Pharmaceutical Ethics Research Articles

The reason for having a code of pharmaceutical ethics: Spanish Pharmacists Code of Ethics

The pharmacist profession needs its own code of conduct set out in writing to serve as a stimulus to pharmacists in their day-to-day work in the different areas of pharmacy, in conjunction always with each individual pharmacist’s personal commitment to their patients, to other healthcare professionals and to society.An overview is provided of the different codes of ethics for pharmacists on the national and international scale, the most up-to-date code for 2015 being presented as a set of principles which must guide a pharmacutical conduct from the standpoint of deliberative judgment.The difference between codes of ethics and codes of practice is discussed. In the era of massive-scale collaboration, this code is a project holding bright prospects for the future. Each individual pharmacutical attitude in practicing their profession must be identified with the pursuit of excellence in their own personal practice for the purpose of achieving the ethical and professional values above and beyond complying with regulations and code of practice.

ФАРМАЦЕВТИЧНИЙ ПІДРОЗДІЛ ТА ТЕХНОЛОГІЇ ВИГОТОВЛЕННЯ ЛІКАРСЬКИХ ЗАСОБІВ

It was established two forms of organization of providing medicines and medical devices to patients of inpatient departments of health care facilities. The distribution of the presence of pharmacies licensed to manufacture drugs in the structure of the health care facilities by the studied regions of Ukraine was analyzed. It was established that the presence of a pharmaceutical department (pharmacy) in the structure of the departmental health care facilities allows to avoid possible risks that arise when organizing the provision of drugs by only one pharmacist in the health care facilities. It is substantiated that the role of pharmacies and pharmacists in the implementation of the therapeutic function of health care facilities is not only in the provision of drugs, as pharmaceutical prevention in departmental health care facilities is part of pharmaceutical care along with pharmaceutical diagnostics, pharmaceutical pharmaceutical assistance, pharmaceutical ethics and deontology, therefore it is inextricably linked with all elements of this complex concept.

Cultivation of Pharmaceutical Ethics and Pharmaceutical Skills of Pharmaceutical Students Before Internship

Cultivating students' moral and practical skills is an important teaching content in pharmacy teaching. The internship stage is the last training stage for the basic practical skills of pharmaceutical students. Before the internship, students should understand the rules and regulations of the internship unit, make clear the contents and objectives of the internship, strengthen the basic skills training of four pharmacy majors, which are prescription preparation, drug analysis and inspection and drug maintenance, and develop good pharmaceutical ethics.

EXPERIENCE IN DEVELOPING A WORKING PROGRAM AND APPROBATION OF THE DISCIPLINE "BASIS OF PHARMACEUTICAL ETHICS AND DEONTOLOGY"

The article discusses the experience of creating the work programs for the disciplines "Bioethics with the basics of deontology" and "Basics of pharmaceutical ethics and deontology" at the Department of organization, economics and history of pharmacy. The relevance of addressing this topic is that in the educational process of training a pharmacist there are no disciplines that give a first-year student an idea of what he will do in his future professional life, what tasks await him, what bioethical problems he will solve in his professional life. When developing of approaches to the creation of educational and methodological complexes, the main tasks of the discipline were formulated: consideration of the main stages of the formation and development of pharmaceutical ethics as an independent discipline; analysis of the main directions of pharmaceutical ethics with the studying of practical issues of the main problematics; developing ideas about the meaning of the activities of a pharmaceutical specialist in the modern pharmaceutical market within the framework of the ethical components of the profession. Approaches are described to the development of modules of the work program, of the choice of topics for classes and of the filling of the block "Students' independent work". A list of students' practical skills is offered: annotation and abstracting, compilation of grouping tables; application of methods of analysis in the study of ethical and deontological problems; conducting discussions
 and polemics; solving of situational problems in professional pharmaceutical activity from the standpoint of pharmaceutical ethics and deontology. It is concluded that it is possible to use the experience of the Perm State Pharmaceutical Academy in the development of work programs for the discipline "Basics of Pharmaceutical Ethics and Deontology" by other universities.

