Pharmacotherapy Policy 2005

8/14/2019 Pharmacotherapy Policy 2005

http://slidepdf.com/reader/full/pharmacotherapy-policy-2005 1/23

national



These guidelines were prepared by the IntergovernmentalCommittee on Drugs sub-committee on Methadone and OtherTreatments, and are funded by the Australian Government.

These guidelines have been prepared to provide a broadpolicy context and a framework for State and Territory policiesand guidelines that are concerned with the treatment of heroindependence with methadone, buprenorphine and naltrexone.For clinical matters associated with pharmacotherapy treatmentsplease refer to respective national clinical guidelines.

The contribution of various individuals in the drafting and reviewprocess is gratefully acknowledged.

NATIONAL

PHARMACOTHERAPY

POLICY for People Dependent on Opioids



© Commonwealth of Australia 2004

ISBN: 0 662 82455 X

“This work is copyright. Apart from any use as permittedunder the Copyright Act 1968, no part may be reproducedby any process without prior written permission from theCommonwealth available from AusInfo. Requests and inquiriesconcerning reproduction and rights should be addressed to theCommonwealth Copyright administration, Intellectual PropertyBranch, Department of Communication Information Technology

and the Arts, GPO BOX 2154, Canberra ACT or Posted athttp://www.dicta.gov.au/cca”.

Publication approval number: 3448



page 3

Both methadone and buprenorphine are listed as Schedule 8drugs in Australia. As drugs of dependence, they have strictregulatory frameworks around their use, particularly with respectto their use in the management of opioid dependence. In contrast,naltrexone is listed as a Schedule 4 drug and, as such, does nothave as many regulatory controls associated with its use. For thisreason this policy document is divided into three sections:

Section 1: addresses general treatment issues, common acrossall pharmacotherapies;

Section 2: addresses the use of the schedule 8 drugs –

methadone and buprenorphine - in the managementof opioid dependence; and

Section 3: addresses the use of naltrexone in the managementof opioid dependence.

The information contained in this policy should be read inconjunction with agreed National Clinical Guidelines for the useof methadone1 , buprenorphine2 and naltrexone maintenance3 .These clinical guidelines have been developed under the auspicesof the National Expert Advisory Committee on Illicit Drugs, inconsultation with the National Evaluation of Pharmacotherapiesfor Opioid Dependence (NEPOD), the Royal Australian Collegeof General Practitioners (RACGP) and the Australian ProfessionalSociety on Alcohol and other Drugs (APSAD).

The following pharmacotherapies for opioid dependent peopleare registered in theAustralian Register of Therapeutic Goods:

Methadone oral liquid– Methadone Syrup is registered for thetreatment of dependence on opioid drugs, and Biodone Forteis registered for the detoxi cation and maintenance treatment ofdependence on opioid drugs.

Buprenorphine sublingual tablet (Subutex)– buprenorphine isregistered for the treatment of opioid dependence, includingmaintenance and detoxi cation, within a framework ofmedical, social and psychological treatment.

Naltrexone tablet (ReVia)– naltrexone is registered asadjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids suchas diamorphine (heroin) and morphine.

ReVia tablets are listed in the Pharmaceutical Bene ts Schedule(PBS) for use within a comprehensive treatment program foralcohol dependence with the goal of maintaining abstinence.The PBS notes that naltrexone is contraindicated in patientsreceiving opioid drugs.

1 Clinical Guidelines and Procedures for the use of Methadone in the Maintenance Treatment of Heroin Dependence, Commonwealth of Australia (2003)2 National Clinical Guidelines and Procedures for the use of Buprenorphine in the Treatment of Heroin Dependence, Commonwealth of Australia (2001)3 Clinical Guidelines and Procedures for the use of Naltrexone in the Management of Opioid Dependence, Commonwealth of Australia (2003)



