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Pharmacist Ethics and Professional Autonomy - Imperatives For Keeping Pharmact Aligned With The Public Interest
Pharmacist Ethics and Professional Autonomy - Imperatives For Keeping Pharmact Aligned With The Public Interest
Table of content:
Introduction........................................................................................................... 3
FIP Consideration of Pharmacist Ethics and Professional Autonomy ................... 3
Long-Standing Interest in Ethics ........................................................................ 3
Potential Erosion of Professional Autonomy .................................................... 4
Opinion of European Court of Justice ............................................................... 4
Symposium on Professional Autonomy ............................................................ 5
Review of Codes of Ethics.................................................................................. 6
Support of the Efforts of Others ........................................................................ 6
Survey of FIP Member Organisations .................................................................... 7
Literature Review .................................................................................................. 8
Contemporary Issues in Pharmacist Ethics ........................................................... 8
The WG identified the following four categories (with specific examples) of
ethical issues experienced by pharmacists in all areas of practice: .................. 8
Necessity of Professional Autonomy for Fulfilment of the Pharmacist’s Mission 9
Additional WG Observations and Findings .......................................................... 11
Threats to Professional Autonomy in Health Care .......................................... 11
Moral Courage ................................................................................................. 11
Universal Issue in Pharmacy ............................................................................ 11
Pharmacy’s Professional Transition ................................................................ 12
Opportunities for FIP ....................................................................................... 12
Oath / Promise of a Pharmacist ...................................................................... 12
Conclusion ........................................................................................................... 13
Appendix A – Members and Process of the FIP Working Group on Pharmacist
Ethics and Professional Autonomy ...................................................................... 14
Appendix B – Terms of Reference: Working Group on Pharmacist Ethics and
Professional Autonomy ....................................................................................... 15
Introduction..................................................................................................... 15
Objective ......................................................................................................... 15
Desired Outcomes ........................................................................................... 16
Working Group Process and Time Schedule ................................................... 16
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Composition .................................................................................................... 17
Appendix C—FIP Statement of Professional Standards: Codes of Ethics for
Pharmacists (2004) .............................................................................................. 18
Appendix D—Summary of FIP Symposium on Professional Autonomy
“Understanding, Preserving, and Protecting Pharmacists’ Professional
Autonomy” .......................................................................................................... 21
Objective of the Symposium ........................................................................... 21
Opening of the Symposium ............................................................................. 21
Corporatisation of Pharmacy Practice and Pharmacist Autonomy ................. 21
Market-Driven Pharmacist Services ................................................................ 23
Patient-Care-Driven Pharmacist Services ........................................................ 23
Case Studies on Seeking Balance between Market-Driven and Patient-Care-
Driven Approaches to Pharmacist Practice ..................................................... 24
Open Discussion .............................................................................................. 26
Summary and Conclusions .............................................................................. 26
Faculty of the Symposium ............................................................................... 28
Appendix E - Results of Ethics/Autonomy Survey of FIP Member Organisations
(September-December 2012).............................................................................. 30
Appendix F—Literature Review on Pharmacist Ethics and Professional
Autonomy ............................................................................................................ 32
Overview.......................................................................................................... 32
Background...................................................................................................... 32
Ethics in the Professional Life—Some Evolving History .................................. 32
Pharmacy as a Profession ................................................................................ 35
Lack of Recognition of the “Professional” Status of Pharmacists ................... 37
Challenges to Pharmacist Professionalism and Autonomy ............................. 37
Conflicts of Interest in Pharmacy—Duality of Interest ................................... 41
Pharmacists’ Relationships with the Pharmaceutical Industry ....................... 42
Pharmacists Working within the Pharmaceutical Industry ............................. 42
A Major Challenge: Corporatisation of Pharmacies and Diminishing Autonomy
......................................................................................................................... 43
Commodification (Commercialisation) of Healthcare and Divided Loyalties . 44
Conclusion ....................................................................................................... 45
References ....................................................................................................... 45
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Introduction
The Working Group (WG) on Pharmacist Ethics and Professional Autonomy was
appointed by the International Pharmaceutical Federation’s Board of
Pharmaceutical Practice Executive Committee (BPP ExCo) in April 2012 (see
Appendix A). The rationale for creating the WG was as follows:
The WG was requested (see Appendix B) “to write a report on the key issues
related to ethics, autonomy, and professionalism that face pharmacists in
contemporary practice settings around the world.”
