ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 22, 2009 No. 529

About creation of form system of ensuring health care with medicines of institutions

In pursuance of the resolution of the Cabinet of Ministers of Ukraine of 13.06.2007 No. 815 "About approval of the National development plan for health care system for the period till 2010", orders of the Cabinet of Ministers of Ukraine of 10.09.2008 No. 1247 "About approval of the actions plan on enhancement of the state control of drug circulation and products of medical appointment", for the purpose of creation of form system and providing the most rational, highly effective and economically reasonable methods of pharmacotherapy of PRIKAZYVAYU:

1. Approve:

1.1. Technique of creation of forms of medicines it (is applied).

1.2. The regulations on the State form of medicines (are applied).

1.3. The regulations on the regional form of medicines (are applied).

1.4. The regulations on the local form of medicines of institution of health care (are applied).

1.5. The regulations on the Central form committee of the Ministry of Health of Ukraine (are applied).

1.6. Regulations on form committees of the Ministry of Health of the Autonomous Republic of Crimea, managements of health care of the regional, Kiev and Sevastopol city public administrations (are applied).

1.7. The regulations on the pharmakoterapevtichesky commission of institution of health care (are applied).

2. To the Minister of Health of the Autonomous Republic of Crimea, chiefs of managements of health care of the regional, Kiev and Sevastopol city public administrations within three months from the date of entry into force of this order:

create form committees of the Ministry of Health of the Autonomous Republic of Crimea, managements of health care of the regional, Kiev and Sevastopol city public administrations under the Ministry of Health of the Autonomous Republic of Crimea, managements of health care of the regional, Kiev and Sevastopol city public administrations and to provide their functioning;

provide creation and functioning in institutions of health care of the state and municipal patterns of ownership of the pharmakoterapevtichesky commissions of institutions of health care;

create on the basis of the State form of medicines in regions and institutions of health care respectively regional forms of medicines and local forms of medicines and to determine that purpose of the medicines which did not enter forms is performed according to requirements of clinical situation and instructions for their medical application.

3. Repeal the order of the Ministry of Health of Ukraine of 21.05.2009 No. 343 "About statement of structure and Regulations on the Central form committee of the Ministry of Health of Ukraine".

4. To the director of the department of regulatory policy in the sphere of drug circulation and products in health care system Konstantinov Yu. B. provide in accordance with the established procedure state registration of this order in the Ministry of Justice of Ukraine.

5. To impose control over the implementation of the order on the deputy minister Mytnik Z. M.

6. To the director of GP "State Pharmacological Center" of the Ministry of Health of Ukraine Chumak V. T. provide necessary conditions for work of the Central form committee of the Ministry of Health of Ukraine.

7. The order becomes effective from the date of official publication.

Approved by the Order of the Ministry of Health of Ukraine of July 22, 2009 No. 529

Technique of creation of forms of medicines

1. General provisions

1.1. The technique of creation of forms of medicines (further the Technique) determines the mechanism of creation of effective national form system in Ukraine for the purpose of optimization of use of medicines in health care institutions for improvement of quality of treatment, its unification and economy of resources.

1.2. Determination of terms:

1.2.1. Certain daily dose (Defined Daily Dose (DDD)) - the supporting daily dose of the medicine applied according to the main indication at adults with a body weight of 70 kg calculated average. It is formal international unit of measure of consumption of medicines which is established by WHO and not always corresponds to recommended average therapeutic dose;

1.2.2. The state form of medicines (further - the State form) - management on rational use of medicines, the containing list of the medicines registered in Ukraine including high-quality, effective, safe, economically reasonable medicines that is proved by evidential medicine. The state form belongs to industry standards in health sector (article 14-1 of Bases of the legislation of Ukraine about health protection);

1.2.3. The local form of medicines of institution of health care - the list of medicines with the greatest evidential base concerning their efficiency, safety and economic use of means of institution of health care which affirms the head of institution of health care in coordination with the Ministry of Health of the Autonomous Republic of Crimea, structural divisions concerning health care regional Kiev and Sevastopol the city public administrations;

1.2.4. The regional form of medicines (further the Regional form) - the list of medicines with the greatest evidential base concerning their efficiency, safety and economic use in this region approved by the order of the Ministry of Health of the Autonomous Republic of Crimea, structural divisions concerning health care of the regional, Kiev and Sevastopol city public administrations;

1.2.5. Standard daily dose - formal unit for display of the price characteristic of medicine for which it is not calculated by DDD and corresponding to the smallest registered force of effect of medicine;

1.2.6. The Pharmakoterapevtichesky commission of institution of health care (further - the Commission) - permanent working body of institution of health care which is created for the purpose of development and permanent updating of the local form of medicines of institution of health care;

1.2.7. Form system - complex of managerial techniques in health care which provides application rational, organizationally and cost-efficient methods of delivery and use of medicines for the purpose of providing in high-quality specific conditions of medical care and optimum use of the available resources; information and economic doctrine of rational use of medicines. The basic principle of form system - use of drugs with the proved efficiency of their action in case of certain pathological process;

1.2.8. The form Article of medicine which - is clinically oriented, the systematized information on medicine intended for ensuring its rational use;

1.2.9. Form committees of the Ministry of Health of the Autonomous Republic of Crimea, structural divisions concerning health care of the regional, Kiev and Sevastopol city public administrations (further - Committees) - permanent working bodies of the Ministry of Health of the Autonomous Republic of Crimea, structural divisions concerning health care of the regional, Kiev and Sevastopol city public administrations which are created for the purpose of development and permanent updating of the Regional form, introduction of form system in health care institutions;

1.2.10. The central form committee of the Ministry of Health of Ukraine (further the Central form committee) - the permanent working body under the Ministry of Health of Ukraine created for the purpose of development and permanent updating of the State form, introduction of form system which organizes the activities based on GP "State Expert Centre of the Ministry of Health of Ukraine";

1.3. The state form system of Ukraine enters forms of 3 levels into medical practice:

1.3.1. The state form (in format of the form reference book).

1.3.2. The regional form of the Ministry of Health of the Autonomous Republic of Crimea, structural divisions concerning health care of the regional, Kiev and Sevastopol city public administrations (in format of the form list).

1.3.3. The local form of medicines of institution of health care (in format of the form list).

2. Functions of form system:

2.1. Medical - determination and development of methods of rational pharmacotherapy of widespread diseases.

2.2. Pharmacological - ensuring control of the correct use of medicines and taking measures for the prevention and correction of yatrogenny mistakes.

2.3. Social - providing patients with drugs with the proved clinical efficiency.

2.4. Economic - use clinically and economically the most effective medicines.

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