Improving Access to Controlled Medicines for Pain Management and Other Purposes Technical Briefing...

Improving Access to Controlled Medicines for Pain Management and Other Purposes


Technical Briefing Seminar4 November 2011Geneva, Switzerland

Willem Scholten, Team Leader, Access to Controlled MedicinesWorld Health Organization

Improving Access to Controlled Medicines | Geneva 4 November 20112 |

International Drug Control ConventionsInternational Drug Control Conventions

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)


WHO Roles in Drug ControlWHO Roles in Drug Control

Advisory function to the UN system– Substance evaluation– Commission on Narcotic Drugs

Improving access to controlled medicines– Century of drug control– Resolutions by WHA, ECOSOC and CND


Controlled medicines on the WHO EMLControlled 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


Conventions' ObjectivesConventions' Objectives

1961 and 1971 Conventions:

Two goals:

● Prevention of harm from drug dependence

● Availability for rational medical use


Adequacy Consumption of Opioid Analgesics (2007)

Adequacy Consumption of Opioid Analgesics (2007)

Source: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18


Adequacy of Consumption Measure (ACM)Adequacy of Consumption Measure (ACM)

≥1 Adequate

0.3 – 1 Moderate

0.1 – 0.3 Low

0.03 – 0.1 Very Low

< 0.03 No consumption


ACM for countries present at TBS (1)ACM for countries present at TBS (1)

ACM (2006)Required increase

Annual need

Afghanistan0 2007∾6,065 kg

Angola0∾5,342 kg

Cambodja0.000220075000 x

Cameroon0 2007∾7,500 kg

France0.818722%

India0.00081250 x

Jordan0.058117 x

Nigeria0 2007∾48,500 kg


ACM for countries present at TBS (2)ACM for countries present at TBS (2)

ACM (2006)Required increase

Pakistan0.00052000 x

Philippines0.0035286 x

Portugal0.36422.7 x

Sierra Leone0.00005200720,000 x

Sudan0.0013769 x

Switzerland1.4337-

United Kingdom0.537686 %

Zambia0.000110,000 x


ACM for top-10 HDIACM for top-10 HDI

ACM (2006)

Norway0.86

Australia0.88

Netherlands0.51

United States2.47

New Zealand0.41

Canada2.56

Ireland0.51

LiechtensteinUnknown

Germany2.07

Sweden1.06

HDI top-10 for 2011


Adequacy as a function of Development Adequacy as a function of Development

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

HDI

log

(AC

M)

Data for 2006


Patients affected (global figures, annually)

Patients affected (global figures, annually)

Cancer pain patients untreated5.4 million

HIV pain patients untreated1 million

Lethal injuries

Surgery

0.8 million

8-40 million

Preventable HIV infections130,000

Mortality from post-partal haemorrhage 75,000


Adequacy of Consumption MeasureAdequacy of Consumption Measure

Based on

Morbidity

Consumption of all strong opioids except methadone

Benchmark: average of Top-20 countries in Human Develop Index

Method for calculating long term needs Long term targets for countries

Seya MJ et al, J Pain and Pall Care Pharmacother, 2011;25:6-18


Reasons for low access to controlled medicines

Reasons for low access to controlled medicines

Excessive fear for dependence

Excessive fear for diversion

Neglected medical needs


Categories of BarriersCategories of Barriers

Legislation and Policy

Knowledge

Attitudes – Health-Care Professionals– General Public

Economic


WHO Access to Controlled Medicines Programme

WHO Access to Controlled Medicines Programme

To assist countries in improving access

through:

Development of tools (e.g. guidelines and manuals)

Analysis of policy and legislation

Country assistance


WHO Policy Guidelines (1)WHO Policy Guidelines (1)

15 languages including Russian, Polish and English

On-line: free (15 languages)

http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html

In print: US$ 25.– (English and French only)

Ensuring Balance in National Policies on Controlled Substances, Guidance for accessibility and availability of controlled medicines (Geneva 2011)


WHO Policy Guidelines (2)WHO Policy Guidelines (2)

Based on Principle of Balance:

Obligation of governments to establish a system of drug control that

– ensures the adequate availability of controlled substances for medical and scientific purposes

