การพัฒนากลไกการเฝ้าระวังความปลอดภัยด้านยาและผลิตภัณฑ์สุขภาพ อำเภอเวียงแหง จังหวัดเชียงใหม่

Abstract

The objectives of this action research were to develop and evaluate the mechanisms of safety surveillance for pharmaceutical and health products (PHPs) in Wiang Haeng District, Chiang Mai, by using participatory process among healthcare staffs in community hospital, and village health volunteers (VHVs). This study conducted during May – October 2022 with 4 steps of quality process: Plan-Do-Check-Act (PDCA). The study composed of 2 parts, including 1) Proactive hospital-based surveillance and 2) Active community-based surveillance, by focus group interview among key informants in planning, establish safety surveillance system guideline, select groups of PHPs adverse reactions that should be monitored, manage activities and evaluate results. Proactive hospital-based surveillance mechanism was developed by focus group interview with 10 hospital staffs, including doctors, pharmacists, and nurses, selected by purposive sampling. Assess the results from finding patients affected by PHPs, and the number of incident reports that have been forwarded to the community. Active community-based surveillance mechanism development was conducted by focus group interview with 11 staffs, selected by purposive sampling, consist of community hospital staffs and VHVs. They designed and developed guideline for PHPs safety surveillance system in community which linked to the hospital and conducted by develop-potential skill VHVs. Active community-based surveillance mechanism was evaluated by collect data operations in community from 30 VHVs, including the number of PHPs surveillance in community, and numbers of case finding affected from PHPs by using trigger tool. This study also assessed impact of system on VHVs by using rational drug use literacy (RDUL) tools of Thai people and comparative results of RDUL score between before and after implementation system as one-group pretest-posttest on mean level. The results showed that safety surveillance system for PHPs arising from participatory process among stakeholders between hospital and community. All stakeholders chose PHPs adverse reactions and developed appropriated trigger tools to detect risks from steroids, NSAIDs, sibutramine, and sildenafil. The proactive hospital-based surveillance mechanism was able to find patients affected by PHPs 11 times. Also forwarded all information to the community through the VHVs using the LINE application, to make the community aware of the unsafe news about medicines and health products in the area. Active community-based surveillance operated by VHVs with the survey of 146 households, indicated that there were 15 households using harmful PHPs. A total of 17 cases were screen any harm events by using trigger tool and find out that 2 cases associated with PHPs, and forward data to the hospital. The study of RDU literacy score on VHVs after developing the potential and implementing the surveillance mechanism was significantly higher than before (p< 0.001), which average of 40.76±13.70 and 37.09±12.93, respectively. Development of safety surveillance mechanism for PHPs leads to a system for transferring health products data and linking information between the hospital and the community. In conclusion, Development of safety surveillance mechanism for PHPs between hospitals and communities by multidisciplinary and community network partners, including the potential development of VHVs in rational drug use literacy skills resulting in problem-finding practices, the transfer of information on PHPs uses of patients between hospitals and communities, and effective problem management.