Dispensing of Medicinal Products

 

March 26, 2022

BRACE Law Firm ©

 

Dispensing medicinal products is the primary activity of any pharmacy organization. New Rules for Dispensing Medicinal Products for Medical Use, approved by Order of the Ministry of Health of Russia No. 1093n dated November 24, 2021 (the "Rules for Dispensing Medicinal Products for Medical Use").[1] These rules entered into force on March 1, 2022, and will remain in effect for six years until September 1, 2027.

The new Rules for Dispensing Medicinal Products for Medical Use replace three previous Ministry of Health orders simultaneously:

• Order 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 and Individual Entrepreneurs Holding a Pharmaceutical License;
• Order No. 562n dated May 17, 2012, On Approval of the Procedure for Dispensing Medicinal Products for Medical Use Containing, in Addition to Small Amounts of Narcotic Drugs, Psychotropic Substances, and Their Precursors, Other Pharmacologically Active Substances to Individuals;
• Order No. 735n dated August 26, 2010, On Approval of the Rules for Dispensing Medicinal Products for Medical Use by Medical Organizations Holding a Pharmaceutical License and Their Separate Subdivisions (Ambulatories, Feldsher and Feldsher-Obstetric Stations, General Medical (Family) Practice Centers (Departments)) Located in Rural Settlements Lacking Pharmacy Organizations.

Regulatory acts do not define the term "dispensing of medicinal products". In practice, it includes the retail sale of medicinal products to consumers, dispensing to medical organizations, and the free or discounted provision of drugs to specific categories of patients. Under Article 4 of Federal Law No. 61-FZ dated April 12, 2010, On Circulation of Medicinal Products (the "Law on Medicinal Products"), medicinal products mean dosage forms used for the prevention, diagnosis, and treatment of diseases, rehabilitation, and the preservation, prevention, or termination of pregnancy. As a general rule, medicinal products must undergo state registration and be entered into the State Register of Medicinal Products, except for those manufactured by pharmacies according to prescriptions, radiopharmaceutical products, and products imported into the Russian Federation for life-saving indications for specific patients or for personal use.

This article analyzes the requirements for dispensing medicinal products (the "MPs"), taking into account recent changes and established law enforcement practice. We should also note that these requirements apply only to products for medical use, as directly follows from the title of the Rules.

Who Is Entitled to Sell Medicines?

Under Article 55 of the Law on Medicinal Products, only a limited circle of entities may engage in the retail trade of medicinal products:

• Pharmacy organizations (pharmacies, pharmacy points, including those serving as structural subdivisions of a medical organization, and pharmacy kiosks);
• Veterinary pharmacy organizations;
• Individual entrepreneurs holding a pharmaceutical license;
• Medical organizations holding a pharmaceutical license and their separate subdivisions (ambulatories, feldsher and feldsher-obstetric stations, general medical (family) practice centers (departments)) located in rural settlements lacking pharmacy organizations. The executive authority of the relevant constituent entity of the Russian Federation approves the list of such organizations.

Each of the above entities has the right to dispense specific categories of products.

Types of Dispensed MPs	Types of Entities Entitled to Dispense Medicines
Over-the-counter (OTC) drugs	All types of pharmacy organizations (pharmacies, pharmacy points, pharmacy kiosks)
	Licensed individual entrepreneurs
	Medical organizations and their separate subdivisions
Prescription drugs (excluding narcotic drugs and psychotropic substances)	Pharmacies and pharmacy points
	Licensed individual entrepreneurs
	Medical organizations and their separate subdivisions
Narcotic drugs and psychotropic substances	Pharmacies and pharmacy points holding a license for activities involving the circulation of narcotic drugs, psychotropic substances, and their precursors
	Medical organizations and their separate subdivisions holding a license for activities involving the circulation of narcotic drugs, psychotropic substances, and their precursors
Immunobiological products	Pharmacies and pharmacy points
	Pharmacy kiosks (only over-the-counter immunobiological products)
	Licensed individual entrepreneurs
	Medical organizations and their separate subdivisions

Thus, pharmacy kiosks do not have the right to dispense prescription medicinal products, including immunobiological products. Individual entrepreneurs and pharmacy kiosks may not dispense narcotic drugs and psychotropic substances.

