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Appendix A
OPIATE PRESCRIBING PROTOCOLS
The following protocols contained in Appendices A and B are included as
guidelines in good clinical practice. It is anticipated that the initiation of
prescribing will be undertaken at the Substance Misuse Service prior to the
patient becoming the responsibility of a practitioner within the scheme. Ongoing
treatment will then be reviewed regularly in conjunction with the GP liaison
nurses.
There may be exceptional circumstances when it is considered necessary to
undertake prescribing prior to referral to the Substance Misuse Service. In such
circumstances the available guidance should be adhered to and a referral to the
SMS should continue to be processed as normal
Responsibilities of the prescribing doctor:
1. Substitute prescribing should not be undertaken in isolation. A multidisciplinary
approach is essential.
2. Prescribing is the ultimate responsibility of the doctor. The responsibility cannot
be delegated. Further advice will be available from GPwS1 and the Consultant in
Substance Misuse.
3. The doctor prescribing controlled drugs for the management of drug dependence
should have an understanding of the basic pharmacology, toxicology and clinical
indications for the use of drug, dose regime and therapeutic monitoring strategy
to prescribe responsibly.
4. In general no more than one week’s prescription should be dispensed at one
time, except in exceptional circumstances e.g. proven stability/ disabled/ holiday.
Instalment prescription forms (FP10 MDA) should be used for opiate prescribing.
5. The client should be advised of safety in storage of medication and advised
regarding driving and other risks. A patient information leaflet will be provided
by the SMS for participating practices.
6. Thorough, clearly written computer records of prescribing should be kept.
Drugs to Prescribe for Opiate Dependence:
Substitution of heroin for a longer acting oral preparation has proven health and social
benefits and is an accepted treatment of opiate dependence.
Methadone or Buprenorphine are the drug of choice as they are both long acting,
straightforward to titrate, less likely to be diverted or injected and is backed by evidence
of efficacy.
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More detailed information on the evidence that underpins these protocols are obtainable
from:
http://www.nta.nhs.uk/clinical guidelines:
http://www.smmgp.co.uk
Protocol for Prescribing Methadone- this is for information only.
Patients will only be eligible to join the NES when stabilised and assessed as suitable for
management in primary care.
1. Titration from heroin to methadone.

At this point a full assessment of the client’s illicit drug use has been obtained
and a recommended range of prescribed methadone has been established. It
has been explained to the client that:-

It is a once daily liquid dose.

It will not cause euphoria

That the initial dose may not be high enough and may need some adjustment.

It has been explained to the client to abstain from using heroin 6-8 hours prior to
commencing methadone.
Day 1

Methadone should be prescribed in a mixture of 1mg in 1ml. The starting dose
should be no more 30 mg to reduce the risk of overdose.

Ideally start at the beginning of the week to ensure that the client will get specialist
support in the initial phase of their treatment allow easier titration and stabilisation
and prevent overdose.

Advise the client against using on top of methadone due to the high risk of overdose
and delayed stabilisation.

Explain the methadone effects last for approximately 24 hours, and that the drug
builds up over several days.
Day 2
 Discuss any withdrawal symptoms or over medication. If continued withdrawal
symptoms the methadone may be increased 5-10 mls every 2-4 days but not more
than 30 mg weekly above the starting dose.

Discuss any illicit drug use, and the potential risks.
Day 3
2

Continue to titrate upwards until stabilisation has been achieved.
Research has shown that:

Higher dosing of methadone (i.e., 60-80mls) has higher retention rates in treatment.

Greatly reduces illicit drug use and offending behaviour.

