|Title:||Authority Required to Prescribe and Supply Risperidone Long-Acting Depot Injection (Risperdal Consta®)|
|Document ID:||Operational Circular OP 1809/04|
|Date of issue:||Thursday, 8 July 2004|
|Status:||NO LONGER APPLICABLE|
|Description:||WATAG recommends that authority is necessary to prescribe and supply risperidone long-active depot injection (Risperdal Consta®) and that this authority shall rest with the most senior administrative staff of each health service.|
|Applicable to:||Clinical staff, pharmacists and managers|
|Period of effect:||from 16 June 2004|
|Authorised by:||Dr Andrew Robertson, Acting Deputy Director General, Health Care, 01-Jul-2004|
|Print version:||View print version|
Authority Required to Prescribe and Supply Risperidone Long-Acting Depot Injection (Risperdal Consta®)
The WA Department of Health requires that authority is necessary to prescribe and supply risperidone long-acting depot injection (Risperdal Consta®), and that this authority shall rest explicitly with the most senior administrative staff of each health service, even if that individual is at a separate site and/or not medically qualified.
This requirement removes the authority to approve supply of depot risperidone by clinical psychiatric staff and places it explicitly on the most senior administrative staff.
Risperdal Consta® has been declined by the PBAC because of uncertainties over clinical benefit and cost-effectiveness. Locally, WA Therapeutic Advisory Group (WATAG) has resolved not to list Risperdal Consta® on the formulary of public hospitals on the basis of marginal clinical efficacy and potential for very high acquisition costs. However, while not listing this drug, WATAG did provide for clinical situations where there was a need for a depot atypical drug due to poor compliance with oral therapy or intolerable side-effects to typical depot neuroleptic drugs. A highly restrictive protocol was developed to provide both initial supply and continued access, dependent on restrictive clinical criteria, and compliance with measures for clinical efficacy and side-effects. A recent review of Risperdal Consta® use in WA revealed that this protocol was not being adhered to, and this has resulted in unexpectedly high expenditure without demonstrated clinical benefit.
The purpose of this Circular is to instruct all Health Service administrators and managers:
The following Schedule for Risperdal Consta® use shall apply,
Schedule: Treatment guidelines for risperidone long-acting injection (Risperdal Consta®)
Applications for initial use of Risperdal Consta® must be made in writing to the Health Service's senior administrative officer or manager. The application must include details of the nature of the non-compliance, the dates on which each of the relevant treatments referred to were started and stopped, and a description of non-response or adverse effects encountered, preferably in the form of a photocopy of clinical notes. Application for continuing therapy should include a copy of the results of at least two standard measures of disease activity in schizophrenia. The administrator to whom the applications are addressed shall normally approve the applications if the provisions below have been properly met and the documentation provided is within the spirit of these guidelines.
1. INITIAL TREATMENT (4 months only)
2. CONTINUING TREATMENT
According to the Schedule, applications for initial use of Risperdal Consta® must be made in writing to the Health Service's senior administrative officer or manager. Application for continuing therapy should include a copy of the results of at least two standard measures of disease activity and adverse effects (BPRS and ESRS). The administrator to whom the applications are addressed shall normally maintain records and monitor local use.
This information shall also be submitted on a periodic basis to the Office of Mental Health, which will monitor and review usage within WA. The Office of Mental Health will advise Health Service's senior administrative officers or managers of details of these arrangements as required.
Dr Andrew Robertson
This circular last updated: Thursday, 8 July 2004 at 12:00am