General Requirements for Dispensing Medicines

The Rules for Dispensing Medicinal Products for Medical Use outline requirements that apply equally to the dispensing of any medicinal product. Let us examine them in more detail.

1. The dispensing of falsified, substandard, and counterfeit medicinal products is prohibited.

Despite the obvious nature of this rule, pharmacies are frequently held liable for this violation in practice. Typically, internal affairs bodies or inspectors conducting test purchases identify these violations. Analysis of judicial practice shows that attempts to challenge liability decisions or to classify the violation as minor or replace the penalty with a warning generally fail. For example, a regional department of the Ministry of Internal Affairs discovered the drug Gabapentin in a pharmacy without secondary packaging and with damaged primary packaging lacking the batch number and expiration date. The inspection materials were sent to the regional Roszdravnadzor office, which issued a resolution holding the legal entity administratively liable under Part 1 of Article 6.33 of the CAO RF for the sale of a counterfeit medicinal product, imposing a fine of 1,000,000 rubles. The pharmacy's arguments that the sale was not proven and that the violation should be reclassified under Article 14.2.2 of the CAO RF (violation of wholesale trade rules) were rejected by all courts, including the Supreme Court of the Russian Federation.[2] This court position appears correct given the significance of the interests protected by law, such as the life and health of citizens.

2. The person purchasing (receiving) the medicinal product must be informed about the dosage and administration regimen, home storage rules, and interactions with other medicinal products.

The order does not regulate the duration or volume of pharmaceutical counseling, which largely depends on the specific requests of the buyer. Typically, special attention is paid to the storage conditions of the product. In any case, even if a patient does not wish to receive information, we recommend advising them to read the instructions. It is prohibited to provide inaccurate or incomplete information about the availability of medicinal products, including those with the same INN, or to hide information about the availability of lower-priced medicinal products.

The intent of this rule to protect buyers is clear. However, the pharmaceutical community is debating when and to what extent such information should be provided. Regarding liability for this violation, it is not explicitly established in the CAO RF, although relevant bills have been submitted to the State Duma. Typically, this violation is identified alongside others, and the entity is held liable under Part 1 of Article 14.1 of the CAO RF for violating licensing requirements.[3]

We should also address the issue of splitting primary packaging. Previously applicable dispensing rules [4] prohibited breaking primary packaging; secondary packaging ("splitting the pack") could be divided provided the buyer was given the instructions for use or a copy thereof. The new Rules for Dispensing Medicinal Products for Medical Use stipulate that the dispensing of an medicinal product must be carried out in primary and secondary packaging, the labeling of which must comply with legislative requirements (Paragraph 14 of the Rules for Dispensing Medicinal Products for Medical Use). Only pharmacies with the right to manufacture medicines and when dispensing upon the request of a medical organization are permitted to break primary packaging. This rule triggered disputes among professionals regarding the possibility of splitting secondary packaging. In an information letter, the Ministry of Health of the Russian Federation stated that the Rules for Dispensing Medicinal Products for Medical Use do not prohibit this and explained how to comply with labeling procedures in such cases.[5] However, one should keep in mind that such a conclusion does not strictly follow from the literal reading of the order. It remains to be seen which path law enforcement practice will take.

Rules for Dispensing Prescription Drugs

Stricter requirements apply to the dispensing of prescription drugs, and non-compliance may lead to administrative liability. Let us examine them in detail.

First, it is prohibited to dispense prescription MPs without a prescription or with a prescription of an improper form.

The Rules for Dispensing Medicinal Products for Medical Use define medicinal products that are subject only to prescription dispensing, as well as the prescription forms permitted for their dispensing.

