Annual prescriptions: there is an announcement from the health ministry

The purpose of the amendments was to transfer the obligation to calculate the quantity of the dispensed drug, foodstuff or medical device from the person filling the prescription to the IT system. As a result, the system is fully responsible for correct calculations in this regard.
This standard was introduced in connection with the provisions of Article 96a, paragraph 7a and paragraph 7aa of the Pharmaceutical Law, which state:
"7a. In the case of execution of an electronic prescription:
(1) after the expiration of 30 days from the date of issuance of the prescription or the "as of date" date stamped on the prescription, the prescription shall be filled excluding the days of use that have already elapsed, counting them from the date of issuance of the prescription or the "as of date" date stamped on the prescription,
(2) the patient from the date of filling the prescription may receive a maximum amount of a medicinal product, foodstuff for special nutritional use or medical device necessary for the patient for a 120-day period of use calculated on the basis of the dosage regimen specified on the prescription
- while in the case of a medicinal product, foodstuff for special nutritional use or medical device issued in packages whose size does not allow it to be issued in the amount necessary for use for the calculated period, it is permitted to issue it in excess of this amount, but not by more than one smallest package.
7aa. If the prescription referred to in paragraph 7a(2) prescribes a quantity greater than for 120-day use, the next quantity of the medicinal product, foodstuff for special nutritional use or medical device necessary for the next 120-day period of use may be given to the patient after three-fourths of the period for which the prescription was filled.".

As of March 1, 2024, the IT system (the so-called P1 system) should calculate the amount of a drug, foodstuff or medical device prescribed on a so-called annual e-prescription to be dispensed to a patient in a pharmacy, within the scope of the rules indicated above.
It should be emphasized that the IT system will indicate the amount of a drug, foodstuff or medical device to be dispensed on the condition that the e-prescription is issued according to the new scheme for recording dosage information. The mechanism of automatic calculation of the quantity of a product by the IT system will not apply to a prescription drug, a product intended for use for a period not exceeding 120 days, target imports, pharmaceutical e-prescriptions and products with a complex packaging structure. In the first period, it will also not make the aforementioned calculations for medical devices and international units. At the same time, it should be noted that for the aforementioned exceptions, it will be possible to issue an e-prescription using a dosage schedule under the existing rules.

Accordingly, if the aforementioned teleinformation system, in the period from March 1, 2024, in a specific case of filling a so-called annual prescription, fails to calculate the quantity of a drug, foodstuff or medical device intended for dispensing to a patient under the rules referred to in Article 96a (7a) and (7aa) of the Pharmaceutical Law, the person filling the prescription shall not apply the limitation referred to in Art. 96a (7aa) of the Pharmaceutical Law, according to which "(...) the next quantity of a medicinal product, foodstuff for special nutritional use or medical device necessary for the next 120-day period of use may be obtained by the patient after three-fourths of the period for which the prescription was filled." In such a case, the person filling the prescription - in accordance with Article 96a (7a)(2) of the Pharmaceutical Law - shall issue the maximum amount of the drug, foodstuff or medical device necessary for the patient for the 120-day period of use calculated on the basis of the dosage method specified in the prescription. This rule applies to each subsequent filling of the prescription.

The provisions of paragraphs 7aa and 7ab in Article 96a of the Pharmaceutical Law are closely related. The rules for dispensing a drug, foodstuff or medical device are specified in paragraph 7aa, while paragraph 7ab contains the norm that the calculation, resulting from paragraph 7aa, of the quantity of a drug, foodstuff or medical device is carried out by the IT system. Consequently, as already indicated, the inability of the IT system to calculate the aforementioned quantity excludes the application of the restriction of paragraph 7aa of Article 96a of the Pharmaceutical Law. The provision of paragraph 7aa could be the basis for calculating the quantity of a drug, foodstuff or medical device until the entry into force of the provision of Article 96a paragraph 7ab, up to a maximum of February 29, 2024.

At the same time, the Minister of Health informs that he has taken legislative action to amend the Regulation of the Minister of Health on the general terms and conditions of contracts for the fulfillment of prescriptions, so that pharmacies or persons fulfilling the so-called annual prescription will not bear negative consequences in connection with a possible violation of the provision of Article 96a (7aa) of the Pharmaceutical Law, caused by an incorrect calculation of the amount of a medicinal product, foodstuff for special nutritional purposes or medical device that could be issued to a patient.

In particular, the amendments will aim to avoid obliging pharmacy owners to pay contractual penalties or reimbursement of the price of a drug, a foodstuff for special nutritional purposes, a medical device.

Source: MZ