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7 recordsLinked to original sources
PubMed1998

Supply of medicines: paternalism, autonomy and reality.

Radical changes are taking place in the United Kingdom in relation to the classification of, and access to, medicines. More and more medicines are being made available over the counter both in local pharmacies and in supermarkets. The provision of more open access to medicines may be hailed as a triumph for patient autonomy. This paper examines whether such a claim is real or illusory. It explores the ethical and legal implications of deregulating medicines. Do patients benefit? What is the impact on pharmacists? Are the true beneficiaries of change largely the pharmaceutical industries?

Beneficence↗
PubMed2002

Deep venous thrombosis and venous thrombophlebitis associated with alprostadil treatment for erectile dysfunction.

We report a patient who developed deep vein thrombosis of the calf and thrombophlebitis after treatment with intracorporeal alprostadil (Viridal). The reaction recurred on rechallenge with Viridal. This adverse effect has not been reported in the literature but six patients have been reported to the Medicines Control Agency in Great Britain. The history of deep venous thrombosis or thrombophlebitis may not be a formal contraindication to treatment with alprostadil, but the patient should be made aware of this possible complication before embarking on this form of treatment.

Alprostadil↗
PubMed2000

A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain.

INTRODUCTION: Since April 1997, UK hospital pharmacists have been invited to submit reports of suspected adverse drug reactions (ADRs) to the Committee on Safety of Medicines (CSM) and Medicines Control Agency. Three studies have investigated the involvement of hospital pharmacists in ADR reporting; however, they did not investigate the possible factors that could affect ADR reporting. OBJECTIVES: (i) To analyse the extent to which hospital pharmacists think that specified factors could affect reporting ADRs; (ii) to identify any additional factors that could hinder reporting; and (iii) to recommend possible methods to improve reporting. METHODS: Piloted questionnaires were sent to 548 hospital pharmacists in Great Britain randomly selected by the Royal Pharmaceutical Society of Great Britain (RPSGB) from their computer database. 346 questionnaires were returned and 280 were included in this study. RESULTS: 46% of the pharmacists had identified ADRs that were considered to be reportable according to the CSM criteria in the 6 months prior to the survey. 39% did not report these ADRs either to the CSM or the manufacturers. Only 8.2% reported that their hospitals had a written policy; conversely, 73.7% agreed that such a policy could enhance ADR reporting. Although not statistically significant, the result showed an increasing tendency to report ADRs by pharmacists who had received training. Furthermore, there was an increasing tendency to report ADRs with increasing seniority. DISCUSSION: The results show that hospital pharmacists say they are more likely to report serious and rare ADRs and ADRs associated with newly marketed drugs. Factors that could reduce ADR reporting included being busy at work, lack of confidence in recognising ADRs and the fear of breaching patient confidentiality. Most common suggestions on methods to improve ADR reporting were to provide ADR training and meetings (34%) and a hospital written policy (24%). RECOMMENDATIONS: ADR training and meetings would be a useful step in improving hospital pharmacist ADR reporting. Therefore, we recommend that the CSM and the RPSGB liaise with regional drug information centres and schools of pharmacy to provide more study days and training programmes for hospital pharmacists. Furthermore, the CSM should write to the 'Drugs and Therapeutics Committee' of each hospital and encourage them to develop a written local policy for pharmacist ADR reporting. Further studies should be conducted to test the recommendations noted here, assessing the response of the pharmacists in terms of absolute numbers of reports made. It would be particularly interesting to study the need for a written hospital policy and education.

Adverse Drug Reaction Reporting Systems↗
PubMed1998

Experience of gene therapy in the United Kingdom.

The UK Committee on the Ethics of Gene Therapy recommended the establishment of a supervisory body with collective expertise, experience, and authority to regulate gene therapy. In November 1993, the supervisory body, known as the Gene Therapy Advisory Committee (GTAC), was established. It interacts with other bodies, including the Medicines Control Agency, local research ethics committees, the Health and Safety Executive, and the Hospital Trust. When proposals for gene therapy are reviewed, there is careful assessment of the scientific merits, the competence of those undertaking the research, and the risks involved. Each proposal is assessed by several independent expert advisors, in specific aspects of the research. The researchers are apprised of the issues raised by the assessors and given the opportunity to modify their proposals. The research team is then given the opportunity to make a brief presentation to the GTAC. The proposals may be approved subject to conditions, deferred until further issues are resolved, or rejected on the basis that the proposal is unethical or the science unsound. Researchers are expected to provide the committee with regular progress reports. This paper discusses the experience of gene regulation in the United Kingdom.

Animals↗