Monitoring of medicines Roszdravnadzor. The new version of the KMIS pharmacy has added an integration function with the federal service for “operational monitoring of medicines”

The procedure for operational monitoring of medicines is carried out by Roszdravnadzor. The examination, as well as further decision-making, is assigned to the Ministry of Health of the Russian Federation. In the article we read how exactly drugs are monitored, what exactly the departments request and what work is being done in relation to dangerous drugs.

Operational monitoring of medicines: conducting an audit

Regular operational monitoring of medicines by Roszdravnadzor concerns all drugs that are in open or restricted access in Russia. The main purpose of the verification procedure is to protect patients and promptly detect unsafe medications that can harm health and life. To prepare for monitoring, keep records of all medications in a convenient program

Medicines accounting

The authority responsible for drug monitoring is Roszdravnadzor. Specialists from the Ministry of Health of the Russian Federation also participate in the decision-making process and the examination.

Why do you need to audit medications?

From March 1, 2017 internal audit is considered mandatory. Regular internal audits allow you to:

• reduce the likelihood of risks of using drugs that are dangerous to the health and life of patients;
• minimize the problems of drug circulation;
• optimize the work of a medical institution;
• prepare for inspections by authorities - detect problems, reduce or avoid penalties.

How is interaction with the department structured?

All medical enterprises working with medicines must transmit a number of data to regulatory authorities. Thus, for operational monitoring of drugs, data is provided on:

• negative reactions not expected after taking medications;
• side effects that were not declared by the manufacturer;
• recorded non-standard interactions of drugs when they were prescribed together as a result of clinical trials.

Any operational monitoring of medicines by Roszdravnadzor involves the regular provision of relevant information to the agency from any entities using medicines in their work.

Legislatively, the procedure for interaction between subjects and authorities is enshrined in two Orders:

• for products used in the field of veterinary medicine, Order of the Ministry of Agriculture of the Russian Federation No. 357 of October 10, 2011 is in force;
• For products used in work practice, Order of the Ministry of Health and Social Development of the Russian Federation No. 757n dated August 26, 2010 is relevant.

Monitoring of drugs by Roszdravnadzor

The agency arranges an inspection after it receives. Monitoring of drugs by Roszdravnadzor is possible if the medical organization provides the relevant information:

• use of medications in clinics. In particular, here we are talking about recorded adverse and unplanned reactions, including threats to the patient’s life, as well as data on the features of interaction and compatibility of drugs;
• reports that are related to the safety of drugs. They are formed based on requests from medical organizations, patients and other entities. Reports from the Federal Service for Surveillance in Healthcare contain detailed information about whether a particular product is effective and what dangers there are when using it;
• current data transmitted by other executive authorities, for example, relating to a constituent entity of the Russian Federation in the field of healthcare, based on the results of their own audit.

Penalties depending on the grounds:

• for violation of licensing requirements (clause 3 of article 14.1 of the Code of Administrative Offenses of the Russian Federation). For officials 3,000-4,000 rubles, legal entities 30,000-40,000 rubles.
• gross violation of licensing requirements (clause 4 of article 14.1 of the Code of Administrative Offenses of the Russian Federation). For officials 5,000-10,000 rubles, for individual entrepreneurs – 4,000-8,000*, for legal entities – 100,000-200,000* rubles.
• violation of the legislation on the circulation of drugs (Article 14.4.2 of the Code of Administrative Offenses of the Russian Federation). For officials - 5,000-10,000 rubles, for legal entities - 20,000-30,000 rubles.
• sale of goods, performance of work or provision of services in the absence of established information (Clause 1 of Article 14.5 of the Code of Administrative Offenses of the Russian Federation). For officials 3,000-4,000 rubles, for legal entities – 30,000-40,000 rubles.
• inflated prices for vital and essential drugs (clause 1 of article 14.6 of the Code of Administrative Offenses of the Russian Federation). For officials - 50,000** rubles, for legal entities - two times the amount of excess revenue for the entire period of violations, but not more than a year.

