Changes in Prescription and Dispensing of Medications and Other Prescriptions – Decree N° 345/2024
Healthcare & Life Sciences Department’s report | Changes in Prescription and Dispensing of Medications and Other Prescriptions – Decree N° 345/2024
Dear all:
On April 22nd, Decree No. 345/2024 (the “Decree”), issued by the National Executive Power was published in the Official Gazette. This decree introduces modifications to Decree 7123/1968, which regulates Law 17,565 – that regulates the operation of pharmacies-, and Decree 98/2023, which regulates Law No. 27,553 – that regulates electronic, digital prescriptions, and telecare platforms.
In this regard, Decree 345/2024 officially enacted the regulation of mandatory use of electronic prescriptions starting from July 1st, 2024. Particularly, it stipulates that electronic and/or digital prescriptions will be the mandatory means for prescribing medications, study orders, practices, and any other indications that health professionals consider relevant for their patients throughout the territory of the Argentine Republic, “provided that local jurisdictions adhere to it.”
Regarding the most significant modifications incorporated in the Decree, we can mention the following:
– Medicine Identification: It is established that the Enforcement Authority -the Ministry of Health- will implement an identification and reference tool, for medications to be prescribed in electronic and/or digital prescriptions to promote their use, access, and interoperability. This requirement will be progressively implemented, in coordination with the competent jurisdictional authorities.
– All prescriptions of digital and/or electronic prescriptions and telecare platforms, must comply with the legal requirements regulating their exercise. Pharmacy management systems or platforms must allow the recording of medicines substitutions at the time of dispensing, as well as providing information to the prescriber about the substitution of the dispensed product or its partial dispensing. The implementation of this requirement will be progressively coordinated by the Enforcement Authority, through coordination with the competent jurisdictional authorities and relevant agencies.
– Jurisdictional authorities may adhere to the use of the Federal Health License, in order to implement the prescription of digital or electronic prescriptions or other practices defined in the National Health Interoperability Network.
– Current implementations of electronic prescriptions will remain valid for use as long as they comply with the provisions set forth in the Decree, those established in future regulations or by the Enforcement Authority, and in accordance with the implementation schedule agreed upon.
– The Electronic Prescription Registry is created, to which those responsible for prescribing electronic prescriptions, study orders, practices, and any other indications must report the format and model of the prescriptions to be issued, determine the required data (complying with the minimum fields according to the regulations of Law 17,132), define the requirements and procedures, and audit their compliance.
– Sale and Dispensing of Medications: This modification is understood to be one of the most important, as it eliminates the exclusivity of medicines sales in “physical” pharmacy establishments. It is now established that, both the sale and delivery of medications to the patient, can be arranged through electronic channels determined by the pharmacy, with delivery to the location specified by the patient (it is the responsibility of the pharmacist to ensure that the delivery is carried out safely, according to the requirements determined by the Health Authority). However, it is clarified that the sale and dispensing of medications must be carried out from the pharmacy, in the presence of a responsible pharmacist. There are no changes regarding establishments not authorized as pharmacies, solely authorized for the sale of antacids and analgesics.
Furthermore, the Decree repeals Articles 14, 15, 16, 27, 40, 41, 42, and 44 of the Regulations of Law No. 17,565, approved by Decree 7123/1968, which generally refer to the request for authorization for the installation of a pharmacy, limits on the absence of the Technical Director, voluntary closures of authorized pharmacies, shifts; and the same regarding the installation of herbalist shops.
Finally, as mentioned earlier, it is important to note that the Decree and its provisions will enter into force on July 1, 2024.
Sincerely,
Ana Andrés
aandres@beccarvarela.com