Transcript Dronabinol (INN) - syn.Δ-9-THC

Access to Controlled
Medicines
Technical Briefing Seminar
2 November 2010
Geneva, Switzerland
Willem Scholten, Team Leader,
Access to Controlled Medicines,
Department of Essential Medicines
and Pharmaceutical Policies
Overview of the presentation
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Introduction
Background
Barriers for Access
Pain treatment
Treatment of Dependence and
Prevention of HIV Transmission
How to improve access to
controlled medicines?
Introduction
Controlled medicines on
the WHO EML
– Opioid analgesics:
Morphine
moderate to severe pain
– Long-acting opioid
agonists: methadone,
buprenorphine
treatment of opioid
dependence
– Ergometrine and
ephedrine
emergency obstetrics
– Benzodiazepines
anxiolytics, hypnotics,
antiepileptics
– Phenobarbital
antiepileptic
Morphine consumption per capita
Graphic: New York Times
Patients affected
(global figures, annually)
Cancer pain patients untreated
HIV pain patients untreated
Lethal injuries
Surgery
Preventable HIV infections
Mortality from post-partal haemorrhage
5.4 million
1 million
0.8 million
8-40 million
130,000
75,000
Background
International Drug Control
Conventions
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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)
Conventions' Objectives
1961 and 1971 Conventions:
Two goals:
1.
Prevention of harm from drug dependence
2.
Availability for rational medical use
Public health interests are best served if all
control measures aim at the optimum
between medical availability and prevention
of abuse
Reasons for low access to
controlled medicines
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Excessive fear for dependence
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Excessive fear for diversion
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Neglected medical needs
Barriers for Access
Policy and Legislation I
Examples:
Prescribing limitations
–
–
–
Who can prescribe
Dosage and duration
Disease (e.g. cancer only)
Dispensing limitations
–
–
Hospital pharmacy only
Police offices only
Policy and Legislation II
Examples:
Functioning of the estimates system
Non-medical authorities taking medical
decisions
Exclusion of certain patient groups from
pain treatment, e.g. people who were
dependent on drugs
Knowledge
Examples:
Dosage regimen
- how to start?
- how to titrate?
- how to stop?
- recognizing overdosage
- treatment of overdosage
Pseudo-dependence
Prescription formalities
Attitudes
Examples:
Thinking that opioid analgesia …
leads to dependence
leads to death (contrary was shown recently)
Family or nurses not allowing patient to take
medicines
Pain Treatment
Opioid analgesics
Used for all moderate to severe pain due to:
• Cancer
• Traffic and other
accidents
• AIDS/HIV
• Myocardial infarction
• Chronic pain
– Some exceptions • Sickle cell anaemia
• Surgery
Three Step Ladder
WHO Three step ladder on cancer pain (1986)
1.
Non-opioid + adjuvant e.g. paracetamol
If pain persisting/increasing:
2.
Weak acting opioid (e.g. codeine, tramadol)
If pain persisting/increasing:
3.
Strong acting opioid (e.g. morphine, methadone)
Increase dosage until freedom from pain
There is no maximum dose: the right dose
is the dose that works
Adequacy of opioid consumption
(x million people)*
AFRO
AMRO
EMRO
EURO
SEARO
WPRO
World
Adequate
0
335
0
129
0
0
464
Moderate
0
0
0
228
0
25
252
Low
0
0
0
127
0
128
255
Very low
1
206
77
94
0
79
457
No cons.