INTRODUCTION 6

Management of Drug Dependence 6

Pharmacotherapies for Opioid Dependence 7

1. Methadone 7

2. Buprenorphine 7

3. Naltrexone 8

SECTION 1 TREATMENT WITH PHARMACOTHERAPIES 10

1.1 Goals of Treatment 101.2 Optimising the Bene ts of Pharmacotherapy Treatment 10

1.2.1 Quality of Care 10

1.3 Assessment for Treatment 10

1.4 Informed Consent 11

1.5 Rights and Responsibilities 11

1.6 Monitoring Drug Use 11

1.7 Maintenance of Client Records 11

1.8 Aftercare and Assertive Follow-up 12

1.9 Accreditation/Service Standards 12

1.10 Safe Storage and Transport 12

1.11 Management of Special Client Groups 12

1.11.1 HIV/AIDS 12

1.11.2 Hepatitis B 12

1.11.3 Hepatitis C 12

1.11.4 Prisoners 13

1.11.5 Polydrug Use 13

1.11.6 Comorbidities 13

SECTION 2 TREATMENT WITH SCHEDULE 8 DRUGS – METHADONE AND BUPRENORPHINE 14

2.1 Takeaway Doses 14

2.1.1 Preparation and responsibility for takeaways 14

2.1.2. Dilution of Methadone Takeaway doses 14

2.2 Facilitated Entry 15

2.3 Treatment Termination 15

2.3.1 Voluntary termination 15

2.3.2 Involuntary termination 15

2.4 Acute Pain 15

2.5 Chronic Pain 15



2.6 Transfers – Interstate 16

2.7 Overseas Travel 16

2.8 Monitoring and Regulation 16

2.9 Authorisation of Prescribing Methadone and Buprenorphine 17

2.10 Approval of Pharmacotherapy Prescribers 17

2.11 Other Service Providers 17

2.12 Methadone 17

2.12.1 Methadone Dosing 17

2.12.2 Methadone in Pregnancy 17

2.13 Buprenorphine 18

2.13.1 Buprenorphine Dosing 18

2.13.2 Buprenorphine Withdrawal 18

2.13.3 Buprenorphine Maintenance 18

SECTION 3 NALTREXONE 20

3.1 Suitability of Naltrexone Treatment 20

3.2 Opioid Withdrawal Treatment 20

3.3 Naltrexone Relapse Prevention Treatment 20

3.4 Medication Compliance 20

3.5 Overseas Travel 20

3.6 Diverted Naltrexone 20



page 7

Pharmacotherapies for OpioidDependence

There are now a number of pharmacotherapies for themanagement of opioid dependence available in Australia:

1. MethadoneMethadone was developed in Germany in 1941 for the reliefof pain. It was used as a treatment for heroin dependence

in New York in 1964 and was subsequently introducedin Australia for the same purpose in 1969. Methadone iscurrently the most common pharmacotherapy used in Australiaand is recognised nationally and internationally as an effectivemethod for treating opioid dependence.

Methadone is a synthetic opioid agonist primarily used inmaintenance therapy and may also be used as a withdrawalagent for those dependent on opioids. Methadone reducesthe use of heroin through cross tolerance which results in areduction of heroin withdrawal symptoms; less desire to useheroin; and reduced euphoric effect when heroin is used.Methadone is taken orally on a daily basis.

Methadone is listed under Schedule 8 of the Standard for theUniform Scheduling of Drugs and Poisons and is registered asMethadone Syrup (5mg/mL) for the treatment of dependenceon opioid drugs, and Biodone Forte (5mg/mL) for thedetoxi cation and maintenance of dependence on opioiddrugs. Methadone tablets and injections are registered inAustralia for analgesia but not for the treatment of opioiddependency.

A research report ‘ produced by the National Drug andAlcohol Research Centre4 , based on a review of the nationaland international medical and scienti c literature, foundamongst other things that:

- “Methadone maintenance treatment has beendemonstrated to be more effective than either no-treatment, drug-free counselling and rehabilitation,placebo medication, and detoxi cation/withdrawal inrandomised controlled trials.”

- “Methadone maintenance therapy is associated witha lower risk of death compared to that associated withno treatment, drug free treatment or detoxi cation/withdrawal.”

- “Methadone maintenance treatment repays $4-$5 to thecommunity in terms of reduced health care costs, reducedcrime and other bene ts for every $1 spent on it.”

At June 2001 there were approximately 32,000 clients inmethadone treatment in Australia – an average annual growthrate of approximately 14% per annum since 1985-86. Althoughthe rate of growth has been different in each jurisdiction andhas varied between the public and private health sectors,there has generally been an increasing reliance on the privatesector for the provision of methadone services in Australia. Thenumber of clients attending private prescribers has increased byapproximately 20% per annum since 1985-86.

2. BuprenorphineBuprenorphine (Temgesic5 ) has been used around the world(including Australia) since the 1980s as a pain-relieving drug.The use of buprenorphine for treating opioid dependencestarted in the 1980s and buprenorphine has since beenapproved for the treatment of opioid dependency in severalcountries around the world, including France, which becamethe rst country to use buprenorphine as a substitution therapyin 1996. By 1998, 55,000 patients were in buprenorphinetreatment in France.

Buprenorphine is often called a mixed opioid agonist/antagonist drug but is more accurately described as a partialopioid agonist with high receptor af nity. It has actionssimilar to the full agonist drugs but with less ef cacy such thatincreases in dose have progressively less increase in effect untilall receptor sites are saturated. Further dose increases beyondthat point or the consumption of other opioids have little or nofurther effect because of the receptor saturation and the factthat buprenorphine is not easily displaced.

