11 April 2022

Prescription of Medicinal Products and Medical Devices

April 11, 2022

BRACE Law Firm ©

In modern conditions, drug therapy remains an integral part of medical care. Regulatory acts governing the prescription of medicinal products are regularly revised. The new Procedure for Prescribing Medicinal Products, approved by the Order of the Ministry of Health of Russia No. 1094n dated November 24, 2021 (the "Prescription Order", the "Order No. 1094n"),[1] entered into force on March 1, 2022, and will remain effective for seven years until September 1, 2028.

This Order replaces several previous orders of the Ministry of Health of Russia:

Order No. 4n dated January 14, 2019, On Approval of the Procedure for Prescribing Medicinal Products, Prescription Forms for Medicinal Products, the Procedure for Completing Said Forms, Their Accounting and Storage;
Order No. 562n dated May 17, 2012, On Approval of the Procedure for Dispensing Medicinal Products for Medical Use to Individuals Containing Other Pharmacologically Active Substances in Addition to Small Quantities of Narcotic Drugs, Psychotropic Substances, and Their Precursors;
Order No. 54n dated August 1, 2012, On Approval of the Form of Prescription Blanks Containing the Prescription of Narcotic Drugs or Psychotropic Substances, the Procedure for Their Manufacture, Distribution, Registration, Accounting, and Storage, as well as the Rules for Completion.

In this article, we analyze the requirements for prescribing medicinal products (the "Medicinal Products"), the procedure for manufacturing, completing, and storing prescription forms in light of recent changes and established law enforcement practice. We also provide an overview of the specifics of prescribing and issuing medical devices regulated by the Order of the Ministry of Health of the Russian Federation No. 1181n dated December 20, 2012, On Approval of the Procedure for Prescribing and Issuing Medical Devices, as well as Prescription Forms for Medical Devices and the Procedure for Completing Said Forms, Their Accounting and Storage (the "Procedure for Prescribing and Issuing Medical Devices").

Who Is Authorized to Prescribe Medicinal Products?

The right to prescribe medicinal products for medical use is granted to a limited circle of entities:

The attending physician;
A paramedic;
A midwife;
Individual entrepreneurs holding a license for medical activity (the "Medical Workers").

Regarding paramedics and midwives, the law includes a caveat: they may prescribe only if the head of the medical organization has assigned them the functions of an attending physician in accordance with the Order of the Ministry of Health and Social Development of the Russian Federation No. 252n dated March 23, 2012.[2] This occurs when they provide emergency medical care as part of emergency teams, primary pre-hospital healthcare at paramedic-midwife stations and health centers, or primary medical healthcare in cases of physician shortages.

Furthermore, individual entrepreneurs are prohibited from issuing prescriptions for narcotic drugs and psychotropic substances.

The following also have the right to prescribe medicinal products to citizens entitled to receive medicinal products free of charge or at a discount:

Medical workers working in a medical organization on a part-time basis;
Medical workers of stationary social service organizations, provided they hold a license to provide primary healthcare in outpatient settings (regardless of departmental affiliation);
Medical workers providing primary healthcare in facilities subordinated to federal executive authorities or executive authorities of the constituent entities of the Russian Federation;
Individual entrepreneurs engaged in medical activity and included in the register of medical organizations operating in the field of Compulsory Medical Insurance (OMS).

General Requirements for Prescribing Medicinal Products

Order No. 1094n outlines requirements that apply equally to the prescription of all medicinal products. Let us examine them in detail.

1. Medical workers must prescribe medicinal products by their International Nonproprietary Name (INN), or in its absence, by their grouping or chemical name.

Prescribing a medicinal product by its trade name is permitted:

If there is no INN, grouping name, or chemical name;
By decision of the Medical Commission of the medical organization due to medical indications (individual intolerance, life-saving indications). If a patient was prescribed a medicinal product with a specific trade name while receiving inpatient care, the further prescription of the medicinal product with the same trade name continues when providing medical care in another medical organization or in outpatient settings.

A medical organization may face administrative liability for violating these rules. For instance, during an unscheduled on-site inspection by a territorial body of Roszdravnadzor, violations in the provision of medical care at a health center were identified, including the prescription of medicinal products "Phenazepam" and "Keterol" by trade names. Based on the identified violations, the company was held administratively liable under Part 4 of Article 14.1 of the CAO RF for conducting business in gross violation of licensing requirements, resulting in a fine of 50,000 rubles.[3]

2. As a general rule, a medical worker prescribes medicinal products individually, except in the following cases:

When providing inpatient medical care

First, the following require coordination with the head of the department or the duty physician, and if available, with a clinical pharmacologist:

The simultaneous prescription of five or more medicinal products to one patient;
The prescription of medicinal products not included in the List of Vital and Essential Drugs (the "VED List"),[4] in cases of atypical disease progression, complications of the underlying disease and (or) comorbidities, or the prescription of medicinal products whose interaction and compatibility, according to their instructions for use, lead to reduced efficiency and safety of pharmacotherapy and (or) create a potential danger to the patient's life and health.

