Transcript EMathai Makingopioids available_vienna_EM

Ensuring Balance in National Policies on
Controlled Substances
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Ensuring Balance in National Policies | August 4, 2016
Inequality in Opioid use
 93.8% of licit morphine consumption by 21.8% of the world
population (INCB 2010, Data for 2009)
 4.7 billion people live in countries where medical opioid
consumption is near to zero (on a total world population of 6.5
billion) (Seya et al. 2011, Data for 2006)
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Patients suffering from pain
(world wide, annually)
Cancer pain patients untreated
HIV pain patients untreated
Lethal injuries
Post-surgery pain
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5.4 million
1 million
0.8 million
8-40 million
Adequacy of Consumption Measure (ACM)
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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Adequacy of Consumption Measure
(ACM)
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≥1
Adequate
0.3 – 1
Moderate
0.1 – 0.3
Low
0.03 – 0.1
Very Low
< 0.03
No consumption
Ensuring Balance in National Policies | August 4, 2016
Adequacy of Consumption of Opioid Analgesics (2007)
Based on: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18
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ACM for countries of interest
ACM (2006)
Tajikistan
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0.0004 (2007)
Required
increase
2500 x
Kyrgyzstan
0.002
500 x
Armenia
0.0045
222 x
Ukraine
0.0145
69 x
Kazakhstan
No data
No data
Ensuring Balance in National Policies | August 4, 2016
ACM for top-7 HDI
ACM (2006)
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Australia
0.86
Norway
0.88
Netherlands
0.51
Ireland
0.51
Canada
2.56
United States
2.47
New Zealand
0.41
Ensuring Balance in National Policies | August 4, 2016
Based on INCB statistics (Country profiles of Morphine Equivalence)
http://www.painpolicy.wisc.edu/opioid-consumption-data
Armenia
mg/cap
ME
ita
mg/capita
0.0045
0.3773
Drug
Fentanyl
Hydromorphone
Methadone
0.8486
Morphine
0.3904
Oxycodone
Pethidine
Total Morphine Equivalence
3.3946
0.3904
4.1622
Drug
mg/capita ME mg/capita
Fentanyl
0.0080
0.6653
ME
Drug
mg/capita
mg/capita Hydromorphone
1.9473
7.7892
Fentanyl
0.0045
0.3744 Methadone
Morphine
0.6418
0.6418
Hydromorphone
Oxycodone
Methadone
Morphine
0.2059
0.2059 Pethidine
Total Morphine Equivalence
9.0964
Oxycodone
Pethidine
Total Morphine Equivalence
0.5803
Tajikistan
Kyrgyzstan
ME
mg/capita
0.0026
0.2148
Drug
Austria
mg/capita
Fentanyl
Hydromorphone
Methadone
3.8112
Morphine
0.1048
Oxycodone
Pethidine
Total Morphine Equivalence
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Ukraine
Kazakhstan
15.2448
0.1048
15.5645
Drug
mg/capita
Fentanyl
2.4817
Hydromorphone
8.9301
Methadone
7.5942
Morphine
122.5037
Oxycodone
6.6721
Pethidine
0.8057
Total Morphine Equivalence
Ensuring Balance in National Policies | August 4, 2016
ME
mg/capita
206.7966
44.6503
30.3769
122.5037
8.8740
0.2014
413.4029
Drug
ME
mg/capita
0.0004
0.0292
mg/capita
Fentanyl
Hydromorphone
Methadone
Morphine
0.0125
Oxycodone
Pethidine
Total Morphine Equivalence
0.0125
0.0417
UN Resolutions
 ECOSOC 2005/25
 World Health Assembly 58.22
 Commission on Narcotic Drugs (2010 and 2011)
Call on the World Health Organization to improve access
WHO Access to Controlled Medications Programme
http://www.who.int/medicines/areas/quality_safety/access_Contr_Med/en/index.html
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Why low access to controlled medicines
 Excessive fear for dependence
 Excessive fear for diversion
 Neglected medical needs
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Categories of Barriers
 Legislation and Policy
 Knowledge
 Attitudes
– Health-Care Professionals
– General Public
 Economic
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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, Armenian
and English
 On-line: free (15 languages)
http://www.who.int/medicines/areas/quality_safet
y/guide_nocp_sanend/en/index.html
 In print: US$ 25.
