New clinical guidelines for opioid substitution treatment (OST) in Ireland have been published.1 They were developed by a working group comprising the Health Service Executive (HSE), the College of Psychiatrists of Ireland, the Irish College of General Practitioners, the Pharmaceutical Society of Ireland and HSE addiction services. The group reviewed all relevant national and international guidelines and consulted stakeholders in the addiction services. Professor Michael Farrell, director of the National Drug and Alcohol Research Centre at the University of New South Wales provided expert opinion throughout the process.

This comprehensive document is divided into seven sections, each covering all different aspects of OST treatment: the guiding principles; rehabilitation and psychosocial components of OST; principles and key operational stages of pharmacological interventions of OST; assessment of dependence and management of OST; drug testing; OST and associated health considerations; and specific treatment situations and populations.

The guidelines emphasise the importance of clinical governance and standards in OST treatment. Governance looks to put the service user first, working towards delivering a quality service and maintaining patient safety (see Appendix 1, p. 70). The need for properly qualified and accredited staff to deliver the right interventions is also spelt out.

There is an acknowledgment of the importance of family/carers in the treatment process. The guidelines recommend that services should proactively engage with family/carers to enable them to be active partners in the treatment, with the service user’s consent. This is particularly important for teenagers. The guidelines also note that this group can have their own issues, distinct from the service user, which may need to be addressed.

The document includes in-depth information for prescribing buprenorphine/buprenorphine-naloxone. The guidelines state that due to the safer profile of these formulations, induction and stabilisation can be quicker. They can be commenced by Level 2 general practitioners (GPs) and HSE addiction clinic prescribers. Other recommendations include:

• The first dose must not start until the service user experiences withdrawal symptoms (usually eight hours after last taking heroin or 24 hours after the last dose of methadone), as there is a risk of precipitated withdrawal.
• Precipitated withdrawal occurs when buprenorphine displaces other opiates from the opioid receptors and, as it is only a partial opiate agonist, this results in a rapid reduction of the effects of opiates, which in turn results in severe withdrawal symptoms.
• The recommended starting dose is between 4 mg and 8 mg daily, which can be increased by between 2 mg to 8 mg daily (usually 4 mg).
• The dose can be increased up to a maximum of 24 mg for buprenorphine/naloxone or 32 mg for buprenorphine alone.
• The stabilisation phase for these drugs is usually between four to six weeks, shorter than methadone, usually between 16 mg and 24 mg.
• Maintenance on buprenorphine/buprenorphine-naloxone can be overseen by Level 1 GPs.
• While it may vary by individual service user, a suitable maintenance dose will reduce or eliminate withdrawal symptoms and cravings over a 24-hour period.
• Once the service user is stable, the frequency of supervision and/or dispensing can be reduced, for example, buprenorphine-naloxone can be taken on alternate days (e.g. 8 mg daily dose can be taken as 16 mg on alternate days). However, the dose given on any one day cannot exceed 24 mg.
• All service users on long-term prescriptions should have regular care plan reviews (three monthly) within a wider treatment plan of social and psychological support.
• For detoxification, buprenorphine/buprenorphine-naloxone can be reduced by 2 mg every two weeks. Detoxification from this formulation is often quicker than with methadone. 

The guide states that evidence shows that contingency management (CM), for example using incentives such as take-home OST, is proven to improve outcomes in this patient group. However, it does have some disadvantages and it is therefore recommended that it be provided as part of a structured care plan in combination with other evidence-based interventions. The guidelines directly address the issue of diversion. They state that take-home OST as an incentive for CM should be balanced against the known positive benefits to the service user and any potential risks, such as unsafe storage in homes or diversion. The criteria for deciding whether or not a client is suitable for take-home OST is based on known risk factors, and an assessment of the individual service user and community safety, but also clinical stability. In the guidelines, clinical stability is defined as:

• Adherence with treatment directives
• No recent problematic drug or alcohol use
• Stable housing
• Stable dose of methadone (with allowances for occasional dose increases)
• Emotional stability and good insight into safety issues 

Contraindications to receiving take-home OST are:

• Repeated intoxication on presentation at the clinic/pharmacy
• Children living in the patient’s household, with concerns that they may be at risk of harm
• Current chaotic and unpredictable behaviour
• Assessed as at risk of self-harm
• Current hazardous use of drugs (including benzodiazepines or alcohol), as this can increase risks of fatal overdose 

A brief summary of the entire guide contents and all key points are reproduced below.

1. Guiding principles

Contents: good governance; therapeutic alliance; and information sharing (p. 11). The key points are:

• OST plays an intrinsic role in supporting patients to recover from opioid dependence.
• OST should be provided at the lowest level of complexity, matching the patient’s needs, and as close to home as possible.
• Service users should be fully involved in the development of their care plans, setting goals and reviewing progress.
• It is good practice to involve service users in the design, planning, development, and evaluation of services.
• One of the strengths of drug treatment and rehabilitation in Ireland is the valuable partnership between statutory drug treatment services and the community/voluntary sectors.
• Services should be proactive in their engagement with family members, with the recognition that they have distinct needs from service users.
• A good therapeutic alliance is crucial to the delivery of any treatment intervention.

2. Rehabilitation and psychosocial components of OST

Contents: OST as a component of rehabilitation; integrated care plans; psychosocial interventions; key steps involved in the integrated care pathway; (p. 13). The key points are:

• All drug users entering treatment:

• • Should have a care plan based on assessed need, which is regularly reviewed.
  • Should have full risk assessments to evaluate immediate health concerns, mental health issues, and risks to children.
  • Should have their needs assessed across the domains of drug and alcohol use, health, offending, and social functioning.

• Key working is a basic delivery mechanism for interventions in addiction services.
• Psychosocial interventions:

• • Are a fundamental part of drug and alcohol treatment.
  • Are the mainstay of treatment for the use of cocaine and other stimulants.
  • Can also address common associated or co-occurring mental disorders, such as depression or anxiety.

• Self-help and mutual aid approaches have been found to be highly effective for some individuals.
• Contingency management (CM), Community Reinforcement Approach (CRA), Community Reinforcement Approach and Family Training (CRAFT) and Adolescent Community Reinforcement Approach (ACRA), and family and couples interventions should be offered, where appropriate.

3. Principles and key operational stages of pharmacological interventions for OST

Contents: aims and objectives of OST; legislative requirements for prescriptions and initiation of OST (including buprenorphine/naloxone); provision of information to the patient; communication between prescriber; dispensing pharmacist and multidisciplinary team; contingency management; diversion of opioid substitution medication; supervised consumption; ongoing assessment of OST; and referral procedure for change of OST location (p. 17). The key points are:

• Good communication between the patient, the prescriber, the pharmacist, and other members of the interdisciplinary team is crucial in providing optimal treatment.
• Carers should be active partners in drug treatment, where consent is given.
• Patients should be made fully aware of the risks of their medication and of the importance of protecting children from accidental ingestion.
• Prescribing, supervision, and dispensing arrangements should also aim to minimise risks to children.
• Supervision of methadone has been proven to reduce deaths related to overdose of methadone.
• Supervised consumption needs to be available for all patients for a length of time appropriate to their needs and risks.
• Ongoing assessment and care planning is central to the treatment process.

4. Assessment of dependence and management of OST

Contents: Phase 1 assessing dependence; Phase 2 induction phase; Phase 3 stabilisation; Phase 4 maintenance; and Phase 5 detoxification (p. 26). The key points are:

• Methadone or buprenorphine, used at the optimal dose range, are both effective medicines for OST.
• Dose induction with methadone should aim to achieve an effective dose, while also exercising caution about the inherent risks of too rapid an increase.
• Dose induction with buprenorphine may be carried out more rapidly, with less risk of overdose.
• Clinicians should aim to optimise treatment interventions for patients who are not benefiting from treatment, usually by providing additional and more intensive interventions (pharmacological and psychosocial) that may increase retention and improve outcomes.
• Once stable on OST, at least one dose per week should be supervised.
• Methadone and buprenorphine are both effective in detoxification regimens.
• OST is a medical treatment and should not be used punitively, i.e. there should be no dose reduction as a sanction for ongoing illicit drug use.
• Opioid detoxification should be offered as part of a care plan to patients ready for and committed to abstinence.
• Health professionals working in isolation must ensure they maintain up-to-date good practice.

5. Drug testing

Contents: objectives of drug testing; rationale; procedures for testing; usefulness of drug testing; urine sample adulteration; supervision of urine samples; testing for alcohol and Z-drugs (p. 38). The key points are:

• Drug testing may be used as an ongoing tool for monitoring illicit drug use and adherence with prescribed medications.
• Most drug testing processes consist of two separate types of analysis: a screening test and a confirmation test.
• The clinical situation will dictate the type of testing (screening or confirmatory) and frequency of testing.
• Once a patient reaches a stable point with OST, a reduction in frequency of drug testing is recommended.
• Drug testing should be randomised where possible.
• Direct observation of urine specimen collection is not required in routine clinical practice.
• The use of oral fluid drug testing is an acceptable alternative to urine drug testing.
• Drug testing results should be shared between treatment locations and agencies, with appropriate consent, to prevent the duplication of testing.
• Addiction services, including Level 1 and Level 2 GPs, nationally should have access to an appropriately accredited laboratory for drug testing / confirmatory analysis.
• Biological fluids should be handled with appropriate standard and transmission-based precautions.
• The recommendations for frequency of testing are to be viewed as a minimum standard for all patients receiving OST. In certain clinical situations, some patients may find that more regular testing may help them reach and maintain stability.
• Stability and safer prescribing of OST is assessed on a range of criteria, drug screening being one of those. There are limitations to the value of drug testing, and clinicians need to assess stability across a range of parameters.

6. OST and associated health considerations

Contents: responses to continued drug and alcohol misuse for patients; mental health; viral infections; vaccinations; health implications for continued drug and alcohol use; pain management for drug misusers; ECG monitoring; and drug-related deaths (overdose, reducing drug-related deaths, dealing with overdose emergency) (p. 43). The key points are:

• OST should be provided with a range of other medical interventions.
• Psychosocial interventions can also address common associated or co-occurring mental disorders.
• Common mental health problems are frequent in people accessing addiction services. Interventions may need to be provided in addiction services, in conjunction with Community Mental Health Teams (CMHTs). Those with severe mental health problems should have care integrated with acute community-based secondary mental health services.
• Reducing potential harm due to overdose, blood-borne viruses, and other infections should be part of patient care.
• All drug users should be offered testing and vaccination against hepatitis A and B, where indicated. This discussion should be documented in the patient’s record.
• All drug users should be offered testing and appropriate treatment for hepatitis C and HIV infections.
• Retaining patients in high-quality treatment is protective against overdose. This protection may be enhanced by other interventions, including training drug users and their families and carers in the risks of overdose, its prevention, and how to respond in an emergency.
• Drug users who are also using alcohol in a problematic way should be offered alcohol treatments.
• Drug users who smoke tobacco should be offered smoking cessation interventions

7. Specific treatment situations and populations

Contents: hidden harm; criminal justice system (Garda custody, Drug Treatment Court, probation, prison); opiate-dependent patients in hospital; pregnancy and neonatal care; young people; older current and ex-drug users; and palliative care and life-limiting conditions (p. 57).. The key points are:

• Effective, safe and responsive services for service users involve working together and with others in teams in primary care and/or secondary care.
• Interventions must be carried out by trained and competent people with a clear understanding of the impact of problematic drug use.
• Appropriate communication and transfer of information between professionals is vital to ensure seamless care in line with the HSE consent policy.
• Assessment and evidence-based care provided by a liaison or multidisciplinary team is appropriate in many cases.
• Quality of treatment should be consistent across the criminal justice system, including prisons.
• Drug users in hospitals will require interventions that facilitate their medical treatment and, if possible, improve their engagement with drug misuse treatment.
• Clinicians working with pregnant women should aim to support the woman in achieving drug stability in order to reduce the risk of neonatal abstinence syndrome (NAS).
• Young people are likely to require different interventions compared to adults, and healthcare professionals will require specific competencies to deliver these interventions.
• Information sharing, governance, policies and practice should include guidance for clinicians working with the parents of under 18-year-old service users.
• Older drug users are likely to have increased drug-related and non-drug-related health needs. Drug users in pain will have needs for pharmacological and other interventions similar to non-drug users.

1   Health Service Executive (2016) Clinical guidelines for opioid substitution treatment. Dublin: Health Service Executive. https://www.drugsandalcohol.ie/26573/