Willem Scholten PharmD MPA Team Leader Access to Controlled Medicines World Health Organization Geneva Switzerland TECHNICAL BRIEFING SEMINAR Geneva 29 October 2 November 2012 Overview ID: 754816
Download Presentation The PPT/PDF document "Access to Controlled Medicines" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Access to Controlled Medicines
Willem Scholten, PharmD, MPATeam Leader, Access to Controlled Medicines,World Health Organization, Geneva, SwitzerlandTECHNICAL BRIEFING SEMINAR Geneva, 29 October – 2 November 2012Slide2
OverviewThe global pain management crisisCauses of the problemWorking methods for improvementIncluding WHO Policy guidelinesSlide3
Uses of Controlled Medicines
Ergometrine and ephedrine: emergency obstetricsBenzodiazepines: anxiolytics, hypnotics, antiepilepticsPhenobarbital: antiepileptic
Opioid analgesics:
e. g. morphine
moderate and severe pain
Long-acting opioid agonists:
methadone, buprenorphine
treatment of opioid dependenceSlide4
Is there a crisis?Slide5
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)Slide6
Other Controlled MedicinesOpioid analgesics best documented. Also access problems with other controlled medicinesOpioid agonist treatment of opioid dependence:World-wide coverage: 8% of patients only
Phenobarbital 80% of epilepsy patients in Africa have no accessKetamine !!!!!!!!!!!Upcoming surgery/anaesthesia crisis world-wideSlide7
Consumption increase Global consumption of strong opioids rose from 1.82 mg/capita of Morphine Equivalents (1980) to59.66 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 countriesSlide8
Patients affected (world wide, annually)
Cancer pain patients untreated5.4 million
HIV pain patients untreated
1 million
Lethal injuries
0.8 million
Surgery
8-40 millionSlide9
Adequacy Consumption of Opioid Analgesics (2007)
from: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;
25
:6-18Slide10
Adequacy of Consumption Measure (ACM)≥1 Adequate0.3 – 1 Moderate
0.1 – 0.3 Low0.03 – 0.1 Very Low< 0.03 "No" consumptionLogarithmic scale!!!Slide11
Adequacy as a function of development
Data for 2006Slide12
Method for ACMBased onConsumption 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 countriesUnsuitable for accurate calculation of short term needsA first comparison between the consumption of and the need for opioid analgesics at country, regional and global levelsSeya MJ et al, J Pain and Pall Care Pharmacother, 2011;25:6-18Slide13
ACM BenchmarkNo generally accepted Good per Capita Consumption LevelAssumption: most developed countries are near to "good"
Average of " Top–x " from Human Development Index (HDI) can be used as benchmarkChoice of x is arbitrary – but major impact on outcome!Slide14
Adequacy of opioid consumption(x million people)*
WorldWPRO
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
172283400304503No cons.433222266449270No data658017631721887540895774Total
* Number of people living in countries where opioid consumption is …Slide15
Global need to treat all painCurrent 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 Care
Pharmacotherapy; 2011;25:6-18Slide16
Validation?For the Netherlands:ACM: 51 % (Seya et al.)
