Download Drug Misuse Management in the Acute Hospital Setting Guidelines

PAT/T 21
Drug Misuse Management in the
Acute Hospital Setting Guidelines
This procedural document supersedes: PAT/T 21 v.1 – Guidelines for the
Management of Patients with Drug Misuse in the Acute Hospital Setting.
Did you print this document yourself?
The Trust discourages the retention of hard copies of policies and can only guarantee
that the policy on the Trust website is the most up-to-date version. If, for exceptional
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Author/reviewer: (this
version)
Shane Peagram – Drug and Alcohol Liaison
Nurse Specialist DRI
Date written/revised:
July 2013
Approved by:
Policy Approval and Compliance Group on
behalf of the Patient Safety Review Group
Date of approval:
9 October 2013
Date issued:
17 October 2013
Next review date:
October 2016
Target audience:
Trust wide
Page 1 of 63
v.2
PAT/T 21
v.2
Amendment Form
Please record brief details of the changes made alongside the next version number. If
the procedural document has been reviewed without change, this information will still
need to be recorded although the version number will remain the same.
Version
2
Date
Issued
17 October
2013
Summary of changes













General restructuring of contents to
improve access and flow of subject
material.
Contents presented to reflect National
Drug Policy focus on Recovery. (DOH
2010)
Clinical governance framework
incorporating NICE QS23 (2012)
New content - General guidance on
prescribing by substance of misuse.
New content – Equity and diversity issues
for Assessment.
New content – inclusion of contact details
for Trust child Protection Nurses and
Doncaster and Bassetlaw social services
departments.
New content – Methadone
Pharmacology.
New content – Buprenorphine
Pharmacology
New content – Patients own supplies,
linked to PAT/MM1B v.4
New content – Pain management.
Major revision – Discharge planning, to
reflect need for TTA doses of OST at
weekends and holidays.
New content – APPENDIX 3 ICD 10
Dependency diagnosis. (WHO 1992)
Revised content – Summary card –
amended to reflect updated discharge
planning arrangements.
Page 2 of 63
Author
S. Peagram
PAT/T 21
v.2
Contents
Section
1
Page
No
6
INTRODUCTION
2
PURPOSE
6
3
DUTIES AND RESPONSIBILITIES
6
GENERAL GUIDANCE
Overview
Rationale for prescribing
Prescribing considerations
Exceptional circumstances
PRESCRIBING BY SUBSTANCE - OVERVIEW
Opiates
Benzodiazepines
Alcohol
Stimulants
Cannabis
New psychoactive substances
ASSESSMENT
Overview
Equity and diversity
Aims of a full assessment
Urine screening
Opiate withdrawal syndrome
Opiate intoxication
Drug using parents
Cardiac assessment
EXISTING COMMUNITY METHADONE / BUPRENORHINE
PATIENTS
Pre prescribing checks
Out of hours
Missed doses
Administration
ILLICIT OPIATE (HEROIN) USING PATIENTS
Overview
Precautions
Choosing and appropriate opioid substitute
Risk factors
METHADONE PHARMACOLOGY
Peak plasma concentration
Peak clinical effects
Duration of action (half life)
Metabolism
Excretion
Dosing
8
8
8
9
9
9
9
10
10
10
11
11
11
11
11
12
12
13
14
15
16
16
4
4.1
4.2
4.3
4.4
5
5.1
5.2
5.3
5.4
5.5
5.6
6
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
7
7.1
7.2
7.3
7.4
8
8.1
8.2
8.3
8.4
9
9.1
9.2
9.3
9.4
9.5
9.6
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16
17
17
18
18
18
18
19
20
21
21
21
21
21
22
22
PAT/T 21
9.7
9.8
10
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
10.9
11
11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
12
12.1
12.2
12.3
12.4
12.5
12.6
12.7
12.8
12.9
13
13.1
13.2
13.3
13.4
13.5
13.6
13.7
13.8
13.9
13.10
13.11
13.12
14
14.1
14.2
14.3
14.4
Equivalence
Tolerance
METHADONE INDUCTION PROCESS – NEW STARTER
Indication
Precautions
Contraindications
Investigations
Principles of safe induction
Dosing
Administration
Risk factors
Other points to consider
BUPRENORPHINE PHARMACOLOGY
Peak plasma concentration
Peak clinical effects
Duration of action (Half life)
Metabolism
Excretion
Dosing
Equivalence
Tolerance
BUPRENORPHINE INDUCTION PROCESS – NEW STARTER
Indication
Precautions
Contraindications
Investigations
Principles of safe induction Dosing
Dosing
Administration
Risk factors for overdose
Buprenorphine + Naloxone (Suboxone)
Precipitated withdrawal
OPIOD DETOXIFICATION
Overview
Consent
Unsuitable populations
Opiods and alcohol
Opioids and benzodiazepines
Methadone or Buprenorphine
Lofexidine
Clonidine
Dihydrocodeine
Other symptomatic medications
Lofexidine dosing
Lofexidine regime
RELAPSE PREVENTION PRESCRIBING (NALTREXONE)
Benefits
Risks
Investigations
Dosing
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v.2
22
22
23
23
23
23
23
24
24
25
25
25
26
26
26
26
26
26
26
26
27
27
27
27
27
28
28
28
28
29
29
29
30
30
30
30
31
31
31
31
32
32
32
32
33
34
34
34
34
34
PAT/T 21
v.2
14.5
15
15.1
15.2
15.3
15.4
15.5
15.6
15.7
15.8
15.9
15.10
16
16.1
16.2
16.3
16.4
16.5
17
17.1
17.2
17.3
17.4
18
Loss of tolerance
GENERAL MANAGEMENT
Ward management
Drug related deaths
Reducing drug related deaths
Dealing with emergency overdose
Sleeplessness
Patients own supplies
Pregnancy
Mental capacity
Illicit opiate use on top of prescribed medication
Drug misusers not admitted to hospital and not in treatment
PAIN MANAGEMENT
Overview
Methadone and pain
Buprenorphine (subutex / Suboxone) and pain
Naltrexone and pain
Peri operative pain
DISCHARGE PLANNING
TTO - Existing community patient
Caution
TTO - New starter
Caution
TRAINING / SUPPORT
35
35
35
35
36
37
37
37
38
38
38
39
39
39
41
42
42
43
43
43
44
44
44
45
19
45
20
MONITORING COMPLIANCE WITH THE PROCEDURAL
DOCUMENT
DEFINITIONS
21
EQUALITY IMPACT ASSESSMENT
46
22
ASSOCIATED TRUST PROCEDUAL DOCUMENTS
46
23
REFERENES
46
APPENDICIES:
Appendix 1 Clinical Governance Framework – Clinical Guidelines 2007
Appendix 2 NICE quality standard 23
Appendix 3 Cardiac assessment and monitoring for methadone prescribing
Appendix 4 ICD-10 Diagnostic Guidelines “Dependency”
Appendix 5 Methadone assessment prior to administration of methadone
Appendix 6 Methadone Safety Care Plan
Appendix 7 Safer Injecting Care Plan
Appendix 8 Methadone summary card
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45
49
50
51
53
54
56
58
60
PAT/T 21
1.
v.2
INTRODUCTION
These guidelines are intended for both medical and nursing staff to act as a resource in
the management of patients with drug misuse issues when prescribing for maintenance
or detoxification.
The main source of evidence used within these guidelines is taken form the ‘Drug Misuse
and dependence – UK Guidelines on Clinical Management, (2007) and should be read in
conjunction with, Guidance on methadone and buprenorphine for the management of
opioid dependence (NICE) ; Drug misuse: opioid detoxification (NICE) ; Naltrexone for
the management of opioid dependence (NICE); Guidance for the use of substitute
prescribing in the treatment of opioid dependence in primary care (RCGP 2011):
“Medications in Recovery – Re-orientating Drug Dependence Treatment” (NTA 2012).
2.
PURPOSE
The purpose of these guidelines is to offer a comprehensive structure that will provide
treatments within the context of the National Drug Strategy 2010’s overarching aims to:


Reduce illicit and other harmful drug use: and
Increase the numbers recovering from their dependence
“Our ultimate goal is to enable individuals to become free from their dependence”
[DOH 2010]
3.
DUTIES AND RESPONSIBILITIES
3.1
DOCTORS’ RESPONSIBILITIES
It is acknowledged that drug misusers have the same entitlement as other patients to the
services provided by the National Health Service and it is the responsibility of all Doctors
to provide care for both general health needs and drug-related problems, whether or not
the patient is ready to withdraw from drugs. [DOH, 1999]
All doctors must provide medical care to a standard, which could be reasonably,
expected of a clinician in their position. The focus for the clinician treating a drug misuser
is on the patients themselves. However, the impact of their drug misuse on other
individuals – especially dependant children – and on communities should be taken into
consideration. [DOH, 2007]
3.2
PRESCRIBERS’ RESPONSIBILITIES
It is the responsibility of the prescriber (Doctor, NMP) to identify the purpose of
prescribing e.g. maintain the continuity of existing community prescribing [sec 7] or to
initiate new prescribing [sec 8].
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In either case the prescriber must ensure that an adequate assessment has been carried
out prior to prescribing. [sec 6]
Where continuity of community prescribing is the goal;
Confirmation of Drug, dose and time last taken should be established and documented.
[sec 7.1]
Missed doses and appropriate actions should be documented. [sec7.3]
Discharge arrangements including Drug , dosage , take home quantities and date of next
community prescribing agreed with the responsible community prescriber and
documented. [sec17]
Where initiation of treatment is the goal;
Attention must be paid to the aim of treatment – stabilisation – abstinence –
detoxification [sec 8]
The choice of treatment [sec 8.3]
Discharge arrangements [sec 17]
NOTE:
While it is important to liaise with the relevant community Drug Team regarding ongoing
treatments it is worth noting that their operational policies may be different from our own.
In the event that a scenario should arise which is not covered within these guidelines the
first point of contact should be the Drug and Alcohol Clinical Nurse Specialist – Shane
Peagram (DRI Blp 1491) Valerie Wood (BDGH Blp 2417)
Methadone and buprenorphine should only be prescribed following liaison
with the community drug team and there is a documented plan for continuation
of treatment upon discharge.
3.3
NURSES’ RESPONSIBILITES
It is the responsibility of nursing staff to ensure the safe administration of medicines as
per PAT/MM 1.
For existing community methadone / buprenorphine patients;
Confirmation of Drug, dose and time last taken should be established and documented.
[sec 7.1]
Missed doses and appropriate actions should be documented. [sec7.3]
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Discharge arrangements including Drug, dosage, take home quantities and date of next
community prescribing agreed with the responsible community prescriber and
documented. [sec 17]
For new treatments;
The presence of an opiate withdrawal syndrome should be assessed [sec 6.5] and
documented. [Appendix 5]
Where Methadone is prescribed, the Methadone Assessment Prior to Administration
checks are completed [sec 6.6] and documented. [Appendix 5]
Methadone and buprenorphine should only be prescribed following liaison with
the community drug team and there is a documented plan for continuation of
treatment upon discharge.
3.3
PATIENT RESPONSIBILITIES
It is the patients responsibility to provide details of current treatment, prescriber and
dispensing arrangements including any missed doses.
Patients in possession of community dispensed medication must inform nursing staff.
4.
GENERAL GUIDANCE
4.1 OVERVIEW
Problematic drug users experience increased rates of morbidity and mortality due to their
substance misuse, and although drug misuse exists in every sector of society, it is most
prevalent in areas of social deprivation where individuals are more likely to experience
poorer health outcomes, independent of substance misuse. (RCGP 2011)
Generally, there is a greater prevalence of certain illnesses amongst the drug-misusing
population, including viral hepatitis, bacterial endocarditis, HIV, tuberculosis,
septicaemia, pneumonia, deep vein thrombosis, pulmonary emboli, abscesses and
dental disease. (DOH 1999)
4.2 RATIONALE FOR PRESCRIBING
For many people, prescribed treatment is an important part of their recovery journey. It is
a component of a broader recovery-orientated system of health and social care and
support that harnesses the full range of individual, social and community assets.
Before deciding to prescribe, the clinician should be clear as to what the functions of
prescribing are. A prescription can:
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v.2
 Maintain current community prescribing.
or
 Reduce or prevent withdrawal symptoms from illicit drugs
 Offer an opportunity to stabilise drug intake and lifestyle whilst breaking with previous
illicit drug use and associated unhealthy behaviours
 Promote a process of change in drug taking and high risk behaviour
 Help maintain contact and offer opportunity to work with the patient
 Achieve abstinence
4.3 PRESCRIBING CONSIDERATIONS






