Deanne E. Knapp

Prescription drug use in 1984 and changes over time.

More than 1.5 billion prescriptions were dispensed from retail pharmacies in 1984 at a consumer cost of

A method for post-marketing screening of adverse reactions to drugs: initial results.

18.4 billion. The number of prescriptions dispensed in 1984 equaled the previous record set in 1973. Over 40% of 1984 prescriptions were for four therapeutic classes: cardiovascular drugs, anti-infectives, psychotherapeutic drugs, and diuretics. Prescriptions for cardiovascular drugs and diuretics increased substantially from 1975 to 1984, while prescriptions for psychotherapeutic drugs decreased. Outpatient use of systemic antiinfectives remained fairly stable over the 10-year period. Trends in the use of specific drug categories within these broad therapeutic classes were variable, as were patient age and sex distributions.

Drug use in Australia and the United States as Reflections of Legislation and Social Attitudes

The FDA is pilot-testing a methodology for signaling previously unsuspected relationships between drugs and important adverse events. This method uses data it receives through the FDA spontaneous reporting program. Reviewing drugs used primarily on an outpatient basis, this screening methodology focuses on “tracer” adverse events and the organization of these reactions into body/functional systems. This review process enables a clinical evaluator to perceive more easily the clinically important drug-adverse event patterns. The method can incorporate drug use data; this enables a drugs proportional share of specific adverse events, relative to its therapeutic class, to be compared to its respective proportional share of drug use. The assumption is that the adverse event distribution of drugs in a therapeutic class should be the same as the distribution of drug use in that class, if all drugs in the class were to carry the same risk. Actual examples of drug-adverse event associations signaled by the screening method are presented. The potential uses of this methodology in other settings, and under other data situations, are discussed.

Discovery of Adverse Drug Reactions: A Comparison of Selected Phase IV Studies With Spontaneous Reporting Methods

The opinions expressed in this paper are those of the authors and not necessarily those of their respective governments. attitudes. Drug use is defined as use in a legitimate, medical context; nonmedical uses of drugs or drug abuse are not considered. Three major aspects are examined: government controls over the distribution of drug products, economics of obtaining drugs and related pharmacy services, and factors affecting individual decisionmaking in prescribing.