Prescription Medicinal Products in Russia: Legal Regulation

 

Anna Ivanova, Attorney at BRACE Law Firm ©

January 12, 2022

 

Current Russian legislation contains no formal definition of the term "prescription medicinal product." However, pursuant to Article 4 of Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products"), a prescription for a medicinal product is a medical document of a prescribed form containing a prescription of a medicinal product for medical use, issued by a medical professional for the purpose of dispensing or manufacturing and dispensing a medicinal product on paper or, with the consent of the patient or their legal representative, in the form of an electronic document signed with the medical professional's enhanced qualified electronic signature (UK(E)P). It may also be a document of a prescribed form containing a prescription for a medicinal product for veterinary use, issued by a veterinary specialist for the purpose of dispensing or manufacturing and dispensing a medicinal product on paper.

According to the Rules for Determining Categories of Medicinal Products Dispensed Without a Prescription and by Prescription, approved by Decision of the Collegium of the Eurasian Economic Commission (EEC) No. 178 dated December 29, 2015, prescription medicinal products are "medicinal products dispensed to a patient only upon presentation of a prescription to a pharmacy employee, issued in accordance with the rules established by the legislation of the member states."

The classification of a medicinal product as prescription or over-the-counter (OTC) occurs during state registration. A change in the dispensing category is possible during the confirmation of registration (re-registration) and upon making changes to the registration dossier that require an expert examination of the expected benefit-risk balance.[1]

This article examines the specifics of the circulation of prescription medicinal products in Russia.

Prescribing Prescription Drugs

Currently, the prescription of prescription medicinal products is carried out in accordance with the Procedure for Prescribing Medicinal Products, the forms of prescription blanks for medicinal products, the procedure for formatting said blanks, their accounting and storage, approved by Order of the Ministry of Health of Russia No. 4n dated January 14, 2019.

The forms of prescription blanks were approved by Order of the Ministry of Health of Russia No. 54n dated August 1, 2012.

However, starting March 1, 2022, instead of these legal acts, the Procedure for Prescribing Medicinal Products, updated prescription blank forms, the Procedure for Formatting said blanks, their accounting and storage, the forms of prescription blanks containing prescriptions for narcotic drugs or psychotropic substances, the Procedure for their manufacture, distribution, registration, accounting, and storage, as well as the Rules for Formatting prescription blanks, including in the form of electronic documents, approved by Order of the Ministry of Health of Russia No. 1094n dated November 24, 2021, will take effect.

Overall, the new documents are similar to those being replaced. However, a new prescription blank Form No. 107/u-NP is introduced. This form will be used for prescribing narcotic and psychotropic medicinal products from List II of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control in the Russian Federation approved by the Government of the Russian Federation, except for medicinal products in the form of transdermal therapeutic systems and medicinal products containing a narcotic drug in combination with an opioid receptor antagonist; such paper prescriptions are formatted on the prescription blank.

The new procedure for prescribing prescription drugs also excludes the requirement for a patient's representative to have a power of attorney to receive a prescription and have narcotic and psychotropic medicinal products dispensed to them. This change addresses the inability of terminally ill patients in the final stages of life to formalize such documents. Furthermore, it establishes the possibility of issuing prescriptions in the form of an electronic document in the Russian language. Another innovation is the obligation of a medical professional who issues an incorrectly formatted prescription to ensure its timely re-formatting.[2]

In effect, these innovations are related to problems previously considered by the Ministry of Health regarding the acquisition of prescription drugs during the pandemic, as well as issues surrounding the transition to electronic prescription circulation.

Specifically, the Ministry of Health indicated that prescriptions for citizens suffering from chronic diseases, whether on paper or in electronic form, may be issued for an entire course of treatment for a maximum term of up to 180 days. Meanwhile, relatives, acquaintances, or volunteers may collect the medicinal products from the pharmacy via prescription. This is particularly important under self-isolation requirements.

