title: Clozapine protocol: a collective approach to use of an unregistered medicine.
abstract: We describe a protocol for the use of an unregistered antipsychotic medicine, clozapine, in a mental health service. Traditionally, prescribing of unregistered medicines has been a matter between prescriber and patient alone. However, clozapine carries a high risk of agranulocytosis and its use requires strict adherence to monitoring procedures. Persons most likely to benefit from it include many who, because of their psychosis, may be unable to give truly informed consent or to react appropriately to adverse reactions. We have designed a protocol which seeks to ensure that this medicine is given only to those whose severity of illness and lack of response to all other reasonable treatment outweighs the risk of agranulocytosis, that it is used with maximum safety and that only persons who have been shown to benefit from the medicine continue to receive it after an initial trial. Although this protocol has been accepted by the medical staff, questions of clinical autonomy and liability in the event of medical misadventure remain.
authors.affiliation: Mental Health Services, Wellington Area Health Board.
authors.forename: A I
authors.initials: AI
authors.lastname: Simpson
authors.forename: T M
authors.initials: TM
authors.lastname: Egan
mesh_terms: D000328:Adult; D000380:Agranulocytosis / Q000139:chemically induced; D002985:Clinical Protocols; D003024:Clozapine / Q000009:adverse effects / Q000627:therapeutic use*; D004335:Drug and Narcotic Control; D006801:Humans; D008875:Middle Aged; D009520:New Zealand; D012559:Schizophrenia / Q000188:drug therapy
chemical_list: D003024:Clozapine