Substitution Treatment for Opiate Dependence in

Europe

Annette VersterMontego BayAugust 2001

2

Acknowledgements

• Reviewing Current Practice in Drug Substitution Treatment in Europe European Monitoring Centre for Drug and Drug Addiction (EMCDDA) Michael Farrell et al. (2000)

• Methadone Guidelines European Commission (EC)/ EuroMethwork – Annette Verster & Ernst Buning

3

Outline

• Part 1: – Introduction– Epidemiology of opiate addiction– Substitution Treatment

• Part 2: – Methadone: pharmacology, evidence– Best practice of methadone treatment– Conclusions

4

Prevalence of problem opiate use in the European Union (EU)

• Estimates interpreted with caution

• Sources include national surveys, capture-recapture studies, extrapolation of treatment and criminal justice indicator data

• Injecting rates 70 - 80% (Greece, Italy) to 14% (Netherlands)

Sources: Annual report on the state of the drugs problems in the European Union (EMCDDA 2000)

5

Introduction of epidemic

• Late 60’s and early 70’s among young people in NW Europe

• Late 70’s and early 80’s in S Europe

• 90’s in C and E Europe

6

Estimated numbers of problem opiate users per 100,000 population aged 15 - 64

Lowest GermanyFinlandSwedenNetherlandsAustriaGreeceBelgiumDenmarkIreland France

200 – 400 per 100,000 population0.2 – 0.4%

High PortugalSpainUnited Kingdom

400 – 600 per 100,000 population0.4 – 0.6%

Highest ItalyLuxembourg

>600 per 100,000 population>0.6%

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Prevalence of HIV (%) infection among IDU’s in EU member states

Belgium - French 1.6

Belgium – Flemish 2.2

Denmark (0 – 3.4)

Germany 3.8

Greece 0.5 – 3.2

Spain 32

France 15.5 – 17.3

Ireland 3.5

Italy 16.2

Luxembourg 3.0

Netherlands (1 – 26)

Austria 0 – (2)

Portugal 14 – (48)

Finland (3)

Sweden 2.6

UK (England and Wales) 1

Source: EMCDDA 2000

8

Substitution Treatment in EU

• In many countries as a response to the HIV epidemic

• 1993 to 1999 - treatment places tripled• 2000 - more than 300,000 drug users in

treatment• General practitioners, treatment centres,

methadone clinics, ‘methadone buses’ and pharmacies

• Methadone but also buprenorphine, levo-alpha-acetyl-methadol (LAAM), dihydrocodeine, slow-release morphine and heroin

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Launch of substitution treatments in the 15 EU member states

Country Methadone treatment first available

Introduction of other forms of substitution treatment

Sweden 1967 None

Netherlands 1968 Heroin (1997)

UK 1968 Buprenorphine (1999)

Denmark 1970 LAAM and buprenorphine (1998)

Finland 1974 Buprenorphine (1997)

Italy 1975 Buprenorphine (1999)

Portugal 1977 LAAM (1994)

Spain 1983 LAAM (1997)

Austria 1987 Buprenorphine (1997) slow-release morphine (1998)

Luxemburg 1989 Methadone (1989) Buprenorphine (2000)

Ireland 1992 None

Greece 1993 None

France 1995 Buprenorphine (1996)

Belgium 1997 None

Source: EMCDDA 2000

10

Estimated number of drug users in methadone treatment in the 15 EU member states (1997) per 100,000 population aged

16 - 60

0

50

100

150

200

250

Spain

Ireland

Netherlands

ItalyBelgium

UK Germ

any

Denmark

Austria

Portugal

France

Sweden

Finland

Luxembourg

Greece

Source: Farrell et al EMCDDA 1998

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Increase in the numbers of drug users receiving methadone in the 15 EU member

states (1993-1997)

0

500

1000

1500

2000

2500

1993 1995 1997

Source: EMCDDA 1998 and others

12

National Methadone Consumption (kg) per 100,000 population aged 16-60 (1996)

0

0.5

1

1.5

2

2.5

3

3.5

4

Denmark

Spain

Belgium

UK Ireland

ItalyNetherlands

Germ

any

Sweden

Portugal

France

Greece

Finland

Source: International Narcotics Control Board

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The balance between methadone maintenance and detoxification treatmentCountry Maintenance or detoxification

FranceIrelandPortugalSweden

Primarily maintenance (75-100% of treatment aimed at maintenance)

DenmarkGermanySpainNetherlandsAustriaFinlandUK

50 – 75% of treatment aimed at maintenance

GreeceItaly

Primarily detoxification (under 30% of treatment aimed at maintenance)

Source:Farrell et al, EMCDDA 2000 (estimates)

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Prescription practice in the 15 EU member states

Country Prescription PracticeGreeceFinlandSweden

Specialised centres, limited number

DenmarkSpainFrance(methadone)ItalyNetherlandsPortugal

Specialised centres

BelgiumGermanyFrance (buprenorphine)IrelandLuxembourgAustriaUnited Kingdom

General practitioners

Source:Farrell et al EMCDDA 2000

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Use of alternatives to methadone for opiate

substitution

• Buprenorphine becoming increasingly popular

• LAAM currently unavailable but a few individuals using it

• Slow-release morphine used very rarely

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Heroin Treatment

• UK: Mid 80s IV Heroin to oral methadone (Mitcheson et al 1983)

• Switzerland : Study results publishedpermanent monitor study on comorbidity Status: new legislation pending

• The Netherlands : IV Heroin/smoked vs Methadone p.o. 3 cities, n=1100Status : results by 2002

