1. The international collaborative project to evaluate the availability and accessibility of opioids for the management of cancer pain in Africa, Asia, Latin America and Middle East Nathan I Cherny Project coordinator Chair, ESMO Palliative Care Working Group Member, EAPC research steering committee Norman Levan Chair in Humanistic Medicine Dept Oncology Unit Head: Cancer pain and palliative Medicine Shaare Zedek Medical Center, Jerusalem, Israel Chernyn@Netvision.net.il

2. The opioid regulatory paradox 2 fundamental and conflicting needs 1.to ensure that opioid analgesics are available to the patients who need them. 2.to prevent these drugs from becoming a source of harm or abuse.

3. World Health Organization (WHO) + International Narcotics Control Board (INCB) on Regulations Aim to maintain a balance between good patient care and diversion prevention. opioid manufacture, distribution, storage, prescription and dispensing Guiding Principles 1.Preventing drug abuse and dependence is important. 2.Regulations should not hinder patients ability to receive the care they need and deserve. 3.Opioids should be available for cancer patients at hospital and community levels. 4.Physicians should be able to prescribe opioids according to the individual needs of each patient.

4. Over regulation High burden of regulations to reduce substance abuse and to restrict the diversion of medicinal opioids into illicit markets that unduly interferes with medical availability for the relief of pain. International public health problem.

5. Forms of overregulation identified by the WHO and INCB 1.requirements for patient permits 2.restrictions on prescriber privileges 3.interfere with clinical decision making regarding drug dosing (dose limits) 4.limits on duration of prescription i.e., 7 days supply only 5.restriction on opioid dispensing 6.complex prescription form requirements 7.intimidatory legal sanctions

7. Rest of the world US, Australia +NZ: Well documented The Rest: Sporadic reporting Inconsistent methodologies Lack of clear picture

9. Aims 1.To evaluate the formal availability and cost to the consumer of the range of opioid drugs used in the management of cancer. 2.To evaluate the barriers to the accessibility of opioid drugs for patients with cancer pain in each participating country.

10. Coordinating partner organizations: 1.European Society for Medical Oncology (ESMO) 2.European Association for Palliative Care (EAPC) 3.Pain & Policy Studies Group, University of Wisconsin Carbone Cancer Center (PPSG) 4.Union for International Cancer Control (UICC) 5.World Health Organization (WHO) Roles 1.Survey design 2.Dissemination and data collection 3.Data analysis 4.Authorship 5.Publication 6.Post publication policy initiatives

11. Collaborating partners: 1.African Organisation for Research and Training in Cancer (AORTIC) 2.Latin American and Caribbean Society of Medical Oncology (SLACOM) 3.Latin American Association for Palliative Care (ALCP) 4.African Palliative Care Association (APCA) 5.Worldwide Palliative Care Alliance (WPCA) 6.Multinational Association of Supportive Care in Cancer (MASCC) 7.Asia Pacific Hospice Palliative Care Network (APHN) 8.International Association for Hospice & Palliative Care (IAHPC) 9.Middle East Cancer Consortium (MECC) 10.Indian Association of Palliative Care (IAPC) 11.Open Society Foundations (OSF) 12.Chinese Society of Clinical Oncology (CSCO) 13.Help the Hospices 14.Japanese Society of Medical Oncology (JSMO) 15.Malaysian Society of Clinical Oncology (MSCO) 16.Myanmar Oncology Society 17.Foundation Akbaraly, Madagascar Roles 1.Identifying potential reporter 2.Authorship 3.Post publication policy initiatives

12. Survey development Based on the survey tool that was previously used in the ESMO/EAPC study Modifications based on input of participants English, Spanish, French versions

13. Identification of data reporters Known credible professionals nominated by coordinating and collaborating partners Minimum of 2 reporters for each country nominated

14. Data Collection and Management Electronic dissemination of surveys and automated data entry coordinated by EAPC Crosschecking data entry and clarification of discrepancies between reporters Conflicting data (Individual reporters, multiple reporters) Clarifications sought Priority given to highly credentialed reporters Representative data presented

15. Results 1.Response rate 2.Formulary and cost 7 essential opioids 3.Actual Availability 7 essential opioids 4.Eligibility Restrictions (Patient permits) 5.Restrictions of prescribing authority 6.Prescription restriction: No. of days supply 7.Prescription restriction: complex prescription forms 8.Pharmacist restrictions 9.Dispensing restrictions 10.Negative laws regarding medical use of opioids

16. Response Rate

17. Formulary and Cost 7 essential opioids Codeine Morphine, Oral Immediate Release (MoIR) Morphine, Oral Controlled Release (MoCR) Morphine, injectable (MoINJ) Oxycodone, Oral Immediate Release (OcIR) Methadone, Oral (MoPO) Fentanyl, transdermal patch (FentTD)

