Background and importance Patients enrolled in oncology clinical trials are frequently at risk and often live far from the oncology centre. Starting from 21 February 2020, during the lockdown caused by SARS-CoV-2, oncological patients were allowed to travel for health reasons, but their clinical conditions, organisational difficulties and the risk of COVID-19 suggested adopting prudential solutions.
Aim and objectives The AIFA and EMA authorised centres to adopt exceptional measures, promoting the dispensation of more cycles and the delivery of therapies to patients at home. This work aims to verify the impact of these solutions in an oncological centre.
Material and methods The number of experimental drugs dispensed from January to 3 June were analysed using an Excel database. Dispensations were divided in three periods to evaluate the trend: daily intravenous (IV) and oral (PO) dispensations before 21 February 2020 (P1), between 22 February and 3 March (P2) and from 19 March (start of shipments) until the end of lockdown (P3), analysing the main issues noticed and the percentage of therapies shipped.
Results Therapies in the entire period were 4154; mean daily dispensations in P1 was 39.46 (16.03 PO, 23.43 IV), in P2 40.06 (16.12 PO, 23.94 IV) and in P3 38.71 (14.71 PO, 24.00 IV). During P3, 109 shipments of PO medications were delivered, representing 13.72% of the total therapies. The slight increase in dispensations in P2 was due to the anticipation of visits due to the fear of an imminent closure; the subsequent decrease was due to a higher drug quantity dispensed/shipped per single dispensation. PO therapies decreased slightly (−8.23%) compared with the pre-lockdown period, while IV therapies remained steady over the three periods. Seven transport issues occurred, leading to therapeutic discontinuity in 4 of 109 cases. No therapeutic error was detected during the period analysed, probably due to telephone feedback on the arrival of the drugs.
Conclusion and relevance Investigational drug shipment was effective in lowering the impact of the pandemic on the therapeutic continuity, without however becoming the most frequently used model. Logistical difficulties produced four cases of therapeutic discontinuity and the telephone feedback mechanism limited the risk of errors in therapy.
Conflict of interest No conflict of interest
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