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

Autor: Owen Mugurungi, Hamufare Mugauri, Tsitsi Juru, Mufuta Tshimanga, Gerald Shambira, Notion Tafara Gombe
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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