On September 2, the Council of State issued its opinion in an extraordinary appeal to the President of the Republic for the annulment of measures unfavorable to the personalized preparation of therapies (so-called deblistering) by a pharmacy. The authorities had denied the possibility of providing this service due to the absence of detailed national legislation comprehensively regulating this activity, and during the proceedings, the Ministry of Health highlighted the risks associated with the handling of medicines in terms of storage and tracking of individual doses.

The administrative judges ruled that deblistering should be considered permitted by law, as there are no regulations prohibiting it, considering that it is a practice aimed at ensuring higher levels of therapeutic adherence, as well as simplifying the management of medicines, especially for elderly, multi-treated, and chronic patients. Deblistering, as an after-sales service, offers personalized management of individual drug therapies for patients who particularly need chronic therapies (i.e., in nursing homes or other situations deemed useful), as it helps to avoid errors in the course of treatment.

Furthermore, careful regulation of this practice could contribute to a reduction in healthcare spending, with overall benefits for public finances.

With regard to health protection, the Council of State pointed out that pharmacies do not carry out any activity involving the division of the active ingredient, but merely ‘unpack’ the drugs from their original packaging and place them in blister packs customized for each patient, and that it would be difficult to consider this activity prohibited, given the existence of a regime of substantial liberalization of the activity of producing galenic preparations, for which pharmacies do not need to seek any authorization.

Ultimately, in the absence of evidence of factors posing a danger or risk to human health and safety in the deblistering activity, when carried out in compliance with the precautions prescribed in the regulatory acts adopted by some Regions, the same cannot be hindered; This is true even in regions where it has not been regulated, where the guidelines issued by the Lombardy Region can be taken as a reference point, given their general nature, until the central authority decides to draw up minimum health and safety standards to be applied throughout the country.