Statement of Principles concerning TARDIVE DYSKINESIA (Balance of Probabilities) (No. 79 of 2023) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 25 August 2023. The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Terence Campbell AM Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Application 5 Definitions 6 Kind of injury, disease or death to which this Statement of Principles relates 7 Basis for determining the factors 8 Factors that must exist 9 Relationship to service......................................... 10 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning tardive dyskinesia (Balance of Probabilities) (No. 79 of 2023). 2 Commencement This instrument commences on 26 September 2023. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies. 5 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 6 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about tardive dyskinesia and death from tardive dyskinesia. Meaning of tardive dyskinesia (2) For the purposes of this Statement of Principles, tardive dyskinesia: (a) means a movement disorder which meets the following criteria (derived from DSM-5-TR): (i) abnormal, involuntary movements of the tongue, jaw, trunk, or extremities that develop in association with the use of medications that block postsynaptic dopamine receptors; (ii) the movements are present over a period of at least 4 weeks; (iii) there must be a history of use of the offending agent for at least 3 months in individuals <60 years of age or at least 1 month in individuals age 60 years or older; and (iv) symptoms and signs develop during medication use or within 4 weeks of withdrawal from an oral agent or within 8 weeks of withdrawal of a long-acting injectable agent; and (b) excludes: (i) medication-induced parkinsonism, acute dystonia and acute akathisia; (ii) dyskinesia due to l-dopa or bromocriptine; (iii) spontaneous dyskinesia; (iv) neurological diseases including Huntington disease, Wilson disease, Sydenham chorea, systemic lupus erythematosus, and heavy metal poisoning. Note: DSM-5-TR is defined in the Schedule 1 – Dictionary. (3) While tardive dyskinesia attracts ICD‑10‑AM code G24.01, in applying this Statement of Principles the meaning of tardive dyskinesia is that given in subsection (2). (4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4. Death from tardive dyskinesia (5) For the purposes of this Statement of Principles, tardive dyskinesia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's tardive dyskinesia. Note: terminal event is defined in the Schedule 1 – Dictionary. 7 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that tardive dyskinesia and death from tardive dyskinesia can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary. 8 Factors that must exist At least one of the following factors must exist before it can be said that, on the balance of probabilities, tardive dyskinesia or death from tardive dyskinesia is connected with the circumstances of a person's relevant service: (1) taking an antipsychotic medication for least 3 continuous months for persons under 60 years of age or at least 1 month for persons aged 60 years or older, before the clinical onset of tardive dyskinesia and where the symptoms and signs of tardive dyskinesia develop during antipsychotic medication use or within 4 weeks of withdrawal from an oral antipsychotic medication or within 8 weeks of withdrawal from a long-acting injectable antipsychotic medication; (2) taking antiemetic drug metoclopramide, domoperidone, droperidol, or prochlorperazine, or the anxiety drug buspirone for least 3 continuous months for persons under 60 years of age or at least 1 month in subjects aged 60 years or older, before the clinical onset of tardive dyskinesia and where the symptoms and signs of tardive dyskinesia develop during antiemetic medication use or within 4 weeks of withdrawal from an antiemetic medication; (3) inability to obtain appropriate clinical management for tardive dyskinesia before the clinical worsening of tardive dyskinesia. 9 Relationship to service (1) The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person. (2) The factor set out in subsection 8(3) applies only to material contribution to, or aggravation of, tardive dyskinesia where the person's tardive dyskinesia was suffered or contracted before or during (but did not arise out of) the person's relevant service. 10 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 8 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 5 1 Definitions In this instrument: DSM-5-TR means the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision. Washington, DC, American Psychiatric Association, 2022. MRCA means the Military Rehabilitation and Compensation Act 2004. relevant service means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. tardive dyskinesia—see subsection 6(2). terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.