access to controlled medicines

Access to Controlled Medicines

Willem Scholten, PharmD, MPATeam Leader, Access to Controlled Medicines,World Health Organization, Geneva, Switzerland

TECHNICAL BRIEFING SEMINAR Geneva, 29 October – 2 November 2012

Access to Controlled Medicines | TECHNICAL BRIEFING SEMINAR Geneva, 31 Oct 2012 2 |

Overview

The global pain management crisis

Causes of the problem

Working methods for improvement– Including WHO Policy guidelines


Uses of Controlled Medicines

– Ergometrine and ephedrine:

emergency obstetrics

– Benzodiazepines: anxiolytics, hypnotics, antiepileptics

– Phenobarbital: antiepileptic

– Opioid analgesics: e. g. morphinemoderate and severe pain

– Long-acting opioid agonists:

methadone, buprenorphinetreatment of opioid dependence

Is there a crisis?


Inequality

93.8% of all (licit) morphine consumption by 21.8% of the world population (INCB 2010, Data for 2009)

4.7 billion people live in countries where medical opioid consumption is near to zero (on a total world population of 6.5 billion) (Seya et al. 2011, Data for 2006)


Other Controlled Medicines

Opioid analgesics best documented. Also access problems with other controlled medicines

Opioid agonist treatment of opioid dependence:– World-wide coverage: 8% of patients only

Phenobarbital– 80% of epilepsy patients in Africa have no access

Ketamine !!!!!!!!!!!– Upcoming surgery/anaesthesia crisis world-wide


Consumption increase

Global consumption of strong opioids rose from – 1.82 mg/capita of Morphine Equivalents (1980) to– 59.66 mg / capita (2009)(Pain & Policy Studies Group, University of Wisconsin)

Increase is faster since the introduction of the Three-Step Ladder of Cancer Pain Relief (WHO, 1986)

Most of increase in industrialized countries


Patients affected (world wide, annually)

Cancer pain patients untreated 5.4 million

HIV pain patients untreated 1 million

Lethal injuries 0.8 million

Surgery 8-40 million


Adequacy Consumption of Opioid Analgesics (2007)

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


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

Logarithmic scale!!!


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


Method for ACM

Based on– Consumption of all strong opioids (INCB statistics 2006)– Morbidity (HIV, cancer, lethal injuries)– Benchmark: average of Top-20 Human Develop Index

Method for calculating long term needs Long term targets for countries

– Unsuitable for accurate calculation of short term needs

A first comparison between the consumption of and the need for opioid analgesics at country, regional and global levels

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


ACM Benchmark

No generally accepted Good per Capita Consumption Level

Assumption: most developed countries are near to "good"

Average of " Top–x " from Human Development Index (HDI) can be used as benchmark

– Choice of x is arbitrary – but major impact on outcome!

-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

HDIlo

g (A

CM)


Adequacy of opioid consumption(x million people)*

World WPRO SEARO EURO EMRO AMRO AFRO

464 0 0 129 0 335 0 Adequate

252 25 0 228 0 0 0 Moderate

255 128 0 127 0 0 0 Low

457 79 0 94 77 206 1 Very low

4718 151 172 283 400 304 503 No cons.

433 22 2 26 64 49 270 No data6580 1763 1721 887 540 895 774 Total

*Number of people living in countries where opioid consumption is…


Global need to treat all pain

Current global consumption of strong opioids:

213 000 kg morphine equivalents (2006)

Needed to treat all pain adequately:

1 292 000 kg morphine equivalents

Seya MJ et al., J of Pain and Palliative CarePharmacotherapy; 2011;25:6-18


Validation?

For the Netherlands:

ACM: 51 % (Seya et al.)

43% of chronic non-cancer pain patients report not to receive pain treatment

79% of patients believe their pain is inadequately treatedBekkering GE et al, Epidemiology of chronic pain and its treatment in the Netherlands. The Netherlands J of Med. 2011; 69(3): 141 – 152 (Systematic review)

Studies for other European countries on their way; this will allow validation of ACM-method

Treatment of opioid dependence


Availability of MMT/BMT


References

BM Mathers, Degenhardt L, Ali H et al,. HIV Prevention, treatment, and care services for people who inject drugs; a systematic revie of global, regional, and national coverage.The Lancet 2010; 375: 1014 – 28.

BM Mathers, Degenhardt L, Phillips B et al. Global epidemiology of injecting drug use and HIV among people who inject drugs: a systematic review. The Lancet (www.thelancet.com) Published online September 24, 2008 DOI:10.1016/S0140-6736(08)61311-2

Why do people do this one to another?


Because they have…

Excessive fear for dependence

Excessive fear for diversion

Neglected and ignored medical needs


Why do these barriers exist and what are they?

