A loud topic in the broadly understood pharmaceutical environment are changes in the issuance of e-prescriptions - in this case, we are talking about, among others, limits on their issuance, as well as additional restrictions on the issuance of drugs of a specific category. In this article, we describe the latest rules regarding prescriptions.
Limits on the number of prescriptions issued – is it legal?
From July 3, the system allowing for the issuance of e-prescriptions has quantitative limits for issuing such a document. What is the reason for this? As can be seen from the announcement posted on the government website on June 30: "[f]or the analysis of Centrum-Zdrowie, we have 10 doctors who issued annual bills from PLN 100,000. to over 400 thousand prescriptions. In an extreme case, this means 50 prescriptions per hour for 24 hours. We are dealing here with business, not patient care„[1] – and, as a general rule, the Minister's position should be considered correct. The doctor's primary task is to care for the patient's well-being, not to wait for an easy profit.
The Presidium of the Supreme Medical Council expressed an identical stance, strongly opposing the activities of so-called "prescription machines" – meaning websites or applications that allow one to obtain a prescription for a given medication very quickly, often without direct contact (even by phone) with a doctor, and solely through a completed questionnaire or other form. In accordance with the cited position of the body of the Supreme Medical Chamber, "[i]t is the doctor who should decide whether it is even possible to conduct a telemedicine consultation in the established factual circumstances, while medical considerations, and not solely expectations supported by payment for the service, determine whether a prescription is issued after a consultation conducted via telemedicine."[2]The Ministry partially shifts responsibility for the operation of e-prescription systems onto the National Chamber of Pharmacists (NIL), stating that information was regularly provided about doctors abusing their right to issue prescriptions, which reportedly met with no response from the professional council. The result of this bone of contention is that as of 3 July daily limits for admitted patients and non-reimbursed prescriptions. According to the Ministry's announcement[3], these limits are as follows:
- a doctor can accept for 10 hours of work up to 80 patients, for whom he will prescribe a non-reimbursable prescription; Importantly, patients who receive prescriptions are not included in the limit only for reimbursed medicines;
- number of unreimbursed prescriptions written in a ten-hour work cycle cannot exceed 300 – the limit applies to all persons authorized to prescribe prescriptions, but importantly – This limit does not include prescriptions only for reimbursed drugs;
What raises doubts in this case?
The fact that such limits were introduced without any legal basis, and solely in the form of a change within the P1 system. Just two days after the mentioned restrictions were introduced, the President of the Supreme Medical Council appealed to the Minister of Health with a request "(...) for immediate clarification of the legal basis on which such a decision was made" and for consequences to be drawn against the individuals responsible for "(...) limiting doctors' ability to practice, and consequently for limiting patients' rights to healthcare services".[4]As stated in the appeal: "the Supreme Medical Council fully supports rational measures to regulate the market of entities issuing prescriptions under a commercial basis, so-called 'receptomats'."
We have repeatedly proposed both systemic solutions to prevent the registration of such entities, as well as, for example, limiting the possibility of teleconsultations only to individuals who had their first visit to the entity in person, or – in some specialities, such as psychiatry – using tools that transmit audio and video in real time. However, these proposals have never been discussed, let alone implemented. The medical self-government strongly protests against the restriction of patients' rights to healthcare services and the arbitrary determination of how doctors can use tools such as e-prescriptions to provide assistance to the sick. We also demand the immediate withdrawal of the introduction of prescription limits and the development of systemic solutions in agreement with the medical community." However, this appeal was left unanswered – the limits are still in force, which often hinders the work of doctors who are passionate about helping their patients and are not driven by pure profit. A form of protest by the Supreme Pharmaceutical Chamber was the issuance of "prescription no. 301", where point two of the prescription calls for immediate abolition. unlawful restrictions on the number of prescriptions issued[5]. 
Questions to the Minister of Health regarding the legal basis
As mentioned above, the legal basis for the described actions has, quite rightly, raised doubts from the very beginning. As early as July 6th, the Ombudsman asked the Minister of Health to indicate the legal basis for the limits imposed on doctors issuing e-prescriptions. What response was received? "The introduction of a daily limit of patients seen and non-reimbursed prescriptions issued was and is of a technical nature."[1] – other legal acts were indicated as the basis for the activities of the Minister of Health, but only for the purpose of changing and interfering with the rights of doctors legal basis lackDespite this, according to the Ministry, "(t)he introduced limits, according to analyses by the Centre for e-Health, have not paralysed the work of primary healthcare (POZ) and have not limited doctors with direct patient contact from prescribing prescriptions. The limits, however, have blocked the possibility of issuing[2]. To support his position, the Ombudsman also referred to Art. 68 section 2 of the Constitution, which states that the conditions and scope of providing health services to citizens are determined by act – and in accordance with Art. 31 section 3 of the Constitution any restrictions on freedom and constitutional rights may only be adopted in the form of a law. In this case, we can talk about a two-fold limitation - the rights of patients to receive health services and the rights of doctors to provide these services. Therefore, in the spirit of the Ombudsman's position, it is necessary to legally regulate the limitations described above, which should currently be classified as introduced illegally (as functioning without any legal basis).
