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Area Drug & Therapeutics CommitteeADTC 118: Pharmacological and Other Management of Persistent PainFor Adults aged 16 years and overVersion No: ADTC 118/5 (supersedes ADTC 118/4)Prepared By: Dr Charles Martin, Consultant Anaesthetist, Specialist Pain ConsultantAlexander Adam, Specialist Pharmacist in Substance MisuseArea Drug and Therapeutics Committee - Analgesic Prescribing Group (APG). Effective From: XXXXReview Date: XXXXLead Reviewer: Dr Charles MartinDissemination Arrangements:NHS Ayrshire and Arran IntranetOthers, as relevantPainFor additional information and details regarding any component of this chart please see the referenced pages. Nerve Pain (or Pain with Neuropathic Elements)For additional information and details regarding any component of this chart please see the referenced pagesADTC 118: Pharmacological and Other Management of Persistent PainFor Adults aged 16 years and overContents TOC \o "1-3" \h \z \u Introduction PAGEREF _Toc526510606 \h 6Persistent pain definition PAGEREF _Toc526510607 \h 6PAIN MANAGEMENT – THE GUIDANCE PAGEREF _Toc526510608 \h 7Pain Assessment PAGEREF _Toc526510609 \h 7Goals of therapy / Treatment outcomes PAGEREF _Toc526510610 \h 8Therapeutic choices PAGEREF _Toc526510611 \h 8Review PAGEREF _Toc526510612 \h 8Referral – The Specialist Pain Services PAGEREF _Toc526510613 \h 8Referral – The Specialist Physiotherapy Services PAGEREF _Toc526510614 \h 9Referral – The Specialist Occupational Health Services PAGEREF _Toc526510615 \h 9Referral – The Specialist Addiction and Dependence Services PAGEREF _Toc526510616 \h 9Transitions Between Care Settings and Consistency of Practice PAGEREF _Toc526510617 \h 10Concerning Prescribing Activity and Seeking Support for Practitioners PAGEREF _Toc526510618 \h 10THERAPEUTIC CHOICES PAGEREF _Toc526510619 \h 11Supported Self Management (non-drug options) PAGEREF _Toc526510620 \h 11Pharmacotherapy (drug options) PAGEREF _Toc526510621 \h 15Simple Analgesia – paracetamol and NSAID; alone or combination therapy PAGEREF _Toc526510622 \h 16Paracetamol – Oral PAGEREF _Toc526510623 \h 16Non Steroidal Anti-Inflammatory Drugs (NSAIDs) - Oral PAGEREF _Toc526510624 \h 16COX-2 Inhibitors – oral PAGEREF _Toc526510625 \h 18Antidepressant Drugs - oral PAGEREF _Toc526510626 \h 18Rubefacients PAGEREF _Toc526510627 \h 18Capsaicin Preparations PAGEREF _Toc526510628 \h 18Opioids PAGEREF _Toc526510629 \h 19Notes on prescribing opioids PAGEREF _Toc526510630 \h 19Weak Opioids - oral PAGEREF _Toc526510631 \h 19Strong Opioids – oral and transdermal PAGEREF _Toc526510632 \h 20Additional factors to consider when prescribing opioids PAGEREF _Toc526510633 \h 22Initiation of opioids PAGEREF _Toc526510634 \h 22Opioid dose and adjustments PAGEREF _Toc526510635 \h 23Equivalent doses of opioid analgesics PAGEREF _Toc526510636 \h 23Adverse effects PAGEREF _Toc526510637 \h 24Drug Driving PAGEREF _Toc526510638 \h 25Long term effects of Opioids PAGEREF _Toc526510639 \h 25De-escalation and Detoxification from Opioids PAGEREF _Toc526510640 \h 26Tapering Schedules PAGEREF _Toc526510641 \h 27NEUROPATHIC PAIN PAGEREF _Toc526510642 \h 29Pharmacotherapy (drug options) PAGEREF _Toc526510643 \h 29Tricyclic Anti-Depressants (TCADs) - oral PAGEREF _Toc526510644 \h 30Other Anti-Depressant Drugs - oral PAGEREF _Toc526510645 \h 30Anti-Epileptic Drugs (Gabapentinoids) - oral PAGEREF _Toc526510646 \h 31 De-escalation and Detoxification from Gabapentinoids PAGEREF _Toc526510647 \h 33Capsaicin preparations – topical PAGEREF _Toc526510648 \h 33Anaesthetic preparations - topical PAGEREF _Toc526510649 \h 33Condition Specific Care PAGEREF _Toc526510650 \h 35Low Back Pain/Sciatica PAGEREF _Toc526510651 \h 35Fibromyalgia PAGEREF _Toc526510652 \h 35Special Patient Groups PAGEREF _Toc526510653 \h 37Elderly patients PAGEREF _Toc526510654 \h 37Female patients of reproductive age/pregnant/breastfeeding PAGEREF _Toc526510655 \h 38Secure Environment Patients / Prisoners PAGEREF _Toc526510656 \h 38Abbreviations PAGEREF _Toc526510657 \h 39Appendix 1 – 10% Taper Schedule – Comparing Approaches PAGEREF _Toc526510658 \h 40References PAGEREF _Toc526510659 \h 41IntroductionThis guideline is aimed at the non-specialist management of persistent non-cancer pain excluding headache and although some similar principles apply to cancer and non cancer pain, the patient groups and their treatment are distinct. Pain is a complex condition requiring a holistic approach, patient participation and active self management. Total eradication of pain is unlikely and a combination of pharmacological