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 Jan 30;18(1):44.
doi: 10.1186/s12884-018-1671-y.

Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits

Chimezie Anyakora  1 , Yetunde Oni  2 , Uchenna Ezedinachi  3 , Adebola Adekoya  3 , Ibrahim Ali  2 , Charles Nwachukwu  2 , Charles Esimone  4 , Victor Abiola  2 , Jude Nwokike  3
Affiliations

Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits

Chimezie Anyakora et al. BMC Pregnancy Childbirth. .

Abstract

Background: The high level of maternal mortality and morbidity as a result of complications due to childbirth is unacceptable. The impact of quality medicines in the management of these complications cannot be overemphasized. Most of those medicines are sensitive to environmental conditions and must be handled properly. In this study, the quality of oxytocin injection, misoprostol tablets, magnesium sulfate, and calcium gluconate injections was assessed across the six geopolitical zones of Nigeria.

Method: Simple, stratified random sampling of health facilities in each of the political zones of Nigeria. Analysis for identification and content of active pharmaceutical ingredient was performed using high-performance liquid chromatography procedures of 159 samples of oxytocin injection and 166 samples of misoprostol tablets. Titrimetric methods were used to analyze 164 samples of magnesium sulfate and 148 samples of calcium gluconate injection. Other tests included sterility, pH measurement, and fill volume.

Results: Samples of these commodities were procured mainly from wholesale and retail pharmacies, where these were readily available, while the federal medical centers reported low availability. Approximately, 74.2% of oxytocin injection samples failed the assay test, with the northeast and southeast zones registering the highest failure rates. Misoprostol tablets recorded a percentage failure of 33.7%. Magnesium sulfate and Calcium gluconate injection samples recorded a failure rate of 6.8% and 2.4%, respectively.

Conclusion: The prevalence of particularly of oxytocin and misoprostol commodities was of substandard quality. Strengthening the supply chain of these important medicines is paramount to ensuring their effectiveness in reducing maternal deaths in Nigeria.

PubMed Disclaimer

Conflict of interest statement

Authors’ information

C. Anyakora is the Chief of Party in Nigeria for the USP PQM program. A. Adekoya and U. Ezedinachi are USP PQM staff in Lagos, Nigeria. Y. Oni is the acting Director General of NAFDAC. I. Ali, C. Nwachukwu, and V. Abiola are staff of NAFDAC. C. Esimone is a staff of the Faculty of Pharmacy, Nnamdi Azikiwe University. J. Nwokike is the Director of the USP PQM program.

Ethics approval and consent to participate

Not applicable

Consent for publication

Consent to publish data obtained from the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria.

Competing interests

There is no competing interest. C. Anyakora, U. Ezedinachi, A. Adekoya, and J. Nwokike are USP employees working on the Promoting the Quality of Medicines (PQM) program. Y. Oni, I. Ali, C. Nwachukwu, and V. Abiola are NAFDAC employees.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Percentage Failure of Oxytocin Samples by Geopolitical Zone
Fig. 2
Fig. 2
Quality of Oxytocin by Country of Manufacture
Fig. 3
Fig. 3
Percentage Failure of Oxytocin per Level of Health Facility
Fig. 4
Fig. 4
Storage Conditions of Oxytocin and Quality Effect from Each Geopolitical Zone
Fig. 5
Fig. 5
Percentage Failure of Misoprostol by Geopolitical Zone
Fig. 6
Fig. 6
Percentage Failure of Misoprostol by Country of Manufacture
Fig. 7
Fig. 7
Percentage Failure of Misoprostol Tablets per Level of Health Facility
Fig. 8
Fig. 8
Storage Conditions of Misoprostol Tablets and Quality Effect from Each State
Fig. 9
Fig. 9
Percentage Failure of Magnesium Sulfate by Geopolitical Zone
Fig. 10
Fig. 10
Percentage Failure of Calcium Gluconate by Facility
Fig. 11
Fig. 11
Percentage Failure of Calcium Gluconate by Geopolitical Zone
See this image and copyright information in PMC

References

    1. WHO . Maternal mortality. 2015.
    1. WHO (World Health Organization) b. Trends in Maternal Mortality: 1990 to 2013. Geneva: WHO; 2014.
    1. Filippi V, Chou D, Ronsmans C, Graham W, Say L. Levels and Causes of Maternal Mortality and Morbidity. In: Black ER, Laxminarayan R, Temmerman M, Walker N, editors. Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities Third Edition. Washington DC: The International Bank for Reconstruction and Development/The World Bank; 2016. - PubMed
    1. Hamid R. Misoprostol: an essential medicine for managing postpartum hemorrhage in low-resource settings? Int J Gynecol Obstet. 2011;114(3):209–210. doi: 10.1016/j.ijgo.2011.06.006. - DOI - PubMed
    1. Say L, Chou D, Gemmill A, Tuncalpo O, Moller A-B, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323–e333. doi: 10.1016/S2214-109X(14)70227-X. - DOI - PubMed

Publication types

MeSH terms