Download JCleary revised CND-INCB-WHO

Directions on
Controlled Substances
from the
UNODC, CND and INCB
Dr Jim Cleary
MD FAChPM
Associate Professor of Medicine
UW School of Medicine & Public Health
Director, Pain & Policy Studies Group
UW Carbone Cancer Center
Madison, Wisconsin. USA
1
2
WHO: Cancer Pain Relief
1986
1996
3
CND 2011: Resolution 54/6
• Promoting adequate availability of
internationally controlled narcotic drugs and
psychotropic substances for medical and
scientific purposes while preventing their
diversion and abuse
4
Commission of Narcotic Drugs
• Recalling its resolution 53/4, 12 March 2010
5
CND Resolution 53/4 (2010):
Promoting adequate availability of
internationally controlled licit drugs for
medical and scientific purposes while
preventing their diversion & abuse
• Stressing the importance of promoting adequate
availability of internationally controlled licit
drugs for medical and scientific purposes while
preventing their diversion and abuse,
6
CND Resolution 53/4
• Recalling the Single Convention on Narcotic Drugs
of 1961 as amended by the 1972 Protocol, in
which the parties recognized that the medical use
of narcotic drugs continued to be indispensable
for the relief of pain and suffering and that
adequate provision must be made to ensure the
availability of narcotic drugs for such purposes,
• Recalling also the Convention on Psychotropic
Substances of 1971 in which it is recognized that
the use of psychotropic substances for medical
and scientific purposes is indispensable and that
their availability for such purposes should not be
unduly restricted,
7
“the medical use of
narcotic drugs
continues to be
indispensable for the
relief of pain and
suffering… adequate
provision must be
made to ensure the
availability of narcotic
drugs for such
purposes.” (Preamble,
p. 13)
8
“the medical use of
narcotic drugs
continues to be
indispensable for the
relief of pain and
suffering… adequate
provision must be
made to ensure the
availability of narcotic
drugs for such
purposes.”
(Preamble, p. 13)
9
CND Resolution 53/4
• Recalling further Economic and Social Council
resolution 2005/25 of 22 July 2005, on
treatment of pain using opioid analgesics,
10
U.N. ECOSOC Resolution 2005/25
“Treatment of pain using opioids”
•
Medical use of narcotic drugs is indispensable
for the relief of pain & suffering
•
Morphine should be available at all times in
adequate amounts and appropriate dosage
forms for the relief of severe pain
•
Low national consumption of opioids is a
matter of great concern
11
U.N. ECOSOC Resolution 2005/25
“Treatment of pain using opioids”
• Impediments include national drug regulations
• Many countries have not
– examined their policies for impediments
– or removed regulatory barriers
• Use the WHO/INCB document “Achieving
Balance in National Opioids Control Policy”
12
Achieving Balance in National Opioids Control Policy:
Guidelines for Assessment (2000)
 For governments
and health
professionals
 Explains need,
rationale and
imperative
 16 criteria
 Simplified Checklist
 22 Languages
13
“Баланс” является фундаментальным
принципом
Национальная политика должна устанавливать систему
контроля за оборотом наркотиков, которая предотвратит
их утечку и обеспечит их достаточное наличие для
медицинских целей
Меры по контролю за оборотом наркотиков не должны
мешать медицинскому использованию опиатов
The central principle of balance:
• a dual obligation of governments to establish a system of
control that ensures the adequate availability of controlled
substances for medical and scientific purposes, while
simultaneously preventing abuse, diversion and trafficking.
Many controlled medicines are essential medicines and are
absolutely necessary for the relief of pain, treatment of illness
and the prevention of premature death. To ensure the rational
use of these medicines, governments should both enable and
empower healthcare professionals to prescribe, dispense and
administer them according to the individual medical needs of
patients, ensuring that a sufficient supply is available to meet
those needs. While misuse of controlled substances poses a
risk to society, the system of control is not intended to be a
barrier to their availability for medical and scientific purposes,
nor interfere in their legitimate medical use for patient care.
