Dr Lindsay Smith explains how the NICE recommendations aim to promote safe and effective prescribing of strong opioids for pain in palliative care in adults
  • When offering pain treatment with strong opioids, ask the patient about concerns such as: addiction, tolerance, side-effects, and fears that treatment implies the final stages of life
  • Offer patients access to frequent review of pain control and side-effects and information on who to contact out of hours, particularly during initiation of treatment
  • When starting treatment with strong opioids, offer regular oral sustained-release or immediate-release preparations (depending on patient preference and clinical presentation), with rescue doses of oral immediate-release preparations for breakthrough pain to patients with advanced and progressive disease
  • Offer oral sustained-release morphine as first-line maintenance therapy to patients with advanced and progressive disease who require strong opioids. If pain remains uncontrolled despite optimising first-line therapy, review analgesic strategy and consider seeking specialist advice
  • Inform patients that constipation affects nearly all people receiving strong opioid treatment and prescribe laxative treatment (to be taken regularly at an effective dose) for all patients who are initiating strong opioids. Remember to inform patients that treatment for constipation takes time to work and adherence is important. Laxative treatment for managing constipation should be optimised before considering to switch strong opioids
  • Advise patients that the following effects may occur when starting strong opioid treatment or at dose increase, but that they are likely to be transient:
  • Nausea—if this persists, prescribe and optimise anti-emetic treatment before considering switching strong opioids
  • Mild drowsiness or impaired concentration—patients should be warned that impaired concentration may affect their ability to drive and undertake other manual tasks.

NICE Clinical Guideline 140 on Safe and effective prescribing of opioids for pain in palliative care of adults has been awarded the NHS Evidence Accreditation Mark.
This Mark identifies the most robustly produced guidance available. See evidence.nhs.uk/accreditation for further details.

Up to two-thirds of the 300,000 people with cancer in the UK and many others with advanced and degenerative conditions experience pain that needs to be controlled through palliative care with a strong opioid;1 however, the pain that is common in these conditions is often undertreated. Primary care healthcare professionals in particular have an increasingly important role to play in prescribing of medicines for people who have advanced or progressive conditions and who require strong pain relief. Many people with long-term health conditions continue to live at home and will therefore be dependent particularly on the knowledge and advice of their GP.

Several key documents highlight the importance of effective pain control:2-5

  • End of life care strategy: promoting high quality care for all adults at the end of life
  • Improving supportive and palliative care for adults with cancer
  • Control of pain in adults with cancer
  • A strategic direction for palliative care services in Wales.

Strong opioids such as morphine are indicated at step three of the World Health Organization (WHO) pain ladder6 and are the principal treatments for pain related to advanced and progressive disease. Their use has increased significantly in the primary care setting.1 It is important that a suitable opioid is selected for each patient; drug doses must be individually titrated for efficacy.7

In 2010, the Department of Health instructed NICE to produce a clinical guideline on the safe and effective prescribing of strong opioids in palliative care of adults for the reasons given in Box 1 (see below).8 The development of this guideline (Clinical Guideline 140) was completed this year,1 and it is hoped that the recommendations will herald a change in current clinical practice. The new NICE guideline is aimed at all non-palliative-care specialist healthcare professionals who initiate strong opioids for pain in adults with advanced and progressive disease—GPs, independent non-medical prescribers, hospital consultants, and junior staff—and may also be of relevance to palliative care specialists.

Clinical Guideline 140 addresses first-line treatment with strong opioids for patients who have been assessed as requiring pain relief at step three of the WHO pain ladder.1,6 Only a relatively small number of opiates are in common use, and the recommendations cover buprenorphine, diamorphine, fentanyl, morphine, and oxycodone.1 The guideline clarifies the clinical pathway (see Figure 1),9 and should improve pain management and patient safety. However, it does not cover second-line treatment with strong opioids when a change in opioid is required because of inadequate pain control or significant toxicity, or care during the last days of life (for example, while on the Liverpool Care Pathway10).

Box 1: Reasons why guidance on opiates is needed8
  • Misinterpretations and misunderstanding have surrounded the use of strong opioids for decades
  • Prescribing advice has been varied and sometimes conflicting
  • A wide range of formulations and preparations exist
  • Underdosing or overdosing errors, resulting in avoidable pain or distressing adverse effects, are not uncommon
  • Although rare, deaths have occurred resulting in doctors facing the General Medical Council or court proceedings.

