Health Products Vigilance in Thailand: Past, Present and Future (การเฝ้าระวังความปลอดภัยด้านผลิตภัณฑ์สุขภาพในประเทศไทย: อดีต ปัจจุบัน และอนาคต)

Vigilance to detect adverse events related to health products is an important function of public health system. This study aimed to describe health products vigilance system in Thailand and identify challenges to the system so that its future could be properly defined. The study used documentary review and various approaches of stakeholder consultations to collect data. Analysis of the content was performed to detect common opinions. The vigilance system in Thailand started in 1983 with focus on drugs, known as “Pharmacoviglance System”, and was later expanded to include other health products (e.g. herbal medicines, vaccines, and medical devices) and became “Health Product Vigilance System” in 2008. The reports received at Health Product Vigilance Centre (HPVC) grew steadily from a few hundred in the beginning to 50,000 reports per year nowadays. The adverse events were reported mainly from governmental hospitals. A computer program was developed to detect signals in the database. If the signal was true, appropriate risk management and communication was carried out. Signals detected by the HPVC had contributed to regulatory actions at domestic level, and were reported to the World Health Organization. Despite its well established success, a few challenges remained. There may be a need to have regulations that mandate reporting of adverse events. Health products other than drugs need more emphasis. Information on potential risk of certain drug known when the drug is approved should guide postmarketing vigilance on potential adverse events related to the drug. Priority actions may be needed for adverse events in certain vulnerable groups, e.g. pregnant women, children, and elderly. Network to report the adverse events need to be strengthened and expanded and vigilance staff in the network need to be increased. Development or improvement to enhance electronic reporting of adverse events that are linked automatically with medical records will greatly increase the performance of the system. Key words: health products, vigilance, challenges, Thailand