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bioRxiv · 10.1101/358069

Antiretroviral Adverse Drug Reactions Pharmacovigilance in Harare City, Zimbabwe, 2017

Mugauri, H.·Juru, T.·Mugurungi, O.·Gombe, N.·Shambira, G.·Tshimanga, M.
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Abstract

IntroductionKey to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates identification and evaluation of previously unreported ADRs, acknowledging the trade-off between benefits and potential harm of medications. Only 41% ADRs documented in Harare city clinical records for January to December 2016 were reported to Medicines Control Authority of Zimbabwe (MCAZ). We investigated reasons contributing to underreporting of ADRs in Harare city.\n\nMethodsA descriptive cross-sectional study and the updated Centers for Disease Control (CDC) guided surveillance evaluation was conducted. Two hospitals were purposively included. Seventeen health facilities and 52 health workers were randomly selected. Interviewer-administered questionnaires, key informant interviews and WHO pharmacovigilance checklists were used to collect data. Likert scales were applied to draw inferences and Epi info 7 used to generate frequencies and proportions.\n\nResultsOf the 52 participants, 32 (61.5%) distinguished the ADR defining criteria. Twenty-nine (55.8%) knew systems purpose whilst 28 (53.8%) knew the reporting process. Knowledge scored average on the 5-point-Likert scale. Thirty-eight (73.1%) participants identified ADRs following client complaints and nine (1.3%) enquired clients medication response. Forty-six (88.5%) cited non-feedback from MCAZ for underreporting. Inadequate ADR identification skills were cited by 21 (40.4%) participants. Reporting forms were available in five (26.3%) facilities and reports were generated from hospitals only. Forty-two (90.6%) clinicians made therapeutic decisions from ADRs. Averaged usefulness score was 4, on the 5-point-Likert scale. All 642 generated signals were committed to Vigiflow by MCAZ, reflecting a case detection rate of 4/ 100 000. Data quality was 0.75-1.0 (WHO) and all reports were causally assessed.\n\nConclusionThe pharmacovigilance system was useful, simple, and acceptable despite being unstable, not representative and not sensitive. It was threatened by suboptimal health worker knowledge, weak detection strategies and referral policy preventing ADR identification by person place and time. Revisiting local policy, advocacy, communication and health worker orientation might improve pharmacovigilance performance in Harare city.

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Mugauri, H., Juru, T., Mugurungi, O., Gombe, N., Shambira, G., Tshimanga, M.. 2018-06-28. Antiretroviral Adverse Drug Reactions Pharmacovigilance in Harare City, Zimbabwe, 2017. https://doi.org/10.1101/358069

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