Improving Access to Controlled Medicines for Pain Management and Other Purposes Technical Briefing Seminar 4 November 2011 Geneva, Switzerland Willem Scholten, Team Leader, Access to Controlled Medicines World Health Organization

Improving Access to Controlled Medicines | Geneva 4 November |2 | International 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)

Improving Access to Controlled Medicines | Geneva 4 November |3 | WHO 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

Improving Access to Controlled Medicines | Geneva 4 November |4 | Controlled 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

Improving Access to Controlled Medicines | Geneva 4 November |5 | Conventions' Objectives 1961 and 1971 Conventions: Two goals: ● Prevention of harm from drug dependence ● Availability for rational medical use

Improving Access to Controlled Medicines | Geneva 4 November |6 | Adequacy Consumption of Opioid Analgesics (2007) Source: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18

Improving Access to Controlled Medicines | Geneva 4 November |7 | Adequacy of opioid consumption ( x million people)* WorldWPROSEAROEUROEMROAMROAFRO Adequate Moderate Low Very low No cons No data Total * People living in countries where opioid consumption is …

Improving Access to Controlled Medicines | Geneva 4 November |8 | 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

Improving Access to Controlled Medicines | Geneva 4 November |9 | ACM for countries present at TBS (1) ACM (2006)Required increase Annual need Afghanistan ∾ 6,065 kg Angola0 ∾ 5,342 kg Cambodja x Cameroon ∾ 7,500 kg France % India x Jordan x Nigeria ∾ 48,500 kg

Improving Access to Controlled Medicines | Geneva 4 November | ACM for countries present at TBS (2) ACM (2006)Required increase Pakistan x Philippines x Portugal x Sierra Leone ,000 x Sudan x Switzerland United Kingdom % Zambia ,000 x

Improving Access to Controlled Medicines | Geneva 4 November | ACM for top-10 HDI ACM (2006) 0.86Norway 0.88Australia 0.51Netherlands 2.47United States 0.41New Zealand 2.56Canada 0.51Ireland UnknownLiechtenstein 2.07Germany 1.06Sweden HDI top-10 for 2011

Improving Access to Controlled Medicines | Geneva 4 November | Adequacy as a function of Development Data for 2006

Improving Access to Controlled Medicines | Geneva 4 November | 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

Improving Access to Controlled Medicines | Geneva 4 November | Adequacy 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

Improving Access to Controlled Medicines | Geneva 4 November | Reasons for low access to controlled medicines Excessive fear for dependence Excessive fear for diversion Neglected medical needs

Improving Access to Controlled Medicines | Geneva 4 November | Categories of Barriers Legislation and Policy Knowledge Attitudes –Health-Care Professionals –General Public Economic

Improving Access to Controlled Medicines | Geneva 4 November | 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

Improving Access to Controlled Medicines | Geneva 4 November | WHO Policy Guidelines (1) 15 languages including Russian, Polish and English On-line: free (15 languages) afety/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)

Improving Access to Controlled Medicines | Geneva 4 November | 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

Improving Access to Controlled Medicines | Geneva 4 November | 21 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)

Improving Access to Controlled Medicines | Geneva 4 November | 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"

Improving Access to Controlled Medicines | Geneva 4 November | 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

Improving Access to Controlled Medicines | Geneva 4 November | Development 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

Improving Access to Controlled Medicines | Geneva 4 November | New WHO Pain Guidelines 1. WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illness – Publication expected by early Pharmacological Treatment of Persisting Pain in Adults – Starting December Pharmacological Treatment of Acute Pain – Currently finalizing the Scoping Document

Improving Access to Controlled Medicines | Geneva 4 November | WHO Pediatric Persisting Pain Guidelines Selected elements of the Contents Classification of pain in children Evaluation of persisting pain in the paediatric population Pharmacological treatment strategies Improving access to pain relief in health systems Annex 1. Pharmacological profiles for selected medicines. Annex 5. Research agenda

Improving Access to Controlled Medicines | Geneva 4 November | Basic 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").

Improving Access to Controlled Medicines | Geneva 4 November | Recommendations 20 Clinical recommendations 4 Health system recommendations

Improving Access to Controlled Medicines | Geneva 4 November | Selected 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

Improving Access to Controlled Medicines | Geneva 4 November | Furthermore… All moderate and severe pain in children should always be addressed.

Improving Access to Controlled Medicines | Geneva 4 November | Paediatric Persisting Pain Based on systematic reviews of scientific literature GRADE method Recommendations: scale Strong - Weak Evidence level: scale High - Very low

Improving Access to Controlled Medicines | Geneva 4 November | However… For most recommendations: –evidence levels assessed "low" and "very low" Several clinical questions could not be answered  Research agenda Published in: Evidence Based Child Health 6: (2011)

Improving Access to Controlled Medicines | Geneva 4 November | 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

Improving Access to Controlled Medicines | Geneva 4 November | 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: (2011) DOI: /(ebch.777)

Improving Access to Controlled Medicines | Geneva 4 November | Publication 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:

Willem Scholten, PharmD, MPA Team Leader, Access to Controlled Medicines Essential Medicines and Pharmaceutical Policies World Health Organization Geneva, Switzerland Improving Access to Controlled Medicines for Pain Management and Other Purposes