Multi-faceted approach to addressing the challenges of increasing access to controlled drugs for medical purposes

Side event organised by Australia, WHO, INCB, UNODC and the Union for International Cancer Control.


Gilberto Gerra UNODC Chaired.  Double failure of drug system.  Limit opioids worldwide. People continue to die with pain.

Dr. Naidoo INCB President 
Apart from being President of the INCB and a Doctor I am also an African.  Started slide with Hippocratic Oath.  “I will soothe the pain of anyone who needs my art.”  Experiencing pain is unnecessary and a violation of human dignity and human rights.  Inaction and excessive requirements and bureaucracy that Gerra was thinking about.

Alluding to conventions…issue of availability at the center of drug control system.  Overshadowed by other debates.  Availability of opioids in 2001-20013.  Around 5.5 billion people still have no access.  Used same figures as in recent report.  

Prescription drug abuse reached epidemic levels in some countries.

Not due to the lack of raw material.  Production higher than utilisation in 2014 and 2015.  Demand for opioids.  Similar imbalances in psychotropics. Report on stimulants.

Obstacles to availability slide.  Refers to guide on estimating the requirements.  urgently updating the report.  consumption of health benefits and prevalence of health conditions requiring palliative care is new work of INCB.

Recommendations contained in the 2010 report on availability.  Many are not implemented.

Availability

  • Correct assessment of needs
  • Geographical distribution
  • Affordability
  • Information
  • Monitoring

Issue of appropriate use important.

  • Training and education of health professions
  • Appropriate prescription practices
  • education of public on safe use
  • Registrations systems to prevent doctor shopping

National control system

  • Improve regulatory system and combat counterfeits

Prevention of diversion and abuse.

  • Measures against illicit manufacture and diversion
  • Effective interregional cooperation

New Report will focus on implementation. Review of recommendation of governments in 2010.

Gilles Forte, WHO
Core mandate of convention to prevent health, and ensure access guaranteed to population — clearly stated in the Preamble.  WHO has to state this.  Important stream of work done through ECDD which has mandate to carry out risk assessment of dependence potential of substance and harm to health.  When this committee carries out risk assessment looks at therapeutic usefulness of substances. 

  • 2005 Resolution WHA 58.22 on Cancer prevention and control (opioids)
  • 2014 resolution WHA 67.22 on access to EM
  • 2014 resolution WHA 67.19 PC resolution
  • 2015 EB/126/27 Zambia — strengthening emergency and essential surgical care and anesthesia.

Ensuring the balance between improved access to CM while preventing misuse, abuse and trafficking.

Improved access to CM — Global.  Use same figures and maps as INCB

Barriers

  • Insufficient training for prescription and use
  • Legislative barriers (limitations on prescriptions and administration; limitations of outles, export, import authorisation, reporting to INCB
  • Attitudes: fear of abuse and dependence although evidence clear on pain relieving properties and use in PC.

Interactive collaboration.  ATOME programme, consortium of 10 European countries
Joint Global Program to improve access with UNODC and UICC
Development of a Model Law related to availability and accessibility to controlled medicines
WHO -UNODC expert working group on data collection and tools.

UN Task Force for UNGASS

Carey AdamsUICC  
Based in Geneva 800 members in 150 countries.  Works with NCD Alliance.  Issues in health can only be addressed in partnership.  GAPRI program.
Described his relatives dying in England and having enough morphine, unlike in most countries. Target 8 WCC on universal availability.
Highlights from last few years, 2014 WHA resolution.  Not one member state said a negative thing about that resolution  Great work from member states and NGO sector that supported it.  No dissent from the truth.  We have to address this issue.
We do have the means to support it.  Australia living in a lonely world.  Should be member states in this room that can help us to address this issue.  Need more member states to send a signal to this world that this must be done.
UNGASS potential to highlight greatest world drug problem that most people don’t have access to opioids to relieve the pain they are experiencing through cancer.

