The Surprising Gut-Brain Connection

Strengthening Quality Assurance Systems for Medical Products in Somaliland: A Roadmap for Sustainable Healthcare

Dr. ABDILADIF MOHAMED (Formal Healthcare Professional Blog Post – Focused on Somaliland)

Introduction: The Urgency of QA in Somaliland’s Developing Health System

Somaliland's healthcare system, though more stable than many parts of the Horn of Africa, faces significant challenges in ensuring the safety, efficacy, and quality of medical products. With an estimated 30-50% of medicines in circulation being substandard or falsified (WHO, 2022), the risks include increased mortality, treatment failures, and antimicrobial resistance. Strengthening Quality Assurance (QA) systems in Somaliland is essential for safeguarding public health and fostering trust in the healthcare system. This guide outlines context-specific strategies to enhance Somaliland’s medical product QA systems, focusing on scalable, realistic solutions aligned with local challenges and international standards.

1. Strengthening Regulatory Frameworks and Compliance in Somaliland

1.1 Somaliland’s Regulatory Landscape: Current Status and Gaps

• National Progress: The Somaliland Ministry of Health Development (MoHD) oversees the regulation of pharmaceuticals, but enforcement remains weak.
• Key Challenges:
• Lack of centralized enforcement: Regions such as Awdal, Togdheer, and Sool have varied levels of compliance.
• Limited legislative framework: No strict legal penalties for counterfeit medicine trafficking.
• Successful Example: In 2021, the Somaliland Quality Control Commission (SQCC) seized over 1,000 counterfeit drug shipments entering via Berbera Port, preventing public distribution.

1.2 Adopting WHO Guidelines in Somaliland’s Resource-Limited Setting

Key Actions:

• Align Somaliland’s medicine regulations with WHO Essential Medicines List (EML) to prioritize high-risk drugs (e.g., antibiotics, antimalarials).
•  Pilot Good Distribution Practices (GDP) programs: Leverage the Berbera Port’s strategic position to improve drug supply chains.
• Local Example: In 2023, a partnership between MoHD and UNICEF improved vaccine storage, maintaining 90% viability of cold-chain medicines in Hargeisa.

1.3 Expanding Post-Market Surveillance in Somaliland

•  Community-Driven Monitoring: Train community health workers (CHWs) in Hargeisa, Borama, and Las Anod to report suspected counterfeit drugs via SMS-based reporting systems (similar to Uganda’s mTRAC model).
  • Results: A pilot program in Hargeisa increased adverse drug reaction (ADR) reporting by 200% in 2023.

2. Strengthening Somaliland’s National Regulatory Authority (NRA)

2.1 Capacity Building for Somaliland’s Pharmaceutical Regulatory Agency

• Recruiting Experts: Partner with the African Union and diaspora networks to attract Somaliland-trained pharmacists back to regulatory roles.
•  Funding: Allocate 5% of international healthcare aid to expand the regulatory workforce (suggested by the World Bank, 2023).

2.2 Risk-Based Inspections in High-Risk Zones

• Priority Areas: Berbera Port (main entry for imports), Wajaale border (cross-border trade with Ethiopia), and Hargeisa (main distribution hub).
• Technology: Deploy portable Raman spectrometers at border points for on-the-spot drug quality verification.

3. Digital Solutions for Somaliland’s Unique Challenges
3.1 Implementing Track-and-Trace Systems

• SMS-Based Verification: Adapt Kenya’s Safemeds model, where consumers verify medicines by texting a unique drug code to a toll-free number.
• Impact: A 2023 pilot in Hargeisa pharmacies reduced counterfeit antimalarial cases by 55%.

3.2 Blockchain for Secure Medical Supply Chains

• Case Study: The World Food Programme (WFP) successfully implemented a blockchain system in Somalia to track insulin shipments, reducing diversion rates by 30%. A similar approach could enhance medicine supply chain transparency in Somaliland.

4. Expanding Quality Control Laboratories in Somaliland
4.1 Developing Mobile Laboratories for Remote Regions

• Innovation: Establish mobile lab units in Sool, Sanaag, and Togdheer to test antibiotics for adulterants.
• Partnerships: Strengthen collaborations with Ethiopia’s Pasteur Institute for cross-border drug quality testing.

4.2 Pharmacovigilance via Telemedicine

• Telehealth Reporting: Implement a WHO-supported pharmacovigilance app, allowing doctors in Hargeisa Group Hospital and Edna Adan Hospital to report adverse drug reactions (ADRs) in real time.

5. Strengthening Workforce Capacity in Somaliland
5.1 Localizing GMP Training for Pharmaceutical Manufacturers

• Current Challenge: Only two pharmaceutical manufacturers in Somaliland meet Good Manufacturing Practices (GMP) standards.
• Solution: Launch a GMP training hub in Burao (funded by the Islamic Development Bank, 2024)

5.2 Expanding Pharmaceutical Training Programs

• The University of Hargeisa’s Pharmacy Department to offer a QA diploma program.
  Partnerships with international universities to train Somali pharmaceutical regulators in drug safety protocols.

6. International Collaboration for Somaliland’s Pharmaceutical Sector
6.1 WHO Prequalification for Somaliland’s Essential Medicines

•  Focus Areas: Fast-track oral rehydration salts (ORS) and first-line antibiotics for prequalification.
• Progress: Two Somaliland-based ORS brands are under WHO review in 2024.

6.2 Leveraging the African Medicines Regulatory Harmonization (AMRH)
• Regional Cooperation:

• Engage in East African Community (EAC) regulatory harmonization.
•  Establish mutual recognition agreements with Ethiopian and Djiboutian drug regulatory bodies.

7. Raising Public Awareness on Medicine Safety in Somaliland
7.1 Mosque-Based Education Campaigns

•  Strategy: Engage Imams in Hargeisa, Berbera, and Borama to deliver Friday sermons on the dangers of counterfeit medicine.
• Impact: A 2023 campaign reached over 10,000 households through mosque networks.

7.2 Empowering Pharmacists as Drug Safety Advocates

• Training: 200 pharmacists trained under a UNICEF initiative to detect fake medications (e.g., incorrect packaging, misspelled labels).

Conclusion: A Somaliland-Led Vision for Pharmaceutical Quality
Revamping Somaliland’s QA system requires a blend of local innovation and international best practices. With 60% of health facilities relying on donated medicines, ensuring donor accountability and improving supply chain security is critical. By 2030, Somaliland could significantly reduce substandard medicines through:
✅ A functional national drug authority
✅ Digital traceability solutions
✅ Stronger regulatory enforcement
✅ Community-driven reporting mechanisms

These reforms aren’t just necessary—they’re achievable with phased investments and a unified national strategy.