The function of integration with the federal service "operational monitoring of medicines. Online monitoring of medicines Information system for monitoring medicines

The ARM Manager program has the ability to generate a file for uploading to the online monitoring site. For this:

1. On the Manager panel, click the "Run" button, then - "Upload to operational monitoring",

2. The data window will open, set the parameters we need:

• Segment-Outpatient or Hospital,
• Reporting month and year are entered automatically, depending on the date of formation,
• Choose the mode with VAT or without VAT,
• To confirm the upload, click the "Run" button, to cancel - "Cancel".

3. An information window appears at the bottom, which shows the upload process and the errors that occur during it.

4. If the .txt file opens at the end of the upload, it's okay, just close it.

5.In the lower information window, the upload path will appear where the program saved the file.

Possible errors when generating a file for uploading to online monitoring

Vendor ID not specified

In the event that the vendor ID was not specified, the program will give us the following warnings:

• In the information window during upload

• In a warning at the end of the download

We go to the Directories-Counterparties, select a supplier whose ID is not filled in, and in the details in the field No. of the power of attorney we put down VendorID from the monitoring site.

You need to define a vendor for batch no...

Such an error occurs if this position was accepted using the Capitalization document, the counterparty of which is the Manager.

In this case, we proceed as follows:

• In IBExpert, in the AGENTS table, we find the counterparty Manager
• In the DOVERKA field, we put the code of the supplier, from whom we received most of the credited goods.

Working with the website of Roszdravnadzor

To the website of Roszdravnadzor at the link http://mols.roszdravnadzor.ru/. The site works correctly only in the Enternet Explorer browser. For questions about the site, please contact Roszdravnadzor directly.

Authorization on the site

To load the data uploaded by the Manager, go to the Export/Import mode. Specify the required parameters:

• Specify the period
• import mode,
• organization,
• We attach the file created by the Manager program,
• Click "Import".

In the import log, you can see the history of downloads to the site. To see what the warnings were for each download, you can click on it.

In the Imported data mode, you can view the uploaded data.

To see entries that have an error, scroll to the right to the end of the page and check the "Entries with comments" checkbox. In the list that appears, we see positions unloaded with errors. The pharmacy either corrects the data in the Manager, deletes the old download from the site and uploads a new, corrected one, or removes the position from the list on the site. Standard-N employees do not delete anything, they do not have the right to do so, the pharmacy itself is responsible for the removal.

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 a report on time. We analyze in the article whether all organizations participate in monitoring and how to generate a report.

Operational monitoring is a check of the cost of medicines in medical institutions and pharmacies. The goal of monitoring is to make medicines available to all segments of the population. With the help of such control, Roszdravnadzor monitors the situation on the market medicines and timely suppresses undesirable tendencies.

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 the total number of medical organizations in the Russian Federation, which also includes regional and regional institutions, must participate in the operational monitoring of medicines by Roszdravnadzor. Among pharmacies, at least half of the total number must participate. This half is made up 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 cost.

Checking the prices of essential medicines

The state pays special attention to medicines included in the Vital and Essential Drug 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 maintaining the health of citizens of the Russian Federation;
• have proven effectiveness;
• have an acceptable price;
• no side effects, safe.

Consumers can always find price information for essential drugs on the website of the Ministry of Health.

Preparation of a report on the operational monitoring of medicines

To participate in monitoring, you need a special Pharm Auditor program, which not only generates a report on essential medicines, but also tracks goods that are expiring, calculates the final revenue and quickly processes supplier invoices.

Report preparation algorithm:

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

Run the special program "Pharm Auditor", select the button "Download the JV Handbook". Wait for confirmation that the data has been loaded.

1. Adding information about suppliers to the site. To find a supplier in the general list, you need to know his TIN and the name of the organization. However, if there is no supplier in the general list, you need to add it there in order for everything to work correctly.

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

1. Create a report on vital drugs. Open the Farm Auditor program. Click "Lifetime Report", set up all the necessary indicators (price type, period, etc.). Then click on the Generate button. After that, add the codes to the vendor boxes, which are written in red. Save the file by clicking the "Upload" button.

