Formular system: what is it and why is it needed

Formulary Committee of the Russian National Formulary; course of evidence-based medicine Russian medical academy postgraduate education; Maxwell Stamp PLC Healthcare Division

Forms medicines(MP) both as a description and as a reference guide are an important working tool in prescribing drugs of choice.

Up to the present time, full realization potential opportunities Formularies are hampered by a lack of comparative data on drug efficacy and / or safety, as well as a lack of local health system resources for their development and implementation. An even more formidable obstacle, however, is misconceptions about the basic concepts of the form.

At a World Health Organization workshop, collectively titled Drug Information Policies in Central and Eastern Europe and the Newly Independent States (Hillered, 27.03. - 02.04.96), it was stated that objective and up-to-date information is a priority for correct application Drugs and prevent waste of resources.

To achieve this goal, public drug policy must include clear policy guidelines for drug information. At the same time, drugs should be considered not only as a pharmaceutical product, but as a “drug product plus information”. The quality of the information on use is just as important as the quality of the drug itself. The state should be fully responsible for providing all categories of the population with impartial, objective and evidence-based information about drugs.

A universal tool for such a strategic state approach is a formulary system that meets all the specified requirements and ideological attitudes.

Front officials responsible for drug policy, there is a direct and very responsible task to achieve the implementation of the formulary system, its recognition among all health workers. In this regard, the process of introducing this doctrine into practical health care, the development, publication and distribution of the form requires the widespread involvement of the most competent specialists, taking into account their motivations, knowledge and arguments.

Annex 1. SOME COMMENTS AND CONSIDERATIONS OF DOCTORS, DIRECTLY OR INDIRECTLY AFFECTING THE CONCEPT OF THE FORM I have been using this drug in my practice for many years with good result and I don't care if it will be in the form or not. We want to be able to test the drugs recommended for inclusion in the form for ourselves, and then decide whether it is right for us or not. Government approval means that a drug is approved for use by all patients for whom it is suitable. Why else is there a form? You cannot deny a patient the opportunity to use any drug approved by the state. Each doctor works with his usual list of drugs. Do not limit it to the scope of a form. Every patient is different, so we need different drugs. If cardiologists say they need this drug Who are we to dispute this? The Formulary Committee is just a group of lobbyists who come together and make decisions on issues that they do not understand at all. For educational purposes, experience with a variety of drugs is required. Without access to newest drugs, our doctors are not able to provide the work with the patient for which they are ready. In real practice, for which we train doctors, there are no such restrictions. It is the most widely used drug among of this class drugs, how can you do without it? These drugs are widely used all over the world, they are the drugs of today. New is better. New is safer. This new drug has a better side profile. effects compared to the old drug. Its benefits far outweigh any perceived risk. We need special drug for patients who are no longer helping, we have no other choice. The presence of the form requires the patient's health to be sacrificed for the sake of cost (economic costs). Every time we limit the use of a drug because of its high cost, we sacrifice the quality of treatment.

V different countries the concepts of the form system, like the form systems themselves, have significant differences... In some countries, forms are officially recognized documents based on vital important means... In others, the form is more reminiscent of a fundamental drug reference book published by commercial organizations represented on the country's market. In a number of countries, forms are prepared and published by independent organizations and groups.

By 1996 from countries the former USSR the state drug formulary was adopted only in Estonia, and by the end of 1998 it was already in effect not only in Estonia, but also in Kyrgyzstan, Kazakhstan, Georgia, and Armenia. Latvia and Lithuania continue to develop their national forms based on the experience of the British National Formula.

Rational pharmacotherapy as a program must be implemented in practice. The introduction of a properly designed form as the most important tool of such a program can provide almost all the necessary theoretical basis to select the most effective and safe drugs for solving various medical problems.

The history of the development of the formulary system has more than a quarter of a century and, nevertheless, during all these years, both its key problems and contradictions have been discussed in the press. The latter include both a lack of thorough and well-performed comparative studies on drug efficacy and safety, and a common lack of local resources to maintain and further development process for assessing drug use. In addition to the listed problems, which impede the systematic work on the preparation, revision and reprinting of forms, a rather serious obstacle is simply incorrect (or erroneous) ideas on a number of fundamental issues of the concept of a formular system.

The lack of a unified point of view on these, apparently purely ideological roughnesses, not only takes time and effort, but also hinders the full cooperation of healthcare leaders, doctors, pharmacists and patients (subjects for whom the formulary system has been created). In addition, a misunderstanding of the problem itself can impede the correct administrative implementation of a project such as a form.

One of the ways to understand the principles of the structure and operation of the form is to try to critically analyze different points of view on the role of this document in modern healthcare.

It is known that clinically rational and cost-effective drug therapy is main goal introducing a formulary system ... From this point of view, the individual elements of an effective form can be considered, i.e. the main characteristics that make it important tool health management.

The main objectives of an effective form

1. Determination of drugs of choice in accordance with their relative safety and efficacy.

2. Inclusion of alternative means of the second line, if necessary.

3. Minimization of therapeutic purposes.

4. Maximizing the cost-effectiveness of pharmacotherapy without reducing its quality (excluding, if possible, more expensive drugs, without endangering the patient's health).

Operational requirements for an effective form

1. Effective implementation of the form is possible with adequate and adequate administrative support.

2. Decisions on the exclusion / inclusion of drugs should be made taking into account evidence-based scientific information, which is strictly consistent with the main goals and principles of the formulary.

3. New drugs that have entered the pharmaceutical market should be included in the formulary only after a professionally performed analysis of evidence-based information about their unique therapeutic effect.

