Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform

Mosha, Dominic; Mazuguni, Festo; Mrema, Sigilbert; Abdulla, Salim; Genton, Blaise

doi:10.1186/1471-2393-14-322

Cited by 17 publications

(17 citation statements)

References 23 publications

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“…Based on the entire pregnancy, prevalencesof 42% and 34% have been reported in Nigeria [ 16 ] and Ethiopia [ 12 ] respectively. Two studies in Nigeria [ 17 ] and Tanzania [ 18 ] reported higher prevalences (76%, and 94% respectively) of folic acid intake. However, these results were based on exposures across the entire pregnancy and are likely to decrease when restricted to the first trimester as studies in Africa have always reported a far greater proportion (about 40% greater) of medication exposure in the second and third trimesters compared to the first trimester [ 12 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

First trimester medication use in pregnancy in Cameroon: a multi-hospital survey

Leke

Dolk

Loane

et al. 2018

BMC Pregnancy Childbirth

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BackgroundThere is a paucity of epidemiological data on medication use in pregnancy in Cameroon.MethodsBetween March and August 2015, 795 pregnant women attending 8 urban and 12 rural hospitals in Cameroon for antenatal (ANC) or other care were interviewed on first trimester medication use using structured questionnaires. Multivariate logistic regression was used to analyse the association of 18 sociodemographic factors with medication use.ResultsA total of 582 (73.2%) women took at least one orthodox (Western) medication during the first trimester, 543 (68.3%) women a non-pregnancy related orthodox medication, and 336 (42.3%)women a pregnancy related orthodox medication. 44% of the women took anti-infectives including antimalarials (33.6%) and antibiotics (20.8%).The other most common medications were analgesics (48.8%) and antianaemias (38.6%). Sulfadoxine/pyrimethamine, contraindicated in the first trimester of pregnancy, was the most commonly used antimalarial(13% of women).0.2% of women reported antiretroviral use. Almost 80% of all orthodox medications consumed by women were purchased from the hospital. 12.8% of the women self-prescribed. Health unit and early gestational age at ANC booking were consistent determinants of prescribing of non-pregnancy related, pregnancy related and anti-infective medications. Illness and opinion on the safety of orthodox medications were determinants of the use of non-pregnancy related medications and anti-infectives. Age and parity were associated only with non-pregnancy related medications.ConclusionThis study has confirmed the observations of studies across Africa indicating the increasing use of medications during pregnancy. This is an indication that access to medicine is improving and more emphasis now must be placed on medication safety systems targeting pregnant women, especially during the first trimester when the risk of teratogenicity is highest.Electronic supplementary materialThe online version of this article (10.1186/s12884-018-2081-x) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

First trimester medication use in pregnancy in Cameroon: a multi-hospital survey

Leke

Dolk

Loane

et al. 2018

BMC Pregnancy Childbirth

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“…A recent pharmacovigilance study conducted on 994 pregnant females using the platform of the Rufiji Health and Demographic Surveillance System in Tanzania, found that more than 98% of these females reported taking at least one medication during pregnancy. 7 Analgesics were among the most frequently reported medications (24%). Paracetamol (acetaminophen) is a widely used analgesic and antipyretic.…”

Section: Bdnfmentioning

confidence: 99%

Use of paracetamol during pregnancy and child neurological development

Fays¹,

Malderen²,

Smet³

et al. 2015

Develop Med Child Neuro

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BDNFBrain Paracetamol (acetaminophen) remains the first line for the treatment of pain and fever in pregnancy. Recently published epidemiological studies suggested a possible association between paracetamol exposure in utero and attention-deficit-hyperactivity disorder/hyperkinetic disorder (ADHD/HKD) or adverse development issues in children. However, the effects observed are in the weak to moderate range, and limitations in the studies' design prevent inference on a causal association with ADHD/HKD or child neurological development. In parallel, recent animal data showed that cognition and behaviour may be altered following exposure to therapeutic doses of paracetamol during early development. These effects may be mediated by interference of paracetamol with brain-derived neurotrophic factor, neurotransmitter systems (including serotonergic, dopaminergic, adrenergic, as well as the endogenous endocannabinoid systems), or cyclooxygenase-2. However, no firm conclusion can be made on the relevance of these observations to humans. We conclude that additional well-designed cohort studies are necessary to confirm or disprove the association. In the context of current knowledge, paracetamol is still to be considered safe in pregnancy and should remain the first-line treatment for pain and fever.Information on safety of the fetus exposed to drugs during pregnancy is generally limited. 1 Among 172 medications approved in the USA between 2000 and 2010, 73% had no data on the safety in pregnancy and 98% had insufficient data to evaluate teratogenic risk. 2 In the European Union (EU), 68% of marketed product via the EU centralized procedure, and published on the European Medicines Agency (EMA) website, indicate in their Summary of Product Characteristics that there is no clinical experience during pregnancy.3 Pregnant females are typically excluded from clinical trials, thus, there is often an absence of evidence-based information in this group of patients at the time of marketing authorization. The EMA recently conducted an analysis of data sources on drug exposure during pregnancy and has noted several issues in obtaining high quality data. 4 However, use of medication during pregnancy is extremely common. Over-the-counter drugs, in particular, are the most common medications used 5 with about 67% of females reporting the use of over-the-counter medication during pregnancy in Europe. 6 Figures are probably more variable in developing countries. A recent pharmacovigilance study conducted on 994 pregnant females using the platform of the Rufiji Health and Demographic Surveillance System in Tanzania, found that more than 98% of these females reported taking at least one medication during pregnancy.7 Analgesics were among the most frequently reported medications (24%).Paracetamol (acetaminophen) is a widely used analgesic and antipyretic. It is also an active substance in a series of readily available over-the-counter medicines. Taken during pregnancy, paracetamol is generally considered safe and effective when used at the ...

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“…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%

<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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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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Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform

Cited by 17 publications

References 23 publications

First trimester medication use in pregnancy in Cameroon: a multi-hospital survey

First trimester medication use in pregnancy in Cameroon: a multi-hospital survey

Use of paracetamol during pregnancy and child neurological development

<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>

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