Xuemei Zhang1,2, Rui Niu1,2, Bianling Feng1,2, Jiadong Guo1,2, Ying Liu1,2, Xinyu Liu3. 1. a The Department of Pharmacy Administration and Clinical Pharmacy , School of Pharmacy, Xi'an Jiaotong University , Xi'an Shannxi , China. 2. b The Center for Drug Safety and Policy Research , Xi'an Jiaotong University , Xi'an Shannxi , China. 3. c The Department of computer science and software engineering , Xi'an Jiaotong-liverpool Uiversity , Suzhou Jiangsu , China.
Abstract
BACKGROUND: Although China's adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. RESEARCH DESIGN AND METHODS: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April-December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. RESULTS: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities. CONCLUSIONS: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.
BACKGROUND: Although China's adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. RESEARCH DESIGN AND METHODS: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April-December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. RESULTS: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities. CONCLUSIONS: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.