WHO Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence Dissemination, Implementation & Evaluation

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1 WHO Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence Dissemination, Implementation & Evaluation Nicolas Clark Department of Mental Health and Substance Abuse WHO, Geneva

2 Overview What is the main message? WHO has developed a guideline according to evidence and expert opinion in a method designed to be as free from bias as possible. Safe, high quality methadone treatment should be available, affordable and accessible Dissemination & Implementation Analysis of barriers to implementation Specific strategies Evaluation & Revision Proposal for a multi-country survey revision within 3 years 2

3 Guidelines for treatment of opioid dependence Set of recommendations developed according to WHO procedures for clinical guidelines Based on: systematic reviews of the literature support of procedural and content experts Includes different treatment modalities with use of: Opioid agonists Opioid antagonists Other medicines Dissemination and evaluation in

4 What is the main message of the WHO guidelines? and how did it arrive at this message 4

5 Main message of WHO guidelines Safe, high quality opioid agonist maintenance treatment (primarily using mainly supervised methadone in its syrup or liquid formulation) should be available, affordable and accessible 5

6 Policy perspective Criminal opioid use Legal opioid use and non use Medical opioid use Make opioids available for medical use to people who are dependent on opioids in a way that maximizes the quality of life of people dependent on opioids minimizes the harms to the community 6

7 How did WHO arrive at this message? 7

8 ECOSOC resolution 2004/40 Invited the World Health Organization (WHO), in collaboration with United Nations Office on Drugs and Crime (UNODC), to develop and publish minimum requirements and international guidelines on psychosocially assisted pharmacological treatment of persons dependent on opioids, taking into account regional developments in the field, in order to assist the member states concerned 8

9 WHO Guidelines on Guidelines WHO standards for guidelines: evidence based, where evidence exists evidence assessed using the GRADE profile transparent processes attempts to minimize bias Developing country focused Relevant to different health care systems and settings 9

10 Guidelines Development Group Technical Experts Marina DAVOLI, Italy. Michael FARRELL, UK. David FIELLIN, USA. LI,Jianhua, China. Ratna MARDIATI, Indonesia. Richard P. MATTICK, Australia. Elena MEDINA-MORA, México Afarin RAHIMI-MOVAGHAR, Iran. Fred OWITI, Kenya. Rajat RAY, India. Anthony SMITH, Australia. Emilis SUBATA, Lithuania. Ambros UCHTENHAGEN, Switzerland WHO Hannu Alho Dan Chisholm Nicolas Clark Sue Hill Nicola Magrini Vladimir Poznyak Annette Verster UNODC Juana Tomas-Rosello OBSERVERS Council of Europe Mrs Gabrielle Welle-Strand INCB Mr Pavel Pachta Ms Carmen Selva-Bartolome Ms Margarethe Ehrenfeldner 10

11 Key outcomes of treatment Critical outcomes mortality life threatening adverse events seroconversion to HIV opioid use retention in treatment Important outcomes moderate adverse events completion of opioid withdrawal severity of withdrawal risk behaviours for HIV criminal behaviour well being and quality of life Less important outcomes minor adverse effects (e.g. constipation, sweating) 11

12 12

13 Dissemination the guidelines document printed 5000 copies WHO dissemination list web associated documents for clinicians for policy makers for programme managers workshops presentations at conferences & meetings independently in some regions 13

14 Barriers to implementation (not complete) Policy makers/practitioners unconvinced by the evidence Getting the methadone to the dispensing point No precedent for supervised dispensing systems Cost Restrictive policies on narcotic control limit availability Lack of national clinical guidelines 14

15 Barriers to Implementation: Not convinced by the evidence Problem Many countries are feel that the evidence gathered will not necessarily represent the situation in their country Most RCTs conducted in wealthy country settings Evidence does have its gaps Many myths and disinformation about the effectiveness of methadone Solution Be transparent about the strengths and weaknesses of the evidence Orientate the research agenda towards the gaps in the evidence Assist member states to conduct their own research in a way that there results are comparable to other countries The WHO Collaborative Study on Substitution Therapy of Opioid Dependence and HIV/AIDS - injecting risk behaviour 15

16 WHO Collaborative Study on Substitution Therapy of Opioid Dependence and HIV/AIDS WHO Collaborative Study on Substitution Therapy of Opioid Dependence and HIV/AIDS - Heroin use N u m b e r o f u s e s p e r d a y Baseline 3-month 6-month China Indonesia Thailand Iran Australia Lithuania Poland 16

17 Barriers to Implementation: Getting the methadone to the dispensing point Problem Methadone is not registered in many countries No pharmaceutical company is interested INCB reporting requirements are difficult to negotiate Procedures for marketing and distribution do not normally follow other medications Some countries have specific difficulties using of liquid narcotic medication Need to ensure minimal leakage Solution WHO medication procurement programmes Guide on how to negotiate current INCB requirements included in the guidelines Working with INCB to reduce complexity 17