Violation of the rules for the circulation of narcotic drugs or psychotropic substances (Article 228.2 of the Criminal Code of the Russian Federation). For officials up to 120,000*** rub.

Violation of the rules for the circulation of narcotic drugs or psychotropic substances, which caused harm to health, led to other grave consequences, or for mercenary reasons (Article 228.2 of the Criminal Code of the Russian Federation). For officials - 100,000-300,000*** rubles.

*or suspension of activities for up to 90 days.

**or disqualification for up to 3 years.

*** or income for a period of up to a year, or compulsory work for a period of up to 360 hours with or without deprivation of the right to hold certain positions or engage in certain activities for a period of up to 3 years.

****or income for a period of 1-2 years, or compulsory work for up to 480 hours, or restriction of freedom for up to 3 years, or imprisonment for the same period with deprivation of the right to hold certain positions or engage in certain activities for a period up to 3 years.

Analysis and operational monitoring of medicines in Roszdravnadzor

Operational monitoring of medicines is documented as a set of reports. They are grouped and further analyzed by Roszdravnadzor.

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Entities involved in the circulation of medical devices provide information at the appropriate periods:

• every six months – the drug has been registered for less than 2 years;
• once a year - the drug has been registered for more than 2 years;
• once every three years - the drug was registered 5 years ago.

Data on drug monitoring must be sent no longer than thirty days after the designated periods.

Results of monitoring

Based on the results of drug monitoring, Roszdravnadzor forwards all information to the Russian Ministry of Health. The result of the work of this authority is:

• Correction of accompanying documentation according to detected changes;
• Removal of unsafe and unevaluated medicines from free circulation;
• Restriction on the permitted use of the drug for a certain period;
• Permission to use a previously closed product.

What you need to know about order 4n and the new procedure for filling prescriptions

In some cases, a drug is prohibited from participating in free circulation. However, this decision is permissible only if, based on the results of operational monitoring of the drug, it becomes clear that the drug is dangerous to the health and life of patients.

Responsibility

Persons involved in the drug circulation procedure must provide data on the safety of the product. If information is not provided, the organization will be legally liable in two cases:

• no operational monitoring procedure is carried out, and Roszdravnadzor is not provided with relevant information. In this case, the company faces administrative liability (Article 19.7 of the Code of Administrative Offenses of the Russian Federation);
• deliberately providing false information or concealing information that a product may be harmful to health. For this, the medical organization will bear criminal liability in accordance with Art. 237 of the Criminal Code of the Russian Federation.

https://ru.freepik.com

Suspension of use

Data about new negative reactions of the drug, about its unpredictable properties when interacting with other drugs that can be dangerous to the life and health of people, are grounds for suspending the use of this medicine. This is regulated by order of the Russian Ministry of Health dated November 14, 2018 No. 777n.

Risk assessment

During operational monitoring of medicines, a special department of the Ministry of Health also assesses the risks of using the medicine. 3 days are allotted for the examination.

Depending on the results of the audit, the agency may initiate an examination of the quality of the medicinal product. The task is transferred for examination to a federal expert institution.

If dangerous properties are identified, the Ministry of Health of the Russian Federation stops the use of the drug within 5 days until the reasons for this are determined or until the manufacturer corrects the accompanying documentation. Besides:

• written notification of the decision is sent to the manufacturer. He also receives documents on the results of the examination;
• information is transmitted to Roszdravnadzor. After this, the department posts the information on its website.

Information about the drug on the Roszdravnadzor website

Conducting operational monitoring of medicines implies that the result of the examination will be made publicly available. The Roszdravnadzor website is used for this.

The following information is promptly posted there:

• about medicines whose use has been temporarily stopped;
• on the withdrawal of drugs from free sale;
• about the return of the drug to sale.

Operational monitoring of medicines was introduced by a government commission to support economic growth in the country and improve all segments of the population. The decision was approved by the protocol formalized in the order of the Ministry of Health and Social Development of the Russian Federation 277n in May 2009.

