ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of September 7, 2018 No. KR DSM-12

About modification and amendments in the order of the Minister of health and social development of the Republic of Kazakhstan of January 26, 2015 No. 32 "About approval of Rules of use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan"

According to Item 1 of article 16 of the Law of the Republic of Kazakhstan of July 10, 1998 "About drugs, psychotropic substances, their analogs and precursors and measures of counteraction to their illicit trafficking and abuse of them" I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of January 26, 2015 No. 32 "About approval of Rules of use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 10404, it is published on March 31, 2015 in information system of law of Ad_let) the following changes and amendments:

in Rules of use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan (further - Rules), approved by the specified order:

to state heading of Chapter 1 in the following edition:

"Chapter 1. General provisions";

state Item 2 in the following edition:

"2. In these rules the following basic concepts are used:

1) the special prescription form - the form for writing out of the recipe on the medicines containing drugs, psychotropic substances of the Table II of the List;

2) state body in the field of drug circulation, products of medical appointment and medical equipment - department of authorized body in the field of health care;

3) medical documents of the patient - the clinical record, the out-patient map, leaf of record of consulting survey;

4) signature - the document confirming legality of acquisition of the medicines containing drugs, psychotropic substances and their precursors

5) the Table II of the List - the list of the drugs and psychotropic substances used in the medical purposes and which are under strict control;

6) the Table III of the List - the list of the drugs and psychotropic substances used in the medical purposes and which are under control;

7) the Table IV of the List - the list of precursors (the chemical and vegetable substances which are often used in case of illegal manufacture of the narcotic and psychotropic substances) which are under control.";

to state heading of Chapter 2 in the following edition:

"Chapter 2. Procedure for use in the medical purposes of drugs, psychotropic substances and their precursors, subjects

to control in the Republic of Kazakhstan";

and 5 to state items 4 in the following edition:

"4. Calculation of need for the medicines containing the drugs which are subject to control in the Republic of Kazakhstan is performed by the organizations of health care according to settlement standard rates of need for the medicines containing drugs on one bed (case) a year according to appendix 1 to these rules.

Calculation of need for the medicines containing psychotropic substances, and calculation of need for precursors, which are subject to control in the Republic of Kazakhstan is made on consumption level for previous year. Requirement (reorganized) organizations of health care which are again put into operation and requirement on new medicines is predicted with accounting of data on incidence.

5. The organizations of health care represent to local authorities of public administration by health care of areas, cities of republican value and the capital:

1) annually, till March 1 of the request of the organization of health care for approval of the standard rate of consumption of the drugs which are subject to control in the Republic of Kazakhstan in form according to appendix 2 to these rules; requests of the organization of health care for approval of the standard rate of consumption of the psychotropic substances which are subject to control in the Republic of Kazakhstan in form according to appendix 2-1 to these rules; requests of the organization of health care for approval of the standard rate of consumption of the precursors which are subject to control in the Republic of Kazakhstan in form according to appendix 2-2 to these rules. The made calculations are applied to requests;

2) quarterly, to the 10th following reporting quarter, the report on the actual consumption of the medicines containing drugs, psychotropic substances and their precursors in quarter including in the automated mode;

3) annually, till March 1 of the year following after accounting year, the report on the actual consumption of the medicines containing drugs, psychotropic substances and their precursors in year including in the automated mode.";

add with Item 5-1 of the following content:

"5-1. Local authorities of public administration by health care of areas, cities of republican value and the capital perform collection of the requests which arrived from the organizations of health care for approval of standard rates of consumption of drugs, psychotropic substances and their precursors, and also their control on compliance:

1) the declared quantities to settlement standard rates of need for the medicines containing drugs;

2) the declared quantities to the actual amounts of consumption for previous year.

In case of submission of the correct request for each organization of health care by the order of the head of local state body health care of areas, cities of republican value and the capital or person replacing it the standard rate of consumption of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan in form according to appendix 3 to these rules affirms.

Within administrative and territorial unit within the current calendar year modification and amendments in the approved standard rates of consumption of the organizations of health care or approval of the standard rate of consumption for again formed (reorganized) organization of health care is allowed.