Prescription Form	Types of Dispensed MPs
No. 148-1/y-88	Narcotic and psychotropic medicinal products (the "Narcotics and Psychotropics") of Schedule II [6] in the form of transdermal therapeutic systems
	Psychotropic medicinal products (the "Psychotropics") of Schedule III
	Individually manufactured combined medicinal products containing a narcotic drug or psychotropic substance from Schedule II of the List, and other pharmacologically active substances in a dose not exceeding the maximum single dose (if it is not a Narcotic or Psychotropic)
	MPs containing a narcotic drug in combination with an opioid receptor antagonist from Schedule II of the List
	MPs included in the list of products subject to quantitative accounting (the "PQU")[7]
No. 148-1/y-88 and No. 148-1/y-04(l)	MPs dispensed free of charge or at a discount
No. 107/y-NP	Narcotics and Psychotropics of Schedule II of the List (except for transdermal therapeutic systems and MPs containing a narcotic drug in combination with an opioid receptor antagonist)
No. 107-1/y	Other MPs subject to prescription dispensing

Analysis of judicial practice shows that dispensing such products without a prescription, in the absence of criminal elements, is classified as a gross violation of licensing requirements under Part 4 of Article 14.1 of the CAO RF. This is punishable by a fine ranging from 100,000 to 200,000 rubles or administrative suspension of activities for up to 90 days.[8]

Second, it is mandatory to comply with the regulated procedure for dispensing medicines.

Prior to dispensing, the pharmaceutical worker must verify the prescription for compliance with the rules for issuing prescriptions. The procedure for prescribing medicinal products, the design of prescription forms, and the forms themselves are determined by Order of the Ministry of Health of the Russian Federation No. 1094n dated November 24, 2021.[9] In practice, they verify the compliance of the form with the prescribed MP, the presence of mandatory details, the authority of the person who issued the prescription, the correctness of the prescription and the route of administration, the maximum single and daily doses for the patient, the quantity of the prescribed MP, and the validity period of the prescription.

Dispensing based on prescriptions issued in violation of the rules is not permitted. Under Paragraph 20 of the Rules for Dispensing Medicinal Products for Medical Use, such prescriptions are recorded in a Register, which indicates the identified violations in the prescription design, the full name of the medical worker who issued it, the name of the medical organization, and the measures taken. The prescription is stamped "Prescription Invalid" and returned to the person who presented it. The retail entity informs the head of the relevant medical organization about the violations to ensure measures are taken and the prescription is reissued.

For instance, courts found it legal and justified to hold a pharmacy organization administratively liable under Part 1 of Article 14.1 of the CAO RF for dispensing an medicinal product based on an improperly issued prescription (it lacked the medical organization's seal). Further violations included improper processing at the pharmacy (missing full name of the pharmacy worker, product name, quantity, organization name, seal) and the absence of a Register for Invalid Prescriptions. The fine amounted to 100,000 rubles.[10]

When dispensing medicinal products, the pharmaceutical worker marks the prescription "Medicinal Product Dispensed", including the details provided for in Paragraph 15 of the Rules for Dispensing Medicinal Products for Medical Use. If a prescription was issued for a long-term course of treatment with a validity period of up to one year, the dispensing details must be recorded to be considered during subsequent visits. Once the maximum quantity has been dispensed under such a prescription, or upon its expiration, it is stamped "Medicinal Product Dispensed" and returned to the individual.

The possibility of substituting medicinal product dosages deserves separate attention. If the retail entity has the medicinal product in a dosage different from that specified in the prescription, the following rules apply:

• If the dosage is lower than specified in the prescription, the pharmaceutical worker recalculates the quantity based on the prescribed treatment course.
• Substitution with a higher dosage may only be performed upon agreement with the medical worker who issued the prescription. The order does not specify the method of agreement.

Third, it is necessary to comply with the terms for delayed service.

If the retail entity lacks the MP at the time of the request, the prescription is subject to delayed service, which is the period during which the retail entity must provide the necessary product to the prescription holder. Paragraph 12 of the Rules for Dispensing Medicinal Products for Medical Use regulates the timelines for the delayed service of prescriptions:

• Prescriptions marked "statim" (immediately) – within 1 business day;
• Prescriptions marked "cito" (urgently) – within 2 business days;
• Prescriptions for medicinal products prescribed by decision of a medical commission – within 10 business days;
• Prescriptions for medicinal products included in the minimum assortment of medicinal products approved by Directive of the Government of the Russian Federation No. 2406-r dated October 12, 2019 – within 5 business days; if dispensed free of charge or at a discount – within 2 business days;
• Prescriptions for medicinal products not included in the minimum assortment – within 10 business days; if dispensed free of charge or at a discount – within 5 business days.