4. Prescriptions not described in the formulary may only be authorized in accordance with a carefully controlled patient management protocol.

Problematic issues

Repeated discussions on the implementation of the formulary system have shown that the emerging discussions are less concerned with the critical assessment of scientific data, and mainly focus on the problem of the formulary as such, its goals and objectives. At the same time, it is not so much the relative advantages of the drugs proposed for inclusion in the form that are discussed, but the very concept of the form, which attracts the main attention.

Terminology problem

For several years, the term "formulary" was used quite easily, as it was convenient for a number of organizations that used it to refer to any separate list(list of) medicinal products and related medical products.

A formulary was the sum of all pharmaceutical products available on the market; the totality of all drugs permitted for use in certain conditions (in a given area); an administrative list separating approved drugs from the entire database of commercial drugs approved for use under state program Drugs; a mechanism that determines the criteria for benefits (primarily, purely economic) within the framework of a public or private insurance scheme.

In our understanding, a formulary system is an information and methodological doctrine, the purpose of which is the development of socially oriented health care in a market economy .

The form is defined as one of the main tools for the implementation and successful functioning of the form system - as a reference guide that includes the main provisions of the system to ensure effective and safe drug therapy.

At the heart of the form there are practical recommendations (standards) of treatment agreed and accepted at the international and / and national level, an evidence-based approach to the management of rational pharmacotherapy, a thorough analysis of the morbidity structure, evidence-based data on the most clinically and cost-effective and safe drugs, research data on the level of consumption and the cost of a course of treatment for each disease.

The form is a dynamically developing document with constantly refined and replenished content of individual sections and articles.

The form is restrictive and encourages the use of only those drugs that are included in it. ... This achieves a significant reduction in the range of drugs used, increases the therapeutic effect and simplifies the process. drug supply.

The form is not analogous to the list of essential drugs, which is of a recommendatory nature.

The problem of misunderstanding the concept

The effectiveness of the forms can vary. It is based on the ability with their help to achieve certain therapeutic, economic and / or administrative goals. In addition, forms are capable of demonstrating different levels of cost effectiveness in achieving key objectives. However, it is not possible to assess all the advantages of the formulary by mixing different variables, for example, simultaneous changes in the cost effectiveness of treatment and the corresponding success in drug supply, suboptimal use of formulary products and the effectiveness of the control program for the use of similar drugs, legal capacity educational programs and a lack of accurate data on patient outcomes.

Some experts are convinced that implementation use assessment programs The drug can effectively replace the formulation. However, the most adequate is the understanding of both programs as complementary. And this is quite logical, since in the process of introducing a program for assessing the use of drugs, the question arises of the clinician's appointment of the drug of choice. And this requires a scientifically based collection of information about the drugs of choice and prospective or retrospective quality control of treatment, i.e. distinction between compulsory and educational standards.

The problem of form and standards

There is an opinion that "the form should reflect the standards of world practice." However, the formulary is needed not to perpetuate world achievements, but to optimize pharmacotherapy, increase the frequency of prescribing drugs that differ high degree efficiency and safety.

Form , not treatment standards, should become the main tool effective work doctor , since in this case, the focus will always be put forward solving patient problems, rather than adhering to strict conditions of the standard .

A doctor who has free access to a selection of the most tested drugs is able to provide best help sick. In addition, it is difficult to imagine how many standards need to be created to meet all possible clinical situations.

The problem of quality information

Objective, reliable and up-to-date professional information is a priority for the adequate management of medical diagnostic process and preventing waste of resources.

The quality of information on drug use is just as important as the quality of the drug itself. . World organization Healthcare believes that the state should be fully responsible for providing all categories of the population with unbiased, objective and evidence-based information about drugs. Medicines should be considered not only as a pharmaceutical product, but as a “drug product plus information”.

The lack of an authoritative, independent, comprehensive and objective source of information on the use of drugs in Russia (and in a number of other countries of the former USSR) can be considered as the main barrier to the modernization of healthcare. In recent years, several new versions of information guides have been developed and presented to the government and the medical community (Vidal, the Register of Medicines, etc.), but none of them can claim the role of such a document, which should be a state formulary.

The introduction of national information documents, such as the drug formulary, will require defining its role in practice and ensuring that the document itself is impeccable in terms of information quality and meets the highest standards.

The problem of choosing a prototype

The development of a form (primarily a national one) is associated with a number of important points... Without considering purely administrative problems, one should dwell on organizational ones, including the provision of the necessary information resources, principles of classification of information, selection, systematization of evidence, etc. As a rule, all this requires long-term painstaking work, which is not entirely justified in cases where such a structure already exists.

Today it is clear that one of the most rational solutions to the issue of creating a state form that meets world standards can be the use of the model and organizational practice of the most recognized publication.

British National Form (with special applications for dentists and nurses) plays a significant role in the evidence-based communication of the management of rational pharmacotherapy in the UK and is considered by many international experts as world sample of regulatory documents on a national scale ... The keys to success are evidence-based information, rigorous editorial process, authority, and independence.

The problem of trust in the state

“The state has registered and authorized the use of the drug for treatment. It was included in the pharmacopoeial reference book. Why do we also need a form? "

Official state registration drug practically means approval for clinical use. However, this does not mean that the state approves the widespread use of this drug and it should be included in the formulary.

State registration confirms the safety and effectiveness of the drug in accordance with the stated indications and parameters. However, the approval for use does not address the key issues of drug inclusion in the formulary - is this drug more effective or safer than other drugs; how justified are the additional costs associated with the introduction into medical practice of drugs with insignificant advantages over the known ones.

