Prescribing of medication

Substitute medication and medication for the prevention of relapse should only be prescribed by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (who have undergone additional training in such treatment and are supported by a specialist team for updates and supervision).

Local Drug and Alcohol services

Contact details for local services and resources for patients are available from MyhealthDevon here.

Guidance

Refer to your local service’s guidance for information on prescribing and administration of medicines for opioid dependence:

• Livewell Southwest prescribing policy for the management of substance misuse

Drug Misuse and Dependence: UK Guidelines on Clinical Management (DHSC, issued 2017) The 'Orange Book' provides guidance for clinicians on the treatment of drug misuse and drug dependence.

Oral methadone and buprenorphine recommendations (DHSC, issued 2024) Updated recommendations on the choice between and the use of oral methadone and buprenorphine in opioid substitution therapy to supplement the Orange Book.

NICE CG51 - Drug misuse: psychosocial interventions (July 2007)

Supervised consumption

NICE TA114 published in 2007 recommends methadone and buprenorphine (oral formulations) as options for maintenance treatment for opioid dependence. TA114 states these medicines should be administered daily, under supervision, for at least the first 3 months. Supervision should be relaxed only when the patient's compliance is assured. The UK guidelines on drug misuse and dependence (‘the Orange book’) state that the duration of supervised consumption should be dependent on assessed clinical need and should not be applied in an arbitrary way. Refer to your local service’s guidance for further information.

Pain management in opioid dependence

For the management of pain in substance misuse disorders, refer to formulary guidance here.

Interactions

Specialist services should notify the person’s GP when treatment is initiated, so that GPs are aware of potential interactions when prescribing other medicines. Specific information regarding potential interactions can be found in the BNF and individual product SmPCs.

Buprenorphine or methadone and drugs acting on the central nervous system (CNS) (including gabapentin and pregabalin): use of two or more drugs that have effects on the CNS increases the risk of CNS depressant effects (which could range from sedation to unconsciousness, coma, respiratory depression, and/or cardiovascular depression)

MHRA Drug Safety Update (March 2020): Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression

Opioid substitution therapy

Sublingual buprenorphine

• Sublingual tablets sugar free 400micrograms, 2mg, 8mg (£34.80 = 8mg x 3 daily)

Indications and dose

• Substitution treatment for opioid drug dependence in adults and adolescents aged 16 years or over
  • By sublingual administration, initially, 0.8–4mg on day 1, adjusted if necessary by 2–4mg daily to usual dose of 12–24mg daily (maximum 32mg daily); withdraw gradually
• Not to be used in primary care for the treatment of pain

Notes

1. Sublingual buprenorphine should only be prescribed by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (see above).
2. Sublingual buprenorphine is not interchangeable with Espranor (below), as the bioavailability of products differ. Espranor has a higher bioavailability (25-30%) compared to Subutex.
   1. Once the appropriate dose has been identified for a patient with a certain product (brand), the product cannot readily be exchanged with another product.
3. Sublingual tablets should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes.
4. Buprenorphine blocks the effect of illicit opioid use at doses of 12mg and above.
5. NICE TA114: Methadone and buprenorphine for the management of opioid dependence (January 2007)
   1. Methadone and buprenorphine (oral formulations), using flexible dosing regimens, are recommended as options for maintenance therapy in the management of opioid dependence.
   2. The decision about which drug to use should be made on a case by case basis, taking into account a number of factors, including the person's history of opioid dependence, their commitment to a particular long-term management strategy, and an estimate of the risks and benefits of each treatment made by the responsible clinician in consultation with the person. If both drugs are equally suitable, methadone should be prescribed as the first choice.
   3. Methadone and buprenorphine should be administered daily, under supervision, for at least the first 3 months. Supervision should be relaxed only when the patient's compliance is assured. Both drugs should be given as part of a programme of supportive care.

Espranor

(Buprenorphine)

• Oral lyophilisates sugar free 2mg, 8mg (£152.40 = 8mg x 2 daily)

Indications and dose

• Substitution treatment for opioid drug dependence in adults and adolescents aged 15 years or over
  • By oromucosal administration: Initially 2mg daily, an additional 2-4mg may be taken on day one if required. Then, adjust dose in steps of 2–6mg daily if required, consult the product literature for adjustment of dosing interval following stabilisation. Maximum 18mg per day
• Not to be used for the treatment of pain

Notes

1. Espranor should only be prescribed by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (see above).
2. Prescribe by brand: Espranor is not interchangeable with other buprenorphine products, as the bioavailability of products differs. Espranor has a higher bioavailability (25-30%) compared to Subutex.
   1. Once the appropriate dose has been identified for a patient with a certain product (brand), the product cannot readily be exchanged with another product.
3. Oral lyophilisates should be placed on the tongue and allowed to dissolve which usually occurs within 15 seconds. Patients should be advised not to swallow for 2 minutes and not to consume food or drink for at least 5 minutes after administration.
4. Buprenorphine blocks the effect of illicit opioid use at doses of 12mg and above.
5. Espranor educational materials: click here to access the following materials:
   1. Health professionals’ guide
   2. Patients’ guide
6. NICE TA114: Methadone and buprenorphine for the management of opioid dependence (January 2007)
   1. Methadone and buprenorphine (oral formulations), using flexible dosing regimens, are recommended as options for maintenance therapy in the management of opioid dependence.
   2. The decision about which drug to use should be made on a case by case basis, taking into account a number of factors, including the person's history of opioid dependence, their commitment to a particular long-term management strategy, and an estimate of the risks and benefits of each treatment made by the responsible clinician in consultation with the person. If both drugs are equally suitable, methadone should be prescribed as the first choice.
   3. Methadone and buprenorphine should be administered daily, under supervision, for at least the first 3 months. Supervision should be relaxed only when the patient's compliance is assured. Both drugs should be given as part of a programme of supportive care.

