Press conference dedicated to the World Patient Safety Day

On September 17, 2019, the World Patient Safety Day will be held for the first time in all countries of the globe. Its goal is to raise global awareness of patient safety and to encourage international solidarity in the actions of the professional community.

On the eve of the memorable date of September 16, 2019, a press conference for the regional media dedicated to patient safety was held in the great hall of the Health Department of the Lipetsk region.

The event was attended by the head of the territorial body of the Federal Service for Supervision of Healthcare in the Lipetsk Region A. S. Frolov, the head of the department of organization of medical care for adults of the Lipetsk Region Health Department S. V. Koroteeva, the head of the Department of Licensing, Quality Control and Safety of medical activities of the Lipetsk Region Health Department N. V. Vasilyeva, the director of the OSU "Center for Quality Control and Certification of Medicines" O. N. Smuseva, the first deputy director of the Territorial Compulsory Health Insurance Fund of the Lipetsk Region L. S. Selishcheva, the deputy Chairman of the Public Council under the Lipetsk Region Health Department E. I. Gokova and the Chief Executive Officer of the Lipetsk Region Health Department.freelance specialist epidemiologist of the Health Department of the Lipetsk region A. N. Filatov

Currently, the definition of patient safety is primarily concerned with preventing errors in the process of providing medical care and reducing the risk of adverse events associated with the provision of medical care to an acceptable minimum. Such a minimum should be considered as a consensus of all stakeholders, taking into account the current knowledge, resources and conditions in which medical care is provided.

Effective control over the observance of citizens ' rights to affordable, high-quality and safe medical care is a priority area of Roszdravnadzor, which conducted 50 inspections of medical and pharmaceutical organizations of state and non-state ownership in 6 months of 2019, during which 172 violations of legislation in the field of healthcare were identified.

The main violations identified during the inspections were: violation of the rights of citizens approved by the State Guarantee Program; violations of the organization of internal control in medical organizations; violations of the rules of equipment and standards of medical care; untimely preferential provision of medicines to citizens; violation of the circulation of medicines and medical products.

According to the results of the inspections, 32 orders were issued; 12 cases of administrative offenses were initiated against legal entities and officials; administrative fines were accrued in the amount of 132.0 thousand rubles. 3 protocols on administrative offenses were sent to the courts of the Lipetsk region, and in order to prevent offenses in the first half of 2019, 15 warnings were issued.

For 6 months of 2019, the territorial authority received 209 appeals from citizens, which is 28% less than in the same period of 2018. According to the results of the review, the number of justified appeals was 35 (18%), for the same period of 2018 – 76 (29%). For 6 months of 2019, 114 appeals (54%) were received from citizens on the issue of unsatisfactory organization of the work of public and private medical organizations.

Since October 01, 2019, the project on "Labeling of medicines" in terms of the release of preferential medicines for high-cost nosologies received through the Ministry of Health of the Russian Federation begins to be implemented on the territory of the Russian Federation. From January 01, 2020, all medicines in the country will be marked with the Data Matrix code and entered in the information system "Monitoring the Movement of medicines", which will contribute to the fight against the effective fight against substandard and falsified pharmaceutical products.

Also, in order to improve the quality and accessibility of medical care in state medical organizations in the region, the Health Department of the Lipetsk Region, in cooperation with the Federal Service for Healthcare Supervision, initiated the implementation of a pilot project on the implementation of the Roszdravnadzor voluntary certification system "Quality and Safety of medical activities".

The project includes five state medical organizations: Lipetsk Regional Clinical Hospital, Lipetsk Regional Perinatal Center, Lipetsk Regional Oncology Dispensary, Yelets City Hospital No. 1 named after N. A. Semashko and Lipetsk City Polyclinic No. 1.

The curator of the project at the level of Roszdravnadzor is the Federal State Budgetary Institution "National Institute of Quality".

The pilot project provides for working out the activities of a medical organization in 10 sections:

• Personnel management system. Medical personnel.
• Epidemiological safety.
• Drug safety.
• Quality control and safety of medical devices handling.
• Organization of emergency and emergency care in the hospital, organization of the work of the emergency department.
• Continuity of medical care. Transfer of clinical responsibility for the patient.
• Surgical safety. Prevention of risks associated with surgical interventions.
• Prevention of risks associated with the transfusion of donated blood and its components, drugs from donated blood.
• Environmental safety in a medical organization. Organization of patient care.
• Organization of medical care in accordance with clinical recommendations.

