Scientific Justification of Medication Support of a Regional Multiprofile Hospital

The dissertation is devoted to the scientific justification of medication support of a regional multiprofile hospital using the principles of pharmacoeconomics and evidence-based medicine. The study was conducted at the basis of Voronezh Regional Clinical Hospital No. 1 and covers a complex of questions: analysis of hospitalized morbidity, study of the medication support financing system, development of a local drug formulary, organization of microbiological monitoring of causative agents of hospital infection, and optimization of antibiotic procurement. The work demonstrates the possibilities of integrating information technologies into the process of hospital medication support.

Rational medication support is one of the most important medical and social problems of healthcare in our country under current conditions of transition to market relations in economic activity, deterioration of the medical-demographic situation, and decline in the population's health level. Given the limited resources of Russian healthcare, rational use of medications is a matter of national importance (Starodubov V.I., Lugovkina T.K., 2003).

Under conditions of mandatory medical insurance standards, it is also necessary to reduce the duration of inpatient treatment, which is feasible only through improvement of medication support and modification of pharmacotherapy tactics (Chesnokov P.E., 1999; Mezentsev E.V., 2003; Mylnikova I.S., Ternavsky A.P., 2003).

It should be noted that at present, regional multiprofile hospitals are experiencing an increase in the severity and diagnostic complexity of hospitalized patients, changes in the structure and etiology of infectious morbidity, including nosocomial. Agents of hospital infection acquire multiple antibiotic resistance, which substantially worsens the prognosis of the disease and increases the cost of inpatient treatment (Pokrovsky V.I., 2000; Strazhunsky L.S., 2001; Onessenko G.G., 2006, et al.).

In this complex situation, against the backdrop of clearly insufficient state funding, healthcare institutions are compelled to seek new approaches to organizing medication support and rational use of medications. One of the approaches to optimizing drug procurement and use is the implementation of a formulary system based on evidence-based medicine and pharmacoeconomics data (Strazhunsky L.S., 2001; Vyalkov A.I., Belousov Yu.B., Leonova M.V., 2002; Starodubov V.I., Lugovkina T.K., Mikhailova Yu.V., Kalininskaya A.A., 2003, et al.). Implementation of a formulary system in each specific healthcare institution requires studying and developing own approaches, taking into account regional financing, the specifics of hospitalized morbidity, and the level of medical care provided. In the Russian Federation, only in some large healthcare institutions (in Moscow, St. Petersburg, Ryazan, Yekaterinburg, Pskov, Voronezh) have drug formularies been developed and a formulary system implemented. To accomplish these tasks, by Order of the Ministry of Health of the Russian Federation No. 131 of 1997, a new medical specialty - clinical pharmacology - was introduced in healthcare institutions.

In most inpatient healthcare institutions, antimicrobial agents constitute the most important part of the medication arsenal. Their procurement costs, by some estimates, account for up to 50% of hospital budgets. From 25 to 35% of all hospitalized patients receive antimicrobial agents for various indications (Strazhunsky L.S., 2001; Belousov Yu.B., Leonova M.V., 2002, et al.). However, according to WHO experts, antimicrobial agents are used irrationally in almost 50-70% of cases. Given the costliness and serious consequences of their improper use both for individual patients and at the scale of the hospital and the country as a whole, optimization of antibiotic procurement and use is of particular importance (Onessenko G.G., 2006, et al.). When developing drug formularies and systems for evaluating medication use, primary attention should be given to the group of antimicrobial agents (Ushkalova E.A., 2002). At the same time, the main criteria for selecting procured agents should be local data on the causative agents of purulent-septic diseases and their antibiotic resistance (Strazhunsky L.S., 2001; Rudakova A.B., 2002; Zubkov M.N., 2002; Yakovlev V.P., Yakovlev S.B., 2003, et al.).

At present, in most hospitals of Voronezh Oblast and other regions of the Russian Federation, the formulary system is only beginning to be implemented, microbiological monitoring is absent, and pharmacoeconomic calculations of costs and effectiveness of various treatment and prevention schemes for different nosologies are practically not used.

The priority tasks facing regional healthcare organizers and administrators of large hospitals are the development of local drug formularies, systems for evaluating medication use, implementation of microbiological monitoring of causative agents of hospital infection, and optimization of drug procurement and use, which determined the goal and objectives of our study.

The goal of the work: scientific justification of medication support of a regional multiprofile hospital based on pharmacoeconomics and evidence-based medicine data using information technologies.

To achieve the goal of the study, the following tasks were formulated:

1. Conduct an analysis of hospitalized morbidity based on materials from a regional multiprofile hospital.

2. Study the established system of medication support financing for the hospital and compare hospitalized morbidity with expenditures on various groups of medications.

3. Develop organizational foundations for implementing local microbiological monitoring aimed at determining the structure and antibiotic resistance of causative agents of purulent-septic diseases, including nosocomial ones. Formulate a policy for rational use of antibiotics in a regional multiprofile hospital.

4. Compile a scientifically justified drug formulary for a regional multiprofile hospital and determine the procedure for its maintenance.

5. Organize a system for evaluating the rationality of use of medications and indirect factors affecting the quality of pharmacotherapy.