The goal of the actions of Roszdravnadzor, whose employees are entrusted with the main responsibilities, is the affordability of medicines for the population. Operational monitoring of medicines checks the assortment and pricing policy of clinics and pharmacies.

Operational monitoring will help perform several tasks:

• objectively assess the situation on the pharmaceutical market;
• identify negative trends in a timely manner and correct them.

The result of the inspections will be a report that will appear on the Roszdravnadzor website and the state price register.

Checking prices for vital drugs

Separately, it is worth highlighting the provision of vital and essential drugs (VED). Federal legislation clearly defines the regulation of the circulation of these medical products, and since 2010, state regulation of prices for them has been introduced.

According to WHO definition, drugs of vital necessity and importance include those that:

• correspond to the goals of medical care of the population;
• are significant for the country's health objectives;
• have proven effectiveness and safety;
• differ in economic efficiency.

Solving the problems of the pharmaceutical market

The problem of regulating the range and prices in the pharmaceutical market of the Russian Federation remains relevant, since the share of available drugs is decreasing every year, inflated prices for products are set, and regional and municipal purchases are becoming more expensive compared to federal ones.

The government publishes an updated list based on medical statistics:

1. The list of drugs in this category is approved annually.
2. Operational monitoring has the main goal - to ensure the prevention and treatment of diseases that predominate in terms of incidence among the population of the Russian Federation.

Priority healthcare needs are named in Law No. 61-FZ, namely in paragraph 6, article 4.

State price register

The regional portal for pharmaceutical activities and drug supply farmcom.info contains all the legislative acts regulating the circulation of medicines. On this website you can get complete information about reporting:

• for medical purposes;
• a list of drugs prescribed by medical commissions;
• a list of medications for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, blood cancer, multiple sclerosis, and patients after organ transplantation.

Operational monitoring of prices for vital drugs by Roszdravnadzor is intended to make the most necessary medicines more accessible to socially vulnerable segments of the population. On the website you can find out about the requirements for the minimum range of medical care products for pharmacies with production activities, pharmacy points and kiosks.

A register of prices for vital and essential drugs for each specific period for the constituent entities of the Russian Federation is presented. The table contains information about the name of the medicine, trade name, manufacturer, release form and price.

Monitoring stages

The Law on State Regulation of Prices determines that operational monitoring of Roszdravnadzor on vital and essential drugs is carried out in several stages:

1. Approval of a list of products under chemical names that do not have a patent and are recognized throughout the world. Drugs must be used for the treatment, prevention or detection of diseases characteristic of the population of the Russian Federation, have advantages over other drugs, and have pharmacological properties that are equivalent to similar drugs.
2. A methodology is established for calculating the limit retail prices for drugs on the list.
3. State registration of drugs and prices set for them by manufacturers is carried out.
4. Methods are being approved for determining by executive authorities the boundary levels of wholesale and retail markups on prices offered by manufacturers of vital and essential drugs.
5. The procedure for issuing orders to approve allowances is established in accordance with the law. Instructions on the established boundaries of wholesale and retail markups are sent to executive authorities.
6. Conducting federal state supervision in the field of circulation of medicines and control at the regional level over price levels by authorized executive authorities of the federation and at the level of constituent entities. Operational monitoring will allow you to receive information in a timely manner.
7. Bringing to justice persons who violate the procedure for setting prices for vital drugs.

Regular price monitoring

Operational monitoring of prices for life-saving drugs is carried out in accordance with Order No. 277n.

Medical and pharmacy organizations must register on the Roszdravnadzor website in the “Operational Monitoring” section before June 1, 2012. Each organization issues an order and appoints a responsible person who provides data electronically and in paper form, according to the proposed form, with the signatures of managers.

Operational monitoring of vital and essential drugs is the responsibility of medical and pharmacy organizations of any form of ownership. Every month, before the 25th day, a report is submitted that lists the stocks on the 15th day of the reporting period for drugs from the list of vital and essential drugs:

• pharmacies report at the place of trading activity;
• treatment and preventive organizations provide reports on branches.

