Safety Profile of Drug Use During Pregnancy at Peripheral Health Centres in Burkina Faso: A Prospective Observational Cohort Study.

Drugs -- Real World Outcomes
Toussaint RouambaFati Kirakoya-Samadoulougou

Abstract

Safety data of many drugs used during pregnancy remain scarce. This is especially true in developing countries characterised by the absence of a robust pharmacovigilance system, high prevalence of different tropical diseases affecting patients and potential for drug-drug interactions. This study aimed to assess the safety profile of drugs used in women at high risk of malaria during pregnancy and delivery in Burkina Faso's health facilities. It also aimed to assess factors associated with the use of potentially risky drugs over the entire course of pregnancy. We enrolled pregnant women from their first antenatal care visit and followed them up until delivery, and collected data on drug use. Based on United States Food and Drug Administration (FDA) or Australian Therapeutic Goods Administration (TGA) drug risk classification, drugs were classified into three groups: 'probably safe', 'potentially risky' or 'unclassified'. A modified classification was built to take into account national malaria policy treatment guidelines and World Health Organization Malaria Treatment Guidelines recommending malaria chemoprophylaxis during pregnancy. Out of 2371 pregnant women enrolled, 56.7% used at least one medication during the entire course...Continue Reading

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Methods Mentioned

BETA
pregnancy section

Clinical Trials Mentioned

NCT01703884

Software Mentioned

R
R Foundation for Statistical Computing
R Development Core Team
OpenClinica

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