On January 1, 2022, a comprehensive amendment to Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts (hereinafter referred to as the “Medicines Act”) entered into force. In this article, we provide a summary of the most important changes that the amendment has brought to practical application in 2022.
The most significant changes for patients introduced by this amendment concern the area of so-called delegated prescribing, which in practice most often occurs in the relationship between a specialist physician—who issues a referral—and a general practitioner acting as the prescribing physician. Under the new legislation, medications are prescribed by the physician who indicated the treatment for the patient, thereby increasing the prescribing physician’s responsibility for the correct indication of the medication and for issuing a prescription with the correct content. As of January 1, 2022, therefore, prescription drugs subject to conditions regulated by the Medicines Act are not prescribed by a general practitioner but by a specialist.
The Ministry of Health of the Slovak Republic issued a Decision on the Regulation of Prescribing Human Medicines, medical devices, and dietary foods, with the aim of standardizing the interpretation and procedures for prescribing human medicines, medical devices, and dietary foods by general practitioners and specialists as set forth in the amendment to the Medicines Act, which stipulated:
- the validity of recommendations issued by a specialist physician before January 1, 2022, allows a general practitioner to prescribe a human medicine, medical device, or dietary food until the recommendation expires, but for a maximum of 12 months. Thus, a medicine recommended by a specialist in 2021 may be prescribed by a general practitioner in 2022
- During a medical examination, a specialist is required to prescribe a human medicine, medical device, or dietary food whose prescription is restricted to the specialist’s field of expertise, always following a medical examination related to the indicated treatment
- A specialist may, by mutual agreement (which need not be in writing), authorize another physician to prescribe for a maximum of 2 months, even in cases other than absence from the workplace or malfunction of technical equipment. The specialist shall note the authorization in the electronic record of outpatient/inpatient care or in the medical/discharge report on the healthcare provided. The delegated physician may be either a specialist or a general practitioner. Thus, a general practitioner may also prescribe a medication from a specialist—by mutual agreement and for a period of 2 months
The amendment to the Medicines Act also streamlined the use of so-called REPETATUR, a recurring electronic prescription for chronic patients issued by prescribing physicians. REPETATUR allows a physician to set up, for a specific period—most often until the next follow-up visit—a regular pickup of the prescribed medication by the patient directly at the pharmacy. The patient will therefore regularly pick up their prescribed medications at the pharmacy—for example, once a month or every three months—in accordance with the frequency, type, dosage, and quantity of the medication set by the prescribing physician. Unlike an electronic prescription, where the patient must contact their doctor after running out of medication and ask them to issue a new prescription, REPETATUR allows medications/medical devices to be prescribed up to one year in advance. Thanks to the use of REPETATUR, duplicate prescriptions are reduced, the cost-effectiveness of treatment is increased, and unnecessary visits to outpatient clinics are reduced.
At the same time, the conditions for patients upon discharge from inpatient care have been amended so that that the prescribing physician at an inpatient healthcare facility is required, upon a patient’s discharge from inpatient care and when providing inpatient emergency services, to prescribe—in accordance with prescribing restrictions and indication restrictions—a human drug included in the list of categorized drugs, a dietary food included in the list of categorized dietary foods, and a medical device included in the list of categorized medical devices in the number of packages necessary for the patient’s treatment for a maximum period of 30 days, as well as a custom-made medical device. Upon discharge from the hospital, patients will no longer receive only “three days’ worth of medication,” which was often handed out to patients in an unhygienic manner—unwrapped in individual doses—and posed a high risk of harm to the patient’s health due to mix-ups or incorrect dosing. After discharge from the hospital, the patient picks up the prescribed medications at a pharmacy and, upon returning home, does not need to contact their primary care physician “within three days” regarding the prescription. This is a significant and important change, especially for patients with limited mobility or whose treating physician is located far away.
The amendment also introduced several provisions aimed at imposing further restrictions to prevent the re-export of human medicines included in the list of categorized medicines, or aimed at ensuring the availability of medicines for patients in the Slovak Republic. The issue of so-called re-export had already been addressed in previous amendments to the Medicines Act, but several of the existing measures were deemed insufficient. Under the new legislation, the activities of holders of a wholesale distribution license for medicinal products are regulated such that a wholesale distributor of medicinal products who has acquired a categorized medicinal product from another wholesale distributor may supply this medicinal product only to a holder of a license to provide pharmaceutical care. If a holder of a license for the wholesale distribution of medicinal products for human use acquires a medicinal product for human use included in the list of categorized medicinal products from a holder of a license for the wholesale distribution of medicinal products for human use who is also the manufacturer, the marketing authorization holder, an authorized representative of the manufacturer or marketing authorization holder, or a parallel importer of that supplied medicinal product for human use, they may supply that medicinal product for human use to another holder of a license for the wholesale distribution of medicinal products for human use exclusively for its direct supply to a holder of a license to provide pharmaceutical care.
Another restriction on the wholesale distributor concerns the storage of categorized medicinal products in warehouses. The holder of a license for the wholesale distribution of medicinal products is required to store medicinal products exclusively at the locations specified in the license to conduct business. At the same time, the holder of a license for the wholesale distribution of medicinal products is prohibited from storing medicinal products owned by the holder of a license to provide pharmaceutical care. The holder of a license for the wholesale distribution of medicinal products is authorized to store the pharmaceutical care provider’s medicinal products exclusively in the exercise of a security interest. Medicines of a pharmacy care provider stored in this manner may be sold by the holder of a wholesale distribution license for medicines, as a secured creditor, exclusively to another holder of a license to provide pharmacy care.
Another restriction to prevent the re-export of human medicines included in the list of categorized medicines is the expansion of options to suspend the activities of a holder of a license for the wholesale distribution of medicines. Failing to allow authorized persons to carry out state supervision is considered a new serious violation of the Medicines Act. For such an offense, the State Institute for Drug Control (ŠÚKL) may suspend the activities of a holder of a license for the wholesale distribution of human medicines for up to 90 days.
If a wholesaler failed to maintain itemized records of medicines, medical devices, and dietary foods or failed to retain documents regarding the acquisition of medicines, medical devices, dietary foods, or refused to submit them upon request by a state supervisory authority or health insurance company, operations may be suspended for up to six months. This situation reflects the alleged fact that, in practice, there were frequent instances where holders of a license for the wholesale distribution of human medicines, when inspected to ensure they were not re-exporting categorized medicines, refused to submit to inspectors from the State Institute for Drug Control documentation regarding the receipt (acquisition, procurement) and delivery of categorized medicinal products.
Among other things, the amendment also established the Ethics Committee of the Ministry of Health of the Slovak Republic for clinical trials of medicinal products, medical devices, and for performance studies of in vitro diagnostic medical devices. Together with the State Institute for Drug Control, the Ethics Committee for Clinical Trials will review applications for authorization of clinical trials of medicinal products and medical devices, as well as applications for authorization of performance studies of in vitro diagnostic medical devices.
