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At least 181 records · Page 10Linked to original sources
PubMed1996

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research.

Clinical Protocols↗
PubMed2001

[The development of ethics. Identifying what training in medical ethics is needed by family physicians].

OBJECTIVE: To identify what training in medical ethics physician teachers need. DESIGN: Qualitative research study using a modified nominal group technique. SETTING: Family practice units affiliated with the Department of Family Medicine at Laval University in Quebec. PARTICIPANTS: Fifty-three physician teachers in six family practice units. METHOD: During seven meetings, the teachers shared information on clinical situations that had posed ethical problems. Data were analyzed using Strauss and Corbin's method. MAIN OUTCOME FINDINGS: The 277 clinical situations were classified under nine themes: ethics; confidentiality; consent, refusal of treatment, and the right to information; level of care and abstention from and cessation of treatment; relationships with pharmaceutical companies and the ethics of research; ethics of teaching; allocation of resources; influence of third parties; and euthanasia and assisted suicide. Learning objectives were developed. CONCLUSION: This research forms the basis of the ethics curriculum in the family medicine residency program at Laval University. It also offers a strategy for integrating ethics into daily teaching activities because the learning objectives derive directly from the concerns of the teaching faculty.

Adult↗
PubMed1999

The protection of the person in medical research in Germany.

Because of its history Germany has many rules concerning the protection of persons in medical research. In fact Germany was the first state to issue a directive regulating medical experimentation with human beings in the year 1900. The ten principles of Nuremberg originated out of the medical case. Germany adheres to the Revised Declaration of Helsinki of the World Medical Association and will probably sign the European convention on biomedicine. The pharmaceutical act contains elaborate provisions for the protection of the patient or proband, e.g. informed consent, risk-benefit ratio, no experimentation on prisoners, approval of a local ethics committee. Moreover in pharmaceutical trials there has to be third party accident insurance for the experimental subject. There is no strict liability for medical experimentation, but the standard of care is high. In general the German law seems to be adequate for the protection of experimental subjects.

Confidentiality↗
PubMed2006

North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis.

Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.

Biodiversity↗
PubMed2002

[Medical ethics as output of economically motivated industrial objectives].

Ethics and economics are not mutually exclusive, but rather related concepts that help the human race in dealing with scarce resources. Safeguarding the resources employed and making a profit are general industrial objectives. Product-specific objectives, such as optimising medicinal safety and creating benefits for the individual and society, are discussed. Healing disease, improving quality of life and prolonging length of life are very important considerations. The contributions of the pharmaceutical industry in fulfilling ethically based demands will be primarily treated as the careful use of resources (e.g. by renunciation of state support). Other ethical contributions are the early communication of research results for intersectoral use and a voluntary code of conduct to regulate the actions of pharmaceutical companies with regard to information and advertising. In the Third World pharmaceutical industry is mainly faced to potential waste of valuable medicines, due to insufficient infrastructure of logistics and distribution capacities in one region, given a shortage of these very medicines in other and better structured regions. The value of medicines is defined by a comparison of competing therapies (difference in consumption of resources). Possible ethical deficiencies arising from a lack of direct contact of the patient with industry and the quasi-penalisation of patients because of faulty lifestyle are briefly discussed.

Cost-Benefit Analysis↗
PubMed2000

Ethics applied to pharmacy practice.

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 nonmaleficience 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.

Ethics, Pharmacy↗
PubMed2000

British community pharmacists' views of physician-assisted suicide (PAS).

