PubMed · 5741893
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U Mogestad. 1968-09-25. [The delayed narcotic care program].. https://pubmed.ncbi.nlm.nih.gov/5741893/
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AIMS: To indicate how the system of pharmaceutical regulation of the sale and use of opium in Great Britain continued throughout the first half of the 20th century. DESIGN: An oral history investigation of community pharmacy in Great Britain (n = 50), together with an analysis of standard pharmaceutical texts. SETTING: Community pharmacies in Great Britain during the 20th century. PARTICIPANTS: Retired community pharmacists with experience of the sale and use of opium during the period. MEASUREMENTS: Oral testimony of retired community pharmacists about the use and sale of opium, and quantitative analysis of numbers of official preparations of opium available during the period. FINDINGS: The popular use of opium continued well after the First World War, and its use as an ingredient of prescribed medicines continued well beyond the introduction of the National Health Service in 1948. CONCLUSIONS: Although the role of pharmacy in the regulation of opiates and other drugs was displaced by medicine following the passage of dangerous drugs legislation in the 1920s, pharmacists continued to play an important part in this regulation, exercising considerable discretion in the process.
Throughout 1999, the Food and Drug Administration approved several new drugs and medical devices. The agency also took an active role in defining public policies regarding pharmacologic issues for the American consumer. This article provides an overview of these topics.
To answer the question of the benefit and the cost/benefit ratio of the activities of a drug regulatory agency, the most important, clinically relevant "products" of a licensing authority in general, and the Swiss licensing authority (IKS) in particular are discussed. The activities of the medicines licensing authority assure that: For all new substances the efficacy and a positive benefit/risk ratio have been demonstrated before a marketing authorisation. For all marketed medicines an information for professionals and patients is available that has been evaluated and approved by an independent and competent reviewer. An independent post marketing surveillance of the side effects profile continues after a medicine has been put on the market. All clinical trials investigating medicinal products are performed according to GCP rules corresponding to international ethical and scientific standards. An international comparison of the time needed for the evaluation of a marketing authorisation application for a new medicine reveals that the IKS is one of the most efficient agencies. This is illustrated with an example showing the evaluation times of the EMEA and the IKS for products approved in 1997.