18 Negotiating importation process 18

19 Barriers to implementation: No precedent for supervised dispensing systems Problem Most member states do not have established systems for supervision of medication, particularly medication with a potential for abuse Consequent need to establish system Difficult to develop a system with wide enough coverage such that people can get to a dispensing point daily Solution Gather data on different treatment systems Provide technical advice on request to member states of suitable alternative solutions based on different approaches in different parts of the world 19

20 Problem Barriers to Implementation: Cost Cost of methadone and buprenorphine varies enormously around the world Countries under pressure to implement OST do not negotiate well with pharmaceutical companies Solution Database on prices on WHO website Procurement assistance available Assistance including OST in global fund proposals 20

21 Manufacturer/Distribut Generic Name Brand Name Dosage Form Strength or (Concentration of Drug) ARROW Génériques buprenorphine hydrochloride BUPRENORPHINE ARROW cp subling (Subutex generic) Base Unit of Measure Price Per Base Unit of Measure sublingual tablets 0,4 mg 7 tablets $ mg 7 $ mg 7 $ Bedford laboratories CTS Chemical Industries LTD buprenorphine hydrochloride buprenorphine hydrochloride Buprenorphine Hydrochloride injection (Buprenex) liquid (injection) 0.3 mg/ml 10x1ml Nopan sublingual tablets 0.2 mg 2x10 tablets 5x10 $8.02 Essex pharma GmbH buprenorphine hydrochloride TEMGÉSIC sublingual tablets 0.2mg/tab. 20 tablets /20 tab. TEMGÉSIC forte sublingual tablets 0.4mg/tab. 20 TEMGÉSIC ampullen solution for injection 0.3mg/ml amp. Hospira, Inc buprenorphine hydrochloride Buprenorphine Hydrochloride Carpuject liquid (injection) 0.3mg/ml 1mlx /ml Merck Génériques buprenorphine hydrochloride BUPRENORPHINE MERCK sublingual tablets 0.4 mg 7 tablets $ mg 7 tablets $ mg 7 tablets $17.00 Mundipharma Pty Ltd. buprenorphine Norspan transdermal patch 5 mg 2 patches $ mg 2 $ mg 2 $30.70 Narcotics Control Division 21 buprenorphine Nicosia hydrochloride May 2009 Temgesic sublingual 0.2 mg/tab tablet ~0.60 baht buprenorphine Temgesic injection 0.3 mg/ml ml ~3.33 baht

22 Barriers to Implementation: Restrictive narcotic control policies Problem narcotic control policies restrict attractiveness of treatment Solution i.e. no take home doses punitive responses to drug use on treatment non therapeutic culture in treatment centres bring together health and drug control agencies in member states to form drug treatment policies (UNODC/WHO Joint Programme on Drug Dependence encourage treatment agencies to work with user groups 22

23

24 Barriers to implementation: lack of national policies and clinical guidelines Support to member states to develop their own policies and clinical guidelines Georgia Kyrgyzstan Lebanon Romania Ukraine WHO regions and South East Asian Regional WHO Office WHO guidelines 24

25 Evaluation distribution of draft for feedback questionnaire from target audience policy makers programme managers clinicians monitoring for changes in clinical guidelines monitoring for changes in practice 25

26 Evaluation Distribution of draft for feedback Some positive I would like to reiterate my favorable review of such a comprehensive and thoughtful set of evidence-based recommendations. It is rare that a document of this kind is so carefully balanced and offers evidence-based policy guidance, which can be readily implemented. It is an excellent draft document and obviously, many experienced and knowledgeable professionals worked to created it. some critical significant editing clarification of many points presentation changes correcting some errors 26

27 Evaluation monitoring for changes in clinical guidelines and practice repeat the review of clinical guidelines that was conducted during guideline development multi country survey on opioid dependence treatment availability cost accessibility quality safety what proportion of people are in treatment? 27

28 WHO, UNODC & UNAIDS Technical Guide for countries to set targets for Universal Access to HIV prevention, treatment and care for injecting drug users (WHO, 2008) Availability Is opioid substitution therapy available? OST sites per 1000 opioid injectors OST sites per 1000 opioid dependent people Coverage Percentage of OST treatment slots against number of opioid dependent people Ratio of OST treatment slots against number of opioid injectors Quality Adherence to WHO guidelines on OST OST programmes with psychosocial support Percentage of patients in OST receiving recommended maintenance dose Percentage of individuals currently on OST who have been on OST continuously for the last 12 months Average duration of treatment on OST Average maintenance dose of OST 28

29 Barriers to WHO disseminating, implementing and evaluating the guidelines People Funding Goodwill Thank you 29

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