Extract from the meeting of WHO GACVS, published in the WHO Weekly Epidemiological Record of 1st March 2024

The objective of the session was to provide updates on safety issues related to medication and immunization errors.  The WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC) provided an overview of reports of medication errors in VigiBase (WHO global database on Individual Case Safety Reports).  Using “medication error” as the search term, there were more than 1.5 (October 2023) million cases of medication errors reported in VigiBase, with 78% medicines and 22% vaccines. General characteristics such as top reporting countries, reporters, products with the most frequent reports, proportion of reports in males and females, and different age groups were described.

The Committees were briefed on the third WHO Global Patient Challenge- Medication Without Harm, which began in 2017. WHO commissioned a meta-analysis to investigate the preventable burden of medication-related harm. A draft report has been developed, and initial findings show   that one in 20 patients is impacted by an avoidable medication-related harm. Globally, the pooled prevalence is around 5%, (7% in lower- and middle-income countries, and 4% in high-income countries). Approximately, 25% of these are life-threatening harm. The aim of the Challenge is to reduce severe avoidable harm related to medications by 50% globally.

The Committees recognized that the opportunity should be taken to conduct further analysis of reports in VigiBase to determine the magnitude of adverse events. An in-depth analysis of each medication error report would be required to fully understand how the error occurred.

The Committee welcomed the initiative of the third WHO Patient Safety Challenge, “Medication Without Harm”, and discussed the overlap of nomenclature between drug-related problems, preventable adverse drug reactions, and medication errors. It is important that there is more clarity around definitions to ease reporting.

Full report of WHO GACVS and WHO ACSoMP 13–15 November 2023, published on 1st March 2024

Access to novel medical products in LMICs is increasing. New treatments are available, or in preparation, for HIV/AIDS, tuberculosis and malaria. Likewise, vaccines targeting cervical cancer, diarrhoeal diseases and conditions that prevail mostly in LMIC, such as Ebola virus disease, dengue, epidemic meningitis and malaria, are at various stages of implementation in those countries.

The availability of post-licensure data is essential for local regulators as well as for public health programmes in developing strategies based on adequate benefit and risk analyses. For products that are used globally, safety data are usually available from high-income settings only, and differ from LMICs in terms of their health-care systems, health profiles and population demographics. While many LMICs participate as national centres in the WHO Programme for International Drug Monitoring (PIDM), their capacity to undertake data collection and contribute to the international database of drug safety may be limited. For example, with vaccines, 60% of the PIDM database comprises reports from some countries in Europe, and the USA, and this may not fully satisfy the needs of local authorities with limited capacity to analyse data and take necessary action.

The Bill & Melinda Gates Foundation (BMGF) has acknowledged the need to build pharmacovigilance capacity in LMICs. In 2013, the BMGF Safety Surveillance Working Group convened and highlighted the need to develop a strategy for post-marketing surveillance given the existing challenges.³ Their report called for leveraging existing scalable platforms (WHO PIDM and its network of national centres), using current standards for safety, and building on current harmonization platforms. The report also recommended devising a single system for both vaccines and medicines, with adjustments only when required.

The BMGF proposed support for the WHO Safety and Vigilance (SAV) team in implementing a strategy for LMICs that would include a regulators network to strengthen pharmacovigilance systems. This would involve continued work with other participants such as the GAVI Alliance (GAVI), UNICEF, PATH and sub-Saharan African regulatory agencies, as well as the engagement of industry to promote alignment between participants/agencies to support implementation as accountable license holders.

GAVI, meanwhile, has prioritized the monitoring of vaccine safety in its data strategy for 2020. The aims are to improve the ability to identify and investigate, to respond efficiently and effectively, and to address related public concerns. GAVI already funds a number of initiatives, partly through its grants for strengthening health systems for capacity-building in LMICs for the surveillance, investigation and management of adverse events following immunization (AEFI) and for the establishment of surveillance systems and the development of tools, guidelines and AEFI training. Surveillance which covers the safety of other drug products, including substandard and falsified drugs and vaccines, remains a specific challenge.

The BMGF, SAV and GAVI presented strategies and approaches relating to vaccine safety to GACVS. Additionally, GAVI set out its resourcing plans including funding for its Data Strategic Focus Area (SFA) and vaccine safety activities. Currently, GAVI Data SFA does not include enhanced investigation capacity and guidance on communication and response; this is an area that needs to be addressed.

GACVS acknowledged both the increased attention being given to the pharmacovigilance of drug products – especially to capacity-building in safety monitoring, and to the work of WHO SAV and its promotion of, and collaboration on, vigilance activities with public health programmes, and the response to safety concerns and international crises. The aims of the BMGF in its support for pharmacovigilance and vaccine safety were also recognized, and included capacity-building through country training supported by GAVI and WHO SAV – training that has recently focused on countries in sub-Saharan Africa. GACVS also identified the very different pharmacovigilance needs of vaccine products compared with other drug products, especially in LMICs where programme delivery of vaccines and drugs may vary and pose unique challenges. Merging is to be considered with caution, although lessons learned from vaccine vigilance could be applied to some of the unique drug product classes as outlined above.

GACVS welcomes future collaboration with, and contribution to, this endeavour as well as providing input to identified gaps and evolving priorities.

³ Bill & Melinda Gates Foundation. A report of the safety surveillance working group. Available at: https://docs.gatesfoundation.org/documents/SSWG%20Final%20Report%2011%2019%2013_designed.pdf, accessed June 2016

Full report of GACVS meeting of 15-16 June 2016, published in the WHO Weekly Epidemiological Record on 15 July 2016