This report offers a framework for thinking about and assessing issues related
to ethics and professional autonomy—issues of vital importance in pharmacy
and, indeed, in all the health professions. Separate from this report, the WG has
recommended to FIP officials steps that the Federation, its member
organisations, and others can take to ensure that pharmacists, regardless of
practice setting, have the motivation and the professional autonomy necessary
to always serve the best interests of patients.
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For a number of years, the annual FIP Congress has featured plenary sessions
on issues of ethics and professionalism associated with pharmacy’s expanding
scope of practice.
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The Court added, Member States can decide that “there is a risk that legislative
rules designed to ensure the professional independence of pharmacists would
not be observed in practice, given that the interest of a non-pharmacist in
making a profit would not be tempered in a manner equivalent to that of self-
employed pharmacists and that the fact that pharmacists, when employees,
work under an operator could make it difficult for them to oppose instructions
given by him.”
Many European Member States have been influenced by this Court opinion to
strongly favour pharmacist ownership.
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Nearly all of the respondents said they have a code of ethics for pharmacists in
their country, and more than half of them said that their code includes “explicit
guidance about professional autonomy.” The most frequently cited “barriers to
professional autonomy” were “interprofessional constraints (e.g., power
imbalance with doctors, hierarchy in the workplace, lack of cultural sensitivity
towards older colleagues)” and “financial pressures.” Next in frequency were
“political constraints on the profession,” “pharmacists’ lack of self confidence,”
and “pharmacists’ lack of motivation.”
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Literature Review
Although the WG did not have the resources to conduct a comprehensive
review of the world’s literature on pharmacist ethics and autonomy, Dr Betty
Chaar, co-chair of the WG, led the preparation of a selective review of English-
language literature on the topic (see Appendix F). In general, this review
showed a vast literature on ethical issues and professional behaviour in
pharmacy practice but limited discussion of pharmacist autonomy. However, it
must be noted that professions by definition have a high degree of autonomy
and self-regulation, and it is self-evident that any threats to these essential
features of professions have the potential of eroding practitioners’ ability to
serve clients unencumbered by conflicts of interest.
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h. Counterfeit drugs.
i. Conflict of interest in continuing education presentations.
j. Conflict of interest in publishing research findings.
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Moral Courage
Immense strength of character (moral courage) is often required for health
professionals, including pharmacists, to resist employer or insurance mandates
that are economically motivated and contrary to the best interests of patients.
The moral courage of individual health professionals, including pharmacists, can
be buttressed through support from mentors, peers, and professional
associations.
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Conclusion
Throughout its history, the profession of pharmacy has served humanity well
around the globe. Although pharmacy has great potential for extending its
record of service, it faces many obstacles in attempting to do so, not the least
of which are challenges related to professional ethics and autonomy. Pharmacy
cannot achieve its full potential, and patients will not benefit from that
potential, unless pharmacists are committed to the highest standards of
professional conduct and have sufficient autonomy to serve patients’ best
interests. In explicating the most important dimensions of this issue, this report
reinforces FIP’s long-standing support of ethical principles, and it suggests the
need for FIP to also strongly advocate for a sufficient measure of pharmacist
autonomy in all sectors of the profession.
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Co-chairs:
Betty B. Chaar (Australia)
William A. Zellmer (United States)
Members:
Nkwenti Davidson Achu (Cameroon)
Daisuke Kobayashi (Japan)
Arijana Meštrović (Croatia)
Sirpa Peura (Finland)
Farshad H. Shirazi (Iran)
Luc Besançon (FIP)
The WG was appointed in April 2012 and met in July 2012 at FIP headquarters
in The Hague and in October 2012 at the FIP Congress in Amsterdam.
Other work was conducted via electronic communications.
The final version of the report, dated 25 September 2013, takes into account
comments from the Council.
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Introduction
FIP leaders have devoted substantial attention in recent years to issues related
to pharmacist autonomy, stimulated in part by movements in some countries to
liberalise laws that limit community pharmacy ownership to pharmacists. When
pharmacists are employed, whether by a pharmacy owner or a health care
institution, the tension between the professional imperatives of the practitioner
and the financial interests of the owner or institution may compromise the
professional service provided to patients. An official FIP document on this topic
would serve to broaden understanding within pharmacy and among consumers
and public officials about why these issues are important and what steps should
be considered to ensure that the public receives optimal value from the
profession of pharmacy.
