Guidelines for the Pharmacological Management of Chronic Pain in Primary Care December 2012 NHS Portsmouth CCG Fareham and Gosport CCG South Eastern Hampshire CCG 1
Guidelines for the Pharmacological Management of Chronic Pain in Primary Care Purpose To facilitate the appropriate Primary Care management of adults suffering with chronic pain. Introduction Pain is one of the most common reasons that patients present to Primary Care and it is important that GPs optimise the pharmacological management of patients pain BEFORE considering referral to a Community Pain Self Management Service. It is kwn that there are widespread changes within the nervous system that give rise to persistent pain (Siddall, 1997). According to the British Pain Society, one in seven people is thought to suffer from persistent pain and twenty percent of those report suffering for more than 20 years. People with pain consult their doctor up to five times more frequently than others, resulting in nearly 5 million GP appointments each year. Poorly managed chronic pain can affect quality of life for sufferers and their carers, leading to helplessness, isolation, depression and family breakdown. It is important that the GP optimises the pharmacological management of patients pain before referring to the Community Chronic Pain Self Management Service Scope of Guidelines These Guidelines are to assist in the management of chronic pain in all patients aged 18 years or over. Chronic pain is continuous, long-term pain of more than 12 weeks or after the time that healing would have been thought to have occurred in pain after trauma or surgery This document does t cover the management of pain associated with cancer For use by all n-specialist prescribers within Primary Care. Recommendations This guidance is intended to guide management and recommendations are based on established practice throughout the UK and relevant NICE guidance. References are listed below. It should be emphasised that medicines play only a mir part in managing persistent pain. Maintaining fitness, pacing activities and a generally healthy lifestyle are important. Nonpharmacological methods of pain relief such as TENS, acupuncture, physical methods for the reduction of muscle spasm are equally important. All patients should be screened for common mental health problems that may result from experiencing difficult to control pain. A mental health needs assessment should be made before starting strong opioids. References Opioids for Persistent Pain: Good Practice. January 2010. The British Pain Society Finnerup N B, Otto M, McQuay H J, Jensen T S, and Sindrup S H. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain, 2005, 118(3):289-305 The Oxford Pain Internet Site. www.jr2.ox.ac.uk/bandolier/booth/painpag/ NICE CG 88 Low back pain: Early management of persistent n-specific low back pain,may 2009 NICE CG 96 Neuropathic pain: The pharmacological management of neuropathic pain in adults in nspecialist settings, March 2010 NICE CG 59 Osteoarthritis: The care and management of osteoarthritis in adults February 2008 Page 2 of 9
Algorithm for the Pharmacological Management of Persistent Pain Does the patient have chronic pain? (Pain continuing after healing or in the absence of injury) See Pain Clinic referral guidelines (page 9) Refer as appropriate yes Is there a component of neuropathic pain? (e.g. shingles-like pain) See Neuropathic Pain Guideline (Appendix 1 page 7) Is there serious medical pathology? (Red Flags - page 8) yes yes Commence a trial of medication based upon the Neuropathic Pain Guideline (Appendix 1) Commence a trial of regular medication to weak opioid level based on the Analgesic Ladder (page 3). Encourage activity Has pain settled to a reasonable level? Is the patient compliant with the medication regimen? yes Step-up to strong opioid based on the Analgesic Ladder See prescribing tes to enhance concordance Check Psychosocial factors (Yellow flags) yes yes Refer to Community Chronic Pain Self Management Service (where available) Has pain settled to a reasonable level? Consider exercise programme to maintain fitness/flexibility and reduce flare ups If appropriate management does t improve pain management consider referral to Community Chronic Pain Self Management Service (where available) If reasonable pain relief and reactivation achieved, consider trial of reduction in analgesia in step-wise fashion over several weeks Yes No Page 3 of 9