These timelines will only remain in effect until September 1, 2022. Service timelines for prescriptions after this date have not yet been determined.

Upon accepting a prescription for delayed service, the pharmacy organization must fill out a delayed service register (Paragraph 5 of the Rules of Good Pharmacy Practice for Medicinal Products for Medical Use).[11]

Failure to comply with delayed service timelines carries legal risks, particularly regarding discounted prescriptions. For example, the Supreme Court of the Russian Federation upheld a decision to recover from a pharmacy organization (responsible for providing medicinal products under Federal Law No. 178-FZ dated July 17, 1999, On State Social Assistance) the costs incurred by a citizen to purchase the medicinal product amounting to 95,500 rubles, moral damages of 5,000 rubles, and legal costs.[12] As the courts stated, if the required medicinal product is unavailable at the time of the citizen's request, the pharmaceutical organization must organize delayed service. Instead, the organization requested the medical institution to revoke the issued prescription. The Supreme Court rejected the pharmacy's argument that it was not at fault because the quantity provided for in the contract had already been issued to other beneficiaries. Furthermore, administrative liability under Part 4 of Article 14.1 of the CAO RF for violating licensing requirements is not excluded.[13]

Fourth, it is necessary to ensure the storage of prescriptions for the established periods.

The Rules for Dispensing Medicinal Products for Medical Use define the following storage periods for prescriptions after they have been dispensed:

1. Medicinal products dispensed free of charge or at a discount – for 3 years;
2. Medicinal products classified by ATC as antipsychotics (code N 05A), anxiolytics (code N 05B), hypnotics and sedatives (code N 05C), and antidepressants (code N 06A), which are not subject to quantitative accounting – for 3 months;
3. Narcotic and psychotropic medicinal products of Schedule II, and psychotropic medicinal products of Schedule III – for 5 years;
4. Combined medicinal products containing narcotic drugs or psychotropic substances from Schedules II and III of the List manufactured in the pharmacy, and medicinal products subject to quantitative accounting – for 3 years.

Other prescriptions on form No. 107-1/y are not subject to storage and are returned to the person purchasing the product.

Failure to comply with the procedure and periods for storing prescriptions may lead to adverse consequences, particularly for controlled Narcotic and Psychotropic drugs or PQU products. During operational-search activities, it was revealed that a pharmacy point sold 260 packs of Piralgin, 100 packs of Sedal-M, and 262 packs of Pentanov N, but failed to provide the prescription forms for the dispensed products. The legal entity was held administratively liable under Part 4 of Article 14.1 of the CAO RF, resulting in a suspension of activities for 30 days.[14]

Dispensing via Electronic Prescriptions

Dispensing via prescriptions in the form of an electronic document is possible if the executive authority decides to use electronic prescriptions alongside paper ones in a specific constituent entity of the Russian Federation. To work with electronic prescriptions, pharmacy organizations must be connected to the Unified State Health Information System in the Sphere of Healthcare (EGISZ). Dispensing may only occur in the constituent entity of the Russian Federation where the prescription was issued.

Under Paragraph 19 of the Rules for Dispensing Medicinal Products for Medical Use, a prescription in the form of an electronic document signed with an enhanced qualified electronic signature is generated by a medical worker whose details are entered into the federal register of medical workers. This is also conditional on the registration of the medical organization where the prescription is issued in the federal register of medical organizations of the EGISZ and the connection of such a medical organization to the regional state healthcare information system.

