Improving Access to Controlled
Medicines for Pain Management and
Other Purposes
Technical Briefing Seminar
4 November 2011
Geneva, Switzerland
Willem Scholten,
Team Leader, Access to Controlled Medicines
World Health Organization
International Drug Control Conventions
 Single Convention on Narcotic Drugs (1961)
 United Nations Convention on Psychotropic
Substances (1971)
 United Nations Convention against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances (1988)
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Roles in Drug Control
 Advisory function to the UN system
– Substance evaluation
– Commission on Narcotic Drugs
 Improving access to controlled medicines
– Century of drug control
– Resolutions by WHA, ECOSOC and CND
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Controlled medicines on the WHO EML
– Opioid analgesics:
Morphine
moderate to severe
pain
– Long-acting opioid
agonists: methadone,
buprenorphine
treatment of opioid
dependence
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Improving Access to Controlled Medicines | Geneva 4 November 2011
– Ergometrine and
ephedrine
emergency obstetrics
– Benzodiazepines
anxiolytics, hypnotics,
antiepileptics
– Phenobarbital
antiepileptic
Conventions' Objectives
1961 and 1971 Conventions:
Two goals:
●
Prevention of harm from drug dependence
●
Availability for rational medical use
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Adequacy Consumption of Opioid Analgesics
(2007)
Source: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Adequacy of Consumption Measure (ACM)
≥1
Adequate
0.3 – 1
Moderate
0.1 – 0.3
Low
0.03 – 0.1
Very Low
< 0.03
No consumption
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Improving Access to Controlled Medicines | Geneva 4 November 2011
ACM for countries present at TBS (1)
ACM (2006)
0
∾
∾
Cambodja
0.00022007
5000 x
Cameroon
0 2007
∾
France
0.8187
22%
India
0.0008
1250 x
Jordan
0.0581
17 x
Nigeria
0 2007
∾
Afghanistan
Angola
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Required
increase
0 2007
Improving Access to Controlled Medicines | Geneva 4 November 2011
Annual
need
6,065 kg
5,342 kg
7,500 kg
48,500 kg
ACM for countries present at TBS (2)
ACM (2006)
Required
increase
Pakistan
0.0005
2000 x
Philippines
0.0035
286 x
Portugal
0.3642
2.7 x
0.000052007
20,000 x
Sudan
0.0013
769 x
Switzerland
1.4337
-
United Kingdom
0.5376
86 %
Zambia
0.0001
10,000 x
Sierra Leone
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Improving Access to Controlled Medicines | Geneva 4 November 2011
ACM for top-10 HDI
ACM (2006)
Norway
0.86
Australia
0.88
Netherlands
0.51
United States
2.47
New Zealand
0.41
Canada
2.56
Ireland
0.51
Liechtenstein
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Unknown
Germany
2.07
Sweden
1.06
Improving Access to Controlled Medicines | Geneva 4 November 2011
HDI top-10 for 2011
Adequacy as a function of Development
1.00
log (ACM)
0.00
-1.00
-2.00
-3.00
-4.00
-5.00
0.0
0.1
0.2
0.3
0.4
0.5
HDI
Data for 2006
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Improving Access to Controlled Medicines | Geneva 4 November 2011
0.6
0.7
0.8
0.9
1.0
Patients affected
(global figures, annually)
Cancer pain patients untreated
HIV pain patients untreated
Lethal injuries
Surgery
Preventable HIV infections
Mortality from post-partal haemorrhage
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Improving Access to Controlled Medicines | Geneva 4 November 2011
5.4 million
1 million
0.8 million
8-40 million
130,000
75,000
Adequacy of Consumption Measure
Based on
 Morbidity
 Consumption of all strong opioids except methadone
 Benchmark: average of Top-20 countries in Human Develop
Index
 Method for calculating long term needs  Long term targets for
countries
Seya MJ et al, J Pain and Pall Care Pharmacother, 2011;25:6-18
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Reasons for low access to controlled
medicines
 Excessive fear for dependence
 Excessive fear for diversion
 Neglected medical needs
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Categories of Barriers
 Legislation and Policy
 Knowledge
 Attitudes
– Health-Care Professionals
– General Public
 Economic
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Access to Controlled Medicines
Programme
To assist countries in improving access
through:
 Development of tools (e.g. guidelines and manuals)
 Analysis of policy and legislation
 Country assistance
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Policy Guidelines (1)
Ensuring Balance in National Policies on Controlled Substances,
Guidance for accessibility and availability of controlled medicines
(Geneva 2011)
 15 languages including Russian,
Polish and English
 On-line: free (15 languages)
http://www.who.int/medicines/areas/quality_s
afety/guide_nocp_sanend/en/index.html
 In print: US$ 25.– (English and
French only)
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Policy Guidelines (2)
Based on Principle of Balance:
 Obligation of governments to establish a system of drug control
that
– ensures the adequate availability of controlled substances for
medical and scientific purposes
– while simultaneously preventing abuse, diversion and
trafficking
21 Guidelines and Country Check List
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Improving Access to Controlled Medicines | Geneva 4 November 2011
21 Guidelines
Topics
 Content of drug control legislation and policy (2 recommendations)
 Authorities and their role in the system (4 recommendations)
 Policy planning for availability and accessibility (4 recommendations)
 Healthcare professionals (4 recommendations)
 Estimates and statistics (3 recommendations)
 Procurement (3 recommendations)
 Other (1 recommendation)
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Cancer Pain Guidelines (1)
 Cancer Pain (1st Ed: 1986, 2nd Ed: 1996)
 Cancer Pain and Palliative Care in Children (1998)
 Introduced Three Step Analgesic Ladder
 Systematic approach:
–
–
–
–
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"By the ladder"
"By the clock"
"By the appropriate route"
"By the individual"
Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Cancer Pain Guidelines (2)
 Still actual for the systematic approach:
– "By the clock"
– "By the appropriate route"
– "By the individual"
 Obsolete now for some recommended opioids
– E.g. levorphanol, pethidine
 Three step ladder / Two step approach?