Current community treatment plan
The overall treatment plan for the individual client
National and Locally agreed protocols
The clinicians experience and competencies
Discussion with member of a multi-agency team
Advice, where necessary from a specialist in drug misuse
Methadone and buprenorphine should only be prescribed following liaison with
the community drug team and there is a documented plan for continuation of
treatment upon discharge.
4.4 EXCEPTIONAL CIRCUMSTANCES
Only in exceptional circumstances should the decision be made to offer substitute
medication without specialist advice being sought i.e.

a drug misuser presenting with opioid withdrawal in late pregnancy

a patient with serious concomitant physical or psychiatric illness where withdrawal
is complicating the clinical problems

someone who is opioid-dependent and demonstrating withdrawal.
Indeed, in such circumstances it is vital that the doctor fulfils their responsibilities by
ensuring adequate assessment and appropriate management that facilitates the
retention of the patient in treatment. (DOH, 1999).
5
PRESCRIBING BY SUBSTANCE - OVERVIEW
5.1 OPIATES
Heroin users are the largest single group in treatment and use an especially tenacious,
habit forming drug in the most dangerous ways. (NTA 2012)
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There is robust evidence showing that Opiate Substitution Therapy can significantly
improve outcomes for most opioid dependent people. Treatment can reduce symptoms
of dependence, and being in treatment can help to reduce associated difficulties.
OST allows people the time, space and platform to make meaningful choices. OST:





Prevents people dropping out of treatment.
Suppresses illicit use of heroin.
Reduces crime.
Reduces the risk of BBV transmission
Reduces risk of death.
Exiting treatment prematurely can harm individuals, especially if it leads to relapse, which
is also harmful to society.
Coming off OST can lead to greater risk of relapse, BBVs and overdose; and that
treatment orientated to rapid abstinence produces worse outcomes than treatment
initially orientated to maintenance. (National Drug Strategy 2010)
Prescribing options – Methadone [sec 9] Buprenorphine [sec 11] Detoxification [sec 13]
5.2 BENZODIAZEPINES
Benzodiazepines prescribed for benzodiazepine dependence should be at the lowest
possible dose to control dependence and doses should be reduced as soon as possible.
It is common to consolidate Benzodiazepine use to a single preparation i.e. Diazepam
and divide doses evenly.
Prescribing options – Diazepam [BNF]
Benzodiazepines should only be prescribed following liaison with the
community drug team and there is a documented plan for continuation of
treatment upon discharge.
5.3 ALCOHOL
Acute alcohol withdrawal syndrome is a medical emergency and requires timely and
appropriate intervention to prevent potentially life threatening complex symptoms.
Prescribing options – Chlordiazepoxide, Lorazepam, Diazepam, Midazolam
For guidance on alcohol withdrawal management refer to PAT/T 25
5.4 STIMULANTS
There are no licenced pharmacological treatments to eliminate the symptoms of
withdrawal from stimulants (including cocaine).
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Prescribing options – There is limited evidence supporting the use of Dexamphetamine
in the treatment of habitual amphetamine use. Treatment should only be considered
by experienced practitioners within specialist drug treatment settings.
Short term symptomatic relief of agitation with Anxiolytics may be considered i.e.
Diazepam. [BNF]
For psychosis short term management with Antipsychotics i.e. Haloperidol.
5.5 CANNABIS
There are no licenced pharmacological treatments to eliminate the symptoms of
withdrawal from cannabis.
Short term symptomatic relief of agitation or insomnia with Anxiolytics may be considered
i.e. Diazepam. [BNF]
5.6 NEW PSYCHOACTIVE SUBSTANCES
New psychoactive substances (NPS) so called “designer drugs” or “legal highs” such as
Mephadrone present a unique challenge as users might not know exactly which
compound has been taken as many are sold under a variety of brand names.
Prescribing options – no substitute medications, consider symptomatic relief.
In all cases of acute intoxication or poisoning TOXBASE should be consulted
6
ASSESSMENT
6.1 OVERVIEW
Good assessment is essential to the continuing care of the patient. (DOH 2007),
Furthermore, “Assessment for recovery aims to deliver an informed understanding of the
person’s wishes, substance use, and the severity and complexity of clinical and other
problems: and it needs to identify their strengths and key obstacles to their recovery.”
(NTA 2012)
6.2 EQUITY AND DIVERSITY
All assessments should be accessible to people with additional needs such as physical,
sensory or learning disabilities, and to people who do not speak or read English. People
who need a comprehensive assessment should have access to an interpreter or
advocate if needed.
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6.3 AIMS OF A FULL ASSESSMENT
A comprehensive assessment should consider both drug use and resources for recovery
and include:
 treating the emergency or acute problem
 confirming the person is taking drugs (history, examination and drug testing)
(Table 1)
 assessing the degree of dependence (Table 2, 3 and 4 )
 assessing physical and mental health
 identifying social assets, including housing, employment, education and support
networks
 assessing risk behaviour including domestic violence and offending
 determining the person's expectations of treatment and desire to change
 determining the need for substitute medication
 obtaining information on any dependent children of parents who misuse drugs, and
any drug-related risks to which they may be exposed. (Table 5 )
The clinician must ensure that an adequate assessment has been made before
prescribing substitute opioids or controlled drugs.
6.4 URINE SCREENING
Urine analysis should be regarded as an adjunct to the history and examination in
confirming drug use, and should be obtained at the outset of prescribing and randomly
throughout treatment (request Full Drug Screen).
Results should always be interpreted in the light of clinical findings, as false negatives
and positives can occur.
If results do not correspond to the patient’s history, repeat the urine toxicology test before
taking any action, as laboratory errors can occur.
If the urine test is negative for opioids, and there is no evidence of opioid withdrawal
symptoms; the drug misuser is very unlikely to be physically dependent on opioids and
needs to be reassessed in the light of this.
Table 1 – Drug detection times
Drug Or Its Metabolite(s)
Amphetamine/amfetamines, including methylamphetamine
and MDMA
Benzodiazepines
 Ultra-short-acting[half-life 2h] [e.g. midazolam]
 Short-acting [half-life 2-6h] [e.g. triazolam]
 Intermediate-acting [half-life 6-24h] [e.g. temazepam,
Page 12 of 63
Duration of
Delectability
2 days
12 hours
24 hours
2-5 days
PAT/T 21
chlordiazepoxide]
 Long-acting [half-life 24h] [e.g. diazepam, nitrazepam]
Buprenorphine and metabolites
Cocaine metabolite
Methadone [maintenance dosing]
Codeine, dihydrocodeine, morphine, propoxyphene
[heroin is detected in urine as the metabolite morphine]
Cannabinoids
 Single use
 Moderate use [three times a week]
 Heavy use [daily]
 Chronic heavy use [more than three times a day]
v.2
7 or more
8 days
2 – 3 days
7 – 9 days
48 hours
3 – 4 days
5 – 6 days
20 days
up to 45 days
Detection times are only approximate and highly dependant upon dose, frequency, route
of administration and urine excretion and concentration.
6.5 OPIATE WITHDRAWAL SYNDROME
The onset of physical withdrawal symptoms is a key characteristic of opiate dependency
and there presence is required to establish a diagnosis.
Table 2 – Opiate Withdrawal Syndrome
Signs and Symptoms
Drug craving, anxiety, drug – seeking
Yawning, sweating, running nose, lacrimation
Increase in above signs and:
Dilated pupils, goose-flesh, tremors, hot/cold flushes,
aching bones/muscles, loss of appetite, abdominal
cramps and irritability
Increase in intensity of above and:
Insomnia, increased blood pressure, low grade fever,
increased respiration, increased pulse rate, restlessness,
nausea and vomiting
Increase in intensity of above and
Weight loss, diarrhoea, weakness, febrile, foetal position
(curled up on a surface), increased blood sugar
Page 13 of 63
Heroin
6 hours
8 hours
12
hours
Methadone
34-48 hours
48-72 hours
18-24
hours
24-36 hours
364days
36-4days
PAT/T 21
Table 3 – Opiate Withdrawal Syndrome
Objective signs of opiate withdrawal
 Yawning
 Coughing
 Sneezing
 Runny nose
 Lacrimation
 Raised blood pressure
 Increased pulse
 Dilated pupils
 Cool, clammy skin
 Diarrhoea
 Nausea
 Fine muscle tremor
v.2
Subjective signs of withdrawal
 Restlessness
 Irritability
 Anxiety
[The signs above may also be useful
objective signs]



Sleep disorders]depression
Drug craving
Abdominal; cramps
Source: Ghodse (1998)
The use of a clinical tool such as the Short opiate Withdrawal Scale is recommended to
establish the presence of a physical withdrawal syndrome.
The Short Opiate Withdrawal Scale is include as part of the Methadone Assessment
Prior to Administration Tool [ Appendix 5 ].
6.6 OPIATE INTOXICATION
Mortality rates amongst Opiate users are 12 x higher than their none opiate using peers,
and rise to 22 x higher for Intravenous drug users. The ability to identify and respond to
acute opiate intoxication is key to maintaining patient safety. (DOH 2007)
Table 4 - Opioid Intoxication
SIGNS
 Euphoria/Relaxation
 Constricted pupils (pinned)
 Drowsiness
 Slurred speech
 Unsteady gait
 Smell (alcohol)
SYMPTOMS
 Feelings of well-being
 Poor attention/concentration
 Slurred speech
Methadone Pre Administration checklist and assessment

The Methadone Pre Administration checklist needs completing by the person
dispensing the initial dose (nurse, doctor or pharmacist) the same person should also
assess patient, [sec 3.2,3.3] completing the pre administration checklist. [Appendix 5]

The assessment should ensure that the patient is not showing evidence of
intoxication due to opioids, alcohol or other drugs. (Table 4)
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
Patients who appear intoxicated with CNS depressant drugs should not be given their
usual dose of methadone but be reassessed at a later time when they are no longer
intoxicated.

