DEVELOPMENT OF AN INTERVENTION MODEL FOR HEALTHCARE PROFESSIONALS AND PATIENTS FOR IMPROVING AWARENESS OF ADVERSE DRUG REACTIONS (ADR) REPORTING

• Main Author: Tri Yuniar, Cindra
• Format: Dissertations
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/86737
• Institution: Institut Teknologi Bandung

Adverse drug reactions (ADRs) are a drug-related events that is noxious and unintended and occurs at normal doses used in humans for prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function. Adverse drug effects are influenced by the type of disease, the number of drugs, and the duration of therapy. The potential for ADRs is higher in elderly patients due to multicomorbidity and polypharmacy. One of the diseases in elderly patients is type 2 diabetes mellitus (DM), which can develop into cardiovascular complications and kidney disorders. In 2020, the prevalence of type 2 DM patients in Indonesia was high (11.3%), which was the 3rd highest in Southeast Asia. Therefore, it is important to evaluate the ADR reporting, especially for type 2 diabetes mellitus patients. In addition, along with technological developments, the concept of using cellular applications and remote consultation services for patients has also developed. These technological developments can be an opportunity to increase ADR reporting by patients. Adverse drug reactions experienced by patients should be reported by healthcare professionals (HCPs) to the pharmacovigilance team at the National Agency of Drug, Food, and Cosmetic (NADFC). To date, the level of ADR reporting remained low in Indonesia due to lack of awareness and lack of knowledge about the reporting system. The purpose of this study was to develop an intervention model for healthcare professionals and patients to increase the awareness of ADR reporting, especially in the Bandung area. This study applied a mixed-methods design, which was divided into 3 stages. Stages 1 and 3 were quantitative studies, while stage 2 of the study was qualitative study. Stage 1 was a crosssectional study design using questionnaire to 2 groups of subjects, such as type 2 diabetes mellitus patients and healthcare professionals. Of the 122 healthcare professionals, most had good knowledge (53.3%), but showed a negative attitude towards ADR reporting (77.9%). Experience in reporting ESO was dominated by reporting activities to the internal team (79.6%) compared to reporting to the pharmacovigilance team at NADFC. Of all HCPs, only 7 subjects had ever reported ADR to NADFC. The seven subjects consisted of 6 pharmacists and 1 specialist doctor who all practiced in hospitals. In the subjects of type 2 diabetes mellitus patients, there were 170 patients who filled out the questionnaire, and 54 patients (84.4%) of them had reported ADR to HCPs, especially to physician. The patients had good knowledge about reporting ADR to healthcare professionals (74.1%) and positive attitude towards ADR reporting(65.3%). The study on patient was expanded to the public to identify the potential for utilizing mobile applications as an alternative method of ADR reporting. From the study of 419 subjects, it was found that 54.9% of the public were interested and 31.7% of them were very interested in using mobile applications. The study was continued to phase 2 with a qualitative study design using the focus group discussion (FGD) method. This study focused on healthcare professionals by considering the results of the phase 1 study and the NADFC regulations in Indonesia, which showed the important role of HCPs in the ADR reporting process. The phase 2 study aims to analyze the optimal interprofessional collaboration to improve ADR reporting. The results of 2nd phase study indicate that pharmacists are expected to play a major role in reporting ADR to NADFC. Physicians and nurses play a more dominant role in handling and managing ESO. Nurses act as the first party on receiving ADR reports, while the physicians play an important role in handling, managing, or recommending therapy in collaboration with pharmacists and nurses. From the results of the 1st and 2nd phases of the study, an appropriate intervention model design was obtained for healthcare professionals. The 3rd phase of the study aimed to evaluate the effectiveness of educational interventions on knowledge and attitudes of HCPs towards ADR reporting. The intervention model was the distance learning using a website, routine reminders, and an initial screening form for ADR reporting. The study design was a quasi-experimental non-randomized pretest-posttest design. The study began with the website development, followed by functionality test and effectiveness evaluation. In the functionality test on 18 subjects, the website could be used as indicated by a SUS score of 86 out of 100, and an SEQ of 6.56 out of 7. After functionality test, the intervention effectiveness evaluation was applied to 81 HCPs. The effectiveness test was carried out 3 times within a span of 3 weeks (1 week 1 time) and routine reminders 1 time per week. The website also provides an initial screening report for ESO reporting. The results showed an increase in participants' knowledge and attitudes regarding ADR reporting between control and intervention group (p <0.001). In addition, 9 subjects were encouraged to report ESO during the intervention period with a total ESO reporting figure of 48 reports. It can be concluded that distance learning education intervention using a website can increase the awareness of ADR reporting for HCPs.