choices in various fields: A choice for development of new medicines in private industry, the limitation of the health budget which means a choice between pri- vate and public interests or the choice between the autonomy of the patient and the autonomy of the care provider. The basis from which these choices are made is often created by traditional elements mixed with emo- tional and practical motives, rather then by a careful analysis of moral incentives in today’s human behavi- our. Today’s society asks for a rational approach to problems that result from conflicting interests. Moral principles which are not based on rationality will lead to conflicts between practitioners and society. Ethics applied to pharmacy practice • R.P.Dessing Pharm World Sci 2000;22(1): 10-16. © 2000 Kluwer Academic Publishers. Printed in the Netherlands. R.P.Dessing: Apotheek AAN ZEE, Parallelboulevard 214A 2202 HT, Noordwijk, The Netherlands E-mail:[email protected] Keywords Adverse effects Autonomy Cost control Medication surveillance Nonmaleficence Pharmaceutical care Pharmaco economics Pharmacovigilance Pharmacy Pharmacy profession Philosophy Abstract This article tries to develop an ethical reasoning that can be applied to (the practice of) pharmacy. Only general principles, based on accepted values in western society, lead to guidelines for ethical behaviour. Such essential values are personal autonomy, democracy and solidarity.The principle of nonmaleficence can be derived from these. Results of this analysis can be applied to health care and pharmacy practice. Subchapters deal with questions such as budget limitations and the autonomy of the patient versus that of the care provider. It concludes that protocols are important tools for ethical behaviour in every day practice. The ethical problem appears to be the unequal access to the health care system. An analysis of pharmaceutical care in the light of ethics can help to formulate the pharmacist’s responsibilities. The principle of nonmaleficence is strongly connected to the pharmacy profession. Pharmacists should focus more on possible negative outcomes of pharmacotherapy. Monitoring the patient’s medication, identification and prevention of possible adverse effects, medication surveillance, proper communication and information about the use of medicines are therefore priority items within our profession. A definition of target groups for pharmaceutical care will facilitate this task. A suggestion for a general code of ethics for pharmacists is proposed and compared with the code of ethics as currently accepted by the International Pharmaceutical Federation (FIP)- council. Accepted December 1999 This article tries to build up a rationality based on principles that have been generally respected and accepted in western society for almost a century. It seeks to apply it to the practice of pharmacy and to related fields in healthcare. Can we identify ‘universal’ values? As a first step, it is necessary to analyse the nature of todays western society it’s organisation and it’s individual’s in terms of belief, values and practical behaviour. Moral values and ethics do not seem to be dependent on metaphysical ( = based on any ‘objec- tive external, non physical reality) principles any more [1 2]. People often consider moral principles as something that rises above culture and tradition. They see it as something objective. As an example one could accept the virtues as defined by Aristotle as ‘supra cultural’ values [3]. But till now it is not pos- sible to prove that this type of ‘supra cultural’ princi- ples have eternal validity [4]. The only thing that you could suggest is that if there is a set of ‘universal’ principles, these principles will manifest themselves in different ways in different places and different times, depending on culture and tradition. One should accept that every culture explains and applies these ‘virtues’ in it’s own way. We don’t even know exactly how they were understood in the time and place of their conception. All literature that we depend on is secondary and for that reason is influenced by cultures that passed information on to following generations. A second important example of a philosopher who tried to formulate these ‘eternal values’ was Kant. His contruction of ethical principles is elegant but his main ‘universal principle’ that ‘I should always act in such a way that my behaviour could be a universal law of nature’, is disputable [5]. An interesting point is that Kant claimed that we are not only bound by this law but we can consider ourselves as authors of this law at the same time. In this way he introduced the concept of personal autonomy. The idea of people being free human beings, free to think and free to act in matters of morality. Freedom is essential to make choices. Essential values in today’s western society Today many people accept that there is no set of uni- versal and transculturally valid moral principles. The local conception of what is a ‘good’ life, a ‘happy’ life, a ‘healthy’ life and what is ‘quality’, plays an impor- tant role. The actions and decisions of individuals need to be examined in terms of values of the society to which they belong. The consequence is that ethics should be observed through windows of time and place. It means that in ethics people can have differ- ent opinions about what are ‘moral principles’. The consequence is that you can disagree about a particular view of ethics and the application to phar- macy profession if you disagree about values that we consider in our western culture as fundamental.

