Accessibility of Opioids in the Republic of Kazakhstan G.U. Raimkulova – Head of

1. Ministry of Health Republic of Kazakhstan SALAMATTY KAZAKHSTAN Accessibility of Opioids in the Republic of Kazakhstan G.U. Raimkulova – Head of Pharmaceutical Activities Administration , Medical and Pharmaceutical Activities Committee, Ministry of Health of the Republic of Kazakhstan Almaty 2012

2. 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 activitiesin the field of health; 3) state marketing authorizationof the medicinal products, health products and medical devices (MPHPMD); 4) safety and quality assessmentof the marketed medicinal andhealth products; 5) state price control of medicinal products,purchased under the scope of the guaranteed free medical care. (Codeof the Republic of Kazakhstan –On National Health and Health System)

3. Regulatory base of the provision of narcotic, psychotropic substances and precursors Codeof the Republic of Kazakhstan (RoK) “On National Health and Health care System”; Law of the Republic of Kazakhstanas of July 10, 1998,No 279-I“On narcotic, psychotropic substances and precursors, and countermeasures to their trafficking and abuse”; 3. Government Resolutionof the Republic of Kazakhstanas of November 10, 2000,No 1693 «On adoption of regulationsfor state regulationof the narcotic, psychotropic substances and precursors distributionin the Republic of Kazakhstan»; Government Resolutionof the Republic of Kazakhstanas ofMarch 30, 2012, No 396 “On adoption of regulationsfor medicinal use narcotic, psychotropic substances and precursors, subject to control in the Republic of Kazakhstan”; Government Resolutionof the Republic of Kazakhstanas of May 23, 2007, No 413 “On adoption of exclusion out of control regulationsfor 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 productslist for free public out-patient provision with specialized medical products in selected diseases (conditions) under warranted free medical care capacity“.

4. State regulationmodes for narcotic, psychotropic substances and precursors distribution (NPP) 1. quota allocation – demand rate for the Republic of KazakhstaninNPPbased onrequirement computation. Is approved by Governmentof the Republic of Kazakhstan and submittedin accordance withinternational treatiesfor international quota approval Republic of KazakhstanUN INCB); 2. distribution–Republican internal market provision with specified remediesand professional activities guarantee for different agencies under allocated quota in accordance withregulations: - 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).

5. Formation of demands order for narcotic, psychotropic substances and precursorsin the Health system of the Republic of Kazakhstan State quota INCBUN MIF of the RK Government of Kazakhstan Republican consumption standard International quota Health system demand MH of the RK Composite bod General request MPAC MH of RoK Territorial subdivisions Oblast, Astana, and Almaty health departments, Bid and demand calculation Bid and demand calculation Republican medical organizations Medical organizations

6. Medicinal Provision Systemin the Republic of Kazakhstan Warranted free medical care capacity (WFMCC) Medicinal products provision Emergency care, hospital and hospital replacement care Out-patient care In accordance withapproved 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 the 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) 6

7. Republican Drug Formulary

8. Drug list in accordance with List(Order No 786) Palliative therapy for malignancies Morphine,solution for injection; Trimeperidine hydrochloride, solution for injection; Tramadol,sustained release tablet, capsule, suppositories, solution for injection; Fentanyl,transdermal therapeutic system; Ketoprofen,capsule, tablet, suppositories, solution for injection; Diazepam,tablet, solution for injection;

9. Opioids availability at the pharmaceutical market of the Republic of Kazakhstan(in accordance with StateMPHPMDregistry 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: Morphine hydrochloride – 1 PP (solution for injection); 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);

10. Pharmaceutical Control Committee State marketing authorizationprocedure for medicinal productsin the Republic of Kazakhstan Information, analysis and marketing center Applicant Department of Almaty Pharmaceutical Control Committee General Department Archive Expert services Marketing Authorization Expert Advisory Body Expert services Marketing Authorization Test Center Pharmacological Center Pharmacopoeial Center

11. State Marketing Authorizationfor 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 onmedicinal 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

12. Current opioids prescription and delivery procedure PHYSICIAN Out-patient level In-patient level Medication administration record of the Medical History is certified by Head of Department and/or Organization Manager 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 Patient 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 Pharmacy Is provided by the list of doctors eligible to prescribe opioids Patient

13. 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.

14. THANK YOU FOR YOUR ATTENTION Ministry of Health Republic of Kazakhstan SALAMATTY KAZAKHSTAN