Dialogue between hospital pharmacists, hematologists and oncologists for the correct use of special use drugs
Unity between disciplines to respond to the 'time' factor
ROME – “We experienced two significant days promoted by SIFO Giovani, to address with a multidisciplinary attitude the problems related to the safe, timely and sustainable management of off-label therapies in the oncology-hematology field.
An important appointment which confirms the hospital pharmacist as an interlocutor for the entire healthcare system, even in its most delicate aspects, and underlines the great vitality of young hospital pharmacists, who within SIFO represent a dynamic, competent and propulsive soul, a reality on which our Company has been aiming for for some time with conviction.”
Thus the president Arturo Cavaliere at the end of the course Special uses of medicines in onco-haematology: hospital pharmacists, oncologists and haematologists in comparison just concluded in Trieste and organized by the SIFO Youth Area.
A comment that is confirmed by the coordinator of the Area, Chiara Lamesta (also responsible for the event): “We are truly very satisfied with what emerged in Trieste, because we managed to bring together three scientific societies of national importance – ours, AIOM and SIE – also involving the regulatory body, AIFA, in the discussion. We were thus able to discuss all points of view, from clinical to legal ones, from those connected with preparation to those relating to sustainability today the development of collaboration between companies to guarantee a systematic approach capable of offering increasingly uniform and coherent responses to needs throughout the national territory”.
The event – opened by the introductory speeches of President Cavaliere and Chiara Roni (SIFO regional secretary for Friuli Venezia Giulia) – saw the presence and interventions not only of hospital pharmacy experts, but also of Martina Pennisi (secretary of the Society Italian Hematology), Lorenzo Gerratana (associate professor at the Department of Medicine of the University of Udine and of the IRCCS CRO of Aviano, as well as member of the AIOM Youth Working Group) and Claudia Santini (AIFA), as well as the forensic medicine Rosario Barranco (INAIL Genoa).
In the background of the work, law 648.96 remained which allows the provision – precisely in the form of ‘special use’ – pharmacological therapies paid for by the NHS when there is no valid therapeutic alternative, when the marketing of a drug is authorized in other States but not in Italy, medicines not yet authorized but undergoing clinical trials or, finally, medicines to be used for a therapeutic indication other than the authorized one.
From the scientific rationale of the event, fourteen detailed reports were developed which explored the topic of off label, use according to law 96/648, expanded access including the compassionate use of medicines from various observation points, in particular regarding: the choice of reference sources for the pharmacist and for the oncologist in the case of off label, the transposition of regulations in regional territories, the development and role of molecular tumor boards, the development of innovative and gene therapies, the current function of ethics committees, the impact in the field of rare tumors and the contribution that radiopharmacy and theranostics can offer in the sector.
“In the vastness of these approaches, a common element was highlighted several times during the conference”, underlined Gabriele Bagaglini (second scientific coordinator of the two days), “the centrality of a multidisciplinary approach, capable of guaranteeing early and safe access to medicine. For us, the dialogue with our colleagues in hematology and oncology is becoming increasingly important and fundamental. Added to this is the dialogue with the world of nuclear medicine, which is certainly one of the advanced frontiers of healthcare innovation we intended to create a place of innovative collaboration both in content and methods and we are convinced that we have laid an important first stone in this construction”.
A belief shared by Martina Pennisi: “The proposal for disciplinary collaboration between hospital pharmacists, oncologists and hematologists is a stimulating novelty and furthermore the fact that it all started from the SIFO Youth Group is a positive thing, which lays the foundations for a dialogue also in the future among the young people of our scientific societies – concluded Pennisi – that this event was interesting both in terms of content and in terms of understanding their respective roles: this collaboration is in fact very important in clinical practice because it offers the possibility of guaranteeing patients an optimal, safe and up-to-date level of care”.
Multidisciplinarity was an essential value in the common dialogue, as also confirmed by Lorenzo Gerratana: “We now work in a context where mutual contamination is essential, because the sharing of different professional and scientific cultures is the only way to ensure quality care for the patient in line with the most advanced research. From this point of view I would also like to underline the increasingly leading role of the Molecular Tumor Boards, which today no longer constitute just a decision-making hub for personalized medicine, but also a research tool, given that from the data collected within them, new preclinical and translational experimentation models can then be informed.”
“What has emerged most – is the comment proposed by Marcello Pani (SIFO national secretary) – is that the hospital pharmacist is today the hub around which the rationalization of the entire early access system revolves, in which many and various professionalism, but which requires a figure of particular importance when it comes to experimentation: early access to the drug means ensuring more advanced therapies, hopes of a cure for many people, but also guaranteeing safe paths without costs for the patient. SSN”.
Lastly: what do the over one hundred participants of the two days take home with them in their professional daily lives?
Nicola Nigri (third scientific coordinator of the event) responds: “As hospital pharmacists we have a shared slogan, which is grow, share and learn. Here: certainly the comparison with clinicians has allowed us to understand what their point of view is, and they too were able to understand what ours is. A key word at the center of this comparison was that of time: the patient needs a therapy to access in the shortest possible time understanding that we as hospital pharmacists act as a bridge between the clinician, the management and the patient, all to ensure that time – in compliance with all safety and appropriateness considerations – is increasingly limited”.