Current status of pharmacovigilance regulatory structures, processes, and outcomes in the Asia‐Pacific region: Survey results from 15 countries

Abstract

Purpose Regulatory discrepancies may exist in pharmacovigilance (PV) structure, process, and outcome status worldwide. Our study's objective was to survey the current status of PV in each regulatory body in the Asia‐Pacific Economic Cooperation (APEC) region. Methods A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries. Results Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea. Conclusion We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators

“…The accuracy and completeness of the information provided could be affected depending on the individual completing the questionnaire. Not all countries formally participated so regional situations are not fully described 24 Zhang et al [ 56 ] To assess the current status of ADR reporting and monitoring in pharmaceutical manufacturers, drugstores, and medical institutions in China Cross-sectional study Chinese provinces (East: Jiangsu and Guangdong; West: Shaanxi and Sichuan; and Centre: Henan and Hebei) Pharmaceutical manufacturers', drugstores', and medical institutions' pharmacovigilance systems 589 institutions (194 pharmaceutical manufacturers, 191 drugstores, and 204 medical institutions) Self-administered questionnaire by ADR reporters in charge of drug safety (e.g. heads of vigilance units and drug safety coordinators) at Pharmaceutical manufacturers, drugstores, and medical institutions A questionnaire based on previous studies 1—Current status of the ADR monitoring system; 2—Basic resources for ADR reporting; 3—ADR reporting; and 4- Other PV activities Data might not fully reflect current adverse drug reaction monitoring and reporting systems in China.…”

“…Three studies [ 43 , 46 , 51 ] focussed on PV at the regional level within a country. Five studies [ 40 , 45 , 47 , 56 , 57 ] focussed on PV in stakeholder institutions including pharmaceutical companies/manufacturers, Public Health Programmes (PHPs), drugstores and medical institutions.…”

“…The main limitation described by the reviewed studies related to information validity and completeness. Eight studies [ 39 , 40 , 42 , 43 , 48 , 50 , 52 , 56 ] cited limitations that included pertinent data missing, reliance on the accuracy of information provided or inability to verify or validate information. The second limitation was related to the collected data's currency [ 39 , 48 , 50 , 56 ].…”

Characteristics and trends of spontaneous reporting of therapeutic ineffectiveness in South Korea from 2000 to 2016

“…Among 21 countries surveyed, seven countries (Philippine, USA, Brunei, Peru, Indonesia, Chile, Malaysia) responded to the therapeutic ineffectiveness and medication errors. The Philippines had approximately 16% of therapeutic ineffectiveness reports, the USA had 5%, and the others less than 5% [9]. Reports involving therapeutic ineffectiveness changed continuously from 2000 to 2016.…”

Automation Opportunities in Pharmacovigilance: An Industry Survey

“…5) process steps to help readers understand the end-to-end ICSR process from case receipt through case distribution. Not all process steps apply to all companies, and some companies may have a different sequence of steps, different names to represent their specific steps, or slight variations in the workflow [12]. Companies receive cases from different sources (e.g., spontaneous reports, clinical trials, and literature) and in structured or unstructured formats depending on the reporter and channel of data collection (e.g., via phone call/email/ other).…”