 Not evidence-based / no transparency
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Development of WHO Pain Guidelines
 To cover all various types of pain
 Developed by the Access to Controlled Medications Programme
 "Quality control" by WHO Guidelines Review Committee
 WHO "Guidelines for Guidelines" impose rigour:
–
–
–
–
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Methodology
Evidence
Transparency
Quality control
Improving Access to Controlled Medicines | Geneva 4 November 2011
New WHO Pain Guidelines
1. WHO Guidelines on the Pharmacological Treatment of Persisting
Pain in Children with Medical Illness
– Publication expected by early 2012
2. Pharmacological Treatment of Persisting Pain in Adults
– Starting December 2011
3. Pharmacological Treatment of Acute Pain
– Currently finalizing the Scoping Document
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Basic Principles
Principles from the pediatric persisting pain guidelines:
 Comprehensive approach
– non-opioid analgesics, opioid analgesics, adjuvants and nonpharmacological strategies
 Correct use of analgesic medicines will relieve pain in most
children with persisting pain due to medical illness
 Key concepts:
–
–
–
–
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using a two-step strategy
dosing at regular intervals ("by the clock")
using the appropriate route of administration ("by the mouth")
tailoring treatment to the individual child ("by the individual").
Improving Access to Controlled Medicines | Geneva 4 November 2011
Selected Recommendations
 Two Step Approach according to the child's level of pain
severity.
 First step: paracetamol or ibuprofen (mild pain)
– both to be made available
 Second step: morphine (moderate to severe pain)
 Codeine is no longer recommended
 Tramadol also not recommended
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Furthermore…
 All moderate and severe pain in children should always
be addressed.
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Call for Research (1)
Identified Research Gaps
 Clinical studies needed on paracetamol, NSAIDs and
opioid analgesics
– 8 research topics
 Clinical studies needed on adjuvant medicines for
neuropathic pain
 Pharmacokinetics
 Pain assessment tools
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Improving Access to Controlled Medicines | Geneva 4 November 2011
WHO Call for Research (2)
Barbara Milani, Nicola Magrini, Andy Gray, Phil Wiffen
and Willem Scholten
WHO Calls for Targeted Research on the
Pharmacological Treatment of Persisting Pain in
children with Medical Illnesses
Evid.-Based Child Health 6: 1017- 1020 (2011)
www.evidence-basedchildhealth.com
DOI: 10.1002/(ebch.777)
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Publication of Ped Pain Guidelines
Package containing:
–
–
–
–
–
–
–
Guidelines book
Brochure "Important information for physicians and nurses"
Brochure "Important information for pharmacists"
Brochure "Important information for policy makers"
Dosing card (pocket size)
2 Ped. pain assessment scales
Wall chart (waiting room)
 English version in print (US$ 25) and on-line (free)
 Translations subject to availability of funding and to national
initiatives
– Licences for national languages: [email protected]
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Improving Access to Controlled Medicines | Geneva 4 November 2011
Improving Access to Controlled
Medicines for Pain Management
and Other Purposes
Willem Scholten, PharmD, MPA
Team Leader, Access to Controlled Medicines
Essential Medicines and Pharmaceutical Policies
World Health Organization
Geneva, Switzerland
[email protected]
+41 22 79 15540
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No access to controlled medicines: who does not suffer