Objective
The objective of this working group is to write a report on the key issues related
to ethics, autonomy, and professionalism that face pharmacists in
contemporary practice settings around the world.
The report should be drafted with the intent that it will be officially adopted
and disseminated by FIP.
The primary facets of the report should be as follows:
1. Discussion of the general relationship between pharmacist professional
autonomy (in all sectors of practice) and the responsible use of
medicines.
2. Discussion of the importance of practitioner autonomy in fulfilling the
profession’s societal mandate, highlighting the relationship between
pharmacist autonomy and public trust.
3. Discussion of the challenges related to ethics, autonomy, and
professionalism that confront practicing pharmacists, including why this
issue is important to the public.
a. Specific issues in community pharmacy practice (e.g., effect of
pharmacy ownership on pharmacist behaviour).
b. Specific issues in hospital pharmacy practice (e.g., effect of
institutional bureaucracy and financial imperatives on pharmacist
behaviour).
c. Specific issues in other areas of pharmacy practice, including
industrial pharmacy, long‐term‐care pharmacy practice and
population‐based pharmacy practice (i.e., pharmacy benefit
management companies).
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Desired Outcomes
The FIP Board of Pharmaceutical Practice Executive Committee (BPPEC)
requests that the report specifically addresses the following topics and make
related recommendations as appropriate:
1. How ethics, autonomy, and professionalism worldwide are:
a. Discussed in pharmacy codes of ethics and
b. Integrated into legal frameworks relating to the practice of
pharmacy.
2. Whether governments are influencing or overriding self-regulation in
the implementation of codes of ethics and in other means of controlling
the profession of pharmacy.
3. Importance of practitioner autonomy in fulfilling the profession’s
societal mandate.
4. Whether the pharmacist’s legal scope of practice allows for practitioner
intervention based on clinical judgment, as a facet of professional
autonomy.
5. Whether there is sufficient education and training of pharmacists in
ethics and professionalism.
6. Whether there are conflicts or dualities of interest in pharmacist
practice.
7. Whether financial factors affect pharmacist behaviour.
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The working group is requested to submit a draft of its report in time for review
by the BPPEC at the FIP Centennial Congress in October 2012 by and to manage
(in consultation with appropriate FIP leaders and staff) the overall process so as
to conclude its work by March 2013.
Composition
Among the interests or areas of expertise that should be considered for
appointment to the working group are the following:
Community pharmacy practice
Hospital pharmacy practice
Long-term‐care pharmacy practice
Population‐based pharmacy practice
Pharmacy academia
Pharmacy practice regulation
Professional ethics
Patient advocacy
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Against this background, and for this purpose, the FIP recommends that
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References:
1
FIP Statement of Professional Standards on the Role of the Pharmacist in
Encouraging Adherence to Long-Term Treatments (Sydney 2003)
2
FIP Statement of Policy on Confidentiality of Information gained in the course
of Pharmacy Practice (2004, New Orleans)
3
FIP Statement of Professional Standards on Continuing Professional
Development (2002, Nice)
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4
The Tokyo Declaration (1993) Standards for quality of pharmacy services (FIP
Guidelines for Good Pharmacy Practice, September 1993) and revised version
FIP/WHO GPP (1997, Vancouver)
5
FIP Statement of Policy on Counterfeit Medicines (2003, Sydney)
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Istanbul, Turkey
8 September 2009
The environments where pharmacists practice today are diverse and changing
rapidly. Dispensing services have been augmented with cognitive services. The
traditional model of a pharmacist owning his/her own pharmacy has given way
to the chains and multinational operators. Mail-order pharmacy and e-
pharmacy (e.g. internet) has changed the availability and accessibility of
services. The aim of this leadership conference is to examine how we can assure
that these changing conditions will continue to allow pharmacists to provide
independent professional judgments and decisions in the best interest of the
patient. The other aim is to discuss what kind of social contract we retain with
the patient and what kind of regulation is needed in order to provide the best
possible pharmaceutical care.
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Central to this topic is the issue of why society needs pharmacists. If the
pharmacist’s mission is only to provide the medicine, then society may support
other safe, efficient, and low-cost ways for that function to be performed.
