Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Sep;5(3):193-206.
doi: 10.1007/s40801-018-0141-1.

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

Toussaint Rouamba  1   2 , Innocent Valea  3 , Joel D Bognini  3 , Herve Kpoda  4 , Petra F Mens  5 , Melba F Gomes  6 , Halidou Tinto  3 , Fati Kirakoya-Samadoulougou  7
Affiliations

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

Toussaint Rouamba et al. Drugs Real World Outcomes. 2018 Sep.

Abstract

Purpose: 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.

Methods: 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.

Results: Out of 2371 pregnant women enrolled, 56.7% used at least one medication during the entire course of the pregnancy (excluding sulphadoxine-pyrimethamine and iron-folic acid). A total of 101 different types of medications were used by study participants and 36.6, 49.5 and 13.9% were, respectively, classified as 'probably safe', 'potentially risky' and 'unclassified'. Antimalarials and antibiotics were the most frequently used drugs. Around 39% of women used a least one medication classified as potentially risky. However, this proportion dropped to 26% with the modified classification. Living in urban areas and attending the first antenatal care within their first trimester of pregnancy (longer health surveillance) were associated with using 'potentially risky' medications.

Conclusion: This study provides rare and valuable information on the current use of drugs among pregnant women in Burkina Faso. Many pregnant women used medications classified as potentially risky. Our findings suggest the need for rational drug prescription and community education to reduce hazardous drug exposure during pregnancy.

PubMed Disclaimer

Conflict of interest statement

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committee (Centre Muraz Bobo-Dioulasso, Burkina Faso), National health research ethics committee and WHO Ethics Review Committee, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of interest

Toussaint Rouamba, Innocent Valea, Joel D. Bognini, Herve Kpoda, Petra F. Mens, Melba F. Gomes, Halidou Tinto, and Fati Kirakoya-Samadoulougou declare that they have no competing interests.

Data availability

The datasets generated during and/or analysed during the current study are available from the World Health Organization data repository and from the Clinical Research Unit of Nanoro on reasonable request.

Figures

Fig. 1
Fig. 1
Proportion of women (%) using ‘potentially risky’, traditional or herbal medicines, ‘probably safe’ and unclassified medications during pregnancy according to health facilities and place of residence according to the modified classifications
Fig. 2
Fig. 2
Safety of medication used during the trimesters of pregnancy and at delivery according to the to the modified classifications. Asterisk indicates total number of drugs used by women according to pregnancy trimester and at delivery
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Ridde V, Nitièma AP, Dadjoari M. Improve the accessibility of essential drugs for the populations of one medical region in Burkina Faso. Cah Santé. 2005;15:175–82. http://www.ncbi.nlm.nih.gov/pubmed/16207580. Accessed 6 Sep 2017. - PubMed
    1. World Health Organization | Malaria control improves for vulnerable in Africa, but global progress off-track. WHO. 2016. http://www.who.int/mediacentre/news/releases/2016/malaria-control-africa.... Accessed 28 Sep 2017. - PubMed
    1. Mbwasi R, Mlaki W. Increasing access to medicines in Tanzania. Lancet. 2008;372:205–206. doi: 10.1016/S0140-6736(08)61070-3. - DOI - PubMed
    1. Brazier E, Andrzejewski C, Perkins ME, Themmen EM, Knight RJ, Bassane B. Improving poor women’s access to maternity care: Findings from a primary care intervention in Burkina Faso. Soc Sci Med. 2009;69:682–690. doi: 10.1016/j.socscimed.2009.06.023. - DOI - PubMed
    1. Ndyomugyenyi R, Neema S, Magnussen P. The use of formal and informal services for antenatal care and malaria treatment in rural Uganda. Health Policy Plan. 1998;13:94–102. http://www.ncbi.nlm.nih.gov/pubmed/10178189. Accessed 7 Sep 2017. - PubMed

LinkOut - more resources