ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

For thousands of years, humans have sought cures for and symtomatic relief from disease. Initially, remedies relied heavily upon spontaneous remission of disease and the placebo response. However, during the nineteenth and twentieth centuries, a more systematic approach was taken to drug development that resulted in some medicines having greater efficacy. Nevertheless, around three-quarters of the medicines that were licensed in 1975 had disappeared by 1990 when the work of the Committee on the Review of Medicines was concluded.The increased effectiveness of drug therapy came at a price, namely that of adverse drug reactions, some of which occurred despite pre-clinical and clinical toxicity testing. In practice, many adverse reactions could be predicted from the known pharmacological properties of the drug in question. They tended to occur when the normal pathways of elimination (metabolism and renal excretion) were compromised − as in the elderly. However, others were unpredicted and led to the need for new systems of pharmacovigilance.It has been common to downplay the contribution of medicine to the average 30 years of life added during the twentieth century. Nevertheless, the prevention and treatment of infectious diseases and those affecting the cardiovascular system represent considerable successes. However, where improvements in psychotropic drugs have improved mental health, they have been widely over-prescribed. The concept of a panacea is therefore rejected, as is that of a polypill for cardiovascular disease.Looking to the future, the following needs are identified: a well-educated medical workforce, able to make an accurate diagnosis; a workforce capable of individualising drug therapy based on knowledge of pharmacokinetics and pharmacodynamics; better public understanding of medicines; improved ways of explaining risk (and risk benefit); and better/additional techniques of pharmacovigilance.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

This paper provides an anecdotal view from a Dutch perspective on some historical aspects of both the awareness and the systematic attention regarding adverse drug reactions in a period before the term ‘pharmacovigilance’ even existed.What we can learn from history is illustrated by the 1971 study by Lely, who discovered that 19 people died from digitalis intoxication, caused by a production error of the digitalis tablets. Observations of the symptoms of digitalis intoxication had been previously described in the 18th century by Whitering in his study on the foxglove.The Professor of Medicines, Van Doeveren provided another early example of awareness of adverse drug effects when he gave the academic lecture calledRemedio Morbiin 1789 on diseases caused by treatment. This academic lecture was given attention by Meyler, who wrote his famous book on adverse drug reactions in 1951. His bookSide Effects of Drugsis currently in its 14th edition and is still a standard work in this field. An early example of a systemic collection of adverse drug reactions occurred in the beginning of the 19th century when reactions were reported during a smallpox vaccination campaign in the Netherlands.Systematic attention to adverse drug reactions, including the collection of adverse drug reaction reports, was boosted by the so-called thalidomide disaster in the early 1960s. Since then, governments have started to organise national pharmacovigilance centres to prevent such a disaster happening again.The World Health Organization (WHO) has played an important role in developing this reporting of adverse drug reactions with its WHO International Drug Monitoring Program and the WHO Uppsala Monitoring Centre, which maintains the international database of adverse drug reactions. A comprehensive review of the history of pharmacovigilance is still to be written.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

The role of pharmacoeconomics has evolved as a consequence of cost-containment pressures from the pharmaceutical industries’ ‘external environment’. This paper reviews the published literature on the role of pharmacoeconomics in the pharmaceutical industry and gives a historical background and state-of-the-art picture on the function and importance of pharmacoeconomics for the different stakeholders and decision makers in the healthcare area, with a special focus on the pharmaceutical industry in Europe.Pharmacoeconomics is analysed as a part of decision processes at several stages of drug development and drug marketing. The review focuses on the practices of the application of pharmacoeconomics in various countries in Europe, and the drivers for the development of pharmacoeconomics within pharmaceutical companies are described. Investments made by companies with respect to the pharmacoeconomic function in terms of personnel and budget are derived.It is expected that within Europe, the pharmacoeconomic function will continue to grow in importance in the pharmaceutical industry in the coming years and will have at least a moderate commercial impact on pharmaceutical manufacturers through the pricing and reimbursement mechanism.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS