Prudent Healthcare Chronic pain pathway workshop Opioid analgesics 1. Products Opioid analgesics are listed in British National Formulary (BNF) section 4.7.2. They include: 1.1 Strong opioids Oxycodone (Oxycontin®) Buprenorphine (Temgesic®) Fentanyl (Durogesic®) Tramadol (Non-proprietary) Morphine (Oramorph®) Diamorphine (Non-proprietary) Pethidine (Non-proprietary) Tapentadol (Palexia®) Dipipanone (Diconal®) Pentazocine (Non-proprietary) 1 Methadone (Non-proprietary) 1.2 Weak opioids Dihydrocodeine (non-proprietary) Codeine (non-proprietary) Meptazinol (Meptid®) The symbol is used to denote preparations that are considered by the BNF Joint Formulary Committee to be less suitable for prescribing. Although such preparations may not be considered as drugs of first choice, their use may be justifiable in certain circumstances. Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 1 1.3 Combination products Combination products are also available. These include: Codeine with paracetamol (co-codamol) (non-proprietary Dihydrocodeine with paracetamol (co-dydramol) (non-proprietary) Tramadol with paracetamol combination (Tramacet®) Codeine with aspirin (co-codaprin) (non-proprietary) (The hyperlink links to one manufacturer’s summary of product characteristics (SPC) for one formulation/ strength of the drug. The SPCs for alternative manufacturer’s/ formulations/ strengths can be searched for at eMC) 2. Indications Opioid analgesics are usually used to relieve moderate to severe pain particularly of visceral origin. Indications vary between products and according to dosage. Opioids can also be used to treat neuropathic pain, but not all neuropathic pain is opioid-responsive. The use of strong opioids for treating nonmalignant chronic pain conditions is controversial because of concerns about the long-term side effect profile of the drugs. Opioids can also be used for their cough-suppressant effect and to reduce intestinal motility. Some opioids are used in the management of opioid dependence. This briefing focuses on the use of opioids as analgesics. 3. National Institute for Health and Care Excellence (NICE) 3.1 Clinical guidelines Clinical guidelines in which the use of opioid analgesics is recommended or may be considered for use where appropriate: Opioids in palliative care (CG140) Osteoarthritis (CG177) Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 2 Low back pain (CG88) Neuropathic pain - the pharmacological management of neuropathic pain in adults in non-specialist settings (CG96) Lower limb peripheral arterial disease (CG147) 3.2 Do not do recommendations From CG 140 Opioids in palliative care (ID: 1073, 1074). Do not routinely offer transdermal patch formulations as first-line maintenance treatment to patients in whom oral opioids are suitable. Do not offer fast-acting fentanyl as first-line rescue medication. From CG 173 Neuropathic pain - pharmacological management (ID 1473, ID 470). Do not use morphine to treat neuropathic pain in non-specialist settings, unless advised by a specialist to do so. Do not use tramadol to treat neuropathic pain for long-term use in non-specialist settings, unless advised by a specialist to do so. For short-term use, see recommendation 1.1.10 in the guidance. 4. Medicines and healthcare products regulatory agency drug safety updates Codeine: very rare risk of side-effects in breastfed babies Rarely, opioid effects can occur in a breast-fed baby of a mother being treated with codeine. This is likely if the mother has especially active form of CYP2D6 isoenzyme, leading to rapid conversion of codeine to morphine. [Drug Safety Update Vol 1, Issue 4. November 2007] Intrathecal drug pumps Opioids administered through an implantable intrathecal pump can induce an inflammatory mass near the tip of the intrathecal catheter. [Drug Safety Update Vol 1, Issue 10. May 2008] Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 3 Fentanyl patches: serious and fatal overdose from dosing errors, accidental exposure, and inappropriate use Inappropriate use of fentanyl patches can be very dangerous. Patches should be prescribed with care and instructions on their use should be followed closely. [Drug Safety Update Vol 2, Issue 2. September 2008] Over-the-counter painkillers containing codeine or dihydrocodeine Restriction on the sale of codeine and dihydrocodeine products to reduce abuse; the products can no longer be sold for indications relating to colds, flu, cough and sore throat. Over-the-counter supply is limited to shortterm use for pain not relieved by aspirin, ibuprofen or paracetamol. Drug Safety Update Vol 3, Issue 2. September 2009] Addiction to benzodiazepines and codeine: supporting safer use Reminder to use benzodiazepines and over-the-counter codeine products for the shortest possible time. [Drug Safety Update Vol 4, Issue 12. July 2011] Codeine-containing pain relief in children: safety review initiated following post-surgical fatalities in ultra-rapid metabolisers The ongoing review was triggered