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Page 1: Ethics applied to pharmacy practice

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Pharmacy W

orld & ScienceVolum

e 22 Nr. 1 2000

Artic

le

IntroductionMany of us use the word ethics or the idea ethicswhenever we are in a position to reflect on conflictinginterests of individuals, groups or systems. In private,professional or in public life, choices whether explicit-ly stated or not are to be made at various occasions.

Today’s practice of pharmacy will reveal thesechoices in various fields: A choice for development ofnew medicines in private industry, the limitation ofthe health budget which means a choice between pri-vate and public interests or the choice between theautonomy of the patient and the autonomy of thecare provider.

The basis from which these choices are made isoften created by traditional elements mixed with emo-tional and practical motives, rather then by a carefulanalysis of moral incentives in today’s human behavi-our. Today’s society asks for a rational approach toproblems that result from conflicting interests. Moralprinciples which are not based on rationality will leadto conflicts between practitioners and society.

PHAR 230 pips 257914

Ethics applied to pharmacy practice• R.P.Dess ing

Pharm World Sci 2000;22(1): 10-16.© 2000 Kluwer Academic Publishers. Printed in the Netherlands.

R.P.Dessing: Apotheek AAN ZEE, Parallelboulevard 214A2202 HT, Noordwijk, The NetherlandsE-mail:[email protected]

KeywordsAdverse effectsAutonomyCost controlMedication surveillanceNonmaleficencePharmaceutical carePharmaco economicsPharmacovigilancePharmacyPharmacy professionPhilosophy

AbstractThis article tries to develop an ethical reasoning that can beapplied to (the practice of) pharmacy. Only general principles,based on accepted values in western society, lead to guidelinesfor ethical behaviour. Such essential values are personalautonomy, democracy and solidarity.The principle ofnonmaleficence can be derived from these. Results of thisanalysis can be applied to health care and pharmacy practice.Subchapters deal with questions such as budget limitationsand the autonomy of the patient versus that of the careprovider. It concludes that protocols are important tools forethical behaviour in every day practice. The ethical problemappears to be the unequal access to the health care system.An analysis of pharmaceutical care in the light of ethics canhelp to formulate the pharmacist’s responsibilities. Theprinciple of nonmaleficence is strongly connected to thepharmacy profession. Pharmacists should focus more onpossible negative outcomes of pharmacotherapy. Monitoringthe patient’s medication, identification and prevention ofpossible adverse effects, medication surveillance, propercommunication and information about the use of medicinesare therefore priority items within our profession. A definitionof target groups for pharmaceutical care will facilitate this task.A suggestion for a general code of ethics for pharmacists isproposed and compared with the code of ethics as currentlyaccepted by the International Pharmaceutical Federation (FIP)-council.

Accepted December 1999

This article tries to build up a rationality based onprinciples that have been generally respected andaccepted in western society for almost a century. Itseeks to apply it to the practice of pharmacy and torelated fields in healthcare.

Can we identify ‘universal’ values?As a first step, it is necessary to analyse the nature oftodays western society it’s organisation and it’sindividual’s in terms of belief, values and practicalbehaviour. Moral values and ethics do not seem to bedependent on metaphysical ( = based on any ‘objec-tive external, non physical reality) principles any more[1 2]. People often consider moral principles assomething that rises above culture and tradition.They see it as something objective. As an exampleone could accept the virtues as defined by Aristotle as‘supra cultural’ values [3]. But till now it is not pos-sible to prove that this type of ‘supra cultural’ princi-ples have eternal validity [4].

The only thing that you could suggest is that ifthere is a set of ‘universal’ principles, these principleswill manifest themselves in different ways in differentplaces and different times, depending on culture andtradition. One should accept that every cultureexplains and applies these ‘virtues’ in it’s own way. Wedon’t even know exactly how they were understoodin the time and place of their conception. All literaturethat we depend on is secondary and for that reason isinfluenced by cultures that passed information on tofollowing generations.