There is also a 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, which changed the order of prescribing painkillers, including narcotic and psychotropic ones. More about this, as well as how to calculate the need for narcotic drugs for a polyclinic and a hospital, how to choose opioid analgesics for relief chronic pain, you will learn at the International Practical Conference "Medical organization: a new look", which will be held August 13-15 in Sochi.

The building of the Moscow Mining Academy. 1930

The history of NUST MISIS goes back to the distant past, when the Moscow Mining Academy (MGA) was founded in 1918. MGA, created on the basis of the Mining Faculty of the Warsaw University of Technology, which during the First World War was evacuated to Moscow, became one of the first technical universities in Soviet Russia. Even though it was going Civil War and devastation reigned in the country, the academy was actively working a year later, attracting the best scientific and teaching staff of that time. Initially, the Moscow State University was conceived as an exclusively educational institution, but already in the first years of its existence, research laboratories were created in it, which later grew into separate research institutes. Thus, as early as 1919, the scientists of the academy studied the properties of radioactive elements, for which a special department was established, and the course "Radioactive Substances" was included in the curriculum.

The teachers of the academy and its graduates are a galaxy of outstanding specialists who made an enormous contribution to the development of Soviet industry and until the 1950s determined the agenda of all specialized scientific areas (materials science, metallurgical, mining and exploration). For example, through the efforts of I. M. Gubkin, active oil and gas exploration began in the USSR, during which, in particular, the Volga-Ural oil and gas basin was discovered, which was called the “Second Baku”. Gubkin also came up with the idea of ​​a large-scale study of the Kursk magnetic anomaly, which led to the discovery of the world's largest iron ore deposit. MGA graduate E. P. Slavsky headed the Soviet nuclear project for almost thirty years, being the Minister of Medium Machine Building of the USSR. A.P. Zavenyagin, who also studied at the Moscow State Academy of Sciences and became the first rector of the Moscow Institute of Steel, led the Magnitogorsk Iron and Steel Works, and later headed the construction of the Norilsk Mining and Metallurgical Combine. In the post-war years, he served as Minister of Medium Machine Building and Chairman of the Committee on the Use of Atomic Energy. Ferrous metallurgy of the USSR for many years was headed by I.F. Tevosyan, and non-ferrous metallurgy was led by P.F. Lomako.

Leonid Vaisberg, Doctor of Technical Sciences, Professor, Academician of the Russian Academy of Sciences, Chairman of the Board of Directors of Mekhanobr-Tekhnika, Member of the International Scientific Council of NUST MISIS

“The Moscow Mining Academy was formed exactly when the industrialization of the country was needed, specialists in the field of mineral resources were needed. The academy has given industry executives. These were iconic people who did a lot for their country. The current generation of NUST MISIS students is lucky – they study at the university, where fantastic conditions for life and study are created.”

With the beginning of large-scale industrialization, the Moscow State University was reorganized and divided into six branch technical colleges: mining, ferrous metallurgy, non-ferrous metals and gold, peat, oil and geological exploration. The Institute of Ferrous Metallurgy, by order of the first rector Zavenyagin, was almost immediately renamed the Moscow Institute of Steel (MIS). In those days, the country needed specialists and organizers of industry like air, capable of directing technological processes at large industrial facilities immediately after graduation, able to create new units and technologies, new materials. The development of metallurgy largely determined the level of many other branches of the national economy, as well as the level of the country's defense capability. After graduating from MIS, young engineers went to work, and during the years of the first five-year plans they managed to solve the most difficult task - to modernize Soviet industry. By the end of the 1930s, the technical and economic backwardness of the country had been practically eliminated.