6. Develop recommendations for scientific justification of medication support of a regional multiprofile hospital based on the implementation of a formulary system.

The scientific novelty and theoretical significance of the study lie in the fact that under new socio-economic conditions, at the stage of healthcare reform in the Russian Federation, in the largest inpatient-polyclinic institution of the country, for the first time:

- an analysis of hospitalized morbidity was conducted and diseases with the greatest proportion in a multiprofile hospital were identified;

- the system of medication support financing was studied, the structure of expenditures on various groups of medications was analyzed and compared with the structure of hospitalized morbidity; organizational foundations for local microbiological monitoring of the structure and antibiotic resistance of causative agents of purulent-septic diseases in departments of various profiles were developed, and factors contributing to the reduction in the prevalence of resistant strains of causative agents were identified;

- principles for rational use of antibiotics in a multiprofile hospital were formulated, which made it possible to optimize antibiotic procurement and use and reduce the proportion of resistant causative agents; a system for evaluating the rationality of medication use and indirect factors affecting the quality of pharmacotherapy in a multiprofile hospital was developed;

- the modern organizational technology of the formulary system, criteria for selecting medications for inclusion in the drug formulary, and the procedure for its maintenance were justified.

Scientific and practical significance of the work. As a result of the study:

- a scientifically justified drug formulary of a regional multiprofile hospital was developed;

- local microbiological monitoring was organized and data on the structure and dynamics of antibiotic resistance of causative agents of purulent-septic diseases, taking into account the profile of hospital departments, were obtained;

- the need for financing medication support of a multiprofile hospital was calculated;

- optimized forms of documentation were developed: forms of medication requests from clinical departments of the hospital, templates of acts of inspections by intra-hospital commissions for control of accounting and rational use of medications of various groups, a template for directing biological material for microbiological examination, a new form of prescription sheets;

- an automated system for organizing medication support was created;

- an electronic database of pharmacological information was created in the local computer network of the hospital;

- schemes for conducting antibacterial therapy and prevention of various purulent-septic diseases were optimized;

- scientifically justified methodological recommendations were developed for organizing the clinical pharmacology service in healthcare institutions, medication support of a multiprofile hospital, and microbiological monitoring in healthcare institutions.

As a result of changing the assortment and volume of antibiotic procurement based on data from local microbiological monitoring, implementing the sanctioned release of reserve drugs, and a complex of measures for rational use of antibiotics, the prevalence of antibiotic-resistant strains of causative agents was reduced in most departments of the multiprofile hospital, which made it possible to effectively use available antimicrobial agents.

The implementation in VOKB No. 1 of optimized forms of documentation related to medication support and microbiological examinations substantially increased their informativeness and speed of processing, and reduced material costs for maintaining documentation on paper media by 12 times.

The implementation of optimized schemes and protocols of main components of pharmacotherapy of acute mediastinitis (rational antimicrobial therapy, correction of nutritional status) over 2001-2005 made it possible to reduce the duration of stay of patients in the ICU by an average of 25% and reduce patient mortality by 20%. The implementation of modern principles of antibacterial prophylaxis during operations for implantation of cardiac pacemakers made it possible to reduce the number of purulent-inflammatory complications in the postoperative wound area by 2.2 times, reduce antibiotic expenditures by 52.6-83.4%, and reduce the number of injections for this type of operation by 3.5-10 times.

The implementation of the formulary system developed by us, taking into account the specifics of VOKB No. 1, made it possible to reduce medication expenditures by an average of 11.5 million rubles per year. At the same time, over 2000-2004, the average duration of inpatient treatment of patients at VOKB No. 1 was reduced by 14.6%, and patient mortality decreased by 5.2%.

Five rationalization proposals, five methodological recommendations, and one textbook have been implemented across various aspects of the work. The materials of the study were used in the preparation of 8 orders of local and regional level concerning questions of medication support and rational use of medications.

The results of the study have been implemented in the activities of VOKB No. 1, 14 healthcare institutions of Voronezh Oblast, City Clinical Hospital No. 1 named after N.I. Pirogov (Moscow), as well as in the educational process of the Department of Public Health and Healthcare and the Department of Hospital Surgery of Voronezh State Medical Academy named after N.N. Burdenko.

Validation of the obtained results. The materials of the study were presented at the IV All-Russian Scientific Conference 'Modern Problems of Antimicrobial Chemotherapy' (Moscow, 2002), the All-Russian Scientific and Practical Conference 'The Role of Healthcare in Protecting Public Health' of the National Research Institute of Public Health of the Russian Academy of Medical Sciences (Moscow, 2005), and the annual Voronezh Oblast Scientific and Practical Conferences of physicians and microbiologists on problems of hospital infection and antimicrobial therapy (2001, 2002, 2003, 2004, and 2005).

Structure and scope of the dissertation. The main content of the work is presented on 150 pages of typed text, the dissertation is illustrated with 66 tables, 13 figures, and appendices. The work consists of an introduction, four chapters, a conclusion, conclusions and practical recommendations, materials confirming the implementation of the research results in practice, a bibliography consisting of 167 sources, of which 47 are foreign.