The optimal outcome of endoscopy is conditioned by numerous factors: the most important are represented by trained endoscopists with standard techniques, by a systematized approach to event management, by a good documented patient informed consent and communication before and after the procedure. Complications are quite rare, but when they occur they can cause adverse events and patient injury, increasing the probability of malpractice actions. This article will focus on potential lawsuits that are likely to be pursued when there is the lack of one of these procedures.

We report a case of a cutaneous ulcer in a 49 years-old patient with diabetes and hypertension. Penicillin in pownder for local use was prescribed. A severe anaphylactic reaction was observed. This case leads to some considerations concerning the off-label prescribing, that is to say the prescription of a registered medicine for a use that is not included in the product information. Thus off-label prescribing in dermatology may sometimes be clinically appropriate, it may be associated with a number of clinical, safety and legal issues. Off-label prescribing is acceptable if there is no suitable alternative and an appropriate process for informed consent is needed. The practice of prescribing off-label drugs is common among dermatologists, many of whom had misperceptions about which are the approved indications of the drug and about the legal ramifications of off-label therapies. The authors suggest that understanding the principles of off-label prescribing in conjunction with the mechanisms of drug action in diseases may help clinicians in increasing the safety of their patients and in avoiding legal litigations.