ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 6, 2019 No. KR DSM-67

About approval of Rules of evaluating rational use of medicines

According to subitem 70-2) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", I ORDER:

1. Approve according to appendix to this order of the Rule of evaluating rational use of medicines.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" the Ministries of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Nadyrov K. T.

4. This order becomes effective after the expiration of ten calendar days after day of its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of May 6, 2019, No. KR DSM-67

Rules of evaluating rational use of medicines

Chapter 1. General provisions

1. These rules of evaluating rational use of medicines are developed according to subitem 70-2) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for evaluating rational use of medicines in the organizations of health care (further - Rules).

2. In these rules the following main terms and determinations are used:

1) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, drug circulation and medical products, control of quality of medical services;

2) the medicinal form of the organization of health care - the list of medicines for delivery of health care within the guaranteed amount of free medical care and in system of compulsory social medical insurance, created on the basis of the Kazakhstan national medicinal form and approved as the head of the organization of health care according to the procedure, determined by authorized body;

3) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

4) rational use of medicines - the drug treatment corresponding to clinical indications in the doses meeting individual needs of the patient during the sufficient period of time and in case of the smallest costs;

5) the international unlicensed name of medicine - the name of medicine recommended by the World Health Organization;

6) medicine - the medicine in the form of dosage form applied to diagnostics, treatment and prevention;

7) undesirable reaction - the inadvertent, adverse reaction of organism connected using the medicinal (researched) medicine and assuming availability of possible interrelation using this medicinal (researched) medicine;

8) the clinical pharmacologist - the specialist with the higher medical education in the profiles "medical case", "pediatrics", "general medicine" who studied residency or retraining in clinical pharmacology and having the certificate of the specialist of the clinical pharmacologist;

9) the clinical protocol - the document establishing general requirements to delivery of health care to the patient in case of certain disease or clinical situation;

10) the Kazakhstan national medicinal form - the list of medicines with the proved clinical safety and efficiency, and also orphan (rare) medicines which is obligatory basis for development of medicinal forms of the medical organizations and forming of lists of purchase of medicines within the guaranteed amount of free medical care and in system of compulsory social medical insurance;

11) the trade name of medicine - the name under which medicine is registered;

12) form system - the system of periodic assessment and selection of medicines for medicinal forms, maintenance of medicinal forms and provision of information in the form of the corresponding management and the list directed to rational use of medicines;

3. Assessment of rational use of medicines in the organizations of health care is performed by carrying out internal and external assessment of rational use of medicines.

Chapter 2. Procedure for carrying out health care of internal assessment of rational use of medicines by the organizations

4. The organizations of health care annually within 1 half-year carry out internal assessment of rational use of medicines (further - internal assessment) for previous year.

5. Internal assessment represents assessment of conformity of use of medicines to requirements of the current legislation of the Republic of Kazakhstan.

6. Internal assessment is carried out by the structural division of the organization of health care performing activities for quality management of medical care at the level of the organization of health care (further - structural division) with participation of the clinical pharmacologist. The clinical pharmacologist is attracted from out of in case of its absence in the organization of health care.

7. The structural division and the clinical pharmacologist are provided with access to medical information system of the organization of health care.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info