The problem of "limiting clinical freedom"

An effective formulation does not limit clinical freedom. Moreover, it only confirms the simple reality that each when prescribing a doctor does not use all 10,000 - 12,000 names of drugs on the market, and applies only a limited set of 25 - 400 titles ... Thus, the main question is whether such a personal doctor's form will be more or less optimal compared to that comprehensive document (form), which was prepared by a group of highly qualified experts and discussed by the national doctor's quorum.

Pharmaceutical manufacturers often take advantage of small differences in their products for the purpose of commercial segment fragmentation. pharmaceutical market... This combination of poorly defined clinical differences and artificially created distinctions between similar drugs (even at the level of commercial names), are two main components of the process leading to irrational drug prescription.

Since the total number of pharmaceutical alternatives has exceeded 8000, the likelihood that competing agents have equal performance and safety performance is very low. That's why the main task of each formulary committee is to define 400 - 500 drugs , which have reliable evidence-based data on efficacy, safety and have successfully proven themselves in practice. Failure to identify therapeutic priorities in formulary development can lead to undesirable outcomes for patients and adversely affect the performance of the insurance system.

The thinking clinician must recognize that the formulary not only aids in therapeutic decision making, but also protects his carefully guarded clinical freedom.

The problem of limiting the choice of drugs

There is little convincing evidence that formulary adoption will reduce drug use.

An effective formulary does not aim to reduce drug intake. If there are 18 names of non-steroidal anti-inflammatory drugs on the market, and the formulary certifies only 3 drugs of choice, then the doctor simply uses these 3 drugs in his practice. Thus, it is not the consumption of drugs that is limited, but the use of ineffective (unjustified, unproven) alternatives.

The problem of "uniqueness" of each patient

There is a point of view, and quite popular, that only the doctor treating the patient can choose the appropriate drug and only he can take into account and take into account the unique individual characteristics the patient, and any attempt to narrow the range of therapeutic choice fails when faced with the real disease and heterogeneity of patients.

A good formulation does not deprive the physician of therapeutic flexibility in treating a patient, but rather directs the clinician towards the optimum in choosing the drug of choice in accordance with clinically identified diagnostic indications.

The problem of specialist ambitions

In addition to the argument that only the attending physician “knows best” what the patient needs and what he needs, the view is put forward of the exclusive right to prescribe a special (not bound by the formulary) treatment by a narrow specialist. However, nothing prevents the specialist from participating in the development and consultation of the draft form.

It is the narrow specialists who must be especially competent in the interpretation and presentation of drug data within their field. Moreover, one of the principles of drawing up the form is to instruct exactly narrow specialists development of sections for certain classes of drugs.

Problematic issues of clinical education

It is often argued that the lack of access to the latest pharmaceutical products can adversely affect the quality of education, limiting the range of therapeutic interests.

One of the main ideas reflected in the concept of the form is that best shape learning is the acquisition of skill in the use of a limited range of drugs belonging to all therapeutic classes, but with proven superiority.

The formulary development process is useful both for physicians who use it and for pharmaceutical companies (drug developers), as it significantly expands the audience of people interested in their data. This reveals one of the most important aspects the introduction of a formulary system - the educational value of studying all the characteristics of a drug at all levels of implementation, considering its potential disadvantages and advantages in the context of the implementation of therapeutic programs.

During the entire period of a doctor's practice, many different drugs appear and disappear, and the clinician does not always have to "try" or "gain experience" with the latest products that have just entered the market. It is much more important for a novice doctor to know a number of principles by which he can be guided throughout his medical practice. These include: 1) moral and legal responsibility for the fate of the patient; 2) a critical attitude towards new drugs and therapeutic programs; 3) knowledge of pharmacokinetics and pharmacodynamics, adverse reactions and drug interactions; 4) prognosis of potential negative reactions of pharmacotherapy.

Moreover, the form should constantly remind novice physicians that the patient is interested , first of all, in receiving guaranteed reliable treatment, and not in fashionable innovations .

Problems of inquiries of doctors and patients

At first glance, the arguments that “if a doctor does not use modern drugs, then he loses his reputation and rating,” is quite interesting, and the requests of many patients cannot be accidental, since if everyone wants to be treated with this drug, this is more than proof its effectiveness.

However, these arguments can be viewed from other positions as well. Prescribed drug may be “trendy”, but not fully fit the specifics clinical picture diseases. Also, do not forget that history recent years the Russian pharmaceutical market knows enough facts of record-fast implementation in medical practice Medicines that subsequently exhibit unacceptable toxicity and delayed adverse reactions.

In addition, the popularity of drugs among patients, and, accordingly, the level of sales may increase not so much due to the advantage of the product in comparison with other drugs, but due to the policy of the manufacturer, which, through an advertising campaign, affects directly the consumer, while actively distributing new drugs among doctors. ... The growth in the prescription of such drugs is more reflected in the growth of sales of the manufacturer than in the indicators of reducing the incidence.

The problem of justified effective innovations

“The use of new drugs is in keeping with the times. Successfully developing healthcare cannot be imagined without effective innovation. ”

Is it necessary to look for additional evidence of this? Should the entire process of clinical confirmation of efficacy and safety be practically repeated?

Even within the expert committee, there are frequent discussions related to the discussion that the "acquired experience", supplemented by cases from personal practice or examples from publications, is a sufficient basis for the inclusion of a new drug in the formulary. At the same time, most doctors agree that any innovation in medicine requires basic research and truly evidence-based data. In order to successfully treat the sick personal experience and the experience of close colleagues may not be enough .

However, the idea that competitive replacement of outdated or simply not quite high-quality drugs with the best is possible only as a result of a series of well-organized and expensive studies demonstrating such an advantage, unfortunately seems to many doctors somewhat absurd.

