Pharmacogenomic Indicators in Australia

Pharmacogenomics is a field of precision medicine that applies knowledge of human genetic variation to individualise drug prescribing. It aims to prevent adverse drug reactions and improve drug effectiveness. Pharmacogenomic testing is available in Australia.

This website provides guidance to Australian healthcare practitioners about drugs for which pharmacogenomic testing may be indicated.

Pharmacogenomic testing can be done at three times in relation to the prescribing of a drug.

• The test may be done reactively after the patient has taken a particular drug because there are unexpected side-effects or lack of efficacy. Reactive testing is included in these indications as appropriate.
• The test may be done pre-emptively, well in advance of any prescribing decision being made for any drug. Pre-emptive testing is being trialled in several large healthcare systems overseas, and lies outside the scope of these indications.

The Indications relate to prescription drugs that are available in Australia and have Clinical Pharmacogenetics Implementation Consortium (CPIC®) prescribing guidance.

CPIC® is an international consortium that assesses the evidence for the prescribing guidance for a drug being modified on the basis of a patient’s pharmacogenomic test result. CPIC® has published 26 guidelines of over 100 drugs for use by healthcare practitioners. CPIC® guidelines are designed to help practitioners understand pharmacogenomic test reports and to individualise drug prescribing on the basis of such a report.

CPIC® guidelines do not specify the indication for testing as this decision may be influenced by local factors such as the availability of the drug and of the relevant pharmacogenomic test.

A list of the drugs included in this resources can be found here.

The Indications were developed by a multidisciplinary advisory group of prescribers, pathologists and pharmacologists with expertise in pharmacogenomics, and with feedback from Australian organisations representing healthcare professionals. They are informed by peer reviewed International and Australian guidelines and approved product labels. Australian Genomics and the National Health and Medical Research Council provided support (Grant GNT2000001).

The indications for pharmacogenomic testing are listed by drug.

For each drug, the website identifies the strength of the indication for pharmacogenomic testing. The four strengths of indication are as follows:

Recommended: Pharmacogenomic testing is recommended in the specified clinical setting, ideally before exposure to the drug. Evidence shows that adverse effects can be severe or life-threatening, or that therapeutic failure can cause significant patient harm. International regulatory agencies or key professional organisations recommend testing.

Consider: Pharmacogenomic testing could be considered in the specified clinical setting. Evidence suggests that the risk of adverse effects or therapeutic failure is significant. International regulatory agencies or key professional organisations generally recommend testing.

Available: Pharmacogenomic testing is available. Evidence suggests an association with adverse effects or therapeutic failure. There is no consensus from international regulatory agencies and key organisations regarding testing.

No indication identified: Although a pharmacogenomic test may be available, a search of international regulatory agencies and key organisations yielded no recommendations for pharmacogenomic testing.

Additionally, each entry includes:

• Rationale for pharmacogenomic testing
• Prevalence of relevant gene variants (where available)
• A link to the associated CPIC® guidance
• Links to further information
• Availability of the pharmacogenomic test in Australia
• The availability of a Medicare rebate for the test specified.

A list of the drugs included in this resource can be found here.

You can search this resource for a generic drug name or other keyword by using the search bar at top left. (If this is not visible, click on the double arrow >> to open the navigation sidebar).

You can also use the links below to explore the list of drugs by the category of indication for testing i.e., recommended, consider, available, and no indication identified.

Pharmacogenomic tests are available through some, but not all, public and private pathology providers in Australia. The number of providers, the range of tests provided, the scope of each test and the availability of a Medicare rebate are subject to change.

Rather than provide a test and interpretation for a specific gene and drug, a laboratory may analyse of a panel of genes and alleles, and provide prescribing guidance for multiple drugs.

This resource documents whether a test is rebated by Medicare, but does not provide a list of the current providers of a specific test. Your local pathology provider will be able to provide or refer on pharmacogenomic tests. You can also find details of testing laboratories for these and other genetic tests at RCPA Genetic Test Catalogue.

A pharmacogenomic result is just one factor to consider in prescribing decisions. Responses to drugs are influenced by many non-genetic factors, including patient age, co-morbidities, and exposure to other drugs taken concurrently. The potential utility of a pharmacogenomic test for an individual patient may also be altered by non-clinical factors such as cost and accessibility. The clinical utility of pharmacogenomic testing may be limited by knowledge of alleles and their prevalence in the Australian population.

When interpreting pharmacogenomic results, professional advice can be sought from experienced colleagues, a pharmacist accredited to provide medication management reviews or a clinical pharmacologist.

Several online resources freely provide practitioner education for pharmacogenomics:

www.pharmgkb.org - Provides links to several educational materials.

www.mydruggenome.org - Vanderbilt University Medical Centre education portal.

www.ce.mayo.edu - Mayo Clinic online resources.

www.upgx.eu - UPGx e-learning education resources platform.

www.stjude.org/pg4kds - St Jude Children’s Research Hospital educational resources.

For queries please email:

RCPAPharmacogenomics@rcpa.edu.au

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