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

Jaquet, Antoine; Djima, Mariam Mama; Coffie, Patrick A.; Kacou, Henri Die; Eholié, Serge; Messou, Eugène; Minga, Albert; Guéhi, Calixte; Yavo, J. C.; Bissagnené, E.; Dabis, François; Ekouévi, Didier K.

doi:10.1002/pds.2182

Cited by 15 publications

(12 citation statements)

References 18 publications

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“…Indeed, in low and middle-income countries long-term safety data of ART is still limited due to the lack of pharmacovigilance systems. Nevertheless, adverse events related to ART are common and represent the first cause of treatment modification in HIV-infected people on ART in sub-Saharan Africa [ 4 , 5 ]. The WHO classifies ART related toxicities into four grades of severity.…”

Section: Introductionmentioning

confidence: 99%

Incidence of Severe Neutropenia in HIV-Infected People Starting Antiretroviral Therapy in West Africa

et al. 2017

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BackgroundIn sub-Saharan Africa, antiretroviral therapy (ART) including drugs with potential toxicity such as Zidovudine (ZDV) are routinely prescribed. This study aimed at estimating the incidence of severe neutropenia and associated factors after ART initiation in five West African countries.MethodsA retrospective cohort analysis was conducted within the international epidemiologic database to evaluate AIDS (IeDEA) collaboration in West Africa. All HIV-infected adults, initiating ART between 2002 and 2014, with a baseline and at least one follow-up absolute neutrophil count (ANC) measurement were eligible. Incidence of severe neutropenia (ANC <750 cells/mm3) was estimated with 95% confidence interval (CI) according to age, gender, HIV clinic, hemoglobin, CD4 count, clinical stage, and ART duration. A Cox proportional hazard model was used to identify factors associated with severe neutropenia, expressed with their adjusted hazard ratios (aHR).ResultsBetween 2002 and 2014, 9,426 HIV-infected adults were enrolled. The crude incidence rate of a first severe neutropenia was 9.1 per 100 person-years (95% CI: 8.6–9.8). Factors associated with severe neutropenia were exposure to ZDV <6 months (aHR = 2.2; 95% CI: 1.8–2.6), ≥6–12 months (aHR = 2.1; 95% CI: 1.6–2.8) and ≥12 months (aHR = 1.6; 95% CI: 1.2–2.2) [Ref. no ZDV exposure], CD4 count <350 cells/mm3 (aHR = 1.3; 95% CI: 1.1–1.5) and advanced clinical stage at ART initiation (aHR = 1.2; 95% CI: 1.0–1.4).ConclusionThe incidence of severe neutropenia after ART initiation in West Africa is high and associated with ZDV exposure and advanced HIV disease. In this context, efforts are needed to scale-up access to less toxic first-line ART drugs and to promote early ART initiation.

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Section: Introductionmentioning

confidence: 99%

Incidence of Severe Neutropenia in HIV-Infected People Starting Antiretroviral Therapy in West Africa

et al. 2017

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“…This study revealed that even though majority of the health-care providers had a positive attitude towards ADR reporting, awareness was low among nursing officers. 21 Our data suggest that health-care providers who had training in pharmacovigilance were better at reporting ADR when compared to those not trained. However, the low awareness amongst nurses poses and important challenge.…”

Section: Discussionmentioning

confidence: 62%

Awareness and Reporting of Antiretroviral Adverse Events among Clients and Health Care Providers at Kilimanjaro Christian Medical Centre: A Cross-Sectional Study