A second important example of a philosopher whotried to formulate these ‘eternal values’ was Kant. Hiscontruction of ethical principles is elegant but his main‘universal principle’ that ‘I should always act in such away that my behaviour could be a universal law ofnature’, is disputable [5]. An interesting point is thatKant claimed that we are not only bound by this lawbut we can consider ourselves as authors of this law atthe same time. In this way he introduced the conceptof personal autonomy. The idea of people being freehuman beings, free to think and free to act in mattersof morality. Freedom is essential to make choices.

Essential values in today’s western societyToday many people accept that there is no set of uni-versal and transculturally valid moral principles. Thelocal conception of what is a ‘good’ life, a ‘happy’ life,a ‘healthy’ life and what is ‘quality’, plays an impor-tant role. The actions and decisions of individualsneed to be examined in terms of values of the societyto which they belong. The consequence is that ethicsshould be observed through windows of time andplace. It means that in ethics people can have differ-ent opinions about what are ‘moral principles’.

The consequence is that you can disagree about aparticular view of ethics and the application to phar-macy profession if you disagree about values that weconsider in our western culture as fundamental.

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An example of a value which can be considered asbasic is the individual’s autonomy. Autonomy can bedefined as the individual’s right or freedom to exist, toact, to think and to communicate [6].

A definition of this principle will give importantmotivation to moral and ethical guidelines. Throughthis perception morality and ethics can be developedin a rational way. It implies that new moral principlescan be introduced, after a careful analysis and athorough debate with participation of the partieswhich are directly involved and with society. Thispoint reveals a connection to the Greek philosophers:Aristotle explained already that ethics meant actingwithin and with society itself. In other words ethicswas connected to politics, to the public life [7].

This approach demonstrates also the limitations ofthe autonomy concept. Public life is organisedaccording to democratic rules which should berespected, as they represent a synthesis or equilibriumbetween individual autonomy and man being part ofsociety. The political basis for individual liberty wasformulated by the French thinker Montesquieu.Democracy is not a rigid protocol. A democraticsystem can function at various levels. But in practiceour society is organised as a state and democracyorganised as the system of the parlementary democ-racy. It includes the separation between the legative,executive and judicial powers. Through the commoninterests of all individuals, democracy will result in aform of solidarity. It will not result in the maximumform of solidarity as proposed by Levinas [8], whereonly the OTHER is the leading principle. In thisabstract and strictly philosophical approach, thechoice between personal interest and the interest ofthe other human being will always be in the interestof the OTHER. It would be impossible to make anychoice in personal life(9).To summarise: our reasoning implies that ethics andmorality are a result of a rationality, not of somesupernatural objectivity. Values which are consideredas ‘essential’ in today’s western society are theindividual’s autonomy, democracy and solidarity.

How to interprete these values in healthcarepractice?

AutonomyIf the individual’s autonomy is an important leadingprinciple in todays morality all efforts of society shouldbe mobilised to maintain this quality. Disease is one ofthe conditions that affects or at least threatens autono-my. At this point the connection between our profes-sion and this fundamental ethical principle is revealed.When a person has a health problem, activities ofhealth professionals should be aimed at analysingwhere, how and to what degree the individual’s auton-omy is threatened or compromised by this condition.One should careful analyse all elements or fields whichare covered by the forementioned definition:‘Autonomy means freedom to exist, to think, to actand to communicate’. The request of the patient to thehealth care provider will always relate to this principle.But to regard a person who is a ‘patient’ as an autono-mous human being is more complicated than it seemsat first sight.

An example: Take for instance the autonomy as

seen in terms of civil rights. According to law, a per-son has a democratic right to vote until the last sec-ond of his life and almost regardless of his mental orphysical condition.

But in healthcare, the mental and physical state willdetermine whether a part of the individuals right todecide over herself or himself is (perhaps unintention-ally) taken away and transferred to some ‘professional’. Later, I will refer to this in the frame of‘informed consent’ as a part of this process.

In practice, a patient with an illness or health prob-lems will ask for help. It means that a patient asks forassistance to inhibit possible worsening factors, tostabilise the personal health condition and if possiblefor a total restoration of autonomy.

All solutions will have a central theme: A properassessment of the factors which threaten personalautonomy and which are therefore the subject ofinteraction between patient and health care profes-sional. This will include a closer look at techniqueswhich are required to get proper access not only tothe body but also to the mind of the patient in orderto verify that both parties understand each otherproperly in respect of the personal health-topic [10].

