Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK's Training and Mentoring Pilot Project in the Abidjan Region.

INTRODUCTION: Pharmacovigilance (PV) in sub-Saharan Africa relies on passive surveillance but underreporting of adverse events (AEs) by health care professionals (HCPs) is a major challenge. A PV enhancement project was implemented to address this in Côte d'Ivoire. OBJECTIVE: To improve safety surveillance of medicines through PV training and mentoring of HCPs in selected health care facilities (HCFs). METHODS: This collaborative project between national PV stakeholders, GSK, and PATH was implemented from September 2018 to February 2020 in Abidjan region, Côte d'Ivoire. Trained PV focal points provided training and regular mentoring of HCPs. Key performance indicator (KPI) categories for AE reporting were the volume of AE reports, efficiency of report transmission and data entry, quality of reports, and quality of the central (Vigilance Unit) response to AE reports. RESULTS: Overall, 1427 HCPs at 91 HCFs were trained. In the 8 months before implementation, 33 AE reports were received versus 85 after 3 months and 361 after 18 months of implementation (71 [83.5%] and 278 [77.0%], respectively, from Abidjan). The KPIs with the highest proportions were: AE reports received centrally (100%), complete AE reports (69.0%), AE reports entered into the local PV database within 48 h (99.6%), and AE reports entered into the global database, VigiBase (86.7%). Report notification within 72 h, causality assessment, and serious AE reporting had proportions below 20%; feedback to reporters was provided for only 0.4% of reports. CONCLUSION: Regular PV trainings and mentoring improved AE reporting in Côte d'Ivoire but further enhancement is required to improve passive safety surveillance.

Medicines and vaccines should be safe and effective for use in the general population. Health care professionals therefore have the responsibility to continuously monitor medicinal products and report any unwanted medical occurrence (adverse event). Training and mentoring of health care professionals can improve adverse event reporting. In Côte d'Ivoire, a training and mentoring project was implemented by GSK, PATH (a non-governmental organisation), and the Ministry of Health, with the objective of increasing adverse event reporting. Over the period of 18 months, 1427 health care professionals from 91 health care facilities in the Abidjan region received training and mentoring. Between January and August 2018, before the project began, 33 adverse event reports were submitted at the central level (to the country's Vigilance Unit), with 11 (33.3%) from the Abidjan region. From September to December 2018, the first three months of project implementation, 85 reports were received, with 71 (83.5%) coming from the Abidjan region. This number increased to 361 by the end of the 18-month project, with 278 (77.0%) coming from the Abidjan region. Training of health care professionals therefore improved adverse event reporting, mainly from the Abidjan region but also nationwide. Assessments of the efficiency of adverse event reporting and the quality of adverse events reports received by the Vigilance Unit showed promising results, although there was room for improvement. Lessons learned from this project can flexibly serve the needs of other countries with less functional systems for reporting adverse events associated with medicinal products.

[Evaluation of the knowledge of intermittent preventive treatment during pregnancy (IPTp) with sulfadoxine-pyrimethamine in Ivory Coast]. / Évaluation de la connaissance du traitement préventif intermittent au cours de la grossesse (TPIg) par la sulfadoxine-pyriméthamine en Côte d'Ivoire.

In 2006, because of the chloroquine-resistance and following the World Health Organization (WHO) recommendations, Côte d'Ivoire adopted a new policy for the prevention of malaria during pregnancy by intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP). However, its implementation remains limited. Objectives of this study were to evaluate the knowledge of the TPIp-SP regimen and prescribers opinion concerning this protocol. It was a knowledge attitude and pratices (KAP) cross-sectional descriptive study. We used a two-stage stratified sounding. The study took place in 12 health facilities in the health region of Abidjan 2 from march to august 2016 and involved 187 health professionals. We performed descriptive analysis, univariate and bivariate comparative analysis. The study found that half of the prescribers surveyed actually knew the ITPp program (SP - 3 doses - 2nd and 3rd trimesters). Knowledge was better among practitioners with more than 5 years of exercise (P=0.011) and at the level of first contact of health institution (P=0.001). Half of the prescribers were in favor of applying the protocol. The level of knowledge of prescribers has changed little in 2016 compared to 2008 for physicians (Pr (|Z|<|z|)=0.4861) or midwives Pr (|Z|<|z|)=0.4786). Prescribers remained faithful to the old 2-dose protocol. The opinion on the protocol was better in 2016 compared to 2008 Pr (Z

[Hepatonephritis during the treatment of malaria by the therapeutic combinations from a pharmacovigilance database]. / Hépatonéphrites au cours du traitement du paludisme par les combinaisons thérapeutiques à partir d'une base de données de pharmacovigilance.