Second, by decision of the Medical Commission, medicinal products are prescribed that are not included in the VED List, as well as those not included in medical care standards or not provided for by the relevant clinical recommendation, if they are replaced due to individual intolerance or for life-saving indications. The Medical Commission records its decision in the patient's medical documentation and the Medical Commission log. No decision is required if the patient receives treatment on a paid basis (paid medical services).

This does not apply to cases where medicinal products are prescribed by workers of a medical organization (or its structural unit) located in a rural settlement, which is clearly due to the shortage of medical personnel in such areas.

When providing primary healthcare and palliative medical care in outpatient settings, the following cases require a decision by the Medical Commission:

The simultaneous prescription of five or more medicinal products to one patient within 24 hours or more than 10 items within 30 days;
The prescription of medicinal products in cases of atypical disease progression, complications of the underlying disease and (or) comorbidities, or the prescription of medicinal products whose interaction and compatibility, according to their instructions for use, lead to reduced efficiency and safety of treatment and (or) create a potential danger to the patient's life and health;
The initial prescription of narcotic and psychotropic medicinal products from Schedules II and III of the List to a patient (if the head of the medical organization decides it is necessary to coordinate the prescription of such medicinal products with the Medical Commission).

Failure to comply with this procedure may lead to various adverse consequences for medical organizations, ranging from the recognition of costs as improper to the recovery of moral damages. For example, during a TFOMS inspection, the medical organization's expenses for the purchase of medicinal products not included in the VED List without a Medical Commission decision were deemed improper in the amount of 91,335.98 rubles. The hospital was ordered to return the funds and pay a fine of 10 percent of the amount plus interest at one-three-hundredth of the Bank of Russia refinancing rate for each day of delay.[5] In another case, moral damages in the amount of 500,000 rubles were recovered from a medical organization in favor of the mother of a deceased patient due to improper medical services. One of the medical care defects cited was the unsubstantiated prescription of the drug "Trimetazidine" and the simultaneous prescription of five medicinal products without coordination with the head of the department.[6]

3. Medicinal products are prescribed by issuing a prescription, except when providing inpatient medical care.

When providing medical care in inpatient settings, the medical worker records the prescription of medicinal products in the patient's medical documentation. Issuing a prescription is permitted upon the patient's discharge from the hospital if it is necessary to continue taking the medicinal product in outpatient settings (except for products to be dispensed free of charge or at a discount).

It is prohibited to issue prescriptions:

In the absence of medical indications for the patient;
For unregistered medicinal products;
For medicinal products which, according to the instructions for medical use, are intended for use only in medical organizations;
For narcotic drugs and psychotropic substances included in Schedule II, registered as medicinal products, for the treatment of drug addiction.

The prescription is issued in the name of the patient for whom the medicinal product is intended. Information about the prescribed product (name, dosage, method of administration and use, dosage regimen, duration of treatment, and justification for the prescription) is entered into the patient's medical documentation.

The prescription may be received by the patient, their legal representative, or a person holding a power of attorney issued in accordance with the Civil Code. A power of attorney is not required for a caregiver to receive a prescription for an incurable patient at the final stage of life. In such a case, the medical worker issues a document confirming the patient's incurable state, specifying the full name of the person who will receive the medicinal products, certified by the signature and seal of said medical worker and the seal of the medical organization. The fact of issuing a prescription for a medicinal product to a legal representative or authorized person is recorded in the patient's medical documentation.

