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Medicine information leaflets: Paper, digital or both?

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The European Commission’s proposed pharmaceutical strategy leaves it to the countries to decide whether the medicine information leaflet is in paper format electronic, or both. However, moving exclusively towards the electronic version could risk leaving behind those lacking digital skills.

Currently, medication instructions including dosage, storage or potential side effects are provided through a written, standardised leaflet enclosed in each package of medicines. But the revamp of the bloc’s regulatory framework for pharmaceuticals, presented by the European Commission on 26 April, gives an option for having only an electronic format of the leaflet.

With only half of Europeans having basic overall digital skills, according to Eurostat data, having only digitally available information on medicines could put some patients at risk and reduce medicines’ safety and efficiency. To address this Commission is proposing that “the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge”. But this could add additional work to pharmacists.

In a series of articles, EURACTIV looks at the benefits and obstacles of digitalising medical information.

Green MEP advocates for keeping paper medicine leaflets

Interview Health

Est. 3min

The European Commission’s recent proposal to review pharmaceutical legislation has sparked a significant debate. The directive’s suggestion to allow Member States to opt between electronic and traditional paper medical leaflets raises valid concerns about the potential marginalization of older and vulnerable demographics.



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