It is registered
Ministry of Justice of Ukraine
August 17, 2009
of July 24, 2009 No. 531
About approval of the Procedure for carrying out monitoring of safety and efficiency of medicines in hospitals of institutions of health care
According to Bases of the legislation of Ukraine on health care, the Law of Ukraine "About medicines" and for the purpose of enhancement of system of postregistration supervision concerning safety and efficiency of medicines of PRIKAZYVAYU:
2. To the director of GP "State Pharmacological Center" of MZ Chumak V. T. within two weeks to submit for approval the Actions plan concerning improvement of implementation of postregistration supervision of safety and efficiency of medicines and monitoring of safety and efficiency of medicines in hospitals of institutions of health care.
3. 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 this order on the deputy minister Mytnik Z. M.
V. M. Knyazevich
Approved by the Order of the Ministry of Health of Ukraine on July 24, 2009, No. 531
1.1. This Procedure establishes the main requirements concerning carrying out monitoring of safety and efficiency of medicines (further - monitoring) in hospitals of institutions of health care (further - medical institution).
1.2. Regulations of this Procedure extend to the health care institutions subordinated to the Ministry of Health of Ukraine (further - MZ).
1.3. Monitoring - the method of receipt of information on safety and efficiency of medicines allowing to determine the frequency of collateral reactions, features of interaction of medicines at sick one or several hospitals.
When during the certain period of time under control there are all patients of hospital(s), all medicines which are appointed, and all arising collateral reactions are considered.
1.4. Carrying out monitoring in hospitals of medical institutions is assigned by MZ to the State company "State Pharmacological Center" of the Ministry of Health of Ukraine (further the Center).
1.5. Contents of terms which are used in this Procedure are determined by the Law of Ukraine "About medicines" and other regulatory legal acts.
2.1. Implementation of the organization and carrying out monitoring of medical institution happens to involvement of clinical pharmacists. If regular standard rates of medical institution do not provide the specialist's position - the clinical pharmacist, that carrying out monitoring happens to involvement of person with the higher pharmaceutical education (the pharmacist of the medical institution which underwent specialization in "clinical pharmacy" with receipt of the standard certificate) (further - the responsible person).
2.2. The clinical pharmacist or the responsible person performs monitoring of safety and efficiency of medicines in hospital of institution of health care and its analysis.
2.3 The head of medical institution is responsible for carrying out monitoring and its analysis.
2.4. Heads of medical institutions shall give timely to the Center the reliable information obtained when carrying out monitoring which corresponds to primary documentation.
2.5. The center develops and free of charge provides to medical institutions the software of carrying out monitoring.
2.6. The center exercises control concerning the accuracy of the information received when carrying out monitoring.
3.1. Clinical pharmacist (responsible person) of medical institution:
3.1.1. Daily receives in organizational and methodical (statistical) division of the data on movement of patients in hospital.
3.1.2. Performs primary examination of pharmakoterapevtichesky appointments by criteria of compliance of indications, contraindications, features of application and interaction of the medicines specified in the instruction for medical application of medicine within no more than 48 hours from the moment of hospitalization by the analysis of primary documentation in departments that is confirmed by record in "Medical card of the inpatient" which form is approved by the order MZ of 26.07.99 N 184.
3.1.3. Performs final examination of the carried-out pharmakoterapevtichesky appointments by criteria of compliance of indications, contraindications, features of application and interaction of the medicines specified in the instruction for medical application of medicine, and results of treatment in hospital within no more than 48 hours after disposal of the patient from hospital (in case of the death of the patient - before opening) by the analysis of primary medical documentation that is confirmed by record in "Medical card of the inpatient".
3.1.4. Provides accounting of these rather pharmakoterapevtichesky appointments in the database of monitoring according to number of the patients who were disposed from hospital.
3.1.5. In process of identification or after conducting final examination enters information in the database of monitoring of rather collateral reactions or lack of efficiency of medicine which automatically arrives in the Center.
3.1.6. Carries out the analysis of results of monitoring.
3.2. Monthly (the first day of the next month), in quarter (to the 15th of the following for reporting month) and in year (till January 20 of the following for reporting years) provides these databases of monitoring in electronic form to the head of medical institution.
4.1. The center receives from the head of medical institution these databases of monitoring in electronic form monthly (to the 10th day of the next month) and in year (till February 1 of the following for reporting years).
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