and non-pharmacological measures will typically be necessary to achieve functional improvement and reduce pain to tolerable or manageable levels. Information on assessment and early management is available at neuropathic pain pathway is at strong opioid pathway is at Faculty of Pain Medicine produced Core Standards in Pain Medicine in 2015. This document covers a wide range of aspects of Pain Medicine, including standards of education and training for health care professionals working in this field. pain definition Persistent pain is that which has lasted longer than the expected healing time following injury. This is typically defined as pain that has been present for more than 12 weeks. Pain Authoritative sources use the terms persistent and chronic interchangeably when describing pain. A concise history, examination and biopsychosocial assessment, identifying pain type (neuropathic/ nociceptive/mixed/unknown), severity, functional impact and context should be conducted in all patients with persistent pain. This will inform the selection of treatment options most likely to be effective1. PAIN MANAGEMENT – THE GUIDANCEPain Assessment Use a patient centred, culturally sensitive approachExplain the treatment optionsEncourage the patients’ involvement in decision makingConsider red flags for serious pathologyInvestigate and refer if necessaryAvoid further investigations unless serious pathology is suspectedidentify the stage at which no more investigations are planned and explain this clearly to the patientIdentify the duration of the painmake a clear diagnosis of persistent pain where appropriaterecord and code appropriatelyAssess severityuse a narrative clinical history to clarify the complexityconsider a visual analogue scale or numerical score to help gauge the response to treatmentAssess functional impactwork, relationships, sleep, mood, disability etcIdentify patients at risk of poor outcomeclinical judgementtools e.g. Keele STarT Backco-morbidities – mental health problems including depression and anxietyyellow flags indicate poor outcome:biomedical – severe pain at presentation, previous pain episodes, multiple site pain, non-organic symptoms, iatrogenic factorspsychological – belief that pain indicates harm, expectation of passive rather than active treatment, fear avoidance, catastrophising, passive coping, atypical health beliefs, distresssocial – low expectation and lack of confidence regarding return to work, heavy work, lack of control, medico-legal issues1.Pain is often under-recognised and under-treated in older and younger people. Assessing pain becomes more challenging in the presence of cognitive impairment, communication difficulties or language and cultural barriers. People with communication problems should be offered assistance with self-report through the use of suitably adapted scales and facilitation by skilled professionals.All patients with persistent pain should have an allocated read code of 1M52 in order to facilitate audit and reviewGoals of therapy / Treatment outcomesThe goal of treatment should be to reduce pain sufficiently to allow engagement with rehabilitation and the restoration of useful function. Therapeutic choices The various therapeutic interventions available for pain are covered in more detail in the following section - these consist of both pharmacotherapy and non-drug options. Individual patient needs and specifics of their pain experience may support a preference for one or more approaches but all options should be considered with a view towards longer term improvement in function and rehabilitation. The involvement of multiple professionals or services may be needed for each individual to avoid poor outcomes and practitioners should be aware of the available options. ReviewAt each review opportunity consider any non-drug options which are appropriate to include in the patient’s care package and whether these are being engaged with.On initiation, or following a dose increase or drug change, review according to need but within four weeks as a maximum. Reassess for benefit and determine the value of the intervention to improve patient wellbeing and function.Once stability is achieved a review should take place within twenty-six weeks (6 months)Subsequent reviews should be at least annualAt review, re-assess medication concordance and efficacy, adverse effects, alcohol and illicit drug use, mood, function and review management plan if appropriate. Consider a trial of dose reduction or medication withdrawal to assess response. Referral – The Specialist Pain ServicesA small number