Ethical Evaluation of Pharmaceutical Marketing in Sana’a City, Yemen

Objectives: To evaluate the ethics of pharmaceutical marketing practices in Sana’a city, Yemen.
 Methods: A cross-sectional study was conducted among 400 physicians and 50 pharmaceutical companies in the period from March to August 2018. Data about pharmaceutical marketing ethics were collected from physicians and pharmaceutical companies using two types of self-administrated, structured questionnaires. Data were analyzed with appropriate statistical tests using IBM SPSS Statistics, version 21.0.
 Results: The majority of physicians (60.0%) agreed that medical samples had been used most frequently as a promotional tool for pharmaceutical marketing, followed by gifts (14.0%). More than half of physicians were satisfied with the way of pharmaceutical marketing in Yemen. Personal relationships and medical samples and gifts were the factors affecting their prescriptions, being reported by about a third of physicians each. Meanwhile, most physicians (44.0%) preferred medical conferences and exhibitions as a promotional benefit to be gotten for prescribing the company’s products. The majority of physicians (62.0%) agreed that the availability of medical samples affect their prescriptions, and about 28.2% of physicians reported that all medical samples are used by their patients. Most physicians (37.0%) perceived that only 50% of medical representatives respond well to their queries related to marketed drugs, and 41.5% of physicians agreed that global companies are more compliant with ethical marketing. About 60% of the physicians reported not facing unethical promotions, and the majority (54.0%) agreed that unethical pharmaceutical marketing is the responsibility of companies, physicians, and representatives. There was a statistically significant difference in the proportion of drug prescriptions affected by medical representative visits and availability of medical samples on prescription in relation to the work experience of physicians. On the other hand, there was a statistically significant difference in facing an unethical promotion offered by companies for prescribing their products and the attribution of unethical pharmaceutical marketing in relation to the type of medical profession of physicians.
 Conclusions: Pharmaceutical marketing in Yemen still depends on traditional tools, with the lack of ethical guidelines or codes for pharmaceutical marketing in the country. Work experience and medical profession of physicians can significantly affect pharmaceutical marketing. The spread of unethical marketing is the responsibility of pharmaceutical companies, physicians and medical representatives. Therefore, it is recommended to develop well-defined and updated ethical standards and national guidelines for pharmaceutical marketing by the Ministry of Public Health and Population. Furthermore, official campaigns should be regularly carried out to control and restrict unethical promotion. Further studies on the ethics of pharmaceutical marketing are also recommended. Pharmaceutical companies should continuously train their medical representatives and provide physicians with the latest medical knowledge about new drugs.
 Keywords: Pharmaceutical marketing, Ethics, IFPMA guidelines, Sana’a

Évaluation de l’éthique des pratiques pharmaceutiques : une revue de la littérature

Ethics are at the heart of pharmacy practice. This is a literature review. The main objective is to carry out a review of studies relating on the evaluation of ethics in pharmacy practice. Documentary research on Pubmed was carried out from 1990 to 2020. All studies relating to pharmaceutical ethics that may be applied to the pharmacy practice in pharmacies or in health establishments and that conducted a qualitative or quantitative evaluation of pharmaceutical ethics (e.g. surveying pharmacists or pharmacy students, using a measurement tool, quantifying or qualifying a perception or behaviour) were included. The studies come mainly from Anglo-Saxon countries (29/38). Studies related to pharmacy practice, mainly target pharmacists (n=27) and pharmacy students (n=16), and more often have a quantitative component of (n=28). The main ethical dilemmas observed dealt with emergency oral contraception (EOC), voluntary termination of pregnancy with drugs, euthanasia, commercial practices of the pharmaceutical industry, refusal to dispense a prescription in a broader context and plagiarism or dishonesty in academic settings. Few studies have been conducted on the review of ethics of pharmacy practices from 1990 to 2020. Pharmacy students and practicing pharmacists are regularly exposed to ethical dilemmas and respond to these dilemmas with due consideration, taking into account six principles, eight values and other factors. Exposure to these dilemmas creates inaction, stress and distress. A few possible solutions have been identified.

Analysis of modern employers’ requirements to responsibilities and competencies of pharmaceutical staff

