Article Text

Download PDFPDF

2SPD-029 Off-label drugs: use analysis and pharmacoepidemiology in a COVID centre in Rome
  1. G Gambarelli1,
  2. G Gambarelli2,
  3. L Fiorito3,
  4. R De Feo3
  1. 1Ministero Della Sanita, DGDFDM, Roma, Italy
  2. 2Ministero Della Sanita, DGPM, Roma, Italy
  3. 3AOU Policlinico Umberto Primo Roma, UOC Farmacia, Roma, Italy


Background and importance The coronavirus pandemic has involved the sudden management of innovative therapeutic opportunities to counter it. A drug’s off-label use has required a sudden supply and the production of legislation to settle such handling to target real data towards a shareable and objective data collection flow.

Aim and objectives The aim of the study was to analyse the supply process of off-label drugs and reference to the national legislation for each medicinal product, regarding consumption data and the number of COVID-19 patients treated in a COVID centre in Rome, with 200 COVID beds and 40 beds in two intensive care units.

Material and methods For the following products, the supply and handling data were analysed from 1 February 2020 to 31 July 2020: chloroquine, hydroxychloroquine, lopinavir/ritonavir, darunavir/colbicistat, raltegravir and tocilizumab. The AIFA’s reference regulations of these drugs were highlighted in the same period. Pharmacoepidemiological data were obtained.

Results The drug’s off-label request was first considered. After the AIFA’s decision to include in the 648/96 Law (GU 69 17.03.2020) chloroquine, hydroxychloroquine, lopinavir/ritonavir, darunavir/colbicistat, the UOC Pharmacy drafted a specific request form according to the 648/96 Law, to convey the supply and distribution of drugs to the departments through a reporting channel as the regulations required. 10 658 tablets of lopinavir/ritonavir were given to 250 patients, 660 tablets of darunavir/colbicistat to 32 patients, 302 150 tablets of hydroxychloroquine to 350 patients and 330 tablets of chloroquine to 33 patients. Raltegravir tablets were obtained for compassionate use for one patient. Tocilizumab was introduced through an off-label company procedure. Later, the centre was included in the TOCIVID-19 clinical trial (19 March 2020) and patients were moved to the clinical trial. During the off-label use period, 54 therapies were provided and 34 of these required a second dose. From an analysis of the epidemiological data, 80% of patients had at least one comorbidity and age over 75 years; 60% were men. Death occurred in 6% overall, with a 30% death rate for patients over 75 years, according to national data.

Conclusion and relevance The COVID-19 emergency has highlighted the pharmacist’s role in the supply of innovative drugs and in the management of National Regulations. A close relationship with physicians has allowed sharing of views, focused on streamlining bureaucracy that often slows down the drug distribution process. Sharing opinions, bureaucratic streamlining and development of communications with online systems, web servers and phone chats can speed up the timing of organisation of the services.

References and/or acknowledgements


Conflict of interest No conflict of interest

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.