In 2008 ASCIA was informed that Hollister Stier food extracts for skin prick testing (SPT) are no longer manufactured. ASCIA was also advised that other Hollister-Stier SPT reagents were unaffected, and that shortages of dust mite extracts that occurred earlier in 2008 were delivery-related. Issues surrounding the lack of SPT food extracts have been addressed by communication with the TGA and distributers of SPT extracts manufactured by Hollister Stier, Stallergenes and ALK-Abello. in order for ASCIA members to be able to access currently unregistered diagnostic food SPT extracts, the practical routes of access have become apparent:
(1) Section 19(5): Obtain "Authorised Prescriber status" by endorsement from the Royal Australasia College of Physicians (RACP) or the Royal College of Pathologists of Australasia (RCPA). This has now been obtained by ASCIA on behalf of its Full members who are fellow of the RACP or RCPA for both Stallergenes-Alyostal and ALK-Abello skin prick testing reagents;
(2) Section 19(5): Obtain "Authorised Prescriber status" by endorsement by an ethics committee (possible for some but not all ASCIA members who work outside hospitals/universities);
(3) Additional provisions (Section 19A) that allow another manufacturer to supply reagents to a market where a currently registered reagent is no longer available. ALK-Abello skin prick testing reagents for skin prick testing food allergens registered in other countries, which have been discontinued by Hollister-Stier, are available under Section 19A.
CURRENT ACCESS STATUS
Doctors can access the Stallergenes Alyostal OR ALK-Abello skin prick test reagents if they have "Authorised Prescriber" status by application to the TGA. Application forms and other documents have been distributed to all RACP/RCPA Fellows who are Full ASCIA members.
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if you need additional copies. Hollister-Stier skin prick testing reagents which are TGA registered are still available to all medical practitioners, except for food allergens which have been discontinued. Access to ALK-Abello skin prick test reagents for food allergens which have been discontinued by Hollister-Stier is available under Section 19A and does NOT require Authorised Prescriber status, so it is open to all medical practitioners.
NOTE: Products available by the TGA 'Authorised Prescriber' route are not registered in Australia. Users are reminded that patient consent needs be obtained before use and there are also reporting requirements to the TGA about their use.
CONTACT INFORMATION Hollister Stier and Stallergenes therapeutic and diagnostic products - Contact Link Pharmaceuticals(those requiring copies of Stallergenes catalogues or product information should contact Jenny Hillas email:
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; mobile telephone 0415279994). Applicants will be required to supply proof of "Authorised Prescriber" status (eg. letter from the TGA).
ALK-Abello products and product information - Steve Lee at Australasian Medical and Scientific Limited (web: http://www.amsl.com.au/SPT/ ; email:
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; Mobile telephone 0448022855).
Diater-DAP skin prick testing reagents for penicillin allergy testing are also available from Australasian Medical and Scientific, subject to a separate Authorised Prescriber application.
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