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He who pays the piper calls the tune: the role of the industry sponsor in acute stroke trials.

Ischemic stroke remains a complex neurobiological and clinical disease, and stroke drug development remains time consuming and costly. In addressing these challenges, the pharmaceutical industry has a principal responsibility to ensure that the acute stroke trials it sponsors are ethically conducted, scientifically sound and satisfy global regulatory requirements. The industry must also be a leader in promoting the innovative and effective partnerships between the public, private and academic sectors that are necessary if new therapies for patients with acute stroke are to be developed.

Acute Disease↗

[Safety of medications].

Safety evaluation is an essential part for the registration of new drugs. Animal studies are performed to assess toxicity by single and repeated dose administration, potential effects on reproduction, genotoxicity, carcinogenic potential and local tolerance. Guidelines have been harmonized in the European Union since 1975, but there is no comparison in a world-side view-point, because many differences exist between the European Union, USA and Japan. This situation is very detrimental for industry, inducing the need for duplicate studies (with a waste of time and money) and to construct new files. From an ethical view point, this situation also induces overuse of laboratory animals. For all theses reasons, more or less successful harmonization of the guidelines for the safety evaluation of new products has developed since 1991. Prior to the 4th International Conference on Harmonization, important problems were still not resolved (duration of repeated dose studies in non-rodent species). Moreover, a more flexible and less complex system must be developed in the near future for better efficacy.

Drug Therapy↗

[The competences of doctors and apothecaries in relation to the prescription or medicines according to the analysis of ordinances from 1796].

The tasks and duties of apothecaries were perfectly outlined and regulated by the Real Tribunal de Protomedicato (Royal Tribunal of the Protomedicate) as well as the Real Colegio de Boticarios (Royal College or Apothecaries). However, when the Real Colegio de Medicina de Madrid (Madrid Royal College of Medicine) was set up, this institution began to take over certain responsabilities which, until then, had been regulated and controlled by a series of instutions such as the Royal Colleges. This was clear interferences in the privated affairs of these institutions in the presumible aim of newly centralizing power in one medical centre as had occurred throughout history. In any case, professional Colleges began to spring up and clearly define the frontiers between the three branches of health care. They also began to dictate deontological standards both in the professional terrain and between professionals and society in general.

Ethics, Medical↗

Pharmacist misconduct: the pitfalls of practice.

This article identifies the changing role of pharmacists in the provision of health care and analyses 78 complaints against pharmacists over a recent 12-year period in New South Wales, finding that the majority of complaints were in relation to the oversupply of particular medications, from which some pharmacists made significant financial gains. A number of other areas of complaint were identified, including issues in relation to the recording and labelling of medications and the roles and responsibilities of pharmacists, dispensing errors, fraud, and sexual misconduct. As the roles of pharmacists continue to expand, with the growth of "compounding chemists", and the suggestion that pharmacists are now performing basic medical tasks which were once the domain of a general practitioner, it is increasingly important that pharmacy take its place in any debates about the provision and regulation of health services.

Community Participation↗