pharmacological therapy policy, practice guidance note ...…prescribing guidelines in psychiatry...

Cumbria Northumberland, Tyne and Wear NHS Foundation Trust PPT-PGN-21 – Benzodiazepine and Z Drug Prescribing – V04-Iss2-Dec 19 Part of CNTW(C)38 - Pharmacological Therapy Policy

Pharmacological Therapy Policy, practice guidance note

Benzodiazepine and Z-drug prescribing in anxiety and insomnia - V04

V04 - issued Issue 1- Mar 2019

Issue 2 – Dec 2019

Planned review Mar 2022

PPT-PGN-21

Part of CNTW(C)38 Policy on Pharmacological Therapies

Author/Designation Kamron Ashtiani– Senior Clinical Pharmacist

Responsible Officer / Designation

Claire Thomas – Deputy Trust Chief Pharmacist

Section Contents Page No:

1 Introduction 1

2 General prescribing principles 2

3 Interface between primary and secondary care 6

4 Longer term use of benzodiazepines 7

Appendices-Attached with PGN

1 Benzodiazepines equivalent doses 9

2 Further Information/Education Resources for Clinicians 10

3 Guidance on the use of Benzodiazepines & Z-Drugs (BZD/ZDs)

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1 Introduction 1.1 Although benzodiazepines and Z drugs (zopiclone, zolpidem and zaleplon) may

have a valid place in the short-term management of severe anxiety and insomnia, tolerance and dependence can occur with these drugs.

1.2 This aim of this document is:

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Cumbria Northumberland, Tyne and Wear NHS Foundation Trust PPT-PGN-21 – Benzodiazepine and Z Drug Prescribing – V04-Iss2-Mar 19 Part of CNTW(C)38 - Pharmacological Therapy Policy

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To support the current guidance on the rational, safe and effective prescribing of benzodiazepines within Cumbria Northumberland, Tyne and Wear NHS Foundation Trust (the Trust/CNTW)

Promote effective communication on any transfer of prescribing with primary care colleagues

1.3 It is expected that these guidelines will be followed in the majority of cases where

these medicines are used. However, in light of the complex nature of conditions and treatment packages amongst patients under the care of the Trust there may be some circumstances where prescribing out with these standards is necessary; the reasoning for this should be fully documented in clinical records.

1.4 To ensure that there is a robust review process in place from the point of initiation,

and that reviews continue throughout therapy, as well as before discharge from the inpatient setting or secondary care services.

2 General prescribing principles – Appendix 3 summarizes key points in the form

of a flowchart to aid prescribing, monitoring and review. It is designed to be used in conjunction with this policy.

2.1 Indications for benzodiazepine and Z drug (where indicated) use

Short term treatment of severe anxiety disorders

Acute alcohol withdrawal

Severe insomnia (Z drug). In the case of benzodiazepines, to treat insomnia only when it is also disabling or causing the patient extreme distress.

Control of arousal/agitation

2.2 General prescribing principles

These principles should be applied each time benzodiazepines or Z-drugs are prescribed and are applicable across all areas of benzodiazepine and Z drug prescribing.

2.2.1 Initiation of therapy

On initiation of therapy the following points should be considered

o Existing physical health issues and/or prescribed medicines/illicit drug use that could affect sleep, and refer to primary care if appropriate

o Provide advice on good sleep hygiene e.g. relaxation techniques, avoiding daytime napping, large alcohol/fluid/caffeine/food intake/nicotine/exercise before

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bedtime and information/reassurance on the varying amount of sleep required by an individual

o Consider assessing for re-experiencing symptoms of trauma – i.e. poor sleep due to nightmares. Veterans for example may be reluctant to volunteer such information

o Do not offer benzodiazepines to women in pregnancy and the postnatal period except for the short-term treatment of severe anxiety and agitation

o Consider referring a woman to a secondary mental health service (preferably a specialist perinatal mental health service) for preconception counselling if she has a current or past severe mental health problem and is planning a pregnancy