43% of chronic non-cancer pain patients report not to receive pain treatment79% 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 Slide17
Treatment of opioid dependenceSlide18
Availability of MMT/BMTSlide19
ReferencesBM 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)61311-2Slide20
Why do people do this one to another?Slide21
Because they have…
Excessive fear for dependenceExcessive fear for diversionNeglected and ignored medical needsSlide22
Why do these barriers exist and what are they?One century of drug control23 January 1912, The Hague: first Opium ConventionFocus has been on prevention of
abuse, dependence and crime related to traffickingMedical and scientific supply "forgotten"Slide23
Preamble Single ConventionSingle 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 …Slide24
Barriers frequently encounteredSlide25
Categories of barriersLegislation and PolicyKnowledgeAttitudes Health-Care ProfessionalsGeneral Public
EconomicSlide26
Legislative barriersInappropriate laws and regulationsRules often not preventing abuse, dependence and diversion
Rules often a barrier for medical accessLimitations on prescriptions and administrationDurationMaximum dosageAdministration of medicines restrictedSpecial prescription formsLimitation of outletsLimitations on who is allowed to prescribeSpecial licensing in spite of medical degreeSlide27
Policy barriersAccess to controlled medicines not included in national policy plansNational Pharmaceutical Policy PlanNational Cancer Control Plan
National HIV/AIDS PlanInvestigation/prosecution of prescribersInvestigation of those who subscribe at an adequate level Too much red tapeSpeed of licensing proceduresSlide28
Knowledge barriersMedical SchoolsMany do not teach opioid analgesiaPhysicians
Fear for dependenceUnfamiliarity with prescribing and dosingPrescribing obsolete medicines (pethidine=meperidine still in use)Unfamiliarity with pain assessmentLearned "not to treat symptoms, but disease"Slide29
Attitude barriersPatient and familyAssociation morphine impending death
Conviction that suffering chastensHealth-care and other professionalsContinuing use of obsolete or counter-productive terminologySeniors not allowing juniors to introduce new techniquesSlide30
Economical and procurementbarriersGeneral issues as for other medicines e.g.Insurance and affordability
Distribution problemsIn some countriesSeparate distribution systems for controlled medicinesSlide31
How to Beat the Global Pain Management Crisis? Slide32
Improving accessSuggested stepsPolicy analysisLegal analysis (external lawyer, trained on the issue)
National policy on improving accessNational one-day symposia for awareness raisingSlide33
Working methods (1)Preferrably: working group that includesauthoritiesrepresentatives of relevant health-care professionalsPharmacists, GPs, PC, oncology, surgery…. (pain everywhere!)
Treatment of opioid dependenceVeterinarians?patient representativesSlide34
Working methods (2)Full analysis of barriersPolicy planningPriority settingImplementation
Evaluate, set new priorities and adjust policy planetc…Slide35
ToolsWHO Policy guidelinesWHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illness Published 2012 on-line (free) and in printOther WHO pain guidelines to follow
Persisting Pain in AdultsAcute PainSlide36
WHO Policy GuidelinesSlide37
WHO Policy GuidelinesEnglish, French and Spanish in print formIn print form: US$ 25.– (US$ 17.50 for developing countries)
On-line: 15 languages available free of charge onlinehttp://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)Slide38
Policy principleBased 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 purposeswhile simultaneously preventing abuse, diversion and trafficking 21 Guidelines and Country Check ListSlide39
21 GuidelinesTopicsContent 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)Slide40
WHO Pain Treatment GuidelinesSlide41
Ground breaking guidelinesCancer Pain Relief (1986)2nd Edition: 1996WHO Cancer Pain and Palliative Care in Children (1998)Slide42
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 opioidsE.g. levorphanol, pethidine Not evidence-based / no transparencySlide43
WHO Pain Treatment Guidelines SeriesWHO Treatment Guidelines on Persisting Pain in Children
with Medical IllnessesOn-line since February 2012In print: next week!Persisting Pain in Adults (in progress)Scoping document online availableAcute Pain (Planned)Slide44
Persisting Pain in Children PackageSlide45
Persisting Pain in Children PackagePrinted version will be available as a package: Guidelines and brochuresWall chartDosage card
2 Pain measurement schales (FPS-R and VAS)Slide46
Contents (1)Principles All moderate and severe pain in children should always be addressed. 19 clinical recommendations
Two-step approach4 health system recommendationsMost evidence levels assessed "low" and "very low" Research agenda Evidence Based Child Health 6: 1017-1020 (2011)Slide47
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 Slide48
Contents (3)Annex 1. Clinical recommendations
Annex 2. Evidence retrieval and appraisalAnnex 3. Research agenda Annex 4. Health system interventions recommendation Annex 5. Opioid analgesics and international conventionsSlide49
ConclusionSlide50
ConclusionPotentially 4.7 billion people affectedMedical opioid consumption needs to go up 6 timesPolicies needed to identify and overcome barriersConcerted action by health-care professionals of all specialties and policy makers required
Tools include WHO policy and treatment guidelinesSlide51
Willem Scholten, PharmD, MPA
Team Leader, Access to Controlled Medicines,World Health Organization, Geneva, Switzerlandwk.scholten@ bluewin.ch
Access to Controlled Medicines