New boundaries of prescription: focus on section 13 of the new Italian code of medical ethics.

2758 Dear Editor, Each code of medical ethics should undergo periodical revisions and updates inspired by the need to align the ethical evaluation to the latest medical issues determined by scientific progress and the passage of time1. However, compared to the advances of biomedical knowledge and practices the considerable time frame spent on code renewal (e.g. an average of 8 years, in Italy) may be considered something that approaches a geological era. The above-reported consideration allows to agree with the authors that any revision may lose the matching with changed reality Any new code should, basically, provide an educational background to adapt the behavior to future, potential scenarios, rather than to take a retrospective note of changed conditions in which physicians were already involved. In terms of novelty, it seems appropriate to point out that one section of new Italian ethic code carries out some relevant changes. We are talking about section 13, which deals with “prescription”, in the broadest acceptation of any pharmacological or surgical treatment. For the first time, a clear statement about guidelines can be found in the ethical code. This prediction follows a new law on medical liability, named “Decreto Balduzzi” from the name of Health’s Minister who promoted it. This law substantially changes the penal code about the profiles of medical liability in our country, by introducing a decriminalization of medical injury caused by physicians, who can demonstrate a behavior adherent to guidelines. This innovation in the new ethical code brings up the importance of protocols and guidelines as medical rules that should drive any medical act. At the same time, it represents a positive meaning of the term “responsibility”, differently from what happened the previous version of the ethical code, where the only clearly noticeable meaning of liability was negative and related to defensive medicine. Moreover, current Code’s section 13 better defines the boundaries of “optimal use of resources”, making references to clinical efficacy, safety and appropriateness, and in this way trying to adjust both the maximum prudential measures required from Law Courts and the logic of procedural economy. This can be considered as an attempt to combine two potential conflicting aspects: health and economy. On one side, health has to be obviously considered as the stronghold of any patient interest to a complete health condition. On the other side, physicians have to take care of costs, as a medium of resources optimization, necessary for the protection of the community. In this respect, the new version of section 13 introduces the same principles already expressed by the American Medical Association2. According to the strategies of the health system to achieve efficacy, quality, reliability and efficiency3 in connection with clinical risk prevention, the new code highlights autonomy of physician in prescription, an activity that should be considered with particular caution in the case of non-conventional therapies. The most recent example of questionable and not scientifically supported therapies is that of the “Stamina case”. Following the previous versions, the code reiterates that these therapies are not lawful. These treatments indeed fall in the grey area that the code of ethics relegates in as unauthorized ones, overcoming the catchword not to deprive patients of alternative therapies available. Commentary New boundaries of prescription: focus on section 13 of the new Italian code of medical ethics