[The orphan preparations: international approaches and national regulation].

The medication support of patients with rare (orphan) diseases is an actual issue, since it requires significant financial costs due to high price of medications. The accessibility of these medications to such patients should be regulated by state incentives for development of orphan medications with following taking out to the market, by procedure of composing list of medications for treatment of orphan diseases and determination of financial support sources. The article considers aspects of regulation of issues related to orphan diseases and orphan medications in the Russian Federation and Europe. On the basis of regulated list of orphan diseases in Russia, the results of comparative analysis of list of orphan medications in Russia and list published at website of the European Union are presented. On the basis of data obtained, it was established that many medications for treatment of rare diseases registered in Europe are not available in Russia. Also, many orphan drugs in Europe do not have this status in Russia. At the same time, there are no state incentives for development of orphan medications in the Russian Federation, and there are only some benefits in registration procedure of such drugs. The analysis demonstrated availability of development and taking out to the Russian pharmaceutical market large list of orphan drugs from the European listing for National corresponding manufacturers.

[The leaflet for patient as requirement for information support format under registration of medicinal preparation according recommendation of the Eurasian Economic Union].

The article considers such new approaches to information maintenance of medicinal preparation in package as requirements for presentation of information, its location according its importance, availability of warning information. The article focuses on necessity of updating format of information maintenance of medicinal preparation and its inclusion in registration dossier.

[The anti-retrovirus therapy: Medicinal resources and their rational choice].

The purpose of the study was to determine potential availability of anti-retrovirus therapy and to justify proposals for selecting and prescribing rational combining of anti-retrovirus medications for HIV treatment. The objects of the study were anti-retrovirus medications authorized in the Russian Federation, information on current national and international approaches and recommendations concerning management of HIV-infected patient and application of anti-retrovirus therapy, including criteria of selecting medications and their combinations. The mathematical approach was applied to calculate the number of potential combinations of anti-retrovirus medications that can be applied to objects in certain conditions. The systemic approach was implemented including content analysis, methods of comparative and one-off analysis, generalization and grouping of information from regulatory documents on anti-retrovirus therapy and official materials on anti-retrovirus medications to develop algorithm of rational selection of anti-retrovirus treatment. Based on the results of the study, large number of potential combinations of anti-retrovirus medications were established to select the proper combination for treatment of HIV infection. The approach included organizational steps, evaluation criteria and algorithm of selecting rational combination of anti-retrovirus medications. The practical implementation of developed proposals can contribute to development of system of rational use of medications at the level of medical organization and to improve medication support of patients with HIV infection.

[The Activities of Representatives of Companies-Manufacturers of Pharmaceuticals Related to Informing Specialists with Purpose of Efficient Application of Medications].

The article presents the role of representative of company-manufacturer of pharmaceuticals in informing health care specialists about medications according WHO documentation. The analysis of regulation of procedure and permitted modes of their interaction with specialists in the Russian Federation. Also, an opinion of medical specialists is presented concerning the role of representatives of pharmaceutical companies in the portion of informing about medications. The results of questionnaire survey of medical representatives from the position of their role and tasks are presented concerning information activity during interaction with specialists. The proposals are formulated concerning necessity of legislative regulation of activities of representatives of the companies-manufacturers of pharmaceuticals.

CRITERIA OF RATIONAL PHARMACOTHERAPY: EVIDENCE FROM HIV TREATMENT.

Results of evaluation of the impact of drugs on indicators of clinical laboratory diagnostics as a criterion of safety of therapy are presented. Antiretroviral therapy for HIV infection was chosen as an example. Information from official sources (summary of product characteristics and medicinal product labels) on the potential impact of antiretroviral drugs registered in the Russian Federation on indicators of clinical laboratory diagnostics was analyzed and systematized. Individual INN and antiretroviral regimens recommended by WHO documents and protocols of follow-up and treatment of patients with HIV infection in the Russian Federation with the maximum and minimum potential impact on indicators of clinical laboratory diagnostics were revealed. The research results can be used to develop recommendations for the rational choice, prescription and use of medicines.

[The Rational Anti-Retroviral Therapy of HIV-Infected Patients: Opinion of Medical Specialists].

