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Accessibility of Opioids in the Republic of Kazakhstan

G.U. Raimkulova – Head ofPharmaceutical Activities Administration ,

Medical and Pharmaceutical Activities Committee, Ministry of Health of the Republic of Kazakhstan

Ministry of Health Republic of Kazakhstan

Almaty 2012

SALAMATTY KAZAKHSTAN

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State Regulation of Drug Distribution

Managed by the following:

1) state regulation of the pharmaceutical activities;

2) licensing the pharmaceutical activities and narcotic, psychotropic substance and precursor distribution activities in the field of health;

3) state marketing authorization of the medicinal products, health products and medical devices (MPHPMD);

4) safety and quality assessment of the marketed medicinal and health products;

5) state price control of medicinal products, purchased under the scope of the guaranteed free medical care.

(Code of the Republic of Kazakhstan –On National Health and Health System)

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Regulatory base of the provision of narcotic, psychotropic substances and precursors

1. Code of the Republic of Kazakhstan (RoK) “On National Health and Health care System”;

2. Law of the Republic of Kazakhstan as of July 10, 1998, No 279-I“On narcotic, psychotropic substances and precursors, and countermeasures to their trafficking and abuse”;

3. Government Resolution of the Republic of Kazakhstan as of November 10, 2000, No 1693 «On adoption of regulations for state regulation of the narcotic, psychotropic substances and precursors distribution in the Republic of Kazakhstan»;

4. Government Resolution of the Republic of Kazakhstan as of March 30, 2012, No 396 “On adoption of regulations for medicinal use narcotic, psychotropic substances and precursors, subject to control in the Republic of Kazakhstan”;

5. Government Resolution of the Republic of Kazakhstan as of May 23, 2007, No 413 “On adoption of exclusion out of control regulations for medicinal products with low narcotic, psychotropic substances and precursors content, whereof substances mentioned above could not be extracted by immediate availability, and specified products list’;

6. Order of the Deputy Minister of Health of the RoK, as of November 4, 2011, No 786 “On approval of the medicinal products and health products list for free public out-patient provision with specialized medical products in selected diseases (conditions) under warranted free medical care capacity “.

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State regulation modes for narcotic, psychotropic substances and precursors distribution (NPP)

• 1. quota allocation – demand rate for the Republic of Kazakhstan in NPP based on requirement computation. Is approved by Government of the Republic of Kazakhstan and submitted in accordance with international treaties for international quota approval Republic of Kazakhstan UN INCB);

• 2. distribution – Republican internal market provision with specified remedies and professional activities guarantee for different agencies under allocated quota in accordance with regulations:

- provision standard is to be approved for importing domestic manufacturers and legal bodies.

- consumption standard is to be approved for republican administrative-territorial units indicating standards for individual consumer organizations (therapeutic, pharmaceutical, veterinarian, academic, and research organization etc.);

• 3. licensing (narcotic, psychotropic substances, precursors distribution activities, NPP import and export);

• 4. inspections (narcotic, psychotropic substances and precursors distribution order compliance monitoring).

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Formation of demands order for narcotic, psychotropic substances and precursors in the Health system of the Republic of

KazakhstanGovernment

of Kazakhstan

MPAC MH of RoKTerritorial subdivisions

Oblast, Astana, and Almaty health departments,

INCB UN

MH of the RK

Bid and demand calculation

General request

Composite bod

International quota

Republican consumption

standard

State quota

Medical organizations

Bid and demand calculation

Republican medical

organizations

MIF of the RK

Health system demand

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Medicinal Provision SystemMedicinal Provision Systemin the Republic of Kazakhstanin the Republic of Kazakhstan

Warranted free medical care capacity (WFMCC)Medicinal products provision

Out-patient careEmergency care,

hospital and hospital replacement care

In accordance with approved medical Organizations and drug formularies

duly coordinated with regulatory authority(Medicinal product list,

compiled for WFMCC rendering considering organization profile,

to be formed by medical organization itself)

In accordance with approved medical Organizations and drug formularies

duly coordinated with regulatory authority(Medicinal product list,

compiled for WFMCC rendering considering organization profile,

to be formed by medical organization itself)

In accordance withthe List of medicinal products

and specialized health products for free provision of individual populations with

selected diseases (conditions), which is a subject for regulatory authority approval(approved by the order of the MH of RoK

No 786 as of 4 November 2011)

In accordance withthe List of medicinal products

and specialized health products for free provision of individual populations with

selected diseases (conditions), which is a subject for regulatory authority approval(approved by the order of the MH of RoK

No 786 as of 4 November 2011)

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Republican Drug Formulary

No

International non-proprietary name Pharmaceutical form*

  Опиоидные анальгетики

1. Morphine solution for injection 1 %

2. Trimeperidine solution for injection 1 %, 2 %

3. Tramadol

solution for injection 100 mg/2 ml, 50 mg/mL, 5%;oral solution 100 mg/1 mL; drops1000 mg/10mL; film-coated tablet 50 mg; retard tablet (film-coated tablet) 100 mg, 150 mg, 200

mg;capsules 50 mg; rectal suppositories

4. Fentanyl

solution for injection 0,005 %; transdermal therapeutic system 12,5 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, 100 mcg/hour;sublingual tablet 100mg, 200mg, 300mg,400mg, 600mg, 800mg

5. Butorphanol solution for injection 2 mg/mL

* All registered in the Republic of Kazakhstan pharmaceutical forms are to be released

