A review of recorded information given to patients starting to take clozapine and the development of guidelines on disclosure, a key component of informed consent

Abstract

Clozapine is a very effective drug with both significant benefits and significant risks in treatment-resistant schizophrenia. Informed consent is generally accepted as both desirable and necessary in order to ensure that the patient’s human rights and dignity are respected. Disclosure is a key element of informed consent. It is unclear if the adequate documentation of disclosure is standard practice before initiation of clozapine. The aim of this study was to assess the adequacy of the documentation of disclosure in consent to clozapine treatment in an adult mental health service and to develop guidelines on disclosure. The method was a retrospective analysis of charts of patients given clozapine who received the drug through the pharmacy of a single North Dublin psychiatric hospital. Results show that current practice has evident gaps. The professional, ethical and legal issues are discussed.