Abstract

Package leaflets belong to the complex communication system related to the minimization and prevention of pharmaceutical risk. Their legal nature is not exhausted by safety regulation though: as a privileged form of product instruction, they are also subject to liability regulation with a consequent reallocation of damage responsibility through risk disclosure. This article presents the results of a doctoral dissertation devoted to the legal and communicative analysis of PL information. After illustrating the articulation of pharmaceutical risk through risk prevention norms, the paper goes on with a discussion of the PL role within the therapeutic decision as a complementary vehicle to doctor’s information. It results that the liability framework in which both information channels are embedded determines a communication model, which far from promoting a shared decision process, radicalizes the two-step communication structure typical of the informed consent model inherited by surgery judicature. The second part investigates PL information as a source of knowledge updating through the methodological tools provided by Bayesian decision theory. Finally, an empirical study conducted over a sample of 55 drug consumers investigates the impact of PL information on drug risk perception and its perceived value to therapeutic decision.