If intoxication mild the patient may be given a delayed or reduced dose but only after
being reviewed by the prescriber.
The Pre Administration Methadone Assessment Checklist needs completing
prior to every dose [Appendix 5]
6.7 DRUG USING PARENTS
A third of drug misusers in treatment have child care responsibilities. NTA (2009)
Table 5 – Child Protection Considerations
The following should be taken into consideration:









Effect of drug misuse on functioning, for example, intoxication, agitation
Effect of drug seeking behaviour, for example, leaving children unsupervised,
contact with unsuitable characters.
Impact of parent’s physical and mental health on parenting
How drug use is funded, for example, sex working, diversion of family income.
Emotional availability to children
Effects on family routines, for example, getting children to school on time
Other support networks, for example, family support.
Ability to access professional support
Storage of illicit drugs, prescribed medication and drug-using paraphernalia
With consent, information should be gathered from other professionals
If risk of significant harm to a young person is found, involve other professionals
according to local child protection requirements.
Referral to Social Services in Doncaster – 01320 736636
Referral to Social Services in Bassetlaw – 01777 716161
For more information or advice about Child Protection Policies and Procedures within
BDGH contact Safeguarding Team, Named Nurse for Children on ext 4090.
PAT/PS 10 - Safeguarding and Promoting the Welfare of Children.
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6.8 CARDIAC ASSESSMENT
Methadone and QT prolongation
The Medicines and Health Care Product Regulatory Agency [MHRA] recommended in
2006
‘’that patients with the following risk factors to QT interval prolongation are carefully
monitored whilst taking Methadone: heart or liver disease, electrolyte abnormalities,
concomitant treatment with CVP 3A4 inhibitors, or medicines to cause QT interval
prolongation.
In addition any patient requiring anymore than 100mg of methadone per day should be
closely monitored. Further information is included in the product information.’’
Clinicians must make a balanced judgement for each patient according to the MHRA
guidance [and any later expansion or revision] Monitoring, will usually include checking
other medications, general monitoring of cardiovascular disease, liver function tests and
urea and electrolytes. As the risk factors for the QT interval prolongation increase, e.g.
high methadone dose or multiple risk; clinicians will need to consider ECGs. The MHRA
recommendation, suggests that an ECG might be considered before induction onto
methadone, or before increases in methadone dose and subsequently after stabilisation
– at least with doses over 100 mg per day and in those with substantial risk.
[APPENDIX 3]
7
EXISTING COMMUNITY METHADONE / BUPRENOPHINE
PATIENTS
Good communication between hospital and community team is essential to ensure safe
management of the admission and discharge of existing community treatment.
7.1 PRE PRESCRIBING CHECKS
Prior to prescribing Methadone or Buprenorphine the following safety checks need
confirming and documenting.








Drug type and strength (i.e. Methadone 1mg/1ml)
Daily dose
Pick up frequency (daily , 3 x weekly, 2 x weekly, weekly)
Community Pharmacy
Date last collected
Missed doses [sec7.3]
Prescribing agency / keyworker
Amount and whereabouts of any community supplies brought to hospital
by the patient. [sec15.6]
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Information provided by the patient may not be reliable and needs corroborating with the
community pharmacy and community drug team and documenting.
Liaise with the community prescriber as early as possible so that the community
prescriber can cancel the existing community prescription and be prepared to
recommence the prescription on discharge of the patient.
7.2 OUT OF HOURS
Where there is evidence of acute opioid withdrawal and it is not possible to corroborate
the patients information i.e. outside of pharmacy hours, Bank holidays etc., Opioid
Substitution Therapy medications can be prescribed with the following precautions.





Assess the patient [Section 6]
Evidence onset of withdrawal syndrome using Short Opiate Withdrawal Scale.
[Appendix 5]
Methadone 1mg/1ml (PRN) 5 – 10mg 4hrly Max 40mg in 24 hrs
Methadone Assessment Prior to Administration checklist to be completed prior to
every dose. [Appendix 5] TO BE INCLUDED ON RE PRINT AMMEDMENT
Confirm community dose at earliest possible opportunity and review patient in light
of findings.
CAUTION
Patients presenting out of hours in receipt of existing community opiate substitution
therapy may have been dispensed advanced supplies for Weekends and Bank Holidays.
This may be in their possession. Patients do not always disclose this information on
admission. Every effort should be made to establish the whereabouts of patients own
supplies and reassure the patient that continuity of treatment will be maintained
throughout admission and upon discharge. [sec3.2 sec 3.3 sec15.6]
7.3 MISSED DOSES
OST is reIf patient has missed OST doses, for whatever reason, they will need to
be reassessed for intoxication and withdrawal before OST administration is
recommenced. [sec 6.5] [sec 6.6]
Where patients miss OST doses they may use illicit opiates or other drugs
including central nervous system depressants such as alcohol and
benzodiazepines.
When OST doses are missed for 3 days or more days, tolerance to opioids may be
reduced placing patients at increased risk of overdose when introduced.
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Table 6 – Action to be taken in the event of Missed doses
Number of days
missed
Action to be taken
One day
No change in dose
Two days
If no evidence of intoxication administer normal dose.
Three days
Administer half dose in discussion with prescriber.
Four days
Patient must see prescriber. Recommencement at 40mg half
dose which ever is the lower.
Five days or more
Regard as a new medication.
(Australian Gov, 2000)
7.4 ADMINISTRATION
In order to maintain patient safety and reduce drug related deaths [sec 15.3] an
assessment of intoxication [sec 6.6] is required prior to administration.
The Drug and Alcohol Service Methadone Assessment Prior to Administration Checklist
[Appendix 5] needs completing immediately before each administration.
8
ILLICIT OPIATE (HEROIN) USING PATIENTS
8.1 OVERVIEW
Patients who are physically dependent on opioids may need OST to relieve the
distressing symptoms of opiate withdrawal whilst in hospital.
Failure to address the patients dependency may result in continued used of illicit opioids
i.e. heroin within the ward environment or premature discharge from hospital.
8.2 PRECAUTIONS

Do not give in to undue pressure to prescribe immediately. Take time to assess the
patient. Remember a patient who is experiencing withdrawal symptoms may not be
able to co-operate fully with medical or surgical treatment.

A patient suffering from abstinence withdrawal will present with objective and
subjective withdrawal. [See tables 2 and 3]

For safety’s sake rely more on objective signs of opioid withdrawal.[see tables 2 and
3]
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
Poly-drug and alcohol misusers may develop multiple withdrawal syndromes and
hospital doctors will need to differentiate these to prioritise treatment. Methadone may
initially mask alcohol and benzodiazepine withdrawal symptoms.

Exercise particular care in cases of respiratory disease, head injury and liver
diseases.

It is important to be extremely careful when prescribing additional drugs such as
sedatives. It may be necessary, in some cases, to contact the relevant pain control
team for further advice on improving pain control.

If a urine test is negative for opioids and there is no evidence of opiate withdrawal
symptoms, the drug misuser is very unlikely to be physically dependent on opiates
and should be reassessed in the light of this.
It is not appropriate to offer OST to patients who do not meet the diagnostic criteria
for opioid dependency. [Appendix 4]


If there is doubt about the degree of dependence it is advisable and safer to withhold
prescribing of substitute medication initially and observe the patient until the physical
manifestations of opioid withdrawal are evident.[Armstrong, 2003]
8.3 CHOOSING THE APPROPRIATE OPIOID SUBSTITUTE
Opioid substitution Therapy should only be considered following liaison with the
community drug services. Appropriate arrangements for exit prescribing will
need to be in place to ensure a seamless transfer of care back into to community
The clinical need for prescribing should always be paramount [sec 4.2] [sec 5.1]
[Appendix 4]
Methadone and buprenorphine are both approved for the treatment and prevention of
withdrawals from opioids.
Both are approved for maintenance and detoxification programmes (NICE 2007a)
NICE recommends the ‘if both drugs are equally suitable, methadone should be
prescribed as the first choice.” because:





Its clinical effectiveness is supported by extensive research.
It alleviates opioid withdrawal symptoms.
It is taken orally, thus reducing the risk of injection.
The dose can be carefully titrated to the optimal level.
Blood levels can be kept stable, thus eliminating post dose euphoria and pre dose
withdrawal.
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However a patient may express a preference, in which case the following needs to be
considered;







Level of opioid use
Safety, for example likelihood of diversion and overdose risk
Patient experience with both illicit and prescribed medications, treatment history and
response
Patient preference
Retention and treatment compliance
The prescriber’s experience with different medications
Need to take opiate analgesia in the case of Buprenorphine
Opioid substitution Therapy should be commenced in accordance with the principles of
safe induction [sec 10.5]
8.4 RISK FACTORS
Extra caution should be exercised and benefits and risks assessed when prescribing
methadone or buprenorphine in the following situations.

Concurrent use of other sedating drugs or medications: full agonists and
especially methadone have been associated with sedation, respiratory depression
and coma when used in conjunction with central nervous system depressants
such as alcohol, benzodiazepines, barbiturates, neuroleptics and tricyclic
antidepressants. Monamine oxidase inhibitors (MAOI’s) need to be avoided with
methadone because of potential risk of central nervous system hyperexcitation
(hyperthermia, deliriumk etc) which has been noted with pethidine but never, so
far, with methadone. This occurs with buprenorphine, but with much less effect.
However both alcohol and benzodiazepine use is common in those requesting
opioid treatment and should not be regarded as an absolute contraindication.

Medical conditions complicating opioid use: as with other opioids, they should
be used cautiously in individuals with recent head injury, acute abdominal
conditions, severe respiratory, hepatic or renal disease.

Patients suffering with chronic pain: where opioid analgesia is indicate,
patients should normally be given appropriate doses of additional opioid analgesia
on top of that required for the management of dependence. [sec 16]

People with severe mental illness: this group may have limited capacity to
provide informed consent.

Medications that effect methadone levels: some medications have a significant
effect on methadone levels; for example, rifampicin may require a doubling or
trebling of methadone dose and can precipitate severe withdrawal. Methadone is
excreted more rapidly by urine acidifiers, e.g. ascorbic acid, so can significantly
reduce methadone levels. Urine alkalinisers such as sodium bicarbonate, reduce
excretion and so may increase methadone levels. For further details, see
appendix 1 in the British National Formulary (BNF)
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
Transfer of patients on more than 30mg of methadone to buprenorphine: this
is more likely to be associated with precipitated withdrawal and should only be
attempted after consultation with a specialist or experienced prescriber.

