Gilberto Gerra

Drug Prevention and Health Branch

Access to controlled drugsfor medical purposes:

a commitment for the international community

The Single Convention recognizes the medical use of narcoticdrugs as indispensable for the relief of pain and suffering

and that adequate provision must be made to ensure the availability of narcotic drugs for this purpose.

1961 Single Convention, as amended by the 1972 Protocol

INCB WHOUNODC

International drug control system

National drug control system

Resolution 53/4 and Resolution 54/6 of the

Commission on Narcotic Drugs

Promote adequate availability of internationally controlled drugsfor medical and scientific purposes,

while preventing their diversion and abuse

Access to controlled medications not existent

or almost not existent in many countries

2010

Protecting the health of people from the dangerous effects of drugs

is not in conflict withpromoting

the medical and scientific useof controlled drugs

The risk of a double failure

Medical purpose:indispensable

Non-medical purpose:not permitted

Morphine FentanylPentazocine

Pain treatment

Anaesthesia

Myocardial infarctionacute treatment

Narcolepsy

ADHD

Cocaine addiction(promising)

ADHD Appetite controlin obese patients

Clozapine

Olanzapine

4-Bromo-2,5-dimethoxy-1- benzylpiperazine(2C-B-BZP)

1-Benzylpiperazine (BZP)

2,3-Dichlorophenylpiperazine (DCPP)

4-Chlorophenylpiperazine(pCPP)

Sold as ecstasy Stimulant / hallucinogenic effects

Piperazines

Modern anti-psychotic drugs

Subst Abuse. 1989;1(4):431-51.A review of the history, actions, and legitimate uses of cocaine.Brain PF, Coward GA

Cocaine

Local anaesthetic

Reducing bleeding

Surgery of ear, nose and throat

Ketamine:used for animalsin high income countries

used for humansin low income countries

A dissociative anaesthetic NMDA antagonist (glutamate antagonist)

Pain relief recognized as part of the human right to thehighest attainable standards of mental and physical health

Opioid medications essential for treatment of moderate to severe pain

Helplessness and hopelessness

Pain affects quality of life

Access imbalance for the world’s population

5.5 billion (83%): low or non-existent access

250 million (4%): moderate access

460 million (7%): adequate access

430 million (6%): insufficient data

WHO, 2011

Every year:

5.5 million terminal cancer pain

1.0 million HIV/AIDS end-stage

800.000 lethal injuries accidents and violence

110 million women labour

Surgery (80% insufficient anaesthesia)

WHO, 2011

• Global annual

consumption

of morphine

equivalent

61.66 mg per

person

• fentanyl, • hydromorphone, • morphine • oxycodone Source: • pethidine INCB 2011 and Pain and Policy Studies Group

Disparity in the global consumption or access to pain medication

• High income countries: • 812 - 749 ME/mg/cap

• Low income countries:• 0.014 - 0.015 ME/mg/cap

• High income countries 17 % of population account 92% of medical morphine

Canad

a

United S

tates

Austral

ia

Switzerla

nd

New Zea

land

Irelan

d

United K

ingdo

m

Mauritiu

s

Finland

Israe

l

Slovaki

a

Czech R

epub

lic

Bulgari

a

Estonia

South

Africa

Georgi

aChile

Argentin

a

Costa R

ica

Urugua

yBraz

il

Tunisia

Kazakhs

tanBoliv

ia

Afghan

istan

Pakista

nNige

ria0.00

1.00

2.00

3.00

4.00

5.00

6.00

1.00

5.20

3.10

1.00 1.040.60

0.10

2.60

0.10 0.27 0.40 0.55

1.50

3.60

Annual prevalence of misuse of prescription opioids (%)

Canad

a

United S

tates

Austral

ia

Switzerla

nd

New Zea

land

Irelan

d

United K

ingdo

m

Mauritiu

s

Finland

Israe

l

Slovaki

a

Czech R

epub

lic

Bulgari

a

Estonia

South

Africa

Georgi

aChile

Argentin

a

Costa R

ica

Urugua

yBraz

il

Tunisia

Kazakhs

tanBoliv

ia

Afghan

istan

Pakista

nNige

ria0

100

200

300

400

500

600

700

800

900 812.

749.8

362.7

159.782.9 68.8 30.5

0.39 0.018 0.014

Per capita consumption of opioid painkillers (ME mg/cap)

• Government import-export authorization• Provision to the INCB annually of estimates of medical and scientific needs for narcotic drugs• Record-keeping by governmental authorities and persons engaged in manufacture, trade and distribution, and conduct of inspections by government• Requirement of medical prescriptions for supply or dispensation to individuals• Prohibition of advertising to the general public with due regard to constitutional provisions• Requirement of adequate labelling• Requirements for commercial documents• Prohibition of export to post office box• Establishment of penal provisions for contraventions of the above requirements

Provisions of the Conventions

• Limitations on the number of days” supply that may be provided in a single prescription;• Limitations on doses that may be prescribed in a single prescription;• Excessive limitations on prescription authority, such as only to some categories of medical doctors;• Special prescription procedures for opioids, for example, the use of specific prescription forms, which may be difficult to obtain, and/or a requirement that multiple copies of the prescription be maintained;• Requirements that patients receive special permission or registration to render them eligible to receive opioid prescriptions;• Excessive penalties and prosecutions for unintentional mis-prescription or mishandling of opioids;• Arbitrary restrictions on the number of pharmacies permitted to dispense opioid medications;• Unreasonable requirements relating to the storage of opioid medications.

Unnecessary barriers

Department of Essential Medicines and Health Products

Drug Prevention and Health Branch

WHO

Union for International Cancer Control

GLO-K67

To remove the barriers

Financial (cost of medications/distribution)

Legal (national legislation overruling)

Logistic (distribution/storage modality)

Cultural (mentality attitude)

Professionals qualification (ignorance)

Prepare a new generation of:

Health professionals

Policy makers

Law makers

Family to family programs:

Public opinion mentality

To avoid diversion and abuse

appropriate rules in line with the Conventions

systematic monitoring

case by case management

interpersonal relationship patient/doctor:therapeutic alliance

Electronic monitoring system

Registration of prescribers

Protection of confidentiality (code/not name)

Easy access for prescribers

Technology to connect the entire health system

Pharmacies system engaged

Screening corruption cases

providing drugs together with interpersonal relationships, compassion and support

The fear to create dependence (!)

Drug dependence / addiction is not related to the drug effects only

Psychobiological vulnerability

Complex series of risk factors not affecting patients with pain

complex questions about pain, suffering and mankind condition

full respect for individuals attitude, culture, religion and concrete needs

UNODC Program GLO-K67

UNODC / WHO/ UICC 2013-2014

Pilot project in Ghana

Activities:Training for policy makersTraining for health professionalsRevision of national legislation

Help Member States to improve availability of and accessibility to controlled drugs formedical purposes

Help Member States to control diversion misuse and abuse

AustraliasupportingUNODC Global Program onAccess to Pain Medications(GLO-K67) for 2 years

The suffering of any human being is my suffering…