Summary
- 8,000 newborns die each day: 98% of these deaths occurring in developing countries 13 percent are due to infections.1
- Hundreds of thousands of newborn lives can be saved with scale up and widespread use of quality-assured 7.1% chlorhexidine digluconate in target, high-risk populations.2
- The Promoting the Quality of Medicines (PQM) program contributes to these efforts by providing technical assistance to local manufacturers and national regulatory authorities in Africa and Asia, so they can increase the availability of quality-assured 7.1% chlorhexidine digluconate in communities where it is needed most to treat neonatal infections and reduce preventable deaths.
The PQM program is helping to save newborn lives by supporting the introduction and scale up of 7.1% chlorhexidine digluconate.
Scaling up proven solutions in newborn health—so they reach more people and save more lives—is a major component of USAID’s response to the call to end preventable child and maternal deaths. Chlorhexidine digluconate, 7.1%—an effective and inexpensive WHO-recommended treatment for sepsis during the first week of life—is one of those proven solutions.3 According to the United Nations, its widespread use in settings with extremely high neonatal mortality rates and high rates of home births has the potential to save hundreds of thousands of newborn lives.2
Several barriers prevent rapid scale up and rollout of chlorhexidine in the regions where it is needed most, especially in sub-Saharan Africa and Asia. Regulatory challenges—such as registration delays, lack of oversight of medicines quality, and limited pharmaceutical industry capabilities—negatively affect production, distribution, and availability of chlorhexidine in the targeted communities.
A Monograph for Scaling Up Quality-Assured Chlorhexidine
Since 2013, PQM has participated in the Chlorhexidine Working Group, an international collaboration of organizations committed to advancing use of 7.1% chlorhexidine digluconate for umbilical cord care through advocacy and technical assistance. The group implemented a local production and regional distribution strategy that included capacity building and systems strengthening strategies to ensure that local production translates to accelerated access to quality-assured chlorhexidine in these areas, and is not derailed by local barriers.
As part of this strategy, PQM developed a 7.1% chlorhexidine digluconate monograph. A monograph is a science-based standard that can be used by manufacturers and regulators to evaluate the quality of medicines during production and regulations. Quality standards for medicines consumed in the global marketplace are critical elements of the safety nets that maintain and improve public health. When applied appropriately and consistently, these standards help ensure to their communities that available medicines are of good-quality, and safe, and have the right amounts of the right ingredients needed for them to work.
The monograph that PQM developed is unique: it allows for testing of impurities and content (the amount of chlorhexidine) in a single high-performance liquid chromatography procedure. This is advantageous from both manufacturing and regulatory perspectives. Using the new monograph can significantly reduce the cost of analysis and the burdens of regulations. PQM distributed the monograph to members of the Chlorhexidine Working Group, regulatory authorities, and manufacturers of the medicine to facilitate chlorhexidine production and regulations.
Building Local Capacity for Quality Assurance
PQM also equipped local manufacturers and regulators with technical expertise in quality assurance to meet increased local, regional, and global demands for 7.1% chlorhexidine digluconate.
In Nigeria, where approximately 22 percent of newborn deaths are attributable to infections4, the government is committed to scaling proven interventions such as chlorhexidine nationally to save lives. PQM worked with Drugfield Pharmaceuticals, a local manufacturer of chlorhexidine, to comply with Good Manufacturing Practices, helping it to become the first African manufacturer of the antiseptic gel. This boosted the monthly production capacity supplied to the Nigerian market and environment. In addition, the quality-assured Drugfield-manufactured gel was used as an alternative to the chlorhexidine solution that was withdrawn in Nigeria in September 2015 due to safety concerns.
In Pakistan, where newborn death from infections is a major public health challenge, PQM is working alongside USAID, UNICEF, and the WHO to introduce and scale up chlorhexidine in high-risk populations. Pakistan has the third highest rate of neonatal mortality globally, and infections account for approximately 23 percent of newborn deaths.5 PQM is providing technical assistance to potential manufacturers of chlorhexidine gel in Pakistan to improve their compliance to quality standards. PQM is also strengthening the capacity of the Drug Regulatory Authority of Pakistan to improve medicines registration processes and post-marketing surveillance, and to advance its quality control laboratories toward international standards.
PQM provides technical assistance at no cost to pharmaceutical manufacturers and regulatory authorities to help increase their technical capacity to produce, monitor, regulate, and sustain quality-assured supplies of lifesaving medicines like chlorhexidine. Increasing the availability of quality-assured medicines for the treatment and prevention of priority health challenges strengthens health systems, makes frontline healthcare workers more effective, and empowers communities to solve their own health challenges. By supporting adoption and integration of science-based, quality assurance tools and approaches in the scale up of lifesaving medicines like chlorhexidine, PQM is helping countries close gaps in health coverage, transform and save lives, reduce preventable deaths and illnesses, defeat health challenges, and improve the health and well-being of communities.
1 Liu L, Johnson HL, Cousens S, et al. Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: An updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012;379(9832):2151–2161.
2 Segre, Coffey, Metzler, et al. Chlorhexidine for Umbilical Cord Care. A case study prepare for the UN Commission on Life-Saving Commodities for Women and Children. February 2012.
3 World Health Organization. WHO Recommendations on Postnatal Care of the Mother and Newborn. 2013. http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf
4 Federal Ministry of Health. Saving newborn lives in Nigeria: Newborn health in the context of the Integrated Maternal, Newborn and Child Health Strategy. 2nd edition. Abuja: Federal Ministry of Health, Save the Children, Jhpiego; 2011.
5 Jehan I, Harris H, Salat S, Zeb A, Mobeen N, Pasha O, et al. Neonatal mortality, risk factors and causes: a prospective population-based cohort study in urban Pakistan. Bull World Health Organ. 2009;87:130-8.