Prescribing points

o Benzodiazepines and Z drugs should only be used in the short term i.e. less than 4 weeks

o Use verbal de-escalation strategies in the first instance to manage agitation or anxiety and consult your local team’s ‘Talk 1st’ programme where available.

o The lowest effective dose should be prescribed

o Prescribing in the elderly should be done with caution – consult the individual drug’s Summary of Product Characteristics for guidance on doses and monitoring in this particular population.

o The use of benzodiazepines and Z drugs to treat short term ‘mild’ anxiety, is inappropriate and unsuitable

o Benzodiazepines and Z drugs should not be prescribed for panic disorder, phobic or obsessional states; or to treat chronic psychosis

o There should be a clear plan, stating the indication, intended duration of treatment, and plans for review and discontinuation, documented in the patient’s clinical notes for all newly prescribed benzodiazepines and Z drugs

o All benzodiazepines and Z drugs have a ‘street value’, especially ‘high’ strength formulations. Diazepam 10mg tablets should therefore not be prescribed or supplied and the dose should instead be made up of lower strength 2mg and 5mg tablets

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o Prescriptions for benzodiazepines and Z drugs should not be for greater than 4 weeks at a time, ideally 1-2 weeks

o Benzodiazepines and Z drugs should not routinely be prescribed above BNF doses. There may be a clinical need to exceed BNF max doses. If this is the case, follow GMC guidance on the prescribing of unlicensed medicines 9.

o Where benzodiazepines/Z drugs are initiated during an inpatient stay, as a regular or “as required” medication, their use, dose, indication, frequency and continued use should be reviewed regularly at ward review. This review should be documented in the clinical notes

o If a benzodiazepine/Z drug needs to be prescribed out of hours during an inpatient stay, the ward doctor should review the prescription the next working day to ensure it is not continued unnecessarily

o All benzodiazepines/Z drugs should be reviewed before discharge and, if not discontinued as an in-patient, a plan to reduce the drug as an outpatient should be made. A copy of the plan should be sent to the patient’s GP (see section 3 – Transferring benzodiazepine prescribing to primary care) and Community Mental Health Team

o Combination of different benzodiazepines should be avoided (excluding use when hypnotic plus anxiolytic is used)

Advice to patients

o Patients should be warned of the side effects and tolerance / dependence potential effects and written information, appropriate to their needs, should be provided to the patient. There are drug specific patient information leaflets as well as other general information catered for various levels of understanding which can be found via the Choice and Medication website www.choiceandmedication.org/CNTW

o Patients should be reminded about the importance of keeping their medication in a safe place, out of the reach of children

o Benzodiazepines are the most likely psychotropic medication

to impair driving performance. Alcohol will potentiate these effects – this advice should be communicated prior to or at the point of initiation.

http://www.choiceandmedication.org/ntw

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o Doctors have a duty of care to advise their patients of the potential dangers of adverse effects from medication and interactions with other substances, especially alcohol

o Drug Driving Law changes in March 2015 saw a zero tolerance approach to 8 drugs most associated with illegal use and a road safety risk based approach to 8 drugs most associated with medical use, 6 of them benzodiazepines 5

o The new law gives the police powers to test and arrest drivers suspected of driving after taking certain controlled drugs in excess of specified levels. It also provides a medical defence if the patient is taking medicine in accordance with instructions from a healthcare professional provided they’re not considered to be impaired when driving

o If a patient drives and take prescription medicine, it may be helpful for them to keep evidence of this with them in case they’re stopped by the police

2.2.2 Continuation

Tolerance and dependence is associated with the longer-term (greater than 4 weeks) use of benzodiazepines

Longer term use is not recommended and should be avoided wherever possible

An inpatient stay can be a suitable time to review and make changes to long term benzodiazepines/Z drugs whilst the patient is in a supportive environment

The longer term use of benzodiazepines should be reviewed regularly at least every 3 months (more frequently during an in-patient stay e.g. weekly) with documented evidence in the clinical notes

If long term benzodiazepines can be discontinued, they should be withdrawn gradually as detailed in 2.2.3

2.2.3 Discontinuation

Consider gradually stopping benzodiazepines in women who are planning a pregnancy, pregnant or considering breastfeeding 6.