Kiwanuka

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Alloyce

et al. 2019

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Background: Pharmacovigilance is a means of ensuring drug safety, and thus it ensures that the risks associated with medication adminstration and consumption do not outweigh the benefits. Antiretroviral therapy (ART) for HIV care and treatment has reduced mortality and morbidity, but adverse drug reactions (ADRs), which can lead to treatment failure, remain a concern. In 2015 in Tanzania, 688,800 adults were taking ART. All health-care providers are required to report all suspected ADRs seen or reported by their patients using yellow forms available at all care and treatment centres in Tanzania. However, the actual practice of reporting is not taking place. This study aimed to explore the patients' knowledge and HIV/AIDS health-care providers' reporting of ART adverse events at Kilimanjaro Christian Medical Centre (KCMC). Methods: A cross-sectional study using a semi-structured questionnaire was conducted between June and July 2016 within HIV, dermatology, and infectious disease clinics at KCMC. All health-care providers providing HIV services within these clinics completed a questionnaire. Means and standard deviations were used to summarise the numerical data with normal distributions (age of patients), while numerical data that were not normally distributed (duration on ART) were summarised using medians and ranges. Frequencies and percentages were used to summarise categorical variables. Results: All 63 health-care providers agreed that ADR reporting was necessary. Forty-six (73%) were aware of the national ADR reporting system, but only 32 (50.8%) reported having received training on pharmacovigilance. Only 4 (6.3%) of all health-care providers reported always filling the ADR report forms; 27 (42.9%) rarely filled the forms, and 32 (50.8%) reported having never filled an ADR reporting form. Training on pharmacovigilance had a positive influence on ADR reporting. Lack of motivation, uncertainty about reporting procedures, lack of time, unavailability of reporting forms, and ignorance were the major factors affecting reporting among health-care providers. Conclusion: The majority of health-care providers were aware of the need and importance of ADR reporting and the national pharmacovigilance system. However, ART adverse events are underreported. More effort is needed to strengthen the continuous reporting of ADRs by providing continuous education to health-care providers; this will lead to their active participation in pharmacovigilance.

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“…Increasing numbers of people living with HIV (PLWH) receive ART—13.5 million people in low- and middle-income countries (LMICs) in 2014 [ 4 ]—driving a clear need to enhance global drug safety monitoring [ 5 , 6 ]. Toxicity from ART is a common reason for patients to switch or stop a medication regimen [ 7 – 10 ]. Adverse drug reactions (ADRs) are characterized by the suspicion of a causal relationship between the drug and the occurrence [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

“…Ideally, if a healthcare provider or a patient suspects that a medication may be even partially responsible for a symptom or ADR, then he/she would report it to a national drug safety monitoring center through national channels as part of SR. However, in LMICs, ADRs are often under-reported because of overburdened healthcare systems, significant resource constraints, limited laboratory capacity to identify and manage ADRs, and limited knowledge and unfavorable attitudes among healthcare providers towards reporting [ 9 , 10 , 20 , 23 – 26 ]. Furthermore, many countries do not have a national system.…”

Section: Introductionmentioning

confidence: 99%

Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale

et al. 2016

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IntroductionTargeted spontaneous reporting (TSR) is a pharmacovigilance method that can enhance reporting of adverse drug reactions related to antiretroviral therapy (ART). Minimal data exist on the needs or capacity of facilities to conduct TSR.ObjectivesUsing data from the International epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium, the present study had two objectives: (1) to develop a list of facility characteristics that could constitute key assets in the conduct of TSR; (2) to use this list as a starting point to describe the existing capacity of IeDEA-participating facilities to conduct pharmacovigilance through TSR.MethodsWe generated our facility characteristics list using an iterative approach, through a review of relevant World Health Organization (WHO) and Uppsala Monitoring Centre documents focused on pharmacovigilance activities related to HIV and ART and consultation with expert stakeholders. IeDEA facility data were drawn from a 2009/2010 IeDEA site assessment that included reported characteristics of adult and pediatric HIV care programs, including outreach, staffing, laboratory capacity, adverse event monitoring, and non-HIV care.ResultsA total of 137 facilities were included: East Africa (43); Asia–Pacific (28); West Africa (21); Southern Africa (19); Central Africa (12); Caribbean, Central, and South America (7); and North America (7). Key facility characteristics were grouped as follows: outcome ascertainment and follow-up; laboratory monitoring; documentation—sources and management of data; and human resources. Facility characteristics ranged by facility and region. The majority of facilities reported that patients were assigned a unique identification number (n = 114; 83.2 %) and most sites recorded adverse drug reactions (n = 101; 73.7 %), while 82 facilities (59.9 %) reported having an electronic database on site.ConclusionWe found minimal information is available about facility characteristics that may contribute to pharmacovigilance activities. Our findings, therefore, are a first step that can potentially assist implementers and facility staff to identify opportunities and leverage their existing capacities to incorporate TSR into their routine clinical programs.

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

Cited by 15 publications

References 18 publications

Incidence of Severe Neutropenia in HIV-Infected People Starting Antiretroviral Therapy in West Africa

Incidence of Severe Neutropenia in HIV-Infected People Starting Antiretroviral Therapy in West Africa

Awareness and Reporting of Antiretroviral Adverse Events among Clients and Health Care Providers at Kilimanjaro Christian Medical Centre: A Cross-Sectional Study

Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale

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