Heads of pharmacies and medical organizations are responsible for high-quality, reliable and complete information.

Regulations on price monitoring

The range and prices of drugs in pharmacies and treatment and prevention organizations are subject to monitoring. The basis for inspections is a list of essential medications.

Operational monitoring of prices for vital and essential drugs by Roszdravnadzor is carried out on the basis of a list of drugs, from which a list for verification is generated indicating:

• trade name;
• dosage form;
• dosage;
• manufacturing company.

The basis for the formation of the list is the declaration of conformity of medicines. The list is received by the departments of Roszdravnadzor of the constituent entities of the Russian Federation. If the specified drug is not available in pharmacies and medical institutions for two months, then the list is adjusted at the local level.

Who is required to submit reports?

According to the law, not all pharmacies and medical institutions are required to participate in monitoring on a monthly basis, but their number must reach at least 15% of the total number for a given subject of the Russian Federation.

Specifically, the structure of inspected organizations for each subject of the Russian Federation should include 25% of pharmacies, of which 25% are federal and municipal and 50% are private organizations.

Accountable organizations should include:

• specialized and multidisciplinary medical institutions of the republics, regions, territories and districts;
• city ​​hospitals in cities with a population of over 250 thousand people (4 institutions from each subject);
• municipal institutions (at least 5);
• central district hospitals (at least 3).

Operational monitoring is carried out in all treatment and preventive organizations with federal subordination.

If there are no pharmacies in a constituent entity of the Russian Federation, then the number of monitoring participants increases at the expense of municipal institutions. The following ratio between pharmacies, pharmacy points and kiosks in the report structure is provided - 30:60:10.

Reporting and analytics

The operational monitoring system is multi-stage. Every month, information about medicines in stock on the 15th is collected from pharmacies and medical institutions of each constituent entity of the Russian Federation subject to monthly inspection. No later than the 5th day of the next month, local authorities of Roszdravnadzor provide a summary report for each subject in electronic and paper form, in accordance with the forms specified by law. Additional information for analytics specified in the annexes in the Regulations is also provided.

The task of Roszdravnadzor is, based on the reports received, no later than the 10th day of the next month to provide in electronic and paper form to the Department for the Development of the Pharmaceutical Market and the Medical Equipment Market of the Ministry of Health and Social Development of Russia data on the drug supply to the population.

The report must contain specific detailed information:

• structure of the pharmaceutical market by segments of retail, wholesale, production, hospitals;
• volumes and structure of drugs consumed;
• providing medicines to citizens of certain categories;
• analysis of price levels for medicines;
• review of surcharges in the list of vital and essential drugs in wholesale and retail;
• a list of measures taken to curb price increases.

The department, no later than the 15th day of the next month, prepares a draft report to the government on monitoring of drugs and the range of drugs, measures taken to ensure the availability and quality of medical care. The report is signed by the Minister of Health.

Features of filling out forms

When filling out reports, pharmacy and medical organizations indicate not only the name, manufacturer, dosage of the drug, but also other data:

• replacement of the drug if it is unavailable on the monitoring date, within one generic name;
• the name of the wholesaler who supplies medicines in the event that a specific drug is not in stock;
• reasons for the absence of the drug and timing of the resumption of supplies.

Operational price monitoring serves to improve the quality of medicine supply to hospitals and the population through pharmacy chains.

The pharmacy should regularly monitor medications. This will ensure that quality standards are met, as well as safety of use. Thanks to modern technologies, analysis methods are regularly improved.

The main tasks of drug monitoring:

1. Make sure that medications are safe for the human body.
2. Check the necessary effect on the body, which will allow the patient to get rid of a specific disease.
3. Comply with established quality standards, as well as manufacturing technologies.

Monitoring during drug treatment

The optimal method for determining the required dosage of the active ingredient is laboratory testing.