Analgesic Ladder - Assess each change to analgesic regimen after 4 6 weeks Step 1 Non-opioid analgesic / baseline analgesia Paracetamol 1g four times a day - Continue as patient moves through Steps 2 and 3 (Consider addition of NSAID e.g. ibuprofen or naproxen but only if there is a is a recurrent inflammatory process involved and beware renal, GI, and cardiovascular risks) Step 2 Opioids for moderate to severe pain First Line: Codeine / Dihydrocodeine 30mg four times a day (maximum 240mg daily dose) Up to 10% of caucasians may be unable to metabolise codeine to morphine dihydrocodeine does t rely on this process for action. Co-drugs e.g. co-dydramol, co-codamol may improve compliance in a responsive patient but may have a higher incidence of side-effects and are more difficult to titrate to need due to the fixed doses of each component. Co-drugs are better reserved for use once the efficacy of each component is established Second line alternatives to codeine/dihydrocodeine: Tramadol Starting dose 50mg up to four times a day. Increased up to maximum of 100mg four times a day Tramadol is an alternative opioid and possesses serotonergic and adrenergic properties too. It is generally t well tolerated in elderly patients and can cause psychiatric reactions in patients of all ages. Drowsiness is a commonly reported side-effect. It can lower seizure threshold so should be used with care in epileptic patients. Buprerphine Patch (BuTrans ) Starting Dose 5mcg/hour increased to a maximum of 20mcg/hour Offers an alternative where oral analgesia is t possible or t tolerated. Adverse effects similar to other opioids. Patches are applied ONCE every 7 days. Patches are expensive compared to oral preparations. All opioids should be started at the lowest possible dose (equivalence) and titrated up. Tolerability: Nausea, dizziness can be dose related. Start at low doses and increase slowly. Slow release preparations may be better tolerated; however DHC Continus and Tramadol SR are more expensive. Tramadol / paracetamol combination products (e.g. Tramacet ) are NOT recommended. Step 3 Opioids for severe pain 1 st LINE Morphine SR (Zomorph capsules) 20mg twice daily Increase dose by more than 10mg twice daily at a time 2 ND LINE - (Change opioid if adequate analgesia but intolerable side-effects with morphine) Oxycodone MR or Tapentadol SR may have reduced incidence of hallucinations and nausea Fentanyl patch may accumulate less in renal failure and have reduced incidence of constipation. Only to be used in patients who are established on a regular, steady dose of opioid. Buprerphine (Transtec patches) may accumulate less in renal failure and reduced incidence of constipation. Dose equivalence is less reliable however, so other opioids are preferred before buprerphine. If opioid use does t improve function or doses start escalating due to poor effect, it is likely the patient has n-opioid responsive pain and opiods should be tailed off and stopped. Opioids should be reviewed every six months and doses reduced as soon as possible to the lowest effective dose. Additional information to consider Regular laxatives for patients taking opioids (moderate severe pain) e.g magnesium hydroxide or docusate sodium and senna. Encourage regular fluid intake. Dietary changes alone rarely improve opioid-induced constipation. Anti-emetics during first 2 weeks of opioid therapy, especially in opioid naïve patients. Cyclizine rmally first line Consider n-drug therapies education, explanation and reassurance. Pacing activities, physical therapies, TNS machine, Non-steroidal anti-inflammatory drugs are t appropriate for chronic pain management unless there is a recurrent inflammatory process involved Page 4 of 9
Strong opioids for persistent n-cancer pain Dosage equivalence table These dose equivalences are intended only as an approximate guide; patients should be carefully monitored after ANY change in mediation and dose titration may be required to avoid either underdosing or excessive dosing. The order of products in the table below does t imply any order of preference. Starting Dose Titrate slowly ( more frequently than every 2 weeks) FIRST LINE Morphine Sulphate MR (Zomorph capsules) 10mg every 12 hours 20mg every 12 hours 30mg every 12 hours 40mg every 12 hours 50mg every 12 hours Buprerphine transdermal patches (Butrans ) BuTrans 5 microg/hr changed ONCE every 7 days BuTrans 10 microg/hr changed ONCE every 7 days BuTrans 20 microg/hr changed ONCE every 7 days Transtec 35 microg/hr changed TWICE weekly Transtec 52.5 microg/hr changed TWICE weekly Fentanyl transdermal patches (Matrifen ) Oxycodone MR tablets (Oxycontin ) 5mg every 12 hours Tapentadol SR (Palexia SR ) 12 microg/hr changed every 3 days 10mg every 12 hours 50mg every 12 hours 25 microg/hr changed every 3 days 15mg every 12 hours 20mg every 12 hours 25mg every 12 hours 100mg every 12 hours Suggested MAXIMUM DOSE for n-cancer pain initiated in primary care. Seek specialist advice if patient requiring higher doses. Maximum dose in primary care 60mg every 12 hours Transtec 70 microg/hr changed TWICE weekly 50 microg/hr changed every 3 days 30mg every 12 hours 150mg every 12 hours 5
