The Ministry of Health of the Slovak Republic issued a decision to regulate the prescription of medicinal products for human use, medical devices and dietetic foods. The purpose of the decision is to harmonise the interpretation and prescribing procedures of medicinal products for human use, medical devices and dietetic foods by general and specialist physicians, as set out in the Amendment to the Act on medicinal products, in force from the beginning of 2022.MZ SR modified the following areas by decision: Validity of recommendations for prescribing a human medicinal product, a medical device and a dietetic food issued before the entry into force of the amendment
- The validity of recommendations issued by a specialist before 1.1.2022 allows the general physician to prescribe a medicinal product for human use, a medical device and a dietetic food until the recommendation expires, but for a maximum period of 12 months. Thus, the medicine recommended by a physician in 2021 may be prescribed by a general physician this year. Prescription of a human medicinal product, medical device and dietary food at a visit by a specialist
- In medical examination, the physician must prescribe a medicinal product for human use, a medical device or a dietetic food, the prescription of which is linked to the physician's expertise, always after a medical examination has been carried out for indicated treatment. Granting of a delegation and its form
- The specialist may, by mutual agreement (not to be written), delegate to prescribe another doctor for a maximum of 2 months in cases other than absence from the workplace or malfunctioning of the technical equipment. The doctor shall indicate in the electronic record of the provision of outpatient/constitutional care or in the medical/releasing report on the healthcare provided. The assigned physician may be a specialist and a general physician.
The medicine from the specialist can also be prescribed by the general physician, by mutual agreement and for 2 months. Technical security in eHealth
- The decision amended the granting of a mandate so that the attribute so far called the "Recommendation Doctor's Code" will be used to report the -code of the entrusting physician and the -code of the PCS of the referee's Doctor, until the issue of the higher version of the eRecept (V6) service.Prescription of medicinal products for human use, medical devices and dietetic foods after release from institutional health care (hospitals)
- It is specified that when a person is released from institutional care, prescribers are required to prescribe a medicinal product, a medical device, including an individual medical device and a dietetic food, which has been indicated to the person during hospitalization, their administration is necessary even after being discharged from institutional care and are listed in the release report in the number of packages needed for the treatment of the person for a maximum period of 30 days. Prescription of medicinal products for human use, medical devices and dietetic foods after discharge from hospital by a general practitioner
- The discharge report may include a general practitioner mandate with which the person has an agreement on the provision of health care for prescribing the medicinal product, medical device and dietary food for a maximum period of 6 months from the date of release from institutional healthcare. Prescription of medicinal products for human use, medical devices and dietetic foods by untested physicians
- In order to prescribe medicinal products for human use, medical devices and dietetic foods when a person is released from institutional health care (hospitals), the prescriber is entitled to entrust the prescription in writing to an untested physician. This decision was issued by the Ministry of Health of the Slovak Republic on the basis of § 128 (8) (a). (c) the Law on Medicinal Products and Medical Devices. Law No 532/2021 Coll. amending Law No 362/2011 The Z.z. on medicinal products and medical devices entered into force on 1 January 2022. The aim of the amendment was, among other things, to improve the patient's medical and legal safety. Another significantly positive element of the amendment is the introduction of the obligation to prescribe a medicinal product, a medical device and a dietetic food when a person is released from institutional health care for up to 30 days. The aim of this measure is to relieve the patient of a follow-up visit to the doctor within three days of completion of the hospitalisation. Before issuing this Decision, the Ministry acted in close cooperation with the entities concerned, identifying potential areas that may make it difficult for patients to access medicinal products for human use, medical devices and dietetic foods, collecting and evaluating the complaints received. In this context, the Ministry organised a meeting on 20.01. 2022, attended by representatives of professional companies, the National Health Information Centre and health insurance companies. On the basis of the conclusions of this meeting, the Ministry submitted and forwarded to the representatives a draft solution to the situation that had arisen - those then sent comments to the Ministry on the proposal. A further meeting took place on 08.02 2022 at which interested parties commented on the assessment of the comments received, while the Ministry also incorporated part of the comments in that decision. The decision was therefore prepared on the basis of a discussion and a joint consensus with the professional companies, the NCZI and the health insurance companies.
The approved document is legally binding on all entities. The decision to regulate medicinal products for human use, medical devices and dietetic food is valid only during a crisis situation and is available on the website of MZ SR: https://www.health.gov.sk/Clanok?Head-right-COVID-19 in part: Measures and Decisions of MZ SR.