Over the past 30 years, great strides have been made globally to address child mortality, especially in the poorest countries. However, statistics for newborn deaths have not kept pace with the overall reduction in child mortality since the start of the new millennium. According to the World Health Organization, 5.9 million children under age five died in 2015 — with 45 percent of these deaths occurring in the first four weeks after birth.
Four countries alone account for 1.4 million newborn baby deaths annually. Many of these deaths are easily preventable with the right care and access to affordable, quality-assured medicines.
A new approach to an old problem
“Addressing infant mortality rates requires developing local capacity to produce essential medicines in-country. This will bring down costs and increase the speed of distribution, driving up use and saving lives.”— Dr. Souly Phanouvong, senior manager of the Promoting the Quality of Medicines program in Asia
World leaders committed to addressing the high levels of infant mortality with the adoption of the Sustainable Development Goals in 2015. But achieving SDG 3 — healthy lives and well-being for all — and the target of reducing neonatal mortality rates to as low as 12 deaths per 1,000 live births, will require a different approach to the single-disease strategies used previously.
According to WHO, the challenge now lies in ensuring countries with the highest infant mortality rates have the capacity and capabilities to provide care and treatment for their most vulnerable. This means a collective effort across government and the private sector to ensure access to quality, life-saving medicines.
However, the challenges many countries face come from low production capacity, limited laboratory capabilities to test for quality and weak regulatory frameworks to identify and remove substandard and falsified medication from the supply chain. Until recently, Nigeria — the most populous country in Africa — had no internationally-accredited laboratories for testing pharmaceutical products. Under the United States Agency for International Development-funded Promoting the Quality of Medicines program, implemented by U.S. Pharmacopeia, they were able to accredit three national laboratories to international standards.
According to WHO, in 2005 only about 7 percent of the 46 sub-Saharan African countries had a moderately developed medicine regulatory capacity. Of the remaining countries, about 63 percent had minimal capacities and 30 percent did not have a national medicines regulatory authority in place. The situation remains broadly the same today.
While progress has been made globally, gaps still exist in many countries. As the complexities around medicine quality increase and as long as quality-assured medicines are not readily available, the lives of newborn babies will continue to be threatened.
Domestic production of quality-assured medicines — solutions closer to home
Since 2009, PQM, funded by USAID and implemented by USP, has been helping low- and middle-income countries strengthen their existing health systems. By building capacity in the regulation and manufacturing of medicines for tuberculosis, malaria, HIV and AIDS, neglected tropical diseases, and maternal, newborn and child health, the program is accelerating progress towards quality-assured essential medicines, ensuring healthy lives, and promoting well-being for all people of all ages.
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Low production capacity, limited laboratory facilities and weak regulatory frameworks mean many low- and middle-income countries import essential medicines, despite the fact that some medication can be produced locally at low cost. Importing medication not only increases expenditure, it can also mean delays as pharmaceuticals work their way through customs and complicated supply chains to reach front-line staff and patients. These delays can cost lives.
“Addressing infant mortality rates requires developing local capacity to produce essential medicines in-country,” said Dr. Souly Phanouvong, senior manager for the PQM program in Asia. “This will bring down costs and increase the speed of distribution, driving up use and saving lives.”
A common cause of death among newborns in developing countries is umbilical cord infection, which kills an estimated 400,000 babies each year globally during their first month of life. By simply keeping the umbilical cord clean and free from infections, these deaths can be avoided. In 2009, the government of Nepal — until recently a country with a stubbornly high infant mortality rate — with technical assistance from the PQM program, and in partnership with PATH and Lomus Pharmaceuticals, started producing and selling an inexpensive and easy to use gel, chlorhexidine, known as CHX, to clean umbilical cords.
The results were stark: Infant mortality figures rates fell by one quarter to one third, depending on how soon the gel was applied after birth. The trial in Nepal and others in Pakistan and Bangladesh, where similar positive results were recorded, led WHO to include CHX in its list of recommended essential medicines. However, many countries still face challenges with the availability and distribution of the gel, despite the fact that the raw ingredients only cost about $0.23 per tube — enough for one baby.
Many of these issues reflect challenges within health systems themselves, which are in charge of sourcing medicine, frequently from suppliers outside the country, and distributing them to where they are needed. The bottlenecks in the pharmaceutical supply-chain are often caused by challenged management and information systems, inefficient procurement practices, ineffective policies and complicated logistics.