One century of drug control– 23 January 1912, The Hague: first Opium Convention

Focus has been on prevention of – abuse, – dependence and – crime related to trafficking

Medical and scientific supply "forgotten"


Preamble Single Convention

Single Convention on Narcotic Drugs (1961; as amended)

Recognizing 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 …

Barriers frequently encountered


Categories of barriers

Legislation and Policy

Knowledge

Attitudes – Health-Care Professionals– General Public

Economic


Legislative barriers

Inappropriate laws and regulations– Rules often not preventing abuse, dependence and diversion– Rules often a barrier for medical access

Limitations on prescriptions and administration– Duration– Maximum dosage– Administration of medicines restricted

Special prescription forms

Limitation of outlets

Limitations on who is allowed to prescribe– Special licensing in spite of medical degree


Policy barriers

Access to controlled medicines not included in national policy plans

– National Pharmaceutical Policy Plan– National Cancer Control Plan– National HIV/AIDS Plan

Investigation/prosecution of prescribers– Investigation of those who subscribe at an adequate level

Too much red tape– Speed of licensing procedures


Knowledge barriers

Medical Schools– Many do not teach opioid analgesia

Physicians– Fear for dependence– Unfamiliarity with prescribing and dosing– Prescribing obsolete medicines (pethidine=meperidine still in

use)– Unfamiliarity with pain assessment– Learned "not to treat symptoms, but disease"


Attitude barriers

Patient and family– Association morphine impending death– Conviction that suffering chastens

Health-care and other professionals– Continuing use of obsolete or counter-productive terminology– Seniors not allowing juniors to introduce new techniques


Economical and procurementbarriers

General issues as for other medicines e.g.– Insurance and affordability– Distribution problems

In some countriesSeparate distribution systems for controlled medicines

How to Beat the Global Pain Management Crisis?


Improving access

Suggested steps

Policy analysis

Legal analysis (external lawyer, trained on the issue)

National policy on improving access

National one-day symposia for awareness raising


Working methods (1)

Preferrably: working group that includes– authorities– representatives of relevant health-care professionals

• Pharmacists, GPs, PC, oncology, surgery…. (pain everywhere!)

• Treatment of opioid dependence• Veterinarians?

– patient representatives


Working methods (2)

Full analysis of barriers

Policy planning– Priority setting

Implementation

Evaluate, set new priorities and adjust policy plan

etc…


Tools

WHO Policy guidelines

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

Published 2012 on-line (free) and in print

Other WHO pain guidelines to follow– Persisting Pain in Adults– Acute Pain

WHO Policy Guidelines


WHO Policy Guidelines

English, French and Spanish in print form

In print form: US$ 25.– (US$ 17.50 for developing countries)

On-line: 15 languages available free of charge online

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

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


Policy principle

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 Guidelines

Topics

Content of drug control legislation and policy (2 GLs)

Authorities and their role in the system (4 GLs)

Policy planning for availability and accessibility (4 GLs)

Healthcare professionals (4 GLs)

Estimates and statistics (3 GLs)

Procurement (3 GLs)

Other (1 GL)

WHO Pain Treatment Guidelines


Ground breaking guidelines

Cancer Pain Relief (1986)– 2nd Edition: 1996

WHO Cancer Pain and Palliative Care in Children (1998)


Cancer Pain Relief (in children)

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

Three Step Analgesic Ladder No maximum dose on morphine

– "The right dose is the dose that works"

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

Not evidence-based / no transparency


WHO Pain Treatment Guidelines Series

WHO Treatment Guidelines on Persisting Pain in Children with Medical Illnesses

– On-line since February 2012– In print: next week!

Persisting Pain in Adults (in progress)– Scoping document online available

Acute Pain (Planned)


Persisting Pain in Children Package


Persisting Pain in Children Package

Printed version will be available as a package:

Guidelines and brochures

Wall chart

Dosage card

2 Pain measurement schales (FPS-R and VAS)


Contents (1)

Principles – All moderate and severe pain in children should always be

addressed.

19 clinical recommendations– Two-step approach

4 health system recommendations

Most evidence levels assessed "low" and "very low"

Research agenda – Evidence Based Child Health 6: 1017-1020 (2011)


Contents (2)

Chapter 1. Introduction.

Chapter 2. Classification of pain in children

Chapter 3. Evaluation of persisting pain in the paediatric population

Chapter 4. Pharmacological treatment strategies

Chapter 5. Improving access to pain relief in health systems


Contents (3)

Annex 1. Clinical recommendations

Annex 2. Evidence retrieval and appraisal

Annex 3. Research agenda

Annex 4. Health system interventions recommendation

Annex 5. Opioid analgesics and international conventions

Conclusion


Conclusion

Potentially 4.7 billion people affected

Medical opioid consumption needs to go up 6 times

Policies needed to identify and overcome barriers

Concerted action by health-care professionals of all specialties and policy makers required

Tools include WHO policy and treatment guidelines

Willem Scholten, PharmD, MPATeam Leader, Access to Controlled Medicines,World Health Organization, Geneva, Switzerland

wk.scholten@ bluewin.ch

Access to Controlled Medicines

access to controlled medicines

Documents

opioid medicines

europe access

improved access

opioid agonists

medical opioid consumption

policy guidelines access

severe pain

certain countries