CND. Resolution 53/4: Promoting adequate availability of internationally controlled licit drugs
for medical and scientific purposes while preventing their diversion and abuse.
10th Plenary Meeting. 2010.
15
CND Resolution 53/4
• Affirming that the international drug control
conventions seek to achieve a balance between
ensuring the availability of narcotic drugs and
psychotropic substances under international control for
medical and scientific purposes and preventing their
diversion and abuse,
• Reaffirming the important role entrusted to the
International Narcotics Control Board to ensure, in
cooperation with Governments, the availability of
narcotic drugs for medical and scientific purposes and
prevent illicit trafficking in and use of drugs, as set out
in article 9, paragraph 4, of the 1961 Convention as
amended by the 1972 Protocol,
16
CND 53/4
• Concerned that, although there is sufficient supply of licit opiate
raw materials to meet global requirements, as highlighted in the
annual reports of the International Narcotics Control Board for
2008 and 2009 access to opioid-based medications is nonexistent or almost non-existent in many countries and regions,
• Noting the concern expressed by the International Narcotics
Control Board in its annual report for 2009 that some
Governments need to take specific measures to ensure that their
populations have adequate access to opioid-based medications
in line with the international drug control conventions,
• Underscoring the fact that the submission of estimates and
statistical returns by Governments is critical to the actions taken
by the International Narcotics Control Board for the
implementation of treaty provisions regarding the adequate
availability of internationally controlled licit drugs for medical
and scientific purposes,
17
• Acknowledging that an increase in the licit supply of internationally
controlled substances may raise the risk of diversion and abuse of
those substances and that in its annual reports for 2008 and 2009, the
International Narcotics Control Board encouraged Governments to
increase their vigilance regarding trafficking in and abuse of
prescription drugs containing internationally controlled substances
and consider enacting enhanced laws to counter trafficking in such
prescription drugs,
• Noting the medical and scientific needs for internationally controlled
substances worldwide to be met within a regulatory and legal
framework that prevents their diversion and abuse,
• Also noting that the survey of Governments carried out by the
International Narcotics Control Board in 2007 identified concern
about addiction to narcotic drugs to be the primary factor in the
underutilization of essential medicines, followed by the factors of
insufficient training of health-care professionals and the existence of
restrictive laws that did not take into account the need to ensure the
medical availability of narcotic drugs,
18
• Further noting that in the Political Declaration and Plan of Action on
International Cooperation towards an Integrated and Balanced Strategy
to Counter the World Drug Problem, Member States called for
continued cooperation among Member States, the International
Narcotics Control Board and the World Health Organization to ensure
the adequate availability of narcotic drugs and psychotropic
substances under international control, including opiates, for medical
and scientific purposes, while concurrently preventing their diversion
into illicit channels, pursuant to the international drug control
conventions,
• Acknowledging the efforts of the World Health Organization, in
consultation with the International Narcotics Control Board, to
implement activities, under the Access to Controlled Medications
Program, to address impediments to the availability of internationally
controlled substances for medical purposes,
• Noting with appreciation the efforts of the International Narcotics
Control Board and the World Health Organization to develop guidelines
on estimating requirements for internationally controlled substances,
19
CND 53/4: 1-3
1.
2.
3.