Many physicians are unaware of how small the patient population is for new drug registration trials. In such studies, there is often simply no possibility of a detailed study of the action of drugs, and those adverse reactions that may become decisive later. In addition, one should turn Special attention on the design of such studies / trials that do not always meet the requirements of high evidence.

The importance of understanding cannot be overstated the difference between the effectiveness of the drug (by how it performs in a controlled study) and its clinical efficacy (by how the drug is applied in real clinical practice ). All this must be explained as fully as possible to doctors, since the appointment of a new drug to patients who differ from patients control group by age, sex, liver function, drug tolerance, compliance and the level of clinical monitoring, often leads to unexpected adverse reactions.

Ethical issues of the formulary

It is believed that the form may limit the patient's rights (human rights). The form not only does not limit the rights of the patient, but protects them .

The principle of including only evidence-based drugs in the directory, full and thoroughly prepared information on their use, verification of prescriptions, guarantees of drug provision in accordance with the criteria best quality- all this makes the formulary the most important component of rational pharmaceutical management and, accordingly, high-quality treatment.

Conclusion

The form, like any administrative tool, has certain limitations. Thus, he cannot determine and advise the doctor about the therapy of choice (pharmacotherapy or physiotherapy alternative to it). The formulary does not control the adequacy of prescribing drug therapy to a specific patient, is not able to influence the use of more drugs when less can be dispensed with, etc.

Indeed, the form has disabilities in order to prevent the misuse of even the most adequate drugs. Besides, compliance with the formulary's prescriptions can be distorted by ineffective provision of the treatment and diagnostic process and / or even non-compliance with the patient's therapy regimen .

The quality of the form depends on various factors, first of all, on how widely the best drugs are presented in it, as well as on the guaranteed quality of specialized information for doctors and pharmacists. The formulary has enormous potential and is useful to every doctor, as it gives him the right direction in the development of therapeutic policy.

The formulary can and should take the lead in establishing effective health care management. Although the use of the form cannot fully guarantee medical service High Quality, rational prescription of drugs, effective use survey data and control over the cost of medicines, we can confidently state that without the introduction of a formulary system, without creating a formulary, achieving these goals becomes extremely difficult, if not impossible.

Literature 1. Drug Information Policy in Central and Eastern Europe and New Independent States- Report of the WHO workshop. Hillered, Denmark, 27.03–02.04.1996.

2. Birchall A.D., Horsfield P.W., Maskery J., Hambleton K. L., Clark J.E. Similar savings in non-fundholding practices are not similarly rewarded. BMJ. 1995; 311: 127.

3. Dowell J.S., Snadden D., Dunbar J.A. Changing to generic formulary: how one fundholding practice reduced prescribing costs BMJ. 1995; 310: 505-8.

4. Drug Information Policies in Countries of Central and Eastern Europe and the Newly Independent States, Report on a WHO Workshop, Hillerоd, Denmark, 27 March - 2 April 1996, EUR / ICP / QCPH 06.01.01.

5. Easton J. Most savings come from a small number of generic drugs. BMJ. 1995; 311: 128.

6. Management of Pharmaceutical Reform Processes in CCEE / NIS. Report of a Seminar. 21-28 June 1995, Hillerod, Denmark. Action Program on Essential Drugs, WHO Headquarters, Geneva / Program for Pharmaceuticals in CCEE / NIS, WHO / EURO, Copenhagen.

7. McKendrick A.D., Leslie H., Thornton P.W., Crosby F.R.G., Easton A.I.M., McNaughton E., Morton L.J., Hunter J.E., Pflanz S. Reorganization of prescribing practices should not be delayed. BMJ. 1995; 311: 128.

8. Millard R.V. Capitation payments would be fairer. BMJ. 1995; 311: 127-8.

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12. National Essential Drugs Program - Uzbekistan. Report on a WHO Mission 18 September - 3 October 1995. Action Program on Essential Drugs, WHO Headquarters, Geneva / Program for Pharmaceuticals in CCEE / NIS, WHO / EURO, Copenhagen.

In his practice, a doctor, as a rule, operates with a limited list of medicines (MP). Of the multitude similar drugs he usually chooses the one that is well known to him, or the one that is cheaper. However, this does not mean that the choice is made in favor of the best drug. V recent times it is declared that therapeutic tactics should be based on pharmacoeconomic approaches and the requirements of evidence-based medicine. Meanwhile, the general medical community still has little idea of ​​what is hidden behind these, which have already become popular, concepts. The following review materials used Russian-language and English-language Internet materials on these issues.

Economic realities require new thinking from healthcare organizers, primarily in the field of economic justification of diagnostic and treatment technologies. The introduction of the so-called formulary system, which is adopted in many countries as the basis for the activities of treatment-and-prophylactic institutions (MPIs), is one of the possible ways optimization of their work.

BASIC CONCEPTS OF THE FORMULAR SYSTEM

Formular system is an information and economic doctrine, the purpose of which is the development of a socially oriented health care system in a market economy. The formulary system allows you to limit the number of constantly used drugs to a certain list of drugs (called form list or list), which greatly facilitates the procurement of medicines, reduces the costs of healthcare facilities and optimizes drug therapy.

NB! The formulary system can be implemented where the planned procurement of medicines for the needs of a health care institution is carried out.

Possible positive results implementation of the formulary system:

· The use of unsafe and ineffective drugs is excluded (the number of side effects and polypharmacy is reduced);

· The range of purchased drugs is reduced (the costs of medical institutions for the purchase and storage of drugs are reduced);

· The length of hospital stay is reduced (direct cost savings);

The availability of a limited list of drugs allows you to develop and implement targeted programs for staff training, create databases containing complete and objective information about medicines;

· The form is a means of creating and updating quality standards for treatment in healthcare facilities.