ADDITIONAL GUIDANCE ON USE OF OPIOIDS FOR PERSISTENT NON-CANCER PAIN Before initiating opioid therapy Use only as part of a wider management plan aimed at reducing disability and improving quality of life. Set individualised goals of therapy for each patient. Make clear to patients that if trial is unsuccessful then opioid treatment will be discontinued. Give realistic expectations. Opioids are unlikely to give complete pain relief. Some pains do t respond to opioids. Treatment success is demonstrated by functional improvement Cautions Renal impairment. Dose reduction for egfr < 30 ml/min. Seek specialist advice. Patients should t drive when starting opioids, adjust dose or if they feel unfit to drive. Patients should inform DVLA and their car insurance company. Prescribing Be clear who is responsible for prescribing ideally a single prescriber. Use regular dosing with oral modified release preparations only, NOT immediate release formulations. Morphine sulphate MR (Zomorph ) should be the first-line opioid. Start with a low dose and slowly titrate according to analgesia and side effects, increasing more frequently than every two weeks. Discuss alternative strategies for exacerbations of pain short acting opioids are t appropriate for the majority of patients. Review regularly. Initially at least monthly, more often if there are concerns. When on a stable dose monitor at least bi-annually. Switching opioids Efficacy and adverse effects are similar for all opioids, although patients may tolerate one opioid better than ather. When switching, consider reducing dose by 25-50% to allow for incomplete cross tolerance and monitor regularly. See table and approximate opioid equivalences overleaf. Withdrawal symptoms (e.g. sweating, yawning and abdominal cramps) occur if an opioid is stopped/dose reduced abruptly. This is common with tramadol and can occur with weak opioids even after a short course. Adverse effects Constipation: Common. Minimise by encouraging lots of fluids, fruit and fibre. Always prescribe laxatives (senna two tablets at night when required and docusate sodium 200 mg twice a day). If constipation problematic with morphine, transdermal fentanyl is the preferred alternative. Possible long term endocrine / immulogical effects. Consider measuring plasma testosterone or oestradiol after 6 months, seek advice if levels low. There are currently insufficient data to quantify the risks of long term opioid therapy. Concerns relate to the effects of opioids on the endocrine and immune systems and the risk of inducing a hyperalgesic syndrome. Dependence and addiction Physical dependence is inevitable. Addiction (psychological dependence and craving) is rare. Pharmacological effects of physical dependence and ease of discontinuation helped by limiting maximum dose (see overleaf). More information For doctors is available at http://www.britishpainsociety.org/book_opioid_main.pdf For patients is available at http://www.britishpainsociety.org/book_opioid_patient.pdf 6
Pharmacological Management of Neuropathic Pain (use in addition to, or instead of, conventional analgesics) Appendix 1 Step 1 Non-opioid analgesic / baseline analgesia Paracetamol 1g four times a day Continue as patient moves through Steps 2-3 Step 2 Can be combined with Step 3 to optimise treatment Step 3 Tricyclic antidepressant (TCAs, usually first choice, unlicensed indication) Amitriptyline Week 1 Week 2 Week 3 Week 4 Week 5 10mg 20mg 30mg 40mg 50mg Analgesic effect is separate from antidepressant effect Best taken in the evening to reduce hangover effect e.g. 6-8pm Slowly titrate to reduce side-effects but ensure titration occurs even if dose is later reduced Normal maximum dose is 50mg daily but up to 100mg can be used if patient is deriving benefit with limited side-effects Side-effect profiles are similar but alternative TCAs e.g. imipramine or rtriptyline, may be used if patient responds to amitriptyline but cant tolerate side effects. No TCAs are licensed for the treatment of neuropathic pain. Anticonvulsant If TCAs are contraindicated or lancinating pain ( electric shocks ) Gabapentin Week 1 Week 2 Week 3 Week 4 Morning 300mg 300mg 300mg Midday 300mg 300mg Night 300mg 300mg 300mg 600mg Continue increasing as above to maximum 900mg three times a day determined by efficacy and side-effects Gabapentin is renally eliminated. Reduce dose in renal impairment 2 nd Line Pregabalin, only if gabapentin gives good effect but side-effects cant be tolerated (consider starting titration at lower