Skin prick testing is the primary mode of testing for immediate IgE-mediated allergy. This testing is widely practised, carries very low risk of side effects to patients and provides high quality information when performed optimally and interpreted correctly.
This webpage contains information about:
Since mid-February 2016, a range of Greer Skin Prick Test reagents is available, that are authorised for distribution in Australia under section 19A of the Therapeutic Goods Act 1989, which means that no Authorised Prescriber status is required to order them. They are supplied as 5 mL vials by Stallergenes Greer in the USA and are exclusively distributed in Australia by the EBOS Group Pty Ltd for Stallergenes Australia Pty Ltd trading as Stallergenes Greer.
Since 2008 some Hollister Stier allergen extracts for skin prick testing that were registered with the Therapeutic Goods Administration (TGA) for use in Australia have been discontinued and are therefore no longer available. Other Hollister Stier allergen extracts for skin prick testing that are still available and are registered with the Therapeutic Goods Administration (TGA) can be ordered by medical practitioners without having to gain endorsement as an authorised prescriber.
Since 2008 it has been necessary for medical practitioners to use skin testing products that are not TGA registered. This requires endorsement as an authorised prescriber (please refer to information below) or a Specal Access Scheme (SAS) C application. Patient consent needs to be obtained before use of these products and a template may be adapted for this purpose.SPT_Consent_form_template16.02 KB
Medical practitioners can access unregistered products using the following options:
(1) Section 19(5): Obtain "Authorised Prescriber status" by endorsement from a medical college e.g. Royal College of Pathogists of Australasia (RCPA), Royal Australasia College of Physicians (RACP). ASCIA has obtained this on behalf of its Full (ordinary) members who are fellows of the RCPA and/or RACP for some unregistered skin testing products. For details go to www.tga.gov.au/form/authorised-prescribers
(2) Section 19(5): Obtain "Authorised Prescriber status" by endorsement by an ethics committee: This can be used to access unregistered skin testing products for some ASCIA members who work in hospitals and/or universities with ethic committees. For details go to www.tga.gov.au/form/authorised-prescribers
(3) Special Access Scheme (SAS) Category C: This is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products for the respective indications. For details go to www.tga.gov.au/form/special-access-scheme
Content updated April 2018