International drug control process

•Apply measures of international control to substances listed in their schedules

•Encourage countries that are party to the Conventions to protect public health and welfare

•Mandate WHO with the responsibility of reviewing and assessing substances to determine whether they should be controlled under the Conventions

• Assess risks of abuse, dependence and harm to health

• Where it is relevant, the ECDD also consider whether the substance isfor medical or scientific use.

• WHO Mandate reinforced by UNGASS & CND Resolutions e.g. 61/8

1961 Single Convention on

Narcotic Drugs

*as amended by the 1972

protocol

1971 Convention on

Psychotropic Substances

International drug control process

Evidence of use and harm

Review by WHO Expert Committee on Drug Dependence

Commission on Narcotic Drugs (Vienna)

Mandatory national controls and monitoring

(overseen by International Narcotics Control Board)

3.5 Strengthen the prevention and treatment of substance abuse, including

narcotic drugs and harmful use of alcohol

3.3 Ending the AIDS epidemic and combating hepatitis,

3.4 Prevention and treatment of noncommunicable diseases and

promotion of mental health

3.8 Universal health coverage

3.b Access to essential medicines.

World Health Assembly Resolutions Promoting access to controlled medicines

2014 WHA67.19: Strengthening of palliative care as a component of comprehensivecare throughout the life course: improving access to controlled medicines for pain andpalliative care, including for children

2014: WHA 67.22 on Access to Essential Medicines

2015 WHA68.15: Strengthening emergency and essential surgical care and anaesthesia as a component of universal health coverage: improving access to essential medicines for anesthesia and essential surgery

2015 WHA68.20: Global burden of epilepsy and the need for coordinated action at the country level to address its health, social and public knowledge implications

Mean availability of opioids for pain management (2001-03)

Mean availability of opioids for pain management (2011-13)

Source: INCB and Berterame et al. 2016

<10% of facilities in the AFRO Regionhave access to morphine injection

Source: EMP MedMon Capital Cities 2016-2017

AFRO Max

(Morphine)

PAHO Max (Morphine)

Achieving access to medicines

R&D and innovation

Manufacturing

Marketing registration

Selection, pricing and reimbursement

Procurement and supply

Prescribing

Dispensing

Use

Legislation, regulation, governance, monitoring

PHARMACY

Barriers to relevant access to controlled medicines

Insufficient knowledge & training on efficacy and safety profiles: inappropriate use or no use;

Behaviours

• Fear for abuse and dependence

• Fear for diversion and sanctions

Inaccurate quantification of needs: shortages, diversion & waste

Regulations

• Limited prescription duration; special prescription forms

• Limitation of dispensing outlets; limitation of prescribing

• Restrictions on exports and imports- special licences needed

Controlled medicines in the WHO Model Essential Medicines List

• Ergometrine and ephedrine:

emergency obstetrics

•Benzodiazepines:

anxiolytics, hypnotics,

antiepileptics

• Phenobarbital:

Antiepileptic

• Opioid analgesics: morphine; codeine; fentanyl moderate and severe pain

• Long-acting opioid agonists:

methadone, buprenorphine

treatment of opioid dependence

WHO EML 2017, 2015

2017 BANGLADESH NEML

2016 BHUT AN NEML

2012 DPRK NEML

2015 INDIA NEML

2013 INDO NESIA NEML

2017 MALD IVES

NEML

2016 MYANMAR

NEML

2015 NEPAL NEML

2014 SRI LANKA

NEML

2017 THAI LAND NEML

2015 TIMOR LESTE NEML

Palliative care (n=15)

Non-opioid analgesic

ibuprofen ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

paracetamol ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Opioid analgesiccodeine ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

morphine ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Medicine for other common

symptoms in palliative care

cyclizine ✔

dexamethasone✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

docusate sodium✔ ✔

haloperidol ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

hyoscine hydrobromide

✔

lactulose ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

loperamide ✔ ✔ ✔ ✔ ✔

metoclopramide✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

midazolam ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

ondansetron ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

senna ✔ ✔ ✔ ✔

*also listed in palliative care section; ✔ = API included in list; = API not included in list; = API not included but alternative within same pharm class included.

• WHO guidelines for the management of cancer

pain in adults and adolescents (2019)

• WHO guidelines for the Psychosocially Assisted

Pharmacological Treatment of Opioid Dependence

• WHO guidelines for community management of

opioid overdose (2014)

WHO Therapeutic Guidelines

Guidance on medicines prices, affordabilityand supply

WHO guidelines on country pharmaceutical pricing policies

Estimating requirements within countries developed with INCB;

WHO Guidelines for medicines procurement

Model Quality Assurance System for procurement agencies

Expert Committee on Drug Dependencedecisions and medical availability: ketamine and tramadol

For the medicines ketamine and tramadol, in line with the

Conventions, ECDD has considered both harms (including abuse

and dependence) and the importance of their medical use. This

resulted in decisions not to recommend scheduling at this time.

• ketamine: a unique anaesthetic that is the only option for surgery

in many situations in low income countries

• tramadol: an opioid that is the only option for relief of moderate

and severe pain in many low income countries and is widely used

in disasters and emergencies

WHO - UNODC Joint Global Programme in Timor Leste

Set up of a Coordination Committee lead by the Directorate of Pharmacy

Capacity building: training of health professionals targeting mainly medical

doctors in primary care health centres

Technical assistance to the Directorate of Pharmacy focusing on:

1) Revision of controlled medicines listed in the National EML

2) Development of a register of importers, wholesalers and pharmacies dealing

with controlled medicines

3) Quality requirements for procurement

4) Revision of current import/export regulations and quantification of estimates

for narcotic / psychotropic substances