503
304
400
283
172
151
4718
No data
Total
270
774
49
895
64
540
26
887
2
1721
22
1763
433
6580
* People living in countries where opioid consumption is …
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
0.6
0.7
0.8
0.9
1.0
ACM for selected countries for
2006
Adequate
cons in kg
Top-20 HDI
ACM
Adequate
cons in kg
ACM
1
(by definition)
Afghanistan
5 169
Austria
1 373
No data Nepal
1.99 Pakistan
0.059 Sierra Leone
4 466
0.0017
21 692
0.0005
1 668
No data
Brasil
34 522
China
245 892
0.0110 Sudan
8 020
0.001
Ethiopia
19 962
0.0001 Uganda
12 726
0.0019
Germany
15 039
2 923
0.0012
Kenya
17 835
2.08 Yemen
0.004
Seya MJ et al., J of Pain and Palliative Care
Pharmacotherapy, March 2011 (accepted)
ACM for selected countries
(SADC) for 2006
Adequate
cons in kg
ACM
Angola
6 104
Botswana
1 747
0.004 Seychelles
Dem Rep
Congo
1 399
0.0002 South Africa
Lesotho
2 316
No data Swaziland
Malawi
8 858
Mauritius
Mozambique
132
14 654
0.0000 Namibia
Adequate
cons in kg
ACM
1 692
0.002
14
0.037
34 367
0.008
228
No data
0.0000 Tanzania
18 509
No data
0.058 Zambia
9 342
0.001
16 120
No data
0.0004 Zimbabwe
Seya MJ et al., J of Pain and Palliative Care
Pharmacotherapy, March 2011 (accepted)
Treatment of Dependence
and
Prevention of HIV Transmission
Long-Acting Opioid
Agonist Therapy
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Methadone Maintenance Therapy (MMT)
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Supervised administration of Methadone oral
solution
Dosage level high enough to stop heroin use
Continuously
Other modalities (e.g. buprenorphine: BMT)
Long-Acting Opioid
Agonist Therapy
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To treat opioid dependence (which is a
disease)
Methadone/buprenorphine less reinforcing
then heroin
Normalization of body responses and social
life
Interruption of transmission of
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HIV
Hepatitis C Virus (HCV)
Other blood borne disease
How to improve access to
controlled medicines?
Access to Controlled Medications
Programme
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Response to
Resolutions ECOSOC
2005/25 and WHA
58.22
WHO Programme to
improve access to
controlled medicines
Launched in 2007 by
WHO and the INCB
Access to Controlled
Medications Programme
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Addresses all medicines controlled under the
international drug conventions
Essential Medicines in particular
Problems and solutions for various medicines
supposed to be very similar, giving opportunities
–
for finding allies
–
to prevent duplication of work
ACMP Priority Countries
AFRO: Cameroon, Ethiopia, Ghana, Ivory Coast, Kenya,
Malawi, Nigeria, Rwanda, Senegal, Sierra Leone,
Tanzania and Zambia
EMRO: Egypt, Iran, Morocco, Oman, Pakistan and Sudan
EURO: Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus,
Czech Republic, Estonia, Finland, Greece, Hungary,
Italy, Latvia, Lithuania, Malta, Poland, Romania, Serbia,
Slovenia, Slovakia and Turkey
AMRO: Argentina, Colombia and Panama
SEARO: Indonesia, Bangladesh and India
WPRO: Vietnam, China and the Philippines
ACMP Activities
Normative work
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Guidelines
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Technical standards
etcetera
Country support
Normative work
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Pain treatment guidelines – next slide
Policy guidelines "Ensuring Balance in
Opioid Control Policies" (2011)
WHO/INCB Manual for estimates
Model legislation
Guidelines treatment opioid dependence
(Dept of MSD; 2009)
Pain Treatment Guidelines
WHO Treatment Guidelines on
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Persisting Pain in Children with Medical
Illness (early 2011)
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Chronic Pain in Adults
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Acute Pain
Persisting Pain in Children
with Medical Illness
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Transparent, evidence based
Guidelines Development Group meeting
(March 2010)
Currently under review (worldwide)
Publication main document (as pdf):
Spring 2010
Persisting Pain in Children
with Medical Illness
All moderate to severe pain in children
needs addressing
Two step pain treatment
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Codeine – obsolete
Tramadol – insufficient safety data
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Steps:
1.
2.
Non- opioids (paracetamol, NSAIDS)
Strong opioids (oral morphine etc)
Country support
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Situational analysis and drafting a plan
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E.g. review of legislation and policies
Introduction of balanced policy
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optimum for accessibility for medical use and prevention of
dependence and abuse
Model plan drafted with involvement of MoH
Ghana, APCA and health care workers
can easily be adapted to local needs elsewhere
Country support
• Update of national essential medicines list
• Oral morphine
• Oral methadone
• Update of National Medicines Policy Plan
• Training of civil servants
• Estimates/statistics
• Support to health education institutions
Access to Controlled
Medicines
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