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Summary of the Thirteenth Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP)

Core Content

The Thirteenth Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP), held in Geneva on 21–22 June 2016, focused on strengthening pharmacovigilance (PV) systems globally, particularly in low- and middle-income countries (LMICs). The meeting emphasized the need for a more comprehensive, sustainable, and responsive PV framework to ensure the safe use of medicinal products, including drugs, medical devices, and diagnostics.

Main Priorities and Recommendations

1. Strengthening Global Pharmacovigilance

• Access to safe and effective medicines is a key WHO leadership priority.
• The SAV team aims to build PV capacity in selected countries by supporting the full cycle of PV activities, from data collection to regulatory decisions.
• A global approach to PV is recommended, including the safety of all healthcare products, not just medicines.
• The WHO Programme for International Drug Monitoring (PIDM) should be expanded, leveraging lessons from past initiatives.
• PV systems should be enhanced to address emerging priorities such as monoclonal antibodies, biosimilars, and products of human origin.

2. Enhancing Pharmacovigilance Systems

• Mobile and smartphone technologies are increasingly used for adverse event (AE) data collection, but offline tools should also be promoted in areas with limited internet access.
• The Uppsala Monitoring Centre (UMC) will continue to improve PV training and data management tools like VigiLyze and VigiFlow, while providing automated feedback to national PV centres (NPCs).
• The WHO CC in Accra, Ghana will focus on strengthening PV in sub-Saharan Africa through comprehensive surveillance systems and training.
• The WHO CC in Rabat, Morocco will develop courses on medication errors and promote root cause analysis, while also working on integrating PV systems and harmonizing Arabic terminology.
• The WHO CC in the Netherlands will support the integration of PV in medical education and provide insights into patient reporting.

3. WHO-Bill and Melinda Gates Foundation (BMGF) Partnership

• BMGF highlighted the need for targeted PV systems in LMICs to monitor new drugs, vaccines, and diagnostics developed specifically for these regions.
• Coordination among various stakeholders is crucial to avoid duplication and improve efficiency.
• WHO is positioned to lead in risk management planning and global safety data review, especially for newer products that reach the market earlier in development phases.

4. Medicines in Pregnancy

• Sodium valproate is known for its teratogenic effects and neurodevelopmental risks.
• A diagnostic tool has been developed to identify robust cases of thalidomide-associated limb deformities with high predictive value.
• ACSoMP recommended the development of a generic tool for similar situations with other medications used during pregnancy.
• The European Medicines Agency (EMA) is encouraged to organize a scientific workshop on drugs in pregnancy to support WHO's guidance development.

5. Minimum PV Requirements

• The WHO Minimum PV Requirements (Core Components) document needs to be revised to be more comprehensive and adaptable for smaller countries.
• It should align with WHO PV indicators and National Regulatory Agency (NRA) assessment tools.
• A stepwise approach is recommended to ensure practical implementation across different PV capacities.

6. Pharmacovigilance of TB Medicines

• New TB medicines like bedaquiline (BDQ) require careful monitoring due to their complex regimens.
• Three levels of PV monitoring are proposed: core, intermediate, and advanced, based on national PV capacity.
• A national PV system in India (PvPI) has been established, with data sharing between TB programs and PV centres.
• Pre-market and post-market data should be shared with all stakeholders to support benefit-harm assessment and therapeutic recommendations.

7. Seasonal Malaria Chemoprevention (SMC) Programmes

• PV is critical for the success of the SMC programme, which involves monthly administration of amodiaquine and sulfadoxine-pyrimethamine.
• A tailored PV training curriculum has been developed and will be used in future trainings.
• A SMC safety review committee will be established to evaluate PV data and provide risk management advice.

8. Antimalarial Cardiotoxicity

• Several quinoline antimalarials are linked to QTc interval prolongation, increasing the risk of ventricular tachyarrhythmias.
• Torsades de pointes (TdP) is an underestimated risk, and clinical studies should report AEs to VigiBase® for global monitoring.
• Risk management is necessary, and PSURs from the EU should be shared with WHO NTDs for review.

9. Soil-Transmitted Helminthiasis (STH) Control

• Mass drug administration of anthelminthic drugs is recommended for at-risk groups.
• Drug resistance is a concern, so limited distribution to at-risk populations and maintaining unexposed groups is advised.
• New drug combinations are being proposed to expand treatment options, and safety data will be collected through literature reviews, NTD campaigns, and clinical trials.
• ACSoMP will be involved in reviewing safety data and providing guidance for NTD recommendations.

10. Updates on PV in the EU

• The Pharmacovigilance Risk Assessment Committee (PRAC) reviews over 600 risk management plans annually.
• A significant portion of signals leads to label changes, showing the impact of PV on regulatory decisions.
• KPIs for measuring PV impact are being developed and may be shared with ACSoMP.
• The EudraVigilance system will transition to a new ISO-ICSR format and send reports directly to UMC starting in late 2017.