Risk-based assessment of the possibility for falsification during post-marketing surveillance of medicines

Abstract

The prevalence of falsified medicines and the figures undoubtedly differ between countries (WHO, 2017); nonetheless it is necessary to establish an effective system for post-marketing surveillance of the quality of medicines on a national level, in order to monitor, detect and diminish the appearance of substandard and falsified medicines on the market (Pisani et al., 2021). In most lowand middleincome countries, post-marketing surveillance is often limited to sporadic sampling or the collection of medicine samples as part of routine inspections. This may be due to poor planning, unclear oversight objectives, and/or limitations in the methodology for sampling or analysis. This means that while regulatory agencies may spend significant resources on medicine sourcing and analysis, these efforts often result in poor quality data that cannot be used to make evidence-based decisions (PQM, 2018). Additionally, the limited capacity of quality control laboratories and large quantities of medicines that need to be analyzed suggest that a risk-based approach can prioritize activities accordingly (EDQM, 2020). Article 30 of the Guidance on the manner of quality control of medicines of Republic North Macedonia (Official gazette, 2021) stipulates that all segments of trade should be covered when sampling medicines for regular quality control and the geographical and demographic criteria should be taken into account as well. However, there is no targeted strategy for identification and subsequently sampling of medicines that, at some point, may be at a higher risk of being falsified. The aim of this paper is to depict the critical aspects of market surveillance of medicines, which would facilitate the transition from a sporadic to a risk-based postmarketing surveillance program for monitoring of the quality of medicines present on the market in our country.