The Ministry of Health also previously recommended that regions analyze the availability of 24-hour pharmacies and, if necessary, take measures to increase the number of pharmacy organizations operating around the clock.[3]

Furthermore, in 2021, the Ministry of Health developed methodological recommendations for the transition of medical organizations to electronic document management. This document establishes that a medical organization independently decides on the full or partial transition to maintaining medical documentation in the form of electronic medical documents without duplication on paper, as well as the timing of such a transition based on its technical readiness. If a patient (or their legal representative) submits a simple written application to maintain their medical documentation in paper form, the medical documentation of that patient, which is maintained in the medical organization in electronic form, is duplicated on paper.[4]

Thus, the innovations approved by Order No. 1094n dated November 24, 2021, are driven by the relevant issues regarding the prescription of prescription drugs previously raised by the Ministry of Health.

As a general rule, the medical professional enters information about the prescribed medicinal product (name of the medicinal product, dosage, method of administration and use, dosing regimen, duration of treatment, and justification for the prescription) into the patient's medical documentation.

Prescription blank Form No. 148-1/u-88 is formatted when prescribing: narcotic and psychotropic medicinal products of List II in the form of transdermal therapeutic systems; narcotic medicinal products of List II containing a narcotic drug in combination with an opioid receptor antagonist; psychotropic medicinal products of List III; medicinal products with anabolic activity; and medicinal products containing other pharmacologically active substances in addition to small amounts of narcotic drugs, psychotropic substances, and their precursors.

Prescription blank Form No. 148-1/u-04 (l) is formatted when prescribing medicinal products to citizens entitled to receive medicinal products free of charge or at a discount.

Prescription blank Form No. 107-1/u is formatted when prescribing other prescription medicinal products.

When providing medical care to a patient in inpatient settings, the prescription of medicinal products is performed without formatting a prescription by the medical professional alone.

However, in certain cases, the prescription of medicinal products requires coordination with the head of the department, the responsible duty physician, or another person authorized by the chief physician's order:

• simultaneous prescription of 5 or more medicinal products to one patient;
• prescription of medicinal products not included in the List of Vital and Essential Drugs (the "VED List") in cases of atypical disease progression, complications of the primary disease and/or comorbid conditions, or when prescribing medicinal products whose interactions and compatibility according to their instructions lead to reduced efficacy and safety of pharmacotherapy and/or create a potential danger to the patient's life and health.

If immediate or urgent (within 2 business days) dispensing of a medicinal product to a patient is required, the designations "cito" (urgent) or "statim" (immediate) are placed at the top of the paper prescription. Similar designations are placed as marks when formatting a prescription in electronic form. In this case, when prescribing medicinal products to citizens entitled to receive them free of charge or at a discount, the prescription must indicate a telephone number through which a pharmacy employee can, if necessary, coordinate the replacement of the medicinal product with a medical professional.[5]

Existing legislation also establishes maximum dosages of active ingredients when formatting prescriptions for medicinal products.

In addition to these general requirements for prescribing and formatting prescriptions, it is important to remember the general restrictions related to the advertising of drugs on prescription blanks. Pursuant to Article 74 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection"), medical professionals and heads of medical organizations are prohibited from issuing prescriptions for medicinal products or medical devices on blanks containing advertising information, or on prescription blanks where the name of the medicinal product or medical device is pre-printed. In turn, Article 67.1 of the Law on Circulation of Medicinal Products prohibits pharmaceutical organizations from inducing medical professionals to prescribe drugs on blanks containing advertising information or on prescription blanks where the name of the medicinal product for medical use is pre-printed.

Thus, the prescription of prescription drugs is strictly regulated, and a trend toward the transition to electronic document management in medical organizations, including the possibility of issuing electronic prescriptions, is currently observed.

