In 2008 ASCIA was informed that Hollister Stier food extracts for skin prick testing (SPT) were no longer going to be manufactured. ASCIA was also advised that other Hollister-Stier SPT reagents were unaffected. 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, there are a few options available:
(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 a repalcement copy or have recently become a Full ASCIA member.
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' or Section 19A options 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 - Link Pharmaceuticals
Email:
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or
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Phone: 1800 824 166 or 0415 279 994 (Jennie Hillas).
Applicants will be required to supply proof of "Authorised Prescriber" status (eg. letter from the TGA).
ALK-Abello products and product information - Australasian Medical and Scientific Limited
Email:
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or
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Phone: 02 9882 3666 or 0448 022 855 (Steve Lee)
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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