Summary requirement for area, the cities of republican value, the capital is created taking into account comparison of the summary declared quantity by the organizations of health care with settlement standard rates of need for drugs on 1000 people of the population a year (in grams) specified in appendix 4 to these rules and also taking into account the actual consumption for previous year and loudspeakers of incidence and population.";

state Items 6 and 7 in the following edition:

"6. Local authorities of public administration by health care of areas, cities of republican value and the capital represent to state body in the field of drug circulation, products of medical appointment and medical equipment by March 15 of the current year the summary request for drugs, psychotropic substances and their precursors for area, the cities of republican value and the capital the next calendar year.

7. The state body in the field of drug circulation, products of medical appointment and medical equipment represents to authorized state body in the field of drug trafficking, psychotropic substances, their analogs and precursors by April 1 of the current year the next calendar year the generalized request for drugs, psychotropic substances and their precursors for use in the medical purposes in the Republic of Kazakhstan.";

state Item 9 in the following edition:

"9. In case of delivery of health care in the form of emergency medical service, sanitary aircraft, medical care in case of emergency situations, and also in case of visit of patients mobile crew of palliative care at home (further - mobile crews) the medicines containing drugs, psychotropic substances and their precursors are appointed by the doctor of mobile team of emergency medical service or the doctor of department of emergency aid (home visiting service) of the organization of health care.

In the absence of doctors as a part of the mobile teams of emergency medical service and mobile crews, prescription of medicines containing drugs, psychotropic substances and their precursors it is made by the paramedic of crew.

Registration of use of the medicines containing drugs, psychotropic substances of the Table II of the List is made after rendering the emergency medical care to the patient.";

exclude Item 17;

state Item 19 in the following edition:

"19. Recipes are written out by the patient on the medicines containing drugs, psychotropic substances and their precursors of the Table II, III, IV of the List in Latin on the basis of standard assessment of condition of the patient the paramedics, obstetricians, doctors of the organizations of health care or doctors conducting independent acceptance in the presence of the corresponding medical indications and the organizations of health care are certified by the signature, personal seal (in the presence), stamp and seal (in the presence).";

state Item 23 in the following edition:

"23. If prescription of medicine, the List containing drugs, psychotropic substances and their precursors of the Table II, III, IV is performed at the out-patient level within the guaranteed amount of free medical care, in addition to the special prescription form the recipe on free leave is in addition written out. The written-out recipes automatically are reflected in the Information system of provision of medicines.";

state Item 28 in the following edition:

"28. For improvement of quality of life incurably the patients having the heavy, progressing diseases in terminal (final) stage amount of the medicine which is written out in one recipe containing drugs, psychotropic substances and their precursors of the Table II, III, IV of the List are allowed to be written out on several recipes in the number sufficient on 10-15 of calendar days of therapy, and for living in the settlement, remote from the district center, - on 25-30 calendar days of therapy, but no more maximum permissible Regulations.";

4) of Item 33 to state the subitem in the following edition:

"4) on one prescription form to write out and provide the medicines containing drugs, psychotropic substances and their precursors in the quantities exceeding the regulations specified in maximum permissible Regulations;";

exclude Item 44;

52, of 53, of 54, of 55, 56 to state Items in the following edition:

"52. The medicines which became useless, counterfeited, expired and others (marriage, fight), the legislations of the Republic of Kazakhstan which are not conforming to requirements, and also the raw materials, materials, remaining balance of materials, tests, waste, the semi-products which are not subject to further conversion after production of medicines and (or) testing (analyses) which are not relating to medicines, containing drugs, psychotropic substances and their precursors are liable to destruction.

53. The medicines containing drugs, psychotropic substances and their precursors in the organizations of health care are subject subject quantitatively to accounting in the registers of drugs, psychotropic substances and their precursors numbered, strung together, fastened with seals and signatures of heads of the organization of health care and territorial subdivisions of state body in the field of drug circulation, products of medical appointment and medical equipment in pharmaceutical warehouses according to appendix 11, of accounting of the medicines containing drugs, psychotropic substances and their precursors in departments and offices according to appendix 12, of accounting of the drugs, psychotropic substances and their precursors which are subject subject quantitatively to accounting in drugstore to appendix 13, of accounting of the medicines containing drugs psychotropic substances and their precursors on posts of nurses according to appendix 14 to these rules.