Dispensing Prescription Drugs

Currently, the dispensing of prescription drugs is carried out in accordance with the Rules for Dispensing Medicinal Products for Medical Use, including Immunobiological Medicinal Products, by pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activity, approved by Order of the Ministry of Health of Russia No. 403n dated July 11, 2017. However, starting March 1, 2022, these Rules will be replaced by new ones approved by Order of the Ministry of Health of Russia No. 1093n dated November 24, 2021. This document contains few changes to the current procedure. Specifically, it introduces the possibility of dispensing medicinal products to persons caring for terminally ill patients upon their simultaneous presentation of the prescription, an identity document, and a document confirming the patient's terminal condition.[6]

As a general rule, when dispensing medicinal products via a paper prescription, the pharmaceutical worker places a mark on the prescription regarding the dispensing of the medicinal product, indicating:

• the name of the pharmacy organization (or the full name of the individual entrepreneur);
• the trade name (except for medicinal products manufactured in the pharmacy), dosage, and quantity of the medicinal product dispensed;
• the full name of the medical professional if the dosage of the medicinal product available at the retail entity exceeds the dosage indicated in the prescription, or if a one-time dispensing of the medicinal product is performed via a prescription formatted on blank Form No. 107-1/u with a one-year validity period that specifies the periods and quantities of dispensing (for each period);
• the details of the identity document of the person receiving the medicinal product if narcotic and psychotropic medicinal products of List II are dispensed, except for medicinal products in the form of transdermal therapeutic systems and medicinal products containing a narcotic drug in combination with an opioid receptor antagonist;
• the full name of the pharmaceutical worker who dispensed the medicinal product and their signature;
• the date the medicinal product was dispensed.

When dispensing medicinal products via a prescription formatted on blank Form No. 107-1/u with a one-year validity period that specifies the periods and quantities of dispensing (for each period), the prescription is returned to the person purchasing the medicinal product with a mark containing the information specified above.

Upon subsequent visits to the retail entity with this prescription, the marks of previous dispensing are taken into account. After the prescription's expiration date, a stamp "Medicinal Product Dispensed" is placed on the prescription, and it is returned to the person.

When dispensing a narcotic or psychotropic medicinal product of List II, the pharmacy or pharmacy point's seal, indicating its full name, is placed on the dispensing mark (if a seal is available).

The dispensing of medicinal products via electronic prescriptions is carried out by pharmacies, pharmacy points, and individual entrepreneurs located in the constituent entity of the Russian Federation where the electronic prescription was issued, provided the authorized body of said constituent entity has adopted such a decision.

Technical requirements for information exchange between the pharmacy organization and the system, including requirements for the identification of the electronic prescription and the person requesting the drug, are established by the decision of the authorized body of the constituent entity of the Russian Federation.[7]

The requirements above are mandatory for the dispensing of prescription drugs. Dispensing without a prescription entails administrative liability under Article 14.2 of the Code of Administrative Offenses of the Russian Federation (CAO RF). Thus, dispensing prescription medicinal products without a prescription may be qualified as the illegal sale of goods whose free sale is prohibited or restricted by law, carrying an administrative fine for citizens of 1,500 to 2,000 rubles with or without confiscation of the offenses' subjects; for officials, 3,000 to 4,000 rubles with or without confiscation; and for legal entities, 30,000 to 40,000 rubles with or without confiscation.

There is also another approach to qualifying this offense, where dispensing a drug without a prescription leads to liability under Part 4 of Article 14.1 of the CAO RF for performing entrepreneurial activity in gross violation of the requirements and conditions provided for by a special permit (license). This entails an administrative fine for individual entrepreneurs of 4,000 to 8,000 rubles or administrative suspension of activity for up to 90 days; for officials, 5,000 to 10,000 rubles; and for legal entities, 100,000 to 200,000 rubles or administrative suspension of activity for up to 90 days.

In particular, the Supreme Court sided with a prosecutor who, during an inspection, found that the party sold a medicinal product without a doctor's prescription via a remote method in violation of the rules for dispensing medicinal products. Consequently, the prosecutor held the party liable under Part 4 of Article 14.1 of the CAO RF, and a fine of 100,000 rubles was imposed.[8]

Within this practice, it is important to note that the remote sale of prescription medicinal products is currently prohibited. Specifically, Decree of the Government of the Russian Federation No. 697 dated May 16, 2020, establishes that the remote sale of drugs may be carried out except for prescription medicinal products, narcotic medicinal products, and psychotropic medicinal products.