dose in elderly or in patients who are susceptible to side-effects). Day1 Day 4 Day 8 Day 12 Morning 75mg 75mg 150mg Night 75mg 75mg 150mg 150mg Titration can be continued to a maximum of 300mg twice daily determined by efficacy and side-effects. Do NOT prescribe pregabalin more than twice a day. Pregabalin is renally eliminated. Reduce dose in renal impairment Step-wise reduction of both gabapentin and pregabalin is required if ineffective and/or t tolerated ON RECOMMENDATION OF SPECIALIST ONLY Lidocaine plaster (Versatis ) for focal neuralgia where other treatment options have failed or cant be used due to co-morbidities etc. A maximum 4 week trial should be used to establish efficacy and the prescription should cease if good effect is t established. Plasters can be cut to match the size of the affected focal site; therefore, t all patients will require a full plaster to be used each day. Duloxetine (Cymbalta ) 3 rd line where other neuropathic agents have failed or for a clear diagsis of diabetic neuropathy. Page 7 of 9
Red and Yellow Flags Appendix 2 Red flags are clinical indicators of possible serious underlying conditions requiring further medical intervention. Red flags were designed for use in acute low back pain, but the underlying concept can be applied more broadly in the search for serious underlying pathology in any pain presentation. YYeel lloow flf laaggss are psychosocial indicators suggesting increased risk of progression to long-term distress, disability and pain. Yellow flags were designed for use in acute low back pain. In principle they can be applied more broadly to assess likelihood of development of persistent problems from any acute pain presentation. They can be summarised as distress, disability, dependence and drugs (4Ds). The STarT Back Screening tool is designed to screen Primary Care patients with low back pain for progstic indicators that are relevant to initial decision making. Click here for link to STarT Back Tool Red Flags Differential diagsis Red Flags from patient history Red Flags from examination Possible fracture Possible tumour or infection Possible significant neurological deficit Major trauma Mir trauma in elderly or osteoporotic Age < 20 or > 50 years old History of cancer Constitutional symptoms (fever, chills, weight loss) Recent bacterial infection Intraveus drug use Immusuppression Pain worsening at night or when supine Severe or progressive sensory alteration or weakness Bladder or bowel dysfunction Evidence of neurological deficit (in legs or perineum in the case of low back pain) The presence of red flags in acute low back pain suggests the need for further investigation and possible specialist referral as part of the overall strategy. Yellow Flags Attitudes and Beliefs Emotions and Behaviour Other psychosocial factors Pain is harmful or severely disabling Expectation that passive treatment rather than active participation will help Feeling that -one believes the pain is real may relate to previous encounters with health professionals Fear-avoidance behaviour (avoiding activity due to fear of pain) Low mood and social withdrawal Poor family relationships or history of abusive relationships Financial concerns particularly related to ill-health or ongoing pain Work related factors e.g. conflict over sick leave, ability to perform current job tasks Ongoing litigation related to persistent pain condition Appendix 3 Page 8 of 9
Referral Criteria for Pain Clinic at Portsmouth Hospitals NHS Trust The PHT Pain Clinic is accepting referrals for patients meeting the following criteria:- Patients with cancer struggling with pain control Patients developing or having suspected Complex Regional Pain Syndrome (CRPS) Neuropathic pain (as per NICE guidance) Trigeminal neuralgia Spinal patients suffering acute brachalgia or sciatica will be seen via the Spinal Pathway, and may be offered injection treatment according to clinical evidence. Patients with acute deterioration of symptoms of spinal claudication from spinal stesis will be considered for epidural, via the Spinal Pathway. GPs are also advised to consider using Advice and Guidance (via Choose and Book) as an alternative to referral Author: Katie Hovenden, Associate Director Medicines Management and CCG Development NHS Portsmouth CCG With grateful thanks to Emma Davies, Pharmacist with a Specialist Interest in Pain Management who produced the original guidance for the Basingstoke, Southampton and Winchester DPC. This was used as starting point for this guidance for use within the Portsmouth and South East Hampshire health ecomy. Approved by: Portsmouth and South East Hampshire Area Prescribing Committee, December 2012 Review Date: December 2014 Page 9 of 9