Development of ADR Monitoring Activities in Poland Subsequent to Changes in the Pharmaceutical Market
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Drug Information J o u m l . Vol. 32, pp. 13-11, 1998 Printed in the USA. All rights reserved.
DEVELOPMENT OF ADR MONITORING ACTIVITIES IN POLAND SUBSEQUENT TO CHANGES IN THE PHARMACEUTICAL MARKET ANDRZEJ
CZARNECKI, MD, RID, DSc
Director, Pharmacoepidemiology Center and Central Register of Clinical Trials, Drug Institute, Warszawa, Poland
The monitoring of adverse drug reactions (ADRs) has a history of more than 25 years in Poland. Its desirability was not well perceived for many years due to the availability of primarily oldgeneric drugs on the market. With economic changes in the period of 199&1996 some 6,000 new preparations were registered and put on the market. This large number of new drugskhemical entities along with other homeopathic and herbal products made it necessary to revitalize ADR monitoring. The new Pharmaceutical Act of 1991 introduced the obligation for marketing authorization holders to monitor and report ADRs to a regulatory authority. Detailed guidelines on company reporting followed. To improve the work and eflciency of spontaneous reporting, efforts were undertaken to restructure the central national system into a regional organization based on the French experience. Also, a number of educational and promotional activities were undertaken such as training courses, lectures, publications, and so forth. A new reporting form and the Drug Bulletin (as a source of relevant information) were introduced. Other activities preceded those specified in the World Health Organization (WHO)Guidelinefor Establishing and Functioning of Pharmacovigilance Centers drafted in 1996. The current organization, everyday work, and background to national and international cooperation on ADR monitoring is also presented. Key Words: Monitoring of adverse drug reactions; Pharmacoepidemiology ; Poland
early 1970s. That system was based on spontaneous reporting from the medical profession (physicians and pharmacists). With time, data from industry and focused studies were also collected. Although the Center for Monitoring of Adverse Effects of Drugs had established links with the WHO Programme for International Drug Monitoring since 1972, activities were not extensive due to a number of factors (Table 1). The most apparent factor, however, was the presence of only very well known drugs on the market, primarily in generic form, and the lack of initiative to monitor them once the safety profile was well established. The financial situation
THE MONITORING OF adverse drug reactions started in many countries more than 30 years ago and has resulted in a great deal of important information on drug safety that influenced pharmacotherapy and the market. An adequate system for monitoring ADRs (that collected information from the local population) has existed in Poland since the
Presented at the DIA 33rd Annual Meeting “Optimizing Pharmaceutical Development: The Global Experience,” June 22-26, 1997, Montreal, Canada. Reprint address: Professor Andrzej Czamecki, Medicines Control Agency, Market Towers, 1, Nine Elms Lane, Londo
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