However, the prospect of revising this exception to allow the remote sale of prescription drugs cannot be denied. According to Rospotrebnadzor, while prescription drugs are an exception for remote sales, in the event of an emergency or the threat of the spread of a dangerous disease, the Government may establish a temporary procedure for the remote sale of some of them, allowing the remote sale of certain prescription drugs.[9]

Besides dispensing without a prescription, disputes also exist regarding the possibility of refusing to dispense a drug due to the prescription's non-compliance with established requirements. According to the rules, prescriptions issued in violation of the rules are registered in a log specifying the detected violations, the medical professional's name, the medical organization's name, and the measures taken; they are stamped "Prescription Invalid" and returned to the person. The retail entity informs the head of the relevant medical organization of the violations. Often, such actions by pharmacy workers cause patient dissatisfaction, as the patient is not at fault for the incorrect formatting. However, if a pharmacy provides a drug via an incorrectly formatted prescription, it may be held liable for dispensing drugs via an invalid prescription. Conversely, no liability is established for medical professionals for errors in prescriptions.[10] In this regard, we believe that the obligation of a physician to re-issue a correctly formatted prescription (if initially incorrect), as established by Order of the Ministry of Health No. 1094n dated November 24, 2021, will serve as the basis for a patient's subsequent visit to the physician.

It is also important to note that when a medicinal product is prescribed for vital indications based on a decision of a medical commission, and such provision is funded by the budget, courts side with patients in cases of refusal. For example, a patient applied to the Department of Health of his region for provision of a drug required for vital indications. The Department notified him of the impossibility of considering the matter due to his failure to submit a full package of documents corresponding to the procedure for prescribing drugs under current law. However, the Supreme Court of the Russian Federation ruled that a patient cannot be denied a drug solely because the medical documents proving the prescription were formatted by medical professionals in violation of formatting rules.[11]

Thus, the rules for dispensing prescription medicinal products are quite detailed. Although the assessment of the possibility of dispensing a drug is subject to the pharmacy worker's opinion, pharmacy organizations are recommended to conduct a detailed check of the prescription's compliance with formatting requirements. Meanwhile, the problem of timely provision of drugs to patients for vital indications remains relevant.

Advertising Prescription Medicinal Products

Pursuant to Part 8 of Article 24 of Federal Law No. 38-FZ dated March 13, 2006, On Advertising, the advertising of medicinal products in forms and dosages dispensed by prescription, methods of prevention, diagnostics, treatment, and medical rehabilitation, as well as medical devices requiring special training for use, is prohibited except at medical or pharmaceutical exhibitions, seminars, conferences, and similar events, and in specialized printed publications intended for medical and pharmaceutical workers.

Consequently, it is vital to pay attention to the location where advertising materials for prescription drugs are distributed. In one case, FAS Russia found that advertising for a prescription drug was distributed in educational and medical institutions via the brochure "Everyone Should Know This." Such distribution was recognized as contradicting Part 8 of Article 24 of the Law on Advertising.[12]

Another common violation is the advertising of drugs on the official websites of pharmaceutical organizations where advertising materials are placed in the public domain. For example, advertising for a prescription medicinal product was distributed as text information on a website page. The control body recognized this distribution as a violation of the Law on Advertising.[13]

Notably, situations sometimes arise where medicinal products with the same names are advertised, but the drug in one dosage is OTC while in another dosage it is prescription-only. FAS Russia established that according to the instructions for use approved during the drug's registration in 2011, the dispensing conditions for 10 mg and 20 mg dosages were the same—by prescription. According to the 2014 instructions, the dispensing condition for the 10 mg dosage changed to OTC. The 20 mg dosage remained prescription-only. The control body concluded that minor differences in the packaging of the 10 mg and 20 mg dosages were insufficient to individualize the prescription and OTC versions, and thus did not influence the distinctive capacity of the names and packaging when perceived by consumers. Consequently, the 10 mg drug in the advertisement was associated with the 20 mg drug. Such advertising was recognized as violating Part 8 of Article 24 of the Law on Advertising.[14]

This article has examined the primary requirements for the prescription, dispensing, and advertising of prescription medicinal products. It is important to note the current trend toward the introduction and wider distribution of electronic prescriptions, as well as the ongoing debates regarding the possibility of the remote sale of prescription drugs. Additionally, when advertising prescription medicinal products, it is vital to conduct an additional analysis of advertising materials and distribution locations to avoid non-compliance with established access restrictions.