In the terrible years of the Great patriotic war the very salvation of the country depended on whether the flagships of the industry would be able to solve new, sometimes it seemed - unsolvable tasks that arose in the Soviet industry. Miners and metallurgists managed to do the impossible. So, in 1941-42. a grandiose evacuation of large industrial facilities was carried out, which has no analogues in world history. The most important role in the export of factories to the eastern regions of the country and the launch of these facilities was played by graduates of institutes. They showed not only the highest professionalism, but also combat courage - often the equipment had to be evacuated under enemy fire. As a result of the heroic efforts of home front workers, already in 1943, the shortage of metal for the country's defense plants was eliminated. The contribution of the institute's specialists to the creation of new alloys for military equipment, without which it is impossible to imagine the Great Victory, is invaluable. As a consequence, for successful work In 1944, MIS received its first award for training personnel for the ferrous metallurgy - the Order of the Red Banner of Labor.

Rector of the Moscow Institute of Steel and Alloys, Professor, Doctor of Technical Sciences V.I. Javanese. 1967

Students of the Moscow Institute of Steel and Alloys. I.V. Stalin, Stalin's fellows in the classroom in the laboratory of metallography; 2nd from the left - S.S. Gorelik, 3rd from the left - N.T. Chebotarev. 1940

In the classroom at the sponsored school No. 7 of the Moscow Institute of Steel; classes are conducted by the master of the institute. 1955

5th year students of the Moscow Institute of Steel and Alloys Ferenc Kern (Hungary) and Lyubov Lyubavskaya (USSR) at a consultation with the assistant of the Department of Theory and Automation of Furnaces A.M. Belenky (center). 1970

Post-graduate student of the Moscow Mining Institute Viktor Pashchenko supervises the geodetic practice of students during summer holidays. 1960

Mixing the solution in a mixer at the Department of Analytical Chemistry of the Moscow Institute of Steel and Alloys. 1980

In the laboratory of the Moscow Institute of Steel and Alloys. 1973

Operators of the computer "Minsk-22" Tatyana Fedotova and Ella Buchinskaya at work. 1981

Graduate student V. Saurin (foreground) and senior laboratory assistant K. Shamody check instruments for the laboratory of the Department of Semiconductor Physics at the Moscow Institute of Steel and Alloys. 1963

Mikhail Nevzorov, a 2nd year student at the Moscow Institute of Steel and Alloys, works on a computer. 1969

A group of graduates of the Mining Institute after graduation. 1979

If in the pre-war period the institute focused on the training of engineering personnel for industrial enterprises, then after the war research work became a priority. New scientific schools were formed, the research profile was expanded, more and more laboratories were opened - the institute was transformed into a polytechnic university, which, meeting the requirements of the time, now trained not only metallurgists, but also physical chemists, specialists in semiconductor and radioactive materials. These personnel were, in particular, extremely in demand in the two main Soviet projects of the post-war years - atomic and space. Engineers and scientists of the institute, which since 1962 was called the Moscow Institute of Steel and Alloys, took a direct part in the creation and development of high technologies for space and nuclear programs.

The reform of the institute's activities, which reoriented MISIS to solve new tasks of national importance in the development of materials science, was carried out by the rector of MISIS V.P. Elyutin, an outstanding statesman, metallurgist scientist and teacher. After graduating from MIS in 1930, already in 1945 he headed the institute, and it was Yelyutin who initiated the opening of the Faculty of Physical Chemistry, which launched the process of "scientific modernization" of the university. Three new faculties were opened at the institute, and over a decade and a half, MISiS turned from a branch metallurgical institute into a multidisciplinary polytechnic university. This breakthrough was provided by such representatives of the leadership of the institute as rectors V.I. Yavoisky, P.I. Polukhin, Vice-Rector V.A. Romenets and others.

Anatoly Sedykh, Chairman of the OMK Board of Directors, graduate of the Moscow Institute of Steel and Alloys

“When I entered MISiS in 1982, Vladimir Andreevich Romenets was the first vice-rector, professor. He taught us the course "Introduction to the specialty." And it was at the lectures of Vladimir Andreevich that I realized that I had done absolutely right choice deciding to become a metallurgist. Vladimir Andreevich was in love with metallurgy and his profession. And this, of course, infected everyone around him.

He achieved tremendous success in the development of our industry, made dozens of breakthrough discoveries that are still being used around the world today. In addition, Vladimir Andreevich made a huge contribution to the development of the MISiS infrastructure.”

