(2004; 109 pages)
4.4.4 Adverse events
TM/CAM-related adverse events are any unintended or undesirable events following the use of TM/CAM (see glossary). Consumers need to be informed about known adverse events and their causality. Consumers with allergies should be particularly observant when using TM/CAM medication therapies in case of an allergic reaction. Furthermore, consumers need to know what to do in case of adverse events or an overdose as well as whom to contact (see section 3.2.2). Examples of consumer information on adverse events are given in the leaflet material prepared by the Department of Health, Hong Kong SAR, China (see Annex I).
It is advisable to use a standard reporting form and to make these widely available. It should, however, be acceptable to receive reports by telephone, letter or e-mail. For health care providers already included in a national pharmacovigilance programme, the reporting form can be the same as the one already in use. A familiar form will facilitate reporting and the introduction of a second type of reporting form may cause confusion. Although the reporting system might coincide with the pharmacovigilance programme, the reports about adverse events following TM/CAM use need to be verified by TM/CAM experts.
Reporting forms should be provided to those involved in the provision of TM/CAM medication therapies, such as TM/CAM practitioners and TM/CAM retailers, who are not part of an existing national pharmacovigilance system. It may be necessary to design a special reporting form for those not familiar with the reporting of suspect reactions to medicines. Educational material regarding adverse events can be developed by TM/CAM professional organizations, for example, in collaboration with relevant authorities, in order to inform other professionals as well as consumers about adverse events and how to write a report about suspected adverse events.
A case report of a suspected adverse event or overdose may contain some of the following information: