Abstract
After a long delay due to concern about agranulocytosis, in 1993 clozapine was approved for use in Australia, but with unique restrictions: it was only available through hospitals, for the treatment of refractory schizophrenia, and it could only be used in accord with a Protocol to which both doctors and patients had to promise to conform. The Protocol's requirements included: a full blood count each month; results had to be reviewed by the prescribing doctor and pharmacist; and the patient had to be seen at that time (each month) by the doctor. A national system was established to record and monitor blood results. There was an evaluation of the first 3 years of haematological monitoring, in terms of prevention of deaths.
Although the 1993 Protocol has had some amendments there has been no disciplined review of whether or not there should be major changes in regard to the constraints on the professional freedom of psychiatrists, the impositions on patients, the restrictions on the use of clozapine, or the manner of supply.
The extensive international literature on the operation of monitoring systems and related topics provides overwhelming evidence that the majority of cases of neutro-penia occurs within the first 6 months of treatment and that after 10 years the incidence of neutropenia is no higher with clozapine than with other drugs. This suggests that a liberalization of controls directed at preventing agranulocytosis warrants consideration. On the other hand, recognition that there is a range of other disabling and potentially fatal complications associated with the use of clozapine implies that, perhaps, some new requirements might be appropriate.
Clozapine continues to have a greater efficacy than all other antipsychotics. The use of clozapine must be optimized and not be limited by the deterrent of unnecessary constraints. Equally, action must be taken to minimize the negative outcomes of its use.
Our College must insist on an urgent review of the controls on clozapine use.