Quasi-experiment Study on Use of Toll-free Phone Systems for Adverse Event Reporting by Patients and Clinicians

• Published in: Drug safety 2022-10, Vol.45 (10), p.1271-1272
• Main Authors: Odongpiny, E A A L, Nicol, M, Kigongo, A N, Katana, E, Nambasa, V, Kesby, M, Holden, M, Ndagije, H B, Meya, D, Wiltshire, C S, Sloan, D
• Format: Article
• Language: English
• Subjects: Adverse events; Antiretroviral agents; Antiretroviral therapy; Cell phones; Cellular telephones; Females; HIV; Human immunodeficiency virus; Menstrual cycle; Patients; Pharmacovigilance; Populations; Quasi-experimental methods; Telemedicine
• ISSN: 0114-5916; 1179-1942

Introduction: African populations are the largest global recipients of antiretroviral therapy (ART) yet contribute less than 1% of post licensing adverse event (AE) reports to the WHO PV database VigiBase TM(1, 2). Dolutegravir (DTG) was rolled out for use in African ART programmes, however there's a paucity of studies providing AE information from those populations. Direct reporting by patients to the national regulator has not been widely adopted in African countries but has improved reporting and detection of new signals elsewhere (3, 4). Use of mobile phone systems has also been proposed as an intervention to improve reporting (5, 6). Objective: To determine whether an intervention of clinicians and patients using toll-free phone systems results in improved reporting of AEs compared to clinicians using standard paper-based reporting methods. Methods: We conducted a quasi-experiment study between MayNovember 2021 at three health centers in Kampala, Uganda with similar baseline reporting rates. We trained clinicians working in the HIV clinic with a standard package on pharmacovigilance and DTG AEs, at one health center (HC1) and also provided details of the tollfree number based at the National Drug Authority. In the second center (HC2) we provided the same training to patients on DTG-based regimens and the toll-free number. In the third center (control) we trained clinicians and encouraged use of existing paper-based reporting methods (HC3). We compared the monthly reporting rates from the two intervention centers to the control using 2-sample Wilcoxon rank-sum test. We summarized the AEs to DTG reported and compared them with the manufacturer's drug information label for new signals. Results: We trained four clinicians in HC1 and another four in HC3. In HC2, 493 patients were enrolled with the majority female (430/ 493,87%) and of median age 32 years (IQR 27-39). Monthly reporting rates were significantly higher in HC2 (138 reports received) compared to HC3 (0 reports) (p = 0.003). While reports in HC1 (3 reports received) were not significantly different compared to HC3 (p = 0.317). HC2 reports were made by 137 patients (87% female) of median age 34 years (IQR 28-40). Patients reported a total of 346 AEs with a median number of 2 AEs per patient (IQR 2-4). New signals emerging reported by patients included forgetfulness (5), loss of libido (8) and menstrual cycle changes (10). One report of forgetfulness was received from HC1. Conclusion: Patients eng