Valutazione dell'attività della commissione tecnico-scientifica della valle d'aosta

Objectives. The aim of this study was to evaluate the activity of the Pharmacy and Therapeutic Committee of the Autonomous Region of the Aosta Valley in the elaboration, management and updating of the Regional Drug Formulary and in formulating opinions on clinical trial protocols in the three-year period 2005-2007. Methods. The Committee's work involving the review and updating of the Regional Drug Formulary and the formulation of opinions on clinical trial protocols was analysed. Results. In all, 58 drugs were evaluated for the inclusion in the Regional Drug Formulary: 53 (91 %) were accepted, and 5 refused. Furthermore, the Committee accepted 6 requests for exclusion of a drug from the formulary. For some drugs (e.g., tacrolimus and omalizumab), the definitive inclusion depended on a one-year systematic monitoring of their use, documented by a report presented to the Committee. The new antineoplastic agents (23% of the inclusions) and the antiretrovirus agents for systemic use (19% of the inclusions) were the pharmacotherapeutic groups that most significantly characterized the extension of the Regional Drug Formulary following various operative units' requests. Among the Committee's activities associated with the Regional Drug Formulary was the review of some drug classes (e.g. antiparkinson agents and ACE inhibitors) carried out by interdisciplinary groups from various operative units. A total of 49 clinical trial protocols were evaluated and 38 (78%) were accepted. Of the original 49 protocols, 25 (51%) concerned drugs: 18 were experimental studies (13 RCTs and 5 CTs, 11 and 3 of which were accepted, respectively) and 7 were observational studies (4 of which were accepted). The 25 clinical trials on drugs involved 13 therapeutic areas: the most numerous was oncology with 5 studies (20%), followed by psychiatry with 4 studies (16%). Conclusions. The Committee's assessment work, based on criteria involving documented safety and efficacy in response to the unanswered and current therapeutic needs in clinical practice, was shown to be as a useful tool for technical-scientific multidisciplinary debates and, as a consequence, for a more appropriate drug use.