OBJECTIVES: To explore British community pharmacists' views on PAS, including professional responsibility, personal beliefs, changes in law and ethical guidance. DESIGN: Postal questionnaire. SETTING: Great Britain. SUBJECTS: A random sample of 320 registered full-time community pharmacists. RESULTS: The survey yielded a response rate of 56%. The results showed that 70% of pharmacists agreed that it was a patient's right to choose to die, with 57% and 45% agreeing that it was the patient's right to involve his/her doctor in the process and to use prescription medicines, respectively. Forty-nine per cent said that they would knowingly dispense a prescription for use in PAS were it to be legalized and 54% believed it correct to refuse to dispense such a prescription. Although 53% believed it to be their right to know when they were being involved in PAS, 28% did not. Most pharmacists (90%) said that they would wish to see the inclusion of a practice protocol for PAS in the code of ethics of the Royal Pharmaceutical Society of Great Britain (CE-RPSGB) in the event of a change in the law on PAS. In addition, 89% would wish to see PAS included in the Conscience Clause of the CE-RPSGB. Males were found to be significantly less likely to favour PAS than females (p < 0.05), as were those declaring an ethnic/religious background of consideration when dealing with ethical issues in practice compared with their counterparts (p < 0.00005). CONCLUSION: Pharmacists view their professional responsibility in PAS to be more obligatory than a physician's, in having to provide the means for PAS. It is worrying that a proportion of the respondents prefer to remain in ignorance of the true purpose of a prescription for PAS; a finding at odds with current developments within the pharmaceutical profession. A practice protocol for PAS and an extension of the conscience clause should be considered in the event of PAS becoming legal. Such measures would allow the efficient provision of the pharmaceutical service whilst at the same respecting the personal beliefs of those who object to cooperating in the ending of a life.

Age Factors↗
PubMed1999

George Fulford and Victorian patent medicine men: Quack mercenaries or Smilesian entrepreneurs?

In the early twentieth century, a time when patent medicine men were stereotyped as evil and dishonest, G. T. Fulford of Brockville, Ontario made his fortune from an iron pill called Dr. Williams' Pink Pills for Pale People. Once successful, Fulford remained in Brockville where he served on the town council and gave generously to charities. In 1900 he was appointed by Laurier to the Senate. When he died in 1905 he was remembered as a kind and ethical man. His story, like that of several other prominent patent medicine men, conforms more with the ideals of Samuel Smiles than with the popular image of disrepute.

Canada↗
PubMed1964

[ON VERACITY].

Explore the source record for details and available documents.

Ethics, Pharmacy↗
PubMed1998

[The relativity and geodiversity of medico-economic realities].

The economic gestion of health care is difficult to handle. It covers several aspects which cannot pride to be accurate sciences. It strikes difficulties such as the geodiversity of problems to be solved and the nuances in the application of principles of social equity and medical ethics. The health-care analysis is also exposed to some politician interpretations biased by doctrinal a priori. Most often, a confrontation ensues between the political cenacle and the professionals directly involved in health-care.

Cultural Diversity↗
PubMed2002

Ethical issues concerning the relationships between medical practitioners and the pharmaceutical industry.

Medical practitioners and the pharmaceutical industry serve interests that sometimes overlap and sometimes conflict. There is strong evidence that associations between industry and doctors influence the behaviour of the latter in relation to both clinical decision making and the conduct of research. In view of the risk of compromising relationships with patients and the integrity of the research process, doctors must exercise care in their dealings with industry. The basic principles underlying the conduct of doctors with respect to pharmaceutical companies should be openness and transparency. Clearly articulated procedures should be developed to deal with specific issues such as travel subsidies, receipt of gifts, sponsorship of conferences and continuing education activities, and dualities of interest arising in clinical and research settings.

Conflict of Interest↗
PubMed1995

Managing pharmaceutical sales activities in an academic anesthesiology department.

To contain costs, departments of anesthesiology must control the use of new, expensive drugs. Conflicts with pharmaceutical companies can arise when they promote drug sales. Pharmaceutical company sales represent anesthesiology department expenses. Anesthesiologists hold diverse opinions on this clash of interests, on the proper roles of pharmaceutical sales representatives in anesthesiology departments, and on the ethics of accepting industry gifts. Our department has managed pharmaceutical sales activities by encouraging discussion of the ethics and legal limits of industry gifts, by banning sales representatives from bringing food into the department, and by adopting The American Medical Association Guidelines on Gifts.

Academic Medical Centers↗