History of cardiac arrhythmias or abnormal ECG: Caution is required when
using methadone, [Appendix 3]
9
METHADONE PHARMACOLOGY
9.1 PEAK PLASMA CONCENTRATION

Four hours after regular oral administration (Range two to six hours)
9.2 PEAK CLINICAL EFFECTS



Two to six hours post oral dose (two to four hours first dose)
It takes four to five days for methadone tissue plasma levels to stabilise, though
accumulation continues beyond this, finally reaching a steady state after ten days.
Once a steady state is achieved, variations in blood concentrations are small.
9.3 DURATION OF ACTION (HALF LIFE)






The length of time it lasts in the body varies.
Single dose; shorter half life than maintenance dosing 12 – 18 hours means 15
hours.
First few days between 13 and 112 hours mean 37 hours.
Because of its cumulative effect until steady state is reached, methadone
induction should be a cautious and gradual process.
Elimination half life is normally 20 – 37 hours but can range up to 91 hours for
some individuals; its rate of clearance from the body can vary by a factor of almost
100.
Optimal doses are usually between 24 – 36 hours.
9.4 METABOLISM





Well absorbed from the gastrointestinal tract into the blood stream
Well distributed in body fats
Metabolised through the liver via cytochrome P450 sub family of enzymes, thus
susceptible to pharmacokinetic interactions with drugs that inhibit or induce liver
enzymes.
Binds well to plasma proteins and to lungs, liver and kidney tissues.
Varies enormously in different people and widely different doses of methadone
are needed to create the same serum methadone level.
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9.5 EXCRETION

Excreted in the faeces and urine; urinalysis is useful only in confirming if being
taken, but not establishing the dose.
9.6 DOSING


While research evidence suggests that optimal doses for most people lie between
60 and 120 mg some people will need more and some people will need less due
to a range of individual factors such as size, gender, age, other health problems
and metabolic clearance rates.
Doses between 10 and 120mg may exert clinical effects for 24 to 36 hours; low
doses exert clinical effects for only a few hours.
9.7 EQUIVALENCE




Direct equivalence to street heroin is difficult to estimate, as purity of street heroin
can vary 9between20 and 60%). One gram of street heroin is usually very roughly
equivalent to 50 to 80mg methadone.
Direct equivalence of methadone and buprenorphine and vice versa is difficult to
estimate, as the pharmacological properties of the two agents are not identical
and it is not a linear relationship.
When comparing the efficacy of maintenance doses, 50 to 80mg methadone is
approximately as effective as 12 to 16mg buprenorphine in reducing heroin use
and retaining patients in treatment.
When comparing the equivalence of methadone to injectable pharmaceutical
diamorphine, half lives must be taken into consideration. This is not a linear
relationship, so equivalence can vary from a methadone: diamorphine relationship
of 1:3 (or even 1:1 for very low doses) to around 1:5 for high doses of diamorphine
(e.g. 120mg methadone is equivalent to between 360 and 600mg of injectable
diamorphine).
9.8 TOLERANCE



Develops at different speed in different individuals, can change in individuals over
time and develops differently for different effects.
With long term use, and in response to continued exposure of the brain to opiates,
neuro adaptation occurs and involves changes in nerve and receptor function.
Level of heroin use is not the only factor in determining the final dose of
substitution that will be required. Patients react differently: some will need more
and some will need less than others using the same amount of heroin.
RCGP 2011 Guidance for the use of substitute prescribing in the treatment of opioid
dependence in primary care.
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METHADONE INDUCTION PROCESS – NEW STARTERS
10
Opioid substitution Therapy should only be considered following liaison with the
community drug services. Appropriate arrangements for exit prescribing will
need to be in place to ensure a seamless transfer of care back into to community
10.1 INDICATION
Methadone, an opioid agonist, can be substituted for opioids such as diamorphine,
preventing the onset of withdrawal symptoms; it is itself addictive and should only be
prescribed for those who are physically dependent on opioids..
It is available in several preparations, Liquid , Injection and Tablet, and strengths
1mg/1ml – 5mg/1ml – 10mg/1ml – 25mg/1ml – 50mg-1ml
The most common and preferred form used for the treatment of opioid dependency is
METHADONE mixture 1mg/1ml
Status – Schedule 2 Controlled Drug
10.2 PRECAUTIONS






Poly drug use – alcohol, benzodiazepines
Respiratory insufficiency
Severe Hepatic dysfunction
Renal impairment
Opiate naive
QT elongation
10.3 CONTRAINDICATIONS



Acute respiratory depression
Raised intracranial pressure
Comatose patient
10.4 INVESTIGATIONS


Establish dependence [Appendix 4]
Establish withdrawal [appendix 5]
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10.5 PRINCIPLES OF SAFE INDUCTION

Delay the first dose of methadone until the patient is experiencing features of opioid
withdrawal (this typically means at least 8 hours after last heron use, 24 hours after
last methadone use).

Objective withdrawal symptoms [table5] are assess using the Short Opioid
Withdrawal Score [Appendix 5] and should be completed at least 4-hourly.

NEVER give more than 10mg (Methadone Mixture 1mg/1ml) as an initial dose to
patients not receiving a methadone prescription in the community.

Do not exceed more than 40 mgs of methadone in the first 24-hour period.

The patient should be reminded that that although there will be a 4-hourly objective
assessment of withdrawal signs and symptoms, should they request a review of their
medication the assessment can be brought forward by 2 hours:
 Whereby an objective assessment of opioid withdrawal can determine; if a further
5 – 10 mg methadone is thought necessary. Consultation with the prescribing
team will be required.

Always complete a methadone assessment form prior to administration of
methadone. [See Appendix 5]

NEVER give methadone to a patient already intoxicated with opioids or other drugs
including alcohol.

After the initial induction [over 2 – 4 days] allow time for methadone levels to reach a
steady state [and so minimise the risk of an excessive cumulative increase in the
blood levels in the early days of treatment], then reassess and give the medication as
a supervised daily dose.
Where doses need to be increased, the increments should be no more than 10 mg
per day and no more than 30 mg per week week.
10.6 DOSING
Table 7 – Methadone Induction Dosing
DAY
DRUG
Day 1
Methadone 1mg/1ml
Day 2
Methadone 1mg/1ml
Day 3
Methadone 1mg/1ml
DOSING
DAILY MAX
5 – 10mg PRN 2 - 4 hrly in 40mg
response to symptoms
Day 1 total as a single dose + 50mg
additional 5-10mg STAT
Day 2 total as a single dose + 60mg
additional 5-10mg STAT
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Day 4
Methadone 1mg/1ml
v.2
Day 3 total as a single dose + 70mg
additional 5-10mg STAT
10.7 ADMINISTRATION
In order to maintain patient safety and reduce drug related deaths [sec 15.3] an
assessment of intoxication [sec 6.6] is required prior to administration.
The Drug and Alcohol Service Methadone Assessment Prior to Administration Checklist
[Appendix 5] needs completing immediately before each administration.
10.8 RISK FACTORS

Deaths during methadone titration are rare but most occur in the first two to three
days.

Over 20% of all methadone deaths in treatment take place within two weeks of
commencement of prescribing and most occur during sleep.

Risk of overdose is increased by low opioid tolerance, too high an initial dose, too
rapid increases and concurrent use of other drugs, particularly alcohol,
benzodiazepines and antidepressants.

Daily assessment, using supervised consumption is the best safeguard to prevent
undetected over sedation in a patient.

Methadone patients should be informed of the ‘increasing effects of a dose’ as steady
state is achieved, so that they do not excessively ‘top up’ with street drugs.

A number of factors can alter methadone plasma levels, including gastric emptying,
pregnancy and liver metabolism, which can increase risk of overdose.
10.9 OTHER POINTS TO CONSIDER

During induction, psychological factors and psychiatric morbidity / illness need to be
taken into consideration on the premise that depression may contribute to suicidal
ideation.

Clinical experience and some published data (though not randomised controlled
trials) suggest that psychiatric conditions, including major depression and psychosis,
sometimes respond to appropriate methadone dosing.

In patients with co-morbidity good control of opioid dependence leads to stability and
improvements in mental health.
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11
v.2
BUPRENORPHINE PHARMACOLOGY
11.1 PEAK PLASMA CONCENTRATION

90 to 150 minutes after regular sublingual administration.
11.2 PEAK CLINICAL EFFECTS


One to four hours post sublingual dose.
It takes three to four days for buprenorphine plasma levels to stabilise.
11.3 DURATION OF ACTION (HALF LIFE)





Related to dose.
Low dose (e.g. 2 to 4mg) may exert clinical effects for only a few hours, up to a
maximum of 12 hours, because receptor occupancy will be minimal and plasma
concentrations suboptimal.
Higher doses (e.g. 16 to 32mg) can exert effects for up to 48 to 72 hours.
Optimal doses are usually between 24 and 36 hours.
Elimination half life is between 20 and 37 hours.
11.4 METABOLISM


Principally in the liver via two hepatic pathways: glucuronide conjugation and Ndealkylation by the cytochrome P450 enzyme system.
The tablets are administered sublingually because it has poor bioavailability. It is
inactivated by gastric acid and has a high first pass metabolism.
11.5 EXCRETION

Excreted in the faeces and urine; urinalysis is useful only in confirming if being
taken, but not establishing the dose.
11.6 DOSING

Maintenance is between 8 and 32mg daily but the blockade dose (dose where the
effects of additional opioids are markedly reduced) is maximal above 16mg daily.
11.7 EQUIVALENCE

Direct equivalence of methadone and buprenorphine and vice versa is difficult to
estimate, as the pharmacological properties of the two agents are not identical
and it is not a linear relationship.
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
v.2
When comparing the efficacy of maintenance doses, 50 to 80mg methadone is
approximately as effective as 12 to 16mg buprenorphine in reducing heroin use
and retaining patients in treatment.
11.8 TOLERANCE



Develops at different speed in different individuals, can change in individuals over
time and develops differently for different effects.
With long term use, and in response to continued exposure of the brain to opiates,
neuro adaptation occurs and involves changes in nerve and receptor function.
Level of heroin use is not the only factor in determining the final dose of
substitution that will be required. Patients react differently: some will need more
and some will need less than others using the same amount of heroin.
RCGP 2011 Guidance for the use of substitute prescribing in the treatment of opioid
dependence in primary care.
BUPRENORPHINE INDUCTION PROCESS – NEW STARTER
12
Opioid substitution Therapy should only be considered following liaison with the
community drug services. Appropriate arrangements for exit prescribing will
need to be in place to ensure a seamless transfer of care back into to community
12.1 INDICATION
Buprenorphine is a sublingual tablet licensed for the treatment of opioid dependence in
individuals over the age of 16 years of age.
It is available in the following doses – 0.4 mg, 2 mg, and 8 mg.
Status - Schedule 3 Controlled Drug
12.2 PRECAUTIONS




Poly-drug use especially benzodiazepines
Chronic pain
Severe psychiatric illness
Methadone maintenance at doses higher than 40 mgs
12.3 CONTRAINDICATIONS



Pregnancy
Breast feeding
Severe hepatic/respiratory disease
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12.4 INVESTIGATIONS



Establish opioid dependency
Liver function test
Pregnancy test
12.5 DOSING
The purpose of the induction is to establish the patient on a safe dose of Buprenorphine
that prevents opioid withdrawals, reduces the need to take additional illicit opioids and
keep side effects to a minimum. It is usual to start on a low dose and increase rapidly
until a stabilizing dose is reached.
Before the commencement of buprenorphine, a full explanation should be given
to the patient covering the properties of the drug, it effects, the induction period
and the possible side effects. Understanding that the first 3 days are usually the
worst is very helpful to the patient, especially when explaining precipitated
withdrawal and the need for compliance to the treatment programme. (RCGP,
2004)
12.6 ADMINISTRATION
In order to maintain patient safety and reduce drug related deaths [sec 15.3] an
assessment of intoxication [sec 6.6] is required prior to administration.
The Drug and Alcohol Service Methadone Assessment Prior to Administration Checklist
[Appendix 5] needs completing immediately before each administration.
12.7 PRINCIPLES OF SAFE INDUCTION




Delay the first dose of buprenorphine until patient is experiencing features of opioid
withdrawal (this typically means at least 8 hours after last heroin use, 24 to 48 hours
after last methadone use)
Commence with an initial dose of between 4 and 8 mgs
Rapidly titrate the dose on subsequent days according to clinical response (daily
increases of up to 4 mgs are possible)
Buprenorphine are administered sublingually, therefore it is important that the patient
is observed the entire period that it takes the tablet to dissolve, and then be given a
full glass of water to drink.
Table 8 - Suggested buprenorphine induction regime for the ward setting
DAY
MORNING
EVENING
DAY 1
4 mgs
4 mgs
DAY 2
8 mgs
4 mgs
DAY 3
16 mgs
Subsequent days
Continue as above
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12.8 RISK FACTORS FOR OVERDOSE


