1. Current System of Drug Control In Georgia Prof. D. Kordzaia – Georgian National Association for Palliative Care VIENNA - March 5-6, 2013 “Making Oral Opioids Available in Eastern Europe and Central Asia”

2. COUNTRY POPULATION ill, but curable people people with chronic incurable disease healthy people Health Care Health CareSystem Medicine palliative curative preventive

3. Palliative Care in its modern understanding started the integration into Healthcare and Social Affair systems of Georgia in 2000

4. WHO Public Health Model 3. Education 4. Implementation 1. Policy 2. Drug Availability

5. International Palliative Care Initiative Open Society Foundations Decrees, reports, declarations for Palliative Care; Palliative Care as a human rights UN, WHO, EC, IAHPC, EAPC, OSI Standards and Educational Materials for Palliative Care IAHPC, EAPC, Pain & Policy Studies Group International Experts sharing with us the Experiences of different Countries

6. Single Convention Establishes a Framework to: 1.Prevent abuse and diversion, and 2.Ensure the availability of drugs for medical purposes

7. “the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering… adequate provision must be made to ensure the availability of narcotic drugs for such purposes.” (Preamble, p. 13)

8. In 2006, seven countries together accounted for almost 84% of global consumption of morphine. These countries represent less than 12% of the world’s population. What do the data say? Pain & Policy Studies Group, 2008 (based on 2006 INCB data).

9. Pain is Curable and Controllable! Thus: The pain, which is not controlled and continue to suffer patients, represents the violation of Human rights. So, it can’t be considered as only a medical mistake, but as a crime

10. POLICY: ACHIEVING BALANCE IN NATIONAL OPIOIDS CONTROL POLICY: Guidelines for Assessment ( WHO - 2000) ENSURING BALANCE IN NATIONAL POLICIES ON CONTROLLED SUBSTANCES Guidance for availability and accessibility of controlled medicines (WHO – 2011)

11. “Balance” is the Fundamental Principle National policy should establish a drug control system that prevents diversion and ensures adequate availability for medical use Drug control measures should not interfere with medical access to opioid

12. Pain control and management as a system can not exist unless based on the rational national drug policy ”The law and normatives must provide the full availability to opioids for patients in suffering” (WHO, 2002)

13. The health right implies: (Universal declaration of human rights of UN General Assembly) Accessibility to essential medications; For chronic and terminal patients: - Prevention of controllable pain - Dying with dignity Prevention from drug diversion

14. In 1961 the single convention on narcotic substances identifies the following mechanisms of control: 1) Creation of the Estimate System, to evaluate the demand on narcotic drugs 1) Creation of the Estimate System, to evaluate the demand on narcotic drugs 2) Continuous renewal and provision of information to the statistical return system of narcotic substances in the country

15. ! PROBLEM in Georgia: Pain Control and Drug Availability

16. The factors impedeing opioid availability (INCB 2002) Inadequate methods for evaluation of demands Over-strict regulations Complicated administrative procedures Fear to develop drug dependence Doctors fear for punishment and super-strict control Lack of medical knowledge in pain management

17. WHO’s recommendations : Before beginning strategy implementation, we should be sure that politics and drug availability has adequately been interested. It is unrealistic to import opioids while special rules for prescribing drugs will not be prepared and also spatial training courses for patient care. Do not start training if you have no politics and drug availability. It will result desperation of doctors, patients, their families and society.

18. Drug availability Normative order Protocols Instructions Governmental Budget Education of medical professionals / social workers / students, etc. Policy Law Public Awareness Education of decision makers

19. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request

20. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request

21. The pain management guidline was published in 1986 by World Health Organization (WHO 1986) and was renewed in 1996 The mentioned guidelines became the gold standard in the management of patients with oncological pain, where the opioids represent the necessary treatment

22. World Health Organization Recommendations Oral opioids –Morphine is an “Essential Medicine” (since 1977) –For relief of moderate to severe pain –Cancer, HIV/AIDS, other conditions Cancer Pain Relief (1986) - Three-step Analgesic ladder

23. Individual approach There are no standard doses of opioid drugs. The dose which allow effective pain relief is called the “Correct dose” For example – per oral morphine dose is ranging from 5 mg to 1000 mg per 4 hours Hourly Next dose of analgesics must be given before entire neutralization of previous dose – this schedule allows long term analgesia

24. Opioidmethod of applicationEcvianalesic Doses MorphineParenteral Enteral 10 mg 30 mg CodeineParenteral Enteral 130 mg 200 mg Table of analgesic effect identity

25. Drug availability Normative order Protocols Instructions Policy Law Education of decision makers

26. Healthcare system in Georgia is regulated by hierarchy: a) laws of Georgia b) Normative orders c) Instructions d) Protocols -Adoption and acceptation of laws are the obligation of Parliament of Georgia. -Issuing of normative orders is an obligation of Government of Georgia (in peculiar of Minister of Healthcare, Labor and Social Affairs). - Preparation of Instructions and Protocols is an obligation of Professional Associations and/or Experts

27. No “Palliative Care” in Laws of Georgia Normative Order of Two Ministers 2006 No Instructions and Protocols on Palliative care

28. Prescription of medicine, determination of single and daily doses or changing of dose is exercised by special commission: Deputy director of out-patients' clinic is the chairman of commission, family doctor and/or oncologist are members of commission. (In case of non- cancer diseases, the member of the commission is a doctor according of disease type).