Democracy and solidarityIs it immoral to discuss cost in health care [11]. Is itunethical behaviour to refuse a treatment to a specificpatient for financial reasons?

First, healthcare as a common good is strongly connected to democracy. The result is that the statethrough democratic procedures plays a vital role inorganising the availability and activities in the health-care field. At the other side, there is a huge innovating,privately organised health care industry. The publichealth budget is per definition insufficient to meet allpossible requests for support.

And within the various sections in health care thereis competition as well. Take for instance pharmaco-therapy: today it is clear that the costs of drug treat-ment are in competition with the costs of other fieldsof care: care for the elderly, care for the mentally ill,drug addicts etc.

This all reveals fundamental and controversial inter-ests. And it implies that ethical questions are at stake.As we pointed out before, the individual’s autonomyis one of the leading principles and an important cor-nerstone for ethical behaviour. But at the same timewe know that a compromise between this autonomyand general interests is necessary to avoid a climate ofanarchy.

In daily life, these types of compromises are real-ised on many levels. To compromise in this respect isin fact an important result of our upbringing. On alarger scale, in society, we know that total autonomywithout a controlling system would result in thestrongest individuals making the rules. A societywould emerge where a large part of the populationwould be condemned to poverty and dependence. Asociety where many health provisions would not beaccessible for a significant part of the population.Such a picture is recognisable to some minoritygroups in various megacities in the (western) world.These limitations for individual behaviour and thepolitical consequences where already recognised bythe american philosopher Richard Rorty in his bookContingency, Irony and Solidarity (1989) [12].

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Rorty explains that a certain level of solidarity guar-antees a society that is stable enough to secure indi-vidual safety and prosperity. In fact, the public agree-ment about this is translated in a democratic politicalsystem which forces by majority vote every citizen tocomply with this system. The result is a constant anddynamic tension between what Rorty calls the privateand the public domain.

The practice of pharmacy

Clinical researchThe main purpose of clinical pharmacology researchis to investigate whether a specific treatment withmedicines has an effect in terms of benefit versus risk[13]. Outcomes from a particular trial show positiveeffects on the patients condition. Or they indicate noeffect or a worsening of the patients health. In the ter-minology of ethics it is an assesment of the effects ofthe drug on the patients autonomy. This approachbecomes really complicated when we study theeffects of medicines which should prevent diseases.The so called ‘number needed to treat’ (NNT, whichmeans the number of persons that must be treated toprevent one defined incident in a certain period or tohave one succesful treatment) should be ideally 1. Formany (preventive) therapies the NNT is much higher,up to a few hundred to be treated for many years.Apart from the financial aspects, it means that oneperson will benefit from this stategy but simultane-ously many persons will gain nothing, but will be ‘medicalised’ for a long time, while others definitelyexperience adverse effects. These effects are neverfully quantified (or published?) and balanced againstthe one ‘fatal’ accident. Is this a matter of ethics,where ‘to avoid death’ is the leading principle?

This balancing is a culturally dependent process. Adifferent society could have different ‘moralstandards’ with respect to this process. The standardsfor such an evaluation are developed by professionalswho hopefully present the results as clear choices tothe public. At this level there should be a thorough,creative and imaginative discussion. The conclusionsshould be accepted on a democratic-political level. Sofar it seems to be a clear pathway. But then we impli-citly assume that every individual will have personalvalues which comply with this system. The question isif we accept the result of a group decision if it touchesour personal life.

A specific clinical study may seem sound and logi-cal but ethical issues are always concealed in this pro-cess. The ethical aspects become more clear later,when practitioners must apply this knowledge on alarger scale in daily life. It brings forward the relationbetween knowledge, research, innovation and phar-macotherapy practice. How does a general conclu-sion from a study match with the individual’s beliefand moral feelings. What type of relation existsbetween these elements and the interests of societyas a whole? It is clear that today we think that theresponsibility of the practitioners, of the researchersand of the politicians is that they should find thegreatest possible fit between ‘general interests’ andthe individuals sense of justice. That they should evendevelop provisions for exceptions to the general rules.But can the tension between individualism and soli-

darity be avoided? Is healthgain the most importantvariable in life compared with other aspects of well-being? For instance employment, or a chance to havechildren?

