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AESGP: Rx Status For Antifungals And Antivirals Risks Health System Overload

 
• By David Ridley

New prudent use rules that would make some commonly used medicines prescription-only should be restricted to antibiotics, the AESGP tells the European Commission in its feedback to the proposed revision of the region's pharmaceutical legislation. 

EU flags fly in front of EU Commission buildings, Brussels
• Source: Shutterstock

Prescription-only medicine status should be reserved for antibiotics with a proven antimicrobial resistance risk (AMR), rather than for all “microbials,” including OTC topical antifungals and antivirals, says the Association of the European Self-Care Industry, AESGP.

Including self-care products – for which AMR risk has “not been sufficiently investigated to draw final conclusions” – within the scope of the European Commission’s proposed revision of the region’s pharmaceutical legislation would negatively impact individual health and the

Antimicrobials In The Revised Directive

In Article 4, Section 22 of the revised “Directive on the Union code relating to medicinal products for human use,” published on 26 April 2023, the EC introduces a definition of “antimicrobials” as “any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals and antifungals.”

In Article 51, antimicrobials are then included in the conditions for making medicinal products subject to medical prescription, which are laid out in Article 71 of current Directive (2001/83/EC).

Under the new rules (see Article 69), marketing authorization holders (MAHs) for antimicrobials will also be required to “ensure availability of educational material to healthcare professionals … regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial

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