[Drug use during the covid-19 pandemic in Italy.] / L'uso dei farmaci durante la pandemia di covid-19 in Italia.

The Italian Medicines Agency has started, since the first months of 2020, a monitoring of drug use during the covid-19 pandemic. This made it possible to identify specific trends in hospital and local purchases, such as the extensive use of off-label drugs with little evidence of efficacy during the first weeks of the epidemic, and to progressively assess the degree of implementation of regulatory and ministerial recommendations.Fin dalle prime fasi dell'emergenza covid-19 è emersa per l'Agenzia Italiana del Farmaco (AIFA) la necessità di monitorare in modo specifico l'uso dei farmaci utilizzati nel corso dell'epidemia. È infatti fondamentale, in un contesto caratterizzato da grande incertezza e da continui aggiornamenti delle linee guida, disporre di informazioni utili a una corretta lettura e interpretazione dei dati. È stato quindi realizzato un primo rapporto dell'Osservatorio Nazionale sull'Impiego dei Medicinali (OsMed) sull'uso dei farmaci utilizzati, a livello ospedaliero e territoriale, nella fase iniziale dell'epidemia1. Questo metteva a confronto i consumi relativi al periodo compreso tra marzo a maggio del 2020 con quelli del trimestre immediatamente precedente, da dicembre 2019 a febbraio 2020. In seguito, il 4 marzo 2021, è stato pubblicato un aggiornamento dei dati in riferimento alle fasi successive dell'epidemia2. Il monitoraggio ha preso in considerazione diverse categorie di farmaci, andando a valutare le oscillazioni negli acquisti in riferimento al progressivo aggiornamento degli indirizzi regolatori. I volumi osservati per ciascun farmaco sono stati standardizzati per 10.000 abitanti/die, andando a valutare le differenze pre- e post-covid-19 in termini di differenza assoluta, differenza percentuale e di p-value (p).

Public expenditure for plasma-derived and recombinant medicinal products in Italy.

BACKGROUND: In Italy, the supply of plasma-derived medicinal products funded by the National Health Service can be through public healthcare facilities, accredited pharmacies or toll fractionation agreements between Regions and the manufacturer. Pharmaceutical public expenditure includes the supply related to the first two channels and costs can significantly vary because of channel-specific price reductions. This paper describes 2011 public expenditure for plasma-derived medicinal products purchased on the market, as well as the cost analysis per active substance. MATERIALS AND METHODS: Analysis of the usage of plasma-derived medicinal products and of the related expenditure in public facilities has been carried out using medicinal product traceability data. The analysis related to the accredited pharmacies channel has been carried out using quantities for every medicinal package recorded by Pharmacy Associations and applying reference prices in force on March 1(st), 2012 as well as discounts for the accredited pharmaceutical expenditure imposed by law. RESULTS: At national and regional level, total and total per capita expenditures on plasma-derived medicinal products by market channel and funded by the National Health Service are shown. Analysis was conducted considering the active substances in three groups: substances included in toll fractionation agreements, recombinant coagulation factors, and other substances not included in toll fractionation agreements. In 2011, the national expenditure estimate for plasma-derived and recombinant medicinal product acquisition on the market was about € 535 million. DISCUSSION: The purchased volumes and mean purchased prices per unit of each substance have a significant influence on the observed regional variability of the pharmaceutical public expenditure. A strategy of regional comparison aimed at both sharing a national range of reference for purchase prices and evaluating modalities for centralised purchasing is desirable.