Low opioid tolerance,
Use of CNS depressant drugs, including alcohol,
There is also a risk of increased precipitating withdrawal, if insufficient time is left before
administering buprenorphine in patients who have:


Recently used heroin, particularly at higher doses,
Recently consumed long-acting opioids such as methadone
12.9 BUPRENORPHINE + NALOXONE (SUBOXONE)
A new form of buprenorphine has been developed that includes the opioid antagonist
naloxone (buprenorphine: naloxone 4:1) in a combined sublingual tablet. This new form
is for use at the same buprenorphine dose (the current 8 mg sublingual buprenorphine
being considered as the same therapeutic dose as the new combination of 8 mg
buprenorphine plus 2 mg naloxone).
It has been presented as a new product, under the trade name Suboxone®, and
received product approval for addiction treatment throughout the European Union in
December 2006. The rationale is that, when taken sublingually as intended, the naloxone
has very low bioavailability and does not diminish the therapeutic effect of the
buprenorphine.
However, if injected, the naloxone has high bioavailability and is liable to precipitate
withdrawal in an opioid-dependent patient, therefore discouraging further misuse. If taken
intranasally, the effect of the naloxone appears to be variable. The combination tablet is
therefore expected to provide the same therapeutic benefit while preventing or reducing
the liability for misuse. Clinical experience with this new combination product is, at the
time of publication, extremely limited in the UK, and it is too early to indicate the relative
positions of these two versions of buprenorphine.
NOTE – This medication is not included in the Trust formulary; but is widely prescribed
within the community setting
To ensure minimum delay in treatment for the patient generic buprenorphine (Subutex)
can be prescribed as an alternative to Suboxone at an equivalent dose.
12.10 PRECIPITATED WITHDRAWAL
Precipitated withdrawal occurs in someone commencing buprenorphine who has recently
taken heroin (less than 6 hours previously) or methadone (less than 24 hours
previously).
It is caused by the high affinity of buprenorphine displacing other opioids e.g.
methadone, heroin from opioid receptors, but having less opioid activity (partial agonist).
This rapid reduction in the opioid effects can be experienced as precipitated withdrawal,
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typically occurring 1 to 3 hours after the first buprenorphine dose, peaking in severity
over the first 3 to 6 hours, the gradually subsiding.
If it occurs, reassure the patient and offer symptomatic treatment such as Lofexidine e.g.
400 – 600 mcg 8 hourly, as appropriate, if withdrawal symptoms are severe.
Do not prescribe more buprenorphine until opioid withdrawal symptoms have
settled.
13
OPIOID DETOXIFICATION
13.1 OVERVIEW
Detoxification should be a readily available treatment option for people who are opioid
dependent and have expressed an informed choice to become opioid abstinent.
13.2 CONSENT
In order to obtain informed consent, staff should give detailed information to service
users about detoxification and the associated risks, including:




the physical and psychological aspects of opioid withdrawal, including the duration
and intensity of symptoms, and how these may be managed
the use of non-pharmacological approaches to manage or cope with opioid
withdrawal symptoms
the loss of opioid tolerance following detoxification, and the ensuing increased risk of
overdose and death from illicit drug use that may be potentiated by the use of alcohol
or benzodiazepines
the importance of continued support, as well as psychosocial and appropriate
pharmacological interventions, to maintain abstinence, treat comorbid mental health
problems and reduce the risk of adverse outcomes (including death).
13.3 UNSUITABLE POPULATONS





With a medical condition needing urgent treatment
In police custody, or serving a short prison sentence or a short period of remand;
Who have presented to an acute or emergency setting; the primary emergency
problem should be addressed and opioid withdrawal symptoms treated, with
referral to further drug services as appropriate.
For women who are opioid dependent during pregnancy, detoxification should
only be undertaken with caution.
For people who are opioid dependent and have comorbid physical or mental
health problems, these problems should be treated alongside the opioid
dependence.
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13.4 OPIOIDS AND ALCOHOL
If the person is alcohol dependent, alcohol detoxification should be offered. This should
be carried out before starting opioid detoxification in a community or prison setting, but
may be carried out concurrently in an inpatient setting. For alcohol detoxification refer to
PAT/T 25.
13.5 OPIOIDS AND BENZODIAZEPINES
If the person presenting for opioid detoxification is also benzodiazepine dependent,
healthcare professionals should consider benzodiazepine detoxification. When deciding
whether this should be carried out concurrently with, or separately from, opioid
detoxification, healthcare professionals should take in to account the persons preference
and the severity of dependence for both substances.
13.6 METHADONE – BUPRENORPHINE
Methadone or Buprenorphine can be offered as the first line treatment in oioid
detoxification. When deciding between these medications, healthcare professionals
should take in to account:




Whether the service user is receiving maintenance treatment with methadone or
buprenorphine; if so, opioid detoxification should normally be started with the
same medication.
The preference of the service user
Detoxification can be achieved through regular 1 – 2 x weekly dose reductions not
usually more than 10% of the total daily dose.
Symptomatic relief of withdrawal symptoms may also be required. [sec 13.10]
13.7 LOFEXIDINE
Lofexidine may be considered for people:



Who have made an informed and clinically appropriate decision not to use
methadone or buprenorphine for detoxification.
Who have made an informed and clinically appropriate decision to detoxify within
a short time period
With mild or uncertain dependence (including young people).
See section [sec 13.11] [sec 13.12]
13.8 CLONIDINE
Clonidine should not be used routinely for opioid detoxification.
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13.9 DIHYDROCODEINE
Dihydrocodeine should not be used routinely for opioid detoxification.
13.10 OTHER SYMPTOMATIC MEDICATIONS





Diarrhoea – loperamide 4 mg immediately followed by 2 mg after each loose stool
for up to five days; usual dose 6-8 mg daily, maximum 16 mg daily.
Nausea, vomiting, may also be useful for stomach cramps – metoclopramide 10 mg
eight hourly or prochlorperazine 5 mg three times a day or 12.5 mg intramuscularly
12-hourly.
Stomach cramps – buscopan 20mgs qds
Agitation and anxiety, sleeplessness – diazepam (oral) up to 5-10 mg three times
daily when required (or zopiclone 7.5 mg at bedtime for patients who have been
dependent on benzodiazepines). In severe cases of anxiety and agitation, obtain
suitable psychiatric advice from an addiction psychiatrist or the on-call duty
psychiatrist.
Muscular pains and headaches – paracetamol, aspirin and other non-steroidal
anti-inflammatory drugs. Topical rubefacients can be helpful for relieving muscle
pain associated with methadone withdrawal.
13.11 LOFEXIDINE CONSIDERATOINS
Lofexidine is a non-opioid alpha-adrenergic agonist and is not a controlled drug. It is
licensed for the management of symptoms of opioid withdrawal but is being used much
less frequently. Lofexidine comes as a 200mcg tablet and the effect lasts only a few
hours.
The treatment course is between 7–10 days with doses starting at 800 micrograms daily
and rising to a maximum of 2.4 mg in divided doses. The dose is then reduced over
subsequent days.
Reported side effects of Lofexidine are dry mouth and mild drowsiness. Patients
sometimes complain of a metallic taste in their mouth and that their urine smells of yeast.
There is a risk of bradycardia and hypotension hence pulse and blood pressure need to
be monitored. There is also a risk of rebound hypertension when treatment with
lofexidinbe ends.
Use lofexidine with caution in-patients with cardiac disease, cerebrovascular accidents,
and chronic renal failure. The safety in pregnant and breastfeeding women has not been
established.
Sedation is increased with concomitant use of alcohol or central nervous system
depressants and overdose can result in hypotension, bradycardia, sedation and coma.
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It is most likely to be successful for patients who are using small amounts of opioids or
have uncertain dependence, and those with shorter drug use or treatment histories.
Lofexidine can be used in patients whom it is clinically appropriate and in those who
have made a decision not to be detoxified using methadone or buprenorphine. In every
case the patient needs to be carefully assessed and selected, should make and informed
choice and want to stop using opiates.
There is an increased risk of overdose amongst patients returning to illicit opioid (heroin)
use following a period of abstinence.
13.12 LOFEXIDINE REGIME
Before commencing a patient on Lofexidine, it is advisable to obtain a baseline blood
pressure (BP) reading and pulse (P); then measure the BP and P prior to administration
of medication. Lofexidine should be discontinued if the blood pressure drops
significantly i.e. if diastolic falls below 60 and pulse rate fall below 55 beats per
minute.
Table 9 – Procedure for induction of Lofexidine
DAY 1
 All opioids stopped, record
withdrawal symptoms using
Short Opioid Withdrawal
Scale (A
 Check BP/Pulse
 Commence lofexidine
regime as shown above
 Check BP/Pulse 30 minutes
post dose
 If BP/Pulse stable continue
Lofexidine 0.2mg q.d.s
 If diastolic BP falls below 60,
pulse rate falls below 55
beats per minute or if client
develops physical
symptoms e.g. dizziness or
fainting then omit the next
Lofexidine dose and seek
medical advice.
DAY 2
 Chart withdrawal
symptoms
 Check BP/Pulse
 Lofexidine as per
regime
 Symptomatic
treatment as
required
DAY 3 - 6
As day 2
DAY 7
 No further
medication
unless objective
withdrawals
present. If
observed 0.2mgs
q.d.s
 May be
considered with a
reduction of 1
tablet daily.
Table 10 - Lofexidine regime
DAY 1
DAY 2
08.00
14.00
18.00
22.00
2
3
2
2
2
2
2
3
Page 33 of 63
TOTAL
TABLETS
(200
micrograms)
8
10
PAT/T 21
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
3
3
3
2
0
3
3
2
2
0
3
3
2
2
0
3
3
3
2
0
v.2
12
12
10
8
0
Additional short-term medication for symptoms such as stomach cramps and diarrhoea
may be required. Withdrawal symptoms can be monitored using the Short Opiate
Withdrawal Scale [Appendix 5], which provides a comparison over time.
14
RELAPSE PREVENTION PRESCRIBING
14.1 BENEFITS
Naltrexone is an opioid antagonist which, when taken regularly, blocks opiate receptors
within the brain thus preventing a former opiate user from experiencing the effects of
opioids.
It can be helpful following detoxification in enabling a patient to maintain abstinence.
In the UK naltrexone is only licensed for use orally.
Before considering commencement of naltrexone, the patient needs to be fully informed
of the effects, side effects and risks of naltrexone so that they are able to make an
informed choice.
14.2 RISKS
There is a risk of fatal overdose should the patient attempt to ‘override” the opioid
blockade with illicit drug use.
14.3 INVESTIGATIONS
Due to the potentially hepatotoxic nature of naltrexone, liver function tests should be
conducted before and during naltrexone treatment.
14.4 DOSING
Naltrexone is a long-term therapy and will need to be continued via a community
service on discharged. Appropriate arrangements for exit prescribing will need to
be put in place to ensure a seamless transfer of care back into the community
before the patient is discharged.
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Following a negative urine or oral fluid test for opioids the patient is given a single
dose of naltrexone (25 mg) orally
Observe the patient for any withdrawal or other ill effects.
If the patient does not experience any withdrawal a 50 mg. dose may be given
the next day
The usual maintenance dose is then 50 mg a day
14.5 LOSS OF TOLERANCE
The patient should be warned of the risk of drug overdose on leaving hospital, due to
loss of tolerance.
Accidental overdose is often due to reduction in tolerance after period of abstinence (e.g.
release from prison, discharge from rehabilitation or hospital).[ACMD, 2000]
Appropriate written support information should be given to the patient to refer to on
discharge, alongside a good, effective explanation of the literature to ensure
understanding and informed choice.
See DRUG RELATED DEATHS [sec 15.2] [sec 15.3]
15
GENERAL MANAGEMENT
15.1 WARD MANAGEMENT





