Fentanyl: New hospital rules require safes, alarms and named access

Italy’s Health Ministry is preparing a broad security overhaul for narcotic medicines after 80 fentanyl vials were stolen from the pharmacy of Rome’s Israelitic Hospital. The draft decree reached the regions less than three months after the theft.

The proposal would establish uniform minimum standards across public and private healthcare facilities. Certified safes, alarm systems, individually assigned electronic access, video surveillance and mandatory stock checks at least every 48 hours are among the measures outlined in the draft.

The rules would cover hospital and community pharmacies, wards, central warehouses, prison facilities and veterinary services. They would also prohibit generic delegations for security duties and require every transfer of keys or access credentials to be recorded. Medicines moved inside facilities would have to travel in sealed, tamper-resistant containers.

The draft sets out an immediate response for thefts, tampering or missing stock. Staff would have to notify the responsible manager within 12 hours, begin an extraordinary inventory and formally report the incident to the Italian Medicines Agency, Aifa, as well as the competent authorities. Facilities would have 60 days from the decree’s entry into force to adapt their procedures.