Decides that the agenda for the 54th session of the Commission will
include an agenda item on adequate availability of narcotic drugs &
psychotropic substances for medical & scientific purposes in
accordance with the international drug control treaties, in order to
examine the impediments to adequate availability encountered &
efforts to prevent the diversion & abuse of those drugs & substances;
Calls upon Member States to fulfil in a timely manner their reporting
obligations to the International Narcotics Control Board and the
Secretary-General, as appropriate, concerning the use of
internationally controlled substances for medical and scientific
purposes and the diversion of, trafficking in and abuse of those
substances, as required under the international drug control treaties;
Encourages Member States to regularly examine, and report to the
International Narcotics Control Board for inclusion in its annual
report, trends in their countries in the use of internationally
controlled licit substances for medical and scientific purposes, as well
as trends in the diversion of, trafficking in and abuse of those
substances and to take appropriate action, if necessary;
20
CND 53/4: 4
4. Supports recommendation 39 of the International Narcotics Control
Board contained in its annual report for 2009, in which the Board
called on Governments to promote access to and rational use of
narcotic drugs and psychotropic substances, to adopt measures
against unlawful medical practice and to ensure that domestic
distribution channels were adequately controlled, and Board
recommendation, in which the Board requested Governments of
countries in which factors such as knowledge limitations and
administrative barriers stricter than the control measures required
under the Single Convention on Narcotic Drugs of 1961 affected the
availability of opioid analgesics to identify the impediments in their
countries to the access and adequate use of opioid analgesics for
the treatment of pain and to take steps to improve the availability of
those narcotic drugs for medical purposes, in accordance with the
pertinent recommendations of the World Health Organization;
21
CND 53/4; 5 & 6
5. Encourages Member States to include in public awareness
campaigns, as appropriate, the issue of the increased risk of
diversion of narcotic drugs and psychotropic substances and
their abuse, particularly among young people;
6. Also encourages Member States, where necessary, to educate
regulators and health-care professionals, including through
targeted awareness-raising campaigns, to recognize that the
medical use of narcotic drugs continues to be indispensable
for the relief of pain and suffering and that adequate
provision must be made to ensure the availability of narcotic
drugs for such purposes, taking into account the pertinent
recommendations of the World Health Organization and in
line with the international drug control conventions;
22
CND 53/4: 7
• Supports recommendation 22 of the International Narcotics Control
Board contained in its annual report for 2009, in which the Board
encouraged Governments concerned to introduce or expand
programs for monitoring the domestic distribution of prescription
drugs and recommended that in order to reduce the problem of
improper prescription practices, Governments should consider
carrying out program, to be targeted appropriately, to inform
health-care professionals and the general public of the dangers of
misusing prescription drugs containing narcotic drugs and
psychotropic substances; and noted that program for medical
professionals should include information on the risk of diversion,
including secondary access to prescribed medications by family
members and friends of the intended user, appropriate prescription
practices and attempts by individuals to illegally obtain
prescriptions from multiple doctors through fraudulent methods
(“doctor shopping”);
23
CND 53/4: 8 & 9
8.
Invites the International Narcotics Control Board, as in previous
years, to include in its annual report for 2010, to be presented to the
Commission at its fifty- fourth session, information on the
consumption of narcotic drugs and psychotropic substances used for
medical and scientific purposes worldwide, including an analysis of
impediments to their adequate availability and actions to be taken to
overcome those impediments and, when available, specific
information about the status of and progress made by countries;
9. Requests the United Nations Office on Drugs and Crime to continue
its efforts to ensure the adequate availability of internationally
controlled drugs for medical and scientific purposes, cooperating, as
appropriate, through the Access to Controlled Medications Program
of the World Health Organization, while continuing its activities to
prevent diversion and abuse;
24
CND 54/3 Member States
10. Encourages Member States to consider working with the International
Narcotics Control Board and the United Nations Office on Drugs and Crime to
update policies and legislative frameworks, as appropriate, to ensure
adequate availability of internationally controlled substances and to prevent
the diversion and abuse of those substances, in line with the provisions of the
international drug control treaties;
11. Invites Member States to ensure that the International Narcotics Control
Board and the United Nations Office on Drugs and Crime are funded
adequately, as appropriate, to support their activities to ensure adequate
availability of narcotic drugs and psychotropic substances for medical and
scientific purposes, including the development and implementation of
guidelines to assist Governments in estimating their requirements for
internationally controlled substances and to address the risk of the diversion
and abuse of those substances;
12. Also invites Member States to consider ways to leverage existing health and
development programs in countries without adequate availability of narcotic
drugs and psychotropic substances for medical and scientific purposes,
including by building the capacity of those countries through training;
25
13. Recognizes that the Internet can offer
increased access to information about
narcotic drugs and psychotropic substances
and can lead to the diversion of those
substances, and accordingly invites Member
States to consider the implementation of
the International Narcotics Control Board
Guidelines for Governments on Preventing
the Illegal Sale of Internationally Controlled
Substances through the Internet.