A risk assessment to should be completed to determine the risks to patient, staff,
public and the environment.
To avoid illicit drug use on the ward: ingestion of medication should be observed;
freedom to wander the hospital should be controlled; visitors should be limited and
regular urine samples should be taken.
Consideration should be given to placing the patient’s bed close to the nursing
station to facilitate observation
Some opioid users abuse other drugs. Concurrent dependence on alcohol and
sedative drugs (e.g. benzodiazepines/barbiturates) can cause severe withdrawal
symptoms and may require stabilisation on a sedative drug of the same class (e.g.
diazepam, chlordiazepoxide, phenobarbitone)
Reassurance that any existing community treatment will be continued on
admission.
15.2 DRUG RELATED DE ATHS
Rates of recorded drug-related deaths among UK drug misusers are among the highest
in Europe. The four main causes of drug-related deaths are:


overdose
suicide
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accidents
physical health complications of drug misuse
Drug-related overdoses are most commonly caused by opioid drugs (heroin or
methadone) and often involve the use of other depressant drugs like alcohol and
benzodiazepines. Drug overdose remains the second most common cause of years of
life lost in young men.
Drug-related deaths are especially high in the first weeks following release from prison.
Those at most risk have a history of injecting drug use immediately prior to entry to
prison, and a long history of opioid dependence or poly-drug dependence (Farrell and
Marsden, 2005).
Mortality in the first few weeks of OST is significantly elevated, as it is in the weeks after
leaving treatment. (Cornish et al 2010) Strang
Clinicians have an important role in minimising the risks of all four causes of drug-related
deaths among drug misusers and the risks of death to others due to diversion or due to
unsafe storage of prescribed medication.
15.3 REDUCING DRUG RELATED DEATHS
The 2007 Clinical Guidelines suggest that clinicians can help to reduce drug-related
deaths in their patients by:










identifying and assessing patients at greatest risk of drug-related death.
providing education and training to drug misusers and their families on the risks of
overdose and how to respond effectively advising drug misusers of the dangers of
combining drugs, especially alcohol and benzodiazepines.
educating drug misusers that the use of methadone, outside its medical purpose,
is extremely dangerous.
educating new patients starting on methadone and buprenorphine on the risks of
loss of tolerance.
using supervised consumption, especially in the early stages of methadone and
buprenorphine treatment,
adjusting dispensing frequency according to risks.
requiring that patients moving on to take home methadone and buprenorphine
provide details of satisfactory home storage arrangements and recording these in
the patient’s notes, especially when children are in the home.
conducting or arranging for mental health assessments in patients who present a
suicide risk.
making use of local specialist support and referral in complex cases, such as
cases of polypharmacy requiring specialist review.
Contributing to effective care pathways between hospital and community
services.
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15.4 DEALING WITH EMERGENCY OVERDOSE
Treat opioid overdose with standard resuscitation techniques and with the use of
naloxone. Naloxone is given 0.4-2.0 mg parenterally (IV/IM/SC) and this can be repeated
after every 3–4 minutes, up to a maximum dose of 10 mg.
It is important to remember the half-life of naloxone is much shorter than methadone and
other opioids. This fact should be made clear to patients, particularly in A&E and in other
situations where the patient may leave the hospital suddenly. Patients should be helped
to understand that they are at risk of re-emergence of life-threatening sedation when the
naloxone wears off. Given that some patients may find it difficult to cope with the
precipitated discomfort that can occur on administering naloxone, and may choose to
leave, it is important that they are helped to understand this risk.
To accommodate the above recommendations the following care plans need to
be completed prior to discharge:


Methadone Safety Care Plan [Appendix 6]
Safer Injecting Care Plan [Appendix 7]
15.5 SLEEPLESSNESS
There is recognition that sleeplessness can present a management problem. It has to be
appreciated by the patient and the team that sleeplessness is a feature of opioid
withdrawal and therefore as the titration of methadone progresses there will be a limited
need for night sedation. This minimises the over reliance of sedative medication which is
dependence producing.
Night sedation should not be considered in the first 2 –3 days of stabilisation. The use of
benzodiazepines should be actively discouraged unless there is evidence of concurrent
benzodiazepine dependence. However should the insomnia persist in exceptional
circumstances Nitrazepam 5-10 mgs may be given at the discretion of the medical team
and at the first appropriate opportunity discontinue the medication.
15.6 PATIENTS OWN SUPPLIES
PAT/MM 1B v.4 POLICY FOR THE SAFE AND SECURE HANDLING
OF MEDICINES PART B Controlled Drugs
“6.10 Patient’s Own Medicines
Patient’s own Controlled Drugs that are brought on a ward or department that
stock CDs shall normally be destroyed in that ward or department following procedure in
Section 7.15.”
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Any community methadone / buprenorphine brought to hospital on admission must not
be returned to the patient. Take home supplies should be issued to maintain continuity
of community treatment and prevent accumulation of doses whilst in hospital.
Liaison with the community drug team is essential.
The ward to inform the patient’s GP and community pharmacy of any methadone /
buprenorphine that may have been accrued by the patient in the community setting
during their admission.
15.7 PREGNANCY
The number of women misusing drugs has increased considerably in the past 30 years,
and many are of childbearing age. [DOH, 1999].
Any patient found to be pregnant and misusing drugs will require a sensitive approach
and every opportunity taken to encourage them into mainstream service.





Sudden withdrawal of opioids should not be encouraged during pregnancy
because of the risks to the mother and baby.
Advised take the lowest amount of drug needed to avoid withdrawal, in the safest
way [e.g. smoke rather than inject]
Offer urgent referral to drug services / specialist midwife.
Where appropriate initiate methadone prescribing [section 3]
SUBOXONE is not suitable for treatment during pregnancy
15.8 MENTAL CAPACITY

For patients with impaired mental capacity refer to the trust policy in relation to the
mental capacity act (PAT/PA 19)
15.9 ILLICIT DRUG USE ON TOP OF PRESCRIBED MEDICATION
At the beginning of treatment, people may not have decided to become immediately
abstinent and may not have agreed their level of need and the full package of care.
They may continue to use illicit opiods albeit at a reduced amount.
If there is evidence of regular additional heroin use concurrent with a methadone
prescription, limiting heroin use solely by admission may result in, heroin being brought
on to the ward, or the patient discharging themselves prematurely.
In these circumstances, advice should be sought from the community prescriber
regarding any adjustments that might be needed to the existing methadone daily dose.

Discuss and Document concerns and risk of overdose with patient.
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


v.2
Consider increasing the dose - no more than 10mg per day no more than
30mg above starting dose in a week. [sec 10.6]
Complete Methadone Assessment Prior to Administration. [Appendix 5]
Review daily.
If little or no improvement results from the current treatment interventions they may need
to be adapted then reviewed again. This can help ensure treatment remains dynamic
and responsive to need. Identifying “little or no improvement” is important but must take
into account continued harm reduction benefits and the prevention of deterioration. (NTA
2012).
15.10 DRUG MISUSERS NOT ADMITTED TO HOSPITAL AND NOT IN
TREATMENT
Where patients receive care in departments and do not require admission it is
inappropriate to initiate treatment, however;
Attendance at A&E or admission into hospital may present a window of opportunity to put
drug misusers in touch with other services and consider their drug misuse. (DOH 2007)
On discharge, the following information should be given as a minimum:




16
General health promotion advice,
Contacts for further help (such as needle exchange services, drug treatment services
or self-help groups),
Advice on preventing overdose,
Advice on reducing the risk of blood-borne virus infection and its consequences
(including support for hepatitis B vaccination). This information is available from local
drug treatment services.
PAIN MANAGEMENT
16.1 OVERVIEW
Pain is subjective and person defined; it is always unpleasant.
It can be acute, which is a protective warning, predictable and responding well to
treatment OR chronic, tending to be continuous, of moderate to high severity for more
than six months and in contrast unpredictable.
Pain can be affected by fears, age, gender, culture, previous experience of either self or
significant others. A history of substance use including alcohol, is commonly linked with
chronic anxiety and chronic depression, which may negatively affect a patients
experience of pain.
Chronic pain affects between 10 – 15% of the general population rising to between 30
and 50% of substance misusers.
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Pain in people who use drugs is common, complex and often forgotten and poorly
treated. Up to 25% of people who use opioids say they start opiates because of pain.
Under-treatment is common and is often based on misconceptions.
There are a number of reasons why individuals who are drug dependent may have
greater than expected needs regarding pain relief:

Compared to those who are not dependent, the presence of a drug misuse
syndrome seems to worsen the experience of pain – hyperalgesia.

Drug misusers have a low tolerance of non-pharmacological interventions to
achieve pain control.

By nature of their condition, drug misusers have frequent episodes of intoxication,
and withdrawal, which may alter the intensity of the pain experience.

Virtually all forms of addiction are associated with sleep disturbance and this is a
well established exacerbating factor in chronic pain.

Depression and anxiety are common features in addiction and these have an
important influence on the pain experience.

Drug misusers are more likely to suffer from accidental and non accidental injury,
and medical complications related to their drug use. This places them at high risk
from physical problems that may require analgesia.
When a known substance misuser presents with a need for analgesia

A full substance misuse and medication history should be taken. This can be used
to check for drug interactions and to assist with choice and appropriate analgesic.

The accurate assessment of contemporaneous treatment for addiction is also
mandatory as many of these treatments have important implications for the use of
opioid medications.

It is important to discuss the patients use of alcohol as this has specific relevance
to the experience of and management of pain.

Pain symptoms must be properly evaluated including relevant investigations and
taking note of potential contributors to the patients experience of pain.

If non pharmacological interventions are known to have utility for the pain
condition described they should be offered to the patient, with a clear explanation
of why such interventions are likely to help. Similarly non opioid medications
should be used where supported by evidence, again with clear discussion of the
rationale for any drug used.
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
There is little published guidance for management of patients who have chronic
pain requiring opioid therapy, and who currently exhibit aberrant behaviour which
may indicate misuse or addiction, or have a history of substance misuse.
Nevertheless, some general principles may be applied:

The therapeutic regimen should be selected with the risk of aberrant drug related
behaviours in mind i.e. short acting opioids are widely acknowledged to have
greater abuse potential than long acting or sustained release preparations.

The prescriber must communicate clearly with the patient about setting
reasonable expectations or goals for therapy and bout the necessity to frequently
assess the progress towards these goals. This must include a regular review of
the prescription.

The process of building trust between the clinician and the patient should include
a candid discussion of acceptable and unacceptable behaviour. The results of
such a discussion should be written down and given to the patient. This may take
the form of a treatment contract although this is not required by law.

Be aware of the various potential presentations and drug seeking behaviour.
Refer patient to, or seek advice from, a pain specialist or substance misuse
specialist at an early stage where appropriate.

Treatment decisions need to made in compliance with pertaining laws and
regulations.