The health care cost dilemmaTo take health care: Society decides to limit the healthbudget, being aware of numerous claims of groupsand individuals on public finances. As a consequencethe so called ‘right’ of the individual for medical treat-ment is in practice reduced to only that volume thatsociety is prepared to pay for. Moreover, we shouldrealise that health, maintaining health and healthgain is not exclusively a result of medical treatment. Itwill also lead to a discussion about the effectiveness ofa particular treatment. Pharma-economics can behelpfull to develop a cost-related protocol for treat-ment of a group of individual’s. A debate about prior-ities in the field of healthcare and in society in generalwill be the result. There we meet the private interestsof individuals. Should limited resources be mobilisedfor people who for there own convenience perform a‘risky’ lifestyle : smoking, bad food, drinking, wearingno seatbelts??

At the same time one could formulate the ques-tion: What is the relation between the well-being ofthe individual, even with the risky lifestyle, and that ofsociety as a whole? Moreover, we should not overesti-mate the impact of (pharmaco-)therapy. As we sawbefore, for many medicines the effect is predictableonly on the basis of statistics, which do not give anyguarantee for effects in the individuals. The same rea-soning can be applied to the ‘risky’ lifestyle.

The role of protocols and formulariesToday,protocols are a popular tool to secure ‘quality’.‘Quality of outcome’ translated as: an optimised, pre-dictable and more uniform outcome of a specifiedintervention. In pharmacotherapy it implies that aspecific disease, indication or problem is treatedaccording to principles of ‘evidence based medicine’.A compilation of protocols in a particular practice,region or country is called a ‘formulary’. Protocols aredesigned within a group of professionals and subse-quently communicated to the professional domainand to society. ‘Society’ means in our culture the ‘people’ ,the politicians, the decision makers.

The responsibility of professionals is to present theirchoices in an clear and unambiguous way. Theresponsibility of politicians is to oversee the total fieldof requests for public interference in individual’s livesand to communicate their view to the electorate. Theresponsibility of the individual is to recognise his oftenambiguous role in society. Today a healthy prosper-ous individual might simultaneously be a shareholderof a pharmaceutical company, a subscriber to anhealth-insurance company, a member of a pensionfund which invests in cigarette industry and possibly apatient at the same time? Recognition of these differ-ent qualities and resposibilities is very important andwill appear to be fundamental for an acceptance ofthe daily consequences of any decision concerning(personal) healthcare.

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Democracy, budget restrictions and unequalaccess to health careAnd what about minorities? Will 51% of the peopledecide about the access to health provisions of theother 49%? In a modern democratic society thisdemocracy has many faces. As I pointed out before, itis not only the parlamentary forum were the decisions,for instance about health care, are taken. In manycountries democracy functions on a state level, in thelocal community, by means of membership of a tradeunion, possibly in the church, in consumer organisa-tions and through a critical press. Legislation organis-es the role and responsibilities of insurance compa-nies and other health related industry in society [14].An individual can play more than one role in thiscomplicated arena. A particular person could eventake various standpoints depending on the forum andtime. This leads to a result which is much more com-plex than the output of a one-dimensional ‘demo-cratic’ decision. The result will mould into concreteforms of solidarity. An acceptable form of limitation ofthe personal autonomy emerges. The result can beseen as the product of a much more complicated, butat the same time more mature society and shouldtherefore be respected carefully [15].

In practice, many of us will sometimes face thequestion of a very expensive medicine or treatmentthat exceeds by far the health budget. If there hasbeen a discussion and a consensus in a practice, in ahospital or in a country how to act in such a case. Ifthis is covered by public agreement, then it is notimmoral nor unethical behaviour to follow such a pro-tocol, even in the case that one has to abandon treat-ment for an individual. It is the result of the balancebetween the well-being of the individual and thewell-being of society.

The responsibility of pharmacists and doctors is todevelop protocols, which respect patients as individu-als and discuss these in public. Only balanced andupdated guidelines will protect health practitionersfrom unbalanced moral dilemmas. Following thisroute, we are still free human beings who decide fortheir own, instead of people who’s decisions are dic-tated by technological possibilities. A clear public dis-cussion will show society where the ethical questionsare [16 17]. They will force society to take a position,not to hide from its responsibility and leave it to prac-titioners. A dynamic process of discussion, develop-ment and updating of guidelines and protocols, willbe necessary to adjust to changes in time and thechange in generations, in other words to the changesin culture.

