Effect of modified TaWai mobile system on adverse drug reaction reports in Lao PDR

Abstract

Background: Adverse drug reactions (ADRs) are major global public health problems and one of the leading causes of morbidity, mortality, and hospitalization. ADRs will continue to pose a threat to public health as long as drugs are being used to treat various ailments. Pharmacovigilance (PV) is one of the main tools for monitoring patient’s safety through detecting problems associated with medicines use and assessing their benefits and effectiveness to strike through maximize therapeutic outcomes. However, the under-reporting of ADRs is the main challenge of PV systems worldwide, especially in low/middle income countries (LMICs) including Lao PDR. This study aimed to determine the effectiveness of all available tools for enhancing ADRs reports, develop a modified TaWai mobile tool in Lao version, and evaluate effects of the modified TaWai in reporting ADRs in Lao PDR.

Methods: The methodology of this study was divided into 3 phases. Phase 1: A systematic review and meta-analysis was performed to determine effectiveness of available tools for enhancing ADR reports. Five databases were systematic searched from inception through September 2021. Two reviewers performed study selection, data extraction, and quality assessment independently. Data were evaluated and analyzed using a random-effects model. Heterogeneity was evaluated using I2 and chi-squared tests. Phase 2: Tawai for health in Lao version was developed as chatbot by adapting the template of TaWai for health in Thai version. The situation match for Lao PDR, such as pharmacovigilance and the regulation of ADR report or law related to ADR report in Lao PDR, were used to develop the detail of each component of TaWai chatbot in Lao version. The Lao version was back-to-back-translated from the Thai version, and content validity was performed. Phase 3: A cluster- randomized controlled trial (RCT) was conducted to evaluate the effects of a modified Tawai mobile system for enhancing ADRs reports in Lao PDR from May to August 2022. The group of healthcare professionals (HCPs) in tertiary hospitals at Lao PDR were randomized to intervention or control group. Both groups were trained about ADRs and ADR reports but intervention group was received addition training on using modified TaWai mobile tool for ADR report. Outcomes of interest were rate and quality of ADRs report, and satisfaction of HCPs.

Result: In phase 1 study, a total of 12 studies (9 RCTs and 3 Non-RCTs) with 24,298 participants were included but only eight studies were analyzed in meta-analysis. Interventions evaluated in included studies were educated of HCPs in different strategies used to improve ADR reporting including face to face workshop (n=9 studies), repeated telephone (n=2), and email or letter (n=2). Meta-analysis indicated that using all interventions increased number of overall ADRs report with risk ratio (RR) 4.80 (95% confidence interval (CI) 2.44 to 9.41, I2=83%, n = 8). However, based on types of interventions, only educated HCPs by face to face workshop can increase ADRs report with risk ratio (RR) 4.39 (95%CI 2.81 to 6.81, I2= 79 %, n = 6). In phase 2, the modified TaWai tool in Lao version was developed. The content validity test indicated that this tool is representative of the domain being assessed/ interest in ADR report. In phase 3, 16 and 18 HCPs were included in the intervention and control groups, respectively. Age, experience, and characteristics of HCPs in both groups were comparable. Rate of ADRs report in intervention group was higher than those in control group (28 vs. 3 report in 4 months). The number of high quality reports in the intervention group were also higher than those in the control group (28 vs 2 reports). One report in control group was judged as low quality report because there was no several key information including seriousness of the reaction, date to start/ stop of drug, date of the reaction start/stopped, comorbidity, dose of use, frequency, dosage form, route of administration, and the detail of reporter. In addition, the HCPs satisfied to used modified TaWai tool to report ADRs in hospital setting.

Conclusion: TaWai program intervention showed an improvement in ADRs report at the hospital and had a benefit for providers at PV center in collecting data. TaWai mobile App were reduced time, quickly to report ADRs, and it also gave a high satisfaction of HCPs to use TaWai mobile showed that is suitable appropriate to the context for HCPs report ADRs at the hospital in Lao PDR. In the future will do many department or difference hospital to support this TaWai tool.

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