Dispensing via Medical Organization Demands

Medicinal products are dispensed to a medical organization for its diagnostic and treatment processes not by prescriptions, but by "demands" (requisitions). The procedure for formalizing demands is established by Order of the Ministry of Health and Social Development of the Russian Federation No. 110 dated February 12, 2007, On the Procedure for Prescribing and Writing Out Medicinal Products, Medical Devices, and Specialized Medical Food Products (the "Order No. 110"). A demand must have a stamp, the round seal of the medical organization, and the signature of its head or deputy for clinical work. Mandatory details for demands are defined in the Instructions on the Procedure for Prescribing Medicinal Products and Designing Prescriptions and Demand-Invoices (Appendix No. 13 to Order No. 110).

The storage period for demands is identical to that for prescriptions:

• For medicinal products dispensed free of charge or at a discount – for 3 years;
• For medicinal products classified by ATC as antipsychotics (code N 05A), anxiolytics (code N 05B), hypnotics and sedatives (code N 05C), and antidepressants (code N 06A), which are not subject to quantitative accounting – for 2 months.

The requirement for the monthly commission-based destruction of demands, previously established by Paragraph 3.8 of Order No. 110, has been abolished, which simplifies document management.

Procedure for Dispensing Narcotics and Psychotropics, and MPs Containing Narcotic Drugs and Psychotropic Substances

In addition to the previously discussed requirements, the Rules for Dispensing Narcotic Drugs and Psychotropic Substances Registered as Medicinal Products for Medical Use, and Medicinal Products for Medical Use Containing Narcotic Drugs and Psychotropic Substances, approved by Appendix No. 2 to Order of the Ministry of Health of the Russian Federation No. 1093n dated November 24, 2021 (the "Rules for Dispensing Narcotic Drugs and Psychotropic Substances"), establish several additional requirements.

First, only individuals holding positions included in the list of pharmaceutical and medical worker positions in organizations entitled to dispense such products may perform the dispensing of Narcotics and Psychotropics. The list of such positions was approved by Order of the Ministry of Health of the Russian Federation No. 681n dated September 7, 2016.[15]

Second, as a general rule, the person named in the prescription, their legal representative, or another person presenting a power of attorney issued in accordance with the legislation of the Russian Federation may personally receive Schedule II Narcotics and Psychotropics (except for patches and MPs combined with an opioid receptor antagonist). If a power of attorney does not specify its validity period, it is considered valid for one year from the date of its issuance (Part 1 of Article 186 of the Civil Code). The Rules for Dispensing Narcotic Drugs and Psychotropic Substances do not require the power of attorney to be notarized or for a copy to be kept. Dispensing is performed upon presentation of a document certifying the identity of the person receiving the product.

For the first time, the Rules for Dispensing Medicinal Products for Medical Use make an exception for receiving products for incurable patients in the final stage of life when they are unable to issue a power of attorney. In such cases, dispensing may be performed to other persons caring for them upon presentation of a document confirming the patient's incurable condition and containing details of the person who may receive the medicinal products. This medical certificate remains with the pharmacy organization.

Third, after dispensing Narcotics and Psychotropics, a "signature" (duplicate prescription label) is issued with a yellow stripe at the top and the word "Signature" in black font. It must indicate:

1. Name and address of the pharmacy, pharmacy point, medical organization, or separate subdivision of the medical organization;
2. Number and date of the issued prescription;
3. Full name and age of the person for whom the medicinal product is intended;
4. Medical record number of the patient receiving outpatient medical care for whom the medicinal product is intended;
5. Full name and contact phone number of the medical worker who issued the prescription, or the medical organization's phone number;
6. Contents of the prescription in Latin or Russian;
7. Full name and signature of the pharmaceutical or medical worker who dispensed the medicinal product;
8. Date of dispensing.

When dispensing a Schedule II narcotic or psychotropic medicinal product, the seal of the pharmacy or pharmacy point showing its full name must be placed on the prescription (if a seal is available).

Specifics of Dispensing Immunobiological Medicinal Products

Under Paragraph 7 of Article 4 of the Law on Medicinal Products, immunobiological medicinal products (the "ILP") are those intended to form active or passive immunity, or to diagnose the presence of immunity, or to diagnose specific acquired changes in the immunological response to allergenic substances (vaccines, toxoids, toxins, serums, immunoglobulins, and allergens).