However, if the pharmacist’s mission is to help people make the best use of
medicines, then the profession has a role that is of high value to society,
probably more satisfying to pharmacists, and perhaps more protective of
autonomy in corporate practice environments.
The educator Parker Palmer has written that many people today work for
businesses, institutions, and organisations to which they subordinate their
personal sense of what is right; in Palmer’s words, these individuals lead
“divided lives.” Palmer has argued that professional persons must be taught
how not to subsume their knowledge and ethics to the needs of the corporation
or institution that employs them. He has appealed to universities to prepare a
“new professional,” which he defines as “a person who is not only competent in
his or her discipline but [also] has the skill and will to deal with the institutional
pathologies that threaten the profession’s highest standards.” Palmer’s ideas
have direct application in pharmacy.
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Pharmacists must find the courage not to tolerate situations in which they are
prevented from exercising their professional autonomy and where work
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Although pharmacists in Australia are eligible for a $200 fee for a “Home
Medicines Review,” very few have been accredited to provide this service and
fewer than 5% of high-risk patients are offered the service because pharmacists
are preoccupied with supply functions in a market-driven model of practice.
The essential step on a path from the current situation is for pharmacists to
agree upon an aspirational goal and a model for delivery of patient-focused
pharmaceutical care. It would then be possible to establish a competency-based
training program and build mentoring systems for young and early-career
pharmacists. Pharmacists should be required to demonstrate competence in
the delivery of patient-focused pharmaceutical care as a prerequisite to
licensure. The FIP vision for patient-focused pharmaceutical care will be realised
only if individual pharmacists embrace the principles of the vision.
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European Union. John Chave said that optimal pharmacy practice requires both
(1) pharmacist behaviour focused on patient safety and appropriate health
outcomes and (2) patient and payer willingness and expectation to receive a
professional service based on knowledge and skill. Community pharmacists and
the European Commission are debating the following questions: are
pharmacists’ professional standards alone sufficient to resist commercial
pressures that could cause a decline in pharmacist services, and are
government regulations (e.g., restrictions on pharmacy ownership, limits on
pharmacy locations, and restrictions on the sale of nonprescription medicines)
in the public interest or do they only serve to protect pharmacists’ income and
reduce innovation? Community pharmacists believe that the following factors
may contribute to the decline of pharmacy: the European Commission’s
support of the “efficient markets” paradigm, the “consumer choice” paradigm,
excessive use of retailing to support pharmacy activities, and belief in the “self-
reliance” of informed patients. The limits of consumer sovereignty are
demonstrated by under-appreciated pharmaceutical risk, active resistance to
counselling, self-determined concept of adherence, acceptance of increased
risk for lower cost, preference for brand names over generics, requests for
advertised medicines, and preference for traditional remedies over evidenced-
based therapies. Current income levels of pharmacists, which are under
downward pressure, have positive societal value in terms of ensuring service in
less economically attractive areas, ensuring parity with comparable health
professions, and ensuring that good students are attracted to the profession.
Some regulation of the profession is necessary, but it must not be allowed to
stifle innovation.
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Open Discussion
The following points were raised by members of the Council in open discussion
following the formal presentations:
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that do not put the needs of patients first. As a profession, pharmacy has a
covenant with society, and its practitioners must behave appropriately to
preserve the public’s trust and to preserve their autonomy. Because of
prevailing social, economic, and political forces, there will continue to be
immense tension between corporate and professional imperatives in pharmacy.
The profession should address this tension forthrightly, actively studying the
context in which it functions and outlining a path that will preserve the
practitioner autonomy that is necessary for pharmacy to serve the public well.
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John Chave
Secretary General
Pharmaceutical Group of the European Union
Brussels, Belgium
Dominique Jordan
President
PharmaSuisse
Bern, Switzerland
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Monika Sidler
Delegate
Federation of Swiss Patient Organisations
Zurich, Switzerland
Nobuo Yamamoto
Vice President
Japan Pharmaceutical Association
Tokyo, Japan
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Strongly Strongly
Statement Disagree Agree
Disagree Agree
Pharmacists in my country understand 0 6 12 1
completely their ethical obligations.
In my country the profession devotes a lot of 1 6 8 3
time to promoting ethical behaviour.
In my country pharmacists receive good 1 5 12 1
education on profess. ethics.
