Maternal mortality rates have continued to decline around the world in recent decades, which is news worth celebrating. According to the World Health Organization (WHO), since 2000, child deaths have reduced by nearly half and maternal deaths by more than one-third, mostly due to improved access to affordable, quality health services.
Even with the welcome declines, millions of mothers and infants continue to die from complications associated with pregnancy and childbirth annually, with sub-Saharan Africa and Southeast Asia accounting for the most (86%) maternal deaths. Several medicines are available to treat life-threatening conditions that can develop during childbirth. Standards are essential to ensuring the quality of these medicines and that they will work as expected in those critical moments when they are needed.
What is the current state of maternal mortality in Nigeria?
Nigeria has one of the world’s highest levels of maternal mortality, accounting for 19% of global maternal deaths. Every day in Nigeria, about 145 women between the ages of 15 and 45 years die from preventable causes linked to pregnancy and childbirth. It’s been declared a state of emergency: in 2019, the National Primary Healthcare Development Agency (NPHCDA) declared a state of emergency on both maternal and child health in Nigeria following the alarming statistics on the frequency of maternal and child deaths, especially at the primary healthcare level. Severe bleeding, high blood pressure during pregnancy, and infections account for most fatalities, many of which are preventable. It is widely acknowledged that obstetric hemorrhage, especially postpartum hemorrhage, is one of the leading causes of maternal morbidity and mortality. Poor-quality medicines used to treat these conditions contribute to the high number of preventable maternal and infant deaths.
There are proven treatments for postpartum hemorrhage. WHO recommends the use of oxytocin, an affordable and effective medicine, to prevent and treat postpartum hemorrhage. However, quality must be carefully ensured and maintained throughout the supply chain for oxytocin to work appropriately when used. There are concerns about its proper use and quality.
What are the challenges in ensuring the quality of oxytocin?
Studies have documented that a considerable proportion of oxytocin injection available in Nigeria and other countries fail to meet acceptable international quality standards, which compromises effectiveness and safety of this critical medicine. These studies have suggested that poor-quality oxytocin could be a result of either substandard manufacturing, improper transportation and storage conditions along the supply chain, or a combination of both.
One central concern is that oxytocin must be kept within a specific temperature range to maintain potency. However, maintaining these temperature ranges throughout the supply chain can be a challenge, particularly for facilities that have few refrigerators or unreliable electrical power. There is growing evidence showing that when poor-quality oxytocin is used and it fails to prevent and manage postpartum hemorrhage adequately, healthcare providers increase doses of oxytocin or switch to other uterotonic medicines in efforts to stop severe blood loss. Poor-quality oxytocin can result in untimely maternal death, negatively influence public confidence in the healthcare system, lead to financial, psychological, and social impact, and economic losses to families.
How are USP standards helping?
More than 20% of drugs on the WHO Model List of Essential Medicines lack pharmacopeial standards, which is dangerous. Without a documentary standard to articulate the quality attributes for a product, and which tests can be performed to assess those attributes, quality cannot be assured.
Since 1820, USP has created public quality standards and programs to ensure the safety and benefit of medicines. In 2017, we established the Global Health Standards program to ensure that monographs and reference standards exist for essential medicines that may not be legally marketed in the United States, but which have been approved by a stringent regulatory authority in other parts of the world. In Nigeria, the Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for International Development (USAID) and implemented by USP, has strengthened good manufacturing practices for local manufacturers of oxytocin, targeting the country's high maternal mortality rate by offering greater patient access to these lifesaving medicines.
Previous studies on the quality of medicines used for maternal health in Nigeria found that 74% of oxytocin samples failed laboratory tests, indicating a high occurrence of poor-quality oxytocin available in the country.
In 2019, in collaboration with MSD for Mothers, USP conducted a study to assess the knowledge around oxytocin, usage, storage practices and perceived quality of oxytocin used by healthcare providers that directly administer it for the prevention of postpartum hemorrhage across Nigeria.
Oxytocin study findings
The cross-sectional study surveyed a representative sample of more than 6,000 healthcare providers—practicing doctors, nurses/midwives, and community health workers—who offer obstetrics and gynecological services, and recruited from nearly 2,000 public and private healthcare facilities in 12 states across Nigeria.
The study revealed that only 46% of respondents (52.8% private sector; 40.0% public sector) had proper knowledge that oxytocin storage is in the refrigerator. Only 34% of the respondents (41% private sector; 27.5% public sector) reported good practices for oxytocin storage in the refrigerator in their facilities. Half of respondents used above the WHO-recommended oxytocin dose for postpartum hemorrhage. Meanwhile, 23% of respondents reported experiencing oxytocin failure in postpartum hemorrhage prevention. Of these, 54.3% changed to another uterotonic and more than a third doubled the dose of oxytocin for their patients.
Our study findings should be used to establish clinical guidelines and trainings for healthcare providers to improve their knowledge, storage practices, and use to help safeguard the quality of these lifesaving medicines. The USP study was published in Oct. 2021.