Prescription Forms and Their Validity Periods

Order No. 1094n approved the following prescription forms for use:

Prescription Form	Types of Dispensed Medicinal Products
No. 107/u-NP	Narcotic drugs and psychotropic substances (the "NS and PS") of Schedule II[7], except for transdermal therapeutic systems and medicinal products containing a narcotic drug in combination with an opioid receptor antagonist.
No. 148-1/u-88	Schedule II NS and PS in the form of transdermal therapeutic systems; Schedule II narcotic medicinal products containing a narcotic drug in combination with an opioid receptor antagonist; Schedule III PS.
	Combination medicinal products listed in sub-clause 2, clause 9 of the Prescription Order.
	Individually manufactured combination medicinal products containing Schedule II NS or PS and other pharmacologically active substances in a dose not exceeding the maximum single dose, which are not NS and PS.
	Medicinal products included in the list of products subject to quantitative accounting (the "PQU").[8]
No. 148-1/u-88	Medicinal products dispensed free of charge or at a discount.
No. 107/u-NP and No. 148-1/u-88	Schedule II NS and PS of the List subject to discounted dispensing.
No. 107/u-NP, No. 148-1/u-88, and No. 148-1/u-88	Schedule II NS and PS in the form of transdermal therapeutic systems; Schedule II narcotic medicinal products containing a narcotic drug in combination with an opioid receptor antagonist; Schedule III PS; medicinal products included in the PQU list subject to discounted dispensing.
No. 107-1/u	Combination medicinal products listed in sub-clause 2, clause 11 of the Prescription Order. Other medicinal products subject to prescription dispensing.

Order No. 1094n also approved the templates for the forms. Compared to previously effective ones, they have not undergone significant changes; they now contain a reference to the new order. Prescription forms of template 107/u-NP manufactured before March 1, 2022, may be used until March 1, 2023.[9]

Prescription forms No. 148-1/u-88 and No. 107/u-NP are manufactured exclusively by printing; others may be printed using printing devices. Furthermore, No. 107/u-NP forms are secure printing products and have a series and number. Medical organizations receive such forms through the Ministry upon an application submitted annually before October 1.

Requirements for Completing Prescription Forms

Requirements for completing prescription forms (except for form No. 107/u-NP) are defined in Appendix No. 3 to Order No. 1094n, the Procedure for Completing Prescription Forms for Medicinal Products, Their Accounting and Storage (the "Procedure for Completing Prescription Forms"). The format of this article allows for the consideration of only the most significant of them.

Prescriptions may be issued in paper form or as an electronic document. The issuance of electronic prescriptions is possible if such a decision is made by the executive authority of the constituent entity of the Russian Federation. An electronic prescription may be generated by a medical worker whose details are entered in the federal register of medical workers, provided that the medical organization where the prescription is issued is registered in the federal register of medical organizations of the EGISZ and connected to the EGISZ of the constituent entity of the Russian Federation.

Paper prescription forms are filled out with ink or a ballpoint pen or using printing devices, except for the signature. No corrections are allowed in the prescription. The use of abbreviations specified in the appendix to the Prescription Order is permitted, except in cases where it would be unclear which product is prescribed.

The prescription must include the date of issue, as well as the stamp of the medical organization indicating the name, address, and telephone number, or the details of the individual entrepreneur indicating the number, date, and body that issued the license. If immediate or urgent (within 2 business days) dispensing of a medicinal product is necessary, the designations "cito" (urgently) or "statim" (immediately) are placed at the top of the paper prescription.

The medical worker enters the following data into the relevant columns of the prescription:

The patient's last name and initials, and their date of birth;
The full name of the medical worker who issued the prescription;
SNILS and the OMS policy number (only in prescription forms No. 148-1/u-04(l));
The residential address or the patient's medical card number (only in prescription forms No. 148-1/u-88).

Regarding the content of the prescription, the following aspects should be noted:

1. The name, composition of the product, dosage form, and address to the pharmaceutical specialist in paper prescriptions may be indicated in Latin or Russian; in electronic prescriptions, only in Russian.

2. Only one name of a medicinal product may be prescribed on a single prescription form No. 148-1/u-88 and form No. 148-1/u-04(l). On form No. 107-1/u, such restrictions apply only to products categorized under ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), and antidepressants (code N06A) not subject to quantitative accounting; for others, up to three names of medicinal products may be included in one prescription.

3. The prescription must specify the method of using the medicinal product, including the route of administration, dose, frequency, time of intake relative to sleep (morning, at night) and its duration, and the time of consumption relative to meals (before meals, during meals, after meals) for medicinal products that interact with food.

4. The quantity of active substances is indicated in accordance with the instructions for medical use of the medicinal product.

5. When prescribing medicinal products included in the PQU list, where the dose exceeds the maximum single intake, a "!" sign is placed.

6. The medical worker signs the prescription and certifies it with their seal. A prescription issued on form No. 148-1/u-88 and form No. 148-1/u-04(l) is additionally certified with the seal of the medical organization "For prescriptions". For medicinal products prescribed by decision of the Medical Commission, a special mark (stamp) is placed on the back of the prescription form.

7. On discount prescriptions, digital coding is additionally used, and a mark about the dispensed product is made on the prescription stub.