For example, after a person has taken a drug, a blood test is performed. It must contain a certain number of active components. The main thing is that the drug is effective, but does not cause harm to the body.

Drug monitoring is organized in the following cases:

1. When receiving messages from people regarding drugs sold in your pharmacy.
2. If there are side effects, including those that are not prescribed in the official instructions for the drug.
3. In case of undesirable reactions of the body, which have led to the occurrence of various anomalies, as well as the development of a threat to health and life, which require immediate hospitalization. This also applies to cases when a person loses his ability to work or becomes disabled.
4. In case of undesirable effects that appeared after using the product in accordance with the manufacturer's instructions.
5. To calculate the characteristics of the effect of a drug when used in combination with other drugs.

High-quality monitoring of medicines allows you to ensure the absence of violations or identify their presence. The data obtained allow us to verify the safety of the drug and the absence of dangerous side effects on the body.

Drug safety testing

From time to time, safety checks on the use of medicines should be carried out. As a result of the studies, specific data on the safety of the drug will be obtained.

Drug monitoring results

All results must be sent to the Ministry of Health of the Russian Federation for subsequent study of the possibility of making certain changes to the instructions for use of the drug. In some cases, an act is issued that prohibits the sale of a medicine if it has been found to be hazardous to health.

Monitoring of medicines can be carried out in any pharmacy upon receipt of a complaint from a client or due to other reasons that we discussed above.

If, as a result of research, it is confirmed that the use of a medicine is dangerous and the data provided by the manufacturer does not correspond to reality, the issue of banning the sale of this medicine will be considered. In this case, it should be withdrawn from sale in all pharmacies in the country. Only in exceptional cases is it possible to make changes to the instructions for use.

Suspension of drug sales

The issue of a possible ban on the drug upon receipt of confirmed data on the harmful effects on the body that were not prescribed in the instructions, as well as adverse reactions associated with the use of the drug, is considered as soon as possible. The same applies to the occurrence of side effects after using the medicine together with other drugs. This is also associated with a threat to the life and health of the patient.

If any violations are detected, a thorough investigation is carried out, after which the drug is removed from sale until the negative aspects are completely corrected.

After this, the drug will be re-tested, and if it is found safe, it will go on sale again. Drug monitoring can improve the quality of drugs sold in pharmacies.

Operational monitoring is carried out to identify undesirable trends in drug pricing and eliminate them. The duty of health care facilities and pharmacies is to provide reports on time. In the article we will examine whether all organizations participate in monitoring and how to generate a report.

Operational monitoring is checking the cost of medicines in medical institutions and pharmacies. The purpose of monitoring is to make medicines accessible to all segments of the population. With the help of such control, Roszdravnadzor monitors the situation on the medicines market and promptly suppresses undesirable trends.

The document that regulates the monitoring process is the order of the Ministry of Health and Social Development of the Russian Federation dated May 27, 2009 No. 277n.

Who is required to participate in monitoring?

According to the law, at least ⅙ of medical organizations from the total number in the Russian Federation, which also includes regional and regional institutions, must participate in the operational monitoring of medicines by Roszdravnadzor. At least half of the total number of pharmacies must participate. This half consists of private, federal and state pharmacies.

Every month, Roszdravnadzor organizes data collection; organizations are required to provide information on the availability of medicines and their costs.

Checking prices for vital drugs

The state pays special attention to medications included in the Vital and Essential Drugs list. Medical institutions and pharmacies cannot sell such medicines at a price higher than the established one.

Criteria by which vital drugs are determined:

• are important for preserving the health of citizens of the Russian Federation;
• have proven effectiveness;
• have a reasonable price;
• have no consequences and are safe.

Consumers can always find information on prices for vital drugs on the Ministry of Health website.

Preparation of a report on operational monitoring of medicines

To participate in monitoring, you need a special program Pharm Auditor, which not only generates a report on vital medications, but also tracks products that are expiring, calculates total revenue and quickly processes supplier invoices.