18. Formulary and Cost: Latin A+ Caribbean

19. Formulary and Cost: Africa

20. Formulary and Cost: Middle East

21. Formulary and Cost: Asia

22. Formulary and Cost: Indian States

23. Actual Availability 7 essential opioids

24. Actual Availability: Latin A and Caribbean

25. Actual Availability: Africa

26. Actual Availability: Middle East

27. Actual Availability: Asia

28. Actual Availability: Indian States

29. Eligibility Restrictions (Patient permits)

30. Eligibility Restrictions: Africa + ME

31. Eligibility Restrictions : L Am + Caribbean

32. Eligibility Restrictions : Asia + Indian States

33. Restrictions of prescribing authority

34. Prescription Privileges: Africa

35. Prescription Privileges: Middle East

36. Prescription Privileges: L Am. +Caribbean

37. Prescription Privileges: Asia

38. Prescription Privileges: Indian States

39. Prescription restriction: Number of days supply that can be prescribed

40. Days allowed/prescription: Africa + ME

41. Days allowed/prescription: L Am + Caribbean

42. Days allowed/prescription: Asia + Indian States

43. Prescription restriction: Increased bureaucratic burden with multiple copies or special forms

44. Prescription forms: Africa + ME

45. Prescription forms: L Am + Caribbean

46. Prescription forms: Asia + Indian States

47. Pharmacist restrictions

48. Pharmacist Restrictions: Africa +ME

49. Pharmacist Restrictions: L Am + Caribbean

50. Pharmacist Restrictions: Asia + Indian states

51. Dispensing restrictions

52. Dispensing: Africa

53. Dispensing: Middle East

54. Dispensing: L Am + Caribbean

55. Dispensing: Asia

56. Dispensing: Indian States

57. Negative laws regarding medical use of opioids

58. Laws: Africa + ME

59. Laws: Lat. Am +Caribbean

60. Laws: Asia + Indian States

61. Summary

62. Summary Slides: Formulary

64. Restrictive regulations summary: Africa

65. Restrictive regulations summary: M.E.

66. Restrictive regulations summary: Lat Am +Caribbean

67. Restrictive regulations summary: Asia

68. Restrictive regulations summary: Indian States

69. Restrictive regulations summary

70. Disclaimers Field reports +/- verification of actual regulations Data not YET subject to open peer review Conflicting data Individual reporters Multiple reporters

71. Conclusions 1.In many places across Africa, Asia, ME and L Am+ Caribbean governments are failing cancer patients in delivery of adequate pain relief. 2.There is a need for increased availability of affordable opioids for the management of cancer pain. 3.In many places opioids on formulary are not routinely available. 4.Field reports suggest that overregulation of opioids is widespread. 4 + barriers of varying severity 79/93 (84%) 6 + barriers of varying severity 36/93 (39%)

72. Priority actions 1.Formulary review 2.Improving affordability 3.Improving availability of opioids on formulary by better distribution and dispensing 4.Examination of drug control policies 5.Repeal of excessive restrictions which impede this most fundamental aspect of cancer care.

73. Advocacy In action: India Dr. Nagesh Simha Human Rights Watch Report Documentary: Why Millions of Indians Live in Unbearable Pain? Supreme court Ruling

74. Special Acknowledgments Logistics Gracemarie Bricalli Heidi Blumhuber Amelia Giordano Silvana Gori Coordinating Partners 1.European Society for Medical Oncology (ESMO) 2.European Association Palliative Care (EAPC) 3.Pain and Policies Studies Group, University of Wisconsin Carbone Cancer Center (PPSG) 4.Union for International Cancer Control (UICC) 5.World Health Organization (WHO) 156 individual reporters Collaborating Partners 1.African Organization for Research and Training in Cancer (AORTIC) 2.Latin American and Caribbean Society of Medical Oncology (SLACOM) 3.Latin American Association for Palliative Care (ALCP) 4.African Palliative Care Association (APCA) 5.World Palliative Care Alliance (WPCA) 6.Multinational Association for Supportive Care in Cancer (MASCC) 7.International Association of Hospice and Palliative Care (IAHPC) 8.Asia Pacific Hospice Palliative Care Network 9.Middle East Cancer Consortium (MECC) 10.Indian Association of Palliative Care (IAPC) 11.Open Society Foundation (OSF) 12.Chinese Society of Clinical Oncology (CSCO) 13.Help the Hospices 14.Japanese Society of Medical Oncology (JSMO) 15.Malaysian Society of Clinical Oncology (MSCO) 16.Myanmar Oncology Society 17.Foundation Akbaraly, Madagascar