Pharmacy

The transition toward wide-scale use of single-dose administration systems such as prefilled syringes has primarily occurred in high-income countries due to economic considerations. This has resulted in a disparity of access to such technologies in low- and middle-income countries, which continue to utilize multi-dose vial-based presentations and syringes for parenteral delivery. Single-dose innovations currently available or in the product development pipeline represent the promise of enhanced access globally and the potential for public health impact. This perspective article discusses the reported benefits of pre-filled single-dose delivery systems compared to multi-dose vials, as well as the higher standards of infection control regulations and practices that resulted in the increasing use of and benefit from single-dose administration systems in high-income countries. We evaluated how these benefits and standards could enhance health initiatives in low- and middle-income countries. Finally, we explored the potential for making pre-filled single-dose delivery methods both accessible and affordable in low- and middle-income countries.

As one of the biggest challenges for healthcare in the 21st century, COVID-19 placed a sustained and intense demand on the European Medicines Agency’s resources and required constant adaptation and mobilization of different regulatory processes. In this situation, drug repurposing appeared as a promising potential approach in quickly emerging health crises due to its main advantage of reducing the time and cost for addition of new indications since it uses products proven to be of high quality, safe, and effective. We performed an analysis of European Public Assessment Reports for medicinal products authorized for the SARS-CoV-2 infection by the European Medicines Agency, showing a total of eight products with this indication, three (37.5%) of which used repurposing as a mechanism for development (remdesivir, tocilizumab, and anakinra). The application of this mechanism by these medicines highlights the importance of the life cycle stage at which repositioning is undertaken, which resulted in different volumes of data submitted in the respective European Public Assessment Reports. The participation of organizations other than the marketing authorization holder in key stages in the drug development process of repurposed products was once again confirmed, which emphasizes the need to regulate this interaction.

Chronic obstructive pulmonary disease (COPD) is a major global health burden. The fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) triple therapy provides new treatment, but its long-term real-world safety lacks evidence. A post-marketing analysis used the FAERS database to identify adverse event (AE) signals for FF/UMEC/VI. Disproportionality methods including reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM), were applied to detect AE signals, focusing on reports from third quarter (Q3) 2019 to Q3 2024. Among 16,238 reports listing FF/UMEC/VI as primary suspect, significant AE signals occurred in ‘injury, poisoning and procedural complications’ (n = 9067, ROR 2.46, PRR 2.08, IC 1.06, EBGM 2.08), and ‘respiratory, thoracic and mediastinal disorders’ (n = 6567, ROR 4.87, PRR 4.15, IC 2.05, EBGM 4.13). A total of 196 significantly disproportionate preferred terms (PTs) were identified, including previously undocumented AEs such as chronic eosinophilic rhinosinusitis, dysphonia, and vocal cord dysfunction. This post-marketing safety study revealed significant signals for dysphonia and vocal cord dysfunction associated with FF/UMEC/VI, suggesting that clinicians should remain vigilant for these events.