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
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.
How are estimated requirements
established for a country?
• 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
Who is responsible?
IV. TABLE 1. COMPETENT NATIONAL AUTHORITIES
ALBANIA
KYRGYZSTAN
Ministry of Health
Department of Pharmacy
Tirana
Albania
State Service on Drugs Control of the
Kyrgyz Republic
80 Toktogula Street
Bishkek 720021
The Kyrgyz Republic
Phone: 355 - 42 - 34636
FAX: 355 - 42 - 28303
Phone: 996 - 312 - 662217
Fax:
996 - 312 - 625143
Web: www.gskn.kg
BANGLADESH
SRI LANKA
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
Medical Supplies Division
357, Deans Road
Colombo 10
Sri Lanka
Phone: 880 - 2 - 831 2131
Fax:
880 - 2 - 831 1155
E-mail: dgdnc@bttb.net.bd
Phone: 94 - 1 - 694 - 111
Fax:
94 - 1 - 697 - 096
INDIA
UKRAINE
Central Bureau of Narcotics
Ministry of Finace
19, The Mall
Morar
Gwalior 474006
Madhya Pradesh
India
State Service on Drugs Contol
Prospect Chervonozoryanyi 51
03680 Kiev
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: narcom@sancharnet.in
Phone: 380 - 44 - 275 - 6814
Fax:
380 - 44 - 275 - 4287
E-mail: info@narko.gov.ua
Web: www.narko.gov.ua
Published Estimates for 2012
http://www.incb.org/incb/narcotic_drugs_estimates.html
Estimated Requirements - Morphine, 2012
Country
Albania
Bangladesh
India
Kyrgyzstan
Sri Lanka
Ukraine
Est. in grams*
3,500
100,000
9,743,726
3,500
16,000
62,840
Source: * INCB Estimated World Requirements for 2012 report (June 2012 update)
** CIA World Factbook (July 2011 estimates)
Population**
3,002,859
161,083,804
1,205,073,612
5,496,737
21,481,334
44,854,065
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/guideon-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
Example: Calculating morphine requirement of country X for 2013
Year
Morphine use (kg)
2010
17
2011
15
2012
18
Average = 16.7 kg
+ (10%) 1.67 kg
18.4 kg
Estimated Morphine
Requirement for 2013
1) Consumption–based method
Appropriate to use when:
Limitations:
 reliable data about recent
opioid consumption can be
collected,
 Does not provide a basis
for improving rational use
and accuracy,
 demand for health-care
services has reached a
relatively steady level,
 stock-outs, losses, and
waste may reduce
accuracy, and
 well-functioning supply
management system, and
 incomplete data due to
poor stock management,
inadequate record-keeping
or reporting to authorities
 use of controlled
substances is rational
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
Example: Total annual estimated morphine requirement for country x
Type of
Facility
Total
number of
facilities in
country
Expected
number of
patient contacts
at all facilities
Avg.
morphine
consumption
Regional
Cancer Center
5
90,000
5 kg
450 kg
Nat’l Cancer
Center
1
40,000
4.375 kg
175 kg
10
50,000
6 kg
300 kg
Hospice
Total
per 1,000 patient
contacts (at
standard facility)
Total
requirement
per facility
type
925 kg
2) Service–based method
Appropriate to use when:
Limitations:
 prescribing, administering
and dispensing patterns in
standard facilities are rational,
 may not take into account
medical needs of patients
that cannot be met due to
constraints of existing health
system,
 pattern of morbidity in
standard facilities is
representative of the
region/country
 detailed data on patient
morbidity and standard
treatment guidelines are not
available.
 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
Example: morphine requirement for late-stage cancer pts. in country x
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 homebased care
300
10
3,000
2,400
6,075 mg
14.58 kg
Sample
Facility
Total
31.59 kg
3) Morbidity-based method
Example: morphine requirement for late-stage HIV/AIDS pts. in country x
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 homebased care
500
10
5,000
2,500
6,075 mg
15.19 kg
Sample
Facility
Total
30.99 kg
3) Morbidity-based method
Example:
morphine requirement for late-stage HIV/AIDS and Cancer pts. in country x
Total: late-stage
cancer patients
31.59 kg
Total: late-stage
HIV/AIDS patients
30.99 kg
GRAND TOTAL
62.58 kg
3) Morbidity–based method
Appropriate to use when:
Limitations:
 patterns of data on past use
are unavailable or unreliable,
 Healthcare infrastructure
may not have the capacity
to treat all morbidity
 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).
 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 Maurer
mamaurer@uwcarbone.wisc.edu
Pain & Policy Studies Group
WHO 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