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Off-label prescription to a child who is an involuntary patient

Reporting to the Chief Psychiatrist

Under section 304 of the MHA 2014 the provision of off-label treatment to any child who is an involuntary patient must be reported to the Chief Psychiatrist.

In order to simplify and streamline the process of reporting the Chief Psychiatrist has developed a form which should be completed and submitted to the Chief Psychiatrist. A copy of the form should also be filed in the patients records.
Notification Forms –

MHA2014_s304 – Off Label prescription to a child

The report needs to contain:

  • the decision to provide the off-label treatment, including a description of the off-label treatment; and
  • the reasons for the decision.

Approved product information: for registered therapeutic goods, means the product information approved under the Therapeutic Goods Act 1989 (Commonwealth) in relation to the registered therapeutic goods;

Off-label treatment: means the use of registered therapeutic goods other than in accordance with the approved product information for the registered therapeutic goods;

Product information: has the meaning given in the Therapeutic Goods Act 1989 (Commonwealth) section 3(1);

Registered therapeutic goods: means registered goods as defined in the Therapeutic Goods Act 1989 (Commonwealth) section 3(1).

Further Information from the Child & Adolescent Mental Health Service

There is increasing scrutiny around the prescription of “off label” psychotropic medications for children and adolescents. The Council of Australian Therapeutic Advisory Groups (CATAG) report “Rethinking medicines decision making in Australia: Guiding Principles for the quality use of off-label medications” in November 2013 reflected this.  It provided guiding principles and specific recommendations for paediatric population. There was also a study released in June 2014 from the University of Sydney, and Drug Utilisation Subcommittee of PBAC that tracked the  marked increase in use of off label psychotropic medication in children and adolescents and expressed significant concerns about this trend and lack of monitoring.  Perhaps as a result, a late amendment to the Mental Health Act 2014 included a clause that a record must be made of off-label prescribing in involuntary paediatric inpatients and that the Chief Psychiatrist must be notified.

Off-label treatment simply means the use of registered therapeutic goods other than in accordance with the approved product information for the registered therapeutic good. If the medication is being used outside of the age group, dose, indication or route as mandated by TGA registration and/or official manufacturers Product Information (PI) then it constitutes off-label prescribing. Most pharmaceutical companies have not gone through the process of registering psychotropic medications for children and adolescents, hence they are off label. This does not in itself indicate whether there is an evidence base to support prescription.

To assist CAMHS clinicians to make informed decisions about prescribing off label, and to create a platform to obtain informed consent the following resources have been developed and will be placed in the CAMHS Medication Safety Toolbox.

  1. Off-Label Psychotropic Prescribing Guide for CAMHS Clinicians: This guideline is a quick-reference guide to determine the licensed age, indication and dosage for psychotropic medication used in paediatric patients. This guide also contains a very brief description of the level of evidence for use of the psychotropic medication in major international clinical guidelines. This guide is not intended to be used as a primary reference for medication dosages. The guideline should also be used in conjunction with Appendix 1 – Responsibilities of CAMHS Clinicians, and Appendix 2 – Flowchart for assessing appropriateness of off-label medicines use.
  2. Consent for Off-Label Medication Use form: CAMHS clinicians are required to attain consent for the use of off-label medication from the parent when prescribing off-label treatments. A completed signed consent form should be included in the patient’s permanent record.

Please ensure you use both resources. This is an important medico-legal and medication safety initiative.

Acknowledgement is made to the Child & Adolescent Mental Health Service for this information.


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