Lessons learned and shared
Building on the success of CHX in Bangladesh, Pakistan and Nepal, the PQM program looked at how this essential medicine could be manufactured and distributed in Nigeria. The program identified a local pharmaceutical company, Drugfield Pharmaceuticals, and started collaborating with them to build up their core capacities and competences to produce a quality-assured CHX gel.
Drawing on the learnings about formulation work already done by PATH and commercialization by Lomus Pharmaceuticals, Drugfield started upgrading its facilities and documentation with technical support, training and mock inspections conducted by experts from the PQM team.
Drugfield Pharmaceuticals’ Managing Director Dr. Ekundayo Olakunle described the project as “a good model for transferring technology and skills to developing countries and to develop local capacity.”
Olakunle pointed out that the program not only focuses on the transfer of technical skills and competencies, it also focuses on good practices that contribute to the improvement of standards across a whole company.
“When we do the upgrades and get the training, it doesn’t just affect the product in question, but also the quality of all the other products we make.”
Supply and demand both critical to public health
According to the World Health Organization, roughly one-third of the world’s population lacks access to even the most basic medicines. Devex drills down on ways development stakeholders can increase the sources and supplies of quality medicines in low- and middle-income countries, from approaching pharmaceutical manufacturers to increasing access to generic medicines and addressing supply chain issues.
One of the challenges the private sector faces to sustain these efforts is to ensure there is public demand for the product. This is important given that 90 percent of the population in many developing countries buy medicines from out of pocket expenses rather than through other means such as community-based health insurance schemes. Currently, in Nigeria, companies like Drugfield Pharmaceuticals need to assume the marketing costs of products and this can be very expensive in a country where people are not aware of, or not used to using, such products.
Olakunle pointed out that return on investment is slow.
“We didn’t quite anticipate the importance of advocacy and behavior change communication in driving up acceptance and demand for the product,” he said.
The usage of CHX in Nigeria remains minimal; according to some observers only 5 percent of women use the gel, despite the fact that over 90 percent of women apply some substance, such as chalk, sand, palm oil, or leaves, to help the umbilical cord fall off.
The government of Nigeria has developed a scale up strategy for CHX gel; however the governance system in the country means that decisions can take time to trickle down to the local level. Working through community health committees may accelerate this process.
Governments and markets working together hold the solution
Well-regulated and supported domestic markets play a critical role in responding to public health needs with domestic production and distribution of essential medicines as one of the most effective means of ensuring a sustainable, affordable supply of essential medicines, such as CHX gel. Donor governments have a critical role to play in supporting programs that will ensure the transfer of technical skills and scientific know-how to low- and middle-income countries, as well as supporting them to establish tighter regulatory frameworks to ensure the production and distribution of quality-assured medicine and to squeeze out falsified and substandard alternatives from the market.
Dr. Chimezie Anyakora, chief of party for the PQM program in Nigeria, believes the private sector is also critical when it comes to tackling falsified and substandard medication.
“Companies need the right incentives to invest in and take on the risk of producing quality medicines in a market like Nigeria,” he said. “We have been supporting companies as they develop their processes to comply with international standards, however they will only maintain this if they are encouraged to maintain these standards through higher sales.”
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Anyakora added that organizations can contribute to making this happen by only procuring medicines companies that comply with international standards for quality, which will force producers of poor-quality pharmaceuticals out of business.
Domestic capacity to both produce and regulate the supply of essential, quality-assured pharmaceutical products, as well as tighter international frameworks to control the flow of falsified and substandard medicines may prove to be one of the most effective means of ensuring newborn babies and their mothers are provided with the care they need.
Discussing the success of programs such as PQM, USP’s lead for Asia, Dr. Phanouvong, said that it could have “an enormous impact on the 22 to 23 newborn babies who die every hour in Pakistan. [It] will save millions of lives in the future.”
How can the international community come together to increase the sources of quality medicines in lower- and middle-income countries? Have your say by leaving a comment below.
This article is the third in a series of four articles on global health challenges caused by poor-quality medicines and approaches to achieving quality-assured medicines in low- and middle- income countries. For more information, visit www.usp-pqm.org.