The aim of the study is to determine the need of Ukrainian employers for specialists with pharmaceutical education and to summarize their requirements to the responsibilities and key competences of different categories of pharmaceutical personnel. This should become the basis for the training programs for degree seeking applicants in NUPh.Materials and methods: statistical analysis methods, observation method, frequency analysis method.Results. The results of the analysis have demonstrated that the transformation of health care and pharmaceutical sector requires constant monitoring of health-care institutions’ needs for specialists with pharmaceutical education. This monitoring should be carried out systematically. We have analyzed job offers in the pharmaceutical healthcare sector for such vacancies as pharmacist, retail pharmacist, pharmaceutical analyst, medical (pharmaceutical) representative, production manager, pharmacy director and regulatory affairs manager published on 10 websites. According to the analysis results, it has been found that the highest demand is observed for retail pharmacists, medical (pharmaceutical) representatives, and pharmacy directors. It has also been established that recently, together with the increasing competition in the pharmaceutical labor market, employment requirements for applicants for vacant positions of retail pharmacist, pharmacy director, and medical (pharmaceutical) representative have been revised. In general, employers put forward more than 50 requirements for applicants for the positions under consideration; these requirements can be divided into functional, professional and personal. Having compared the compliance of the competencies, enlisted in the NUPh educational and professional programs (EPP) in Pharmacy, Clinical Pharmacy and Technology of Perfumery and Cosmetics, to employers’ requirements to vacant positions of retail pharmacist, medical (pharmaceutical) representative and regulatory affairs manager, it is established that the specified EPP take into account all necessary directions of the formation of the necessary professional competencies in future pharmaceutical graduates.Conclusions. Considering the clarified modern requirements to the pharmaceutical personnel competencies, it is relevant to improve university curricula for degree seeking applicants in NUPh regarding extra credit additional disciplines such as Foreign Language, and also to advance management and economic disciplines in order to increase the level of competence of NUPh graduates in HR management, economy, pharmaceutical enterprise planning and administration, pharmaceutical assortment building, principles of self-management, pharmaceutical ethics, development of communicative skills in providing professional pharmaceutical help.

THE EFFECT OF GOVERNMENTAL LAWS AND PHARMACEUTICAL ETHICS ON BUILDING A DISTINCTIVE RELATIONSHIP BETWEEN PHARMACISTS AND THEIR CUSTOMERS

Objective: This study aimed to investigate the effect of governmental laws and pharmaceutical ethics on building a distinctive relationship between pharmacists and their customers from the perspective of pharmacists in Jordan through measuring the customers’ satisfaction and their perceived value.
 Methods: This study is a descriptive and correlative one. A self-administrated questionnaire was distributed to a random sample of 110 pharmacists working in private pharmacies to measure the effect of governmental laws and pharmaceutical ethics on building a distinctive relationship between pharmacists and customers.
 Results: ANOVA-test showed a significant effect of governmental laws and pharmaceutical ethics on building a distinctive relationship between pharmacists and their customers (p = 0.003) and on the customer–perceived value (p = 0.00). Multiple regression analysis showed a significant effect of the application of ethical standards on building a distinctive relationship between pharmacists and their customers (p = 0.006) and a significant effect of both dimensions: (application of laws and regulations) and (application of ethical standards) on customer–perceived value (p = 0.004, p = 0.009) respectively. Moreover, there was a statistically significant effect of the application of ethical standards on customers’ satisfaction (p = 0.03).
 Conclusion: Based on the results of this study, there should be an effort by the government and the private institutions responsible for the pharmacy profession in Jordan to contribute to build a distinctive relationship between pharmacies and their customers, as this relationship increases the perceived value and satisfaction of customers.

Is Visiting the Pharmacy Like Voting at the Poll? Behavioral Asymmetry in Pharmaceutical Freedom.

Jessica Flanigan argues that individuals have the right to self-medicate. Flanigan presents two arguments in defense of this right. The first she calls the epistemic argument and the second she calls the rights-based argument. I argue that the right to self-medicate hangs and falls on the rights-based argument. This is because for the epistemic argument to be sound agents must be assumed to be epistemically competent. But, Flanigan's argument for a constitutionally mandated right to self-medicate models agents as epistemically incompetent. For Flanigan, agents are different at the pharmacy than they are at the polls. I identify this behavioral asymmetry and advocate a symmetric and realistic behavioral postulate for both arguments. The result, however, is that the success of the epistemic argument becomes contingent which fails to justify a constitutionally mandated right. I proceed to raise skepticism about the rights-based argument as well. I conclude that there is reason to be skeptical that these arguments can justify a constitutionally mandated right to self-medicate. Ultimately, a bottom-up approach to pharmaceutical ethics is preferable.

Pharmaceutical Ethics and Grassroots Activism in the United States: A Social History Perspective.

Women's health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women's health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry funds; thousands of commercially-funded groups now dominate the advocacy landscape. As pharma funding became normalized, concerns arose regarding a) the lack of transparency and public accountability regarding funding, b) the distortion of groups' agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less well-resourced patient and health advocacy groups. Although industry-funded groups argue that funding allows them to provide useful services, the trade-off in health risks, exorbitant prices and distorted information is far too high. Sincerity is beside the point; patients and the industry have differing interests when it comes to drug safety and efficacy, drug information and drug prices. A growing resistance movement is asserting the values of its activist predecessors and opposing the prevailing culture of pharma-funded advocacy.