Report preparation algorithm:

1. Update the list of vital drugs. To add a new list, you need to go to the Roszdravnadzor website and select the button "Handbook of Vital and Essential Medicines", then save it to your computer.

Launch the special program “Pharm Auditor”, select the button “Download the ZhV directory”. Wait for confirmation that the data has been downloaded.

1. Adding information about suppliers to the site. To find a supplier in the general list, you need to know his tax identification number and the name of the organization. However, if the supplier is not in the general list, you need to add it there for everything to work correctly.

To do this, on the Roszdravnadzor website, select “Settings”, and then in this section click “Add” to enter information about the supplier.

1. Creating a report on vital drugs. Open the Farm Auditor program. Click “Report on residential life”, configure all the necessary indicators (price type, period, etc.). Then click on the “Generate” button. After this, add the codes to the supplier columns, which are written in red. Save the file by clicking the “Upload” button.

To send Roszdravnadzor data, select the section on the website "Export/import". Then fill out all the lines with information about your organization. To download the file, click on the “Import” button.

There is also weekly operational monitoring of medicines; a report for it is generated in the same way as for the monthly one.

We remind you that on March 17, the law on palliative care came into force, which changed the procedure for prescribing painkillers, including narcotic and psychotropic ones. You will learn more about this, as well as how to calculate the need for narcotic drugs for a clinic and hospital, how to choose opioid analgesics for the relief of chronic pain at the International Practical Conference “Medical organization: a new look”, which will take place on August 13–15 in Sochi.

About the history of the system

The decision to create a federal state information system for monitoring the movement of medicines from the manufacturer to the end consumer using labeling (hereinafter FSIS MDLP) was adopted on February 4, 2015 at a meeting of Russian President Vladimir Putin with members of the government. According to order No. Pr-285 signed on February 20, 2015, the Ministry of Health was instructed to ensure the development and phased implementation of the system.

A timeline illustrating the preparation and startup of the system is shown in the figure below.

On November 30, 2015, the Ministry of Health issued Order No. 866 “On approval of the concept of creating a federal state information system for monitoring the movement of medicines from the manufacturer to the end consumer using labeling,” which approved the general concept of creating the system, goals and objectives, a list of functionality and services by its participants, as well as basic requirements.

General description of the system and project participants

The system being developed is designed to protect the population from illegal medicines and provide citizens and organizations with the opportunity to quickly verify their legality. The general functional diagram of the system is shown in the figure below.

By the way, applications for smartphones “” are already available for free download, allowing you to scan a QR code to obtain information about the origin of the medicine packaging and make sure that the drug is legal (however, you won’t be able to test the system on yourself yet - a test experiment on applying QR codes to the packaging of certain groups of drugs, but more on that later).

By the same principle, only with the use of specialized devices, scanners, it is proposed to verify the authenticity of medicines in pharmacies and medical institutions upon receipt of them from the supplier. In addition, the implementation of the system will make it possible to obtain detailed information about the movement of packaging, as well as information that makes its further circulation impossible (for example, the presence of data that the packaging was previously sold or withdrawn from circulation for some other reason).

The developer and operator of the MDLP system is the Federal Tax Service (FTS). A specialized section has been created on the Federal Tax Service website dedicated to the drug labeling system. Also, detailed information on the progress of the project is published on the website of the Federal Service for Surveillance in Healthcare (Roszdravnadzor), another of the federal government bodies involved in the implementation of the system. In addition, state participants, in addition to the Ministry of Health itself, are the Ministry of Finance of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation and the Federal Customs Service.

Direct users of the system will be all subjects of circulation of medicinal products (MD), namely

• Russian drug manufacturers;
• foreign holders of drug registration certificates and their representative offices;
• organizations of wholesale and retail trade of medicines (pharmacies);
• medical organizations (MO).

It is planned that the results of the project will involve more than 350 thousand subjects.

Looking at the general flowchart of organizational interaction between participants (Fig. below), after several minutes of close study, it becomes clear that FSIS MDLP will allow you to track every movement of a medicinal product, starting from the moment it is released from production and ending with sale to the final consumer.

