Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine
(2004; 109 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
View the documentPreface
View the documentGlossary
Open this folder and view contents1. General Considerations
Open this folder and view contents2. Development of Consumer Information
Open this folder and view contents3. General Principles and Activities for Ensuring Reliable TM/CAM Information
Close this folder4. Topics to Consider when Developing Consumer Information Promoting Proper Use of TM/CAM
View the document4.1 General information
View the document4.2 Where to find reliable information
View the document4.3 How to identify reliable information
Close this folder4.4 TM/CAM medication therapies
View the document4.4.1 Therapeutic claims
View the document4.4.2 Quality
View the document4.4.3 Precautions
View the document4.4.4 Adverse events
View the document4.4.5 Potent and/or toxic TM/CAM medication therapies
View the document4.4.6 Interactions and contraindications
View the document4.4.7 Posology
View the document4.4.8 Methods of administration
View the document4.4.9 Self-medication
View the document4.4.10 Preparation of TM/CAM medication therapies
View the document4.4.11 Children, pregnant or lactating women and the elderly
Open this folder and view contents4.5 Procedure-based TM/CAM therapies
View the document4.6 Practitioners
View the document4.7 Pricing and health insurance coverage
View the document5. Use of this Publication
View the documentReferences
Open this folder and view contentsAnnexes
View the documentBack Cover

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:

• Where it is permitted by the country health information privacy code, and with appropriate confidentiality, there should be some form of identification of the consumer/patient in order to avoid duplications and facilitate follow-up.

• Age, sex, and brief medical history (when relevant). In some countries ethnicity may need to be specified.

• Details of suspected TM/CAM therapy if known. For herbal medicines: species name and/or brand or ingredient name(s) including Latin binomial and common name, part of plant used, preparation methods; manufacturer, country of origin, batch number, expiry date and provider.

• Administration details: dose and quantity supplied, dosage form, route, start/stop dates.

• Indication or reason for use.

• Adverse events: date of onset (or duration from first administration to onset of event), description with symptoms and signs, severity and seriousness, results of clinical investigations and tests, course and outcome; and, if appropriate, consider dechallenge/rechallenge with the same product.

• All other medicines used (including self-medication) with administration details.

• Risk factors (e.g. age, impaired renal function, previous exposure to the therapy, previous allergies, drug misuse or abuse, recreational use of drugs).

• Name and address of reporter (to be considered confidential and to be used only for data verification, completion and case follow-up).

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