This is a true receptor blockade state and is reached in opioidtolerant people below the threshold of loss of consciousnessand suppression of respiration which is usually associated withopioid overdose. This action appears to make buprenorphine

safer than methadone in overdose and also protects fromoverdose effects if other opioids are taken in addition toprescribed buprenorphine. It is also the basis of the supposedantagonist action as withdrawal symptoms may be observedif buprenorphine is taken after another opioid and displaces itfrom receptors.

Buprenorphine (Subutex) was included on the AustralianRegister for Therapeutic Goods in October 2000, underSchedule 8 of the Standard for the Uniform Scheduling ofDrugs and Poisons for use as a maintenance and detoxi cationtreatment. Buprenorphine detoxi cation or maintenance

4 Mattick, R.P and Hall, W.H. (1999). Overview of the effectiveness of methadone maintenance treatment. National Drug and Alcohol Research Centre.5 Not used for treatment of opioid dependence.



age 8

treatment is only suitable for people who are clinically assessedas being opioid dependent.

Buprenorphine is considered an important alternative tomethadone for the treatment of opioid dependence, andmay attract more people into treatment. Buprenorphine offersadvantages in terms of safety, the relative ease of withdrawal,the need for less frequent administration, ease of transition intoother treatments and exibility of treatment.

3. NaltrexoneIn the 1970s there was much enthusiasm in the USA aboutthe use of naltrexone for the treatment of opioid dependence.However, for the past decade the clinical use of naltrexonehas been quite limited. The problems which impede theuse of naltrexone include limited patient interest, dif cultieswith pre-naltrexone detoxi cation and a very high prematurediscontinuation rate once naltrexone has been initiated6 .

Naltrexone is an opioid antagonist. Antagonists bind toopioid receptors, without producing opioid effects, and blockboth the analgesic and euphoric effects of opioid agonists,such as heroin, on the receptor sites. Naltrexone is long acting

with few side effects, however patients need to become opioidfree before naltrexone is taken as it induces strong withdrawalsymptoms in people who are opioid dependent.

Naltrexone is quickly absorbed after oral administration. A50mg oral dose of naltrexone will block the effects of 25mgof IV heroin for up to 24 hours (longer for some individuals).Naltrexone is not addictive and for most people its side effectsare minimal.

Naltrexone is listed in Schedule 4 of the Standard for theUniform Scheduling of Drugs and Poisons. Naltrexone wasentered in the Australian Register of Therapeutic Goods (ARTG)

in January 1999, as ReVia lm coated tablets (50mg). ReViais registered in Australia for use as part of a comprehensivetreatment program for alcohol dependence and as anadjunctive therapy in the maintenance of formerly opioiddependent patients who have ceased the use of opioids(detoxi ed).

6 Rawson R.A, McCann, M.J., Shoptaw, S.J., Miotto, K.A., Frosch, D.L., Obert, J.L, and Ling, W., (2001). Naltrexone for opioid dependence: evaluation of a manualized psychosocialprotocol to enhance treatment response. Drug and Alcohol Review 20, 67-68

Naltrexone is not registered for use in accelerated opiatewithdrawal (detoxi cation) methods, known as rapid opioiddetoxi cation or ultra-rapid detoxi cation. The approvedAustralian Product Information for naltrexone contraindicates itsuse in “patients in acute opioid withdrawal”.



age 10

1.1 Goals of Treatment

The broad goal of treatment for opioid dependenceis to reduce the health, social and economic harms toindividuals and the community arising from illicit opioid use.Pharmacotherapies for opioid dependence should be part of acomprehensive treatment program, with access to counsellingand other ancillary services available to all individuals.

The objectives of pharmacotherapy treatment are to:

- bring to an end or signi cantly reduce an individual’s illicitopioid use;

- reduce the risk of overdose;

- reduce the transmission of blood borne diseases; and

- improve general health and social functioning, includinga reduction in crime.

These objectives are achieved by engaging and retainingpeople dependent on opioids in treatment.

1.2 Optimising the Bene ts of Pharmacotherapy Treatment

Optimising the bene ts of pharmacotherapy treatment for

opioid dependence requires a balance between access andquality. Making a drug widely available improves access,but may compromise the quality and safety of treatment.Restricting a drug to use only in specialist settings limits itsusefulness as an intervention. In general, the balance betweenaccessibility and quality is best maintained when generalpractitioners are trained to prescribe pharmacotherapies, andare able to refer patients or to consult with specialist drug andalcohol services.

Jurisdictions vary in their requirements for treatment services.Accessibility will be optimised where the model of servicedelivery involves general practitioners and other health serviceproviders, supported by specialist drug and alcohol services,with jurisdictional monitoring and regulation.

1.2.1 Quality of CareClinical care should be informed by and consistent withevidence based treatment guidelines. A quality of careapproach should include:

- the provision of information to clients, includinginformation about treatment options;

- the obtaining of informed consent;

- mechanisms for ensuring clients’ con dentiality with formalwritten consent should information need to be shared orforwarded;

- grievance procedures;

- professional development for providers;

- regular monitoring and evaluation of clients’ progress andof treatment services; and

- the opportunity for carers’ participation.