Implementation stages

On October 25, 2016, the Presidium of the Council under the President of the Russian Federation for Strategic Development and Priority Projects decided on the priority project “Implementation of an automated system for monitoring the movement of medicines from the manufacturer to the final consumer to protect the population from counterfeit medicines and promptly remove counterfeit and substandard medicines from circulation.” .

According to the project passport (as amended by protocol No. 12 dated December 21, 2016), implementation was supposed to be carried out in two stages:

1. At the first stage On the territory of the Russian Federation, an experiment is being carried out to label medicinal products for medical use with control (identification) marks for a limited set of drugs, mainly from the list of seven high-cost nosologies.

2. At the second stage Labeling of all 100% of medicines should be mandatory.

Initially, the first stage was supposed to last from January 1, 2017 to December 31, 2017, but its start was slightly shifted. On January 24, 2017, Dmitry Medvedev signed a government decree “On conducting an experiment on marking certain types of medicines with control marks and monitoring their circulation.” The signed document launched an experiment on labeling with control (identification) marks and monitoring the circulation of certain types of drugs for medical use, for which an 11-month period was allocated: from 02/01/2017 to 12/31/2017.

The second stage was planned to be completed from January 1, 2018 to December 31, 2018. However, against the backdrop of active public discussion and criticism of the project from drug manufacturers and suppliers, they were revised.

As a result, on December 29, 2017, the President of Russia signed the Federal Law “On Amendments to the Federal Law “On the Circulation of Medicines”, modified by the government.

According to No. 425-FZ, the deadline for labeling 100% of medicines and full-scale use of the system (the deadline for completing the second stage) has been postponed to January 1, 2020, thus the implementation of the system has been extended by one year.

It should be noted that 425-FZ simultaneously gives the government the right to independently establish the features and timing of the implementation of the MDLP system. This means that participants in the circulation of medicines (and, accordingly, developers of the information systems involved) must monitor current changes in the system implementation procedure throughout the entire implementation process.

The experiment (the first stage), in theory, has already been completed. Participants in the experiment were selected on a voluntary basis based on applications submitted to Roszdravnadzor. It is known that 34 drug manufacturers are participating in the experiment, while Roszdravnadzor has not yet disclosed information about the list of trade organizations or medical organizations also participating in the experiment. The results of this experiment should be expected in February 2018. All federal government bodies involved in the project have been instructed to evaluate the results of the experiment and submit a corresponding report to the government of the Russian Federation.

How to prepare for system implementation

Taking into account the above, from January 1, 2020, any medical organization that is involved in the circulation of medicines must work in the MDLP system.

According to Order of the Ministry of Health No. 866, pharmacy organizations must:

1.

2.

3. Upload into the FSIS MDLP the information necessary to monitor the maximum price for drugs from the list of vital and essential drugs.

Medical organizations are obliged to:

1. Download up-to-date information about medicines, including those withdrawn from circulation, from the FSIS MDLP.

2. Upload information on receipt, shipment, return, write-off and transfer of batches of medicinal products for destruction to FSIS MDLP.

According to Order of the Ministry of Health No. 866, pharmacy and medical organizations must have workplaces equipped with personal computers, devices for reading special markings, and also have electronic signature keys (ES), which are required for information interaction with FSIS MDLP. To work with the system, an Internet connection must be provided. If this is not possible, information can be accumulated on the computer equipment of pharmacy and medical organizations and then transmitted offline according to a certain schedule.

And, which is completely logical, it is necessary to improve the information systems of pharmacies and medical organizations in order to integrate with the FSIS MDLP to organize control at the point of receipt and dispensing of medicines. Information about all operations in the process of drug circulation should be automatically transferred from such systems to the FSIS MDLP. For this purpose, the Federal Tax Service has already developed and published descriptions of integration profiles for developers of accounting systems.

