Operational monitoring of medicines was introduced by a government commission to support the country's economic growth and improve the provision of medicines to 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 of the Russian Federation 277n in May 2009.
The goal of the Roszdravnadzor, whose employees have the main responsibilities, is the affordability of medicines for the population. Operational monitoring of medicines checks the assortment and pricing policies of clinics and pharmacies.
On-line monitoring will help to perform several tasks:
- objectively assess the situation in the pharmaceutical market;
- identify negative trends in time and adjust them.
The result of the checks will be a report that appears on the website of Roszdravnadzor and the state register of prices.
Checking the prices of vital drugs
Separately, it is worth highlighting the provision of vital and essential medicines (Vital and Essential Drugs). Federal law clearly defines the regulation of the circulation of these medical devices, and since 2010, state regulation of prices for them has been introduced.
According to the WHO definition, drugs of vital necessity and importance include those that:
- consistent with the goals of medical care for the population;
- relevant to the country's health goals;
- have proven effectiveness and safety;
- differ in economic efficiency.
Solving the problems of the pharmaceutical market
The problem of regulating the assortment and prices on the pharmaceutical market of the Russian Federation remains relevant, since the share of affordable drugs is reduced annually, set prices for products are set higher, regional and municipal purchases are becoming more expensive than federal ones.
The government publishes an updated list based on medical statistics:
- The list of drugs in this category is approved annually.
- Operational monitoring pursues the main goal - to ensure the prevention and treatment of diseases prevailing in the proportion of morbidity among the population of the Russian Federation.
Priority health care needs are specified in Law No. 61-FZ, namely in paragraph 6, Article 4.
State price register
The farmcom.info regional portal for pharmaceutical activities and pharmaceuticals has collected all the laws governing drug trafficking. On this site you can get full information about reporting:
- list of vital drugs for medical use;
- list of drugs that are prescribed by medical commissions;
- list of drugs for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, blood cancer, multiple sclerosis, patients after organ transplantation.
Operational monitoring of prices for Vital and Essential Drugs of Roszdravnadzor is designed to make the most necessary medicines more accessible for socially vulnerable groups of the population. On the site you can find out about the requirements for the minimum range of funds for the provision of medical care for pharmacies with industrial activities, drugstores and kiosks.
The register of prices for vital drugs for each specific period in the constituent entities of the Russian Federation is presented. The table contains information on the name of the medicine, trade name, manufacturer, form of release and price.
Stages of monitoring
The law on state regulation of prices determines that the operational monitoring of Roszdravnadzor on Vital and Essential Drugs is carried out in several stages:
- Approval of a list of products under chemical names that are not patented and 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 that are equivalent to similar drugs.
- The methodology for calculating marginal retail prices for drugs from the list is established.
- State registration of drugs and prices set by manufacturers is carried out.
- Approved are the methods for determining by executive bodies the boundary levels of wholesale and retail mark-ups to prices proposed by manufacturers of vital drugs.
- The procedure for issuing instructions on the approval of allowances in accordance with the law is being established. Executive bodies are sent instructions on the established boundaries of wholesale and retail allowances.
- Conducting federal state supervision in the field of drug circulation and control at the regional level over the price level by authorized federal executive bodies and at the level of entities. Operational monitoring will allow you to receive information in a timely manner.
- Holding liable persons who violate the pricing procedure for essential drugs.
Regular price monitoring
Operational monitoring of prices for essential drugs is carried out in accordance with order No. 277n.
Before 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, according to the proposed form, with signatures of managers.
Operational monitoring of vital drugs is the responsibility of medical and pharmacy organizations of any form of ownership. Every month, before the 25th day, a report is made that lists the reserves for the 15th day of the reporting period for medicines from the vital drugs list:
- pharmacies report on the place of trading;
- health care organizations provide a report on branches.
Responsible for quality, reliable and complete information are the heads of pharmacies and medical organizations.
Price Monitoring Regulation
Monitoring is subject to the assortment and prices of drugs in pharmacies and health care organizations. The basis for the checks is a list of essential drugs.
Operational monitoring of prices for vital drugs of Roszdravnadzor is carried out on the basis of the list of drugs from which the list for verification is formed, indicating:
- trade name;
- dosage form;
- dosage
- manufacturing company.
The basis for the formation of the list are declarations of conformity of medicines. The list is received by the Roszdravnadzor of the constituent entities of the Russian Federation. If the specified drug is absent for two months in pharmacies and medical organizations, then the list is adjusted at the local level.
Who is required to submit reports?
According to the law, not all pharmacy and medical institutions are required to participate in monitoring on a monthly basis, but their number should reach at least 15% of the total number in this subject of the Russian Federation.
Specifically, the structure of the audited organizations in each constituent entity of the Russian Federation should include 25% of pharmacies, of which 25% of federal and municipal and 50% of private organizations.
The accountable organizations should include:
- specialized and multidisciplinary medical institutions of the republics, regions, territories and districts;
- city hospitals of cities with a population of over 250 thousand people (4 institutions from each subject);
- municipal institutions (not less than 5);
- central hospitals of districts (not less than 3).
Operational monitoring is carried out in all medical organizations with federal subordination.
If there are no pharmacies in the subject of the Russian Federation, then the number of monitoring participants at the expense of municipal institutions is increasing. The following correlation between pharmacies, drugstores and kiosks in the report structure is provided - 30:60:10.
Reporting and analytics
The operational monitoring system is multi-stage. Every month, information on medicines that are available on the 15th day is collected at pharmacies and medical institutions in each subject of the Russian Federation, which is subject to a monthly check. Not later than the 5th day of the next month, the local authorities of Roszdravnadzor submit in electronic and paper form a consolidated report for each subject, in accordance with the forms defined by law. Additional information for analytics specified in the appendices in the Regulation is also provided.
The task of Roszdravnadzor is to provide, on the basis of the reports received, no later than the 10th day of the next month, in electronic and paper form, with the Department for the Development of the Pharmaceutical Market and the Medical Technology Market of the Ministry of Health and Social Development of Russia on drug supply to the population.
The report should contain specific detailed information:
- Pharmacy market structure by segments of retail, wholesale, production, hospitals;
- volumes and structure of consumed drugs;
- providing medicines to citizens of certain categories;
- analysis of the price level for drugs;
- review of premiums in the list of vital drugs in wholesale and retail;
- list of measures taken to curb price increases.
The Department no later than the 15th of the next month is preparing a draft report to the government on monitoring 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, as well as other data:
- replacement of the medicine in case of its absence at the date of monitoring, within the limits of one generic name;
- the name of the wholesaler who is involved in the supply of medicines in the absence of a specific drug in stock;
- the reasons for the lack of the drug and the timing of the resumption of supplies.
Operational price monitoring serves to improve the quality of the supply of medicines to hospitals and the population through pharmacy chains.