Definitions and basic requirements for the use of terms for reporting adverse drug reactions (XI): cardiovascular system disorders.

This paper is the report of a meeting held in Geneva under the auspices of the Council for International Organizations of Medical Sciences (CIOMS) on 5-6 November 1997. It contains definitions of terms, and basic requirements for their use, for purposes of reporting adverse drug reactions of the system/organ classes: cardiovascular disorders, general; heart rate and rhythm disorders; and vascular (extracardiac) disorders.

Harmonising adverse drug reaction terminology: the role of the Council for International Organizations of Medical Sciences.

Health professionals from different countries are known to differ considerably in their use of medical terminology, including the terminology used for adverse drug reactions (ADRs) and in the exact meanings attributed to terms. To remedy this situation, the Council for International Organizations of Medical Sciences (CIOMS) has attempted to provide definitions and basic requirements for proper use of ADR terms. The work has concentrated on terms liable to be misinterpreted and those used for serious and frequently reported ADRs.

Ethics and human values in health policy.

Technologies have given us more choices in health matters than ever before. At the same time, the moral ground on which we stand to make such choices has become more uncertain. The author reviews the underlying questions and difficulties, and suggests ways of approaching them.

International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group.

A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.