Higher doses may be required depending on tolerance and specialist advice is
recommended.
Fortnightly prescriptions can be issued using FP10 instalment prescriptions, stating
supervised from 13 months consumption if required.
Protocol for Prescribing Buprenorphine/Suboxone (Suboxone is the preferred
preparation)
A new form of buprenorphine has been developed which includes a dose of the opioid
antagonist naloxone (buprenorphine: naloxone 4:1) in a combined sublingual tablet.
This new form is for use at the same buprenorphine dose (i.e. the current 8 mg
sublingual buprenorphine being considered as the same therapeutic dose as the new
combination of 8mg buprenorphine plus 2 mg naloxone). It has been presented as a
new product, under the trade name Suboxone, and received product approval for
addition treatment in many European countries in 2007. The rationale is that, when
taken sublingually as intended, the naloxone is inactivated or is only absorbed at a dose
which is insufficient to provoke withdrawal symptoms, but that if it is abused – by
intravenous injection for example – opioid withdrawal effects results. The combination
tablet is therefore expected to provide the same therapeutic benefit while preventing or
reducing the liability for abuse. Clinical experience with this new combination product,
is, so far, extremely limited in the UK, and it is too early to indicate the relative positions
of these two versions of buprenorphine. Please refer to inpatient guidelines on
buprenorphine and guidelines on naltrexone.
Stabilization on Suboxone:
Suboxone differs from buprenorphine (Buprenorphine) in that it allows for an initial dose
on day one of 2-4 mgs, which may be followed by a further dose on the same day of 2-4
mg depending on the patient’s requirements. The dose thereafter can be titrated
upwards by 2-8 mg per day to a maximum daily dose of 24 mg.
Buprenorphine can be considered for patients
1. Less than 30 mls methadone daily (or can be reduced to this level).
Direct equivalence between buprenorphine and methadone is difficult to estimate and is
not a linear relationship; 12 to 16 mg of buprenorphine is approximately as effective as
50 to 80 mg of methadone in reducing heroin use and retaining clients in treatment.
3
Ideally baseline liver function studies should be obtained for those clients deemed to be
at high risk if liver damage i.e. heavy drinkers who have established liver damages,
symptomatic hepatitis, and any other disease affecting the liver.
About Buprenorphine:
1. It is a semi synthetic derivative of opium.
2. It has an effective duration of at least 24 hrs with a half-litre of 20-25 hrs.
3. It is available in 0.4mg, 2mg, and 8mg tablets.
4. Administration is via the sub-lingual route, and takes effect in 90-120mins
Typical Opioid Withdrawal Schedule for Inpatients using Buprenorphine
Day
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Buprenorphine
4mgs(+/-2mg)
8-12 mgs
8-12 mgs
10 mgs
8 mgs
6 mgs
4 mgs
Day
Day 8
Day 9
Day 10
Day 11
Day
Day
Day
Buprenorphine
2.8 mg
2.0 mg
0.8 mgs
0.4 mgs
5. It binds to morphine receptors and acts as a partial agonist: because of this effect it
may lead to a greater chance of stabilisation and less illicit use on top.
6. Less risk in overdose and lower risk of respiratory depression.
7. It is a useful alternative to methadone and can be considered for detox or
maintenance.
8. It has lower euphoric effects at high doses.
9 Blockage of other opiates.
10. With doses between 8-16 mg daily it reduces illicit use on top.
Consider Buprenorphine for the following client categories:
1. Clients new to treatment.
2. Clients requesting a detoxification programme
3. Clients wishing for an alternative to methadone
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4. Clients on low doses of methadone and wish to become drug-free, but may
struggle with a methadone detox.
5. Clients who are relatively stable on methadone but are using regularly on top.
6. Clients who have long term opiate problems and have failed to stabilise on
methadone.
7. Clients who have previously been prescribed methadone but did not respond
successfully to their treatment plan.
8. Clients over 18 years.
Do not use Buprenorphine for clients who:1. Are pregnant or breastfeeding without specialist advice/experience.
2. Have severe liver damage
Please Note:
1. There is a risk of injecting buprenorphine as it is only available as sub-lingual
tablets and highly soluble. Therefore supervised consumption is recommended
in the initial stages of treatment.
2. It is not picked up on a routine urine toxicology screen as an opiate and no
buprenorphine specific test is Available locally via urine/mouth swab screening.
Guidelines for prescribing Buprenorphine:
1. Clients using heroin should receive their first dose of Buprenorphine at least 6-8
hours after the last dose of heroin, and preferably experiencing as much
withdrawal symptoms as tolerable. Taking Buprenorphine soon after using
heroin will increase the withdrawal symptoms.
2. Clients on methadone should be reduced to 30 mls or less daily prior to
transferring to buprenorphine. They should receive their first dose of
buprenorphine at least 24 hours after the last dose of methadone and/or when
experiencing withdrawal symptoms.
3. The other option available to the client, maybe to briefly come back to SMS
titration clinic to be established on Buprenorphine. This would be arranged with
keyworker, SMS and GP informed.
4. Full explanation of how Buprenorphine works explained to client.
5. Stabilisation on Buprenorphine usually achieved over three days.
6. Clients are unsettled for the first three days as the dose is titrated.
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Administration procedure for Buprenorphine:
Day 1


Start treatment early in the week to enable daily contact and monitoring for at
least the first three days.
Starting dose normally 4mgs
Day 2

Assess for signs of withdrawal or sedation (it is unusual to experience sedation)
and titrate accordingly.

For withdrawal the dose should increase by 4 mg – 8mg.

If presents sedated reduce by 2mg – 4mg
Day 3

Repeat day two. The most commonly effective maintenance dose is between 816 mg daily, but lower or higher doses may be used (maximum 32mg)
Tablets are taken in one single dose daily sublingual
The GP Liaison nurse should see the client at least weekly for the first three weeks of
treatment.
Any serious side effects should be discussed with the GP Liaison Nurse/Prescribing
Doctor.
Any missed doses of buprenorphine should not be replaced, as buprenorphine is long
acting and the clients should not experience withdrawal symptoms if one day is missed.
Buprenorphine can be prescribed by instalments on an FP10 and in the initial stages of
treatment daily supervised collection is advised.
Liver function tests should be taken prior to treatment.
Contra-indications:
Buprenorphine (Buprenorphine) is contraindicated in cases of known hypersensitivity to
buprenorphine, severe respiratory, severe respiratory or hepatic insufficiency, breastfeeding, acute alcoholism or DTs and in children less than 18 years of age.
Caution: renal insufficiency.
While buprenorphine should not be commenced in pregnancy patients already on
buprenorphine can have the option of remaining on it.
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Appendix B
BENZODIAZEPINE PRESCRIBING PROTOCOLS
The central aim of these guidelines is to reduce all benzodiazepine prescribing to an
absolute minimum.
Key Considerations:
1.
Long term benzodiazepine use may cause harm, particularly at doses greater
than the equivalent of 30 mg of diazepam daily.
2.
They are frequently used as a secondary drug of abuse, either to enhance
the effect of the primary drug, or to reduce withdrawal effects.
3.
They have a strong addictive potential and the withdrawal syndrome can be
dangerous.
4.
Illicit benzodiazepine use is widespread and causes a wide variety of harm
related to:



