Prompt drug monitoring introduced by a government commission to support economic growth in the country and improve the provision of medicines to all segments of the population. The decision was approved by the protocol issued in the order of the Ministry of He alth 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 polyclinics and pharmacies.
Online monitoring will help you accomplish several tasks:
- objectively assess the situation on the pharmaceutical market;
- identify negative trends in time 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 drugs
It is worth highlighting the provision of vital and essential drugs (VED). Feder althe legislation 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, essential and essential medicines are those that:
- correspond to the goals of medical care for the population;
- relevant to the country's he alth goals;
- have proven efficacy and safety;
- are cost-effective.
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 available medicines is decreasing every year, inflated prices for products are set, and regional and municipal purchases become more expensive than federal ones.
Government releases 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 that prevail in terms of the incidence rate among the population of the Russian Federation.
Priority he alth care needs are named in Law No. 61-FZ, namely in paragraph 6, article 4.
State price register
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 compilationreports:
- list of essential drugs for medical purposes;
- list of drugs prescribed by medical commissions;
- medication list for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, blood cancer, multiple sclerosis, organ transplant patients.
Online monitoring of prices for essential drugs by Roszdravnadzor is designed to make the most necessary medicines more accessible to socially vulnerable segments of the population. On the site you can find out about the requirements for the minimum range of products for the provision of medical care for pharmacies with production activities, pharmacy points and kiosks.
The 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 drug name, trade name, manufacturer, dosage form and price.
Stages of monitoring
The law on state regulation of prices determines that the operational monitoring of vital drugs by Roszdravnadzor is carried out in several stages:
- Approval of the list of funds 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, and have pharmacological properties that are equivalent to similar drugs.
- The method for calculating marginal retail prices for drugs from the list is being established.
- The state registration of medicines and the prices set for them by manufacturers is underway.
- Methods are being approved by executive authorities for determining the threshold levels of wholesale and retail mark-ups to prices offered by manufacturers of vital and essential drugs.
- The procedure for issuing instructions on the approval of allowances in accordance with the law is being established. Instructions on the established limits of wholesale and retail allowances are sent to executive authorities.
- Conducting federal state supervision in the field of drug circulation and control at the regional level over the price level by authorized executive bodies of the federation and at the level of subjects. Operational monitoring will allow you to receive information in a timely manner.
- Bringing to account persons who violate the procedure for setting prices for essential drugs.
Regular price monitoring
Online monitoring of prices for essential drugs is carried out in accordance with Order No. 277n.
Medical and pharmacy organizations before June 1, 2012 must register on the website of Roszdravnadzor 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 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, a report is made that lists the reserveson the 15th of the reporting period for medicines from the Vital and Essential Drugs List:
- pharmacies report by location of trading activities;
- treatment organizations provide a report on branches.
Responsible for high-quality, reliable and complete information are the heads of pharmacies and medical organizations.
Price Monitoring Regulations
Monitoring is subject to the range and prices of medicines in pharmacies and medical organizations. The basis for the checks is the list of essential medicines.
Online 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;
- doses;
- 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 the specified drug is not available in pharmacies and medical organizations for two months, then the list is corrected at the local level.
Who is required to file 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.
Specific structureorganizations to be inspected 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 must include:
- specialized and diversified 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).
Online monitoring is carried out for 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 foreseen - 30:60:10.
Reporting and analytics
The operational monitoring system is multi-stage. Every month, information about medicines that are in stock on the 15th 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, the local bodies 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 applications in the Regulations.
The task of Roszdravnadzor - based on the reports received no later than the 10th day of the next monthprovide in electronic and paper form to the Department for the Development of the Pharmaceutical Market and the Market of Medical Equipment of the Ministry of He alth and Social Development of Russia data on drug provision of the population.
The report must contain specific detailed information:
- pharmaceutical market structure by segments of retail, wholesale, production, hospitals;
- volume and structure of drugs consumed;
- providing medicines to citizens of certain categories;
- price level analysis for medicines;
- overview of allowances in the list of Vital and Essential Drugs in wholesale and retail;
- list of measures taken to curb price increases.
The Department, no later than the 15th of the next month, prepares a draft report to the government on monitoring drugs and a range of medicines, measures taken to ensure the availability and quality of medical care. The report is signed by the Minister of He alth.
Features of filling out forms
Pharmacy and medical organizations, when filling out reports, indicate not only the name, manufacturer, dosage of the drug, but also other data:
- replacement of the medicine in case of its absence on the monitoring date, within one generic name;
- name of a wholesaler who supplies medicines in the event that a particular drug is out of stock;
- reasons for the lack of the drug and the timing of the resumption of supplies.
On-line price monitoring serves to improve the quality of drug supply to hospitals and the population through pharmaciesnetwork.