Dr. Volkow From NIH
Chronic pain 30% higher rates of suicide, 100 million individuals that suffer from chronic pain.  US the top country with access.  230 million prescriptions in one year for oxy 2014.  Availability is not a problem, but px may be overprescribed and some not receiving them when needed.  Overprescription and under management of pain the problem in the US.  Efficacy for chronic pain not studied so much.  Tolerance with higher doses.  Nothing much better.  No adequate pharmacological interventions to treat is the problem.  JAYCO demanded that pain be included among vital signs.  Significant increase in number of prescriptions.  Then epidemic of deaths from overdoses.  17K deaths attributed to opioid overdoses.  In some states higher than those from car accidents.  At the same time a significant increase in people being admitted for treatment.  Two ways: people diverting medication or data showing otherwise, increases in death from overdoses, tripled in males, higher increases in women 54 and older.  Prescribing in a way that is not safe.  Jeapordising access for those that need them.  Some physicians refusing to prescribe, some px refusing to take them. 

Treatment for substance abuse disorder most important intervention.

Naloxone very important in interfering with death from overdose.  Should be widely available.
Train physicians in how to properly prescribe and recognise high risk patients, train family members in using naloxone
More research for management of chronic pain.  Opioids not the solution.  Metanalysis shows.  Best medication we have but have to be better managed. 

From Mexico — couldn’t provide opioids to px on burn units.  Need to provide to those that need them in the safest ways possible.

Dr. Jim Cleary,Pain and Policy Study Groups
Morphine consumption highest in US and Canada. Western Europe and Eastern Europe contrast in fentanyl use.  Data available here.

Questions whether we are making progress given low use of opioids in most of the world. Highlighting success in Argentina and Colombia and Vietnam where international PPSG fellows worked.  Shows data.  Introduced fentanyl in Vietnam.  Panama another example.  PC led initiatives for PC resolution at WHA.  Nepal also a good example.  One problem with data is that it relies on countries to support.  Kenya did not report for several years.  Need data to show progress.  India morphine consumption challenge needs to improve after NDPS Act.  International community should collaborate to help.  Malaysia has also improved global opioid consumption. Policies, laws and regulations the key barriers.  Fundamental nature of balance.

Professor Fanelli — Chair of Italian Health Ministry Commission for Pain and Palliative care.
Law 38/2010.  Safeguards right of citizens to have access to palliative care and pain therapy.

Pain therapy is not cancer pain.  Create different but integrated networks for pain therapy and for palliative care and for paediatric patients.  Do not confuse these two networks.  Define from legal point of view. 

Italy and opioiphobic countries.  Created a ministerial structure with aim of monitoring network.  Main thrust to apply the law not just pass it.  Massive information campaign on TV newspaper, for px and physicians. 

By October 31 2015, all Italian regions must define the evaluation criteria for PC and pain therapy network. 

Academic Master Courses in Pain Therapy One year, PC two years.  Recognition of this degree for senior position in hospices and PC centers.  Every year approximately 40 experts certified and 80 doctors qualified. 

Greater increase in opioid use in Italy.  No evidence of increase in abuse and misuse by populations several years after the law.  Also possible to prescribe cannabis.  Doctors do not do it though.

Mr. Kamran Niaz UNODC statistics  
Overly restrictive laws…do not materially contribute to prevention of misuse. Potential to prevent misuse. Disproportionately impedes availability and accessibility. Factors associated with and dynamics of misuse… Dispensing levels of PO are associated with high level of misuse and related harm. Lesser regualtory acecss restrictions — community bsed dispensing mechanisms facilitate higher dissemination levels and availability (diversion) Street level PO replaced heroin. Higher levels of psychotropic drug use. Dynamics of medical professional culture (px expect ions of effective treatment). Pronounced “For profit” orientation of health care system…Fischer et al Addiction Feb. 2014. Heroin completely displaced by Fentanyl in Estonia. For LMICs very little information.  Misuse of opioids more without unregulated healthcare and dispensing systems —driven by black markets for a few prescription markets, mostly from diverted sources.  Also includes counterfeit drugs.  Illicit production and trafficking of opioids also a source to meet demand for misuse of substances.  Less diversion form licit market.  Tramadol etc.  Specific country factors related to misuse of prescription painkillers. Has to be context specific.  

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