Figure 1: Care pathway for the use of opioids in palliative care9

National Collaborating Centre for Cancer (NCCC) (2012). Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults. London: NCCC. Available from: www.nice.org.uk/CG140 Reproduced with permission.

Patient-centred care

Arguably, the biggest hurdles with regard to opioid treatment are overcoming any worries held by the healthcare professional and/or the patient. Good and clear communication should facilitate a helpful and honest discussion about the long-term use of opioids and their side-effects.1

Treatment and care should always take into account patients’ needs and preferences by giving them the opportunity to make informed decisions about their care and treatment in partnership with their healthcare professionals.1 If patients do not have the capacity to make decisions, healthcare professionals should follow national guidance.11-13 Families and carers should have the opportunity to be involved in decisions about treatment and care if the patient agrees to this.

As good communication is key, any verbal exchanges should be supported by evidence-based, culturally appropriate, written information tailored to the patient’s needs. The prescriber–patient discussion should include the points in Box 2 (see below) and patients should be asked about any concerns, such as:1

  • addiction
  • tolerance
  • side-effects
  • fears that treatment implies the final stages of life.
Box 2: Topics to be discussed with patients before prescribing opiates
  • When and why strong opioids are used to treat pain
  • How effective strong opioids are likely to be
  • How, when, and how often to take strong opioids
  • How long pain relief from individual doses should last
  • Side-effects and signs of toxicity
  • Safe storage
  • Follow up and further prescribing
  • Information on who to contact out of hours, particularly during initiation of treatment.

Prescribing opiates

If oral medication is suitable, the first-line opioid should be morphine, unless the patient is known to be intolerant to morphine or if they have moderate-to-severe renal or hepatic impairment. Regular oral sustained- or immediate-release morphine (depending on patient preference) should be prescribed, with rescue doses of oral immediate-release morphine for breakthrough pain.1

Patients with no renal or hepatic co-morbidities should be offered a typical total daily starting dose of 20–30 mg oral morphine (for example, 10-15 mg oral sustained-release morphine twice daily) plus 5 mg oral immediate-release morphine for rescue doses during the titration phase.1

The dose should be adjusted until a good balance exists between acceptable pain control and side-effects. If a balance cannot be reached after a few dose adjustments, specialist advice should be sought. Frequent review should be offered to patients, particularly in the titration phase. Specialist advice should also be obtained before prescribing strong opioids for patients with moderate-to-severe renal or hepatic impairment.1

Once a suitable dose of morphine has been established by titration, oral sustained-release morphine should be offered as first-line maintenance treatment for patients who require strong opioids for advanced or progressive disease. Transdermal patch formulations should not be routinely offered as first-line maintenance treatment to patients in whom oral opioids are suitable. If pain remains inadequately controlled despite optimising first-line maintenance treatment, the clinician should review the analgesic strategy and consider seeking specialist advice.1

If first-line treatment with oral opioids is not suitable and analgesic requirements are stable, initiation of transdermal patches with the lowest acquisition cost can be considered; this should be supported by specialist advice where needed. Caution is advised when calculating opioid equivalence for transdermal patches:1

  • A 12 ?g fentanyl transdermal patch equates to approximately 45 mg/day oral morphine
  • A 20 ?g buprenorphine transdermal patch equates to approximately
    30 mg/day oral morphine.

If oral opiates are not suitable for the patient and analgesia requirements are unstable, the healthcare professional should consider initiating subcutaneous opioids with the lowest acquisition cost, supported by specialist advice where needed.1

Oral immediate-release morphine should be the first-line treatment for breakthrough pain in patients who can take oral opioids and are on maintenance oral morphine treatment. Fast-acting fentanyl should not be offered as first-line rescue medication. If pain remains inadequately controlled despite optimising treatment, healthcare professionals should consider seeking specialist advice.1

Management of side-effects

Patients should be told that constipation affects nearly all patients who take strong opioid treatment; all patients starting strong opioids should be prescribed laxative treatment (to be taken regularly at an effective dose). Patients should be advised that treatment for constipation takes time to work and that adherence is important. Laxative treatment should be optimised to manage constipation before considering switching strong opioids.1

Patients should be told that nausea may occur when starting strong opioid treatment or when doses are increased, but that this effect is likely to be transient. If nausea persists, antiemetic treatment should be prescribed and optimised before considering switching strong opioids.1

Patients should be informed that mild drowsiness or impaired concentration may occur when starting strong opioid treatment or when doses are increased but that this is often transient.8 Healthcare professionals should warn patients that impaired concentration may affect their ability to drive and undertake other manual tasks.1,14 In patients with persistent or moderate-to-severe central nervous system side-effects, consider:

  • a dose reduction if pain is controlled or
  • switching opioids if pain is not controlled.