– while simultaneously preventing abuse, diversion and trafficking

21 Guidelines and Country Check List


21 Guidelines21 Guidelines

Topics

Content of drug control legislation and policy (2 recommendations)

Authorities and their role in the system (4 recommendations)

Policy planning for availability and accessibility (4 recommendations)

Healthcare professionals (4 recommendations)

Estimates and statistics (3 recommendations)

Procurement (3 recommendations)

Other (1 recommendation)


WHO Cancer Pain Guidelines (1)WHO Cancer Pain Guidelines (1)

Cancer Pain (1st Ed: 1986, 2nd Ed: 1996)

Cancer Pain and Palliative Care in Children (1998)

Introduced Three Step Analgesic Ladder

Systematic approach:– "By the ladder"– "By the clock"– "By the appropriate route"– "By the individual"


WHO Cancer Pain Guidelines (2)WHO Cancer Pain Guidelines (2)

Still actual for the systematic approach:– "By the clock"– "By the appropriate route"– "By the individual"

Obsolete now for some recommended opioids– E.g. levorphanol, pethidine

Three step ladder / Two step approach?

Not evidence-based / no transparency


Development of WHO Pain GuidelinesDevelopment of WHO Pain Guidelines

To cover all various types of pain

Developed by the Access to Controlled Medications Programme

"Quality control" by WHO Guidelines Review Committee

WHO "Guidelines for Guidelines" impose rigour:– Methodology– Evidence– Transparency– Quality control


New WHO Pain GuidelinesNew WHO Pain Guidelines

1. WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illness

– Publication expected by early 2012

2. Pharmacological Treatment of Persisting Pain in Adults

– Starting December 2011

3. Pharmacological Treatment of Acute Pain

– Currently finalizing the Scoping Document


Basic PrinciplesBasic Principles

Principles from the pediatric persisting pain guidelines:

Comprehensive approach – non-opioid analgesics, opioid analgesics, adjuvants and non-

pharmacological strategies

Correct use of analgesic medicines will relieve pain in most children with persisting pain due to medical illness

Key concepts:– using a two-step strategy – dosing at regular intervals ("by the clock")– using the appropriate route of administration ("by the mouth")– tailoring treatment to the individual child ("by the individual").


Selected RecommendationsSelected Recommendations

Two Step Approach according to the child's level of pain severity.

First step: paracetamol or ibuprofen (mild pain) – both to be made available

Second step: morphine (moderate to severe pain)

Codeine is no longer recommended

Tramadol also not recommended


Furthermore…Furthermore…

All moderate and severe pain in children should always be addressed.


WHO Call for Research (1)WHO Call for Research (1)

Identified Research Gaps

Clinical studies needed on paracetamol, NSAIDs and opioid analgesics

– 8 research topics

Clinical studies needed on adjuvant medicines for neuropathic pain

Pharmacokinetics

Pain assessment tools


WHO Call for Research (2)WHO Call for Research (2)

Barbara Milani, Nicola Magrini, Andy Gray, Phil Wiffen and Willem Scholten

WHO Calls for Targeted Research on the Pharmacological Treatment of Persisting Pain in children with Medical Illnesses

Evid.-Based Child Health 6: 1017- 1020 (2011)

www.evidence-basedchildhealth.comDOI: 10.1002/(ebch.777)


Publication of Ped Pain GuidelinesPublication of Ped Pain Guidelines

Package containing:– Guidelines book– Brochure "Important information for physicians and nurses"– Brochure "Important information for pharmacists"– Brochure "Important information for policy makers"– Dosing card (pocket size)– 2 Ped. pain assessment scales – Wall chart (waiting room)

English version in print (US$ 25) and on-line (free)

Translations subject to availability of funding and to national initiatives

– Licences for national languages: [email protected]

Willem Scholten, PharmD, MPATeam Leader, Access to Controlled MedicinesEssential Medicines and Pharmaceutical PoliciesWorld Health OrganizationGeneva, Switzerland

[email protected]+41 22 79 15540


Improving Access to Controlled Medicines for Pain Management and Other Purposes Technical Briefing...

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