Italy approves national guidelines for personalized medication packaging

The Italian Ministry of Health has published national guidelines in the Official Gazette regarding the personalized packaging of medications, a service commonly known as ‘deblistering’. Signed by Undersecretary Marcello Gemmato, the decree establishes uniform criteria for pharmacists to unpack and repackulate medicines into customized doses to improve therapeutic adherence, particularly for chronic and fragile patients.

The service is defined as a professional healthcare activity rather than an industrial or manufacturing process. It must be performed exclusively by the pharmacy managing the patient, using only the medications already dispensed to that patient. This prevents the fragmentation of medication between different operators or intermediaries.

Key restrictions and regulations include:

• The service applies only to oral solid formulations. Physically unstable solid forms and antineoplastic drugs are strictly excluded due to manipulation risks.

• For controlled substances, the service is treated as an additional activity that does not alter existing regulatory obligations. Specific rules apply to different sections of the medicinal tables, with certain categories excluded.

• The process requires a direct relationship between the pharmacist, the prescribing physician, and the patient, involving a therapeutic scheme and a formal letter of assignment from the patient.