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September 2, 2018
I would like to provide you with some further details regarding the release of AUVI-Q (previously marketed as Allerject) epinephrine auto-injectors in Canada.
Firstly, the devices that will be released are only of the 0.3 mg strength (and not the 0.15 mg or 0.1 mg strengths). Health Canada is aiming to have them available to pharmacies in Canada by September 7th. So, if prescriptions are written (as of this writing), they will now be accepted, but are unlikely to be filled until then. This is an InterimOrder, but it could be extended for a longer period depending on the future availability of EpiPens. AUVI-Q 0.15 may be considered for Canada if supplies of EpiPen Jrs eventually lag. The Interim Order issued by Health Canada does cover both strengths, but as it is the 0.3 mg dose that is missing, this is the dose being concentrated on.
As mentioned in the previous email blast, there will be no French language emitted by the device, nor any French language labelling on the device itself, as it is literally the US device. The devices will, however, be accompanied by written French language instructions.
The projected cost of AUVI-Q’s suggests they will be more expensivethan the present cost of EpiPens. They will arrive at pharmacies as a ‘2-pack’, which is how they are distributed in the US. Each pack contains 2 AUVI-Q’s anda trainer device. It is our understanding that pharmacists may choose to break these up…at their discretion. As with EpiPens, AUVI-Q’s will not require a prescription, but to obtain re-imbursement from drug plans, etc. a prescription can be provided for those who wish it. Reimbursement from different provinces, territories, etc. remains to be worked out.
These are specific links for: The Health Canada announcement: https://www.canada.ca/en/health-canada/news/2018/08/health-minister-announces-access-to-a-us-approved-epinephrine-auto-injector.html
A very good ‘Dear Healthcare Professional Letter’ from Health Canada: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67658a-eng.php?_ga=2.191235436.716845621.1535932670-717964189.1504358049
Patient Information for AUVI-Q from Health Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/auvi-q-patient-information.html
FAQ’s from Health Canada and Kaléo hosted on the Food Allergy Canada website: http://foodallergycanada.ca/2018/08/auvi-q-temporary-supply-faqs/
We welcome this move by Health Canada and continue to support and advocate for a reliable supply of alltypes of allergy medications for Canadians. This can best be accomplished by allowing our patients with anaphylactic allergies to have secure access to this life-saving therapy by having products available from more than one supplier, and we hope this trend will continue into 2019.
David Fischer MD, FRCPC, FCSACI
August 29, 2018
Members of the allergy community’s hearts go out to 3 year-old Alastair Watson’s family and friends. Alastair died during a routine oral food challenge this week. His death is a tragedy, and we cannot even imagine the horror of this loss.
Oral food challenges have been conducted for decades to test whether someone is allergic to a certain food. This is the first reported fatality associated with an oral food allergy challenge. While even one death is too many, oral food challenges are considered the ‘gold standard’ test to determine if someone is allergic to a food. Allergists use this test when a person’s medical history and/or allergy test results are inconclusive. They are also given to determine if someone with previously diagnosed food allergy has developed tolerance, and may no longer be allergic.Read More »
Les tests de provocation orale sont utilisés depuis des décennies pour vérifier si une personne est allergique à un aliment donné. Il s’agit du premier décès signalé à être associé à un test de provocation orale. Bien qu’un seul décès soit déjà trop, les tests de provocation orale sont considérés comme « l’épreuve de choix » pour déterminer si une personne est allergique à un aliment. Les allergologues utilisent ce test lorsque les antécédents médicaux et/ou les résultats des tests d’allergie d’une personne ne sont pas concluants. Ils sont aussi effectués pour déterminer si une personne préalablement diagnostiquée avec une allergie alimentaire a développé une tolérance et n’est peut-être plus allergique.Lire la suite »
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