Legal and ethical basis of the interaction of provisors (doctors) with public control subjects of the quality assurance of medicines at the stages of their sale and medical use

Modern domestic public activism as a phenomenon that has become widespread relatively recently, creates new challenges for the pharmaceutical sector of the health care branch. Legal and ethical aspects of the interaction of pharmacists and doctors with public control subjects of the quality assurance of medicines remain insufficiently studied, which causes a lack of awareness on these issues among pharmacists and doctors, and therefore errors in interaction with representatives of public organizations, the media or community activists.
 The aim of the work was the scientific substantiation of the legal and ethical basis of the interaction of pharmacists and doctors with public control subjects of the quality assurance of medicines at the stages of their sale and medical use in Ukraine.
 To obtain the results of the work, library-semantic, formal-logical and structural-functional methods, methods of comparative legal and technical-legal analysis of legal and ethical, doctrinal and journalistic sources in the chosen direction were used.
 The work identifies public media control and public monitoring as the forms of public control of the quality assurance of medicines at the stages of their sale and medical use most closely related to the workplaces of pharmacists and doctors.
 It has been established that the legal basis for the interaction of pharmacists (doctors) and journalists, as subjects of public media control, is determined by the Constitution of Ukraine, scattered groups of regulatory and protective legislation. The ethical basis of such interaction is determined by generally accepted ethical standards, sources of professional pharmaceutical (medical) ethics, sources of professional ethics of journalists.
 It has also been established that currently in the current legislation of Ukraine there are no separate or special requirements defining the mechanism of interaction between pharmacists (doctors) and public activists who carry out appropriate public control in the form of public monitoring. It was determined that the concretized methods of lawful and ethical interaction of pharmacists (doctors) with journalists and public activists, as subjects of public control of the quality assurance of medicines at the stages of their sale and medical use, require further research.
 The paper proposed promising areas for improving the legal and ethical mechanisms for realization public control of the quality assurance of medicines at the stages of their sale and medical use by creating a special legislative and ethical-regulatory basis for this type of activity; introducing specialized training in mastering relevant legal and ethical competences for pharmacists (doctors) and for public controllers, which can be either pharmacists (doctors) or any other caring person; introduction of the institute of public inspections to the quality assurance of medicines at the indicated stages of their life cycle, carried out by public inspectors who have passed the specified training.

Étude pilote du niveau d’accord à des énoncés sur l’éthique pharmaceutique d’étudiants en pharmacie et pharmaciens hospitaliers québécois

The main objective was to assess the position of Quebec pharmaceutical community about pharmaceutical ethics statements. The second objective was to compare the level of agreement of pharmacy students and hospitals pharmacists. Survey conducted one day given in 2012and 2013for students in 2013and from 29/08/2014to 02/09/2014for pharmacists. A questionnaire of eight themes and 43statements was developed: training and education (5questions), clinical research (7) advertising and marketing (5) evaluation (5) dispensing medication (4), pharmaceutical care (9) economic aspect (6) and code of ethics (2). A Likert scale with four choices was used to measure the level of agreement. The primary outcome was the difference between the level of agreement of pharmacy students and hospital pharmacists. The Chi2test was used. A total of 347students and 398pharmacists responded to the survey. There was a statistically significant difference regarding the level of agreement with 28statements on 43. The differences focused on eight themes of the questionnaire, or training and education (3/5significantly different questions), clinical research (2/7), advertising and marketing (2/5), Evaluation (4/5) dispensing medication (4/4), pharmaceutical care (5/9), economic aspect (6/6) and ethics (2/2). This study shows that there is a difference between pharmacists and pharmacy students about pharmaceutical ethics statements.

Pharmaceutical Ethics Comes to Life in Therapeutic Innovation & Regulatory Science

Pharmaceutical Ethics Comes to Life in Therapeutic Innovation & Regulatory Science

