The opioid regulatory paradox
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- Ashley Barnett
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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: Final Data 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 l 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 l Aim to maintain a balance between good patient care and diversion prevention. opioid manufacture, distribution, storage, prescription and dispensing l 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 l 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. l 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
6
7 Rest of the world l US, Australia +NZ: Well documented l The Rest: Sporadic reporting Inconsistent methodologies Lack of clear picture
8
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) Roles 16. Myanmar Oncology Society 17. Foundation Akbaraly, Madagascar 1. Authorship 1. Identifying potential reporter 2. 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 l Conflicting data (Individual reporters, multiple reporters) Clarifications sought Priority given to highly credentialed reporters Representative data presented l Open peer review of preliminary data
15 Results
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 (OciIR) 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 Africa, Asia, Middle East, Latin America, Caribbean, India : Formulary.
63 Africa, Asia, Middle East, Latin America, Caribbean, India: Regulatory Restrictions
64 Disclaimers l Field reports +/- verification of actual regulations l Conflicting data Individual reporters Multiple reporters
65 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. l 4 + barriers of varying severity 79/93 (84%) l 6 + barriers of varying severity 36/93 (39%)
66 Special Acknowledgments l Logistics Gracemarie Bricalli Heidi Blumhuber Amelia Giordano Silvana Gori l 156 individual reporters l 49 peer reviewers l 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) l 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
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