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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