26
Commission of Narcotic Drugs
• Recalling its resolution 53/4, 12 March 2010
• Report of the International Narcotics Control
Board on the Availability of Internationally
Controlled Drugs: Ensuring Adequate Access
for Medical and Scientific Purposes
27
28
Preface: Hamid Ghodse
• The international drug control treaties continue to be highly effective in
preventing the diversion of drugs from licit to illicit markets and in
protecting society from the consequences of dependence. However, in
many countries equal attention has not been given to the other
objective of the treaties — ensuring the adequate availability of
controlled substances. Measures taken by Governments to prevent the
abuse of and trafficking in narcotics drugs and psychotropic substances
must not hinder the utilization of such drugs for medical treatment.
Governments need to meet the dual objective of the international drug
control treaties, namely, preventing the diversion and abuse of
internationally controlled substances while ensuring their availability for
legitimate use. This balance should be reflected in national drug control
laws and regulations.
• The first step towards improving access to these essential drugs for
medical and scientific purposes is to identify the impediments, which
are manifold. While economic considerations may play a role with
regard to high-cost medications, low cost preparations do exist, and
examples of countries making use of such preparations demonstrate
that economic impediments can be overcome. Systemic and regulatory
problems may lead to inadequate availability of controlled substances.
29
INCB Action
• 1961: Single Convention
• 1989: Identified with WHO
– “Medical needs for opiates not being fully met”
– Fear of Addiction, poor estimates,
– Lack of resources, poor professional education
• 1994: Effectiveness of Int Drug Control Treaties
– Adequate supply of narcotics: not universally met
• 1995: Availability of Opioids for medical needs
• 1999: Proactive with countries w low estimates
• 2004: Country examples (BR, CA, Fr, USA)
30
Morphine Consumption: 2009
31
Growth in manufacture of opioids: 19892009
32
Europe (low) average consumption of
opioid analgesics, 1997-99 & 2007-09
33
West Asia: average consumption of
opioid analgesics, 1997-99 & 2007-09
34
INCB: Achieving a balance….
92.As affirmed in Commission on Narcotic Drugs resolution 53/4, on
promoting adequate availability of internationally controlled licit drugs
for medical and scientific purposes while preventing their diversion and
abuse, the balance between adequate availability of these drugs and
prevention of their diversion and abuse is at the core of the
international drug control conventions. While in the absence of
indicators of appropriate use it is at present not possible to determine
what appropriate consumption levels would be in individual countries,
let alone at the global level, it is possible to identify consumption levels
that appear to be much too low or disproportionately high.
93.In the case of countries with nil or practically nil consumption levels,
such indicators for adequate levels are not required, as there can be no
doubt as to the inadequacy of availability. The Board considers all levels
of consumption of narcotic drugs below 200 S-DDD per million
inhabitants per day inadequate. However, this does not imply that levels
above 200 S-DDD can be considered adequate as the determination of
whether availability of internationally controlled substances required for
treatment is sufficient depends on the specific morbidity data.
35
Main factors affecting the availability
of opioids for medical needs
36
INCB: Positive Examples
The Board notes with appreciation
that in the past few years, the
Governments of a number of
countries, including Georgia,
Guatemala, Panama, Serbia and
Viet Nam, have introduced policy
reforms aimed at ensuring adequate
access to opioid analgesics. The
Governments of those countries and
others that are in the initial stages of
developing strategies for improving
the availability of opioids should
provide strong support for the
implementation of those strategies.