A practical case which demonstrates how difficult it isto apply these conclusions to the workplace was pub-lished in a Dutch medical journal in the beginning of1998 (18 19). The use of taxoids for a number ofdefined indications appeared to differ from one hos-pital to another, mainly due to financial reasons. Itwas concluded that financial motives were respon-sible for the unequal access of patients to this type ofcare. It is that inequality which represents the ethicalproblem.

Pharmaceutical careThe term ‘pharmaceutical care’ is often confusing for

people within and outside the field of pharmacy. The‘pharmaceutical care’ concept was originally intro-duced by Hepler and Strand as a clinical protocol tochange the role of the (clinical-) pharmacist and hisplace in pharmacotherapy [20]. It tries to organisepharmacotherapy as a more consistent and coherentprocess. The word ‘pharmaceutical’ refers to pharma-ceuticals and for that reason many people think that itis something unique to the pharmacy discipline. Butin fact it is a multidisciplinary approach to a moreconsistent form of pharmacotherapy which emphasis-es on the individual patient, on flexibility and evalua-tion of outcomes from treatments with medicines.

The principle ‘to restore the individual’s autonomy’does not simply translate to ‘to cure’ or in ‘makingthe patient better’. It is widely known that patientswith a health problem are primarily focussed on iden-tification of the nature of that particular problem. Thestate of ignorance, the feelings of insecurity, are oftenvery threatening for a persons well-being. The back-ground of this phenomenon is probably based onbeliefs of western-technology oriented people thatidentification of a problem will be a first step in a pos-sible healing process. This attitude requires a certainexperience from the health care professional in assess-ing the patients feelings, desires and other fundamen-tal elements of that patient’s autonomy (21). Itimplies that the health care professional is properlytrained and experienced in communication with theindividual’s mind and body. When we refer to ‘informed consent’ we must realise that this is the out-come of a complex series of interactions. Psychologyas a science and skill supports this complicated andnot very well understood process.

The relationship between ‘informed consent’ andthe autonomy principle is essential. Only a situationof informed consent, of an open and effective com-munication with a health care practitioner, will createspace for decisions that respect autonomy.

Conversely, patients should also be educated tofeel responsible and to learn to be a partner in health-care. Because the respect for other persons appliesequally to the patient. It will be clear that the health-care professional has also rights in respect of his per-sonal autonomy. In the case of a person’s request forabortion or euthanasia this fact is clearly recognisedby legislation and by professional organisations. Tosummarise, the patient assesment is not a one wayprocess. It rather requires the patient’s contribution asan autonomous and responsible participant.

The pharmacist’s responsibilitiesAs far as this point, individual health problems andthe interaction between patient and the medical-diagnostic discipline does not reveal a clear task forthe pharmacist. One could see the pharmacist mainlyas a specialist in toxicology. He or she could informother practitioners about adverse effects of medica-tion in general. Pharmacy will then be considered as asupporting discipline of the physician analogous toradiology, clinical chemistry or microbiology.

But in special circumstances and in a proper struc-ture, one could think of a more active role of pharma-cists. He or she could alert the physician on possibletoxic effects of an individual’s pharmacotherapy regi-men [22]. One could imagine a personal contact

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between pharmacist and patient regarding this mat-ter. But lack of personal patient data and confidential-ity hinder an effective procedure. If one takes a closer look at responsibilities, the role ofthe pharmacist starts at the point where, on the basisof clinical assesment of the patients condition in thebroadest sense, a therapy with medicines is consid-ered. Based on personal experience, the first priorityof the health professionals is to stabilise the patientscondition, actually to stop a possible worsening pro-cess. The responsibility of the pharmacist overlapswith this principle. It means that he is bound from anethical point of view, to verify whether any pharmaco-therapy meets this principle.

In pharmacy practice we know that many medi-cines harm people instead of curing them[23 24 25]. This is because medicines are being test-ed and approved on the basis of statistical procedures.For instance, a particular painkiller is declared to be ‘effective’ if 60 out of 100 persons have a lower pains-core compared to 40 out of 100 in a placebo group.At the same time, 8 or 10 persons might reportadverse effects such as nausea, gastritis or even anpeptic ulcer problem. Does this fact imply that adefined portion of harm is accepted by society as aconsequence of ‘pharmaceutical technology’? Is it thesame psychology according to which society acceptsthousands of death and wounded as a consequence ofmotorised traffic?

