1. The Estimation of National Opioid Requirements: New INCB/WHO Guidelines International Pain Policy Fellowship Training Session Madison, Wisconsin, USA 8 August 2012 Martha A. Maurer Pain & Policy Studies Group University of Wisconsin Carbone Cancer Center WHO Collaborating Center for Pain Policy and Palliative Care

2. The Single Convention establishes two mechanisms: (1) The estimates system for narcotic drug requirements, and (2) The statistical returns system for narcotic drugs

3. Drug Requirements Definition The Single Convention (Article 19) defines drug requirements as the quantities of drugs that will be used in the country for medical and scientific consumption, as well as for the manufacturing of other licit preparations.

4. Governments estimate amount of controlled substances needed to satisfy all medical and scientific requirements for the next year Submit Estimates to INCB on Form B by June 30 th of each year for the following year (i.e., by 30 June 2012 for 2013 estimated requirements) INCB evaluates, confirms and publishes the estimate for each Government Government may then manufacture or import controlled substances within that amount to distribute to medical facilities for the treatment of patients How are estimated requirements established for a country?

5. Who is responsible?

6. Published Estimates for 2012 http://www.incb.org/incb/narcotic_drugs_estimates.html

7. Estimated Requirements - Morphine, 2012 CountryEst. in grams*Population** Albania3,5003,002,859 Bangladesh100,000161,083,804 India9,743,7261,205,073,612 Kyrgyzstan3,5005,496,737 Sri Lanka16,00021,481,334 Ukraine62,84044,854,065 Source: * INCB Estimated World Requirements for 2012 report (June 2012 update) ** CIA World Factbook (July 2011 estimates)

8. Supplementary Estimates Single Convention authorizes Governments to submit a supplementary estimate Government should include explanation of why an increase is needed Can be submitted at any time, and can be approved quickly by INCB when requested

9. Reasons for not submitting estimated requirements  Governments lack appropriate methods and procedures for estimating opioid requirements  Governments do not allocate sufficient personnel or resources to administer the technical function of estimating drug requirements

10. Why are Estimates of opioids important for the INCB? “Governments and the [International Narcotics Control] Board need to have accurate information about medical needs for narcotic drugs. In the case of narcotic drugs that are opiates, it is particularly important to accurately estimate all medical needs because the Board must make arrangements well in advance to cultivate a sufficient quantity of poppy plants.” (p. 1) (INCB, 1996)

11. Related Issues Impacting Estimates Cost of purchasing, importing medicines Difficulty finding an interested supplier, due to small profit margin for certain low-cost opioids such as IR oral morphine Difficulty identifying Exporter/Supplier with affordable prices, appropriate formulations Challenges in identifying specific formulations and amounts of medicines needed

12. http://www.incb.org/incb/en/guide-on-estimating-requirements.html New Guide published 2012 Joint WHO/INCB effort Purpose to assist Governments in accurately estimating requirements

13. Estimated Requirements vs. Need for Controlled Medicines Estimated Requirements: quantities necessary to provide medical treatment through existing health-care infrastructure Needs: quantities necessary to provide medical treatment for all health problems in country

14. Methods for Estimating Opioid Requirements 1) Consumption–based method 2) Service–based method 3) Morbidity–based method International Narcotics Control Board and World Health Organization. Guide on Estimating Requirements for Substances under International Control. Vienna, Austria: United Nations; 2012. http://www.incb.org/incb/en/guide- on-estimating-requirements.htmlhttp://www.incb.org/incb/en/guide- on-estimating-requirements.html

15. 1) Consumption–based method  Based on use of opioids over recent years  Developed using an average of the amounts consumed in recent years YearMorphine use (kg) 201017 201115 201218 Example: Calculating morphine requirement of country X for 2013 18.4 kg Estimated Morphine Requirement for 2013 Average = 16.7 kg + (10%) 1.67 kg

16. 1) Consumption–based method Appropriate to use when:  reliable data about recent opioid consumption can be collected,  demand for health-care services has reached a relatively steady level,  well-functioning supply management system, and  use of controlled substances is rational Limitations:  Does not provide a basis for improving rational use and accuracy,  stock-outs, losses, and waste may reduce accuracy, and  incomplete data due to poor stock management, inadequate record-keeping or reporting to authorities

17. 2) Service–based method  Calculates requirements for controlled substances based on current levels of use of each substance (for all indications) in a sample of standard healthcare facilities.  Data from standard facilities extrapolated to calculate the requirements for other similar facilities  Targets health services available and takes into account current treatment levels o may reflect financial / administrative constraints in existing healthcare system

18. 2) Service-based method Type of Facility Total number of facilities in country Expected number of patient contacts at all facilities Avg. morphine consumption per 1,000 patient contacts (at standard facility) Total requirement per facility type Regional Cancer Center 590,0005 kg450 kg Nat’l Cancer Center 140,0004.375 kg175 kg Hospice 1050,0006 kg300 kg Total 925 kg Example: Total annual estimated morphine requirement for country x