It must be said that V. Yelyutin's reform activities were not limited to the scale of the university. Later, as Minister of Higher and Secondary Specialized Education of the USSR, which he held for several decades, from 1954 to 1985, it was Yelyutin who created the famous late Soviet system of higher education that delighted the whole world. The current NUST MISIS, developing the potential formed by Elyutin, honors and enhances the traditions of the national engineering school.

Continuing the glorious centuries-old history in the present

View of the building of the new building of the Moscow Institute of Steel and Alloys. 1980

Today, NUST MISIS, like MISIS and MGI in their time, is directly involved in shaping the educational and scientific agenda of the country, together with government agencies and the business community, solving engineering and research tasks aimed at strengthening the welfare of Russia and its scientific potential, for the construction of the digital economy.

Being one of the leading technical universities in Russia, the university is actively developing such strategically important areas for the country as biomedicine, nanotechnology and IT, while remaining a leader in its traditional fields: materials science, metallurgy and mining.

In 2013, becoming one of the winners of the Program for Improving the Competitiveness of Leading Russian Universities among the World's Scientific and Educational Centers (Project 5-100), NUST MISIS pays great attention to the development of the university as the country's leading scientific and educational center.

NUST MISIS became the winner of the RF Government mega-grant competition five times, which resulted in the creation of laboratories that are today leaders in their fields not only in Russia, but also abroad. Thus, under the guidance of Professor Alexei Ustinov, head of the Superconducting Metamaterials Laboratory at NUST MISiS, a group of Russian scientists measured and then created the first domestic qubit. Having started to deal with quantum technologies in 2011, today the university is one of the leaders in this area - in 2018 the university won the competition of the Russian Venture Company to create the NTI Center for Quantum Communications. In the future, the NTI Center will become the basis for the formation of a consortium, which will also include the Russian Quantum Center, Steklov Mathematical Institute, RANEPA, TSU and other specialized organizations.

NUST MISIS cooperates with the world's leading scientific centers, takes part in international collaborations of the MegaScience level - LHCb, SHiP, Horizon 2020. large-scale scientific and educational projects, development of academic mobility. In the same year, NUST MISIS became the first Russian university to sign a cooperation agreement with the European Organization for Nuclear Research (CERN), the practical result of which was a joint course to train young specialists to develop promising technologies and materials to search for new physical effects in CERN experiments.

During the participation in the Project 5-100, more than 30 research laboratories and engineering centers were created at the university, which are not inferior to the best foreign centers in terms of intensity scientific work and headed by leading scientists of Russia and the world. The created research infrastructure has made it possible to significantly increase the volume of research - NUST MISiS, together with business partners, conducts more than 500 research and development projects per year. As a result, during this time, the publication activity of the university more than doubled, and the citation of articles more than tripled. Today, the university ranks first among the universities participating in the Project 5-100 in terms of the number of publications in the field of engineering and materials science over the past five years.

Continuing already age-old tradition, the university works very closely with business and the number of partner companies is approaching two thousand. Among them are the largest domestic and foreign metallurgical, raw materials, energy companies, IT and financial market leaders. These include corporations such as Metalloinvest, OMK, Rosatom, Karakan-invest, Severstal, Sberbank, Vnesheconombank, Norilsk Nickel, RUSAL and many others. Today, this cooperation is not limited to joint research projects, much attention is paid to educational programs aimed at training and retraining qualified specialists, as well as social projects.

Andrey Varichev, CEO Management Company "Metalloinvest"

“Metalloinvest cooperates fruitfully with NUST MISiS and its branches in Stary Oskol and Novotroitsk. Hundreds of university graduates work in our company, and students are actively trained at the Metalloinvest Innovation Center. Now, on the basis of the university, under the advanced training program "Institute of Production Leaders", 206 employees of our enterprises improve their technical competencies, improve their skills design work are learning digital transformation.