Buvidal

(Buprenorphine)

• 1-weekly prolonged release solution for injection pre-filled syringes: 8mg/0.16ml, 16mg/0.32ml, 24mg/0.48ml, 32mg/0.64ml (£55.93 = 1 pre-filled syringe)
• 1-monthly prolonged release solution for injection pre-filled syringes: 64mg/0.18ml, 96mg/0.27ml, 128mg/0.36ml, 160mg/0.45ml (£239.70 = 1 pre-filled syringe)

Indications and dose

• Substitution treatment for opioid drug dependence for use in adults and adolescents aged 16 years or over
  • For subcutaneous administration. Refer to the SmPC for information on dosing (see here)
• Not to be used for the treatment of pain

Notes

1. Buvidal should only be prescribed and administered by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (see above).
2. Patients not previously exposed to buprenorphine should receive a sublingual buprenorphine 4mg dose and be observed for an hour before the first administration of weekly Buvidal to confirm tolerability to buprenorphine (SmPC)
3. Buvidal is commissioned for use within the Together Drug and Alcohol service and by clinicians working in conjunction with the Together service under a locally commissioned enhanced service.
4. Buvidal should be administered by a healthcare professional. Buvidal is given by subcutaneous injection into the buttock, thigh, abdomen or upper arm.

Suboxone

(Buprenorphine and naloxone)

• Sublingual tablets; buprenorphine 2mg / naloxone 500micrograms, buprenorphine 8mg / naloxone 2mg, buprenorphine 16mg / naloxone 4mg (£228.57 = 8mg/2mg x 3 daily)

Indications and dose

• Substitution treatment for opioid drug dependence in adults and adolescents over 15 years of age
  • Dose expressed as buprenorphine: initially 4mg on day 1, dose may be repeated up to 12mg on day 1 depending on the individual patient's requirement. Maintenance, dose adjusted according to response; maximum 24mg per day.
  • Total weekly dose may be divided and given on alternate days or 3 times weekly (maximum 24mg per day)

Notes

1. Suboxone should only be prescribed by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (see above).

Methadone

• Oral solution sugar free 1mg/ml (£7.56 = 14 days x 60mg daily)
• Oral solution 1mg/ml (£7.39 = 14 days x 60mg daily)
• Tablets 5mg (£16.50 = 50 tablets) (see notes below)

Indications and dose

• For the treatment of opioid dependence
  • Oral solution: Initially 10–30 mg daily, increased in steps of 5–10 mg daily if required until no signs of withdrawal nor evidence of intoxication, dose to be increased in the first week, then increased every few days as necessary up to usual dose, maximum weekly dose increase of 30 mg; usual dose 60–120 mg daily.
• For the treatment of chronic pain (secondary care only), treatment must be initiated solely by the pain clinic or palliative care team. In exceptional circumstances, and with ongoing input from the pain clinic or palliative care team, treatment may be continued in primary care
• Cough in terminal disease

Notes

1. Methadone for opioid dependence should only be prescribed by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (see above).
2. Methadone tablets are only licensed for use as an analgesic for moderate to severe pain, not for the treatment of opioid dependency
3. NICE TA114: Methadone and buprenorphine for the management of opioid dependence (January 2007)
   1. Methadone and buprenorphine (oral formulations), using flexible dosing regimens, are recommended as options for maintenance therapy in the management of opioid dependence.
   2. The decision about which drug to use should be made on a case by case basis, taking into account a number of factors, including the person's history of opioid dependence, their commitment to a particular long-term management strategy, and an estimate of the risks and benefits of each treatment made by the responsible clinician in consultation with the person. If both drugs are equally suitable, methadone should be prescribed as the first choice.
   3. Methadone and buprenorphine should be administered daily, under supervision, for at least the first 3 months. Supervision should be relaxed only when the patient's compliance is assured. Both drugs should be given as part of a programme of supportive care.

Opioid-receptor antagonists

Naltrexone

• Tablets 50mg (£99.18 = 50mg daily)

Indications and dose

• Prevention of relapse in formerly opioid-dependent adults (opioid-free for at least 7-10 days before initiating treatment)
  • Initially 25mg (half a tablet) once daily, increased to 50mg (one tablet) once daily. Total weekly dose (350mg) may be divided and given on 3 days of the week for improved compliance (e.g. 100 mg (two tablets) on Monday and Wednesday, and 150mg (three tablets) on Friday).
    • A dose over 150mg on any single day not recommended due to higher incidence of side effects
• Prevention of relapse in formerly alcohol-dependent adults
  • 50mg once daily

Notes

1. Naltrexone should only be prescribed by Drug and Alcohol services and clinicians working under a locally commissioned enhanced service (see above).
2. Refer to local service guidance or the Orange Book for guidance on testing to verify a patient is opioid-free before commencing naltrexone.
3. Patients should be warned that an attempt to overcome the blockage of opioid receptors by overdosing could result in acute opioid intoxication.
4. NICE CG115: Alcohol use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence (February 2011). Naltrexone is supported by NICE following assisted withdrawal or for harmful drinkers and people with mild alcohol dependence who have requested a pharmacological intervention in combination with an individual psychological intervention.
5. NICE TA115: Naltrexone for the management of opioid dependence (January 2007)
   1. Naltrexone is recommended as a treatment option in detoxified formerly opioid-dependent people who are highly motivated to remain in an abstinence programme.
   2. Naltrexone should only be administered under adequate supervision to people who have been fully informed of the potential adverse effects of treatment. It should be given as part of a programme of supportive care.
   3. The effectiveness of naltrexone in preventing opioid misuse in people being treated should be reviewed regularly. Discontinuation of naltrexone treatment should be considered if there is evidence of such misuse.