If any side-effects remain uncontrolled despite optimisation of treatment, healthcare professionals should consider seeking specialist advice.8


Costs associated with the guideline

The NICE guidance is not expected to result in an increase in the prescribing of strong opioids but rather a change in which opioids are used first.15 According to expert opinion, implementation of the guideline recommendations—depending on need in local areas—is unlikely to incur significant costs to the NHS; indeed costs are expected to remain the same and there may even be a small saving in prescribing costs for strong opioids. The NICE guideline may also bring about the following benefits:16

  • Improved patient comfort
  • Reduced misinterpretation and misunderstanding of opioids by patients
  • Consistent advice on the prescribing of strong opioids (for healthcare professionals).

Learning resources and further information

The NICE guideline, including the full and patient versions, is available to download from the NICE website (www.nice.org.uk/CG140).1

A range of tools has also been developed to help primary and secondary healthcare professionals implement the recommendations.1 A training package suitable for small-group learning (for example, at a practice meeting) has been developed by NICE. This package, which will be useful for all prescribers, includes clinical case scenarios for primary and secondary care, powerpoint slides, and pre- and post-workshop quizzes. The cases, which are written by practising clinicians, show how to apply the recommendations in routine practice while taking account of aspects of individualised care.1 In a podcast, Professor Mike Bennett of Leeds Institute of Health Sciences discusses key issues for implementing NICE Clinical Guideline 140, including:

  • significant changes for prescribers
  • how patient concerns about strong opioids should be addressed
  • why the guideline recommends the use of morphine as first-line treatment
  • the likely side-effects of taking strong opioids
  • how best to manage the side-effects.

All of these resources, as well as a costing report for commissioners and an audit tool, can be downloaded from the NICE website (www.nice.org.uk/CG140).1,14

Conclusion

Until now there has been little agreed national guidance regarding the safe prescribing of opioids. Despite the increased availability of these medicines, pain from advanced or progressive conditions remains under treated. This may be due to a variety of reasons, such as fears over side-effects and confusion about which opioid treatment is most effective. NICE Clinical Guideline 140 provides a comprehensive overview of the issue, with clear recommendations, which should instigate a real clinical change in the way opioids are prescribed.


Acknowledgments

This article is based on work undertaken by the National Collaborating Centre for Cancer, which received funding from NICE. The views expressed in this publication are those of the author and not necessarily those of NICE.

NICE implementation tools

NICE has developed the following tools to support implementation of Clinical Guideline 140 on Opioids in palliative care. The tools are now available to download from the NICE website: www.nice.org.uk/CG140

NICE support for commissioners

Costing reportcommissioning icon

Costing reports are estimates of the national cost impact arising from implementation based on assumptions about current practice, and predictions of how it might change following implementation of the guideline.

Costing templatecommissioning icon

Costing templates are spreadsheets that allow individual NHS organisations and local health economies to estimate the costs of implementation taking into account local variation from the national estimates, and they quickly assess the impact the guideline may have on local budgets.

NICE support for service improvement systems and audit

Baseline assessment toolAudit

The baseline assessment tool is an excel spreadsheet that aims to help organisations identify if they are in line with NICE guidance and to assist them in planning activity that will help them meet NICE recommendations.

Clinical audit toolAudit

Audit tools aim to assist organisations with the audit process, thereby helping to ensure that practice is in line with the NICE recommendations. They consist of audit criteria and data collection tool(s) and can be edited or adapted for local use.

Electronic audit toolAudit

Electronic audit tools are developed to assist organisations with clinical audit and to ensure that practice is in line with the NICE recommendations.

NICE support for education and learning

Clinical case scenarios Education and learning

Clinical case scenarios aim to improve and assess users’ knowledge of the Opioids in palliative care clinical guideline.

Educational resource Education and learning

This resource provides specific support for those who want to provide training on the opioid in palliative care clinical guideline.

Podcast Education and learning

Mike Bennett, a Professor in Palliative Medicine at Leeds Institute of Health Sciences and member of the Guideline Development Group discusses the evidence behind the clinical guideline recommendations.