No, we should realise that pharmacists are educat-ed to minimise these risks in pharmacotherapy. Withrespect to this, they could focus on relevant details ofclinical trials and apply the results in practice. Thenmany cases of deterioration of a patients conditioncould be probably avoided.

This principle is recognised in many types of ethicaltheory. It is called the principle of nonmaleficence[26]. In medical ethics it is known as ‘Primum nonnocere’: ‘Above all do not harm’. In a circumstance ofconflict, it is considered to precede over ‘beneficence’.

This principle sounds rather defensive. But, consid-ering the potential danger of pharmacological activesubstances, ‘non nocere’ has through the centuriesbeen an vital task for pharmacists. Which is reflectedin most national legislations. They all show consis-tently that the responsibility of pharmacists towardssociety is still based on the potential toxicity of drugs.

Can we relate care and autonomy in healthcare?In care-ethics the patient’s needs or want’s are theleading principle. Tronto [27] defines care as a contin-uous process in which four elements can be distin-guised: Caring about (which can be considered asinvolvement), to take care of (which implies to takeresponsibilities), care- giving (to take action) and thecare receiving phase (which includes an assessment ofthe effectiveness). In all of those four steps, there is arole for the pharmacist. Sometimes this will be aminor role, sometimes a more pronounced one. Toparticipate in this process means to have a relation-ship with patients. For pharmacists, it means that weshould take care of those patients who need extrasupport, or patients who are vulnerable to adverseeffects of medicines. This relationship should bebased on an effective communicative process as

described before. It implies qualifications such asknowledge, training and skills. It would make clearthat a specific pharmacotherapy is meant to restorethe patients capacity to be him or herself, to restorethe maximum achievable autonomy, not to worsen it. The question is, how can we connect ‘needs’ to theautonomy idea? How does ‘needs’ fit in the informedconsent principle? How can we fit profesionnalresponsibilities in this process without ‘taking over’from the patient?

First, we must realise that care (giving and -receiv-ing) is a continuous process. Care is not a series of iso-lated happenings. Every moment, every action has aclear connection with the past and coming events.The care process is a period in a person’s and patient’slife. During this period there will be shifts in depen-dence: from more dependent to less dependent andback, from more autonomy to less autonomous. Itincludes efforts to foster and effect that person’s out-look on her or his interests [26]. During the treatmentperiod there will be a dynamic equilibrium betweenresponsibilities of the care giver and the care receiver.The average position or the summation of positionsover this time will reflect how the patient’s autonomywas respected.

Target groups for pharmaceutical careHealthcare professionals work in a dynamic environ-ment. A healthy person today can be a patient tomor-row. That implicates that the identification of targetgroups and individual’s for pharmaceutical careshould be performed on a continuous basis. Eachgroup will have specific needs in the field of pharma-cotherapy. Assessment of these needs implies that wedevelop scientific and social criteria and tools to fulfillthose needs together with other health care practi-tioners. This very dynamic task requests great effortsfrom pharmacy practitioners [28]. If performed well,it will fully occupy the pharmacist and leave hardlyany space for commercial or administrative activities.

One can conclude that from an ethical point ofview , an increased attention for chronic patients andthose with a high consumption of medicines is a logi-cal pathway to our professional future [29]. The phar-macotherapy train could here go off the rails mosteasily, unless it is manned with skilled and dedicateddrivers. Again, this seems a defensive approach. But itis a fact that a passive attitude or negligence towardsongoing therapies potentially creates harmful situa-tions and should therefore be countered.The reduc-tion of risks associated with medicines thereforerequires active counseling, vigilance and interven-tions. In a favourable environment, it would alsoallow the pharmacist to point the physician’s orpatient’s attention to better alternatives.

I estimate that a discussion about the role of thepharmacist as a goalkeeper to avoid negative out-comes of pharmacotherapy would result in greatpublic endorsement today. So let that be our first mis-sion. This conclusion can be translated into practiceby advocating a more active role of pharmacists inactivities like medication surveillance, proper instruc-tions about the use of the drug, the systematic moni-toring of adverse effects and in the design of pharma-cotherapy-formularies.