The main functions of the form system:

· Guarantee of providing patients with quality treatment;

· Definition and development of methods for rational pharmacotherapy of common diseases;

· Use of the most clinically and cost effective and safe drugs;

Ensuring control over correct use Drugs and taking measures to prevent and correct iatrogenic errors;

· Wide dissemination of objective information based on the principles of evidence-based medicine among the participants in the health care process;

· Introduction of systemic professional education.

Form or Form Guide is a reference guide that includes the main provisions of the system for ensuring effective and safe drug therapy. The form is based on internationally and (or) nationally agreed practical recommendations (treatment standards) based on an evidence-based approach to rational pharmacotherapy.

For medical institutions of different profiles, appropriate forms are developed, if necessary, on their basis, a form for a region (city, district, oblast, etc.) is compiled. The compilation of the form should be preceded by a thorough analysis of the morbidity structure, collection of evidence-based information on the most clinically and cost-effective and safe drugs, a study of the level of their consumption and the cost of treatment for each disease.

One of the features of the form is the predominant use of generic names of drugs in it. It is believed that the generic name is more informative, since it reflects the belonging of the drug to the chemical structure and a certain clinical and pharmacological class. The use of generic names allows for a generic substitution (replacement of bioequivalent drugs containing the same active substance chemically identical in strength, concentration, dose, dosage form and route of administration), while the commercial nomenclature obliges the pharmacist to release only the drug specified in the prescription. At the same time, a healthcare facility can determine the trade names of a drug that is preferred when purchasing, but this should be done not for opportunistic reasons, but on the basis of a deep pharmacoeconomic analysis, which is impossible for most Belarusian healthcare facilities due to the lack of specialists and clinical and pharmacological service.

FORMULAR PROCESS

To develop the Formulary List of Health Care Facilities (hospital form) and implement the formulary system, formulary or formulary-therapeutic committee (commission).

Tasks of the Formulary Committee (FC):

· Development and implementation of a professional drug selection policy;

· Determination of criteria for evaluating drugs and making recommendations regarding their inclusion (exclusion) in the formulary;

Definition of a restrictive list of drugs for practical application;

Development of methods for rational pharmacotherapy of common diseases ( practical recommendations- treatment standards);

· Creation and implementation of programs for continuous monitoring and evaluation of drug use to ensure their rational use, procurement, and the necessary information support;

· Rendering assistance in the development of medico-pharmaceutical information, identifying the needs for programs to improve professional knowledge in the field of drug use.

The development of the form includes the collection and analysis of information:

· About the problems of the patient or the population;

· O clinical features diseases (clinical epidemiology);

· About the effectiveness of the drugs used and pharmacotherapeutic regimens (pharmacoepidemiology);

· About the economic characteristics of the pharmacotherapeutic process (pharmacoeconomics);

· About the results of therapeutic approaches (study of outcomes).

The policy for regulating the selection and use of drugs should determine:

· Criteria for the selection of drugs for the form;

· Inclusion and exclusion of drugs from the form;

· Requirements for filling out the appointment sheets;

· Use of non-formal drugs;

· Monitoring of side effects of pharmacotherapy;

· Assessment of the use of drugs;

· The possibility of using drugs that are in the process of clinical trials;

· Relations of healthcare facilities with representatives of pharmaceutical companies and distributors.

FC work rules:

· Justification of the need for this drug;

· Exclusion from the hospital formulary of other drugs that satisfy the need for the same drug;

· The cost of the drug should be justified by its effectiveness;

· Limitation of the use of combined drugs, if they do not have clear therapeutic advantages over the monopreparation;

· It is impossible to include drugs in the form, the composition of which is kept secret or their effectiveness has not been established;

· Ensuring the availability of information on clinical trials of this drug;

Medicines should always be available for purchases from suppliers

Formulary list of drugs compiled in accordance with accepted rules, approved by the management of the healthcare facility and distributed among medical staff. Chief physician issues an order on the use and purchase of drugs in strict accordance with the form list. From this moment on, the healthcare facility purchases only the drugs included in the form.

During the formulation process, the following restrictions on the use of drugs should be taken into account:

1. Limitations of the diagnosis- determine the indications for the correct prescription of drugs in a given health facility. The use of relatively more toxic drugs or drugs with special properties permissible only for those diseases in which the expected effect of the use of drugs exceeds the potential risk of side effects.

2. Skill level restrictions- determine the circle of specialists who have the right to use these formulary drugs or drugs of the main pharmacotherapeutic groups. For example, only an infectious disease doctor can prescribe some antibiotics for parenteral administration, thrombolytics - only a cardiologist or resuscitator.

3. Pharmacological limitations- determine and approve doses, frequency of administration, duration of treatment for a given formulary drug.

USE OF NON-FORMULAR MEDICINES

As a rule, in health care facilities it is allowed to use only drugs included in the formulary list. However, in individual cases medications not included in the hospital formulary may be required. For such cases, FC establishes the rules for the use of non-formal drugs.

The request for the use of non-formal medicines is determined by the needs of the individual patient. The attending physician fills out a form specially developed by the FC, and promptly sends it to pharmacy... The pharmacist of the pharmacy (and ideally, the clinical pharmacologist of the healthcare facility) should discuss with the attending physician the justification for prescribing an unformal drug. If the justification for the use of a non-formal drug is recognized as sufficiently weighty, the healthcare facility purchases and allocates required amount drug for the patient.