Deriving and Critiquing an Empirically Based Framework for Pharmaceutical Ethics

Background: The pharmaceutical industry has been responsible for major medical advances, but the industry has also been heavily criticized. Such criticisms, and associated regulatory responses, are no doubt often warranted, but do not provide a framework for those who wish to reason systematically about the moral dimensions of drug development. We set out to develop such a framework using Beauchamp and Childress's “four principles” as organizing categories. Methods: We conducted a qualitative interview study of people working in the “medical affairs” departments of pharmaceutical companies to determine: (1) whether our data could meaningfully be organized under the headings of “autonomy,” “beneficence,” “nonmaleficence,” and “justice”; (2) how principles might be expressed in this particular commercial setting; and (3) if these principles are expressed, whether and how competing principles are balanced. We then critiqued these findings using existing normative theory. Results: Our interviews demonstrated that three of Beauchamp and Childress's four principles were salient to our participants: beneficence, nonmaleficence, and justice. Within each of these principles, participants had two broad ethical orientations: an altruistic public focus (“other-ness”) and a commitment to their companies (“firm-ness”). Our participants also demonstrated efforts to balance these principles and highlighted the importance of phronesis (or practical wisdom) in balancing and enacting principles. Notably, however, our participants did not spontaneously emphasize the importance of autonomy. Conclusions: It is possible to use qualitative empirical research, together with normative analysis, to derive a framework for pharmaceutical ethics. We suggest that our framework would be useful for those who wish to reason ethically within, or in collaboration with, the pharmaceutical industry.

Pharmaceutical Ethics and Physician Liability in Side Effects

We review Side Effects, a 2013 film involving bioethics, pharmaceuticals, and financial conspiracies. After the main character Emily unsuccessfully attempts suicide, she begins receiving care from a psychiatrist, Dr. Banks. Following numerous events, she is placed on a fictional antidepressant, Ablixa, which leads her to suffer from sleepwalking. During an episode of sleepwalking she commits a serious crime. The film poses an interesting dilemma: How responsible would the physician be in this instance? We analyze this question by applying numerous ethical principles.

How Pharmaceutical Industry Employees Manage Competing Commitments in the Face of Public Criticism

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance.

How Pharmaceutical Industry Employees Manage Competing Moral Commitments

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the ‘medical affairs’ departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to both their responsibilities to patients, research participants and the public, and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two, dialectically-related, strategies, one of which embraces commerce, and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory, and consider their implications for pharmaceutical ethics and governance.

Professional Codes versus External Enforcement: Chinese and Australian Norm-Setting in Pharmaceutical Ethics Compared

This paper examines how norms are introduced and implemented in the production and trade of medicines in China and Australia. Through a discussion of the status of the pharmaceutical profession in these two countries, it argues that in China the propagation of professional standards and the control over their implementation are exclusively a matter for external sanctions, while in Australia the validity of a pharmacists’ professional code reduces the need for external supervision. The paper further investigates the systemic and institutional reasons for this difference. Key words : Professional codes; Ethics; Pharmacists; Medicines

LA CONSIDERACIÓN DEL SUJETO DE INVESTIGACIÓN COMO PARTE ACTIVA EN LA EMPRESA FARMACÉUTICA

Although for thirty years researchers involved in biomedical investigation have designed international strategies for the protection of the subject of investigation, the consideration of the patient as an active subject in the pharmaceutical business in practice is minimized. One of these compromises in the patient's protection is contained in the Helsinki VI Declaration, in which the laboratory accepts to continue the supply of the medicament and/or method studied post- protocol, when this has been proved to be a benefit to the participant in the research, in practice, this is not fulfilled. Bioethics, as a pro- dialog discipline, tries to approach the involved sectors looking for languages or common points of view in order to have agreements. That is why I, in the present work, used the pharmaceutical laboratory's own arguments, commercial laws and general ethics.

Transnational pharmaceutical corporations and neo-liberal business ethics in India.

The author critiques the expedient application of market valuation principles by the transnational corporations and other large firms in the Indian pharmaceutical industry on a number of issues like patents, pricing, irrational drugs, clinical trials, etc. He contends that ethics in business is chiseled and etched within the confines of particular social structures of accumulation. An ascendant neo-liberal social structure of accumulation has basically shaped these firms' sharp opposition to the Indian Patents Act, 1970, government administered pricing, etc. The author contents that the practice of neo-liberal economics is strongly associated with a "one-dimensional" ethics that privileges market valuation principles over all others. This seems to inevitably generate a social counter-movement that struggles for social protections. He critiques neo-liberal business practices from a perspective that derives from the work of the economic anthropologist Karl Polanyi. Before the present phase of liberalization in India, markets were "managed", but without a "welfare state" in place. Moving toward deregulation of the markets without a welfare state in place is unethical. Keeping the debilities of the institutional framework of public policy in mind, the author adopts a Polanyian perspective that places its trust and hope in the growing social legitimacy of the counter-movement in opposition to both neo-liberal business practices and the degenerate behavior of state agencies.