Restrictions on remote issuance of prescriptions for narcotic and psychotropic substances – overview
On 26 July, the regulation of the Minister of Health of 12 July 2023 amending the regulation on narcotic drugs, psychotropic substances, category 1 precursors and preparations containing these drugs or substances came into force. The content of the introduced provisions is as follows: § 7: para. 2a. A prescription for preparation containing a narcotic drug IN or II-N groups, psychotropic substance groups II-P, III-P or IV-P or category 1 precursor is issued after verification by the person issuing the prescription via the system referred to in Art. 7 section 1 Act z day April 28, 2011 on the health care information system (Journal of Laws of 2022, items 1555, 2280 and 2705 and 2023 r. pos. 650 and 1234), or after taking a patient's history, that the quantity and type of medicinal products prescribed to the patient on issued and dispensed prescriptions are insufficient for the proper management of pharmacotherapy. par. 2b. A prescription referred to in Article 42(2) of the Act of day December 5, 1996 on the professions of doctor and dentist (Journal of Laws of 2022, item 1731, as amended 2 ), on preparation containing a narcotic drug IN or II-N groups, psychotropic substance groups II-P, III-P or IV-P or category 1 precursor may be issued if no more than 3 months have passed since the patient's last examination. para. 2c. The provisions of para. 2a and 2b do not apply to the primary healthcare physician chosen by the patient by submitting a declaration of choice referred to in Article 10. 1 Act z day 27 October 2017 on primary healthcare (Journal of Laws of 2022, item 2527). Para 8(2): In the case of issuing a prescription for preparation containing a narcotic drug IN or II-N groups, psychotropic substance groups II-P, III-P or IV-P or category 1 precursor during the period of application of this preparation, its equivalent or substitute, the course of verification referred to in § 7(2a) is also described in the medical documentation, and in the case referred to in § 7(2b) – information is also included that no more than 3 months have passed since the patient's last examination. Analysing the above changes, the following restrictions have been introduced:
- issuing a prescription for the purchase of a narcotic drug of group IN or II-N, a psychotropic substance of group II-P, III-P or IV-P or a precursor of category 1 may take place after prior verification of the patient via the P1 system or after collecting an interview from the patient - therefore it is necessary to identify a given patient, check his treatment history and what medications he is taking or has taken;
- issuing a prescription remotely (e.g. via teleconsultation) can only take place if a period of time has passed since the patient's last stationary examination not more than 3 months - this is to prevent the abuse of prescriptions for patients who do not physically visit the doctor and yet still ask for medications that are not the safest when used without medical supervision;
- it is necessary to record in the medical documentation that the patient verification requirement has been met and that no more than 3 months have passed since the patient's last physical visit.
Interestingly, the verification obligation and the three-month period do not apply to the primary healthcare doctor, whom the patient has chosen by submitting a declaration of choice of healthcare provider providing primary healthcare
If you have any questions regarding broadly understood pharmaceutical law, please contact us. As a Pharmaceutical Law Firm, we will try to answer all your questions and doubts.
[1] https://bip.brpo.gov.pl/sites/default/files/2023-07/Odpowiedz_MZ_limity_e-recepty_19.07.2023.pdf (accessed August 2, 2023) [2] https://bip.brpo.gov.pl/sites/default/files/2023-07/Do_MZ_limity_e-recepty_ponownie_24.07.2023.pdf (accessed August 2, 2023) [1] https://www.gov.pl/web/zdrowie/rozwiazania-zapobiegajace-lamaniu-prawa-przy-wystawianiu-recept (access: August 2, 2023) [2] https://nil.org.pl/dla-lekarzy/8128-apel-do-lekarzy-w-sprawie-wystawiania-recept (access: August 2, 2023) [3] https://www.gov.pl/web/zdrowie/od-3-lipca-2023-roku-obowiazuja-dzienne-limity-przyjetych-pacjentow-oraz-przepisanych-recept-nierefundowanych (access: August 2, 2023) [4] https://nil.org.pl/aktualnosci/8124-prezes-nrl-apeluje-do-mz-o-wycofanie-limitu-e-recept (access: August 2, 2023) [5] https://nil.org.pl/aktualnosci/8127-recepta-dla-ministra-zdrowia (access: August 2, 2023)