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.
22.214.171.124 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.