Benzodiazepines should not be stopped abruptly and should be withdrawn gradually (especially in patients who have been on longer term therapy i.e. greater than 4 weeks) as at least one third of long term users experience problems on dose reduction or withdrawal.

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Particular care is needed for patients who are withdrawing from prescribed long term benzodiazepines at high doses. The Maudsley Prescribing Guidelines in Psychiatry lists the physical and psychological problems that can potentially occur on withdrawal from benzodiazepines 3 In patients on longer term benzodiazepines, treatment cessation should be conducted in a planned, stepwise manner, under clinical supervision, with particular attention paid to assessment of mental state

Potential withdrawal effects include seizures, psychosis, paraesthesia, confusion, insomnia, anxiety, loss of appetite, tremor,

perspiration, and tinnitus 1,3. These can occur at any time up to 3

weeks following the cessation of the benzodiazepine. Consult the individual drugs’ Summary of Product Characteristics for a more comprehensive list.

Benzodiazepines with a shorter half-life (e.g. lorazepam, temazepam) are associated with a higher risk of discontinuation reactions

In patients who have been taking shorter-acting benzodiazepines, it may be preferable to switch the patient to diazepam (with a longer half-life) as part of the discontinuation plan; diazepam may be given as a single daily dose and is available in different strengths (2mg and 5mg tablets and liquid) therefore offers the advantage of a more flexible dose regimen. (See dose conversion table Appendix 1)

Although gradual rather than abrupt withdrawal is more acceptable to patients, note that there is no evidence to support the differential efficacy of different tapering schedules, either fixed dose or symptom guided. Gradual dose reduction accompanied by psychological interventions, patient engagement and support from carers is more likely to be successful than supervised dose reduction alone or psychological reduction alone. Maudsley provides a suggested taper schedule.6 See also the resources in Appendix 2

Time needed to withdraw can vary from 4 weeks to a year or more

If a patient has continued withdrawal problems or complex needs, consider seeking appropriate specialist advice

3 Interface between primary and secondary care 3.1 Transferring benzodiazepine prescribing from secondary care to primary care 3.1.1 When prescribing is to be transferred from Secondary Care to Primary Care the following information should be relayed to the GP in the form of a written

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treatment plan. This includes those situations where benzodiazepines have been initiated during inpatient treatment.

Indication for use

Expected duration of treatment

When the treatment will be reviewed and by whom

Advice about discontinuation (where indicated)

Who to contact within Secondary Care if problems arise

Rationale for patients prescribed benzodiazepines outwith BNF recommendations.

3.2 Patients transferred to secondary care

3.2.1 Prescribers in secondary care, who have patients referred to them currently taking benzodiazepines, should be mindful that primary care may already have a plan in place to reduce and/or stop the benzodiazepine. These plans should be considered when prescribing benzodiazepines in secondary care. GPs referring patients to secondary care should communicate any relevant history and management plans in the referral letter.

4 Longer term use of benzodiazepines

4.1 As a general rule long term prescribing of benzodiazepines and Z drugs is not recommended. The drugs should be used in the short term for the above indications for a maximum of 4 weeks. It is recognised however that there are patients for whom long term benzodiazepines are deemed clinically appropriate and where stopping would be detrimental to their mental health. In these cases prescribers should document a clear rationale in the patient’s notes and if prescribing is transferred this should be communicated effectively (see point 3 above) to the receiving provider of care. The appropriateness of the prescription should still be reviewed on a regular basis and recorded in the clinical notes.