Response to treatment including degree of pain control and progress towards
agreed goals needs to be assessed frequently.
Patients already tolerant to a long term illicit or prescription opiates
taken for addiction will derive little analgesic effect from their regular
dose. If the patient needs opiate analgesia these drugs will have to be
prescribed in addition to any existing prescribed regimen.
16.2 METHADONE AND P AIN






Give the usual methadone maintenance dose to address the persons baseline
opioid requirements.
If an opioid analgesic is appropriate for the patients condition, a non-methadone
opioid may be co prescribed in addition to the patients usual methadone dose.
It is not necessary to “rationalise” the patients entire opioid requirements to one
drug.
Relatively high doses of opioids at short interval may be needed because of
tolerance.
Morphine is the preferred opioid agonist.
It is usually necessary to give a dose that is at least the dose that would be given
to a person not on substitute drug maintenance treatment. It is not possible to
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predict how much extra dose will be required. Increased sensitivity to pain or
cross tolerance will often necessitate higher or more frequent doses.
Avoid partial agonist / antagonist drugs should for patients receiving methadone
as withdrawal may be precipitated.
16.3 BUPRENOPRHINE (SUBUTEX / SUBOXONE) AND PAIN
Patients taking high dose Buprenorphine as substitution therapy may be relatively
refractory to opioid prescribed for analgesia.
See specialist advice. Management could follow any of the following options.





Try NSAIDs and paracetamol
If the pain will be of short duration, continue buprenorphine maintenance therapy
and titrate a short acting opioid agonist. Because higher doses of full opioid
agonist analgesics may be required in a person taking buprenorphine, be cautious
if the person’s buprenorphine therapy is abruptly discontinued, as sedation and
respiratory depression may occur.
Alternatively, divide the daily dose of buprenorphine and administer every 6-8
hours (although this not a licensed use of subutex) However if opioid tolerance
has developed, additional opioid analgesia may be required.
Discontinue buprenorphine and treat with an opioid analgesic by titrating the dose
to avoid withdrawal and then to achieve analgesia. Both sustained release and
immediate release morphine may be used. Convert back to buprenorphine using
the initiation and stabilisation protocol.
If the person is in hospital, buprenorphine can be stopped and methadone
maintenance and opioid analgesic used, but close observation is essential and
naloxone should be immediately available. The person may be changed back to
buprenorphine before discharge.
Advice should be sought from the Acute Pain Team on bleep 1449 (at DRI) or 3107 (at
BDGH) or the on-call anaesthetist outside office hours.
16.4 NALTREXONE AND PAIN
Naltrexone is an opiate antagonist with no agonist properties and will totally block the
effects of substantial doses of opioid analgesics. People taking Naltrexone should be
aware of the potential problems and the need to alert clinicians.



Discontinuation of naltrexone produces very few signs and symptoms, but long
term use increases the concentration of opioid receptors in the brain and
produces a temporary exaggeration of response to the subsequent administration
of opioid analgesics.
If unexpected or severe pain should occur, then intravenous paracetamol, high
dose nonsteroidal anti inflammatory drugs, and local anaesthetics are effective.
Ketamine is an effective analgesic and may be useful. There is no information
available about whether Tramadol would be useful.
Minor or intermediate elective surgery: discuss with the person and their
community drug team the possibility of management of the pain with none opioid
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analgesics versus the risk of relapse if naltrexone is withdrawn and opioid
analgesics used. Naltrexone should be withdrawn 48-72 hours before the surgery
is due to take place.
Major surgery, with expected severe post operative pain: naltrexone should be
discontinued 72 hours beforehand. Expect a degree of resistance to opioid
analgesics, although there may be increased sensitivity.
16.5 PERI OPERATIVE PAIN
Methadone may be given as per the patient’s usual requirements within 2 hours before
surgery, as per clear fluids policy. (PAT/T 24)
The anaesthetist will need informing of the amount and time of the last methadone dose
given.
It may be necessary to omit or delay Buprenorphine dosing to prevent either opioid
blockade or precipitated withdrawal effects.
17
DISCHARGE PLANNING
Every effort is taken to minimise the need for take home supplies upon discharge from
hospital, however, there are times such as weekends and Bank holidays when it is
necessary to provide take home doses in order to maintain continuity of care.
It is essential to liaise with the Community Drug Team as part of discharge
planning to establish a plan which minimises both the potential for duplicate
prescribing or a medication shortfall.
17.1 TTO – EXISTING COMMUNITY PATIENT
It is normal Community Substance Misuse Team practice for methadone / buprenorphine
patients receive weekend supplies to take away to allow for pharmacy closed days.
Some patients will routinely receive “take home” supplies in the community i.e. 3 x
weekly (mon / wed / fri), twice weekly or weekly.
For these well establish patients the risks from providing take home supplies upon
discharge from hospital is generally considered to be low, whereas failure to maintain
continuity of treatment could result in withdrawal and illicit drug use which may pose a
greater risk to health.
In order to manage the safe transition from inpatient to community care the following
checks need to carried out, documented in the patient notes and communicated to the
Community Drug Team.




Current drug and dose
Date and time last taken
Reason for giving TTO
Amount of take home medication supplied
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Date of next required community dosing
For patients receiving weekly supplies of methadone in the community the decision to
issue large amounts of TTO medication should only be taken in conjunction with DALNS.
17.2 CAUTION
The JAC default for TTA medication is 28 days. Ensure you have amended JAC
according to the patients individual plan.
A handwritten INTERIM DISCHARGE NOTIFICATION for (HMR 2a) needs
completing in addition to the JAC TTA request.
17.3 TTO - NEW STARTERS
TTO supplies are not routinely given to patients initiated in hospital.
Extra safeguards are required when discharging patients who where not receiving OST
on admission as Mortality in the first few weeks of OST is significantly elevated (Cornish
et al 2010)
Every effort should be taken to minimise the need for take home methadone dosing, for
“new starters” and additional steps should be considered to prevent discharge at
weekends or public holidays which would require the need for take home dosing.
Where it is not possible to prevent a discharge requiring take home dosing, it is
essential to liaise with the Community Drug Team to establish a plan which
minimises both the potential for double prescribing or the patient experiencing an
interruption to treatment.
In order to manage the safe transition from inpatient to community care the following
checks need to carried out, documented and communicated to the relevant Community
Drug Team.





Current drug and dose
Date and time last taken
Date of next required community dosing.
Inform the patient of overdose risks from opiates, Benzodiazepine and Alcohol.
Methadone safety care plan. [Appendix 6]
17.4 CAUTION
The JAC default for TTA medication is 28 days. Ensure you have amended JAC
according to the patients individual plan.
A handwritten INTERIM DISCHARGE NOTIFICATION for (HMR 2a) needs
completing in addition to the JAC TTA request.
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TTA supplied in line with PAT/MM 1A.
18
TRAINING/ SUPPORT
The nurse or healthcare worker in charge of a department is responsible for ensuring
that their staff are competent in the management of patients with substance misuse
problems. In the case of medical staff the consultant is responsible.
The Drug and Alcohol Liaison Nurse Specialist services at Doncaster Royal Infirmary
and Bassetlaw District General Hospital provide “in house” training support via Specific
Study Days, ward based sessions or on a 1:1 case specific supervision basis.
19
MONITORING COMPLIANCE WITH THE PROCEDURAL
DOCUMENT
What is being Monitored





20
Were pre prescribing
checks carried out
and documented
Were discharge /
TTO plans explicit
Were Methadone
Pre administration
checklists used
Were Methadone
Safety care Plans
used
Were Safer injecting
care plans used
Who will carry out the
Monitoring
How often
How Reviewed/
Where Reported to
DALNS / Pharmacist /
Ward Managers
Annual
Audit
Annual Audit Report in
conjunction with
Clinical Audit
DALNS / Ward
Managers
Annual
Audit
Annual Audit Report in
conjunction with
Clinical Audit
DEFINITIONS
ACMD – Advisory Council on the Misuse of Drugs
BDGH – Bassetlaw District General Hospital
BNF – British National Formulary
DALNS – Drug and Alcohol Liaison Nurse Specialist
DOH – Department of Health
DRI – Doncaster Royal Infirmary OST – Opioid Substitution Therapy
ECG – Electro Cardio Gram
NICE – National Institute for Clinical Excellence
NMP – Non Medical Prescriber
NTA – National treatment Agency
PRN – Pro Re Nata (latin “as the occasion arises”)
RCGP – Royal College General Practitioners
TTA – To Take Away
WHO – World Health Organization
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EQUALITY IMPACT ASSESSMENT
An Equality Impact Assessment (EIA) has been conducted on this procedural document
in line with the principles of the Equality Analysis Policy (CORP/EMP 27) and the Fair
Treatment For All Policy (CORP/EMP 4).
The purpose of the EIA is to minimise and if possible remove any disproportionate
impact on employees on the grounds of race, sex, disability, age, sexual orientation or
religious belief. No detriment was identified.
A copy of the EIA is available on request from the HR Department.
22
ASSOCIATED TRUST PROCEDURAL DOCUMENTS
PAT/T 25 - Guidelines for the Management of Alcohol issues in the Acute General
Hospital Setting.
PAT/MM 1B - POLICY FOR THE SAFE AND SECURE HANDLING
OF MEDICINES PART B Controlled Drugs
PAT/MM 1A - Policy for the Safe and Secure Handling of Medicines Part A
PAT/.PA 19 - Mental Capacity Act 2005 Policy and Guidance
PAT/PS 10 - Safeguarding and Promoting the Welfare of Children
PAT/T 24 - Pre-operative fasting guidelines.
23. REFERENCES
1. Advisory Council on the Misuse of Drugs (2000) Reducing Drug Related Deaths. A
Report by the Advisory Council on the Misuse of Drugs. HMSO London
2. Armstrong, D., Phillips T.(2003) Management of Patients with Opiate Dependency on
Medical / Surgical Wards – Guidelines, Hull& East Riding Community Mental Health
NHS Trust
3. Arizona Centre for Education and Research on Therapeutics. Drugs that Prolong the
Qt Interval and/or Induce Torsades de Pointes Ventricular Arrhythmia.
www.torsades.org
4. Australian Government (2003) National Strategy. Clinical Guidelines for Procedures
for the use of Methadone Maintenance Treatment of Opioid Dependency. Australia
5. Botstein P (1993) Is QT Interval Prolongation Harmful. A Regulatory Perspective.
Amer J Cardiology 1993; 72 (6): 50B-52B
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6. Capelhorn J and Drummer OH (1999) Mortality Associated with New South Wales
Methadone
7. Cornish et al (2010) Risk of death during and after opiate substitution treatment in
primary care: prospective observational study in UK General Practice Research
Database. BMJ 341: c5475. doi: 10.1136
8. Programs in (1994): lives lost and saved. Medical Journal of Australia 170, 104–109.
9. UK health departments (1999) Drug Misuse and Dependence – Guidelines on Clinical
Management. London: The Stationery Office.
10. Department of Health, (1999b) National Service Frameworks for Mental Health:
Modern Standards and Service Models. Department of Health
11. Department Of Health, [2005].National Treatment Agency for Substance Misuse –
Models of Care for Drug Misuse. London, HMSO
12. Department of Health. (2007) Drug Misuse and Dependence – Guidelines on Clinical
Management. London: The Stationery Office
13. Drug Strategy (2010) Reducing demand, restricting supply, building recovery:
supporting people to live a drug free life.
14. EAEMP (2001) Public Statement on the Recommendation to Suspend the Marketing
Authorisation for ORLAAM (Levacetylmethadol) in the European Union. London:
European Agency for the Evaluation of Medicinal Products.
15. Farrell M and Marsden J (2005) Drug-related Mortality Among Newly Released
Offenders 1998-2000. London: Home Office, on-line report 40/05.
16. Haigney MC, Alam S, Tebo S, Marhefka G, Elkashef A, Kahn R, Chiang CN, Vocci F
and
17. Cantilena L (2006) Intravenous Cocaine and QT Variability. J Cardiovasc
Electrophysiol. 17(6):610-6.
18. Ghodse, A.H. (2002) Drugs and addictive behaviour: A guide to treatment. 3rd
edition. Blackwell Science. Oxford.
19. Lipski J, Stimmel B and Donoso E (1973) The Effect of Heroin and Multiple Drug
Abuse on the
20. Electrocardiogram. Am Heart J 1973;86 (5);663-668.
21. MHRA (2006) Current Problems in Pharmacovigilance, vol 31 May 2006. London:
Medicines and Healthcare products Regulatory Agency
22. NTA (2012) Medications in recovery – re orientating drug dependence treatment.
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23. NICE (2007a) Methadone and Buprenorphine for the Management of Opioid
Dependence. Technology appraisal 114. London: National Institute for Health and
Clinical Excellence.
24. NICE (2007b) Drug Misuse: Opiate Detoxification. NICE clinical guideline 52. London:
National Institute For Health and Clinical Excellence.
25. NICE (2007c) Naltrexone for the Management of Opioid Dependence. NICE
technology appraisal guidance 115. London: National Institute for Health and Clinical
Excellence
26. NICE (2012) Quality Standards for Drug Use Disorders. QS23. National Institute for
Clinical Excellence.
27. Royal College of General Practitioners, (2004). Guidance for the use of
buprenorphine for the treatment of opioid dependence in primary care.
28. Royal College of General Practitioners, (2011). Guidance for the use of substitute
prescribing in the treatment of opioid dependence in primary care.
29. Rawson, RA et al. (1997) Naltrexone and Behaviour Therapy for Heroin Addiction.
National Institute for Drug Abuse Research Monograph Series p26-43
30. Schmittner J, Schroeder JR, Epstein DH and Preston KL (2004) QT Interval
Increased After Single Dose of Lofexidine. BMJ 329: 1075.
31. Zador D & Sunjic S (2000) Deaths in Methadone Maintenance Treatment in New
South Wales, Australia, 1990-1995. Addiction 95:77-84.
32. National Treatment Agency Media Release (2009) Moves to provide greater
protection to children living with drug addicts.
33. World Health Organisation. (1992). ICD-10 Classifications of Mental and Behavioural
Disorder: Clinical Descriptions and Diagnostic Guidelines. Geneva. World Health
Organisation
34. Joint Formulary Committee (2007). British National Formulary. London: British
Medical Association and Royal Pharmaceutical Society of Great Britain.
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APPENDIX 1
CLINICAL GOVERNANCE