Mechanisms should be in place for
monitoring the implementation and
the long-term effectiveness of
policies to improve access to opioids.
37
Commission of Narcotic Drugs
• Recalling its resolution 53/4, 12 March 2010
• Report of the International Narcotics Control
Board on the Availability of Internationally
Controlled Drugs: Ensuring Adequate Access
for Medical and Scientific Purposes
• WHO’s Ensuring Balance in National Policies
on Controlled Substances: Guidance for
Availability and Accessibility of Controlled
Medicines
38
“ensuring balance opioids”
http://www.who.int/medicines/areas/quality_s
afety/guide_nocp_sanend/en/
39
Guidelines
1.
2.
3.
4.
5.
6.
7.
Content of drug control legislation & policy
Authorities and their role in the system
Policy planning for availability and accessibility
Healthcare Professionals.
Estimates and statistics.
Procurement
Other
40
Commission of Narcotic Drugs
• Recalling its resolution 53/4, 12 March 2010
• Report of the International Narcotics Control
Board on the Availability of Internationally
Controlled Drugs: Ensuring Adequate Access
for Medical and Scientific Purposes
• WHO’s Ensuring Balance in National Policies
on Controlled Substances: Guidance for
Availability and Accessibility of Controlled
Medicines
41
CND 54/6: 1
• Requests the United Nations Office on Drugs and
Crime, in consultation with the International
Narcotics Control Board and the World Health
Organization, to review and, where necessary, to
update its model laws to ensure that they reflect
an appropriate balance between ensuring
adequate access to internationally controlled
drugs and preventing their diversion and abuse,
in line with the provisions of the international
drug control conventions;
42
54/6: 2
• Also requests the United Nations Office on
Drugs and Crime to develop a technical guide
explaining the revised model laws to support
training and awareness-raising activities for its
personnel in regional and country offices and
to ensure that the model laws are accessible
and readily understood by Member States;
43
54/6: 3
• Further requests the United Nations Office on
Drugs and Crime to conduct, for its personnel
in regional and country offices, training and
awareness-raising activities to promote
adequate availability of internationally
controlled drugs for medical and scientific
purposes while preventing their diversion and
abuse;
44
CND 54/6: 4
• Requests the United Nations Office on Drugs and
Crime and the International Narcotics Control
Board to continue their efforts to ensure the
adequate availability of internationally
controlled drugs for medical and scientific
purposes worldwide, cooperating as appropriate,
through the Access to Controlled Medications
Program of the World Health Organization, while
continuing their activities to prevent diversion
and abuse;
45
Essential Medicines
16th edition (updated)
2010 WHO Model List
2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES (NSAIMs),
MEDICINES USED TO TREAT GOUT AND DISEASE MODIFYING AGENTS IN RHEUMATOID DISORDERS (DMARDs)
2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs)
acetylsalicylic acid Suppository: 50 mg to 150 mg. Tablet: 100 mg to 500 mg.
Ibuprofen
Tablet: 200 mg; 400 mg. >3 months.
paracetamol*
Oral liquid: 125 mg/5 ml. Suppository: 100 mg. Tablet: 100 mg to 500 mg.
* Not recommended for anti‐inflammatory use due to lack of proven benefit to that effect.
2.2 Opioid analgesics
Codeine
Tablet: 15 mg (phosphate); 30 mg (phosphate).
Morphine
Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1‐ml ampoule.
Oral liquid: 10 mg (morphine hydrochloride or morphine sulfate)/5 ml.
Tablet: 10 mg (morphine sulfate).
