Rome, September 29 – Since the day before yesterday, September 27, the Legislative Decree August 5, 2022, n. 136 which formalizes the dematerialization of a series of medical-veterinary prescriptions, extending the obligation to use the Rev (Electronic Veterinary Prescription) also to prescriptions for medicines (including galenic preparations) containing narcotics and psychotropic substances listed in the table of drugs (sections B, C, D and E) except those in section A.
The decree specifies “The dematerialization of the veterinary prescription for drugs containing drugs included in sections B, C, D and E of the table of drugs mentioned in Presidential Decree 309/90”. For these medicines, from September 27, the Rev system will be applied, also extended to veterinary prescriptions of magistral galenic preparations containing narcotics and psychotropic substances from the table of medicines, sections B, C, D and E. On the other hand , the medicinal products appearing in the table are excluded from title A medicinal products, for which veterinarians are required to use the special recipe book approved by order of the Minister for Health on 10 March 2006 (prescription printed with tracing). Pharmacies, for their part, will have to continue to keep these recipes in pharmacies.
But decree no. 136/22 goes further, providing for the dematerialization not only of medical prescriptions but also of supply requests by veterinarians and health directors, narcotic drugs in sections A, B and C and escort prescriptions (non zootechnical structure and clean) for narcotics of sections D and E.
With regard to the issue of computerized traceability, on the side of intermediate distribution, which is normally guaranteed by the daily sending to the central database of data relating to the movement of medicines in xml format via the Nsis portal, the Ministry confirms in a note dated September 26 that it is confirmed that nothing changes and that the distribution will have to continue sending the data as it always has. This while actually fulfilling Section 42 Rev-Requests through the Rev app, at least pending further operational guidance from it that may further simplify costs article 42 is in fact authorized to authorized intermediary distributors of the drug to the wholesale sale of drugs in accordance with article 37 of Presidential Decree 309/90: a type of operation that the decree introducing computerized traceability has provided for in the data flow in Nsis in xml format, as also confirmed by the ministerial note of September 26 cited above. It remains to be seen whether it will be necessary to modify the management system of these sites, centered on wholesale and direct sales, programmed to extrapolate the xml file in the if.else logic, i.e. “Everything in Rev goes wrong in xml” and it’s worth it, because things could soon change.
Federfarma, however, points out that some problems still remain to be solved, such as that relating to the proper execution of art. 45, paragraph 5, of the text associating narcotics, which requires the pharmacist to keep for two years, “from the day of the last entry in the register referred to in Article 60, paragraph 1, prescriptions prescribing medicines listed in the table of medicines, sections A, B and C”. In the case of supply of medicines paid for by the NHS, the pharmacist “is required to keep a copy of the original recipe or a photocopy of the original recipe, bearing the date of shipment “. On this point, the pharmacy unions have asked the Ministry for clarifications and precise operational indications.
In the meantime, pending further ministerial details concerning conservation, FarmacieUnite proposes in its circular to associated pharmacies “Adopt procedures to easily find the Rev in the veterinary electronic prescription portal (enter the Rev number in the medicine register in correspondence with the medicine dispensed) and, as a precaution, print a copy of the Rev to keep in the register” .