ILPs are dispensed only if the purchaser (recipient) possesses a special thermal container or can purchase the necessary means for transportation (thermal container, ice packs) at the pharmacy. This rule is established to maintain the cold chain, which is critical for the transportation of this category of MPs. Furthermore, the purchaser must be informed that the ILP must be delivered to a medical organization within a period not exceeding the operating temperature maintenance period of the transport means specified in the instructions. For this same purpose, the exact time (hours and minutes) of dispensing must be indicated on the prescription or the prescription stub remaining with the purchaser.

In conclusion, it is necessary to note the positive trend toward the systematization and unification of regulatory acts governing the dispensing of medicinal products. Furthermore, changes aimed at reducing bureaucratic barriers to obtaining medicines for incurable patients, shortening delayed service timelines, and allowing for electronic prescriptions deserve a positive assessment. Nevertheless, in our view, work in this direction must continue, including improving the legal drafting techniques used in preparing these acts.

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References

1. Order of the Ministry of Health of the Russian Federation No. 1093n dated November 24, 2021, On Approval of the Rules for Dispensing Medicinal Products for Medical Use by Pharmacy Organizations, Individual Entrepreneurs Holding a Pharmaceutical License, Medical Organizations Holding a Pharmaceutical License and Their Separate Subdivisions (Ambulatories, Feldsher and Feldsher-Obstetric Stations, General Medical (Family) Practice Centers (Departments)) Located in Rural Settlements Lacking Pharmacy Organizations, as well as the Rules for Dispensing Narcotic Drugs and Psychotropic Substances Registered as Medicinal Products for Medical Use, and Medicinal Products for Medical Use Containing Narcotic Drugs and Psychotropic Substances, including the Procedure for Dispensing Immunobiological Medicinal Products by Pharmacy Organizations.
2. Ruling of the Supreme Court of the Russian Federation No. 308-ES21-8342 in case No. A32-22725/2020 dated July 26, 2021.
3. Resolution of the Twelfth Arbitration Court of Appeal No. 12AP-11213/21 in case No. A12-26396/2021 dated December 25, 2022.
4. Order of the Ministry of Health of the Russian Federation 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 and Individual Entrepreneurs Holding a Pharmaceutical License.
5. Letter of the Ministry of Health of the Russian Federation No. 25–4/I/2–2643 dated February 18, 2022.
6. The List of Narcotic Drugs, Psychotropic Substances, and Their Precursors (Schedules I-IV) was approved by Decree 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.
7. Order of the Ministry of Health of the Russian Federation No. 183n dated April 22, 2014, On Approval of the List of Medicinal Products for Medical Use Subject to Subject-to-Quantitative Accounting.
8. Ruling of the Supreme Court of the Russian Federation No. 308-ES20-3647 in case No. A53-24334/2019 dated April 6, 2020.
9. Order of the Ministry of Health of the Russian Federation No. 1094n dated November 24, 2021, On Approval of the Procedure for Prescribing Medicinal Products, Prescription Forms for Medicinal Products, the Procedure for Designing 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 Designing Prescription Forms, including in the Form of Electronic Documents.
10. Resolution of the Arbitration Court of the Moscow District No. F05-3301/20 in case No. A40-264265/2019 dated June 8, 2020.
11. Order of the Ministry of Health of the Russian Federation No. 647n dated August 31, 2016, On Approval of the Rules of Good Pharmacy Practice for Medicinal Products for Medical Use.
12. Ruling of the Judicial Chamber for Civil Cases of the Supreme Court of the Russian Federation No. 53-KG17-32 dated February 19, 2018.
13. Resolution of the Seventeenth Arbitration Court of Appeal No. 17AP-14174/21 in case No. A60-13966/2021 dated February 4, 2022.
14. Resolution of the Sixteenth Arbitration Court of Appeal No. 16AP-739/21 in case No. A20-5181/2020 dated March 22, 2021.
15. Order of the Ministry of Health of the Russian Federation No. 681n dated September 7, 2016, On the List of Pharmaceutical and Medical Worker Positions in Organizations Entitled to Dispense Narcotic Medicinal Products and Psychotropic Medicinal Products to Individuals.