Comprehensive Report on the National Pharmaceutical Strengthening Initiative

Project Title: National Pharmaceutical Strengthening Initiative (NPSI) for Essential Medicines and Health Supplies in Uganda

Project Period: July 2021 – June 2023

Implementing Organization: Real Health Uganda (RHU)

Executive Summary: The National Pharmaceutical Strengthening Initiative (NPSI) was a two-year project led by Real Health Uganda (RHU) aimed at transforming the pharmaceutical sector in Uganda to ensure reliable access to essential medicines and health supplies (EMHS). This initiative focused on strengthening local pharmaceutical manufacturing, enhancing the regulatory environment, and optimizing supply chain management to address persistent challenges such as stockouts, high medicine costs, and inefficiencies in the procurement and distribution systems. The project successfully enhanced the availability, affordability, and accessibility of essential medicines, especially in underserved areas.

Background: Before the inception of the NPSI, our healthcare system was plagued by recurrent shortages of essential medicines, particularly in rural areas, where logistical challenges and weak regulatory frameworks exacerbated the problem. PUHMED struggled to maintain consistent supply chains, and the cost of medicines remained prohibitively high for many citizens as has been. Recognizing these challenges, RHU, in collaboration with key national and international partners, launched the NPSI to create a more resilient and equitable pharmaceutical system.

Objectives:

1. Strengthen Local Pharmaceutical Manufacturing: Increase the production capacity and quality of essential medicines produced in Uganda to reduce dependency on imports.
2. Enhance Regulatory Oversight: Improve the regulatory frameworks governing the production, distribution, and quality assurance of medicines.
3. Optimize Procurement and Supply Chain Management: Streamline procurement processes and improve the efficiency and transparency of the supply chain to reduce stockouts and wastage.
4. Improve Access and Affordability: Ensure that essential medicines are available and affordable for all Ugandans, particularly vulnerable populations.

Key Activities:

1. Capacity Building for Local Manufacturers:
   • Partnered with local pharmaceutical companies to enhance their production capabilities through technical assistance and financial support.
   • Introduced Good Manufacturing Practices (GMP) training programs for local manufacturers to ensure compliance with international quality standards.
   • Facilitated technology transfer agreements with international pharmaceutical companies to boost local production of high-demand essential medicines.
2. Regulatory Strengthening:
   • Established a centralized electronic regulatory information system to streamline the licensing, inspection, and monitoring processes.
   • Implemented a pharmacovigilance system to track and respond to adverse drug reactions, ensuring patient safety.
3. Supply Chain Optimization:
   • Developed a Logistics Management Information System (LMIS) to improve the visibility and management of stock levels across the country.
   • Conducted training sessions for supply chain managers at health facilities on inventory management, demand forecasting, and reporting.
   • Upgraded the PUHMED distribution networks, including the rehabilitation of regional office warehouses to reduce lead times and ensure timely delivery of medicines.
4. Community Engagement and Advocacy:
   • Launched nationwide awareness campaigns to educate the public on the importance of using locally produced medicines and reporting stockouts.
   • Worked with community health workers to distribute essential medicines in hard-to-reach areas and monitor supply chain performance at the grassroots level.
   • Advocated for policy changes to support the local pharmaceutical industry, including tax incentives and subsidies for essential medicine production.

Outcomes:

1. Increased Local Production:
   • Local production of essential medicines increased by 40%, significantly reducing the country’s dependency on imported medicines.
   • The quality of locally produced medicines improved, with 90% of local manufacturers achieving GMP certification by the end of the project.
2. Enhanced Regulatory Compliance:
   • Regulatory inspections increased by 50%, leading to a 35% reduction in the distribution of substandard and counterfeit medicines.
   • The pharmacovigilance system reported and addressed over 1,000 adverse drug reactions, improving overall patient safety.
3. Improved Supply Chain Efficiency:
   • The implementation of the LMIS reduced stockout incidents by 60%, ensuring that essential medicines were consistently available in 95% of public health facilities.
   • Lead times for the delivery of medicines from central warehouses to health facilities were reduced by 30%.
4. Greater Access and Affordability:
   • The cost of essential medicines decreased by an average of 25% due to increased local production and bulk purchasing agreements.
   • Access to essential medicines improved in rural areas, with over 85% of health facilities reporting adequate stock levels by June 2023.

Challenges:

• Initial resistance from some local manufacturers to adopt international quality standards, requiring extensive training and support.
• Infrastructure limitations in remote areas continued to pose challenges for timely distribution, despite improvements in the supply chain.
• The need for ongoing regulatory oversight to ensure sustained compliance with quality standards.

Lessons Learned:

• Strengthening local pharmaceutical manufacturing is critical for improving the availability and affordability of essential medicines in Uganda.
• Continuous capacity building and support for both manufacturers and supply chain managers are essential for the successful implementation of such initiatives.
• Regulatory frameworks must be robust and adaptable to respond to the evolving challenges in the pharmaceutical sector.
• Community engagement is crucial for the success of healthcare initiatives, particularly in ensuring that medicines reach underserved populations.

Conclusion: The National Pharmaceutical Strengthening Initiative (NPSI) successfully addressed many of the longstanding challenges in Uganda’s pharmaceutical sector. By enhancing local production, improving regulatory oversight, and optimizing the supply chain, the project ensured that essential medicines became more available, affordable, and accessible to all Ugandans. The outcomes of this initiative provide a strong foundation for continued improvements in the healthcare system and highlight the importance of sustained investment in the pharmaceutical sector.

Recommendations:

1. Sustain and Expand Local Production: Continue to support local pharmaceutical manufacturers through technical assistance, financing, and policy incentives.
2. Strengthen Regulatory Systems: Regularly update regulatory frameworks and invest in our capacity to enforce quality standards.
3. Further Optimize Supply Chains: Expand the LMIS to cover all PUHMED health facilities, including private and faith-based institutions, and invest in infrastructure improvements in remote areas.
4. Promote Public-Private Partnerships: Encourage collaboration between the government, local manufacturers, and international partners to drive innovation and efficiency in the pharmaceutical sector.
5. Continue Community Engagement: Maintain and expand community outreach programs to ensure that all Ugandans, especially in rural areas, have access to essential medicines.

Appendices:

1. List of Local Manufacturers Supported under NPSI. (log in to PUHMED)
2. Training Materials on Good Manufacturing Practices (GMP). (log in to PUHMED)
3. Reports on Regulatory Inspections and Compliance. (log in to PUHMED)
4. Case Studies on Successful Local Pharmaceutical Production. (log in to PUHMED)
5. Detailed Analysis of Supply Chain Improvements and LMIS Performance.(log in to PUHMED)

Contact Information: Real Health Uganda (RHU)
Address: Plot 305 Mbogo Rd, Kampala, Uganda
Email: info@rhu.or.ug
Phone: +256 414 671 109
Website: Real Health Uganda