Development of Safety Surveillance Systems for Pharmaceutical and Health Products in Wiang Haeng District, Chiang Mai Province

Abstract

Objective: To develop and evaluate the safety surveillance systems for pharmaceutical and health products (PHPs) in Wiang Haeng District, Chiang Mai, by participatory process among health staff in a community hospital and village health volunteers (VHVs). Method: This action research employed 2 cycles of quality management process (Plan-Do-Check-Act or PDCA) to develop 2 surveillance systems. The first system or proactive hospital-based surveillance was developed from the information obtained from focus group interview among physicians, pharmacists and nurses. Evaluation of the system was conducted by identifying patients with harms from PHPs and number of warning reports on harms being sent to the community. The second system for active community-based surveillance was designed based on the information gained from focus group interview among pharmacists, staff in primary and holistic care, VHVs representatives and staff from sub-district public health office. The participants worked together to establish procedures in the safety surveillance system for PHPs in community with the link to the system within the hospital. The study selected 30 VHVs and empowered them on skills and knowledge in PHPs, and delegated them to monitor according to the system. Outcomes of the surveillance system were the number of surveillance of PHPs in community, identification of adverse reactions of in PHPs by using trigger tools, numbers of data obtained from the hospital, and the assessment of literacy on rational drug use among VHVs before and after the implementation of the surveillance system. Results: Safety surveillance systems arose from participatory process among stakeholders within the hospital and community. Development of the systems involved the selection of groups of adverse reactions from products that should be monitored including steroids, NSAIDs, sibutramine and sildenafil in order to develop trigger tools to detect harms from risky products in the community. The system also established communication channel between the hospital and the community through the VHV LINE application. Rational drug use literacy among VHVs showed a statistically significant increase after empowerment (P< 0.001) from 37.09 ± 12.93 to 40.76 ± 13.70 (full score of 52). The surveillance systems led the communication of risk through appropriate channel to stakeholders. Conclusion: Analysis of risk and development of surveillance systems for health products by multidisciplinary team and network of partners in community, together with empowerment of VHVs, led to the establishment of procedure to identify risk, communicate information on patients’ use of PHPs between hospitals and communities. The systems could lead to appropriate patient care and avoidance of harm from the use of risky PHPs.