I would like to note the steelmaking laboratory launched this year at OEMK. Its core is a vacuum induction furnace with a small load. It makes it possible to quickly conduct experimental melting in small volumes. Special steels and alloys can be produced in the laboratory complex composition. This allows OEMK to solve almost any task of mastering new steel grades.

We are proud of the Zhelezno! Educational and Career Guidance Exhibition Center, which we opened in 2014 together with the Polytechnic Museum and NUST MISIS. The project has become a center of attraction for schoolchildren and young people, maintaining the prestige and prospects of the metallurgical professions.”

Due to this interaction, there is a global modernization of production and commercialization of scientific developments. So, this year, by order of Severstal PJSC, a Russian metallurgy giant, NUST MISIS scientists have developed a new alloy for oil pipelines that will double their service life and reduce environmental risks from oil production. In 2017, the university, together with RUSAL, one of the world's largest aluminum producers, established the Institute of Light Materials and Technologies (ILMT). It creates new materials for various high-tech industries of mechanical engineering and develops additive technologies and aluminum-ion batteries.

As a result of the transformations that are still taking place at the university, NUST MISIS is included in the THE, QS and ARWU subject ratings in six areas at once, ranking 30th in the world in the category "Engineering - Mining" and entering the TOP-100 in the direction of "Engineering - Metallurgy". As the leading Russian university in the field of materials science, the university occupies a position of 201+ in the world.

“Inclusion in the global and subject rankings of the best universities in the world is a natural result of the systematic work and systematically pursued policy of NUST MISIS on the development of priority scientific areas. In fact, now we are getting the results of the work begun in 2013-14 - on the creation of research laboratories and scientific and educational centers, which were led by the leading scientists of Russia and the world as a result of winning open international competitions, the intensification of scientific research, and as a result - increase in the number of publications in scientific journals indexed in the Web of Science and Scopus databases”.

Since the university maintains close relations with hundreds of foreign universities on academic mobility programs, double diplomas and internships, great emphasis is placed on the study foreign languages. In 2011, NUST MISIS and the University of Cambridge launched a unique language program [email protected] especially for students of technical specialties. As an example of international scientific cooperation between universities, one can cite a collaboration with the Italian National Institute Nuclear Physics (INFN) and the University of Naples. Friedrich II (UNINA), along with NUST MISiS participating in the ShiP experiment of the European Organization for Nuclear Research.

As a leading technical university and a forge of highly professional engineering personnel, NUST MISIS takes an active part in creating the conditions for the country's transition to a digital economy.

In particular, in 2017, the university, together with Vnesheconombank, opened the first Blockchain Competence Center in Russia, which brings together leading world experts and Russian practitioners to implement pilot projects based on blockchain technologies in various fields of activity: from registering real estate transactions to monitoring supply chains. medicines.

AT last years leading universities are looking for ways to reduce the time spent on mastering educational material and increase the efficiency of the educational process. The best result was shown by MOOC (Massive Open Online Courses) and Blended Learning (blended learning) formats. In 2015, NUST MISIS, together with seven leading Russian universities, founded the National Open Education Platform, which now hosts more than 300 online courses. In 2017, the university became a participant in the priority project in the field of education "Modern digital educational environment in Russian Federation aimed at increasing the availability of quality education for all citizens of the country. Contributing to the search for new, best teaching practices and their implementation, NUST MISIS became the ideologist and organizer of #EdCrunch, the largest global conference on technologies in education in Europe.

NUST MISIS has been and remains true to the traditions laid down since the founding of the Moscow Mining Academy - to promote the scientific and technological progress of the country, promptly responding to the challenges of the era.

Alevtina Chernikova, Rector of NUST MISiS, Professor, Doctor of Economics

“For 100 years, MGA has come a bright way. All activities of the Moscow Mining Academy and the institutes created on its basis are inextricably linked with the history of the country. Being on the cutting edge scientific and technological progress The university has always responded to the challenges of the time: it participated in the creation of the largest projects of the era of industrialization, was engaged in the post-war reconstruction of the country, was an active participant in nuclear and space projects, formed scientific schools known all over the world today and developed international academic cooperation. We are opening a new century with the goal of becoming one of the best technical universities in the world. We have everything we need for this: the right strategy, highly professional teachers and staff, talented students, and the support of our business partners.”