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A proposal for an ethical code for pharmacistsIn 1997 a 9-points code of ethics was adopted by thecouncil of the FIP in Vancouver (table 1) [30]. It sum-marizes ‘principles’ to comply with in pharmacy prac-tice. In some cases it refers to ‘principles’ as defined inthis paper. But other statements are very practicalwithout a definition of the underlying notion. Such adetailed code for worldwide behaviour will centainlylead to confusion and misunderstandings. In myintroduction I already explained that cultural diffenc-es count for the fact that ‘principles’ will manifestthemselves in a different way on different places andin different times. For that reason we should define

more general statements, based on generally accept-ed principles and leave them to local interpretation.As we saw, in today’s (western) society the principlesof personal autonomy, democracy and solidarity canbe seen as essential values.

A code of ethics for pharmacists should thereforebe based on such a set of ethical principles. The codeof ethics should also link to other (health) profession-als: For instance the principle of nonmalificence. Acode of ethics for pharmacists could then be formu-lated as follows (in order of importance):

Table 1 FIP statement of professional standards: The code of Ethics for Pharmacists [26]

1 The pharmacist’s responsibility is the good of the individual.obligations:– to be objective,– to put the good of the individual before personal or commercial interests,– to promote the individuals right of access to safe and effective treatment,

2 The pharmacist shows the same dedication to all.obligations:– to show respect for life and human dignity,– to not discriminate between people,– to strive to treat and inform each individual according to personal circumstances.

3 The pharmacist respects the individual’s right of freedom of choice of treatment.obligations:– to ensure that where the pharmacist is involved in developing care and treatment plans, this is done in

consultation with the individual.

4 The pharmacist respects and safeguards the individual’s right to confidentiality.obligation:– to not disseminate information, which identifies the individual, without informed consent or due case.

5 The pharmacist cooperates with collegues and other professionals and respects their values and abilities.obligation:– to cooperate with collegues and other professionals and agencies in efforts to promote good health and

treat and prevent ill health.

6 The pharmacist acts with honesty and integrity in professional relationships.obligations:– to act with conviction of conscience,– to avoid practices, behaviour or work conditions that could impair professional judgement.

7 The pharmacist serves the needs of the individual, the community and society.obligation:– to recognise the responsibilities associated with serving the needs of the individual on one hand and

society at large on the other.

8 The pharmacist maintains and develops professional knowledge and skills.obligation:– to ensure competency in each pharmaceutical service provided, by continually updating knowledge

and skills.

9 The pharmacist ensures continuity of care in the event of labour disputes, pharmacy closure or conflictwith personal moral beliefs.obligations:– to refer the patient to another pharmacist.– to ensure that when a pharmacy closes, the patients are informed of the pharmacy to which their

records, if held, have been transferred.

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Page 7: Ethics applied to pharmacy practice

- To recognise and to respect the individual’s auton-omy.

- To follow and respect democratic principles- To prevent negative consequences of pharmaco-

therapy- To ensure the best possible treatment

These principles ask for a cultural and professionaltranslation. Local circumstances will show how thepractice of pharmacy can be optimised within thisframework. At the same time, the dynamics of thisconcept are attractive. It will enable pharmacists todiscuss professional questions with collegues, withother health professionals and with society in general.

Conclusion‘Abandoning the idea of objective truth in ethicsshould not mean abandoning the standards of consis-tency and relevance we uphold in other aspects ofour lives’ [4]. This means that a particular societycould agree on ‘general’ principles and rank them in aspecific order. A society with a great variety of cul-tures within it’s boundaries will find it more difficult tocope with this idea. Because the various culturalgroups can have different opinions about ‘essentialvalues’ [31]. But the individual’s autonomy, democra-cy and solidarity seem to be accepted in a widespreadarea today. A sharp definition of this basis shouldtherefore be fundamental for a definition of ethics inprofessional as well in personal life.

AcknowledgementsI like to thank Jan Flameling , philosopher, FilosofischBuro Ataraxia, Amsterdam; Maartje Schermer ,philos-opher, Academic Medical Centre AMC, Amsterdam;Steve Hudson, professor of pharmaceutical care,Strathclyde University, Glasgow, UK; for their inspiringdiscussions and remarks about this topic.

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