The article presents the results of questionnaire sociological survey of medical specialists professionally working in the area of medical and medicinal care of HIV-infected patients. The survey data demonstrated that in spite of active implementation of regulating documents in practice of medical and medicinal support of HIV-infected patients the specialists encounter difficulties in case of choosing medications and evaluation of medicinal therapy schemes, including from position of efficiency and safety of anti-retroviral medications. This is also confirmed by analysis of actual practice of prescriptions. The results of study predetermine necessity of development of informational organizational technologies for optimization of choice, prescription and application of medications on the basis of principles of rational application of medications and according to direction of public policy.

[The system of information concerning pharmaceuticals and its role in efficient using of medicines: opinion of medical specialists].

The issues of efficient application of pharmaceuticals by national authorities and supranational institutions are considered as important ones. The WHO recommends implementing twelve key propositions enhancing efficient application of pharmaceuticals. The development of independent information system concerning pharmaceuticals. The WHO recognizes that absence of neatly organized information system concerning pharmaceuticals information is usually spreading through different channels by manufacturers of medicines. The WHO determines admissible sources of information concerning pharmaceuticals and also requirements to content of presented information. The article presents results of survey of opinions of medical professionals about information sources concerning pharmaceuticals regulated in the Russian Federation and the WHO and also about actual information system concerning pharmaceuticals in the Russian Federation and its role in efficient application of medicines.

[THE WHO GUIDELINES ON RATIONAL USING OF PHARMACEUTICALS].

The development of system of rational prescription and application of pharmaceuticals is one of actual and timely solutions in sphere of pharmaceutical support of population. The WHO experts formulated concept of "rational application of pharmaceuticals" and as well 12 key provisions supporting rational application of pharmaceuticals, including development of system independent information. The analysis of all 12 provisions demonstrated that their effective realization is impossible without development of neatly structured system of information and system of informing specialists of health care system and population about pharmaceuticals.

[MEDICO-SOCIAL CHARACTERISTIC OF HIV-INFECTED PATIENTS RECEIVING ANTIRETROVIRAL THERAPY].

The aim of the study was medico-social characteristic of HIV-infected patients receiving antiretroviral therapy in 2006-2012 based on the logical and comparative analysis of medical cards with the use of systemic informational approach. The study yielded the medico-social characteristic of HIV-infected patients suggesting the presence of concomitant disorders requiring prescription of several medications to be used either simultaneously or alternatively (in case of poor efficiency or side effects of primary treatment). The data obtained indicate the necessity of optimization of the choice and prescription of pharmacotherapy taking account of its effects and safety based on the analysis of the potential and cost-effectiveness of different therapeutic modalities. The results of the study can be used to develop organizational measures for the improvement of public drug supply.

[Analysis of effects of pharmacotherapy on certain parameters of clinical laboratory diagnostics].

AIM: To study effects of pharmaceutical products on the results of clinical and laboratory diagnostics. MATERIALS AND METHODS: The list of vitally important pharmaceuticals, clinico-pharmacological articles of the National registry of medicinal products, formulary articles from the Federal guidelines on the use of pharmaceutical products. Formulary system, instructions for use of individual pharmaceutical products. Systemic and information-based approaches, logical and comparative analysis were used throughout the study. RESULTS: Results of analysis enabled the authors to draw up separate lists of pharmaceuticals based on their influence on parameters of clinical laboratory diagnostics, such as the list of pharmaceuticals exerting marked effect on diagnostic characteristics (blood properties, primary and coagulative hemostasis, serum enzymes), the list of pharmaceuticals exerting marked effect on systematized laboratory characteristics; the list of pharmaceuticals exerting no effect on clinical and laboratory diagnostics; the list of pharmaceuticals whose effect on diagnostic characteristics awaits clarification. CONCLUSION: The results of the study can be used for the development of recommendations on pharmaceutical counseling and rational choice of pharmaceutical products being prescribed to concrete patients.

[Organization of drug assistance for the elderly].

The basic directions of optimization of drug help to senior citizens from the standpoint of rational use of medicines, taking into account the features of pharmacotherapy in these patients due to age-physiological processes in the body, polymorbidity, reduction of adaptation to the toxic effects of drugs, and the growing incidence of adverse side effects of drugs. The necessity to take into account these characteristics in the clinical trials of drugs, development of guidelines for their use, development standards or medical care, prescription drugs and establish a regime of receiving from therapists and professional counseling pharmacists by elderly patients when they contact the pharmacy organization is shown. The basic directions of organizational and pharmaceutical approaches for the rational use of drugs are discussed, the results of the analysis of information in the instructions for use are shown.