Key to NICE implementation icons

commissioning icon

NICE support for commissioners

  • Support package for commissioners and others for quality standards
  • NICE guide for commissioners
  • NICE cost impact support for guidance (selection from national report/local template/costing statement, dependent on topic)

Audit

NICE support for service improvement systems and audit

  • Forward planner
  • 'How to' guides (generic advice on processes)
  • Local government briefings (with Centre for Public Health Excellence)
  • Baseline assessment tool for guidance
  • Audit support including electronic data collection tools
  • E-learning modules (commissioned)

Education and learning

NICE support for education and learning

  • Clinical case scenarios
  • Learning packages including slide sets
  • Podcasts
  • Shared learning and other local best practice examples

  • CCGs should:
    • consider adapting the NICE guideline and flow chart, and build in local formulary drugs choices
    • engage with local palliative care providers (often charitably funded) and agree formularies with them
    • ensure that rapid telephone advice on prescribing of strong opiods is available to support prescribers, particularly in cases of renal or hepatic impairment
  • Out-of-hours providers are often involved in end-of-life care and should be engaged in the development of local care pathways, which can then be built into contracts
  • Where possible all local providers, including secondary care and community care trusts, should follow the same formulary and care pathways (this can be a contractual requirement).

CCG=clinical commissioning group

  1. National Institute for Health and Care Excellence. Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults. London: NICE, 2012. Available at www.nice.org.uk/CG140 nhs_accreditation
  2. Department of Health. End of life care strategy: promoting high quality care for all adults at the end of life. London: DH, 2008. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_086277
  3. National Institute for Health and Care Excellence. Improving supportive and palliative care for adults with cancer. London: NICE, 2004. Available at: www.nice.org.uk/guidance/CSGSP
  4. Scottish Intercollegiate Guidelines Network. Control of pain in adults with cancer. SIGN 106. Edinburgh: SIGN, 2008.
    Available at: www.sign.ac.uk/guidelines/fulltext/106/index.html nhs_accreditation
  5. National Assembly for Wales. A strategic direction for palliative care services in Wales. Cardiff: National Assembly for Wales, 2005.
  6. World Health Organization website. WHO's pain ladder. Available at: www.who.int/cancer/palliative/painladder/en/ (accessed 5 July 2012).
  7. British National Formulary website. BNF 63. Available at: www.medicinescomplete.com/mc/bnf/current/29450.htm (accessed 9 July 2012).
  8. National Institute for Health and Care Excellence website. Managing common side effects of opioids in palliative care. pathways.nice.org.uk/pathways/opioids-in-palliative-care (accessed 9 July 2012).
  9. National Collaborating Centre for Cancer. Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults. London: NCCC, 2012. Available at: www.nice.org.uk/CG140 nhs_accreditation
  10. Marie Curie Palliative Care Institute Liverpool (MCPCIL) website. Available at: www.mcpcil.org.uk (accessed 9 July 2012).
  11. Department of Health. Mental capacity. London: DH, 2011. Available at: webarchive.nationalarchives.gov.uk/20110907114137/http://dh.gov.uk/en/SocialCare/Deliveringsocialcare/MentalCapacity/index.htm
  12. Welsh Government. Mental Capacity Act. London: Stationery Office, 2011. Available at: new.wales.gov.uk/topics/health/nhswales/healthservice/mentalhealthservices/mentalcapacityact/?lang=en
  13. General Medical Council. Working with the Mental Capacity Act. London: GMC, 2007. Available at: www.gmc-uk.org/guidance/mental_capacity_act.asp (accessed 5 July 2012).
  14. Driver and Vehicle Licensing Agency. At a glance guide to the current medical standards of fitness to drive. Swansea: DVLA, 2012. Available at: www.dft.gov.uk/dvla/medical/ataglance.aspx (accessed 5 July 2012).
  15. National Institute for Health and Care Excellence website. NICE guideline to standardise opioid use in palliative care and address patients' concerns. London: NICE, 2012. Available at: www.nice.org.uk/newsroom/pressreleases/OpioidsInPalliativeCareGuideline.jsp
  16. National Institute for Health and Care Excellence. Opioids in palliative care: costing report: implementing NICE guidance. London: NICE, 2012. Available at: www.nice.org.uk/guidance/CG140/CostingReport/pdf/English G

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