The FC should regularly review all requests for the use of non-formulary drugs. If, as a result of such an analysis, the FC reveals frequent requests for a certain drug and decides that it is more effective than the drug presented in the formulary, a decision should be made to replace the formulary drug. On the contrary, if the FC considers frequent use non-formulary drug is unreasonable, this is the basis for the development of FC special training programs for doctors or the direction of individual doctors to refresher courses.

The presence of a formulary list of drugs in each health facility allows the implementation of targeted training programs for employees and receive more full information about the drugs used. In addition, the introduction of the drug formulary contributes to the development and improvement of treatment quality standards in each health facility.

ECONOMIC ASPECTS OF THE FORMULAR PROCESS

When developing a drug formulary, it is necessary to take into account the pharmacoeconomic aspects of their use, which make it possible to optimize the treatment process. A useful measure is the cost / effectiveness of drug therapy.

Pharmacoeconomic analysis should include consideration of the indirect costs associated with drug therapy. In some cases, it is advisable to use a more expensive drug, provided that this will reduce overall costs. For example, the costs associated with the use of drugs for oral administration are significantly lower than those for parenteral administration.

Should be considered:

· price full course therapy for each drug;

Costs associated with the use of drugs, including the cost Supplies: containers or bottles for intravenous infusion, solvents, syringes, preservatives, transfusion systems, etc.;

Costs associated with the use of this drug, such as drugs for premedication, products medical purpose and etc.;

Costs associated with laboratory research, including the cost of reagents and monitoring equipment;

· Costs associated with the storage of drugs;

· The possible effect of therapy on the length of hospital stay.

Despite the complexity of calculating the financial costs associated with possible influence Drugs for the duration of the patient's stay in the hospital, the economic analysis should include a mention of the likelihood of such an effect of drugs.

The analysis of the economic aspects of drug therapy should include the identification, calculation and comparison of all costs and consequences (both positive and negative) in the use of drugs. Such costs are part of the overall costs of the LU, therefore, should be taken into account when drawing up the form. Such an analysis is especially necessary in connection with the reduction in budgetary expenditures for health care and the increase in the cost of therapy.

With the constant use of a limited set of drugs, doctors are able not only to thoroughly study their pharmacological properties, but also to acquire practical experience work with these drugs. This greatly facilitates the work of practitioners, reduces the number of medical errors and to avoid complications of drug therapy, helps to improve the quality of treatment, reduce mortality. As a result, the hospital budget is saved by reducing the length of hospital stay, repeated hospitalizations and the cost of treating complications. drug therapy... Finally, the introduction of a formulary system helps to remove ineffective and substandard drugs from the market, since such drugs will not be included in the formulary, and therefore will not be procured.

1.Abdusalyamov A.A., Akhtamov J.A., Shavazi N.M. Form? Form ... Form! // Bulletin of a general practitioner. - 2000.- No. 3.

2. Pavlovich S. Hospitals will "live" according to the form // Pharmacy Weekly. - 2000. - No. 28 (249).

3.Ushkalova E.A. The role of the formulary system in solving the problems of rational use of drugs // Klin. pharmacology and therapy. - 1998. - T. 7, No. 18.

(4) Chuchalin A.G., Belousov Yu.B., Shukhov V.S. Formular system: key concepts// Rus. honey. zhurn. - 1999. - T. 7, No. 15.

Currently, the most important task of national health care is the introduction of standards for the diagnosis and treatment of major human diseases. The cornerstone standardization can be considered the introduction into practical health care and medicine of unified approaches to drug treatment... This problem is at the heart of health economics, as medicines require approximately 70% of all material resources.

The basis for standardization in health care in many countries is the formulary of medicines and the formulary system as a whole. The formulary of medicines is intended for general practitioners who carry out up to 90% of the total volume of treatment, diagnostic and preventive measures in patients. A formulary is a regulated document both in terms of the number of medicines included in it, and in terms of the amount of information related to medicines. The formation of the formulary and the formulary reference book is based on agreed and accepted treatment standards, high requirements for the quality of the drug - not only as the main pharmacological compound, but also as a means that meets international regulations on biopharmaceutical and pharmacokinetic properties; recommendations for use in the main contingents of patients (the elderly and children, pregnant women, lactating women, patients with insufficient liver and kidney function). The amount of information regarding indications and contraindications for the use of drugs, their interactions, doses and dosage regimen of the drug, as well as the side effects caused by it, should be agreed upon by specialists of various profiles.

Formulary and formulary reference book are dynamic developing documents with constant change and clarification of the list of recommendations and articles on drugs, doses, methods of application, indications and contraindications.

