Policies and practice in the disclosure of medical error: Insights from leading countries to address the issue in Italy.

The relationship between physician and patient has undergone profound changes in recent years. Patients increasingly insist on being thoroughly informed with detailed information about treatments and procedures suggested for their best care. This is also due to the growing suspicion towards doctors and the health-care system in general. Therefore, it is no longer possible to hide a medical error. To satisfy the request for honesty and safety of patients and society, it is necessary to enhance the skills and tools that physicians can use when disclosing and explaining an error to the patient. All modern codes of medical conduct acknowledge the importance of strengthening communication between physician and patient, which is the only way to save a relationship under constant threat of rupture and to improve the quality and safety of the treatment. The disclosure and explanation of the error has become not only an ethical duty but also a prudent way of avoiding negligence lawsuits. In this context, in 2013, Germany approved a law known as Patientenrechtegesetz, which we consider a good compromise between patient expectations and the need for doctors to work without the constant fear of being sued for malpractice. This work seeks to provide an overview of the most important issues pertaining to disclosure of medical error and of practice in other countries, with the aim of offering a contribution to the debate on this subject in Italy.

Fatal, Intentional Overdose of Ranolazine: Post-Mortem Distribution of Parent Drug and its Major Metabolite.

PURPOSE: Ranolazine is a selective inhibitor of the late inward sodium-current, approved for the treatment of chronic angina. Here, we report a case of a possibly suicidal death due to acute ranolazine overdosing. A 41-year-old woman was found unconscious by her son and was urgently admitted to the Intensive Care Unit. She had ingested an unknown amount of ranolazine tablets. Seventeen hours after admission, the patient died. An autopsy was performed 4 days post-mortem. METHODS: A routine screening analysis for drugs of abuse and medicinal drugs performed by liquid chromatography ion trap mass spectrometry on autopsy samples of biological fluids did not detect any relevant presence of toxicologically relevant compounds, but ranolazine. A quantitative analysis was then carried out by liquid chromatography- QqQ mass spectrometry in order to quantify ranolazine and its major metabolite O-desmethyl-ranolazine in biological fluids and organs. RESULTS: Ranolazine concentrations in biological fluids were as follows: cardiac blood, 19.5 µg/mL; femoral blood, 12.3 µg/mL; bile, 0.87 µg/mL and vitreous humor, 15.4 µg/mL. For O-desmethyl-ranolazine the concentrations in cardiac blood, femoral blood, bile and vitreous were 10.7 µg/mL; 9.6 µg/mL; 11,103 µg/mL and 11.4 µg/mL, respectively. CONCLUSIONS: The cause of death was attributed to ranolazine overdosing. To the best of our knowledge, this is the first report of a fatality associated with ranolazine, in which the postmortem distribution of ranolazine and its metabolite has been quantitatively assessed. The present study can therefore provide useful information for interpretation of the causes and mechanisms of death in ranolazine associated fatalities.