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