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References

[1] Decision of the Collegium of the Eurasian Economic Commission No. 178 dated December 29, 2015, On the Rules for Determining Categories of Medicinal Products Dispensed Without a Prescription and by Prescription.

[2] Order of the Ministry of Health of Russia No. 1094n dated November 24, 2021, On Approval of the Procedure for Prescribing Medicinal Products, Forms of Prescription Blanks for Medicinal Products, the Procedure for Formatting said Blanks, Their Accounting and Storage, the Forms of Prescription Blanks Containing Prescriptions for Narcotic Drugs or Psychotropic Substances, the Procedure for Their Manufacture, Distribution, Registration, Accounting, and Storage, as well as the Rules for Formatting Prescription Blanks, Including in the Form of Electronic Documents.

[3] Information from the Ministry of Health of Russia "Ministry of Health of Russia: prescription drugs may be received by relatives, acquaintances, and volunteers." Document text provided in accordance with the publication on the Ministry of Health website as of March 25, 2020.

[4] Letter of the Ministry of Health of Russia No. 18-5/1495 dated August 10, 2021, On Sending Methodological Recommendations for the Phased Transition to Maintaining Medical Documentation in the Form of Electronic Documents.

[5] Order of the Ministry of Health of Russia No. 4n dated January 14, 2019, On Approval of the Procedure for Prescribing Medicinal Products, Forms of Prescription Blanks for Medicinal Products, the Procedure for Formatting said Blanks, Their Accounting and Storage.

[6] Order of the Ministry of Health of Russia No. 403n dated July 11, 2017. Starting March 1, 2022, these Rules will be replaced by Order of the Ministry of Health of Russia No. 1093n dated November 24, 2021, On Approval of the Rules for Dispensing Medicinal Products for Medical Use by Pharmacy Organizations, Individual Entrepreneurs Licensed for Pharmaceutical Activity, Medical Organizations Licensed for Pharmaceutical Activity and Their Separate Subdivisions (Ambulatories, Feldsher and Feldsher-Obstetric Points, Centers (Departments) of General Medical (Family) Practice) Located in Rural Settlements Where There are No Pharmacy Organizations, as well as the Rules for Dispensing Narcotic Drugs and Psychotropic Substances Registered as Medicinal Products for Medical Use, Medicinal Products for Medical Use Containing Narcotic Drugs and Psychotropic Substances, Including the Procedure for Dispensing Immunobiological Medicinal Products by Pharmacy Organizations.

[7] Order of the Ministry of Health of Russia No. 403n dated July 11, 2017, On Approval of the Rules for Dispensing Medicinal Products for Medical Use, Including Immunobiological Medicinal Products, by Pharmacy Organizations, Individual Entrepreneurs Licensed for Pharmaceutical Activity.

[8] Determination of the Supreme Court of the Russian Federation No. 305-ES20-23008 dated February 8, 2021, in Case No. A40-334362/2019.

[9] Rospotrebnadzor Memo "Coronavirus COVID-19: Support Measures and Consumer Protection in the New Conditions."

[10] Rospotrebnadzor information on the Rospotrebnadzor website as of April 27, 2020.

[11] Determination of the Supreme Court of the Russian Federation No. 57-KG18-13 dated September 10, 2018.

[12] Decision of FAS Russia dated May 26, 2015, in Case No. 3-24-47/00-08-14.

[13] Decision of FAS Russia dated June 2, 2016, in Case No. 3-24-30/00-08-15.

[14] Decree of FAS Russia dated November 9, 2015, in Case No. 4-14.3-984/00-08-15.