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Results for “ETHICS, PHARMACEUTICAL”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 793 records · Page 44Linked to original sources
PubMed1995

The introduction of new drugs into anaesthetic practice: a perspective in pharmaceutical development and regulation.

This article reviews the process by which new drugs are introduced into anaesthetic practice with particular emphasis on pharmaceutical development and government regulation. After a brief overview of the drug development process, new trends in drug development are discussed including implementation of pharmacokinetic, pharmacodynamic and toxicokinetic studies in both preclinical and human phases of drug evaluation. A synopsis of the drug regulatory process is provided and, in particular, the problem of unapproved drug use in anaesthesia is discussed. Ethical issues regarding physician-industry interactions are highlighted by examples of conflict of interest in anaesthesia. The processes of drug development and regulation require much effort and cooperation between clinicians, pharmaceutical manufacturers and government regulators to achieve a common goal; the development and utilization of safe and effective drugs. A fundamental understanding of these processes may further facilitate optimal drug utilization and the active involvement of anaesthetists in the drug development process.

Anesthetics↗
PubMed1997

[The history of medicine in the scholary work of Professor Bolesława Popielskiego].

Professor Bolesław Popielski, a forensic medical expert, was born in Lwów on 3 May 1907. He earned his medical degree at the Jan Kazimierz University in Lwów. He was an employee of the Forensic Medicine Institute in Lwów and Kraków, and from 1946 he was the director of the Institute in Wrocław. Prof. Popielski remained professionally active even after retirement. As an expert in his field, he contributed over 270 publications, including articles on medical ethics. His studies on the history of medicine were related to the past of medical ethics and the history of the medical corp in Lwów and post-war Wrocław. Prof. Propielski is an active member of the Wrocław chapter of the Polish Society of the History of Medicine and Pharmaceutics. His contributions to the Society as well as his scholarly works are known for their astuteness and for the Professor's talent for capturing his audience's attention and interest.

Ethics, Medical↗
PubMedDate not supplied

Ethical duties when patients make suspicious narcotic requests.

Practicing dentists are likely to be familiar with the prospect of patients who request controlled substances for doubtful indications. Torn between ethical obligations of beneficence and nonmaleficence, the dentist may be uncertain whether to prescribe a medication with the intention of alleviating pain or to refuse the prescription due to concerns related to chemical dependency, underlying emotional illness, or ulterior motives on the part of the patient. Pharmaceutical choices often do not provide a mechanism for sidestepping this dilemma as chemically dependent patients may be quite sophisticated in their knowledge of drugs and the ways in which to couch their requests. Dentists have an ethical obligation to move beyond simply refusing prescriptions for patients suspected to be chemically dependent; they should sensitively discuss the issue with these patients and be prepared to offer referral for intervention. However, dentists must always be open to the possibility that a particular patient's assertion of chronic physical pain may be of complex origin. When this is the case, appropriate treatment is essential and may involve referring the patient to others with specialized skills. Dentists should not withhold pain medication from patients with uncontrolled pain in the final stages of life.

Analgesics, Opioid↗
PubMed2005

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].

In the course of implementing the European directives on pharmaceutical law, focus is set on suspected unexpected serious adverse reactions (SUSARs). SUSARs are essential for expedited reporting to authorities and ethics committees. During on-line monitoring of the study, the investigator documents all adverse events. Serious adverse events are forwarded to the sponsor in due time. The sponsor identifies SUSARs for expedited reporting. Clinical causality assessment between the investigational product and the adverse event is substantial in this process. This requires a balanced clinical assessment of all case relevant aspects and information available reflecting the complexity of the specific case, which cannot be covered by algorithms in general. In the setting of on-line monitoring, SUSARs ensure the safety of the patient and the study. In addition, SUSARs are relevant for generation of the safety profile of the substance.

Algorithms↗
PubMed2006

Pharmacological treatment of non-Alzheimer dementias.

