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Veterinary pharmacovigilance in sub-Sahara Africa context: a pilot study of adverse reactions to veterinary medicine in Cameroon.

ABSTRACT: BACKGROUND:Sub-Saharan African market is highly affected by counterfeit veterinary drugs. Though these counterfeit and non-compliance of drugs can induce adverse effects during their utilization, there is no monitoring system of veterinary medicines. The present pilot study was carried out in Cameroon to identify and describe suspected cases of adverse reactions to veterinary drugs in animals and / or humans as well as inefficacy of veterinary drugs. The methodology involved a descriptive cross-sectional survey of 67 actors in the veterinary medicine sector in Cameroon. RESULTS:A total of 74/120 (62%) cases of suspected adverse effects and or lack of efficacy of veterinary drugs in animals and 46 (38%) cases of adverse reactions in humans were identified. Antiparasitics were the most incriminated therapeutic class in animals (61%) and human (56%). Adverse reactions were reported in dogs (44%) and poultry (24%) while drug inefficacy was most observed in poultry (47%). According to animal health professionals, levamisole (24%) and ivermectin (16%) were identified to be responsible for the adverse effects and that the highest level of inefficacy was most frequently reported for oxytetracycline (29%). The main adverse reactions were systemic (22%), gastrointestinal (20%) and neurological (13%) disorders. CONCLUSION:The results of this study showed that misuse and circulation of poor quality as well as lack of efficacy of veterinary drugs is very common in Cameroon. Adverse reactions were observed in animals and humans. Therefore, the establishment of a national veterinary pharmacovigilance system based on solid legal bases is essential for a continuous assessment of the risks-benefits effects of veterinary drugs marketed in Cameroon.

SUBMITTER: Mouiche MMM

PROVIDER: S-EPMC6701137 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Veterinary pharmacovigilance in sub-Sahara Africa context: a pilot study of adverse reactions to veterinary medicine in Cameroon.

Mouiche Mohamed Moctar Mouliom MMM Njingou Badou Zaki Ndouoya BZN Moffo Frédéric F Mpouam Serge Eugene SE Feussom Jean Marc Kameni JMK Awah-Ndukum Julius J

BMC veterinary research 20190819 1

<h4>Background</h4>Sub-Saharan African market is highly affected by counterfeit veterinary drugs. Though these counterfeit and non-compliance of drugs can induce adverse effects during their utilization, there is no monitoring system of veterinary medicines. The present pilot study was carried out in Cameroon to identify and describe suspected cases of adverse reactions to veterinary drugs in animals and / or humans as well as inefficacy of veterinary drugs. The methodology involved a descriptiv ...[more]

PMID: 31426790

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Project 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.

Project description:BackgroundThe introduction of immune checkpoint inhibitors (ICIs) in clinical practice has brought significant benefits for patients. Seven ICIs are available in Europe: nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, and ipilimumab. Despite their proven clinical efficacy, these innovative drugs may cause serious immune-related adverse drugs reactions (irADRs). Given the significance of these ADRs for patients' health, we analyzed individual case safety reports (ICSRs) related to ICIs, focusing on those reporting irADRs, collected in the Italian spontaneous reporting database.MethodsWe analyzed ICI-induced irADRs collected in the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza [RNF]) from January 1, 2002, to February 28, 2019, focusing on those reported in the Campania Region. We retrieved from an open-access Italian pharmacovigilance system, the RAM system (for national safety data), and from the RNF (for Campania safety data) all ICSRs reporting ADRs related to ICIs authorized until the analysis date. Focusing on irADRs, we performed descriptive and disproportionality analyses through the reporting odds ratio (ROR) with 95% confidence interval.ResultsNational results. Among 2,088 ICI-related ICSRs, 801 reported irADRs. The majority of such ADRs occurred in male patients reporting gastrointestinal and skin toxicities. Nivolumab and pembrolizumab were drugs most commonly reported as suspect drugs. Compared to other ICIs, ROR was statistically significant for pembrolizumab and ipilimumab.Campania Region results. Out of 253 ICI-related ICSRs sent to Regional Pharmacovigilance Center of Campania Region, 121 reported at least one ICI-induced irADR. These were serious in 37.2% of cases and had an unfavorable outcome in 32.2% of cases. Overall, out of 8 ICSRs reported ADR with a fatal outcome, four reported irADRs. From disproportionality analyses on Campania Region ICSRs, statistically significant ROR emerged only for ipilimumab.ConclusionsOur results showed that during the study period several serious irADRs were reported, some of which had fatal outcome. Given the clinical relevance of irADRs, further investigations in real-life context are necessary for a better characterization of ICIs safety profiles. Oncologists should be trained to early recognize and adequately manage irADRs. Patients should also be educated to immediately report any new symptom or worsening of pre-existed ones during the ICI treatment.

Dataset Information

Veterinary pharmacovigilance in sub-Sahara Africa context: a pilot study of adverse reactions to veterinary medicine in Cameroon.

Publications

Veterinary pharmacovigilance in sub-Sahara Africa context: a pilot study of adverse reactions to veterinary medicine in Cameroon.

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