References

1. Joint Formulary Committee. British National Formulary [Online]. London: BMJ Group and Pharmaceutical Press; Accessed via https://www.medicinescomplete.com/#/ on 31/12/2018.

2. Ashton CH. Benzodiazepines: How they work and how to withdraw (aka The Ashton Manual) 2002 Chapter I. http://www.benzo.org.uk/bzmono.htm accessed on 31/12/2018

3. Taylor D, Barnes T, Young A. The Maudsley Prescribing Guidelines in Psychiatry. 13th Edition. Wiley-Blackwell; 2018 p. 373-382

https://www.medicinescomplete.com/#/

http://www.benzo.org.uk/bzmono.htm

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4. Bazire S. Benzodiazepine equivalent doses. Psychotropic Drug Directory 2016. Lloyd-Reinhold Communications

5. https://www.gov.uk/drug-driving-law - accessed 31/12/2018

6. Taylor D, Barnes T, Young A. The Maudsley Prescribing Guidelines in Psychiatry. 13th Edition. Wiley-Blackwell; 2018 p. 445-446.

7. Department of Health (England) and the devolved administrations (Updated 2017). Drug Misuse and Dependence: UK Guidelines on Clinical Management. London: Department of Health (England), the Scottish Government, Welsh Assembly Government and Northern Ireland Executive. Accessed 31/12/2018.

8. NICE guidelines (CG192) Antenatal and postnatal mental health: clinical

management and service guidance, Published date: December 2014, updated April 2018 http://www.nice.org.uk/guidance/cg192 accessed 31/12/2018.

9. Ethical Guidance for Doctors - ‘Prescribing unlicensed medicines’ accessed via

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines on 31/12/2018.

10. ‘A fatal case of benzodiazepine withdrawal’ M Lann et al June 2009, The

American Journal of Forensic Medicine and Pathology. Volume 30, Issue 2. P177-179.

https://www.gov.uk/drug-driving-law

http://www.nice.org.uk/guidance/cg192

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines

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Appendix 1

Equivalent benzodiazepine doses

Drug BNF (1) Maudsley (3)

Bazire (4)a DoH (7) Ashton Manual (2)b

Diazepam 5mg 5mg 5mg 5mg 5mg

Alprazolam 250

micrograms

500 micrograms (0.25-0.5mg)

250 micrograms

250 micrograms

Chlordiazepoxide 12.5mg 12.5mg 15mg

(10-25mg) 12.5 - 15mg

12.5mg

Clobazam 10mg 10mg 10mg 10mg

Clonazepam* 250

micrograms 0.5-1mg

500 micrograms (0.25-4mg)

250 micrograms

250 micrograms

Flurazepam 7.5-15mg 7.5-15mg 7.5 – 15mg 7.5-15mg

Loprazolam 0.5-1mg 0.5-1mg 0.5 – 1mg 0.5-1mg

Lorazepam 500

micrograms 500

micrograms 500

micrograms 500

micrograms 500

micrograms

Lormetazepam 0.5-1mg 500

micrograms 0.5-1mg

0.5mg – 1mg

0.5-1mg

Nitrazepam 5mg 5mg 5mg

(2.5-20mg) 5mg 5mg

Oxazepam 10mg 15mg 15mg

(10-40mg) 10 - 15mg 10mg

Temazepam 10mg 10mg 10mg 10mg 10mg

a. Inter-patient variability and differing half-lives mean the figures can never be exact and should be interpreted using clinical and pharmaceutical knowledge

b. These equivalents do not agree with those used by some authors. They are firmly based on clinical experience but may vary between individuals. Ashton also provides equivalent doses of benzodiazepines not prescribed in the UK

* Please note: While there is broad agreement in the literature about equivalent doses of

benzodiazepines, clonazepam has a wide variety of reported equivalences and particular care is needed with this drug (4).

