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Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017

INTRODUCTION: Key to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates the identification and evaluation of previously unreported ADR’s, acknowledging the trade-off between benefits and potential harm of medications. Only...

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Autores principales: Mugauri, Hamufare, Tshimanga, Mufuta, Mugurungi, Owen, Juru, Tsitsi, Gombe, Notion, Shambira, Gerald
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6300272/
https://www.ncbi.nlm.nih.gov/pubmed/30566442
http://dx.doi.org/10.1371/journal.pone.0200459
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author Mugauri, Hamufare
Tshimanga, Mufuta
Mugurungi, Owen
Juru, Tsitsi
Gombe, Notion
Shambira, Gerald
author_facet Mugauri, Hamufare
Tshimanga, Mufuta
Mugurungi, Owen
Juru, Tsitsi
Gombe, Notion
Shambira, Gerald
author_sort Mugauri, Hamufare
collection PubMed
description INTRODUCTION: Key to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates the identification and evaluation of previously unreported ADR’s, acknowledging the trade-off between benefits and potential harm of medications. Only 41% Antiretroviral (ARV) 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 ARV ADR’s in Harare city. METHODS: A descriptive cross-sectional study and the 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. RESULTS: Of the 52 participants, 32 (61.5%) distinguished the ARV 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 ARV 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 ARV 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 ARV 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. CONCLUSION: The 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 ARV 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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spelling pubmed-63002722018-12-28 Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017 Mugauri, Hamufare Tshimanga, Mufuta Mugurungi, Owen Juru, Tsitsi Gombe, Notion Shambira, Gerald PLoS One Research Article INTRODUCTION: Key to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates the identification and evaluation of previously unreported ADR’s, acknowledging the trade-off between benefits and potential harm of medications. Only 41% Antiretroviral (ARV) 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 ARV ADR’s in Harare city. METHODS: A descriptive cross-sectional study and the 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. RESULTS: Of the 52 participants, 32 (61.5%) distinguished the ARV 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 ARV 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 ARV 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 ARV 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. CONCLUSION: The 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 ARV ADR identification by person place and time. Revisiting local policy, advocacy, communication and health worker orientation might improve pharmacovigilance performance in Harare city. Public Library of Science 2018-12-19 /pmc/articles/PMC6300272/ /pubmed/30566442 http://dx.doi.org/10.1371/journal.pone.0200459 Text en © 2018 Mugauri et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Mugauri, Hamufare
Tshimanga, Mufuta
Mugurungi, Owen
Juru, Tsitsi
Gombe, Notion
Shambira, Gerald
Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017
title Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017
title_full Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017
title_fullStr Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017
title_full_unstemmed Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017
title_short Antiretroviral adverse drug reactions pharmacovigilance in Harare City, Zimbabwe, 2017
title_sort antiretroviral adverse drug reactions pharmacovigilance in harare city, zimbabwe, 2017
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6300272/
https://www.ncbi.nlm.nih.gov/pubmed/30566442
http://dx.doi.org/10.1371/journal.pone.0200459
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