Global pMDI Use and the Potential Impact of European PFAS Legislation on Access to These Essential Inhaled Medications

INTRODUCTION: Many essential inhaled medicines recommended in guidelines are delivered to the lung via pressurized metered-dose inhalers (pMDIs). Global environmental legislation will lead to phasing out of hydrofluoroalkane propellants currently used in pMDIs, owing to their global warming potential (GWP). Furthermore, the European Chemicals Agency is reviewing proposed legislation to ban per- and polyfluoroalkyl substances (PFAS) on the basis of chemical structure, which could also impact pMDI availability. Here, we estimated pMDI use as a proportion of all inhaler use in 60 countries, spanning six geographical regions, to understand the relevance of any pMDI restrictions to patients and prescribers. METHODS: pMDI use as a percentage of total inhaler use during 2022 was calculated by country and geographical region using inhaler sales data (a surrogate of use) from the IQVIA Quarterly MIDAS database; inhaler use for the 10-year period from 2013 to 2022 was also evaluated for these regions. Data were compared by individual inhalations. The total patient population living with asthma and/or chronic lower respiratory disease was calculated on the basis of Eurostat (the statistical office of the European Union [EU]) 2019 data and available disease prevalence statistics. Maintenance pMDI utilization was estimated by adjusting for ratio of maintenance pMDI use to total inhaler use. RESULTS: Across all countries analyzed, pMDIs accounted for the largest proportion of inhaler use in 2022 (77.3%). In 51 out of 55 countries with available country-level data, pMDIs represented > 50% of total inhaler use. After adjusting for pMDI usage, an estimated 8.1 million EU patients received a maintenance pMDI in 2022, with the greatest proportion in Germany and France. CONCLUSIONS: pMDIs are vital inhalers for most patients in Europe and around the world. While transitioning to near-zero or low-GWP inhalers, it is essential to avoid unintended consequences from the proposed PFAS ban by safeguarding patient access to this essential device option.