Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine: 3. General Principles and Activities for Ensuring Reliable TM/CAM Information: 3.2 Dissemination of information: 3.2.2 TM/CAM surveillance system

Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine
(2004; 109 pages)

Table of Contents

Acknowledgements
Foreword
Preface
Glossary
1. General Considerations
	1.1 The benefits of TM/CAM
	1.2 The risks involved in the use of TM/CAM
	1.3 Proper use of TM/CAM by consumers
	1.4 Additional important aspects for the proper use of TM/CAM
2. Development of Consumer Information
	2.1 Cultural influence
	2.2 Health system structure
	2.3 Utilization
3. General Principles and Activities for Ensuring Reliable TM/CAM Information
	3.1 How to develop reliable information
	3.2 Dissemination of information
		3.2.1 TM/CAM information centre
		3.2.2 TM/CAM surveillance system
		3.2.3 The media
		3.2.4 Other information activities
		3.2.5 Activities promoting rational use of medicines
	3.3 Regulatory mechanisms for information and advertisements
4. Topics to Consider when Developing Consumer Information Promoting Proper Use of TM/CAM
	4.1 General information
	4.2 Where to find reliable information
	4.3 How to identify reliable information
	4.4 TM/CAM medication therapies
		4.4.1 Therapeutic claims
		4.4.2 Quality
		4.4.3 Precautions
		4.4.4 Adverse events
		4.4.5 Potent and/or toxic TM/CAM medication therapies
		4.4.6 Interactions and contraindications
		4.4.7 Posology
		4.4.8 Methods of administration
		4.4.9 Self-medication
		4.4.10 Preparation of TM/CAM medication therapies
		4.4.11 Children, pregnant or lactating women and the elderly
	4.5 Procedure-based TM/CAM therapies
		4.5.1 Therapeutic claims
		4.5.2 Precautions
	4.6 Practitioners
	4.7 Pricing and health insurance coverage
5. Use of this Publication
References
Annexes
	Annex I. Leaflets Promoting Proper Use of TM/CAM Published by the Department of Health, Hong Kong SAR, China
	Annex II. Things to Know about Evaluating Medical Resources on the Internet*
	Annex III Medical Products on the Internet: A Guide to Finding Reliable Information
	Annex IV Licence Symbol, Swissmedic¹
	Annex V. Selected WHO Publications and Documents on Traditional Medicine
	Annex VI. List of Participants
Back Cover

3.2.2 TM/CAM surveillance system

A surveillance system is essential in order to improve the safety of TM/CAM therapies in general and to learn more about potential harmful adverse events and interactions following TM/CAM use. In countries with a national surveillance system for conventional medicines, the same system, adapted for collecting reports on TM/CAM medication therapies, could be used for the reporting of suspected adverse events following use of TM/CAM medication therapies. TM/CAM experts should be involved in all TM/CAM surveillance systems in order to verify reports. The context in which a surveillance system functions will determine the appropriate structure of the system, including the means of reporting. For instance, different pathways of reporting may be used for TM/CAM medication therapies depending on their mode of delivery, as proposed in the Guidelines on the safety monitoring and pharmacovigilance of herbal medicines (38). For TM/CAM procedure-based therapies, similar surveillance systems can be developed, tailored to the particular TM/CAM therapy in question.

3.2.2.1 PATHWAYS OF SURVEILLANCE FOR TM/CAM MEDICATION THERAPIES

The setting in which an adverse reaction is noted and the status of the person noting the reaction will determine the most appropriate means of reporting. It is recognized that in some countries a pharmacovigilance programme may consist of a network of national and regional centres. Reports should be sent to the appropriate regional or national centre in line with individual countries’ reporting guidelines. In the absence of a centre, it may be appropriate to report directly to the regulatory authority.

The different pathways for reporting are as follows:

1. Health professionals and providers of TM/CAM medication therapies should report to the national pharmacovigilance centre.

2. Patients/consumers should normally report to their physicians or providers of TM/CAM medication therapies. They may also report directly to the national pharmacovigilance centre, consumer organizations or to companies (or their representatives.

3. Manufacturers and importers/distributors of TM/CAM medication products could be a source of information on adverse events involving their products. Some countries have included this source of information as part of their regulatory framework. Manufacturers should report directly to the national pharmacovigilance centre or to the regulatory authority.