Abstract:
Previous studies evaluated pharmacovigilance (PV) system in term of passive surveillance in only post-marketing phase and did not specify new drugs. None study reviewed PV system of new drugs from pre-marketing phase to post-marketing phase. In addition, the situation of new safety monitoring program (SMP) risk-based approach integrated with risk management plan (RMP) was unknown. The objectives of the study were to review pharmacovigilance system of new drugs in targeted countries and to assess pharmacovigilance system of new drugs in Thailand. Method of the first objective was systematic review and primary data sources were drug regulatory authority websites in 83 high income countries and 56 upper-middle income countries. Method of the second objective was in-depth interview. Results of the first objective, a total of 139 countries, 87 countries had performed PV of new drugs. Thirty countries (34.48%) required new drugs with condition to conduct post-authorization safety studies within pre-specified monitoring period and processed risk assessment to remove new drugs from condition. Of these, 28 countries were high-income countries and 2 countries were upper-middle income countries (Bulgaria and Thailand). Results of the second objective, a total of 36 key informants were interviewed including 6 pharmacists from Thai FDA, 6 pharmacists from drug companies, 16 pharmacists and 8 physicians from hospitals. The achievable issues of RMP were that the compliance of drug companies was good in RMP submission as well as RMP update. The unachievable issue of RMP was that there was no PV inspection. The achievable issues of SMP were that the compliance of drug companies and hospitals was good in reporting complete ADR information, reporting all types of ADR following timetable. The unachievable issue of SMP was that the local data source was insufficient to process signal detection and support to remove new drugs from SMP. Risk communication did not reach all healthcare professionals. Conclusions: Performance of PV new drugs in Thailand was equal to high income countries. Overall, Thai FDA and drug companies understood RMP, SMP and could comply following guideline. Hospitals did not understand SMP guideline. The importance of differentiation of new drugs from non-new drugs was less emphasized.
