Access to skin prick testing reagents
Skin prick testing is the primary mode of testing for immediate IgE-mediated allergy for clinical immunology/allergy specialists and other doctors or nurse practitioners who have been trained to manage patients with allergic disease. Skin prick testing provides high quality information when performed and interpreted correctly.
Important change to TGA Authorised Prescriber scheme
The Therapeutic Goods Administration (TGA) has streamlined the Authorised Prescriber application process to access allergens for skin prick and intradermal testing, by removing the requirement for Human Research Ethics Committee (HREC) approval or specialist college endorsement.
This change to the TGA Authorised Prescriber scheme will simplify access to skin testing reagents for ASCIA members, which was raised as one of ten main issues in the ASCIA Submisison to the Parliamentary Inquiry on Allergies and Anaphylaxis. Access to skin testing reagents has been a major issue for ASCIA members since 2008, so this change is welcome news.
The changes to the TGA Authorised Prescriber scheme (effective October 2020) will streamline the application process for medicines considered to have an established history of use in Australia. The TGA list of ‘medicines’ with an established history of use includes:
- Allergens for skin prick testing (SPT), including control solutions, for confirmation of suspected allergic reactions – TGA code AP3.
- Allergens for intradermal testing (IDT), including control solutions, for confirmation of suspected allergic reactions – TGA code AP2.
The changes include removal of the requirement for HREC approval or specialist college endorsement to be submitted to the TGA in circumstances where a medical practitioner is applying to become an Authorised Prescriber of medicines with an established history of use, as specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.
A printable (pdf) version of the list is on the TGA website list of medicines with an established history of use and is also available here TGA-list-of-medicines-with-an-established-history-of-use-2020-October112.58 KB
The application process has now been updated for use under the new arrangements when renewal applications are due. The updated applcation form is available on the TGA website www.tga.gov.au/form/authorised-prescribers#apf and is also available here TGA-authorised-prescriber-scheme-application-form-201008144.64 KB
HREC or institutional approval may still be required to use certain ‘unapproved’ therapeutic goods within an institution, such as a hospital, and for products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. Further details on applying for approval/endorsement are available in our guidance document Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors.
There have been supply issues for skin testing allergens since 2008, due to the discontinuation of Hollister-Steir allergens, which were registered with the TGA. Since 2008 it has been necessary for medical practitioners in Australia to use allergens for skin testing that are not registered with the TGA, requiring endorsement as a TGA Authorised Prescriber (see above) or a Special Access Scheme (SAS) C application, as detailed below.
TGA Special Access Scheme (SAS) Category C 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.
Suppliers of Inmunotek immunotherapy and SPT, ALK-Abello SPT, Lincoln lancet systems, and SmartPractice patch test products
Ferrer Pharma Pty Ltd
Sanatio Allergy Pty Ltd
Content updated October 2020