Starting this year, the Ministry of Health decided to implement a strategy to reduce the excessive consumption of antibiotics and antifungal drugs for systemic use. This was implemented by issuing an Order no. 63/2024 of January 10th 2024, which states that these medicines can only be issued on the basis of a medical prescription.
Antibiotics and antifungals for systemic use can also be dispensed without a medical prescription if there is a medical emergency. In this case, the maximum amount for an emergency dose must be respected ( calculated in accordance with the product’s method of administration). The emergency dose can be issued only once during a treatment, based on a self-declaration provided by the patient/legal guardian in the pharmacy. The patient must subsequently see the doctor to obtain a prescription adapted to his condition.
Here is everything you need to know about the new methodology for monitoring the prescription and dispensing of antibiotics, as well as the adaptations made in the Cegedim RX applications to integrate these new rules.
Monitoring the prescription and dispensing of antibiotics and antifungals for systemic use
The methodology for monitoring the prescription and dispensing of antibiotics and antifungals was initially approved by Order no. 63/2024 of January 10th, 2024, published in the Official Gazette no. 41 of January 17th, 2024. This was later modified by Order no. 183/2024 of January 22nd, 2024, published in the Official Gazette no. 58 of January 23rd, 2024. The changes made concern the following aspects:
- The emergency dose, in the absence of a medical prescription, can be released in the maximum amount related to the dose for 48 hours (reduced from 72 hours);
- Annex 3 containing the patient’s self-declaration;
- Annex 1 containing the international common names in the category of antibiotics and antifungals for systemic use.
The list of international common names provided in Annex 1 is periodically updated by the Ministry of Health, at the proposal of the National Agency of Medicines and Medical Devices in Romania (ANMDMR), in accordance with the updating of the Nomenclature of medicines for human use.
This new type of prescription is used to prescribe antibiotics and antifungals outside of the insurance system. Insured patients can still benefit from these compensated drugs prescribed on the electronic prescription (Order no. 183/2024, art. 3).
Antibiotic prescriptions: what mandatory fields must they contain?
Order no. 63/2024 also regulates the minimum information that prescriptions must contain and does not impose any special form template for medical prescriptions. According to art. 5 thereof, prescriptions for drugs in the antibiotic and antifungal category for systemic use must contain the following fields:
- Series and number of the medical prescription, unique, generated at the level of each prescriber
- The health facility identified by name, address and telephone number
- Patient data to whom the drugs are prescribed (CNP/CID/Passport No./EU Card No. – for foreign citizens)
- The diagnosis code integrated into the SIUI of the Romanian social health insurance system
- The prescribed drug, characterized by: international common name, concentration, pharmaceutical form, method of administration, quantity, duration of treatment
- Signature of the prescribing physician
- Doctor’s stamp code
- Date of issue of medical prescription
Reporting of antibiotic prescriptions: the new deadline announced
Regarding the reporting of antibiotics dispensing, a new Order no. 1.476/2024 of March 18th, 2024 came to modify the methodology approved by Order no. 63/2024. According to the new order, pharmacies now have a period of 105 days (extended from 60 days) from the issuing of the original order to adapt their IT systems and seend the mandatory daily reports in SER related to dispensed antibiotics prescriptions.
Therefore, the new deadline for this type of reporting is May 2nd 2024. Thus, according to the Ministry of Health, based on the data collected in real time, the best measures can be taken to reduce the excessive use of antibiotics and the associated risks.
Dispensing antibiotics prescriptions in the Pharmec Farmacie application
To ensure compliance with these new regulations, the Cegedim RX team has developed a new type of prescription for antibiotics in the Pharmec FarmacieTM app. Our goal is to make it easier for pharmacies to issue these types of prescriptions and emergency forms in a timely manner.
Here’s how this new type of prescription works:
- When the user/pharmacist accesses the new prescription type “Antibiotics” with the F2 key, the application automatically filters the commercial names of the products in stock according to the DCIs in the Order no. 63/2024;
- When the user/pharmacist selects an antibiotic from the list of products, the application displays an automatic message offering the possibility to choose between the following options, depending on how the product is to be released:
- With a Medical prescription
- As an Emergency dose
- With a Receipt