29. Commission’s decision about prescription of opioids is recorded in special book (numbered and proved by out-patients' clinic director), where is matched name, surname, age, address, diagnose, name of prescribe drug, single and daily dose, prescription or dose increasing date, commission members signatures. One prescription form must be prescribed drug reserve only for 3-4 days

30. In April 08, 2007 by Parliament of Georgia were approved the changes in 4 laws of Georgia: -Law of Healthcare; -Law of medical activity; -Law of patient’s right; - Law of concerning the narcotics, psychotropic materials, precursors and narcological aid.

31. According to these changes: - Definition of Palliative Care (analogous to WHO definition) was added to “Law of Healthcare” and “Law of patient’s right”; - Pain relief in incurable patients was recognized as absolutely necessary issue (“Law of Healthcare”); - Palliative care was recognized as a necessary component of continuous medical aid, receiving by patient during all his life (“Law of Healthcare” and “Law of medical activity”); - Government engages (takes under the obligation) to provide patients by necessary amount and necessary forms of opioids, correspondingly to international standards (“Law of concerning the narcotics psychotropic materials”) - The Ministry of Labor, Health and Social Affairs is obligated to create and sign “The Instruction of Palliative Care for chronic incurable patients (“Law of Healthcare”).

32. Decree of the Minister of Labor, Health and Social Affairs On Approval of the Instruction about “the Palliative Care Providence for Chronic, Incurable Patients” Registration code: 470.230.000.22.035.012.017 2008

33. On March 17, 2009 the policy round table dedicated to improvement of drug availability and oral morphine importation was organized with participation of members of Parliament, representatives of MOH, Organizations providing Palliative Care, WHO Country Office, National Cancer Center, AIDS Center, Insurance Companies, Mass media and international experts: Mary Callaway,Karen Ryan, Katalin Muzsbek, Martha Maurer. The special recommendations to MOH were prepared; The main recommendation was to Import Oral Morphine

34. Normative documents currently regulating legal turnover of opioids in Georgia In order to provide successful management of chronic pain and improve the accessibility to opioids for medical use, the Georgian government made a number of changes in regulating documents during the period of 2008- 2011.

35. A single prescription (recipe) prescribed for chronic incurable patient may cover the amount (dose) of narcotic drug for 7 days (order N157/n, 2008). Responsibiliy for relevant administration and presciption of the drug lies only on the physician prescribing the recipe. (order N157/n, 2008). A primary care physician in rural area, providing the ambulatory service for the population in country-side, is personally responsible for the prescription, which is confirmed by their signature and personal stamp placed on the prescription form (26.02.2010 N55/n).

36. State program of “providing onco-incurable patients with controled medicines” the term “onco-inucarble” is replaced by “chronic incurable”, which gives physicians the basis to prescribe opioids for the treatment of chronic pain in somatic patients as well. Resolution of Georgian government #77, by February 15, 2011

37. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request

38. There are preliminary identified and established 2 days in each week, when the pharmacy, placed in the Police Station can issue opioids to patients or their family members. (Joint decree of two ministers (#32 and #102 – March 13/15, 2000)

39. Narcotic drug prescribed on the recipe must be distributed during the 5 working days. After 5 working days the pharmacist is legally disabled to give out the drug. If the patient’s condition is changed during the course of the treatment, needing the change in a drug, dose or the form, a doctor must issue a new prescription (order N157/n, 2008).

40. “Narcotic drugs of different brand and form can be prescribed on the same single prescription form. No changes or corrections can be made in the prescription form after prescribing the medicine. The pharmacy can only sell the narcotic drug on the basis of the original form of the prescription” (order N18/n – N 96, 2010).

41. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request

42. Quota Determining the demand

43. G METHODS FOR CALCULATION OF THE AMOUNT OF OPIOIDS NEEDED FOR PAIN CONTROLN (Provided by the 1961 single convention on narcotic substances and used by International Narcotic Control Board Population-based Service-based Expenditure-based Expenditure / Consumption ratio

44. Population-based method relies on epidemiological indices of prevalence of general diseases in population Service-based method relies on the types of services and resources in healthcares system Expenditure (consumption) – based relies on the consumption index of previous years; this method is justified for the countries where the consumption index is based upon actual demands.

45. Calculation of the needed amount of morphine according to population-based method (oral morphine) The demand on narcotic drugs in Georgia is determined by population-based method, i.e. by the incidence (morbidity) structure; For patients with cancer: Yearly mortality rate X 80% (patients needing morphine at end- of-life) X 90 days X 60 mg/day (oral morphine) 4033 X 80%= 3226.5 3226.4 X 90 days X 60 mg = 17 422,5 mg annually

46. Recommendations for Country Quota request P/O (IRM) P/O (SRM) P/EOthers 30% 60% 5% 10mg 20mg 30mg 60mg (100mg) 2 mg/ml 10 mg/ml 50 mg/ml

47. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request

48. RELATIVE COST OF OPIOIDS DRUGMORPHINEFENTANYL Drug formper oral (IR M) Rapid action per oral Slow action ( SRM) ParenteralTrans - cutaneous Relative cost 1x 3x 5x > 20x Purchase of narcotic drugs in Georgia is based on the rates of previous years

49. Opioids Purchase by Governmental Budget via STATE TENDERS The winner private companies are importing and distributing opioids in the pharmacies placed in police station buildings throughout the country The transportation of opioids from country border to central office of company and from central office to pharmacies is accompanied by special police team

50. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request

51. COMPONENTS OF DRUG CONTROL SYSTEM Opiod Consumption Analysis and Quota Request Opioids Importation and Distribution throughout the Country Dabble- Monitoring and reporting Storage Of Opioids In Hospitals And Pharmacies Opioids Dispense Opioids Administration and Prescription Opiod Consumption Analysis and Quota Request To be improved and Standardized

52. Thank you for your attention !