Limits on issuing e-prescriptions - the Ministry of Health's fight against "prescription machines"

How to sell a pharmacy? - part two article
Piotr Kłodziński|
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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 rule, the Minister's position should be considered correct. The doctor's primary task is to take care of the patient's well-being, not to look for easy money. The Presidium of the Supreme Medical Council expressed the same position, firmly opposing the activities of the so-called "receptomats" - i.e. websites or applications that allow you to obtain a prescription for a given drug in a very short time, often without direct contact (even by telephone) with a doctor, but only through a completed survey or other form. According to the above-mentioned position of the Supreme Medical Chamber, "[t]he doctor should decide whether it is possible to conduct teleconsultation at all in the given facts, while issuing a prescription after conducting an examination in the form of teleconsultation is determined by medical considerations, and not only by expectations supported by the payment of a fee." for the service"[2].

The Ministry partially shifts the responsibility for the operation of prescription dispensers to NIL, stating that information was provided on an ongoing basis about doctors abusing their right to issue prescriptions, which was not to be met with any reaction from the local government. The result of this bone of contention is introduced on July 3 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 is questionable in this case? Well, the fact is that such limits were introduced without any legal basis, and only in the form of a change within the P1 system. Just two days after the above-mentioned blockades were launched, the President of the Supreme Medical Council asked the Minister of Health "(...) to immediately explain the legal basis on which such a decision was made" and to draw consequences against people who are responsible for "(... ) limiting the ability of doctors to practice their profession and, consequently, limiting patients' rights to health care services"[4]. As we read in the above-mentioned appeal:

"The Supreme Medical Chamber fully supports rational actions aimed at regulating the market of entities issuing prescriptions in a commercial manner, the so-called prescription machines. We have repeatedly proposed both system solutions that prevent the registration of such entities, as well as, for example, limiting the possibility of conducting teleconsultation only to people who made their first visit to the entity in stationary mode or - in some specialties, e.g. psychiatry - using tools transmitting image and sound in real time . However, these proposals were never discussed, let alone implemented.

The medical self-government strongly protests against limiting patients' rights to health care services and arbitrarily determining the manner in which a doctor can use tools such as e-prescription to provide help to the sick. We also demand the immediate withdrawal of the introduction of limits on prescriptions and the development of systemic solutions in consultation with the medical community.

However, this appeal was left unanswered - the limits are still in force, which often complicates the work of doctors who passionately want to help their patients and are not motivated by pure earnings. A form of protest by the Supreme Chamber of Pharmacy was the issuance of "prescription no. 301", in which the second point of the prescription requests the immediate abolition of unlawful restrictions on the number of prescriptions issued[5].

The NIL's position on this matter should be considered to be absolutely correct - it is necessary to prevent pathologies such as receptomat, however, introducing such "restrictions" as limits on patient admission and non-reimbursed prescriptions is, of course, unfounded. Every doctor should not be immediately identified with a person who issues prescriptions "like a machine", without taking into account the patient's health. There are very few such cases (according to the statement of the Minister of Health - 29 doctors), which, however, does not allow us to ignore this problem. However, this form of "control" and an attempt to prevent similar pathologies is not only pointless, but also directly hinders the activities of doctors who do not commit violations. Just look at public clinics, where patients often wait for hours to enter the office. Should the eighty-first patient then be sent home because he is "overweight"? Should he wait for another day to get a prescription billed at the next daily limit? Unfortunately, the effects of introducing such limits (without legal basis) can be very harmful, if not dangerous.

Questions to the Minister of Health regarding the legal basis

As mentioned above, the legal basis for the described activities raised - and justified - doubts from the very beginning. On July 6, the Ombudsman asked the Minister of Health to indicate the legal basis for the introduced limits on issuing e-prescriptions by doctors. What response was received? "The introduction of a daily limit on admitted patients 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 lack. Despite this, according to the Ministry, "the limits introduced, according to the analyzes of the e-Health Center, did not paralyze the work of primary health care (POZ) and did not limit the ability of doctors who have direct contact with patients to prescribe prescriptions. However, the limits have blocked the possibility of issuing prescriptions by entities selling prescriptions whose only goal is financial profit. The response of the Minister of Health was met with further interference from the Commissioner for Human Rights, where it was raised, among other things, that "(in) the legal regulations indicated [by the Minister of Health], there is no generally applicable provision constituting the legal basis for the limits on issuing e-prescriptions introduced by the e-Health Center. by doctors. These provisions also do not grant the Minister of Health the competence to introduce such restrictions.[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 July 26, the regulation of the Minister of Health of July 12, 2023 entered into force, amending the regulation on narcotic drugs, psychotropic substances, category 1 precursors and preparations containing these drugs or substances. The content of the introduced regulations is as follows:

Par. 7:

paragraph 2a. Recipe 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. item 650 and 1234), or after collecting an interview from the patient, that the amount and type of medicinal products prescribed to the patient on the prescriptions issued and filled are not sufficient for the proper conduct of pharmacotherapy.

paragraph 2b. The prescription referred to in Art. 42 section 2 of the Act z 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.

paragraph 2c. The provisions of section 2a and 2b shall not apply to the primary care physician whom the patient has chosen by submitting the declaration of choice referred to in Art. 10 section 1 Act z day October 27, 2017 on primary health care (Journal of Laws of 2022, item 2527).

Par 8 sec. 2:

In 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 medical documentation also describes the course of verification referred to in § 7 section 2a, and in the case referred to in § 7 section 2b - information is also included that no more than 3 months have passed since the last examination of the patient.

Analyzing 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 3-month deadline do not apply to the primary care physician whom the patient selected by submitting a declaration of choice of the provider providing primary care services.

This change should be considered as appropriate - narcotic and psychotropic substances are medicinal products that must be used under medical supervision. Unfortunately, it often happens that a patient has been taking a given drug for a long time and requests the next package via teleconsultation. Excessive use of drugs with this composition, without physical, systematic supervision by a doctor, may lead to serious addictions, with tragic consequences. Therefore, while the first change concerns the P1 system should be assessed negatively - the second of the discussed amendments, supported by law, is absolutely justified.

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)

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