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STATEMENTS OF PRINCIPLES AND ANTIMALARIAL AGENTS Repatriation Medical Authority Mefloquine outreach program Townsville 13 December 2016 WHAT IS THE REPATRIATION MEDICAL AUTHORITY? The Repatriation Medical Authority (RMA) is an independent statutory authority responsible to the Minister for Veterans’ Affairs. It consists of five practitioners eminent in the field of medicine or medical science, and includes at least one experienced epidemiologist. The main role of the RMA is to determine Statements of Principles (SoPs). WHAT ARE STATEMENTS OF PRINCIPLES? Statements of Principles (SoPs) are legal instruments, based on sound medical-scientific evidence (SMSE), which state the factors that must exist for a particular disease, injury or death to be linked causally to prior service. SoPs are the instruments used to determine eligibility for entitlements under the Veterans’ Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA). STANDARDS OF PROOF In assessing associations between risk factors and diseases or injuries, the RMA is required to use published peer-reviewed evidence (sound medical-scientific evidence), to which it brings its expert clinical judgement. For every condition there are two SoPs, called reasonable hypothesis (RH) and balance of probabilities (BoP). This occurs because the Authority is required by the Veterans’ Entitlements Act to interpret the evidence differently at two standards of proof. For the reasonable hypothesis standard, the sound medical-scientific evidence must indicate or point to a causal association between a risk factor and the disease in question. For the balance of probabilities standard the sound medical-scientific evidence must show that it is more probable than not that there is a causal association between a risk factor and the disease. ANTIMALARIALS Antimalarials are among a wide range of drugs that the RMA considers routinely. SoPs are updated regularly, so new evidence is considered. The Authority has reviewed the evidence in relation to mefloquine and tafenoquine and undertaken some additional investigations. MEFLOQUINE Mefloquine is approved for use in several countries and has been in general use since the1990s. It is on the World Health Organisation's list of essential medicines. Mostly only associated with minor adverse reactions Acute neuropsychiatric reactions in some people (1:10 000 of those taking prophylaxis) MEFLOQUINE The RMA cannot consider the temporary and reversible acute effects of exposure to consumable substances, including pharmaceutical agents, but does consider long term effects, including long term consequences of acute effects. Mefloquine is currently included in 14 SoPs, variously worded. Antimalarials, chloroquine, mefloquine, hydroxychloroquine, atebrin, primaquine, quinine and quinine derivatives. MEFLOQUINE The RMA is aware of a view that mefloquine causes a condition variously termed “chronic, mefloquine-induced toxic encephalopathy” or “chronic mefloquine toxicity syndrome” or “chemically acquired brain injury”. The RMA has examined the available information and has concluded that at present there is insufficient sound medical-scientific evidence to warrant initiating an investigation into this hypothesized condition. As yet there is no test for the condition, no distinctive pathology and no distinct and reproducible set of symptoms upon which a case definition could be based. TAFENOQUINE Tafenoquine has not been approved for use in Australia, and its use has been limited to clinical trials in both the ADF and civilian populations. Clinical trials have supported the safety and efficacy of tafenoquine, for both treatment and prevention of malaria. While there is no available evidence concerning long term effects specific to tafenoquine, this drug is covered in six SoPs in which there is likely to be a drug class effect. QUESTIONS More information and contact details are available on the RMA website at www.rma.gov.au