INTRODUCTION: Prior studies have shown an association between the onset of hepatonephritis and the use of arteminisin-based combination therapy (ACT) during the treatment of uncomplicated malaria. The objective of this study was to identify the risk factors of hepatonephritis occurrence because of the uncertainty regarding the appearance and the aggravation of this syndrome. METHODS: A case-non case study was carried out on 428 notifications of pharmacovigilance extracted from the database of the clinical pharmacology department of the teaching hospital of Cocody from 2008 to 2012. Twenty-two cases of hepatonephritis were identified. Univariate analysis and multivariate logistic regression were performed to identify the risk factors and an adjusted odds ratio (AOR) was calculated for each factor. The cut-off for significant association was set at 0.05. RESULTS: The average age of cases was comparable with that of non-cases (34.04±3.68 years versus 33.94±3.92 years) with a median duration of therapy of 5 days and 6 days respectively. Male (AOR: 6.71; P<0.0001), toxic antecedents, traditherapy (AOR: 6.25; P<0.0001), consumption of CTA (AOR: 1.25; P<0.0001), betalactam (AOR: 0.46; P<0.0001), fluoroquinolone and self-medication (AOR: 2.89; P<0.0001) would be the majors risk factors associated with hepatonephritis onset. The risk increased with the number of antimalarial drugs taken. The evolution towards the offset was less frequent (AOR: 0.078; P<0.02). CONCLUSION: The risk factors of hepatonephritis were the consumption of malarial drugs and connected molecules, self-medication and misuse. The outcome was generally unfavourable. Both the general population and health professionals should be trained on the good use of the antimalarial drugs.

Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d'Ivoire.

BACKGROUND: In many malaria-endemic, sub-Saharan African countries, existing pharmacovigilance systems are not sufficiently operational to document reliably the safety profile of anti-malarial drugs. This study describes the implantation of a community-based pharmacovigilance system in Côte d'Ivoire and its use to document the safety of ASAQ Winthrop® (artesunate-amodiaquine). METHODS: This prospective, longitudinal, descriptive, non-comparative, non-interventional study on the use of artesunate-amodiaquine in real-life conditions of use was conducted in seven Community Health Centres of the Agboville district in Côte d'Ivoire. Twenty trained Health Centre employees and 70 trained community health workers were involved in data collection in the field. All patients with suspected uncomplicated falciparum malaria, seeking treatment at one of the participating Health Centres, and treated with artesunate-amodiaquine could be enrolled. Two visits were planned, one for inclusion at the Health Centre and a second at home, performed by a community health worker 3-10 days after the inclusion visit. Administration of artesunate-amodiaquine was unsupervised. Adverse events (AEs) were documented at the home visit or during any unexpected visit to the Health Centre or to the hospital and coded and adjudicated by a local pharmacovigilance committee. Symptoms suggestive of hepatic failure, severe neutropaenia, extrapyramidal disorders and retinopathy were considered a priori as AEs of special interest. RESULTS: Some 15,228 malaria episodes in 12,198 patients were evaluated; 2545 AEs were documented during 1978 malaria episodes (13.0%). The most frequently observed events were asthenia (682 cases), vomiting (482 cases) and somnolence (174 cases). Most reported AEs were of mild or moderate intensity and resolved without corrective treatment. One-hundred and five (105) AEs reported during 100 episodes (0.7%) were considered as serious. Three serious cases of transient extrapyramidal disorders, identified as AEs of special interest were reported in three patients. CONCLUSION: The fixed dose artesunate-amodiaquine combination ASAQ Winthrop® for the unsupervised treatment of uncomplicated falciparum malaria under real-life conditions of care in Côte d'Ivoire is well tolerated. The study emphasizes the interest of involving properly trained community health workers to collect pharmacovigilance data in the field in order to document rare AEs.

[A plea for introduction of hepatitis B vaccination at birth in Côte d'Ivoire]. / Plaidoyer pour l?introduction du vaccin contre l?hépatite virale B à la naissance en Côte d?Ivoire.