1.3 Assessment for TreatmentThe purpose of assessment is to identify clients needs,determine their suitability for treatment and establish a treatmentplan. A thorough assessment should precede all treatmentand should involve a comprehensive drug use, medical andpsychosocial history, physical and mental state examinationand, as clinically indicated, other appropriate investigations.

A medical practitioner with the knowledge and skills in thetreatment of opioid dependence should make the nal decisionabout the suitability of a person for pharmacotherapy treatment.

Treatment with methadone or buprenorphine is only suitable

for people who are clinically assessed as being opioiddependent. Where dependence does not exist, other forms oftreatment should be considered.

Section 1treatment with pharmacotherapies



page 11

1.4 Informed Consent

Legally competent clients have a common law right to maketheir own decisions about medical treatment and a rightto grant, withhold or withdraw consent, before or duringtreatment. The following principles should apply:

- The free and informed consent of each individual to undertaketreatment should be obtained before treatment begins; and

- Information should be given on all aspects of treatment,

including the clients’ obligations, prior to giving consent.

Written information should cover;

- An overview of policies and procedures of the treatmentprogram (including expectations of individual behaviourand any costs involved);

- The nature of the pharmacotherapy (how the drug works,addictive qualities, side effects and drug interactions);

- Hazards and problems associated with the use of thepharmacotherapy, including the risk of drug toxicity,

particularly if there is also use of illicit or prescribed drugs,risk of overdose and accidental poisoning of someonefor whom the pharmacotherapy was not prescribed, risksassociated with ceasing treatment including for example,the risk of overdose following naltrexone treatment andrisks associated with injecting oral preparations;

- Information about other health issues e.g. pregnancy andbreast feeding;

- Alternative treatment options; and

- Con dentiality of treatment records.

1.5 Rights and Responsibilities

Written information should be provided to each individualoutlining their rights and responsibilities in a form that theindividual can take away. Clients who cannot read shouldbe read their rights and obligations at the time they enter theprogram. A competent interpreter should be utilised for clientswho are not uent in English, and where possible, pamphletsin other languages should be available.

Written information provided to persons receiving

pharmacotherapy should cover information about the legalobligations on clients receiving pharmacotherapy treatment,

particularly as they apply to takeaway doses of these drugs,and the legal implications of using them other than prescribedand / or supplying them to others.

In accordance with applicable privacy law, there should beprocedures in place for protecting clients’ personal informationand providing clients’ access to their personal information inappropriate circumstances.

There should be a mechanism, established at the jurisdictionallevel, for resolving grievances between clients and thoseresponsible for their treatment. Clients should have the rightto access these procedures and be informed of them at thecommencement of treatment and on request thereafter.

1.6 Monitoring Drug Use

Monitoring options commonly used in Australia include self-reporting, urine testing and clinical observation. The validityand reliability of these techniques can be improved when usedin conjunction with one another.

Self-reporting, although a subjective measure, can be a useful

indicator of episodes of client drug use. Self-reporting is alsoconducive to facilitating an atmosphere of trust and goodwillbetween clinician and client.

Urine testing should only be undertaken with good reason,such as in the initial assessment of an individual, to con rm theclinical history or as part of program evaluation. Urine testingcan also be useful when clients are unstable (such as in theearly stages of pharmacotherapy treatment) and when there issome uncertainty about their drug use.

There is little evidence to support the use of drug monitoringas a deterrent against unsanctioned drug use. Urine test resultsshould be used, in collaboration with the client, to review andimprove the individual’s progress in treatment.

1.7 Maintenance of Client Records

Case records detailing clients’ clinical history and progress intreatment should be established and adequately maintained.

Jurisdictions may set minimal standards for case records. Thesestandards should cover content, quality, con dentiality, securityand access.



age 12

1.8 Aftercare and AssertiveFollow-up

At the end of pharmacotherapy treatment, continued followup assistance should be offered. The individual should beencouraged to continue contact with a counsellor/casemanager or medical practitioner.

1.9 Accreditation/ServiceStandards

Jurisdictions should have mechanisms in place to monitor andcontinually improve the quality of pharmacotherapy treatment.These mechanisms should ensure that specialist services areengaged in accreditation or formal quality improvementprograms.

1.10 Safe Storage and Transport

Jurisdictions should have policies in place to ensure safestorage and transport of drugs of dependence.

1.11 Management of SpecialClient Groups

1.11.1 HIV/AIDS Clients who are HIV antibody positive should, where possible,be managed in collaboration with specialist services andcommunity based support services.

Generally in the early stages, clients who are HIV antibodypositive are able to cope with the routine and conditionsof pharmacotherapy treatment. However, the medical,psychological and social implications of HIV/AIDS mayrequire some exibility in the arrangements for ongoingtreatment.

