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Access to Controlled Medicines

Access to Controlled Medicines. 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. The global pain management crisis Causes of the problem

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Access to Controlled Medicines

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  1. Access to Controlled Medicines Willem Scholten, PharmD, MPA Team Leader, Access to Controlled Medicines, World Health Organization, Geneva, Switzerland TECHNICAL BRIEFING SEMINAR Geneva, 29 October – 2 November 2012

  2. Overview • The global pain management crisis • Causes of the problem • Working methods for improvement • Including WHO Policy guidelines

  3. Uses of Controlled Medicines • Opioid analgesics: e. g. morphine moderate and severe pain • Long-acting opioid agonists: methadone, buprenorphine treatment of opioid dependence • Ergometrine and ephedrine: emergency obstetrics • Benzodiazepines: anxiolytics, hypnotics, antiepileptics • Phenobarbital: antiepileptic

  4. Is there a crisis?

  5. 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)

  6. 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

  7. 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

  8. Patients affected (world wide, annually)

  9. Adequacy Consumption of Opioid Analgesics (2007) from: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18

  10. 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!!!

  11. Adequacy as a function of development Data for 2006

  12. 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

  13. 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!

  14. Adequacy of opioid consumption(x million people)* * Number of people living in countries where opioid consumption is …

  15. 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 Care Pharmacotherapy; 2011;25:6-18

  16. 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 treated Bekkering 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

  17. Treatment of opioid dependence

  18. Availability of MMT/BMT

  19. 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

  20. Why do people do this one to another?

  21. Because they have… • Excessive fear for dependence • Excessive fear for diversion • Neglected and ignored medical needs

  22. 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"

  23. 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 …

  24. Barriers frequently encountered

  25. Categories of barriers • Legislation and Policy • Knowledge • Attitudes • Health-Care Professionals • General Public • Economic

  26. 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

  27. 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

  28. 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"

  29. 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

  30. Economical and procurementbarriers • General issues as for other medicines e.g. • Insurance and affordability • Distribution problems • In some countries Separate distribution systems for controlled medicines

  31. How to Beat the Global Pain Management Crisis?

  32. 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

  33. 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

  34. Working methods (2) • Full analysis of barriers • Policy planning • Priority setting • Implementation • Evaluate, set new priorities and adjust policy plan etc…

  35. 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

  36. WHO Policy Guidelines

  37. 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)

  38. 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

  39. 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)

  40. WHO Pain Treatment Guidelines

  41. Ground breaking guidelines • Cancer Pain Relief (1986) • 2nd Edition: 1996 • WHO Cancer Pain and Palliative Care in Children (1998)

  42. 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

  43. WHO Pain Treatment Guidelines Series • WHO Treatment Guidelines on Persisting Pain in ChildrenwithMedicalIllnesses • On-line sinceFebruary 2012 • In print: nextweek! • Persisting Pain in Adults (in progress) • Scoping document online available • Acute Pain (Planned)

  44. Persisting Pain in Children Package

  45. 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)

  46. 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)

  47. 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

  48. 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

  49. Conclusion

  50. 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

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