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Table 2 Main issues emerging from the interviews

From: Compassionate use programs in Italy: ethical guidelines

Subjects interviewed

Topic

Three components of the EC

Increasing number of requests

Absence of exceptions to the procedure

Absence of good clinical practice

Safety tests and guarantee of efficacy often lacking

Not adhering to MD 2003

Specific case:

Multiple Bias of the study of the drug requested

Problem of patient information

Importance of an informed decision and the activation of PC

Simultaneous PC

Right to hope

Quality of life

Proposing physician

Patient already self-informed

Patient in good general conditions

excellent evaluation of the PC intervention at the EC’s request

Palliative Care Specialist

Simultaneous PC

Patient awareness, informed decision

Guarantee quality of life

Specific case:

Risk of misunderstanding of PC

No continuity of patient management before and after the interview regarding compassionate requesting