These clients may have a comorbid condition, such as depressionor tuberculosis, and may be treated with pharmacological agentsthat may interact with their pharmacotherapy treatment (refer toClinical Guidelines7 8 9 ).

In the terminal stages of HIV/AIDS pharmacotherapy providersmay need to work with hospice care services both in themanagement of the clients pharmacotherapy treatment and theHIV/AIDS condition.

Where partners or carers of clients with HIV/AIDS have alsohad a history of injecting drug use, additional support may berequired.

1.11.2 Hepatitis B

All clients on methadone, buprenorphine or naltrexone whoare found to have no immunity to the hepatitis B virus should berecommended to have, or be offered, hepatitis B vaccinations.Clients who are chronic carriers of hepatitis B should bereferred to a gastroenterologist for specialist assessment andfollow-up.

1.11.3 Hepatitis CHepatitis C spread through injecting drug use is a major publichealth concern.

It is likely that a high percentage of individuals entering

pharmacotherapy programs will be hepatitis C positive. Testingwhere clinically indicated should be available for all thosewho request it. Where an individual has been infected withhepatitis C it is important to ascertain their hepatitis B status asco-infection with hepatitis B may cause the illness to be moreaggressive.

Education and counselling should be offered to explain theconsequences of hepatitis C infection and to reduce high-riskbehaviour and minimise the spread of the virus. Informationshould include advice on reduction in hazardous use of alldrugs (including alcohol) and the management of ill healthdue to hepatitis C. Clients should be advised against sharing

injecting equipment (including tourniquets, spoons andsolvents), as well as razors, toothbrushes or other instrumentswhich may be vehicles for the exchange of blood.

Service providers should be aware that there are still manygaps in our knowledge about hepatitis C but information isaccumulating rapidly. A report prepared by the NationalHealth and Medical Research Council10 provides up-to-dateinformation on the detection and management of hepatitis C.

7 Clinical Guidelines and Procedures for the use of Methadone in the Maintenance Treatment of Heroin Dependence, Commonwealth of Australia (2003)8 National Clinical Guidelines and Procedures for the use of Buprenorphine in the Treatment of Heroin Dependence, Commonwealth of Australia (2001)9 Clinical Guidelines and Procedures for the use of Naltrexone in the Management of Opioid Dependence, Commonwealth of Australia (2003)10 Commonwealth of Australia, National Health and Medical Research Council. A strategy for the detection and management of hepatitis C in Australia (1997).



page 13

1.11.4 PrisonersThis client group warrants special consideration to providereduced risk to community safety and health uponreassimilation to the community, as well as increased wellbeing and improved social functioning of clients.

Pharmacotherapy treatment with methadone or buprenorphinemay be appropriate for certain prisoners. These include:

- those receiving pharmacotherapy treatment at the time ofimprisonment;

- those who are opioid dependent at the time ofimprisonment and not receiving treatment;

- those who continue unsanctioned use of opioids in prisonin a manner which constitutes a signi cant risk of harm;and

- those assessed with a high probability of returning todependent opioid use upon release, because they are atsigni cant risk of overdose due to their reduced toleranceto illicit opioids developed during imprisonment.

Prisoners who have been through detoxi cation, should beconsidered for naltrexone treatment.

Criteria used to assess prisoners for pharmacotherapy treatmentmay differ from those used in the community. Speci cwritten criteria should be developed regarding the use ofpharmacotherapies in prisons.

Con dentiality of medical records of prisoners onpharmacotherapy treatment should receive specialconsideration so that these records are used for the clinicalmanagement of the individual while in custody, not forcustodial purposes. No prisoner should be forced to acceptpharmacotherapy treatment or have treatment discontinued fordisciplinary reasons.

However, there could be a range of other constraints that mayimpact on the implementation of pharmacotherapy treatmentfor people in prison and in the criminal justice system.

1.11.5 Polydrug UseClients who are using alcohol or other non-opioid drugsin a potentially harmful way at the time of their entry topharmacotherapy treatment should be counseled on thedangers of intoxication, the harms of polydrug use, includingincreased risk of overdose, and on ways to reduce or stophazardous use of alcohol and other drugs.

Service providers also need to be aware thatpharmacotherapy clients may develop signi cant new alcoholand other drug use problems. Some clients mistakenly believethat once on methadone, buprenorphine or naltrexone they willnot develop other drug dependencies. This view should beaddressed at induction and service providers should be alert tothe possible development of new dependencies, and the needfor appropriate interventions with such clients.

Clients who have multiple drug dependence should, wherepossible, be managed in specialist services that providecomprehensive, care. Options for these clients include

selective detoxi cation.

1.11.6 ComorbiditiesA signi cant proportion of people presenting forpharmacotherapy treatment will have co-occurring mentalhealth problems.