Ingestion (intoxication, bizarre behaviour).
Injection (thrombosis, infection).
Withdrawal (psychosis, fitting).
Overdose.
5.
Whilst there is no evidence to support the use for maintenance treatment.
GPs should be able to accommodate and treat benzodiazepine users and
prescribe where appropriate. When prescribed they should be withdrawn
slowly and should only be used for detoxification from benzodiazepine
addiction and not maintenance unless there are specific indications. People
who tend to “binge”, or overuse are not suitable for long-term prescribing.
6.
The illicit market is supplied mostly through prescribed benzodiazepines.
7.
Prescribing benzodiazepines to young people for the treatment of sleeping
problems, anxiety or other psychological difficulties is rarely justified. They
are licensed for a maximum duration of 4 weeks.
8.
There are no licensed indications for the prescription of benzodiazepines for
more than 2-4 weeks.
9.
Benzodiazepines are often taken in conjunction with opiates, and for those
clients prescribed methadone, the methadone dose should be kept stable
throughout the benzodiazepine reduction period, Concurrent detoxification of
both drugs is not recommended in community setting.
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10.
The withdrawal syndrome is unpleasant and potentially dangerous. Sudden
cessation of high-dose or long term regime (more than a few weeks) is not
good practice. Withdrawal syndrome may start within hours, or be delayed a
few weeks after withdrawing long-acting drugs. Symptoms may include:



Confusion, psychotic-like states.
Anxiety, insomnia, loss of appetite/weight.
Tremor, perspiration, tinnitus, perceptual disturbance.
Possibility of convulsions.
Guidelines for prescribing:
1. Prescribing should only be initiated where there is clear evidence of dependency
from the history and urine toxicology. (Caution clients may exaggerate the
amount they are taking). This will be in conjunction with a full comprehensive
assessment via the substance misuse service.
2. In general, it is recommended that a prescribing regime should be negotiated and
agreed with the client. If considering a detox or reduction it should be
determined by the individual capacity to tolerate symptoms or, more often, by
their anticipation of unpleasant withdrawals. Clients may be reassured that they
will suffer less withdrawal symptoms on a regime where the daily dose is reduced
in small portions (range one-tenth to one-quarter) every fortnight. Normally
clients are able to tolerate a reduction of 2.5 mg-5mg every two weeks.
3. For doses below 30 mg reduce by 2mg – 2.5mg every two weeks.
4. If withdrawal symptoms occur maintain the dose until symptoms improve.
5. If severe withdrawal symptoms occur, increase the dose to alleviate symptoms
and reduce by smaller increments.
6. Convert all benzodiazepines to equivalent diazepam dose using the conversion
chart below.
7. Prescribe for daily collection using instalment contract (reduces risks of diversion
to black-market).
8. Overusing of daily dose of loss of medication.
9. Daily doses should be divided to reduce the risk of intoxication.
10. Regular review of the client’s progress by the GP and GP liaison nurse.
11. if carrying out a detox review the client six weeks after successful completion –
consider whether there is a need of treatment for underlying mental health
problems.
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Conversion Table for Benzodiazepines to Diazepam Equivalent
DRUG
DIAZEPAM
CHLORDIAZEPOXIDE
LOPRAZOLAM
LORAZEPAM
OXAZEPAM
TEMAZEPAM
NITRAZEPAM
DOSE EQUIVALENT TO 5 MG
15 MG
0.5MG
0.5MG
15 MG
10 MG
5MG
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Appendix C
Patients suitable for Treatment within Primary Care
The SMS determines whether patients are suitable for management within primary care
under this enhanced service. The following criteria apply:
1. If a patient is under 19 they need to be assessed by specialist under 19’s team and
need to co-ordinate accordingly.
2. No severe and enduring mental heath issues that could affect ability to attend
appointments and engage effectively with service
3. No severe alcohol use that could adversely affect prescribed medication ( e.g.
methadone, benzodiazepine and heavy alcohol use could possibly potentiate
unintentional over dose)
4. Those on benzodiazepines should be willing to convert to appropriate level of
diazepam and be willing to engage in reduction programme
5. Show motivation to reduce or abstain from illicit drug use.
6. Only prescribed medications approved in the Department of Health Clinical
Guidelines (2007) will be prescribed under the NES.
7. Patients must be willing to undertake a prescription on daily collection and the dose
agreed with the individual GP via the GP Liaison Nurses. Frequency of collection may
decrease on evidence of stability/compliance on an individual basis
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