Within the framework of the project, it is planned to create Competence Centers in the Lipetsk Regional Clinical Hospital and in the Lipetsk City Polyclinic No. 1 in order to replicate the experience throughout the regional medical network, as well as to ensure the standardization of basic medical and diagnostic processes.

The implementation of the pilot project provides for a number of activities that are carried out in stages and quarterly throughout 2018-2020 and include:

• external audit (assessment of the initial state of the organization of the quality and safety of medical activities in the state medical network by the forces and means of federal experts),
• introductory seminars on project implementation,
• webinars dedicated to the implementation of the modern quality policy in healthcare, the organization of control and management of the safety of medical activities,
• seminars and workshops on internal audit (quality control) in medical organizations.

Upon completion of the project, all participating medical organizations will receive state Certificates of quality and safety of the Federal Service for Healthcare Supervision.

Currently, the inspection activities are carried out by the experts of the Federal State Budgetary Institution "National Institute of Quality" in the GUZ "Lipetsk City Polyclinic No. 1", GUZ "Yelets City Hospital No. 1". Semashko" and GUZ "Lipetsk Regional Oncological Dispensary".

The result of the pilot project will be an increase in the level of public satisfaction with medical care through the introduction of modern technologies for organizing a safe medical and diagnostic process in strict accordance with the procedures and standards of medical care, clinical protocols and recommendations in all state medical organizations in the region.

In addition, in order to ensure the safety, effectiveness and quality of medicines (LP) in the Lipetsk region, the Health Department has established and effectively operates an accredited OSU "Center for Quality Control and Certification of Medicines".

Without quality control in the OSU "Center for Quality Control and Certification of Medicines", medicines provided under federal and regional programs can not get to the state health institutions of the Lipetsk region. The center clearly controls the quality of medicines at all stages of circulation in the region.

First stage: Monitoring compliance of suppliers with the requirements for the transportation and storage of medicinal products when delivered to the regional pharmacy warehouse. Throughout the entire path of the drug from the manufacturer to the pharmacy or medical institution, the temperature regime (cold chain) is monitored using temperature indicators and temperature recorders. If the supplier does not meet the requirements of the cold chain, the drugs are not taken to the regional pharmacy warehouse and returned to the supplier. For 6 months of 2019, 129 deliveries were made, no violations of the transportation of LP were detected.

Second stage: Acceptance control of LP in OSU "CCC and SLS" upon admission to the Lipetsk region. As part of the acceptance control, the Center conducted 13257 examinations of the quality of medicines, including 7752 received under federal and regional programs, of which 3 series of medicines were rejected and withdrawn from circulation in the amount of 279,000 rubles, which prevented the receipt of low – quality medicines in medical institutions of the Lipetsk region.

The third stage: The legislation of the Russian Federation clearly regulates the mandatory requirements for the organization of storage of LP. Compliance with these requirements in polyclinics and hospitals of the Lipetsk region is also monitored by the OSU "CCC and SLS". In the first half of the year, 12 such on-site inspections were carried out in medical institutions.

The fourth stage: At the federal level, the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of the Russian Federation carries out mandatory serial and selective control of medicinal products in circulation throughout the Russian Federation, and if a falsified or substandard medicinal product is detected, Roszdravnadzor sends letters to the regions demanding that this series of medicinal products be withdrawn from circulation. On the basis of these letters, 396 examinations were conducted, as a result of which 1 series of substandard LP in the amount of 61231.64 rubles was withdrawn from circulation.

The fifth stage: In all developed countries, including the Russian Federation, the occurrence of undesirable drug reactions when using drugs is necessarily controlled. This system allows you to identify unknown, very rare adverse reactions or features of the use of LP in some patients. In the Russian Federation, this is regulated by the Federal Law N61-FZ "On the Circulation of Medicines". If you suspect the occurrence of a side effect of the drug, the doctor is obliged to report it to Roszdravnadzor. In our region, these reports are collected by the OSU "CCC and SLS", where the examination is carried out and the information is sent to the AIS Roszdravnadzor. For 6 months of 2019, the Center received 40 reports of adverse drug reactions, all of them were indicated in the instructions for use of drugs and are associated with the peculiarity of drug tolerance in a particular patient.

Thus, the quality of medicines in the region is clearly controlled in accordance with the legislation of the Russian Federation.