by recent concerns that there is an increased risk of morphine toxicity when certain susceptible children are given codeine for post-operative pain after surgery. The European review will evaluate the impact of the new information on the balance of benefits and risks of codeine-containing medicines when used for pain relief in children. The outcome of the review will be communicated when available. [Drug Safety Update Vol 6, issue 5. December 2012] 5. Additional health issues The British Pain Society, in collaboration with the Faculty of Pain Medicine of the Royal College of Anaesthetists, the Royal College of General Practitioners and the Faculty of Addictions of the Royal College of Psychiatrists produced good practice guidance on opioids for persistent pain.2 The guidance recognises that complete relief of pain is often not achieved with opioids and the aim should be to balance a reduction in pain intensity against potential adverse effects. The British Pain Society. Opioids for persistent pain: good practice. January 2010. www.britishpainsociety.org 2 Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 4 Opioids can provide useful analgesia in the short and medium-term. Evidence for sustained opioid analgesic efficacy in the long-term is poor. Improvements in quality of life are unlikely to be achieved unless opioids are prescribed as part of a broader approach to improve patient function. Serious harms associated with opioids include: Falls leading to fractures. Respiratory depression which can be fatal but is rare with long-term treatment. The increasing use of opioids for chronic non-cancer pain is paralleled by rising numbers of deaths related to prescription opioids. The potential for long-term adverse effects, particularly in relation to endocrine and immune function. The potential for psychological and physical dependence or misuse. The risk is uncertain and seems to depend on a number of factors. This is no deterrent to the control of pain in terminal illness.3 6. All Wales Prescribing Indicators Each year from 2013-13 to the present there have been three national prescribing indicators for opioid analgesics. Currently these are: Total items per 1,000 PUs.4 Items of morphine as a percentage of strong opioid prescribing. Tramadol DDDs per 1,000 patients.5 Further information on national prescribing indicators and their analysis from 2011-12 to 2014-15 can be found in the online AWMSG library. 3 BNF edition 66, September 2013-March 2014, [page 274] 4 PU = prescribing unit 5 DDD = daily defined dosage Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 5 7. Resources to support change 7.1 All Wales Medicines Strategy Group (AWMSG) Educational resource materials were developed to support the appropriate prescribing of tramadol in NHS Wales and to review the prescribing of tramadol within the complex context of pain management. The materials were developed with regard to promoting the appropriate use of tramadol and raising awareness of the risks associated with the misuse and diversion of supplies of tramadol. A protocol for the supply and administration of intranasal fentanyl protocol was produced to facilitate the self administration of intranasal fentanyl preparations for patients admitted to non-specialist palliative inpatient settings within Aneurin Bevan Health Board. Patient information manuals for opioids in palliative care settings Morphagesic SR® version and MST® version represent a useful takehome supplement to consultations where opioids have been discussed, considered and/or prescribed. The patient information leaflet Medicines for mild to moderate pain relief provides written information on the medicines that are available for mild to moderate pain relief, both over the counter and on prescription. 7.2 Welsh Medicines Resource Centre (WeMeRec) The management of chronic non-malignant pain in primary care bulletin will be available soon via www.wemerec.org. The management of acute low back pain bulletin discusses the appropriate management of acute, uncomplicated or non-specific low back pain in the primary care setting. It focuses on overall management strategies including appropriate first-line medicines. The palliative care pain control bulletin and the accompanying issue, on symptom control in palliative care, focus on the care of cancer patients. Stopping compound medications containing codeine e-notes discusses how these medicines can potentially be discontinued safely and beneficially. Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 6 7.3 MHRA opioids learning module The opioids learning module identifies the most important hazards of opioids and informs on actions that health professionals can take in order to anticipate, minimise and manage the risks. 7.4 NICE clinical audit tool Opioids in palliative care: initiating drug treatment clinical audit tool accompanies the clinical guideline Opioids in palliative care (CG140). Prepared by Rosemary Allgeier, Public Health Wales February 2014 v1 Page 7