In particular, the following are currently available:

• interface level exchange protocol, version 2.6;
• schemes and formats for accounting system developers.

The scheme of how users work in the mode of integrating the accounting system with FSIS MDLP is as follows:

1. The user of the pharmacy (or department of the Ministry of Health) receives the drug from the supplier and scans the labeling (box code SSCC, package code sGTIN).

2. The accounting system transmits this information to FSIS MDLP and receives a response from it:

A) if FSIS MDLP “rejects” a drug, then information about it is automatically recorded in the system and it is taken out of circulation. Such a drug must be returned to the supply for destruction - it is counterfeit;

b) if FSIS MDLP returns a positive response, then information about such receipt is recorded in the accounting system, you can work with it, including prescribing and dispensing the drug to patients.

3. If a drug is moved between departments of a pharmacy/medical organization, this information is transferred to the FSIS MDLP.

4. As soon as the drug is actually consumed (the pharmacy organization sold the drug to the patient or issued it on a preferential prescription, or the drug was consumed in a hospital for medical purposes, etc.), the accounting system must transfer this information to the FSIS MDLP, while the patient’s personal data is not are transmitted. With this step, the accounting system removes the drug from circulation in the FSIS MDLP.

Please note that electronic interaction services are currently at the testing stage, which means a possible change in exchange protocols - this is eloquently evidenced by information messages on the Federal Tax Service website. It is expected that after completing the analysis of the experiment results, the methodological recommendations for the implementation and use of the MDLP system can be expanded and supplemented, and also, which is important for the developers of the involved accounting systems, the technical details of the integration will be clarified.

• Familiarize yourself with the current regulations and descriptions of the system’s operation scheme, track changes (here we recommend using the specialized resources of the Federal Tax Service and Roszdravnadzor).
• Develop and issue an order for the organization to appoint someone responsible for implementing the system and create a corresponding working group.
• Prepare employee workplaces: equip them with the required number of personal computers (PCs), scanners, purchase and install an enhanced qualified electronic signature (ECES), software for working with it, and conduct basic computer training.
• Decide and implement a software product to record drug movement, if this has not already been done.
• Register in the system at mdlp.markirovka.nalog.ru. To work with the system, you will have to take into account the technical requirements: Operating system - no older than Microsoft Windows 7 or Mac OS X 10.8, browser no lower than Internet Explorer 10 or Safari, plugin and software "CryptoPro" version 3.6.7777 or later.
• If possible, carry out work with FSISZ MDLP at least in test mode.

For developers of pharmacy systems and MIS MO, the implementation of integration of the corresponding accounting systems with FSISZ MDLP, in our opinion, is still somewhat premature, at least until the publication of the results of the experiment and the official approval of the final versions of the integration mechanisms. After the experiment is completed and all the necessary software and accompanying documentation of the FSISZ MDLP are finally debugged, it will be possible to begin a detailed study of this issue and improvements in terms of integration. However, pharmacy and medical organizations, as well as developers of relevant information systems, now need to “prepare the ground” and actively prepare for the upcoming work.

To clarify questions and provide advice to project participants (pharmacies and medical organizations), specialized “Competence Centers” have been created in the regions of Russia. Information about such a center in your region.

It should be understood that the implementation of the system will affect all business processes associated with the receipt, sale and write-off of medicines. Therefore, if these processes are not yet automated within the medical organization itself, then this issue should be resolved in the very near future. To do this, we suggest paying attention to our product “KIIS.Pharmacy”, which allows you to fully solve these problems.

Fully established and automated processes for drug supply within the organization using KMIS.Pharmacy will make it possible in the future to make the connection of the Moscow Region to the FSIS MDLP invisible to users. For ACS employees, the solution to the technical side of the issue will be significantly simplified - after the completion of debugging of the integration protocols on the part of the Federal Tax Service, the Ministry of Defense, which uses KIIS.Pharmacy in its work, will receive, along with the update, a new version of the product with a ready-to-use integration protocol for integration with MDLP.

About the prospects for the development of the system