A handbook for consumer reporting of ADRs was discussed and requested at the thirty-first meeting of the National Pharmacovigilance Centres held in Uppsala, Sweden from 20–23 October 2008, and the development of this publication has been incorporated into the aims of the Seventh Framework Programme of the Research Directorate of the European Commission and its project Monitoring Medicines (http://www.monitoringmedicines.org/).

This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.

In an increasing number of countries (e.g. Australia, Canada, Denmark, the Netherlands, Sweden, the United Kingdom, and the United States), consumers are being encouraged to report adverse reactions to medicines to a spontaneous reporting system, and organizations such as the World Health Organization (WHO) and the European Commission acknowledge the role of the consumer in spontaneous reporting. Consumers, patients and their organizations are becoming increasingly involved in pharmacovigilance, especially when it comes to risk communication.

Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public. Some countries use the term “patient reporting”, but consumer reporting is a broader term, as not all consumers of medicines are patients. A patient may be defined as a person who receives medical attention, care or treatment from a physician or other health professional. The patient who buys an analgesic against a prescription from his or her physician, and the individual who buys painkillers at the pharmacy without consulting a health-care professional, are both consumers of a medicinal product.

This document aims to help countries set up a well-organized and effective consumer reporting system within their pharmacovigilance centre. Most national pharmacovigilance centres participate in the WHO Programme for International Drug Monitoring and it is recommended that ADR reports, including those from the public, be forwarded to the WHO International Individual Case Safety Reports (ICSR) database.