Tablet (prolonged release): 10 mg; 30 mg; 60 mg (morphine sulfate)
46
47
International Association of Hospice and Palliative Care
List of Essential Medicines for Palliative Care
(http://www.hospicecare.com/resources/pdf-docs/iahpc-list-em.pdf)
 Codeine
 Fentanyl,
 Methadone,
 Morphine (immediate and sustained release),
 Oxycodone,
 Tramadol
NOTE: NO GOVERNMENT SHOULD APPROVE MODIFIED RELEASE MORPHINE, FENTANYL OR OXYCODONE WITHOUT ALSO
GUARANTEEING WIDELY AVAILABLE NORMAL RELEASE ORAL MORPHINE.
48
49
50
CND 54/6: 5
• Encourages the International Narcotics
Control Board to continue its efforts, in
cooperation with the World Health
Organization, to develop guidelines to assist
Member States in estimating their medical
and scientific requirements for internationally
controlled narcotic drugs and psychotropic
substances;
51
52
53
54
55
56
CND 54/6: 6
• Encourages Member States, as appropriate, to
implement the recommendations contained
in the special report of the International
Narcotics Control Board entitled Report of the
International Narcotics Control Board on the
Availability of Internationally Controlled
Drugs: Ensuring Adequate Access for Medical
and Scientific Purposes;
57
CND 54/6: 7
• Also encourages the International Narcotics
Control Board, with the support of Member
States, to continue to provide assistance to
competent national authorities, with the aim
of improving national reporting of statistical
data, the estimation of licit requirements for
narcotic drugs and the voluntary assessment
of licit requirements for psychotropic
substances;
58
CND 54/6: 8
• Reiterates its call upon Member States to fulfil in
a timely manner their reporting obligations to
the International Narcotics Control Board and the
Secretary-General, as appropriate, concerning the
use in their countries of internationally controlled
narcotic drugs and psychotropic substances for
medical and scientific purposes and the diversion
of, trafficking in and abuse of those drugs and
substances, as required under the international
drug control conventions;
59
CND 54/6: 9
• Encourages Member States to report to the
International Narcotics Control Board data on
the consumption of psychotropic substances
for medical and scientific purposes in the
same manner as for narcotic drugs, in order to
enable the Board to analyse levels of
consumption of psychotropic substances in an
accurate manner and to promote their
adequate availability;
60
61
62
63
CND 54/6: 10
• Also encourages Member States to ensure the
involvement and coordinated action of their
relevant bodies and agencies responsible, inter
alia, for health care, justice, drug regulation and
law enforcement, with a view to defining,
updating and achieving, through their respective
national laws, policies and programmes, an
appropriate balance between access to and
availability of internationally controlled drugs for
medical and scientific purposes and the
prevention of their diversion and abuse;
64
CND 54/6: 11
• Invites Member States, the United Nations
Office on Drugs and Crime and relevant
international organizations to facilitate the
provision of technical assistance to
developing countries, in particular developing
countries seeking to improve the availability of
internationally controlled drugs for medical
and scientific purposes while preventing their
diversion and abuse, including, where
appropriate, through support for South-South
cooperation;
65
CND 54/6: 12
• Invites Member States and other donors to
provide extrabudgetary resources for these
purposes in accordance with the rules and
regulations of the United Nations Office on
Drugs and Crime;
66
CND 54/6: 13
• 13. Requests the Executive Director of the
United Nations Office on Drugs and Crime to
report to the Commission, at its fifty-fifth
session, on the implementation of the present
resolution.
67
"We must not only stop the harm caused by drugs: let's
unleash the capacity of drugs to do good.
You think this is a radical idea? Look back to the origins of
drug control. The Preamble of the Single Convention
recognizes that … the medical use of narcotic drugs
continues to be indispensable for the relief of pain…
This is hardly the language of a prohibitionist regime.
Indeed, this noble goal of UN drug policy, the freedom
from physical pain, demonstrates our over-riding
commitment to health."
Antonio Costa, Exec Director,
UN Office on Drugs and Crime (UNODC)
March 2010
68