PURPOSE OF REVIEW: One hundred years after the first description by Alois Alzheimer and with the advent of first pharmacological treatments, most researchers concentrate on Alzheimer's disease. Millions of patients, however, suffer from other dementias and search for help beyond diagnosis. RECENT FINDINGS: New clinical data concerning the treatment of non-Alzheimer dementias mainly relate to the clinical use of antidementiva that is already approved for the treatment of Alzheimer's disease. Few studies test new pharmacological paradigmata. For some forms like vascular dementias, the possibility of prevention is the most valuable approach that should be enforced more aggressively. For other savaging dementias new unconventional treatment trials should be encouraged. SUMMARY: Research for non-Alzheimer dementias lags behind those for the Alzheimer field. For many patients, we still have nothing but words. At the same time, probably with regard to cost constraints, some acteurs like health insurances and legislators are inclined to nurture therapeutic nihilism and cultivate ethical qualms and demurs instead of supporting clinical trials or at least not blocking them with bureaucratic hand-cuffs, whereas pharmaceutical companies contemplate naturally over questions like return of investment. The clinical researchers should fight this fatigue and look for ways out of this quagmire for our patients.

Clinical Trials as Topic↗
PubMed1997

Advice-giving in community pharmacies in the UK.

OBJECTIVES: To review (1) the published evidence on the information provided with prescribed and purchased medicines by pharmacists and pharmacy assistants, (2) clients' expectations of advice about medicines from community pharmacies and their experience and use of it, and (3) appropriateness and rigour of study methods used. METHODS: Papers, published between 1980 and 1995 inclusively, were identified based on searches of on-line databases, a published literature index, key pharmacy practice journals and cited references in the bibliographies of published papers. Those papers selected reported research findings on any aspect of medicines-related communications and the provision of advice about medicines to members of the public who visited pharmacies in the UK. The comparatively small volume of work and lack of design consistency meant that a subjective assessment, rather than a criteria-based objective review, was deemed appropriate. RESULTS: Forty-two suitable studies were identified and are reviewed. No common definition of 'advice' has emerged. Most studies reported were quantitative, concentrating on the frequency of advice-giving in community pharmacies and only one study considered the impact of advice on outcome. The quality of advice given was judged highly variable, although pharmacists' referrals, where made, were considered appropriate. Given that pharmacy assistants appear to make most of the medicine sales, remarkably few studies addressed their contribution to advice-giving. The review can provide little insight into what determines when advice is provided, but it does illuminate the disparity between the advice that clients say they want and what they actually seek. CONCLUSIONS: Where there appears to be a consensus that advice-giving in community pharmacies is wanted, this review reveals a lack of shared understanding between consumer bodies and the pharmacy profession about who needs advice and when and how it should be given. The need for unsolicited advice-giving associated with the sale of medicines is particularly contentious. With the current programme of deregulation of medicines, this is an increasingly important issue to resolve. The authors suggest a need for a consensus-building forum to generate guidelines that meet shared expectations between clients, community pharmacists, government and the pharmaceutical industry.

Community Pharmacy Services↗
PubMed2001

Managing the pharmaceutical industry-health system interface.

BACKGROUND: Direct-to-consumer advertising, media, and Internet marketing to physicians and patients, as well as enticing marketing strategies, are used by the pharmaceutical industry to ensure market share growth of new drugs. Our health system adopted a strict vendor policy governing detailing and sampling activities of pharmaceutical representatives, but realized that further analysis of vendor influence in our system was needed. OBJECTIVE: An assessment of tangible benefits, ethical concerns, and financial liabilities and gains was conducted to reassess the need for further vendor restriction. CONCLUSIONS: Based on our findings, several recommendations have been made. Medical practices and health systems are encouraged to establish and enforce explicit vendor policies, measure their effectiveness, partner proactively with representatives to deliver a drug-detailing message consistent with system initiatives, monitor and regulate continuing medical education funding, and implement strategies to ensure appropriate drug use.

Advertising↗