The Health Department has prepared an amendment to the Act on Medicinal Products, which provides for the possibility of vaccination in pharmacies, better access to new medicines for patients, or a modification of the relationship between professional and general practitioners when prescribing medicinal products for human use, medical devices and dietetic foods.
The Ministry of Health of the Slovak Republic submitted an amendment to Act No 362/2011 to the inter-ministerial commentary proceedings. Z.z. on medicines and medical devices, which will introduce several changes. It should enter into force after approval by the Government and Parliament from 1 March 2023.
Vaccinations in pharmacies
The amendment introduces a new possibility of vaccination in pharmacies. The advantage is the fast and convenient availability of public pharmacies, which is easier access to vaccination, especially for healthy and employed residents.
Vaccination in pharmacies will be carried out by a pharmacist certified in a certified work activity. In adults, pharmacists will be able to administer the vaccine intramuscularly or subcutaneously. In the first phase, this would be the influenza vaccination and possibly the aggravated epidemiological situation against COVID-19. Influenza vaccination through pharmacists can help increase population vaccination, which will help reduce healthcare costs.
New medicines available
The possibility to authorise the use of new medicinal products at risk of life-threatening or serious deterioration of the patient's health is extended. Until now, MZ SR has authorised the use of an unregistered medicinal product, a authorised medicinal product, for a therapeutic indication not listed in the marketing authorisation or for an investigational medicinal product for a patient subject to a clinical trial. This was the period since patient participation in the clinical trial was discontinued until the medicine was registered.
According to the new proposal, such new medicines will also be available to persons who have not been subject to the clinical trial. The Ministry shall issue an authorisation on the basis of the consent of the State Institute for the Control of Medicinal Products, which is the competent authority in the field of clinical trials on medicinal products for human use. The applicant for authorisation shall remain the healthcare provider indicating the treatment. This change should bring patients better access to treatment with new medicines.
Prescription of medicinal products
The amendment aims to improve the availability of medicines for elderly and polymorbid patients. A specialist doctor may instruct a general physician to prescribe medicinal products. The amendment specifies more precisely the mandate and duration of the mandate between the authorising and delegated physician, by mutual agreement, for prescribing the medicinal product, medical device, and dietetic food. The duration of the delegation shall not exceed 6 months. The investigator is responsible for the correct indication of the medicinal product. In the case of patients with persistent and irreversible third degree incontinence and with a permanent and irreversible stoma, the mandate may be granted for an indefinite period by mutual agreement, as the condition is irreversible.
The physician must prescribe a medicinal product, a medical device or a dietary food to the patient if it indicates the need for use for the patient. The general physician shall prescribe to the patient a prescriptively restricted medicinal product for human use, a medical device or a dietetic food, only on a specialist basis.
The amendment also allows nurses to issue a prescription. The nurse shall only carry out administrative activity on the basis of the doctor's instruction and indication.
A doctor-specialist in charge of prescribing medical devices may also have a nurse or midwife for a maximum period of 12 months, except for patients with continuous and irreversible third degree incontinence and in a permanent and irreversible stomomy where the validity is unlimited.
Medication after discharge from hospital
At the same time, the amendment will improve patients' access to needed medicines, medical devices or dietetic foods after being released from hospital. The physician shall prescribe the necessary medicinal products, medical devices or dietary foods that have been indicated to the patient during hospitalisation for at least 28 days. In addition to being tested, the prescriber may also be untested by a physician.
At the same time, the amendment also regulates situations in which the patient receives prescribed medicines before receiving a follow-up outpatient examination from a specialist doctor. His general doctor will be able to prescribe medicinal products on the basis of a discharge report, for a maximum of six months after the release. The prescriber shall indicate in the release report the diagnostic code or, where appropriate, the codes of the relevant institutional health care specialists.
Non-commercial clinical trial
The concept of non-commercial clinical trials carried out by a university (high school), a medical facility, e.g. a hospital, a public scientific organisation, a patient organisation, or individual researcher / clinical team is introduced. Non-commercial clinical trials account for around 15% of the total volume of clinical trials worldwide, in Slovakia less than 3% in the last 3 years, with cancer diseases being the most common among children and adults. Non-commercial clinical trials are mainly conducted in patients with rare diseases or infrequent disease occurrence, to which non-commercial clinical trials will bring new knowledge of more effective and safer treatment, including personalised treatment.
An exemption from the administrative fee for the procedure for the authorisation of a non-commercial clinical trial is proposed. Increasing the use of non-commercial clinical trials may also result in increased availability of innovative, more effective and safer treatment, in addition to increasing biomedical knowledge or efficiency gains, without increasing the cost of medicines from health insurance companies.