Helping save mothers and children in Indonesia: increasing the supply of quality-assured essential medicines

In Indonesia, maternal mortality rates (MMR) declined from 228 per 100,000 live births in 2007 to a low of 228 per 100,000 live births in 2007, but then increased by over a third in 2015. Postpartum hemorrhage was the leading cause of MMR deaths in 2015, accounting for nearly one-third of all deaths. The World Health Organization (WHO) recommends oxytocin for postpartum hemorrhage, but poor-quality oxytocin can negatively affect treatment outcomes. Childhood mortality rates in Indonesia decreased from 85 per 1,000 births in 1990 to 27 per 1,000 in 2015. However, an estimated 147,000 Indonesian children die before their fifth birthdays each year. Pneumonia was a leading cause of childhood deaths in 2015, with approximately 25,000 children dying from the disease. The WHO notes that amoxicillin dispersible tablets (DT) are the antibiotic of choice for treating pneumonia in children under 5, but only one-third of children with pneumonia receive the antibiotics they need. The lack of quality-assured essential medicines in LMICs, including Indonesia, hinders efforts to save lives. Sometimes, medicines are not available due to limited financial gain for local manufacturers. At other times, medicines that are available may be of poor quality, making them ineffective or even dangerous. A recent study found a high prevalence of poor-quality oxytocin samples in LMIC countries, mainly due to inadequate amounts of active ingredient. Medicine can be of poor quality for a number of reasons, including falsification, deficient manufacturing practices, or improper handling and storage. To improve the availability of quality-assured essential medicines in LMICs, local manufacturers sometimes need support from technical experts. The Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for International Development and implemented by USP, helps manufacturers strengthen their quality systems to comply with good manufacturing practices (GMPs). This year, with PQM support, an Indonesian manufacturer demonstrated it met GMPs to earn WHO prequalification for oxytocin injection and the facility in which it manufactures amoxicillin 250 DT was found by WHO to be operating at an acceptable level of compliance with GMPs for pharmaceutical products. The PQM program also works with local partners to build a stronger medicines quality assurance system in Indonesia. For instance, PQM helps develop and advance policies in support of the medicines regulatory authority (MRA) and empowers Indonesia's MRA and national quality control laboratory with locally sustainable capacity to help assure the quality of medicines. The PQM program is funded by the U.S. Agency for International Development (USAID) and implemented by USP, and its goal is to help low- and middle-income countries strengthen health systems by building capacity in the regulation and manufacture of medical products.