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Prerequisites for introducing heroin assisted treatment as an additional

therapeutic option

• Adequate problem size and problem awareness

• Acceptable level of other treatment options within the region

• Realistic rationale and goals for the new option

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Conclusions 1

• Opiate addiction highly prevalent• Substitution treatment all over

Europe• Predominantly methadone

substitution treatment• Wide variety in practice accross

countries

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Part 2: Methadone

• Pharmacology• The evidence• Best practice• Conclusions

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Methadone Guidelines

• European Commission• General character

•background, history, state of the art of methadone in Europe

•evidence of effectiveness •best clinical practice •programme organisation •monitoring and evaluation

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Process

• Draft guidelines

• Working group of European experts from different professional and national background

• Second draft to wider audience

• Final report

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Pharmacology

• Synthetic opioid agonist methadone hydrochloride similar to morphine (6-dimethylamino-4, 4-diphenyl-3-

hepatone hydrochloride) • Elimination half-life of 24-36 hours• Oral administration• 1 daily dose

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Scientific Evidence 1

• Safe substitution treatment• Effective in retaining people in

treatment• Reduces the risk of HIV infection • Improves both physical and mental

health and the quality of life of the patients and their families

• Reduces criminal activities

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Scientific Evidence 2

• Cost-effective 1:3 (NTORS-UK)

• Positive results over different cultural contexts, including the US, Europe, Australia, SE Asia (Hong Kong, Thailand)

(Preston, 1996; Farrell, 1994; Mattick, 1996; Ward, 1998, WHO, 1998).

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Treatment plans and goals (WHO, 1990)

Short-term detoxification: decreasing doses over one month or less

Long-term detoxification: decreasing doses over more than one month

Short-term maintenance: stable prescribing over six months or less

Long-term maintenance: stable prescribing over more than six months.

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Detoxification or maintenance?

• Historically as maintenance thearpy• Assessment of level of dependence

• Treatment plan • individual decision between doctor

and patient•assessing the needs of the patient •goal should be to maximise patient’s

health

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Benefits of MT can be maximised by

• retaining clients in treatment

• prescribing higher dosages of methadone

• orientating programmes towards maintenance

rather than abstinence

• offer counselling, assessment and treatment

of psychiatric co-morbidity

(Preston, 1996; Farrell, 1994; Mattick, 1996; Ward, 1998).

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Low threshold programmes

Are easy to enter Harm reduction oriented Have as primary goal to relieve

withdrawal symptoms and craving and improve the quality of life of patients

Offer a range of treatment options

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High threshold programmes

More difficult to enter Abstinence oriented No flexible treatment options Adopt regular (urine) controls Inflexible discharge policy Compulsory counselling and

psychotherapy

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Comprehensive treatment

• Not an isolated intervention • Identify and address other problems

(medical, social, mental health or legal) • Staff or through liaison with other

services • A multidisciplinary approach is essential

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Staff requirements

• Specific (continuous) training on the pharmacological, toxicological, medical and psycho-social aspects of the treatment

• Non-judgmental attitude • Supervision and regular team meetings• Multi-disciplinary team and

collaboration• Clear division of tasks

32

Service requirements

• A safe place• Easily accessible (centrally located and

flexible opening hours) and clean• Confidentiality of patient information • A good rapport between staff and

patient• Clear rules and regulations

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Special groups

• Pregnant women• Young people• People with HIV/AIDS• People in hospital• People with mental health problems• Minority ethnic groups• Multiple-drug users

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Best clinical practice

• Assessment of addiction and the degree of dependence

• Induction, treatment plan and initial dosage determined with care

• Information about the pharmacological effects of methadone and about the potential risk of overdose

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Induction 1

What’s the right dose?

Purity of heroin varies

Methadone is a long acting opiate

Too much methadone can be fatal

Insufficient methadone is not effective

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Induction 2

• Assessment of opioid dependence– personal interview– medical assessment– urinalysis

• The severer the dependence, the higher the dosage and the longer the treatment

37

Maintenance or detoxification

• Assessment of level of dependence• Treatment plan:

– individual decision between doctor and patient

– assessing the needs of the patient – goal should be to maximise patient’s

health

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Evaluation

• Monitoring activities integral part• Clear definition of goals• Evaluations of outcomes• Qualitative measures • Cost-benefit analysis

39

Conclusions 1

• Opiate addiction highly prevalent• Substitution treatment all over

Europe• Predominantly methadone

substitution treatment• Wide variety in practice accross

countries

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Conclusions 2

• Large scientific body of evidence of effectiveness

• Comprehensive treatment• Maintenance rather than

detoxification• Higher rather than lower dosages• Public health approach

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Conclusions 3

• Methadone treatment proven effective in containing:– Spread of HIV– Overdose mortality– Drug related social harm– Criminal activity– Cost-benefit

42

AbstinenceAbstinence

Heroin useHeroin use

Rel

apse

Ces

satio

n

Dependence Dependence

Substitution TreatmentSubstitution Treatment•Methadone•Buprenorphine•LAAM•Tincture of Opium

DetoxificationDetoxification•Agonist assisted•Partial agonist assisted•Symptomatic treatment•Rapid detoxification

Harm ReductionHarm Reduction•Education about overdose•Hepatitis B immunisation

Relapse PreventionRelapse Prevention•Residential (drug-free)•Outpatient (drug-free)•Psychological counselling•Support group•Antagonist (eg. naltrexone)

Ali and Gowing 2001