It should be mentioned that specific rules apply to electronic prescriptions. In addition to the above information, several additional columns are filled out in accordance with clause 20 of the Procedure for Completing Prescription Forms. The prescription is signed with the enhanced qualified electronic signature of the physician, and in cases of issuance by decision of the Medical Commission or upon coordination with authorized persons of the medical organization, with the signatures of the relevant medical workers.

Prescriptions issued in violation of the rules are considered invalid and must be reissued by the medical worker who issued the prescription. Furthermore, errors in prescription may result in administrative liability for the medical organization. For example, when considering a complaint about medical care, Roszdravnadzor found that the method and time of administration of the medicinal product "Ceftriaxone" were not specified in the medical record of an outpatient. The regulatory body deemed this a failure to comply with internal quality control requirements, which constitutes a gross violation of licensing requirements and conditions. The medical organization's arguments that the actions did not pose a threat of harm to the life or health of the child were not accepted by the court. An administrative fine within the sanctions of Part 4 of Article 14.1 of the CAO RF in the amount of 100,000 rubles was imposed.[10]

Specifics of Issuing Prescriptions for Narcotic Drugs and Psychotropic Substances

The circulation of narcotic drugs and psychotropic substances is subject to special state control due to their specific nature, and therefore the procedure for their prescription has its own characteristics. General principles for prescribing NS and PS are formulated in Federal Law No. 3-FZ dated January 8, 1998, On Narcotic Drugs and Psychotropic Substances. Let us recall them:

Only narcotic drugs and psychotropic substances included in Schedules II and III and registered in the territory of the Russian Federation may be used for medical purposes (Part 1 of Art. 31).
Treatment of drug addiction with NS and PS included in Schedule II is prohibited (Part 6 of Art. 31).
Issuing prescriptions for NS and PS without medical indications is prohibited (Art. 26).
Before prescribing, a medical worker must question the patient about previous prescriptions of NS and PS and make a corresponding entry in the medical documentation (Part 5 of Art. 25).

The procedure for issuing prescriptions for NS and PS is regulated in Appendix No. 6 to Order No. 1094n (the "Procedure for Issuing NS and PS Prescriptions").

When issuing prescriptions for NS and PS, both general requirements (identical to those for other types of prescriptions, such as legible completion with a ballpoint pen, no corrections, etc.) and special ones must be observed. Let us consider them in detail:

The patient's last name, first name, and patronymic are indicated in full.
Several products cannot be prescribed in one prescription, even if they all relate to narcotic or psychotropic drugs.
The maximum quantity of narcotic or psychotropic substances that can be prescribed in one prescription (established in Appendix No. 1 to Order No. 1094n) must be observed. This quantity can be increased only for the following groups of patients:

Those requiring long-term treatment, primary healthcare, and palliative medical care—by no more than 2 times based on clinical recommendations;
Those with chronic diseases, if treatment lasts more than 30 days—for a treatment course of up to 60 days.

On such prescriptions, the inscription "By special prescription" is made, which is separately certified by the signature of the medical worker and the seal of the medical organization "For prescriptions".

The completed prescription is certified by the signature and personal seal of the physician or the signature of a paramedic (midwife), and the seal of the medical organization or its structural unit "For prescriptions", specifying the full name of the authorized person who certified the prescription and their personal signature. To issue prescriptions at home when providing palliative care, preliminary certification of the prescription with the stamp and seal of the medical organization is allowed, with a mandatory entry in the Logbook for Registration and Accounting of Prescription Forms about the issuance of a prescription for completion at home and a record of the fact of its completion.

The Procedure for Issuing NS and PS Prescriptions allows for the issuance of prescriptions for narcotic and psychotropic products not only in traditional paper form but also as an electronic document.

It should be noted that issuing prescriptions containing a prescription of narcotic drugs or psychotropic substances without relevant medical indications or in violation of established completion rules is prohibited and may lead to criminal liability under Article 233 of the Criminal Code of the Russian Federation, the maximum penalty for which is imprisonment for up to 2 years with deprivation of the right to hold certain positions or engage in certain activities for up to 3 years or without it.

Procedure for Accounting and Storage of Prescription Forms

Prescription forms are subject to special accounting and storage. Since March 1, 2022, the procedure for accounting and storage has also been regulated by Order No. 1094n.

The accounting of forms No. 107-1/u, No. 148-1/u-88, and No. 148-1/u-04(l) is carried out in accounting logs, which must be numbered, corded, and sealed with the signature of the head and the seal of the medical organization. Electronic prescriptions are recorded in a unified register of prescriptions maintained in the EGISZ of the constituent entity. Once a quarter, a commission checks the status of storage, accounting, actual availability, and consumption of prescription forms.