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Appendix 2

Further Information/Education Resources for Clinicians

The MHRA benzodiazepine training module – identifies the most important hazards associated with benzodiazepine use and informs health professionals how to anticipate, minimise and manage the risks.

http://www.mhra.gov.uk/benzodiazepines-learning-module/index.htm

Information from the Royal College of Psychiatrists ‘Anxiety, panic and phobias’ may be useful in practice.

https://www.rcpsych.ac.uk/mental-health/problems-disorders/anxiety-panic-and-phobias

Training module from BMJ – Benzodiazepine dependence: an update on management (updated 12/04/2017) https://learning.bmj.com/learning/module-intro/benzodiazepine-dependence-management.html?locale=en_GB&moduleId=6059529

http://www.mhra.gov.uk/benzodiazepines-learning-module/index.htm



https://learning.bmj.com/learning/module-intro/benzodiazepine-dependence-management.html?locale=en_GB&moduleId=6059529

https://learning.bmj.com/learning/module-intro/benzodiazepine-dependence-management.html?locale=en_GB&moduleId=6059529

Prior to initiation:

Consider non-pharmacological methods before

using BZD/ZDs e.g. Talk 1st techniques, sleep

hygiene etc.

On initiation:

Discuss the use of BZD/ZDs with the patient

i.e. side-effects, risk of tolerance/

dependence, cognitive impairment and/or

sedation

Use lowest dose for the shortest time possi-

ble

Consider setting a review/stop date at time

of prescribing.

Indication, intended duration of treatment &

plans for review & discontinuation MUST be

documented on RiO.

During treatment:

Frequently review and document the continued

need for BZD/ZDs, with a view to stopping them.

Review quantity of medication supplied during

leave periods to minimize risk.

Discharge:

Review the BDZ/ZD & stopped before dis-

charge if appropriate.

A treatment plan should be made for BDZ/ZDs

that continue post-discharge.

This plan should be communicated with the GP

via the MHDS.

The treatment plan should include:

Indication for use

Expected duration of treatment

When treatment will be reviewed and by

whom

Advice about discontinuation (if indicated)

Who to contact within Secondary Care if

problems arise

Rationale for any unlicensed prescribing.

Appendix 3—Guidance on the use of Benzodiazepines & Z-Drugs (BZD/ZDs)

Indications:

Benzodiazepines (e.g. diazepam, lorazepam):

Short term (4 weeks, ideally 1-2 weeks) treat-

ment of anxiety or insomnia that is severe,

disabling or causing extreme distress.

Control of arousal/agitation.

Acute alcohol withdrawal (see PPT-PGN 22

for guidance).

Z-drugs (e.g. zolpidem, zopiclone):

For severe insomnia in short courses (max 4

weeks).

If treatment is to continue beyond a 4 week peri-

od, prescribers should document a clear ra-

tionale for this in the patient’s notes.

The need for ongoing prescribing should be

reviewed on a regular basis.

Advice to patients:

As a minimum, discuss side-effects and the potential for tolerance/dependence accompa-nied by written information. Reduced efficacy is noted for those who take BZD/ZDs up to and over a 4 week period. Medication information leaflets are available via the Electronic Medicines Compendium www.medicines.org.uk Use of sedating drugs may affect the perfor-mance of skilled tasks as well as driving. The DVLA states that it is illegal to drive if im-paired by the effects of medication as well as illicit drugs. When driving, it is advisable for patients to carry suitable evidence that the drug was prescribed e.g. repeat prescription slip or a patient infor-mation leaflet. Police can test and arrest drivers who have blood levels in excess of specified limits.

Further information:

NTW policy PPT-PGN-21 ‘Benzodiazepine and Z

-drug prescribing in anxiety and insomnia’.

BNF online (via MedicinesComplete) ‘Hypnotics

and Anxiolytics’.

NICE TA77 ‘ Guidance on the use of zaleplon,

zolpidem and zopiclone for the short-term man-

agement of insomnia’.

pharmacological therapy policy, practice guidance note ...…prescribing guidelines in psychiatry...

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