How can effective medicines become part of policy?

Though clinical trials can show if a biomedical intervention is effective, translating that knowledge to policy is not automatic.

How can effective medicines become part of policy?

By Resham Bahadur Khatri, member of the HSG Translating Evidence into Action TWG, and PhD candidate at the School of Public Health, The University of Queensland, and Australia

Though clinical trials can show if a biomedical intervention is effective, translating that knowledge to policy is not automatic. It requires investing significant resources in ensuring feasibility, monitoring programs at scale, and building political support for the intervention. The introduction of Chlorhexidine (CHX) in Nepal, is an example of how evidence can be translated into policy and scaled into a nationwide program.

Chlorhexidine is an antiseptic product that is used for sepsis prevention. It kills the bacteria and also inhibits the growth of bacteria. For the prevention of newborns’ umbilical cord infection, CHX gel is applied on the newborn’s cord immediately after childbirth.

Evidence of the effective medicine to prevent

In the early 2000s, more than 90 per cent of births in Nepal were conducted at home without the support of skilled health personnel. In most cases, traditional birth attendants, relatives, or mothers would apply cow-dung or mustard oil to newborns’ umbilical cord to prevent possible infection.

In 2002, Nepal Nutrition Intervention Project, Sarlahi (NNIPS) conducted a four-year cluster randomized controlled trial in Sarlahi district of Southern Nepal, in which Female Community Health Volunteers (FCHVs) counselled mothers to apply CHX gluconate gel to a newborn’s umbilical stump within 24 hours of birth. The trial showed that applying CHX reduced the umbilical cord infection (omphalitis) significantly by 75 per cent, also reduced newborn deaths due to sepsis by one third.

How was the evidence translated into policy?

To reduce the higher neonatal deaths in Nepal, the Ministry of Health (MoH) piloted a Community Based Newborn Care Package (CB-NCP), which included other seven interventions, including the treatment of neonatal sepsis by injectable antibiotic such as gentamicin. However, the treatment of neonatal sepsis was only targeted for infected newborns. The provision of such service is possible at health facilities by trained health workers. However, CB-NCP did not have any interventions to prevent newborns’ cord infection.

Following this, the Nepal Family Health Program II (NFHP II) conducted a feasibility pilot to test the cultural acceptability, coverage, and compliance of using CHX to prevent sepsis in 2008. In this pilot program, FCHVs distributed CHX gel to pregnant women during their home visits and counselled its application on newborn’s stumps by mothers. This process demonstrated the feasibility of distribution of CHX by FCHVs and recently delivered mothers could apply it.

The results of the efficacy trial and the feasibility pilot, along with CHX’s low cost, convinced policymakers within the MoH that CHX distribution is an intervention that could truly impact the prospects and lives of mothers and babies. On this basis, it was very evident that it should be part of the newborn care package.

Nationwide rollout of CHX program commenced in 2011, as the MoH distributed CHX through health facilities during antenatal care visits, starting with seven districts in 2012 and increasing to ten in 2013. By 2017, the ministry had rolled it out in all 75 districts, and 64 per cent of all newborns in Nepal received CHX treatment within three days of childbirth.

What led to uptake?

Researchers worked with the MoH to integrate the initial study, the feasibility pilot and scale-up into existing community based maternal and child health (MCH) programs, such as the birth preparedness package and community-based integrated management of neonatal illnesses. The ministry included CHX application into MCH programs through the annual plan, training FCHVs and other providers, procuring CHX through the logistics system, and tracking its use through the health information management system.

The Government of Nepal, development partners, professional associations, and the private sector also developed strong partnerships to support CHX deployment. The MoH formed the CHX technical working group which provided advice for planning, procurement, and monitoring of the program, while external development partners (EDPs) provided technical assistance, supported knowledge dissemination in national and international forums, organized learning visits, and showcased the CHX program for other countries with high newborn mortality rates. Professional associations, such as the Nepal Paediatric Society, advised on technical aspects of the program, while a private pharmaceutical company, Lomus, manufactured CHX.

Using FCHVs to distribute CHX drove community acceptance, as they are trusted individuals in the community and mothers listen to their advice. As a result, mothers made CHX, rather than traditional substances, part of routine cord care practices.

Though evidence shows that CHX is a low-cost method of reducing neonatal deaths, programmatic scale-up was not assured in Nepal. Rather, CHX became the standard cord care treatment because of the combination of clinical evidence, political support, partnerships, and community acceptance. Its continued scale-up will depend on these factors.

* The author would like to thank Taylor Williamson for editorial support for this blog

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