Drug Epidemiology and Post-Marketing Surveillance

This volume is a summary of material presented in the course given in the International School of Phannacology on "Drug Epidemiology and Post-Marketing Surveillance" between September 27 and October 8, 1990, at the "Ettore Majorana Center for Scientific Culture" in Erice, Sicily. The course, which was a NATO Advanced Study Institute, included lectures and workshops presented by experts in the new field of phannacoepidemiology. The material covered includes various approaches to spontaneous reporting of adverse drug reactions, including aggregate approaches, such as those used in France, and detailed analyses of individual reports, such as that done in The Netherlands and in Sweden. Also, included are studies using traditional epidemiology methods. In addition, modern pharmacoepidemiology makes considerable use of automated databases. As such, information is presented on their use as well. Phannacoepidemiology started in hospitals and some of the newest work in the field is returning to the hospital as a site for studies. Material on these topics was presented as well. Finally, selected new methodologic developments were outlined in specific examples presented that were of regulatory and commercial importance. This new field of phannacoepidemiology is exploding in interest internationally. Evidence of this is the increasing development of pharmacoepidemiology programs in industry, medical schools, pharmacy schools, and schools of public health. Also, there is a new International Society ofPhannacoepidemiology. Practitioners in this field tend to specialize in either analyses of spontaneous reporting or the use of formal epidemiologic techniques.

Zusammenfassung
Proceedings of a NATO ASI held in Erice, Sicily, Italy, September 27-October 8, 1990

Inhalt
Section A Spontaneous Reporting.- The Analysis of Postmarketing Drug Surveillance Data at the U.S. Food and Drug Administration.- Postmarketing Surveillance of ADRs by Spontaneous Reporting and Register Data: The Swedish Approach.- Spontaneous Monitoring of Adverse Reactions to Drugs, Procedures, and Experiences in the Netherlands.- Pharmacovigilance in France: A Decentralized Approach.- Section B Traditional Clinical Epidemiology Methods as Applied to Pharmacoepidemiology.- The Use of Vital and Morbidity Statistics for the Detection of Adverse Drug Reactions and for Monitoring of Drug Safety.- The Use of Case-Control Studies in Pharmacoepidemiology.- The Use of Cohort Studies in Pharmacoepidemiology.- Using Randomized Trials in Pharmacoepidemiology.- Section C Use of Automated Databases for Pharmacoepidemiology.- Pharmacoepidemiology Studies Using Large Databases.- Screening for Unknown Effects of Newly Marketed Drugs.- Section D Hospital Pharmacoepidemiology.- Hospital Data Sources.- Hospital-Based Intensive Cohort Studies.- Hospital-Based Adverse Reaction and Drug Utilization Review in the United States.- Section E New Methodologic Developments.- Approaches to Evaluating Causation of Suspected Drug Reactions.- Pharmacoeconomics: Principles and Basic Techniques of Economic Analysis.- N of 1 Randomized Trials for Investigating New Drugs.- Measuring Health-Related Quality of Life in Clinical Trials.- Section F Selected Examples of Regulatory and Commercial Importance.- Evaluation of Bias and Validation of Survival Estimates in a Large Cohort of AIDS Patients Treated with Zidovudine.- The Triazolam Experience in 1979 in The Netherlands, a Problem of Signal Generation and Verification.- Contributors.