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The Council of State rehabilitates theuse of hydroxychloroquine for the treatment of Covid-19. Despite the contrary opinion of the AIFA that prohibited the off-label prescription, that is, for a use other than its purpose, the highest administrative court of justice has given the green light to the use of the drug as a therapy against the coronavirus.
Covid, State Council gives the green light to hydroxychloroquine treatments: the ruling
With ordinance number 7097/2020, published today, Section III of the Council of State has accepted, as a precautionary measure, the appeal of a group of general practitioners for which Aifa’s decision was suspended.
“The persistent uncertainty about therapeutic efficacy hydroxychloroquine, admitted by Aifa itself to justify further evaluation in randomized clinical trials – read full-body ordinance – not reason enough at the legal level to justify the unreasonable suspension of its use in the national territory attending to doctors “.
Covid, the State Council gives the green light to hydroxychloroquine treatments: the Aifa note
In the note of July 22, the Italian Medicines Agency prohibited the authorization of use of the drug not included in the package leaflet, that is, that of antimalarials used in Italy in the rheumatology field, after being allowed at the beginning of the coronavirus pandemic.
The Agency explained the following: “In the early stages of the epidemic, the unauthorized use of hydroxychloroquine was allowed, based on available preliminary data, only in the context of the national COVID-19 emergency management plan and in compliance of the elements reported in previous versions of the card. In light of the evidence from the current literature, theAIFA confirms the suspension of the authorization for the off-label use of the drug outside of clinical trials“.
The State Council ordinance reintroduces the possibility of using the drug in cures against Covid-19, but specifies that on the other hand, the AIFA decision is not subject to suspension (or before litigation) exclude the unauthorized prescription of hydroxychloroquine from the reimbursement scheme.
“The decision to use or not the drug – read the ordinance again – in a situation of doubt and contrast in the scientific community, based on non-unambiguous clinical data, on its effectiveness in the initial stage of the disease only, must be by therefore referred toAutonomy in decision-making and responsibility of the individual doctor in science and conscience.“Take for granted the informed consent of the individual patient and the constant and careful monitoring of the prescribing physician.
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