The Côte d'Ivoire National Immunization Technical Advisory Group 2015 work plan included elaboration of an opinion on inclusion of hepatitis B vaccination at birth in the Expanded Program on Immunization (EPI) in Côte d'Ivoire. A task force was set up to conduct this assessment according to a systematized method. The task force analysed scientific articles on the burden of hepatitis B in Côte d'Ivoire, the burden of mother-child transmission, the impact of hepatitis B vaccination at birth in countries which have adopted this strategy, the efficacy and safety of hepatitis B vaccine in newborns, the cost-effectiveness of hepatitis B vaccination at birth, and the best strategy to introduce hepatitis B vaccination at birth in the EPI. The National Immunization Technical Advisory Group of Côte d'Ivoire finally recommended introduction of a dose of hepatitis B vaccine at birth in the context of the Expanded Program on Immunization with maintenance of three doses of pentavalent vaccine (DPT-HepB-Hib) at 6, 10, and 14 weeks of age.

Sustained Effectiveness of a Fixed-Dose Combination of Artesunate and Amodiaquine in 480 Patients with Uncomplicated Plasmodium falciparum Malaria in Côte d'Ivoire.

The objective of this study was to monitor the effectiveness of artesunate-amodiaquine fixed-dose combination tablets (ASAQ Winthrop®) in the treatment of uncomplicated Plasmodium falciparum malaria in Côte d'Ivoire. Two enrolment periods (November 2009 to May 2010 and March to October 2013) were compared using an identical design. Subjects with proven monospecific P. falciparum infection according to the WHO diagnostic criteria were eligible. 290 patients during each period received a dose of ASAQ Winthrop tablets appropriate for their age. The primary outcome measure was PCR-corrected adequate clinical and parasitological response at Day 28 in the per protocol population (255 in Period 1 and 240 in Period 2). This was achieved by 95.7% of patients during Period 1 and 96.3% during Period 2. Over 95% of patients were afebrile at Day 3 and complete parasite clearance was achieved at Day 3 in >99% of patients. Nineteen adverse events in nineteen patients were considered as possibly related to treatment, principally vomiting, abnormal liver function tests, and pruritus. There was no evidence for loss of effectiveness over the three-year period in spite of strong drug pressure. This trial was registered in the US Clinical Trials Registry (clinical.trials.gov) under the identifier number NCT01023399.

[Summarizing of medicinal alerts in Ivory Coast from 2001 till 2010]. / Bilan d'une décennie d'alertes médicamenteuses en Côte d'Ivoire de 2001 à 2010.

UNLABELLED: STUDY'S AIM: This study aims a more efficient follow-up of the safety of medicines with human usage on the Ivory Coast territory. METHOD: The structure responsible for pharmacovigilance in Ivory Coast i.e. DPM listed the medicinal alerts from 2001 till 2010. RESULTS: It emerges 237 medicinal alerts among which 145 stops of marketing, 55 withdrawals of lots, 33 information notes and 4 levying of suspension of medicines. These alerts result mainly from pharmaceutical companies (49%) and the French Drug Agency or ANSM (ex-Afssaps) (43%). They mainly concern drugs of infectious target (22%) and pneumology (18%) and their motivations are so much industrial with mainly commercial reasons (27%) as of pharmacovigilance dominated by unfavorable profit/risk connections. CONCLUSION: These results constitute an important database for the survey of the medicines market in Ivory Coast and an additional motivation to accelerate the implementation of a real national center of pharmacovigilance.

[Not Available]. / Bilan d'une décennie d'alertes médicamenteuses en Côte d'Ivoire de 2001 à 2010.

STUDY'S AIM: This study aims a more efficient follow-up of the safety of medicines with human usage on the Ivory Coast territory. METHOD: The structure responsible for pharmacovigilance in Ivory Coast i.e. DPM listed the medicinal alerts from 2001 till 2010. RESULTS: It emerges 237 medicinal alerts among which 145 stops of marketing, 55 withdrawals of lots, 33 information notes and 4 levying of suspension of medicines. These alerts result mainly from pharmaceutical companies (49%) and the French Drug Agency or ANSM (ex-Afssaps) (43%). They mainly concern drugs of infectious target (22%) and pneumology (18%) and their motivations are so much industrial with mainly commercial reasons (27%) as of pharmacovigilance dominated by unfavorable profit/risk connections. CONCLUSION: These results constitute an important database for the survey of the medicines market in Ivory Coast and an additional motivation to accelerate the implementation of a real national center of pharmacovigilance.

Sodium and blood pressure in Africa.