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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
Public health interests are best served if control measures aim at optimum
between medical availability and abuse prevention
21 Guidelines and Country Check List
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Scope
 All controlled medicines
– Internationally controlled
– Nationally controlled
 Special attention to medicines on
– WHO Model List of Essential Medicines and
– WHO Model List of Essential Medicines for Children
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21 Guidelines
Topics
 Content of drug control legislation and policy (2 GLs)
 Authorities and their role in the system (4 GLs)
 Policy planning for availability and accessibility (4 GLs)
 Healthcare professionals (4 GLs)
 Estimates and statistics (3 GLs)
 Procurement (3 GLs)
 Other (1 GL)
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Who can use the guidelines
 Governments
 Stakeholders interested in identifying status of national policies
and legislation using the assessment tools such as
– Professional associations in health care disciplines
– Patients groups
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Document structure
 Introduction
– Background, how to work with the document etc.
 Guidelines
– Guideline text
– Explanation
– Relevant law
 Country Assessment Checklist
 Annexes, glossary, reference list, CD-ROM
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Guideline 1 (Example - 1)
Guideline 1 National drug control policies should recognize that
controlled medicines are absolutely necessary for medical and
scientific purposes.
Explanation:
- National policies to be explicit
- State as objective/obligation 'access to all in need'
Based on principles laid down in both Conventions
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Assessment question for GL1
Question
Action required?
(pls tick if yes)
Is there a provision in the legislation or in
official national policy documents that
controlled medicines are absolutely necessary
for medical and pharmaceutical care?
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
yes, please list:

no

unknown
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
Highlights - selected guidelines (1)
 GL 2
– Govt should comply with their international legal obligations to
ensure adequate availability and accessibility of controlled medicines
 GL 4
– Govt should ensure that all authorities involved in developing and
implementing policies on controlled substances cooperate and meet
as necessary for the promotion of their availability and accessibility
for medical and scientific purposes as well as the prevention of abuse,
dependence syndrome and diversion.
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Highlights - selected guidelines (2)
 GL 5
– Govt should ensure that there is a forum where drug control
authorities and public health authorities cooperate and meet as
necessary with health professional organizations and other
stakeholders…
 GL 6
– All govt agencies, depending on their roles and obligations, should
ensure that in the fulfillment of their duties, they do not impede
health policies and access to legitimate treatment with controlled
medicines. Health authorities should provide relevant information on
treatment principles to drug law enforcement and other relevant
agencies.
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Highlights - selected guidelines (3)
 GL 9
–
Govt should examine their drug control legislation and policies for the
presence of overly restrictive provisions that affect delivery of appropriate
medical care involving controlled medicines. They should also ensure that
provisions aim at optimizing health outcomes and take corrective action as
needed. Decisions which are ordinarily medical in nature should be taken by
health professionals.
 GL10
–
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Terminology in national drug control legislation and policies should be clear
and unambiguous in order not to confuse the use of controlled medicines for
medical and scientific purposes with misuse
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Non-compliance examples for Guideline 9
 Quantity on prescription limited (Quick expiry of prescription)
Consequence:
 Patients need to go frequently to the doctor and to the pharmacy
 Special prescription forms in duplicate
Consequences:
 Increased administrative burden
 Risk that doctor forgets to bring forms on home visit
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Guideline 11
Appropriately trained and qualified physicians, and, if applicable, nurses
and other health professionals, at all levels of health care should be
allowed to prescribe and administer controlled medicines, based on
their general professional license, current medical knowledge and
good practice without any further license requirements.
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Highlights - selected guidelines (4)
 GL 19
– Govt should minimize the negative impact of control and safety
measures on the affordability and availability of controlled medicines.