In advanced countries, the form and the form guide are published in an updated form once or twice a year. The formulary system is a health doctrine. The doctor prescribes only those drugs and uses those treatment standards that are optimal in terms of effectiveness, safety and affordable price. Thus, a doctor in today's conditions is not free to use all his scientific knowledge and guide the patient in the way recommended by this or that scientist, this or that scientific school. Today we cannot allow this, although in some cases, of course, this approach is legitimate. The form obliges the pharmacist to assess the need for drugs, the place of each of the drugs and the variety of dosage forms, especially in pediatric practice, as well as to predict the pharmacoepidemiological situation in a given region or in the country as a whole. The formulary system obliges manufacturers, including domestic ones, to produce high-quality drugs, and distributors - to provide the country only with such means that can be included in the formulary reference book. The formulation is based on the definition of treatment standards (consensus), and this has a very great importance, since it is impossible to create a formulary system without using the experience of clinicians. A key link in the standard of care is the definition of the disease. It would seem that it is not difficult to give a definition of the disease, but now Russia does not have an agreed decision, in particular, on the question of what is considered community-acquired pneumonia. At first glance, everything is very simple: pneumonia is acute infection, accompanied by an increase in temperature, the appearance of wheezing in the lungs, X-ray changes, etc. However this definition is still a subject of discussion. The same applies to a number of pathological conditions, which is fundamentally essential... This is the basis for the development of criteria or standards for rational pharmacotherapy, because without the definition of the disease, it is impossible to develop standards for rational pharmacotherapy. In this case, the role of the clinician is undeniable. It is also difficult to overestimate the importance of the work of specialists in a particular field. Evaluation of the effectiveness of treatment standards, determination of the safety of drug use and, finally, pharmacoeconomic justification - this is the order in which the formation of treatment standards should take place. Currently, most of the standards for pharmacotherapy of the main most common diseases have been developed in Russia. For example, on the management of patients with bronchial asthma, peptic ulcer stomach and duodenum, myocardial infarction, heart failure, epilepsy (adults and children), cancer breast etc.

A treatment standard or consensus decision, consensus on drug management is made by a team of leading experts. An example of such an agreed decision is the achievement in Russia of a consensus on the management of patients with bronchial asthma in adults and children, which was preceded by more than six years of discussion of individual positions on the drug management of patients with bronchial asthma at symposia and congresses at various levels. To date, the Russian consensus has been developed and roughly corresponds to European standards accepted by the world community. This standard highlights different kinds gravity bronchial asthma, and from this, several of the most common, based on the most used drugs, are proposed, which are used to relieve and prevent attacks of bronchial asthma (there are not so many of them - the list consists of four to five drugs). It is very important to use the results of international clinical trials of individual drugs, regimens and treatment programs, or meta-analysis data - what is today called evidence-based medicine. This is important for developing a standard of care or helping to achieve quick solution this problem. For example, very long time in the treatment of patients with heart failure, cardiac glycosides were used, however, with the help of large multicenter studies, it was possible to show that the use of digoxin, in particular, does not reduce mortality and does not improve the quality of life of patients with heart failure, but, on the contrary, leads to an increase in the frequency deaths associated with heart rhythm disturbances. At the same time, a study on the use of angiotensin-converting enzyme (ACE) inhibitors, captopril, enalapril, etc. in patients with heart failure showed that these drugs increase life expectancy and improve the quality of life, reduce the number of hospitalizations of patients, reduce the number of repeated myocardial infarctions, seizures angina pectoris, etc. On this basis, a document was developed that regulates the management of patients with heart failure, where ACE inhibitors play the main role in treatment. However, even 15-20 years ago, digoxin in combination with furosemide were the basic drugs for the management of patients with heart failure.

The formulary and treatment standards should include drugs with the greatest efficacy and safety. Therefore, the study of the comparative efficacy and safety of the use of various drugs, the assessment of international experience are of great importance.

Medicines forms define the treatment standards for some of the most common diseases, but this does not mean that we should include in the directory all currently existing human diseases (and there are more than one hundred thousand of them, including genetically determined, rare ones). It is recommended to use less expensive, but effective and high quality drugs in the formulary of drugs. A more expensive drug is prescribed only in cases where the first treatment did not give an effect.

The formulary and formulary system ensures that all patients are treated with available drugs; every patient with this or that disease should receive adequate, high-quality treatment. This does not mean that the formulary should not include highly effective expensive drugs, drugs developed on the basis of high technologies. However, according to large-scale epidemiological studies, there are no more than 10% of patients who need such treatment. Only in certain areas of medicine - in particular, we are talking about oncological, autoimmune and genetically determined diseases - the number of patients who are treated with non-standard drugs and more expensive effective means, increases to 25%. The formulary of drugs contains recommendations for the use of drugs of the first choice and alternative ones, that is, there is no strict restriction for the use of one drug. For example, the formulary of drugs for the treatment of angina pectoris recommends nitroglycerin preparations, beta-blockers and calcium antagonists; verapamil is the most commonly recommended calcium antagonist, but this does not mean that nifedipine cannot be used to treat and prevent angina pectoris.

The first step in introducing a drug formulary is to simply cut costs. Indeed, at the first stage, costs are reduced due to the introduction of rational pharmacotherapy through a comparative assessment of the effectiveness, safety, cost of drugs by therapeutic classes and indications. At the first stage of implementation of the formulary, there really is a reduction in the cost of drugs, and the released funds are invested in the development of the diagnostic base, in the development of new technologies for the production of drugs, in the training of doctors, etc. At the second stage, as a rule, the drug budget approaches the initial or even exceeds it. But this is impossible without the first stage.

The drug formulary guarantees that the prescription of drugs based on the criteria and standards of treatment of the disease will be combined with individual approach to pharmacotherapy. For example, the comparative efficacy of amoxicillin and second-generation oral cephalosporins in the treatment of acute respiratory infections upper respiratory tract about the same, but the cost of the latter is much higher.

