Introduction

Pain is common in advanced and progressive disease. Up to two-thirds of people with cancer experience pain that needs a strong opioid. This proportion is similar or higher in many other advanced and progressive conditions.

Despite the increased availability of strong opioids, published evidence suggests that pain which results from advanced disease, especially cancer, remains under-treated.

Each year 300,000 people are diagnosed with cancer in the UK and it is estimated that there are 900,000 people living with heart failure. Others live with chronic illness such as kidney, liver and respiratory disease, and with neurodegenerative conditions. Many people with these conditions will develop pain for which a strong opioid may be needed.

The 2008 World Cancer Declaration included a target to make effective pain control more accessible. Several key documents highlight the importance of effective pain control, including ‘Improving supportive and palliative care for adults with cancer’ (NICE cancer service guidance 2004), ‘Control of pain in adults with cancer’ (Scottish Intercollegiate Guidelines Network guideline 106), ‘A strategic direction for palliative care services in Wales’ (Welsh Assembly Government 2005) and ‘End of life care strategy’ (Department of Health 2008).

Strong opioids, especially morphine, are the principal treatments for pain related to advanced and progressive disease, and their use has increased significantly in the primary care setting. However, the pharmacokinetics of the various opioids are very different and there are marked differences in bioavailability, metabolism and response among patients. A suitable opioid must be selected for each patient and, because drug doses cannot be estimated or calculated in advance, the dose must be individually titrated. Effective and safe titration of opioids has a major impact on patient comfort. The World Health Organization has produced a pain ladder for the relief of cancer pain; strong opioids are represented on the third level of the three-step ladder.

The guideline will address first-line treatment with strong opioids for patients who have been assessed as requiring pain relief at the third level of the WHO pain ladder. It will not cover second-line treatment with strong opioids where a change in strong opioid treatment is required because of inadequate pain control or significant toxicity.

A number of strong opioids are licensed in the UK. However for pain relief in palliative care a relatively small number are commonly used. This guideline has therefore looked at the following drugs: buprenorphine, diamorphine, fentanyl, morphine and oxycodone. Misinterpretations and misunderstanding have surrounded the use of strong opioids for decades, and these are only slowly being resolved. Until recently, prescribing advice has been varied and sometimes conflicting. These factors, along with the wide range of formulations and preparations, have resulted in errors causing underdosing and avoidable pain, or overdosing and distressing adverse effects. Despite repeated warnings from regulatory agencies, these problems have led on occasion to patient deaths, and resulted in doctors facing the General Medical Council or court proceedings. Additional guidance, including advice on reducing dosing errors with opioid medicines, patient safety incidents arising from medication errors involving opioids and safer use of injectable medicines, is available from the National Patient Safety Agency (NPSA).

This guideline will clarify the clinical pathway and help to improve pain management and patient safety. This guideline will not cover care during the last days of life.

Patient-centred care

This guideline offers best practice advice on the care of people with advanced and progressive disease, who require strong opioids for pain control. These patients are defined as those in severe pain who may be opioid-naive, or those whose pain has been inadequately controlled on step two of the WHO pain ladder.

Treatment and care should take into account patients’ needs and preferences. People with advanced and progressive disease, who require strong opioids for pain control, should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If patients do not have the capacity to make decisions, healthcare professionals should follow the Department of Health’s advice on consent and the code of practice that accompanies the Mental Capacity Act. In Wales, healthcare professionals should follow advice on consent from the Welsh Government.

Good communication between healthcare professionals and patients is essential. It should be supported by evidence-based written information tailored to the patient’s needs. Treatment and care, and the information patients are given about it, should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English.

If the patient agrees, families and carers should have the opportunity to be involved in decisions about treatment and care.

Families and carers should also be given the information and support they need.

1. Recommendations

2. Notes on the scope of the guidance

NICE guidelines are developed in accordance with a scope that defines what the guideline will and will not cover.

3. Implementation

NICE has developed tools to help organisations implement this guidance.

4. Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

5. Other versions of this guideline

6. Update information

August 2016: Recommendation 1.1.12 was deleted and a link added to NICE’s guideline on controlled drugs: safe use and management, which has newer advice on the topic. Two out of date research recommendations were also deleted.

7. Updating the guideline

NICE clinical guidelines are updated so that recommendations take into account important new information. New evidence is checked 3 years after publication, and healthcare professionals and patients are asked for their views; we use this information to decide whether all or part of a guideline needs updating. If important new evidence is published at other times, we may decide to do a more rapid update of some recommendations. Please see our website for information about updating the guideline.

Appendix A. The Guideline Development Group, National Collaborating Centre and NICE project team

Your responsibility: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.

Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.

Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.