Antiretroviral Adverse Drug Reactions Pharmacovigilance in Harare City, Zimbabwe, 2017
Autor: | Owen Mugurungi, Hamufare Mugauri, Tsitsi Juru, Mufuta Tshimanga, Gerald Shambira, Notion Tafara Gombe |
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Rok vydání: | 2018 |
Předmět: |
Male
Health Care Providers Nurses 030226 pharmacology & pharmacy Drug Licensing Geographical Locations Pharmacovigilance 0302 clinical medicine Surveys and Questionnaires Epidemiology Medicine and Health Sciences 030212 general & internal medicine Prospective Studies Medical Personnel Multidisciplinary Pharmaceutics Drugs Professions Anti-Retroviral Agents Scale (social sciences) Medicine Female Research Article Adult Zimbabwe medicine.medical_specialty Drug Research and Development Referral Science Health Personnel Likert scale 03 medical and health sciences Pharmacotherapy Drug Safety Adverse Reactions Drug Therapy medicine Humans Drug reaction Drug Regulation Pharmacology Case detection business.industry Health Care Cross-Sectional Studies Potential harm Data quality Family medicine People and Places Africa Population Groupings business |
Zdroj: | PLoS ONE PLoS ONE, Vol 13, Iss 12, p e0200459 (2018) |
Popis: | IntroductionKey to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates identification and evaluation of previously unreported ADR’s, acknowledging the trade-off between benefits and potential harm of medications. Only 41% ADR’s 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 ADR’s in Harare city.MethodsA 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.ResultsOf the 52 participants, 32 (61.5%) distinguished the ADR defining criteria. Twenty-nine (55.8%) knew system’s purpose whilst 28 (53.8%) knew the reporting process. Knowledge scored average on the 5-point-Likert scale. Thirty-eight (73.1%) participants identified ADR’s 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 ADR’s. 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.ConclusionThe 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. |
Databáze: | OpenAIRE |
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