My country’s code of ethics for pharmacists 1 2 12 3
includes explicit guidance about professional
autonomy.*
My country’s code of ethics for pharmacists is 1 6 10 1
up-to-date and reflects contemporary needs.
My country’s code of ethics is legally binding 1 3 12 2
(i.e., the pharmacist can be held responsible
and disciplined for breaking any of its
principles).
Consumers in my country expect the 0 2 10 5
pharmacist to give independent advice
without bias (conflict of interest).
Administration of a pharmacist oath at 0 1 12 6
graduation is important.**
Please indicate your level of agreement with the following statements: The following
factors are important barriers to pharmacists’ professional autonomy in my country:
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Strongly Strongly
Barrier Disagree Agree
Disagree Agree
Political constraints on the profession 0 3 11 4
Interprofessional constraints (e.g., power 0 2 9 8
imbalance with doctors, hierarchy in the
workplace, cultural sensitivity towards older
colleagues)
Financial pressures 0 2 5 12
Pharmacists’ job security 2 6 8 3
Pharmacist lack of self confidence 0 5 10 4
Pharmacist lack of ethical literacy (i.e., 1 10 3 5
knowledge and understanding of ethical
principles in pharmacy)
Lack of health literacy of the consumer (i.e., 1 5 10 3
ignorance of effect and side effects of
medicines; misunderstanding due to
advertising, etc.)
Legal restrictions 2 9 6 2
Pharmacists’ lack of competence, perceived 3 5 8 3
or real (i.e., feeling lack sufficient
contemporary knowledge and skills)
Pharmacists’ lack of motivation 1 4 10 4
*18 of 19 respondents said their country has a code of ethics for pharmacists.
**11 of 19 respondents said new pharmacy graduates in their country take an oath that
commits them to pursue their profession with high ethical standards.
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Overview
The following is a review of a selection of the English-language literature
relating to the undertakings of the Working Group on Pharmacist Ethics and
Professional Autonomy, International Pharmaceutical Federation (FIP),
conducted in February 2013. Considering the many languages in which ethics in
pharmacy has been written about, it was not possible to comprehensively
review all international literature; however, we believe the scope of the
literature in the English language sufficiently reflects the perspectives of the
majority of pharmacists around the world, particularly in relation to
professional autonomy.
Background
The changing environment in which pharmacy practice operates around the
world today is challenging in many ways, calling for pharmacists to reflect on
their professional ethics, in particular in relation to professional autonomy.
Pharmacy practice has seen the commodification of healthcare and a global
shift towards corporatisation, where pharmacy chains have steadily replaced
the traditional independent ownership model. In this environment pharmacists
appear to experience diminished autonomy, as they subsume their knowledge
and ethics to the needs of the corporation that employs them. Perceptions of
pharmacists as “dispensers” and “shopkeepers” and the lack of recognition of
pharmacists’ professional status have also resulted in young pharmacists across
the globe feeling a loss of professional identity and disillusion in the profession.
In the face of these challenges, pharmacists must re-evaluate how their role in
the healthcare team can fulfill their social mandate and benefit the patient’s
best interests. This review aims to provide a brief overview of the literature
pertaining to aspects concerning professional ethics in pharmacy, with a focus
on professional autonomy, conflicts of interest in healthcare and contemporary
challenges facing the profession of pharmacy today.
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Profound issues and perspectives about healthcare have come to the forefront
in modern history and into the 21st century. In particular, post World War II,
the emergence of human rights has been a driving social and political agenda in
healthcare. Movements such as consumerism, feminism and human rights
movements, have also immensely influenced ethics in healthcare.(5) In addition
to these influences, healthcare professionals operate today in an environment
of intense technical, pharmaceutical and medical progress, giving rise to many
ethical challenges in professional practice, as reflected in the main body of this
FIP Working Group report.
Ethics as it applies to the practice of pharmacy has, with only a few exceptions,
mainly been articulated in codes or pronouncements from professional bodies,
opinions in editorials, textbooks or debates. A few have engaged in
philosophical analysis of the core values in the profession.(7, 11-14, 96)
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Over twenty years ago, at a conference convened in the USA (1985) entitled
“The Challenge of Ethics in Pharmacy Practice,” the importance of codes and
the role of society in pharmacy ethics were examined. Principles such as
beneficence (“to do good”), respect for patient autonomy, veracity, promise
keeping, non-maleficence (“to do no harm”), and justice (both social justice and
distributive justice) were identified as pertinent to the practice of pharmacy.