Clear referral procedures and models of shared care need tobe developed between drug and alcohol services and mentalhealth services.



page 15

2.2 Facilitated Entry

The assessment and admission into treatment of the followinggroups, should be expedited in their interests and the interest ofpublic health:

- opioid users who are HIV positive, and their opioid usingpartner;

- opioid users who are chronic carriers of hepatitis B andtheir opioid using partner;

- pregnant opioid users and their opioid using partner; and

- individuals who are transferred from one setting to another,e.g. newly released prisoners who have been undergoingbuprenorphine or methadone treatment while in custody orindividuals recently released from a correction setting andnot in treatment.

2.3 Treatment Termination

The majority of terminations are initiated at the request of theclient. In instances where clients are involuntarily withdrawnfrom treatment the nal decision to discontinue methadoneand buprenorphine treatment is the responsibility of theprescribing medical practitioner in consultation with the client.The jurisdictional authority responsible for controlling the supplyof methadone and buprenorphine must be noti ed when thetreatment of each client is terminated.

2.3.1 Voluntary terminationDose reductions should be made in consultation with the client.In general, the slower the rate of reduction, the less severeare the effects of withdrawal. Continued reduction of dose

producing or precipitating physical or psychological distressfor the client is usually counter-productive. During methadonewithdrawal, therefore, dose reduction should occur at a ratethat does not cause physical or psychological distress. It maybe appropriate to maintain a client at a reduced dose for aperiod until the client feels comfortable recommencing thereduction regime. Clients usually bene t from psychosocialsupport, including counselling, at this time.

- The Clinical Guidelines and Procedures for Methadone11 or Buprenorphine12 should be consulted for a exibleapproach to dose reduction.

2.3.2 Involuntary terminationRather than discharging a client from a methadone orbuprenorphine program because of behavioural problems, theissue may in some instances, be resolved by referring the clientto another program. Clients who are to be discharged fromtreatment must be advised of the risks of illegal drug use, andinformed of other treatment options.

Where the client is to be involuntarily withdrawn frommethadone or buprenorphine treatment, reduction in dosage

should be gradual and implemented, where possible, withcounselling and support.

Rapid dose reduction or abrupt cessation of treatment may bewarranted in cases of violence, assault or threatened assaultagainst staff or clients associated with the treatment program.In these circumstances the client should be offered referral toother treatment options.

2.4 Acute Pain

Methadone or buprenorphine clients admitted to hospital should

have their methadone/buprenorphine treatment continued. Formore detailed information refer to the Clinical Guidelines andProcedures for Methadone11 or Buprenorphine12 .

Orally administered analgesia is the preferred option for clientsreceiving methadone or buprenorphine, however injectableanalgesia should not be withheld where clinically indicated.

2.5 Chronic Pain

People with chronic pain conditions who experiencedependence related problems may bene t from methadoneor buprenorphine maintenance treatment. The patientswith chronic pain for whom methadone or buprenorphinemaintenance may be considered include those:

- using illicit drugs (heroin) in addition to prescribed analgesics;

- using large amounts of analgesics gained from multiplesources in an unsanctioned way; and

- unable to control their analgesic use (taking more andmore) despite strategies such as having one nominatedprescriber, being dispensed small quantities of opioid eachtime, and dispensing frequently eg daily or second daily.A multi disciplinary approach is required for these peopleincluding representation from pain clinics or appropriatemedical practitioners in drug and alcohol services.

11 Clinical Guidelines and Procedures for the use of Methadone in the Maintenance Treatment of Heroin Dependence, Commonwealth of Australia (2003)12 National Clinical Guidelines and Procedures for the use of Buprenorphine in the Treatment of Heroin Dependence, Commonwealth of Australia (2001)



age 16

2.6 Transfers – Interstate

The transfer of people receiving methadone and buprenorphinetreatment from one State/Territory to another should be arrangedin accordance with the policies and procedures of eachjurisdictional authority. Under usual circumstances transfer shouldnot occur until arrangements have been nalised and this can takeup to 4 weeks. A letter containing the following details shouldarrive at the new destination, prior to the arrival of the individual:

- identifying information (including photograph);

- methadone/buprenorphine dose;

- exact dates of transfer; and

- relevant clinical information as required by each jurisdiction.

2.7 Overseas Travel

Generally, takeaway doses should only be provided forthe shortest period necessary for the individual to reach thedestination.

The following guidelines should apply to takeaway doses foroverseas travel:

- where takeaway doses are required, the prescribermust contact the foreign consulate or embassy (for allcountries to be visited) to clarify the country’s position onforeigner’s entering the country in possession of prescribedmethadone or buprenorphine.

- the prescriber should ensure that the individual satis es theforeign consulate’s requirements in respect to process ordocumentation.