 GL 21
– Govt that decide to bring medicines under national control that are
not controlled under the international drug control conventions
should apply these guidelines equally to those nationally controlled
medicines
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Operationalize each guideline
Country Assessment Checklist
 Several questions on each guideline
– Total approx. 67
 Identifying what needs to be done
 Prioritization
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Suggestions for implementing
the Ensuring Balance Guidelines
 Taskforce
– To collect information
– To agree on which action to take
 Subgroups on important topics
– Legal
– Policy
 Systematic approach (including monitoring, evaluation, reassessment)
 Stakeholder involvement
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Operationalize each guideline
Policy cycle approach:
start
Using
Country Assessment Checklist
Assessment and
evaluation
Using
Guidelines
Implementation
Design new/
adjusted policy
Decision making
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Treatment Guidelines for Pain - WHO
 Cancer pain relief – 1986 (revised 1996)
– Pioneering work on pain relief
– First edition translated to 22 languages
 Cancer pain relief and palliative care in children – 1998
– Collaboration with IASP
– Companion to 'Cancer pain relief'
– Includes modalities using medicines and others
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Highlights of these early guidelines
 Concept of
– by mouth, by the clock, by the ladder (3 step), for the individual,
attention to detail
 Strategies to increase availability
But restricted to cancer
Pharmacological management of pain had to be updated
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Progress on the pain guidelines
 New WHO guidance on Guidelines Development issued
–
–
–
–
Evidence assessment steps
Approval by a designated Committee
Transparent development process
Consensus was not enough for a guideline
 The 1990s Guidelines had to be revised
–
–
–
–
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To update based on progress in medical knowledge
To comply with new WHO recommendations
To improve scientific rigor
To include pain due to many different causes
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New WHO Pain Guidelines
WHO Guidelines on the Pharmacological Treatment of Persisting
Pain in Children with Medical Illness (2012)
Developed by
Access to Controlled Medications Programme
WHO Guidelines Review Committee approved
Under development
Pharmacological Treatment of Persisting Pain in Adults
Scoping document GRC approved
Pharmacological Treatment of Acute Pain
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http://www.who.int/medicines/areas/qualit
y_safety/guide_on_pain/en/index.html
Pediatric Pain Guidelines
Package containing:
Guidelines
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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WHO Pediatric Pain Guidelines
Contents
Classification of pain in children
Evaluation of persisting pain in the paediatric population
Pharmacological treatment strategies
Improving access to pain relief in health systems
Annex 1. Pharmacological profiles for selected medicines.
Annex 5. Research agenda
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Recommendations
 20 Clinical recommendations
 4 Health system recommendations
Based on systematic reviews of scientific literature
GRADE method
Recommendations: Strong - Weak
Evidence level: High - Very low
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Basic Principles
 Comprehensive approach
– non-opioid analgesics, opioid analgesics, adjuvants and nonpharmacological strategies
– Addresses all types of pain
 Correct use of analgesic medicines will relieve pain in most
children with persisting pain due to medical illness
 Key concepts:
–
–
–
–
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Two-step strategy
Dosing at regular intervals ("by the clock")
Appropriate route of administration ("by the mouth")
Tailoring to individual child ("by the individual").
Ensuring Balance in National Policies | August 4, 2016
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 not recommended
Pethidine no longer recommended (removed from EML in 1998)
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Opioid analgesics (2)
 Safe and effective medicines
– No mortality risk if right dosage
– No dependence risk in pain patients (reported: 0,04%)
 Training required for
– Pain assessment
– How to increase (max 40-50% ↑/24 hours)
– How to end medication (max 50%↓/24 hours)
 Right dosage is the dose that works
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Conclusion
 National policies and actions (and at different levels of the
systems) to facilitate balance – access and control
– Improve access
– Prevent misuse
 Treatment guidelines to promote correct use when needed
– Educate care givers
– Improve calculations of requirements of specific medicines
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