Moreover, it was observed that with the advent of contemporary patient-
focused healthcare, a shift in ethical orientation in pharmacy practice had taken
place, rendering traditional paternalism no longer acceptable.(16)
Veatch (22) also launched a case-based series in the late 1980s that analysed 32
examples of ethical dilemmas in hospital pharmacy.(23, 24) The issues tackled
in this exceptional series reflected a vast scope of ethical challenges in the
practice of hospital pharmacy. Examples of issues covered were: maintaining
patient confidentiality, questioning motives for prescribing, pharmacists’ refusal
to supply a medicine (for a number of different reasons), conflicts of interest,
charging for drugs, a request to mislabel a prescription, patients’ right to refuse
medication, drugs in short supply, and unethical research.
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Pharmacy as a Profession
Professionalism in pharmacy has long been a contentious issue creating an
ongoing debate among healthcare professions about the status of pharmacy. A
profession itself as defined in Greenwood’s “Attribute Theory” is an occupation
with attributes such as: a formalised education process, a unique body of
knowledge, community-oriented values, a code of ethics, formal recognition
and ultimately the complete autonomy of the profession. Pharmacy meets all
these attribution criteria, there is no doubt, but there have been challenges
over time. Doubts have been raised concerning certain assumptions about
pharmacy’s professionalism, such as community-orientation vis-à-vis business
viability and aspects of autonomy in evolving business models.(36)
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1. Pharmacy does not have control over the social object of its practice:
medicine.
2. Pharmacy seems to be guided by commercial interests.
3. Pharmacy has not been able to define its professional functions and
roles properly.
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and guidelines, emphasizing integrity, care and prioritizing of patient safety and
principles of ethics in healthcare.
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The major challenge to this concept, however, is that the traditional model of a
community pharmacist owning his/her own pharmacy has given way to the
chains and multinational operators.(53) The majority of pharmacists around the
globe today are employed professionals in one way or another – either by
corporate bodies or by other individual pharmacists; and generally speaking
there are more pharmacists than there are positions. As such they are subject
to divided loyalties between their professional duties and their desire for job
security. (54)
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The fine line between a “duality of interest,” considered legitimate and realistic,
is often crossed to become a clear conflict of interest – which is regarded with
mistrust and disdain.(61, 62) We discuss this issue in further depth later in this
review. Whether the competitive model of community pharmacy, favoured by
many Western country governments, is a suitably ethical framework for the
profession, is a contentious issue. Some highly regulated Northern European
models of pharmacy practice could exemplify good balance between business
concerns and caring for the health and well being of patients/clients. (10)
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Pharmacist, Ethics and Professional Autonomy: Imperatives for Keeping
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Perepelkin et al. found that pharmacy managers (i.e., those in charge of the
pharmacy) working in a corporate pharmacy environment in Canada are less
orientated to their business role when compared to those working in an
independent or franchise pharmacy environment.(54) In addition, while
respondents in the same study rated their authority similarly, autonomy,
decision-making capabilities and control were found to be most limited among
corporate respondents and, to a lesser extent, among franchise managers.
Basak et al. in 2009 (47) revealed that the majority of ownership in India is by
non-pharmacists and the significant rise in the proportion of chain store
pharmacies in the last decade has seen pharmacists’ primary role reduced to
instantaneous dispensing,
without counseling.
Bush et al. (2009) found that corporatisation of the United Kingdom community
pharmacy sector may threaten to constrain attempts at re-professionalisation
through role extension and a drive for greater pharmacy involvement in public
health. (53)
United States and Canadian studies by Latif et al. suggested that the hospital
pharmacy environment was more conducive to clinical reasoning in that it was
devoid of individual financial conflicts of interest. It was found that pharmacists
who remained in practice longer received lower moral reasoning scores and
students also scored lower in moral reasoning scores after exposure to
community pharmacy (33-35, 82-90). Hibbert et al. noted the influence of self-
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Pharmacist, Ethics and Professional Autonomy: Imperatives for Keeping
Pharmacy Aligned with the Public Interest
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Pharmacy Aligned with the Public Interest
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Pharmacist, Ethics and Professional Autonomy: Imperatives for Keeping
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