19. 2) Service–based method Appropriate to use when:  prescribing, administering and dispensing patterns in standard facilities are rational,  pattern of morbidity in standard facilities is representative of the region/country  detailed data on patient morbidity and standard treatment guidelines are not available. Limitations:  may not take into account medical needs of patients that cannot be met due to constraints of existing health system,  inappropriate patterns of prescribing, administering, dispensing in standard facilities will be perpetuated in calculations, and  limitations of healthcare system (frequent stock outs) may make it difficult to select valid standard facilities

20. 3) Morbidity–based method  Based on frequency of diseases and health problems (morbidity) and on accepted treatment norms  Advantage – draws attention to magnitude of the health problem, (i.e., unrelieved pain)  Disadvantage – will likely overestimate the quantities that would actually be consumed

21. Morbidity-based Estimate for Morphine: example standard treatment norm  For Cancer patients: # annual deaths x 80% requiring EOL care with oral morphine x 90 days x 60-75mg per day  For AIDS patients: # annual deaths x 50% requiring EOL care with oral morphine x 90 days x 60-75 mg per day Foley KM, Wagner JL, Joranson DE, Gelband H. Pain control for people with cancer and AIDS. In: Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB et al., eds. Disease Control Priorities in Developing Countries. 2nd ed. New York, NY: Oxford University Press; 2006:981-993. http://files.dcp2.org/pdf/DCP/DCP52.pdfhttp://files.dcp2.org/pdf/DCP/DCP52.pdf

22. 3) Morbidity-based method Sample Facility No. of late-stage cancer patients Total No. of facilities in country Nat’l approx. of late-stage cancer patients for each type of facility 80% of patients who need pain treatment Avg. amount of morphine per pt. for 90-day standard course of treatment Total qty. of morphine consumed by all late-stage cancer patients Nat’l Referral hospital with PC unit 1,0001 8006,075 mg4.86 kg Regional hospital with PC unit 50052,5002,0006,075 mg12.15 kg Hospice with home- based care 300103,0002,4006,075 mg14.58 kg Total 31.59 kg Example: morphine requirement for late-stage cancer pts. in country x

23. 3) Morbidity-based method Sample Facility No. of late-stage cancer patients Total No. of facilities in country Nat’l approx. of late-stage cancer patients for each type of facility 50% of patients who need pain treatment Avg. amount of morphine per pt. for 90-day standard course of treatment Total qty. of morphine consumed by all late-stage HIV/AIDS patients Nat’l Referral hospital with PC unit 1,2001 6006,075 mg3.65 kg Regional hospital with PC unit 80054,0002,0006,075 mg12.15 kg Hospice with home- based care 500105,0002,5006,075 mg15.19 kg Total 30.99 kg Example: morphine requirement for late-stage HIV/AIDS pts. in country x

24. 3) Morbidity-based method Total: late-stage cancer patients 31.59 kg Total: late-stage HIV/AIDS patients 30.99 kg GRAND TOTAL 62.58 kg Example: morphine requirement for late-stage HIV/AIDS and Cancer pts. in country x

25. 3) Morbidity–based method Appropriate to use when:  patterns of data on past use are unavailable or unreliable,  health services are rapidly changing or new,  accurate and complete data on morbidity are available,  standard treatment norms have been developed, and  promoting a change towards more rational prescribing (according to standard treatment norm). Limitations:  Healthcare infrastructure may not have the capacity to treat all morbidity  if standard treatment norms are not followed, calculated requirements will not match their use  For accuracy, need to have complete morbidity data and standard treatment guidelines.

26. Considerations for ensuring accurate Estimates Goal: To ensure that opioids are safely distributed to patients receiving medical treatment and to avoid large unused inventories and diversion: Is there an adequate infrastructure to support the use of medications? Will medicines be appropriately stocked, distributed, prescribed, and dispensed? Are there trained health care professionals willing to prescribe? Are there guidelines for safe handling of controlled medicines?

27. What can countries do to improve their estimates system? Decide on appropriate method to develop Estimated Requirement Implement the method Communication between National Competent Authority and Health Professionals

28. Conclusions Estimates are Single Convention obligation Government responsibility for calculating estimated requirements to submit annually to INCB Supplementary Estimates are possible New Guide from INCB/WHO offers information on responsibilities and 3 suggested methods Important to consider current capacity of healthcare infrastructure

29. Thank you! Martha Maurer mamaurer@uwcarbone.wisc.edu Pain & Policy Studies Group WHO Collaborating Center for Pain Policy and Palliative Care www.painpolicy.wisc.edu

30. Estimates: Questions for Discussion Have the estimates been adequate to satisfy actual needs for pain management? What sources of information are used? Has the method been evaluated? How could the method be strengthened?

31. Guatemala Since 2006, oral morphine had not been available in public hospitals Fellow working to improve distribution of morphine supply from Guatemala City to regional hospitals in rural areas, including training and preparation of paperwork to introduce new supply of oral morphine In early 2009, requested by Government to assist with calculating national estimated requirement for morphine

32. Guatemala Initially, looked at total population that would need oral morphine for pain relief – proposed to increase estimate to cover 50% of those in need WHOCC and IAHPC colleagues cautioned against this approach, advised fellow to consider actual need and safe distribution of morphine first Ultimately considered how many patients were currently being cared for by palliative care units in the country and arrived at a more realistic estimate for morphine