54. In the scientific organizations in the field of health care, the organizations of education in the field of health care, the organizations of health care performing pharmaceutical activities in the form of production of medicines and also in test laboratories (centers) subject quantitatively reactants, active pharmaceutical ingredients (substances), medicines containing drugs, psychotropic substances and their precursors are subject to accounting (including in the automated mode)

Accounting of reactants, medicines, active pharmaceutical ingredients (substances) containing drugs, psychotropic substances and their precursors arriving in test laboratory (center) for the analysis is conducted in register of the medicines containing drugs, psychotropic substances and their precursors, arriving in test laboratory (center) for the analysis (including in the automated mode) in form according to appendix 15 to these rules; for the scientific organizations in the field of health care and the organizations of education in the field of health care - in register of drugs, psychotropic substances, precursors in the scientific organizations and the organizations of education in the field of health care in form according to appendix 16 to these rules; for the organizations of health care performing pharmaceutical activities in the form of production of medicines - in register of active pharmaceutical ingredients (substances) containing the drugs, psychotropic substances and their precursors used in case of production of medicines in form according to appendix 16-1 to these rules.

55. In register on the first page the list of reactants, medicines, active pharmaceutical ingredients (substances) containing drugs, psychotropic substances and their precursors which are subject subject quantitatively to accounting is specified. For each name of reactant, substance or dosage form, dosage, packing of medicine the single sheet (turn) with indication of surname and initials of the responsible person who is filling in the magazine is taken away. Receipt is reflected according to each receipt document with indication of number and date. The expense registers day results (daily records). Registers are conducted within one year.

56. The responsible person on the first day of every month verifies the actual availability with book remaining balance, with creation of the reconciliation statement of drugs, psychotropic substances and their precursors in form according to appendix 17 to these rules.";

state Item 58 in the following edition:

"58. In case of identification of discrepancies of the actual remaining balance with book remaining balance the head of the organization of health care within a day from the moment of detection informs on it territorial subdivision of state body in the field of drug circulation, products of medical appointment and medical equipment and law-enforcement body.";

state Item 70 in the following edition:

"70. On the first day of every month the responsible person verifies the actual availability of special prescription forms with book remaining balance about what the reconciliation statement of special prescription forms in form, according to appendix 20 to these rules is drawn up.

In case of identification of discrepancies by results of reconciliation the head of the organization of health care within a day from the moment of detection informs on it territorial subdivision of state body in the field of drug circulation, products of medical appointment and medical equipment.";

to state heading of Paragraph 7 in the following edition:

"Paragraph 7. Destruction of medicines, become useless, counterfeited, expired and others (marriage, fight), the legislations of the Republic of Kazakhstan, and also raw materials, materials, remaining balance of materials, tests, waste, semi-products which are not subject to further conversion after production of medicines and (or) testing (analyses) containing drugs, psychotropic substances and precursors which are not conforming to requirements";

state Item 83 in the following edition:

"83. For destruction of medicines become useless, counterfeited, expired and others (marriage, fight), the legislations of the Republic of Kazakhstan which are not conforming to requirements containing drugs, psychotropic substances and precursors of Tables II, III, IV of the List in objects in the field of drug circulation, products of medical appointment and medical equipment, the order of the head of the organization creates the permanent commission which structure joins the head and the responsible person of the organization, representatives of law-enforcement bodies and territorial subdivision of state body in the field of sanitary and epidemiologic wellbeing of the population.";

add with Item 83-1 of the following content:

"83-1. In the organizations of health care performing pharmaceutical activities in the form of production of medicines and also in test laboratories (centers) the medicines which became useless, counterfeited, expired and others (marriage, fight), the legislations of the Republic of Kazakhstan which are not conforming to requirements, and also the raw materials, materials, remaining balance of materials, tests, the waste, semi-products which are not subject to further conversion after production of medicines and (or) testing (analyses), not relating to medicines, containing drugs, psychotropic substances and their precursors of Tables II, III, IV of the List are destroyed in the presence of the commission in which structure join the responsible person of the organization, representatives of law-enforcement bodies, territorial subdivision of state body in the field of sanitary and epidemiologic wellbeing of the population by the following methods:

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