Provided there are no restrictions on entering the countryof destination in possession of prescribed methadone orbuprenorphine, authorisation for the provision of takeawaydoses must be obtained from the State/Territory authorityresponsible for the control of methadone or buprenorphine.The authority will consider the takeaway request in view ofpublic and personal safety issues and in light of the justi cationprovided by the prescriber.

It is strongly recommended where approval is given fortakeaway doses that the embassy or consulate of all of the

countries to be visited be contacted to con rm any specialrequirements for personal importation of methadone orbuprenorphine (e.g. number of doses permitted). Usually adoctor’s prescription or letter will be adequate to present toCustoms to con rm that the drugs are required for the treatmentof a medical condition and possession is in accordance withAustralian laws. However, if the overseas authorities require aletter from the Australian Government, this must be obtainedfrom the Therapeutic Goods Administration (TGA).

The TGA require at least ten (10) working days to processany requests. To contact the Treaties and Export Section ofthe TGA phone (02) 6232 4321 or write to The Manager,

Therapeutic Goods Administration, MDP 88, PO Box 100,WODEN ACT 2606.

Instructions as to the purpose and use of the methadone orbuprenorphine should be both in English and the language ofthe country/countries to be visited.

2.8 Monitoring and Regulation

Each jurisdiction will be responsible for central monitoring andregulation of methadone and buprenorphine prescribing.

The Australian Government will be responsible for collatingnational treatment data with respect to methadone andbuprenorphine, this data will be collected and provided byjurisdictions.

The following data should be collected by jurisdictions on anannual basis:

- number of clients registered in buprenorphine andmethadone.

- number of clients registered with a public prescriber,private prescriber and prison medical services.

- a breakdown on the basis of dosing points, ie publicclinics, private clinics, community pharmacies andcorrectional facilities.



page 17

2.9 Authorisation of PrescribingMethadone and Buprenorphine

Jurisdictions should have a formal mechanism to authorise theprescribing of methadone and buprenorphine to individualpeople dependent on opioids. Central jurisdictional records ofthese individual authorisations should be maintained.

2.10 Approval of PharmacotherapyPrescribers

A medical practitioner intending to prescribepharmacotherapies for the treatment of opioid dependenceshould have knowledge and skills in the assessment andtreatment of drug dependence.

Jurisdictions should develop professional training programsfor prescribers intending to prescribe methadone andbuprenorphine and assess the competence of medicalpractitioners wishing to be approved as prescribers.

The number of clients that doctors are approved to treat should

be determined by:- the expertise and experience of the doctor in treating drug

dependence;

- the accessibility of the doctor to the individual;

- whether the doctor is working full-time or part-time in thetreatment of opioid dependence; and

- the type of clients and type of setting in which thedoctor is providing treatment, including for example, theavailability of other clinicians and ancillary services.

2.11 Other Service Providers

All service providers contributing to the treatment of opioiddependence should receive adequate orientation, training,support and supervision. This includes nurses, pharmacists andcounsellors.

2.12 Methadone

2.12.1 Methadone DosingMethadone can be dispensed in syrup or liquid form andshould be taken orally under supervision. Physeptone tabletsinstead of methadone syrup or liquid should only be dispensedin exceptional circumstances - refer to jurisdictional guidelinesfor further information. Physeptone tablets are registered inAustralia for analgesia but not for the treatment of opioid

dependency.For further information regarding dosing, please refer to theClinical Guidelines and Procedures for Methadone13 .

2.12.2 Methadone in PregnancyAntenatal care should be managed, where possible, incollaboration with obstetric services, which specialise in themanagement of drug dependency. Some women may beinitially reluctant to advise other health practitioners of thefact that they are on a methadone program. Clients shouldbe counselled about the bene ts of a partnership approach

between methadone service providers and obstetric services.Pregnancy affects the metabolism of methadone and it maybe necessary to increase the individual’s daily dose and/or tohave a divided daily dosing regimen.

Many women want to decrease their dose during pregnancy.Withdrawal during pregnancy and/or a return to unsanctionedopioid use are associated with risks. In addition there issome clinical research evidence that the nal level of doseof methadone does not correlate well with the occurrence ordegree of neonatal withdrawal. These aspects need to bediscussed with the client. Clients should be closely monitoredthrough pregnancy and in the early post natal period. If areduction in methadone dose is to occur the preferred time isduring the second trimester of pregnancy.

13 Clinical Guidelines and Procedures for the use of Methadone in the Maintenance Treatment of Heroin Dependence, Commonwealth of Australia (2003)



age 18

2.13 Buprenorphine

2.13.1 Buprenorphine DosingBuprenorphine is available in tablet form and should be takensublingually under supervision.

It is noted that the future role for Suboxone (a combination ofbuprenorphine and naloxone) in pharmacotherapy treatmentawaits the approval and registration of this drug combinationby the Australian Government.

