Using health and demographic surveillance systems for teratovigilance in Africa

Kirakoya‐Samadoulougou, Fati; Sombié, Issiaka; Ogutu, Bernhards; Tinto, Halidou; Kouanda, Séni; Tiono, Alfred B.; Otieno, Walter; Dodoo, Alexander; Kamanda, Mamusu; Sankoh, Osman

doi:10.1016/s2214-109x(16)30252-2

Cited by 3 publications

(4 citation statements)

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“…Therefore, the study focused on the feasibility of a PV system using the HDSS platform, as suggested elsewhere. 29 The encouraging results reported here could be used as the basis to improve the national PV system in Burkina Faso by setting up similar approaches in the other four HDSS sites in the country. 31,[41][42][43] This approach can be also replicated in any other limited resource setting where an HDSS platform is available.…”

Section: Discussionmentioning

confidence: 72%

“…54 The HDSS platform will make the pregnancy exposure registry more effective in providing reliable PV data during pregnancy. 29 In both surveillance systems, during the malaria transmission season (which coincides with the rainy season), we noticed that the number of ADRs reported decreased significantly. In addition, with the increase in the number of concomitant medication prescriptions, the risk of occurrence of ADRs increased.…”

Section: Discussionmentioning

confidence: 84%

“…Since developing countries are facing several difficulties in setting up functional PV systems, this platform provided the opportunity to easily monitor and assess public health issues such as PV while significantly reducing the costs of implementation. 29,30 The aim of this study was to monitor passively versus actively adverse events (AEs) among the population living in Nanoro HDSS of Burkina Faso, who attended public health facilities and received an ACT (ASAQ or AL), and to assess the factors associated with the time of reporting a suspected ADR occurrence. In addition, through HDSS, the study aimed to monitor AEs in pregnant women who were inadvertently exposed to ACTs in the first trimester of pregnancy.…”

Section: Introductionmentioning

confidence: 99%

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<p>Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso</p>

Rouamba¹,

Sondo²,

Derra³

et al. 2020

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Background and purpose: Resource-limited countries face challenges in setting up effective pharmacovigilance systems. This study aimed to monitor the occurrence of adverse events (AEs) after the use of artemisinin-based combination therapies (ACTs), identify potential drivers of reporting suspected adverse drug reactions (ADRs) and monitor AEs among women who were inadvertently exposed to ACTs in the first trimester of pregnancy. Patients and methods: We conducted a prospective observational study from May 2010 to July 2012 in Nanoro Health and Demographic Surveillance System (HDSS), Burkina Faso. The HDSS area was divided into active and passive surveillance areas to monitor AEs among patients (regardless of age or sex) who received a first-line ACT (artemetherlumefantrine or artesunate-amodiaquine). In the active surveillance area, patients were followed up for 28 days, while in the passive surveillance area, patients were encouraged to return voluntarily to the health facility to report any occurrence of AEs until day 28 after drug intake. We assessed the crude incidence rates of AEs in both cohorts and performed Cox regression with mixed random effects to identify potential drivers of ADR occurrence. Results: In total, 3170 participants were included in the study. Of these, 40.3% had reported at least one AE, with 39.6% and 44.4% from active and passive surveillance groups, respectively. The types of ADRs were similar in both groups. The most frequent reported ADRs were anorexia, weakness, cough, dizziness and pruritus. One case of abortion and eight cases of death were reported, but none of them was related to the ACT. The variance in random factors showed a high variability of ADR occurrence between patients in both groups, whereas variability between health facilities was low in the active surveillance group and high in passive surveillance group. Taking more than two concomitant medications was associated with high hazard in ADR occurrence, whereas the rainy season was associated with low hazard. Conclusion: This study showed that both passive and active surveillance approaches were useful tools. The HDSS allowed us to capture a few cases of exposure during the first trimester of pregnancy. The passive surveillance approach, which is more likely to be implemented by malaria control programs, seems to be more relevant in the Sub-Saharan African context.

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Section: Discussionmentioning

confidence: 72%

Section: Discussionmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 99%

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<p>Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso</p>

Rouamba¹,

Sondo²,

Derra³

et al. 2020

DDDT

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“…[ 6 ] In African settings, where there is a high disease burden (infectious and non-infectious), there is a need to improve the science of documenting and analysing accurate information regarding medicine exposures in women immediately before and during pregnancy to assess the extent of use and safety. [ 7 ]…”

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confidence: 99%

Assessing the value of Western Cape Provincial Government health administrative data and electronic pharmacy records in ascertaining medicine use during pregnancy

et al. 2018

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BackgroundIn African settings, where there is a high disease burden, there is a need to improve the science of documenting and analysing accurate information regarding medicine exposures in women immediately before and during pregnancy to assess the extent of use and safety in pregnant women and their unborn children.ObjectivesTo compare evidence of medicine use during pregnancy, as documented in paper-based clinical records (maternity case records (MCRs)) against electronic health information resources (Provincial Health Data Centre (PHDC)) and assess the level of concordance between the two as part of baseline investigations before piloting a provincial pregnancy exposure registry and birth defect surveillance system. The PHDC consolidates electronic clinical and pharmacy data.MethodsA folder review of completed pregnancies between November 2013 and January 2016 was conducted on randomly selected MCRs from midwife-run obstetric units and a secondary maternity hospital in Cape Town, South Africa. Medication exposures in the MCR were captured and compared with a customised PHDC data extract. The type and timing of drug exposures were compared. Total exposures were compiled from all data sources.ResultsTwo hundred and six MCRs from three facilities were sampled: 83 women had documented antiretroviral therapy (ART) exposure; all but 1 (1%) had been recorded in the PHDC extract. There was no evidence of ART use in the MCRs of 4 (5%) cases, despite evidence in the PHDC. There were imprecise drug names in the MCRs of 14 (17%) ART patients, discordant dates of onset between the MCRs and PHDC extracts in 10/83 (12%) and inaccurate medicine names and incorrect dates in 1 (1%) case each. Nine of 10 (90%) women who were administered antituberculosis medication were recorded in the PHDC extract. Ten of 21 (48%) isoniazid preventive therapy treatments appeared in the MCRs and PHDC; 9 (42%) in the PHDC only and 2 (10%) in the MCRs only. Half (n=18/36) of all antibiotic use was reflected only in the MCRs, while 13/36 (36%) appeared only in the PHDC extract. In the former cases, antibiotics used for treatment of sexually transmitted infections and urinary tract infections were dispensed from ward stock and not captured electronically. Antibiotics reflected only in the PHDC were either dispensed at a referral facility or before the first recorded antenatal clinic visit. Folic acid and iron were mostly documented in the MCR only (n=79/99 (80%) and n=107/128 (84%), respectively). However, analgesics and antihistamines more often appeared in the PHDC extract only (n=11/16 (73%) and n=5/5 (100%), respectively).ConclusionsThe PHDC extract provided a better and more complete reflection of chronic drug exposures compared with the MCRs, especially when women sought care at facilities other than the antenatal care unit where they first attended, or when exposures occurred before the initial antenatal visit. The exception was antibiotics dispensed from ward stock to treat sexually transmitted and urinary tract infections.

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New models of public health research: optimizing ethics in research using public health data in resource limited countries

Anane-Sarpong¹

2017

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Using health and demographic surveillance systems for teratovigilance in Africa

Cited by 3 publications

References 5 publications

<p>Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso</p>

<p>Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso</p>

Assessing the value of Western Cape Provincial Government health administrative data and electronic pharmacy records in ascertaining medicine use during pregnancy

New models of public health research: optimizing ethics in research using public health data in resource limited countries

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