Democratic Republic of the Congo

Project dates: October 2011–December 2016

Background

The Democratic Republic of the Congo (DRC) is the second largest country in Africa, with an area of 2,345,409 square kilometers and an estimated population of 85 million (National Institute of Statistics 2014). It is characterized by a fast-growing population (2.7% per year) and a fertility rate of 5.9 children per woman (WHO statistical profile 2012).

The average life expectancy of 52 years is below the regional average. Diarrheal diseases are the main cause of death and were attributed to nearly 110,000 deaths in 2012, followed by pneumonia and malaria (WHO statistical profile 2012). DRC is considered post-conflict state however numerous conflicts keep arising rendering it a difficult environment of persistent insecurity especially  in the eastern part of the country.

DRC’s National Health Strategic Plan 2011–2015 describes medicines as an essential link in the development of the health system. The DRC health system lacked a functional pharmaceutical regulatory system and comprehensive national pharmaceutical or medicines policy framework to regulate and coordinate pharmaceutical-sector activities to achieve key health outcomes. 

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The country’s pharmaceutical challenges include:

  • A growing number of illegal and uncontrolled pharmaceutical businesses
  • Circulation of counterfeit and substandard medicines in the country
  • Unreliable information systems, a shortage of trained and qualified personnel, and poor coordination of key stakeholders, resulting in poor availability of medicines in the country

Between October 2011 and December 31, 2016, SIAPS provided technical assistance to the Ministry of Health (MOH), Drug Regulatory Authority (DRA), National Medicine Supply Program (PNAM), national disease programs, and provincial health divisions (DPS) to improve the availability of medicines.

Project Highlights

Regulatory Capacity, Governance, and Leadership
SIAPS supported the DRA to implement a pharmaceutical regulatory system and develop a comprehensive national pharmaceutical policy framework. The National Essential Medicine List, which included 13 lifesaving commodities endorsed by the UN Commission on Life-Saving Commodities for Women’s and Children’s Health, was updated. The DRA and DPS was supported to coordinate the distribution, reallocation, and supply of essential medicines throughout the country.
Pharmaceutical Storage Conditions and inventory management
SIAPS supported the improvement of storage conditions and updated standard operating procedures to ensure good distribution of commodities. 
Quantification of pharmaceuticals
SIAPS supported the assessment of the logistics management information system (LMIS) and developed an LMIS roadmap, including supply chain data and information to inform the quantification process. The MOH implemented QuanTB, Quantimed, and other quantification tools and trained health workers on the quantification of critical pharmaceutical commodities. 
Medicine Management and Distribution at Regional Medical Stores
SIAPS improved the pharmaceutical management and distribution of pharmaceuticals from regional medical stores to health zones and health facilities in USAID-supported provinces. 
Human Resource and Institutional Capacity
The training curriculum of the Faculty of Pharmaceutical Sciences (FOPS) of the University of Kinshasa was revised to ensure that program graduates are equipped with knowledge and skills relevant to the health needs of the country. SIAPS provided institutional capacity building to the pharmacovigilance (PV) center (CNPV). A causality assessment was done with supervision from the university’s clinical team. 
Pharmaceutical Service Delivery and MDR TB Drugs management
Other major SIAPS interventions included supporting the MOH in implementing and training workers on a multidrug-resistant tuberculosis and TB/HIV co-infection active PV system, including appointing TB focal persons for PV activities. 

Results

Governance and Leadership

  • A Medicine Registration Committee was established that has streamlined the registration and regulation of medicines in DRC. The number of registered medicines increased from 200 in 2010 to more than 4,600 in December 2016.
  • Of the medicines currently included in the National Essential Medicines List, 72% have at least one product registered, an increase from 44% in 2011 (figure 1).
Figure 1. Medicines from the National Essential Medicines List with products registered in DRC [Click to enlarge]
  • The number of days to process a new application decreased from 82 in 2013 to 58 in 2016.
  • Therapeutic committees have been deployed at the provincial and hospital levels to ensure rational medicine use.
  • Thirteen pharmaceutical management guidelines, lists, and SOPs were developed or updated and submitted for adoption, including:

-The National Essential Medicine List
-Registered medicines directory
-Standards treatment guidelines
-Standards for the use of oxytocin, misoprostol, and chlorhexidine digluconate
-Maternal, newborn, and child health fact sheets

Stock Availability at the Facility Level

  • By 2016, 75% of facilities used a standardized checklist to monitor storage conditions, an increase from 0% in December 2011.
  • The percentage of SIAPS-supported health facilities and warehouses with stock-outs of a preselected group of medicines for three days or more in the previous three months decreased from 100% in December 2011 to 36% (health facilities) and 13% (warehouses) in July 2016.
  • SIAPS assisted the Regional Procurement Association for Essential Medicines (ASRAMES), the largest warehouse in the eastern part of DRC, to meet the USAID/European Union prequalification standards. ASRAMES is used as a local supplier to address the long lead time needed when importing pharmaceutical products.

Institutionalizing a Training Curriculum to Meet Current Public Health Needs

  • FOPS became the first training institution in DRC to have a strategic plan and is the only one that meets World Bank and other donor requirements for future funding.

Pharmaceutical Service Delivery

  • The CNPV receives approximately 1,500 individual case safety reports per year with a completeness score (> 75%), which is well above the average score for other countries (50%).
  • CNPV staff support the management of adverse events at the point of care.

Project Legacy

During the five years of SIAPS, DRC has built the institutional and individual capacities of the DPM, PNAM, and CNPV; ensured appropriate preservice training for future pharmacy professionals; and strengthened the medicine distribution and data collection and reporting processes. The project succeeded in strengthening governance in the DRC pharmaceutical sector by enabling proper medicine registration at the DPM and producing a national list of registered medicines thereby improving the safety and availability of medicines, including antiretrovirals.

Resources