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

Abstract

IntroductionKey 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.MethodsA 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.ResultsOf 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.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 ARV ADR identification by person place and time. Revisiting local policy, advocacy, communication and health worker orientation might improve pharmacovigilance performance in Harare city.

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators

“…Interviews: Regulatory systems and policies concerning PV Reliance on interviews with key informants. Some details regarding budget and staff, as well as composition and functioning of the national advisory committee, were not uniformly available 33 Mugauri et al [ 44 ] To evaluate the antiretroviral- adverse drug reaction (ARV-ADR) surveillance system in Harare City to identify the reasons for underreporting and recommend solutions Descriptive cross-sectional study and surveillance system evaluation Harare City, Zimbabwe National Pharmacovigilance Centre 52 Health Personnel involved in the ARV-ADR surveillance from 2 hospitals and 17 clinics Documentary review of patient records and notification forms issued by the hospitals and clinics, as well as interviews with healthcare workers using an interviewer-administered questionnaire Updated Centres for Disease Control and Prevention (CDC) guidelines for Evaluating Public Health Surveillance Systems and checklist derived from the WHO assessment criteria for a PV system’s stability status (WHO PV Indicators) Questionnaire: determine health workers' knowledge of the operations and usefulness of the surveillance system; Checklist: evaluates the availability of reporting forms, case definitions and means for communication. Patient records: number of ARV-ADR cases documented, captured, and missed by the surveillance system.…”

“…Ten studies employed self-completion questionnaires for data collection [ 45 , 48 – 53 , 55 – 57 ], and nine employed mixed-methods [ 37 – 41 , 43 , 44 , 46 , 47 ] including interviewer-administered questionnaires alongside a documentary review. Two studies [ 42 , 54 ] employed only qualitative methods including interviews and literature or documentary review.…”

“…Eight studies [ 39 , 44 , 48 , 50 , 52 – 55 ] focussed on national PV centre(s), while three [ 37 , 38 , 41 ] took more of a system-wide approach by also including other levels, i.e. healthcare facilities and PHPs.…”

“…Thirteen studies [ 37 – 44 , 46 , 47 , 49 , 53 , 55 ] employed an analytical approach that relied on the use of a framework. The most frequently used frameworks (n = 3) used were the IPAT framework [ 37 , 38 , 41 ] and the WHO PV indicators [ 46 , 47 , 55 ].…”

“…Two studies used the East African Community (EAC) harmonised pharmacovigilance indicators tool [ 39 , 40 ] and two used the WHO minimum requirements for a functional PV system [ 42 , 53 ]. Two studies [ 43 , 44 ] employed the Centres for Disease Control and Prevention (CDC) updated guidelines for evaluating public health surveillance systems [ 58 ] alongside the WHO PV indicators [ 30 ]. One study employed a framework that combined indicators from the IPAT and the WHO PV indicators [ 49 ].…”