Article Text

Download PDFPDF
Clinical pharmacy and clinical trials (including case series)
Compassionate drug use: the experience of the Lecce-Asl ethics committee
  1. R.I.F. Romano,
  2. M. Canitano,
  3. C. Morciano,
  4. C. Montinari,
  5. D. Conte Camerino
  1. 1Azienda Sanitaria Locale Lecce Segreteria Scientifica Comitato Etico Lecce, Italy
  2. 2Azienda Sanitaria Locale Lecce, Area Servizio Farmaceutico, Lecce, Italy
  3. 3Università degli Studi di Bari ‘Aldo Moro’, Dipartimento Farmaco-Biologico, Bari, Italy


Background Compassionate drug use allows treatment with investigational drugs when there are no therapeutic alternatives. In Italy this is regulated by Ministerial Decree 08/5/2003. The reason for, and conditions of, use must be submitted by the physician for the approval of the competent Ethics Committee. Compassionate use is authorised for individual patients.

Purpose The increasing number of requests for compassionate drug use made it desirable for the ASL Lecce Ethics Committee to set up a database to record the epidemiology.

Materials and methods The Scientific Secretariat of the Ethics Committee receives the request for compassionate drug use, verifies the completeness and examines the information supplied, and prepares documents for submission to the Ethics Committee. Once approved, it is recorded in an Excel database which shows the clinic, hospital ward, physician, the proposed drug use, name of the patient and date of approval.

Results The analysis included all data recorded from 01/01/2009 to 01/09/2011, from which it emerged that during this period 34 requests for compassionate drug use were submitted to the Ethics Committee, 10 of which were in 2009, 7 in 2010, and 16 in the first 9 months of 2011. Seventy-three percent of the requests came from the Oncology ward, 15% from Haematology, 9% from Rheumatology and 3% from Endocrinology.

Conclusions Growing numbers of requests for compassionate drug use underline the need for doctors and patients to have access to innovative drugs when there are no therapeutic alternatives and no possibility of inclusion in clinical trials. The monitoring system has made it possible to find out whether the drugs for which compassionate use was requested were then licensed for that purpose by AIFA; and it will enable the Ethics Committee to suggest that doctors set up non-profit clinical trials when the requests for compassionate drug use become sufficient.

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.