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 exactly how medicines are monitored, what exactly the departments request and what work is being done with respect to dangerous medicines.

Operational monitoring of medicines: conducting an audit

Roszdravnadzor’s regular operational monitoring of medicines applies to all medicines that are openly or restrictedly available in Russia. The main purpose of the verification procedure is to protect patients and promptly detect unsafe medicines that can harm health and life. To prepare for monitoring, keep a record of all drugs in a convenient program

Medication Accounting

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

Why you need to audit medicines

From 1.03.2017 internal audit is considered mandatory. Regular internal audits allow:

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

How is the interaction with the department built?

All medical enterprises working with medicinal products must transmit a number of data to the regulatory authorities. Thus, for operational monitoring of medicines, data are 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 are co-administered 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 the interaction of subjects and instances is enshrined in two Orders:

• for products used in the field of veterinary medicine, the Order of the Ministry of Agriculture of the Russian Federation No. 357 of October 10, 2011 is in force;
• for the means used in working practice, the 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 department arranges an inspection after it receives Monitoring of drugs by Roszdravnadzor is possible if the medical organization provides the relevant information:

• usage medical preparations in clinics. In particular, here we are talking about recorded adverse and unplanned reactions, including threats to the life of the patient, as well as data on the features of interaction and compatibility of drugs;
• reports that are related to drug safety. They are formed on the fact of appeals from medical organizations, patients and other subjects. The reports of the Federal Service for Surveillance in Healthcare contain detailed information about whether this or that remedy is effective and what are the dangers when using it;
• up-to-date data transmitted by other executive authorities, for example, relating to the subject 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, 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, 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 medicines (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, 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.
• overpricing of vital and essential drugs (clause 1, article 14.6 of the Code of Administrative Offenses of the Russian Federation). For officials - 50,000** rubles, for legal entities - twice 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 *** rubles.

Violation of the rules for the circulation of narcotic drugs or psychotropic substances, which caused harm to health, led to other serious consequences, or out of selfish motives (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 up to 360 hours with deprivation of the right to hold certain positions or engage in certain activities for up to 3 years or without it.

**** or income for a period of 1-2 years, or compulsory work for a period of up to 480 hours, or restriction of liberty for a period of 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 drug monitoring is documented as a set of reports. They are grouped and further analyzed in Roszdravnadzor.

https://ru.freepik.com

Involved in circulation medical devices entities provide information in the relevant periods:

• once 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.

Send drug monitoring data no longer than thirty days after the designated periods.

Results of monitoring

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

• Correction of the accompanying documentation according to the detected changes;
• Removal of an unsafe and unassessed drug from free circulation;
• Restriction for a certain period of the permitted use of the drug;
• Admission to the use of funds previously closed for circulation.

What you need to know about the 4n order and the new prescription procedure

In some cases, the drug is prohibited from participating in free circulation. However, this decision is acceptable 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.

A responsibility

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

• there is no operational monitoring procedure, 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);
• Knowingly providing false information or withholding information that the product may be harmful to health. For this, the medical organization will be held criminally liable in accordance with Art. 237 of the Criminal Code of the Russian Federation.

https://ru.freepik.com

Suspension of use

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

Risk assessment

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

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

• the manufacturer is notified in writing of the decision. He also receives documents on the results of the examination;
• information is transferred to Roszdravnadzor. The department then posts the information on its website.

Information about the drug on the website of Roszdravnadzor

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

The following information is posted there:

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

Operational drug monitoring is introduced by a government commission to support the country's economic growth and improve all segments of the population. The decision was approved by the protocol drawn up in the order of the Ministry of Health and social development RF 277n in May 2009.

The purpose 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 polyclinics and pharmacies.

Operational monitoring will help to perform several tasks:

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

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

Checking the prices of essential medicines

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

According to the WHO definition, essential and essential drugs are those that:

• meet the goals of medical care for the population;
• significant for the country's public health goals;
• have proven efficacy and safety;
• differ in economic efficiency.