What are the requirements for drugs included in the formulary and treatment standards? These requirements are of fundamental importance. The formulary should include drugs with certain and proven pharmacological properties; it should not include drugs such as Bitner's balm, Mauer's balm, or other drugs with questionable or uncertain pharmacological properties. The proof of the pharmacological property should be based on the data of serious independent studies. It is necessary to critically approach the information provided by interested companies and firms that sell drugs on the market with good profit. They are recommended for inclusion in the formulary of drugs, the effectiveness of which for the treatment of a specific disease has been proven in the course of numerous clinical trials, including international multicenter trials, in which Russian scientists are now widely participating. The formulary should include drugs not only with certain and proven pharmacological properties, but also with more pronounced pharmacological properties in their pharmacotherapeutic group. An example is nitrates, this group includes five names; probably the most effective of them in terms of pharmacological activity is nitroglycerin itself and isosorbide 5-mononitrate. The rest of the drugs are inferior to them in their antianginal and antiischemic properties. Medicines must be well tolerated and high level safety, especially with long-term long-term use. So, for example, short-acting calcium antagonists, in particular nifedipine, with prolonged use in patients with arterial hypertension do not prevent violations cerebral circulation, repeated ischemic attacks and myocardial infarction, but, on the contrary, they increase. This conclusion was made only by meta-analysis of a large number of studies with long-term use of short-acting nifedipine (that is, conventional nifedipine tablets). It was concluded that for patients with arterial hypertension, the use of long-acting calcium antagonists, including sustained-release nifedipine itself, acting either 12 or 24 hours, is required.

Particular importance is attached to drugs with favorable pharmacokinetic properties, which are essential for determining the quality of a drug. Medicines that are taken by mouth must have a high bioavailability. Absolute bioavailability (100%) is achieved when the drug is administered intravenously or intramuscularly. If a drug taken orally is rapidly absorbed and reaches the systemic circulation by 80–90%, then we can talk about its high bioavailability. Most patients receive their medication by mouth. This means that drugs should have high bioavailability, which is close to intravenous drug administration. Medicines must create sufficient therapeutic concentrations in organs and tissues, since the main theory explaining the relationship between a drug and a pharmacological effect speaks of a relationship between the concentration of drugs in organs and tissues and a pharmacological effect. If the concentration of the antiepileptic drug in the blood, cerebrospinal fluid (respectively, in the brain) does not reach certain values, there is no need to talk about any anticonvulsant activity. Medicines must have a long half-life (T 1/2), which allows them to be administered once or twice a day. In patients with impaired renal function (including the elderly), it is necessary to use drugs that have double way elimination: renal and hepatic.

In the list of medicines included in the formulary reference book, along with the original reference means, big number reproduced generic drugs. This situation economically justified, since the reproduced generic drugs are two to three times cheaper than the reference original drugs. The main requirement for the quality of the generic drug is that the generic must be bioequivalent to the original reference drug. The bioequivalence of the generic is judged after comparative pharmacokinetic studies of the generic drug and the reference original drug in healthy volunteers. In this case, the time to reach the maximum concentration (T max.), maximum concentrations(C max.) And the area under the concentration-time curve for the generic drug should differ from the reference drug by no more than 15%. It should be emphasized that only a few domestic generic drugs have been tested for bioequivalence, that is, generally accepted international requirements for generic drugs are not met. Bioequivalence means that the reproduced drug is equivalent to the reference drug, that is, to the original drug developed by an innovative pharmaceutical company, and there are no more than 15 such companies in the world that create new technologies, fundamentally new drugs.

What are the tasks facing the clinician when creating the form? Making a consensus decision on pharmacotherapy standards is the first step in developing a formulary. A limited number of drugs that meet treatment standards need to be identified. It is limited and not a large number of Drugs, because no budget is able to withstand the amount of drugs that, based on theoretical assumptions, can be used to treat a particular disease. At the same time, the formulary is designed for the treatment of basic human diseases, for the treatment of most patients. For each medicine, it is necessary to highlight the main indications and contraindications, side effects in terms of severity, clinically significant drug interactions - all these points are very important to consider when creating a formulary. The form should contain only the main (two or three) indications for the use of a particular drug. There are a huge number of contraindications, important and not very important, for the use of one or another drug, but the formulary should include only the main contraindications, the most important side effects in terms of their severity.

Enough difficult task- determination of the dose of the drug, the dosage regimen in special contingents of patients (children and the elderly). This is of fundamental importance, because pediatricians, gerontologists, and clinicians alike forget that the body of an elderly patient requires about half the amount of drugs and a different dosage regimen than when it comes to a patient with an average or young age, and in children, especially premature infants and newborns, the dosage regimen and dose of the drug are individualized in accordance with the function of metabolizing and eliminating organs. This is also important because it is for children and the elderly that a large number of different dosage forms are produced that are convenient for taking (in liquid form, in the form of plates, inhalations, suspensions); this also includes dosage forms for visually impaired patients. The form should list the features of dosage and use of drugs in patients with hepatic or renal insufficiency. The risk of using drugs in pregnant and lactating women should be described.

Clinicians on the formulary committee and expert panels should be prepared to revise or replace a formulary.

Only high quality drugs should be included in the form. In this regard, it is necessary to choose a manufacturer with a well-known reputation (this is especially important for antibiotics and chemotherapy drugs). Manufacturing must comply with the principles of Good Factory Practice (GMP); with the absence of complaints from consumers and regulatory authorities, in particular the Pharmacopoeial and Pharmacological Committees, the Control Institute, in the presence of good-quality documentation. For all oral drugs, it is mandatory to present data on the bioequivalence of this drug to the reference one.

The creation of a formulary of medicines, a formulary reference book and a formulary system is a long painstaking multifaceted work in which the Ministry of Health of the Russian Federation, the Russian Academy should be involved medical sciences, specialists in various fields of medicine and pharmacy.

Currently by the Ministry of Health Russian Federation and the Russian Academy of Medical Sciences formed a national formulary committee and expert commissions, which include leading experts in the field of clinical medicine, pharmacy, drug science and healthcare organization, intensively developing the structure and content of the future formulary. During the VI Russian National Congress “Man and Medicine” (April 1999), the main provisions of the formulary and recommendations for its implementation in practical health care will be adopted.