2.13.2 Buprenorphine WithdrawalBuprenorphine can be used to withdraw people from heroin,methadone and other opioids. Where possible people beingwithdrawn from opioids should be linked with effective post-withdrawal treatments and aftercare.

The appropriate starting dose of buprenorphine andduration of withdrawal treatment will vary according to theclinical presentation of each individual. Takeaway doses ofbuprenorphine for people being withdrawn from heroin shouldonly be provided in exceptional circumstances and subject tojurisdictional guidelines.

2.13.3 Buprenorphine MaintenanceBuprenorphine has been shown to be an effective opioidsubstitution treatment and can be used as an alternativeto methadone for long-term maintenance treatment.However caution should be exercised in the prescribing ofbuprenorphine to people under the age of 18 years and useduring pregnancy and breast-feeding is a contra-indication inthe prescriber information for buprenorphine (refer to NationalClinical Guidelines and respective jurisdictional policies and

regulations).For each individual, the aim is to arrive at an effectivemaintenance dose using safe dose increments. Doseincreases should be conditional upon the individual beingclosely monitored by an experienced clinician for signs ofintoxication or toxicity particularly if there is concurrent use ofbenzodiazepines or alcohol. Clients can have buprenorphinedoses increased quite quickly without toxicity, and there issome evidence that slow induction may cause treatment failureas patients leave treatment because the buprenorphine dose

14 National Clinical Guidelines and Procedures for the use of Buprenorphine in the Treatment of Heroin Dependence, Commonwealth of Australia (2001)

is too low. A balance between toxicity and rapid inductionshould be sought. Buprenorphine doses should only bechanged under the prescriber’s instructions and after discussionwith the individual.

On each occasion that a prescription for buprenorphine isprovided or renewed, the prescriber should personally assessthe individual’s progress.

For further information regarding dosing refer to the NationalClinical Guidelines and Procedures for Buprenorphine14.



age 20

3.1 Suitability of NaltrexoneTreatment

Naltrexone is indicated as an adjunctive relapse preventiontreatment in people who have withdrawn from opioids andwho are seeking to remain abstinent.

3.2 Opioid Withdrawal Treatment

While naltrexone can be used to withdraw people from heroin,methadone and other opioids it is not registered in Australiawith the Therapeutic Goods Administration for this purpose.

The drug information provided by the pharmaceutical

company marketing naltrexone lists opioid withdrawal as acontraindication.

Where jurisdictions have produced clinical guidelines forthe use of naltrexone in opioid detoxi cation prepared byaccepted clinical experts in the eld, the procedure should onlybe conducted according to the guidelines and consistent withthe recommendations in the national clinical guidelines15 . Theguidelines would apply in facilities that have the capacity toretain people as inpatients in the event of severe withdrawal,and only in a facility following the drugs approval for use indetoxi cation by that facility’s drug review committee or otherformal approval mechanism. Patients should be properly

informed and consent obtained, which includes informationthat the use of naltrexone in detoxi cation is off indication.

3.3 Naltrexone RelapsePrevention Treatment

If an individual is physiologically dependent on opioids theyneed to be detoxi ed before starting naltrexone. To avoidinadvertently precipitating a withdrawal reaction it is desirableto perform a naloxone challenge test prior to the rst dose ofnaltrexone.

Section 3

Patients should be provided with information regarding risksassociated with cessation of naltrexone and return to opioiduse, in particular the increased risk of overdose.

On each occasion that a prescription for naltrexone isprovided or renewed, the prescriber should personally assessthe individual.

People receiving naltrexone maintenance treatment shouldhave access to a comprehensive range of psychosocialtreatments and supports.

3.4 Medication Compliance

Naltrexone is reported to be most effective in clients who arehighly motivated with good social support and who take thedrug as part of a comprehensive occupational rehabilitationprogram, behavioural contract, or other compliance enhancingprotocol.

Supervised dosing involving a supportive parent, partneror friend may, for some patients, improve compliance withnaltrexone treatment.

3.5 Overseas Travel

As with other Schedule 4 drugs it is recommended that peopleusing naltrexone obtain a letter from their doctor to present toCustoms, the letter should state that the drug is required for thetreatment of a medical condition. It is also recommended thatthe embassy or consulate of all the countries to be visited becontacted to con rm if the drug is permitted in their country.

3.6 Diverted NaltrexoneThere are signi cant risks associated with diverted naltrexone.These include precipitation of acute opioid withdrawal in athird person.

The prescriber should be satis ed that the prescribednaltrexone will be properly cared for, administered as directedand that there is minimal risk of diversion.

15 Clinical Guidelines and Procedures for the Use of Naltrexone in the Management of Opioid Dependence. Commonwealth of Australia (2003).

naltrexone

Pharmacotherapy Policy 2005

Documents

Transcript of Pharmacotherapy Policy 2005