Solving the problems of the pharmaceutical market

The problem of regulating the assortment and prices in the pharmaceutical market of the Russian Federation remains relevant, since the share of available medicines is decreasing every year, inflated prices for products are set, and regional and municipal purchases become 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 pursues the main goal - to ensure the prevention and treatment of diseases that prevail in terms of the incidence rate among the population of the Russian Federation.

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

State Register of Prices

The regional portal for pharmaceutical activity and drug supply farmcom.info contains all the legislative acts on the regulation of drug circulation. On this site you can get complete information about the preparation of reports:

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

Operational monitoring of prices for vital and essential drugs by Roszdravnadzor is designed to make the most necessary medicines more accessible to socially unprotected segments of the population. On the site you can find out about the requirements for the minimum range of funds to provide medical care for pharmacies with manufacturing activities, drugstores 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 drug, trade name, manufacturer, release form and price.

Stages of monitoring

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

1. Approval of the list of products under chemical names that do not have a patent and are recognized throughout the world. Drugs should be used for the treatment, prevention or detection of diseases characteristic of the population of the Russian Federation, have advantages over other drugs, have pharmacological properties, which are equivalent to similar means.
2. A methodology is established for calculating marginal retail prices for drugs from the list.
3. State registration of medicines and prices set for them by manufacturers is carried out.
4. Methods are being approved by the executive authorities for determining the threshold levels of wholesale and retail mark-ups to prices, which are proposed by manufacturers of VED drugs.
5. The procedure for issuing instructions on the approval of allowances in accordance with the law is established. Instructions on the established limits of wholesale and retail allowances are sent to executive authorities.
6. Carrying out federal state supervision in the field of drug circulation and control at the regional level over the price level by the authorized executive authorities of the federation and at the level of subjects. 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 essential drugs.

Regular price monitoring

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

Until June 1, 2012, medical and pharmacy organizations must register on the Roszdravnadzor website in the Operational Monitoring section. Each organization issues an order and appoints a responsible person who provides data in electronic and paper form, in accordance with the proposed form, with the signatures of managers.

Operational monitoring of vital drugs is the responsibility of medical and pharmacy organizations of any form of ownership. Every month, by the 25th day, a report is submitted, which lists the stocks for the 15th day of the reporting period for medicines from the list of Vital and Essential Drugs:

• pharmacies report on the place of trading activity;
• medical and preventive organizations provide a report on branches.

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

Price Monitoring Regulations

The range and prices of medicines in pharmacies and medical and preventive organizations are subject to monitoring. The basis for the checks is the list of essential medicines.

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

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

The basis for the formation of the list are declarations of conformity of medicines. The list is received by the departments of Roszdravnadzor of the constituent entities of the Russian Federation. If a specified drug for two months is absent in pharmacies and medical organizations, the list is corrected 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 in this subject of the Russian Federation.

Specifically, the structure of the audited 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.

Reporting entities should include:

• specialized and multidisciplinary medical institutions of the republics, regions, territories and districts;
• city ​​hospitals in cities with a population of more than 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 medical 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, drugstores and kiosks in the report structure is provided - 30:60:10.

Reporting and analytics

The operational monitoring system is multistage. Every month, information about medicines that are in stock on the 15th day is collected from pharmacies and medical institutions of each subject of the Russian Federation that is subject to a monthly check. Not 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 is also provided, specified in the annexes in the Regulation.

The task of Roszdravnadzor is to provide data on drug supply population.

The report should contain specific detailed information:

• structure of the pharmacy market by segments of retail, wholesale, production, hospitals;
• volumes and structure of drugs consumed;
• providing medicines to citizens of certain categories;
• analysis of the price level for medicines;
• review of allowances 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 the monitoring of drugs and the range of medicines, the 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 in case of its absence on the date of monitoring, within one generic name;
• the name of the wholesaler who is engaged in the supply of medicines in the absence of a particular drug in stock;
• reasons for the absence of the drug and the timing of the resumption of supplies.

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