Aim: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder characterized by hemolytic anemia, bone marrow failure and thrombosis. We evaluated, the cost–effectiveness of pegcetacoplan, a novel proximal C3 inhibitor, versus ravulizumab in patients with PNH and hemoglobin levels <10.5 g/dl despite eculizumab treatment in the UK healthcare and social services setting. Materials & methods: A Markov cohort framework model, based on the data from the pivotal trial of pegcetacoplan (PEGASUS/NCT03500549), evaluated lifetime costs and outcomes. Patients transitioned through 3 PNH hemoglobin level/red blood cell transfusion health states. Results: Pegcetacoplan provides lower lifetime costs/greater quality-adjusted life years (£6,409,166/14.694QALYs, respectively) versus ravulizumab (£6,660,676/12.942QALYs). Conclusion: Pegcetacoplan is associated with enhanced anemia control, greater QALYs and reduced healthcare costs versus ravulizumab in the UK healthcare and social services setting.
BackgroundThe Directive 2011/62/EU (Falsified medicines directive, FMD) provides for measures to prevent the entry into the legal supply chain of falsified medicinal products and has been supplemented by the commission delegated regulation (EU) 2016/161. From February 2019 onwards prescription medicines are required to bear individual safety features that need to be verified and decommissioned by pharmacies before being supplied to the public. While this process has already been tested in some community pharmacies, little is known on the implications the FMD has on healthcare institutions.PurposeAim of the present study was to assess the impact of the implementation of the FMD in a university-based hospital pharmacy that currently provides medicines for approximately 2000 beds and prepares more than 55 000 chemotherapies per year.Material and methodsIn order to simulate the ‘end-to-end’ verification as outlined by the directive, packs of prescription medicines were scanned at goods in and at several points of dispense within the pharmacy. The time required to process the respective number of drugs was measured and clustered for the individual product type.ResultsA total of 1546 packs of 59 different medicinal products were assessed at goods in, which took a median of 2.1 s (0.6–6. 5 s) to process each single pack. However, some drugs such as iv-anaesthetics, iv-antibiotics and iv-painkillers, all of which were stored on pallets, required a significantly higher amount of time to verify. The simulation was repeated at four different points of dispense where 2056 packs of 811 different drugs were scanned. Here the amount of time required was not significantly different (median 2 s) from goods in but with a higher variation between the different products. Based on these data we extrapolated that the amount of time needed to process the 2.8 million packs of prescription drugs supplied by our pharmacy is more than 1,500 hours per year.ConclusionOur study demonstrates that the implementation of the FMD in the hospital pharmacy is a major challenge. Compared with the community pharmacy, a much greater degree of planning, organisation and technical support is needed to cope with the decommissioning of large numbers of drugs.References and/or Acknowledgements1. FMD:https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf2. Commission Delegated Regulation (EU) 2016/161: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdfNo conflict of interest
The Falsified Medicines Directive (FMD) and the Delegated Regulation (DR) impact the pharmaceutical supply chain. Ahead of the deadline for implementation, in February 2019, every entity of the supply chain had to adapt its operations to the regulatory requirements to be compliant with the directive. This paper analyzes the supply chain of a hospital pharmacy and the impact of the FMD implementation. Furthermore, a cost analysis was performed demonstrating that the FMD increases expenditure in the secondary care environment dispensing operations. Governments should be aware that this regulation will certainly impact public healthcare institutions in the long term.
The Falsified Medicines Directive (FMD) and the published Delegated Regulation (DR) has a serious impact on daily operations in secondary care environments. The following study was developed in a German hospital, using medicines authentication software to assess the impact of the implementation of the legal requirement under the FMD. Various dispensing locations were tested in conformity with Article 25 (2) of the DR. The conclusions of this study confirm that the best scenario of implementation will be an authentication of a medicinal product before supplying it to the wards minimizing the effort and other consequences for the hospital.
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