In the pathophysiology of hypertension, the profile hemodynamic is modified by the relation between the increased sodium intake and blood pressure (BP) level. An increased sodium diet is related not only on the amount of fluid volume within the organism but also to the elasticity of the cardiovascular system. In humans, age and salt excess reduced elasticity is linked to BP level and to stiffness material within the vascular wall of larges arteries. Actions of vasoactives hormones such as angiotensin II, antidiuretic hormone, and aldosterone are also linked. The purpose of this article is : (i) to report existing work in Africa relating to "salt and hypertension", (ii) to determine the characteristic of hypertension among black populations, and for epidemiologic study in Ivory Coast, (iii) to determine the various characteristics of hypertension, prevention of cardiovascular risk, and to show usual antihypertensive drugs for reduce rigidity and vascular fibrosis.

Pharmacovigilance for antiretroviral drugs in Africa: lessons from a study in Abidjan, Cote d'Ivoire.

BACKGROUND: Although antiretroviral treatment (ART)-related adverse drug reactions (ADR) are documented in industrialised countries, there is no pre-existing surveillance system dedicated to ADR monitoring in most African countries. We assessed knowledge towards pharmacovigilance among ART prescribers and available capacity of HIV clinics to conduct ADR monitoring in Abidjan, Côte d'Ivoire. METHODS: A questionnaire was administered to ART prescribers to assess their knowledge towards the occurrence of ADRs. A retrospective ADR survey was also conducted based on a data query of treatment modification/interruptions in three HIV clinics. Clinical monitors went back to medical charts to review and validate the reasons of the treatment modification/interruptions. RESULTS: Of the 81 ART prescribers interviewed, 25 (31%) declared not grading ADRs and 12 (14.8%) declared notifying ADRs to the national regulatory authorities. Among 5252 adult ART-treated patients who attended the participating clinics in 2008, 599 treatment modifications were identified. Reasons for treatment modification/interruptions identified in the electronic database were documented in the medical charts in 554 cases (92.5%), ADR accounting for 273 cases (45.5%). Toxicity related to ART was graded in only 58 cases (21%) in the medical charts. DISCUSSION: This study describes challenges limiting the implementation of reliable pharmacovigilance activities in HIV clinics in Côte d'Ivoire. The lack of knowledge of ART prescribers concerning ADR grading does not support the spontaneous reporting of ADRs. Using treatment modification/interruptions for ADR monitoring appears feasible, but improvements are needed to respond to key questions related to drug toxicities in the context of ART scale-up in Africa.

[Clinical trials using medicinal plants: bibliographical review and methodological analysis]. / Essais cliniques des medicaments à base de plantes: revue bibliographique.

BACKGROUND: The importance of traditional medicine, one of the fundamentals of the cultural heritage of African, Asian and South American peoples, is evident in that such medicine is practised by more than 80% of these populations. METHODS: To analyse the methodology of clinical trials using medicinal plants, we reviewed articles published on this topic between 1980 and 2000. RESULTS: Forty-eight clinical trials were identified. Most were carried out in developed countries. Standard methodological principles were applied in almost all the trials: randomisation (85.4%), comparison (87.5%) versus placebo (95.2%), and blinded design (81.3%). The duration of the studies was short. Sample sizes were generally small, ranging from 30 to 99 subjects; statistical tests were used in 90% of the trials. Adverse effects were infrequently collected. CONCLUSION: Most clinical trials included in this survey were conducted in accordance with WHO guidelines. Respect for methodological principles and the implementation of a legislative framework are important in obtaining credibility and international recognition of the traditional pharmacopoeia.

Safety of the yellow fever vaccine during the September 2001 mass vaccination campaign in Abidjan, Ivory Coast.

In 2001, a vaccination campaign against yellow fever was carried out in Abidjan, Cote d'Ivoire. During the campaign and 4 weeks after an active surveillance system for adverse events following immunization (AEFI) was set up. More then 2.6 million doses were administered and 87 AEFI were notified. Eight suspected YF cases were reported after vaccination and considered as AEFI. However, none had IgM for YF and all recovered without sequels. This surveillance system provided reassuring data about the safety of the YF vaccine and proved that it is feasible to set up an active surveillance system during a mass campaign.

[Doping practices and behaviours among Ivorian soccer players]. / Pratiques et conduites dopantes dans le football ivoirien.

We have conducted a survey of doping among soccer players in Côte d'Ivoire with a representative sample of 150 soccer players who filled out an anonymous questionnaire. The aim of this survey was to get a clearer picture of doping in Ivorian soccer in order to suggest preventive actions against doping. The results of this study showed that doping was known by the Ivorian soccer players; about 18.7% admitted to the use of doping substances, 42% recognised that they felt tempted by doping, while 38% knew another soccer player who had already used a doping substance. Government and sports organisations should recognize the importance of education and information in the antidoping campaign and agree on effective preventive as well as repressive strategies.