New regulatory strategies to manage medicines shortages in Europe

Abstract

Medicine shortages have been spreading in European countries. In many cases, the unavailability of medicinal products has a substantial impact on the capability of National Healthcare Systems in ensuring the continuity of care. Shortages originate from multifactorial causes. In particular, they can be due to supply-related factors (e.g., manufacturing issues, regulatory issues, logistics, distribution) and demand-related ones (e.g., fluctuating drug demand, parallel market, tendering, price and reimbursement policies). However, some extraordinary geopolitical events (e.g., Brexit) may also affect medicines' availability. The capability of European Regulatory Authorities and other stakeholders, which are involved in the pharmaceutical distribution chain and the healthcare assistance services, to define suitable problem-solving strategies has been limited for years by the fragmentation of the European regulatory framework, starting from the lack of a univocal definition of a medicine shortage. Only in 2019, the EMA and HMA joint task force released the first harmonized "shortage" definition in the European Economic Area (EEA) and guidance on public communication. This manuscript aims to review the current European regulatory framework on medicine shortages. To support the activities of regulators, manufacturers and other healthcare professionals, an algorithm was also proposed to be used as a harmonized procedure to determine the shortage/unavailability impact on public health and to rationalize the problem-solving strategies adopted in all different settings.

Time-trend analysis of medicine sales and shortages during COVID-19 outbreak: Data from community pharmacies

“…Furthermore, it is possible that patients have already experienced shortages of these brand medicines as this has been a constant problem in the last years. 7,35 Formoterol and dapagliflozin plus metformin remain with a high proportion of shortages, which may indicate an undersupply issue that can compromise access to these therapeutics in the long run.…”

“…However, the long-term impacts of this pandemic are unknown and should be monitored, especially bearing in mind the concerning historical problem of medicine shortages in Europe. 23,35 Limitations Some limitations to this paper should be noted. When it comes to data collection, as monthly medicine sales are validated in the second half of the following month, the presented values for April are provisional estimates.…”

Strategies to promote access to medications during the COVID-19 pandemic

“…Shortages can be linked to interruptions in supply (eg manufacturing, distribution, logistics) or changes in demand (eg exceptional requests, changes to prescribing or reimbursement policies). 1,2 Reasons include raw material unavailability, decreased resilience to demand fluctuation and delocalisation of manufacturing. 2 Last year, the TGA and European Medicines Agency introduced new guidelines for the monitoring and communication of medication shortages.…”

“…1,2 Reasons include raw material unavailability, decreased resilience to demand fluctuation and delocalisation of manufacturing. 2 Last year, the TGA and European Medicines Agency introduced new guidelines for the monitoring and communication of medication shortages. 2,3 The TGA's Medicine Shortages Information Initiative (https://apps.tga.gov.au/prod/MSI/ search) highlights current medication shortages in Australia.…”

Health “Brexternalities”: The Brexit Effect on Health and Health Care outside the United Kingdom

“…Maltese doctors are accustomed to prescribing them and patients to using them. Security of medicines supply is therefore a huge potential Brexternality for a country like Malta (Musazzi, Di Giorgio, and Minghetti 2020). The Maltese authorities sought to mitigate these problems by working with stakeholders to stockpile and to convince them to secure different supply chains, from other EU member states, or at least from a supplier that holds a marketing authorization in another EU member state.…”