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. Front Matter....Pages i-viii The Analysis of Postmarketing Drug Surveillance Data at the U.S. Food and Drug Administration....Pages 1-7 Postmarketing Surveillance of ADRs by Spontaneous Reporting and Register Data: The Swedish Approach....Pages 9-20 Spontaneous Monitoring of Adverse Reactions to Drugs, Procedures, and Experiences in the Netherlands....Pages 21-37 Pharmacovigilance in France: A Decentralized Approach....Pages 39-42 The Use of Vital and Morbidity Statistics for the Detection of Adverse Drug Reactions and for Monitoring of Drug Safety....Pages 43-48 The Use of Case-Control Studies in Pharmacoepidemiology....Pages 49-51 The Use of Cohort Studies in Pharmacoepidemiology....Pages 53-58 Using Randomized Trials in Pharmacoepidemiology....Pages 59-63 Pharmacoepidemiology Studies Using Large Databases....Pages 65-71 Screening for Unknown Effects of Newly Marketed Drugs....Pages 73-82 Hospital Data Sources....Pages 83-90 Hospital-Based Intensive Cohort Studies....Pages 91-98 Hospital-Based Adverse Reaction and Drug Utilization Review in the United States....Pages 99-101 Approaches to Evaluating Causation of Suspected Drug Reactions....Pages 103-113 Pharmacoeconomics: Principles and Basic Techniques of Economic Analysis....Pages 115-124 N of 1 Randomized Trials for Investigating New Drugs....Pages 125-134 Measuring Health-Related Quality of Life in Clinical Trials....Pages 135-142 Evaluation of Bias and Validation of Survival Estimates in a Large Cohort of AIDS Patients Treated with Zidovudine....Pages 143-157 The Triazolam Experience in 1979 in The Netherlands, a Problem of Signal Generation and Verification....Pages 159-167 Back Matter....Pages 169-172 Proceedings of a NATO ASI held in Erice, Sicily, Italy, September 27-October 8, 1990