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One of the roles of the Accountable Officer (AO) for Controlled Drugs is to assure that good governance of controlled drugs (including and up to schedule 5) should apply in all health and social care settings and individual practices. If you have any concerns regarding the use of CD's, you should contact your AO for advice:
Refer to the various formulary treatment guidelines for use of opioids when treating certain conditions (see here).
For the treatment of pain in palliative care (see here).
See section 4.7.2 Opioid analgesics for list of formulary opioids.
Opioids Aware (Faculty of Pain Medicine), is a resource for patients and healthcare professionals to support prescribing of opioid medicines for pain.
Strong opioids should always be used as part of a multimodal strategy for pain management utilising NSAIDs and/or non-opioid painkillers, and/or non-pharmacological interventions when appropriate. It is important to review the risks and benefits of continued opioid therapy on a regular basis.
Opioids are not indicated for the 3 most common pain conditions:
The reason for starting an opioid for non-malignant pain needs to be clear. Set outcome goals before starting and consider the use of an opioid contract (see below).
When prescribing opioids, assess the patient's mental health and current or previous history of addiction to drugs or alcohol:
Opioid analgesics are used to relieve moderate to severe pain. Repeated administration may cause dependence, tolerance or opioid induced hyperalgesia (see opioid side effects below), but this should not be a deterrent in the control of pain due to terminal illness. Dosages can escalate over time without a noticeable effect on the patient's pain or psychological distress. Recent research shows mood state and distress can modulate opioid efficacy. Evidence of early prescription requests or rapidly escalating dose should trigger a concern.
Strong opioids have ceiling effects for analgesia and side effects. Complete pain relief is not always achieved even with strong opioids at high doses in some pain conditions; this should be explained to all patients.
Do not prescribe more than one type of opioid at a time unless following specialist advice (e.g. co-prescription of oral morphine sulphate modified release and transdermal fentanyl). Injectable opioids should never be used as part of a strategy for chronic pain management, except in palliative care.
Opioids should be prescribed mainly as controlled release formulations with limited breakthrough only (e.g. 4 times daily when required). Avoid using large doses of breakthrough medication only. Morphine sulphate oral solution 10mg/5ml should never be prescribed 'when required' without a prescribed dose and dose interval. Morphine sulphate oral solution may contain alcohol, which may be harmful in certain patient groups. Refer to individual Summary of Product Characteristics
It is helpful to consider strong opioid prescribing in different dosage 'bands'. Although the dose which would constitute such bands in practice varies between individuals in terms of age and co-morbidity the dosage bands given below are included as a pragmatic clinical guide.
The guidance below is based upon the Opioids Aware resource and the following article: 'Equianalgesic doses of opioids – their use in clinical practice' written by local specialist Douglas Natusch (Br J Pain. 2012 Feb; 6(1): 43–46). Please also refer to the BNF and Summary of Product Characteristics for further information.
Opioid rotation or switching may be considered if a patient obtains pain relief with one opioid but is suffering severe adverse effects; or it may be required in the context of co-morbidity e.g. renal impairment. Following the guidance of local specialists it may be considered that a patient has developed tolerance over time to the analgesic effect of an opioid that was initially helpful, and the clinician may advise opioid rotation rather than dose escalation.
Consider the following points when rotating/switching opioids:
A guide to equivalent doses of opioid drugs, hosted on the Rowcroft Hospice website and often used in palliative care, has been developed by local specialists across the region. Please note this is not a definitive set of equivalences. Drug conversions can be challenging, it is recommended that conversion calculations are double checked with a colleague. If in any doubt over an opioid switch for a patient receiving palliative care, seek advice from the specialist palliative care team.
See section 4.7.2 Opioid analgesics for a full list of preparations.
Side effects are relatively common – these need to be considered and balanced with potential benefits. If patients continue to take medicines that provide limited analgesic benefit then they are exposed to harms unbalanced by the benefit that the medicines provide.
Tolerance to other opioid side effects such as constipation and nausea occurs at different rates to analgesic tolerance (see Pharmacological treatment of chronic non-malignant pain, Step 4 for guidance on how to manage suspected tolerance). The most common side effects include nausea, vomiting, constipation and drowsiness. Larger doses can produce respiratory depression and hypotension. Anti-emetic therapy should be considered with the initial titration of opioids (see section 4.6 drugs used in nausea and vomiting). When treatment with opioids exceeds 3 days, an osmotic laxative (or docusate which also softens stools) and a stimulant laxative e.g. senna, should be considered (see management of constipation in adults and section 1.6 laxatives).
Prescribers need to be aware of additional side effects that can occur with high dose opioid use (particularly above 120mg), when used long term:
The use of most monoamine oxidase inhibitors (MAOIs) with opioids is contraindicated or cautioned by manufacturers. There is conflicting information in the literature about the degree of risk of an interaction. Some opioid analgesics are associated with a risk of serotonin syndrome in combination with MAOIs; other combinations may result in opioid toxicity. When assessing the risk of combining an opioid with an MAOI, it is important to consider any other serotonergic drugs the patient is taking. It is recommended that the individual Summary of Product Characteristics (SPC) is reviewed before prescribing concomitant opioid and MAOI.
Patients prescribed opioids need to be aware of the risks of drowsiness and the effect on their ability to drive. Patients should not drive if they have changed their dose or if they feel unsafe: it is their responsibility to ensure they are fit to drive; further advice is available from the DVLA.
Opioids Aware (Faculty of Pain Medicine) states it is important to taper or stop the opioid regimen if:
The Royal College of General Practitioners has produced factsheets regarding prescription and over-the-counter medicines misuse and dependence and include guidance to distinguish inadequate symptom control from drug misuse. The factsheets can be accessed here.
The decision to taper/stop an established opioid regimen needs to be discussed carefully with the patient and may require close collaboration between the patient, their carers and all members of the patient's health care team. Consideration should be given to physical and mental health co-morbidities including significant emotional trauma.
Discussions with the patient should include:
Patients who are failing to derive benefit from large doses of opioids may need support from specialist services in order to reduce medication. Opioid tapering/cessation when patients are taking large doses is more likely to succeed if patients' emotional and mental health (including addiction) needs are identified and an appropriate plan for support established.
In general, opioids should not be added to the repeat prescribing system but should be generated as acute prescriptions.
If an opioid has a demonstrable positive benefit for an individual patient and there is a robust system for monitoring use then consideration may be given for short-term authorisation of repeat prescriptions.
The prescriber and patient together should review the continuing benefit of opioid therapy and potential harms at regular intervals (at least twice each year).
An opioid contract is strongly recommended.
The goals of therapy should be agreed before starting opioid treatment and assessed at each review. These goals should be clearly documented. A formal opioid 'contract' can provide a useful basis for further discussion if medication use becomes poorly controlled or the agreed outcomes of therapy are not achieved. It is helpful to plan for the management of flare-ups in symptoms by means other than an increase in stable opioid dose.
Examples of local opioid contracts can be found via the following links:
Supplies of naloxone injection 400 micrograms in 1ml are required in the same clinical storage locations where diamorphine and morphine injections are stored, including in GPs' bags and bags held by out-of-hours providers (NPSA Safer Practice Notice 12; May 2006).