The main stock of prescription forms is stored by an authorized person in a lockable metal cabinet (safe) or metal box. Forms issued for prescribing are stored by medical workers in premises that ensure their safety.

Registration, accounting, and storage of special prescription forms template No. 107/u-NP are carried out under a stricter procedure.

A separate Logbook for Registration and Accounting of Special Prescription Forms is maintained for such forms. It must be numbered, corded, and have an entry on the last page containing the number of pages and the full name of the medical organization, certified by the signature of the head and a seal. The list of mandatory columns for logs is defined in Appendix No. 5 to Order No. 1094n. A standing commission is established in the medical organization, which checks the status of storage, accounting, actual availability, and consumption of prescription forms subject to accounting at least once a quarter.

The main stock of prescription forms template No. 107/u-NP is stored by a responsible person appointed by the head of the medical organization in special rooms, safes, or in specially manufactured cabinets lined with galvanized iron with an internal or padlock. They must be locked and, after work, sealed or lead-sealed. The stock of forms should not exceed the annual requirement.

A medical worker entitled to prescribe narcotic (psychotropic) medicinal products is issued no more than 20 special prescription forms at one time. A medical worker who has received the forms is obliged to store them under lock and key in an inaccessible place (safes, metal cabinets, metal boxes) and bears personal responsibility for their safety.

Violations in the storage of prescription forms are typically identified during inspections and, if combined with other violations in the field of circulation of narcotic drugs, may be qualified under Art. 6.16 of the CAO RF as a violation of the rules for the circulation of narcotic drugs and psychotropic substances.

Prescription of Medical Devices

The procedure for prescribing and issuing medical devices is similar to the procedure governing the prescription of medicinal products, but less detailed. Let us briefly touch upon the main differences.

First, the circle of persons entitled to issue medical devices is narrower. It includes the attending physician and a paramedic/midwife in case the powers of the attending physician are assigned to them.

Second, other prescription forms are used for issuing medical devices: templates No. 1-MI, No. 2-MI, and No. 3-MI.

Third, the law does not provide for issuing a prescription for a medical device to a representative by power of attorney.

Fourth, several specifics for completion, storage, and accounting of prescription forms have been established. For example, there should be no more than a six-month stock of forms, and no more than a two-week requirement should be issued to medical workers, among others.

In conclusion, we emphasize the need for strict compliance with the rules for prescribing medicinal products, as violations may lead to various adverse consequences for medical workers and medical organizations, ranging from significant financial sanctions to criminal prosecution.

________________

References

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

[2] Order of the Ministry of Health and Social Development of the Russian Federation No. 252n dated March 23, 2012, On Approval of the Procedure for Assigning Individual Functions of an Attending Physician to a Paramedic or Midwife by the Head of a Medical Organization When Organizing the Provision of Primary Healthcare and Emergency Medical Care for the Direct Provision of Medical Care to a Patient During the Period of Observation and Treatment, Including the Prescription and Use of Medicinal Products, Including Narcotic Medicinal Products and Psychotropic Medicinal Products.

[3] Resolution of the Arbitration Court of the Volga District dated November 24, 2020, No. F06-67385/20 in case No. A06-2862/2020.

[4] Order of the Government of the Russian Federation No. 2406-р dated October 12, 2019.

[5] Resolution of the Sixth Arbitration Appellate Court dated March 23, 2021, No. 06AP-750/21 in case No. A73-15739/2020.

[6] Ruling of the Judicial Collegium for Civil Cases of the Fourth Cassation Court of General Jurisdiction dated October 6, 2020, in case No. 8G-18004/2020[88-18196/2020].

[7] The List of Narcotic Drugs, Psychotropic Substances, and Their Precursors (Schedules I-IV) was approved by the Resolution of the Government of the Russian Federation No. 681 dated June 30, 1998, On Approval of the List of Narcotic Drugs, Psychotropic Substances, and Their Precursors Subject to Control in the Russian Federation.

[8] Order of the Ministry of Health of Russia No. 183n dated April 22, 2014, On Approval of the List of Medicinal Products for Medical Use Subject to Subject-to-Quantitative Accounting.

[9] Letter of the Ministry of Health of Russia No. 25-4/I/2-2927 dated February 24, 2022, On the Introduction of New Prescription Forms.

[10] Resolution of the Fifteenth Arbitration Appellate Court dated March 10, 2022, No. 15AP-1092/22 in case No. A32-49201/2021.