Clinicians working with drug misusers must be appropriately competent, trained and
supervised.

Effective, safe and responsive services for drug misusers will usually involve
clinicians working together and with others in teams in primary care, in secondary
care or both.

The setting in which health professionals work in treating drug misuse will affect the
clinical governance mechanisms that needs to be in place. Those working in relative
isolation must ensure they have an opportunity to discuss and review their work with
colleagues in the field, to remain good and up-to-date practice

Service should be provided consistent with national guidance and principles, and in
line with the evidence base.

The expansion of non-medical prescribing has implications for drug misuse treatment
and care and clinical governance.

A timely and regular audit and review should be in place.

Patients must be involved in their own treatment.

Carers of adults can be involved in patients’ treatment, usually with the patients,
consent
Taken from Drug misuse and Dependence - UK Guidelines on Clinical management
(2007
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APPENDIX 2
NICE Quality Standards (QS23) – Drug misuse and dependence
Statement 1. People who inject drugs have access to needle and syringe programmes
in accordance with NICE guidance.
Statement 2. People in drug treatment are offered a comprehensive assessment.
Statement 3. Families and carers of people with drug use disorders are offered an
assessment of their needs.
Statement 4. People accessing drug treatment services are offered testing and referral
for treatment for hepatitis B, hepatitis C and HIV and vaccination for hepatitis B.
Statement 5. People in drug treatment are given information and advice about the
following treatment options: harm-reduction, maintenance, detoxification and abstinence.
Statement 6. People in drug treatment are offered appropriate psychosocial
interventions by their keyworker.
Statement 7. People in drug treatment are offered support to access services that
promote recovery and reintegration including housing, education, employment, personal
finance, healthcare and mutual aid.
Statement 8. People in drug treatment are offered appropriate formal psychosocial
interventions and/or psychological treatments.
Statement 9. People who have achieved abstinence are offered continued treatment or
support for at least 6 months.
Statement 10. People in drug treatment are given information and advice on the NICE
eligibility criteria for residential rehabilitative treatment.
NICE (2012)
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APPENDIX 3
Cardiac assessment and monitoring for methadone prescribing
[2007 Clinical Guidelines, p98]
A2.1 Drug-induced prolongation of the QT interval
The QT interval is measured on an ECG* from the beginning of the QRS complex
(caused by contraction of the ventricular mass) until the end of the T wave (caused by
the return of the ventricular mass to the resting state). The QT corrected (QTc) interval is
the QT interval (in milliseconds) corrected for heart rate using a standard formula (for
example, Bazett’s formula: QTc (ms) = QT (ms) / RR½ – QT divided by the square root
of the R-R interval). QTc calculators are available on the internet.
The QTc interval is a useful indicator of risk of polymorphic ventricular tachycardias, or
torsade de pointes which can be fatal. QTc interval prolongation beyond normal limits
(440 ms for men and 470 ms for women) is associated with increased risk of cardiac
arrhythmias and sudden death, especially above 500 ms (Botstein, 1993). Various
psychotropic medications have recently been identified as causing QT prolongation and
sudden death. In the past decade, this has become the most common reason for a drug
to be withdrawn from the market. In the drug treatment field, this was the reason for
levacetylmethadol (LAAM or ORLAAM) being withdrawn (EAEMP, 2001).
A2.2 Methadone and risk of QT prolongation
Methadone may prolong the QTc interval and induce torsade de pointes (Lipski et al.,
1973). However increases in QTc interval following methadone induction may not exceed
specified thresholds (440 ms in adult males and 470 ms adult females). Findings in
relation to the effect of methadone dose have been varied but recently there have been a
number of case reports of patients on high-dose methadone experiencing QT
prolongation and torsade de pointes. Reducing or stopping methadone was followed by
reduction in the QT interval.
Cocaine has been shown to increase QT intervals acutely (Haigney et al., 2006). Other
confounding factors may be the use of antipsychotic and tricyclic antidepressants
(www.torsades.org; Schmittmer et al., 2004).
In summary, the evidence, as currently available, points towards methadone as a risk
factor for QT prolongation and torsade de pointes, with a possible dose-dependent
action.
A2.2.1 MHRA guidance 2006
In May 2006 the Medicines and Healthcare Products Regulatory Agency (MHRA) drew
attention to reports in Europe and elsewhere which “highlighted the risk of QT
prolongation in patients taking methadone, especially at high doses”. The MHRA
recommended that: “patients with the following risk factors for QT interval prolongation
are carefully monitored whilst taking methadone:
 heart or liver disease,
 electrolyte abnormalities,
 concomitant treatment with CYP 3A4 inhibitors,
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or medicines with the potential to cause QT interval prolongation
in addition any patient requiring more than 100 mg of methadone per day should
be closely monitored.” (MHRA, 2006).
A2.3 Patient consent and information
The patient should be fully informed of the available evidence, the reasons for the clinical
assessment and fully involved in the decision making process for their treatment. A
patient information leaflet may be useful to inform the patient of the available evidence.
A2.4 Clinical assessment of patients on methadone maintenance
A standard physical health assessment and physical examination should be carried out
on all patients entering methadone maintenance treatment. For patients already in
methadone treatment, the clinical assessment should cover assessment of heart or liver
disease, concomitant treatment with CYP 3A4 inhibitors, other drugs with the potential to
cause QT interval prolongation and the presence of electrolyte abnormalities. Please
also refer to the general section on clinical assessment for drug misuse patients before
proceeding. [see section 1]
A2.5 Clinical assessment of patients when initiating methadone
At present, the decision to perform an ECG prior to commencing methadone treatment
should be based on a risk-benefit analysis. A baseline ECG should be considered in
patients with evidence of heart or liver disease, concomitant treatment with CYP 3A4
inhibitors, use of other QTc prolonging drugs or electrolyte abnormalities.
If QT prolongation is detected, alternatives to methadone should be considered, and
other QTc risk factors (such as cocaine use) should be reassessed. It is important that
the patient is fully informed and involved in the decision making process.
98
A2.6 Summary
 Methadone may be a risk factor for QT prolongation and torsade de pointes with a
possible dose-dependent action.
 The MHRA recommends monitoring for patients on high dose methadone (>100 mg
daily) and with other QT interval prolongation risk factors where appropriate.
 Patients should be fully informed of the reasons for the clinical assessment and
involved in the decision making process for their treatment.
 Screening before commencing methadone treatment is not currently advocated but
may be considered.
 Any QT prolongation needs full investigation, consideration of specialist referral,
identification of options for QT risk factor modification as well as ongoing ECG
monitoring.
NOTE
Clinicians wanting to refresh their understanding of ECGs might start with Hampton JR
(2003). The ECG Made Easy, 6th edition. London: Churchill Livingstone.
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APPENDIX 4
CLINICAL DIAGNOSIS
ICD-10 Clinical description
A cluster of physiological, behavioural, and cognitive phenomena in which the use of a
substance or a class of substances takes on a much higher priority for a given individual
than other behaviours that once had greater value. A central descriptive characteristic of
the dependence syndrome is the desire (often strong, sometimes overpowering) to take
psychoactive drugs (which may or may not have been medically prescribed), alcohol, or
tobacco. There may be evidence that return to substance use after a period of
abstinence leads to a more rapid reappearance of other features of the syndrome than
occurs with nondependent individuals.
ICD-10 Diagnostic guidelines
A definite diagnosis of dependence should usually be made only if three or more of the
following have been present together at some time during the previous year:






A strong desire or sense of compulsion to take the substance;
Difficulties in controlling substance-taking behaviour in terms of its onset,
termination, or levels of use;
A physiological withdrawal state when substance use has ceased or have been
reduced, as evidenced by: the characteristic withdrawal syndrome for the
substance; or use of the same (or closely related) substance with the intention of
relieving or avoiding withdrawal symptoms;
Evidence of tolerance, such that increased doses of the psychoactive substance
are required in order to achieve effects originally produced by lower doses (clear
examples of this are found in alcohol- and opiate-dependent individuals who may
take daily doses sufficient to incapacitate or kill nontolerant users);
Progressive neglect of alternative pleasures or interests because of psychoactive
substance use, increased amount of time necessary to obtain or take the
substance or to recover from its effects;
Persisting with substance use despite clear evidence of overtly harmful
consequences, such as harm to the liver through excessive drinking, depressive
mood states consequent to periods of heavy substance use, or drug-related
impairment of cognitive functioning; efforts should be made to determine that the
user was actually, or could be expected to be, aware of the nature and extent of
the harm
WHO (1992)
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APPENDIX 8
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