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Italian Medicines Agency Agenzia Italiana del Farmaco

Prescription of Paxlovid by the General Practitioner - Prescription of Paxlovid by the General Practitioner

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Prescription of Paxlovid by the General Practitioner

Press release n. 692 - As of 21 April, general practitioners can also prescribe the antiviral medicine Paxlovid (based on nirmatrelvir/ritonavir) for the early treatment of coronavirus disease 2019 (COVID-19). Paxlovid is indicated for the treatment of adult patients who do not require supplemental oxygen therapy and who are at high risk of progression to severe COVID-19, such as patients with cancer, cardiovascular disease, uncompensated diabetes mellitus, chronic bronchopneumopathy and severe obesity. The decision becomes enforceable with the publication of the AIFA Decision in the Official Journal on 20 April. 

Treatment must be started as early as possible, and in any case within 5 days of the onset of symptoms. The prescription of the medicine requires a prior pharmacological anamnesis, to exclude the presence of any interactions with medicines taken simultaneously by the patient. The Summary of Product Characteristics and links to the main websites for checking medicine interactions are available on the AIFA website (https://www.aifa.gov.it/uso-degli-antivirali-orali-per-covid-19).

The prescription by the general practitioner will take place through the compilation of a therapeutic plan, which is currently on paper and which will be computerised within a few weeks. This therapeutic plan is aimed at supporting the appropriateness of use and providing useful tools for verifying interactions incompatible with the intake of Paxlovid. 

With the prescription of the general practitioner, the patient will be able to collect the medicine directly at the pharmacy, at no cost to the citizen and without additional charges for the NHS. The distribution to the pharmacy network (through the so-called per conto distribution) will be free of charge by pharmacists and wholesalers, thanks to a Memorandum of Understanding between the Ministry of Health, AIFA and the network of pharmacies (Federfarma, Assofarm and FarmacieUnite) and pharmaceutical distributors (Federfarma Servizi and A.D.F.). 

Prescription by all COVID-19 specialist centres identified by the Regions remains possible. This modality will guarantee access to the medicine during the phase of activation of distribution by pharmacies to the public, as well as in the event that distribution by pharmacies is temporarily unavailable. 

The prescription made by the General Practitioner will be monitored through the electronic prescription system, while for treatments prescribed by COVID-19 centres identified by the Regions and P.A. the AIFA monitoring register will remain active.


Published on: 20 April 2022

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