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The Estimation of National Opioid Requirements: New INCB/WHO Guidelines
International Pain Policy Fellowship
Training SessionMadison, Wisconsin, USA
8 August 2012
Martha A. MaurerPain & Policy Studies Group
University of Wisconsin Carbone Cancer CenterWHO Collaborating Center for Pain Policy and Palliative Care
The Single Convention establishes two mechanisms:
(1) The estimates system for narcotic drug requirements, and
(2) The statistical returns system for narcotic drugs
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.
• 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 30th 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?
ALBANIA Ministry of Health Department of Pharmacy Tirana Albania Phone: 355 - 42 - 34636 FAX: 355 - 42 - 28303
KYRGYZSTAN State Service on Drugs Control of the Kyrgyz Republic 80 Toktogula Street Bishkek 720021 The Kyrgyz Republic Phone: 996 - 312 - 662217 Fax: 996 - 312 - 625143 Web: www.gskn.kg
BANGLADESH Department of Narcotics Control (DNC) Ministry of Home Affairs Wage Earners Hostel Complex (Level – 8) 71-72, Old Elephant Road (Eskaton Garden), Ramna Dhaka 1000, Bangladesh Phone: 880 - 2 - 831 2131 Fax: 880 - 2 - 831 1155 E-mail: [email protected]
SRI LANKA Medical Supplies Division 357, Deans Road Colombo 10 Sri Lanka Phone: 94 - 1 - 694 - 111 Fax: 94 - 1 - 697 - 096
INDIA Central Bureau of Narcotics Ministry of Finace 19, The Mall Morar Gwalior 474006 Madhya Pradesh India Phone: 91 - 751 236 8996 Phone: 91 - 751 236 8997 Phone: 91 - 751 236 8121 Fax: 91 - 751 236 8111 Fax: 91 - 751 236 8577 Email: [email protected]
UKRAINE State Service on Drugs Contol Prospect Chervonozoryanyi 51 03680 Kiev Phone: 380 - 44 - 275 - 6814 Fax: 380 - 44 - 275 - 4287 E-mail: [email protected] Web: www.narko.gov.ua
IV. TABLE 1. COMPETENT NATIONAL AUTHORITIES
Who is responsible?
Published Estimates for 2012http://www.incb.org/incb/narcotic_drugs_estimates.html
Estimated Requirements - Morphine, 2012
Country Est. in grams* Population**
Albania 3,500 3,002,859
Bangladesh 100,000 161,083,804
India 9,743,726 1,205,073,612
Kyrgyzstan 3,500 5,496,737
Sri Lanka 16,000 21,481,334
Ukraine 62,840 44,854,065
Source: * INCB Estimated World Requirements for 2012 report (June 2012 update)
** CIA World Factbook (July 2011 estimates)
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
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
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)
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
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
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
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.html
1) Consumption–based method
Based on use of opioids over recent years
Developed using an average of the amounts consumed in recent years
Year Morphine use (kg)
2010 17
2011 15
2012 18
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
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
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
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
5 90,000 5 kg 450 kg
Nat’l Cancer Center
1 40,000 4.375 kg 175 kg
Hospice 10 50,000 6 kg 300 kg
Total 925 kg
Example: Total annual estimated morphine requirement for country x
2) Service–based methodAppropriate 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
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
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.pdf
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
1,000 1 1,000 800 6,075 mg 4.86 kg
Regional hospital with PC unit
500 5 2,500 2,000 6,075 mg 12.15 kg
Hospice with home-based care
300 10 3,000 2,400 6,075 mg 14.58 kg
Total 31.59 kg
Example: morphine requirement for late-stage cancer pts. in country x
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
1,200 1 1,200 600 6,075 mg 3.65 kg
Regional hospital with PC unit
800 5 4,000 2,000 6,075 mg 12.15 kg
Hospice with home-based care
500 10 5,000 2,500 6,075 mg 15.19 kg
Total 30.99 kg
Example: morphine requirement for late-stage HIV/AIDS pts. in country x
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
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.
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?
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
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
Thank you!
Martha [email protected]
Pain & Policy Studies GroupWHO Collaborating Center for Pain Policy and Palliative Care
www.painpolicy.wisc.edu
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?
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
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