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Palliative therapy for malignancies

• MorphineMorphine, solution for injection;

• Trimeperidine hydrochlorideTrimeperidine hydrochloride, solution for injection;

• TramadolTramadol, sustained release tablet, capsule, suppositories, solution for injection;

• FentanylFentanyl, transdermal therapeutic system;

• KetoprofenKetoprofen, capsule, tablet, suppositories, solution for injection;

• DiazepamDiazepam, tablet, solution for injection;

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Opioids availability at the pharmaceutical market of the Republic of Kazakhstan

(in accordance with State MPHPMD registry as of 01.01.2013)

Nowadays, around 77 items of various pharmaceutical forms and dosages for following medicinal products are present in the market of the Republic of Kazakhstan:

1. Morphine hydrochloride – 1 PP (solution for injection);

2. Fentanyl – 16 PP (solution for injection, transdermal therapeutic system and sublingual tablet);

3. Trimeperidine– 1 PP (solution for injection);

4. Tramadol – 41 PP (capsule, drops, tablet, sustained release tablet, solution for injection, suppositories);

5. Combined codein-containing drugs – 18 PP (tablet, syrup, capsule);

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Expert services Marketing Authorization

Expert services Marketing Authorization

Test CenterTest Center

Information, analysis and marketing centerInformation, analysis and marketing center

General DepartmentGeneral Department

ArchiveArchive

Expert Advisory BodyExpert Advisory Body

Pharmacological CenterPharmacological CenterPharmacopoeial CenterPharmacopoeial Center

Applicant

Department of AlmatyPharmaceutical Control

Committee

Department of AlmatyPharmaceutical Control

Committee

Pharmaceutical Control Committee

Pharmaceutical Control Committee

Expert services Marketing Authorization

Expert services Marketing Authorization

State marketing authorization procedure for medicinal products in the Republic of Kazakhstan

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State Marketing Authorization for MPHPMD

Upon expertise completion the Expert Report on Drug Safety, Efficacy, and Quality is compiled

Based on Expert Report the MPAC MH of the RoK makes decision and issue an order on medicinal product state marketing authorization

All data on registered MP within 24 hours are entered in the State MP Registry

An applicant is to be granted by:

Marketing Authorization Approved Company Core Data Sheet Medicinal Product Quality Regulatory document (AND) Package design

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Current opioids prescription and delivery procedure

PHYSICIAN

Medication administration record

of the Medical History is certified by Head of Department and/or

Organization Manager

In-patient levelOut-patient level

PharmacyIs provided by the list of

doctors eligible to prescribe opioids

Patient

Prescription(А6 format blank sheet with code, number, protection level, and to

be certified by a seal of the doctor, Medical Director’s or

Deputy’s signature and Medical Organization seal).

Valid for 7 consecutive days

Use (taking) of opioids is performed strictly under the supervision of medical staff at the moment of drug delivery: oral taking, transdermal therapeutic system application (plaster, patch, etc.) – in the presence of the nurse, injection – in the

presence of the physician

Patient

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Opioids storage and destruction requirements

Лица, допущенные к работе с опиоидными

анальгетиками должны иметь заключения врачей психиатра and нарколога об

отсутствии заболеваний наркоманией, токсикоманией, хроническим

алкоголизмом, а также о пригодности к выполнению данной деятельности and заключение органов внутренних дел по

проведению соответствующей проверки.

1. The persons, authorized to work with the opioids, shall prior get the conclusions from psychiatrist and narcologist regarding the absence of narcotic, toxic substances, alcohol abuse, and Internal affairs authorities conclusion regarding relevant inspection . List of persons authorized to work with narcotic, psychotropic substances and precursors is to be approved by the order of the Health organization Manager annually.

2. Storage facilities, lock boxes, and cupboards must be in blocking state. Outside office hours these are to be sealed up, keys and seal press are to be kept in a responsible person.

3. On the inside of the lock box door, cupboards the check-list of kept medicinal products indicating highest single and daily doses

4. All documents on the opioid income side and consumption are to be kept in a filed, sealed form by months and years in responsible person in conditions providing their security in the lock boxes and metallic cupboards within storage facility.

5. Documents on the opioid income side and consumption are to be kept for five years.

6. On the inside of the door of the lock box, cupboard the check-list of kept medicinal products containing narcotic, psychotropic substances and precursors indicating highest single and daily doses.

7. Medicinal products, containing narcotic, psychotropic substances and precursors are to be delivered form the storage facility only by the responsible person.

8. In the assistant room stock of narcotic, psychotropic substances from the Table II of the List should not exceed five-day demand, in departments (offices) of health organizations – three-day demand, in pharmacy storage facilities — thirty-day demand, apart from holidays and weekends.

9. Unused special prescriptions given by dead patients relatives are to be kept with following destruction. Prescription destruction is to be performed as far as prescription accumulation, but not less than monthly, by incineration of the ongoing committee, included internal affairs body representative. Unused special prescriptions destruction fact is to be registered in relevant act.

10. To destroy the expired opioids, provided by the deceased patients’ family, breakage, rejects, empty ampules and plasters (transdermal therapeutic systems) as well, and ampules and plasters (transdermal therapeutic systems) with partially used content, under the order of the Health Organization Manager, a constantly functioning committee is to be developed including internal affairs body and sanitary-epidemiological services representatives.

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THANK YOU FOR YOUR ATTENTION

Ministry of Health Republic of Kazakhstan

SALAMATTY KAZAKHSTAN