Introduction. Legislation governing the off-label use of drugs is: the law no 94/1998, for the individual patient, and the law no 648/1996 for the populations of patients. The 2007 budget puts the responsibility of revenue off-label use of drugs in the hands of the medical directors, and delegates the regions to regulate the field. The 2008 financial constrains the offlabel use to the availability of phase II clinical trials. In oncology, however, is common the use of therapeutic approaches off-label. The purpose of this work is to photograph the knowledge of the regulatory framework and the roles of those involved in the authorization process and the impact of the procedures in terms of organization and health care in relation to the use of off-label cancer drugs in Puglia. Materials and methods. Two pharmacists have visited 18 hospitals in Puglia with a cancer unit and have submitted to hospital pharmacists end oncologists a questionnaire. Results. 114 health workers were interviewed. The authorization, for 100% of those interviewed, starts from the prescribing physician, is endorsed by the Director of the Medical Unit and is authorized by the Chief Medical Officer (DS), the Pharmacy's Director assesses the appropriateness of the request, the therapeutic options and costs. The Ethics Committee is involved in the authorization process for the 20% of respondents and in cases of extended-access for 68%; Commissions-Therapeutic or small groups interdisciplinary respectively for 36% and for 53%. In no center refers the existence of codified procedures for emergencies or the rule of silence/absinthe. For 30% of respondents take up to 3 days to get a response, for 35% up to 7 days, for 10% up to 15 days, for 1% up to 21 days and for 11% over 21 days, a further 3% do not know, 10% reported variable times. The 10% of the physician, to gather the documentation to be attached, takes less than 1h, the 69% from a quarter to half a working day, the 10% up to a whole day, the 6% time greater than one day, a further 3% doesn't know. The pharmacist, to carry out what is within its competence, in the 36% of cases takes less than 1h, in the 44% from a quarter to half a working day, in the 8% up to the whole day, the 10% doesn't know. Finally, for the respondents, the areas most affected are: pancreas (63%), colorectal (39%), breast (35%), glioblastoma (18%). Thread. the study shows the existence of a relationship between the various health professionals involved and the need to develop faster procedures by producing more knowledge about legislative.
ASJC Scopus subject areas
- Pharmacology (medical)