of individuals may require additional support beyond what is possible within the presenting setting. Consider referral if pain is severe, disabling, not responding to appropriate interventions or for specialist assessment and/or treatment. Making only appropriate referrals will reduce waiting times for access to specialist care. Referral to a pain management programme or into a service providing cognitive behavioural therapy should be considered for patients with persistent pain1. This treatment is available through the Ayrshire and Arran Pain Management Clinic. The Specialist Pain Management Service is a team of professionals including: consultants in pain management; specialist physiotherapists; clinical psychologists and specialist nurses. The specialist team work with individuals to reduce the impact of persistent pain upon normal living. Further details of the service are available at: . Please note that the work of this Service will not facilitate the use of higher potency opioids or unlicensed therapies/doses of analgesics. Please use the NHS Ayrshire and Arran Guidelines for a Positive Referral. ( ) Referral – The Specialist Pain Management Physiotherapy ServiceContact:Daniel Thompson - Daniel.Thompson@aapct.scot.nhs.uk Emma Mair - Emma.Mair@aapct.scot.nhs.uk Referral – Musculoskeletal Advice and Triage Service (MATS)A phone triage service for people experiencing muscle, back or joint problems (musculoskeletal). The service can provide key self-care information, direct to appropriate self-management?resources over or, if required, or refer on to local NHS services. Self-referral Contact 0800 917 9390 or nhsinform.scot/mskReferral – The Specialist Addiction and Dependence ServicesThe SCI Gateway system should be used for all primary care prescriber referrals. The Services offer an open referral system - anyone can refer, including self referrals or referrals by others on behalf of the individual.The contact details for each locality are as follows: For East AyrshireEast Ayrshire Health and Social Care Partnership Addiction ServicesBentinck CentreEast Netherton StreetKILMARNOCKKA1 4AXTelephone: 01563 574237For North AyrshireNorth Ayrshire Drug and Alcohol Recovery Service (NADARS)Caley Court Resource CentreMoorpark Road WestSTEVENSTONKA20 3LATelephone: 01294 476000For South AyrshireSouth Ayrshire Health and Social Care Partnership Addiction ServicesUpper KillochanAilsa Campus Dalmellington RoadAYRKA6 6ABTelephone: 01292 559800Transitions Between Care Settings and Consistency of PracticeTransitions between care providers such as GP practices, hospital care, specialist clinics and prison can produce challenges in ensuring that a consistent care plan is followed. All practitioners should provide similar standards of care in line with evidence-based practice and, however, it may be necessary in some instances to communicate information about an individual’s care plan via electronic records to prevent confusion and dissimilar prescribing practice eg. in secondary care settings. Similarly, communication across boundaries of care can lead to inadvertent confusion and inappropriate prescribing such as when a patient is discharged from hospital and analgesia is continued indefinitely due to a lack of information regarding expectations of recovery and review of analgesic need. When a patient is discharged following acute injury or surgical intervention it is essential that information about expected duration of pain and timeline for improvement is communicated with the GP to facilitate an appropriate review and discontinuation of analgesia. Concerning Prescribing Activity and Seeking Support for PractitionersAppropriate prescribing and patient care involves a shared responsibility between the patient and the prescribing practitioner to arrive at a mutually acceptable care plan and treatment package. There are situations where prescribers may be put under pressure by patients to prescribe against their better judgement or where a patient is inherited from another practitioner in receipt of an established regimen which may not be in keeping with best practice. Trying to establish the nature of the pain, the influence of psychological and lifestyle factors and which therapies have already been unsuccessfully trialled may be complex and problematic. Where a prescriber identifies such a situation they should record their concerns clearly in the patient’s notes and formulate a management plan to transition the patient’s prescribing into line with more acceptable practice. Where this is outwith the prescriber’s skill additional support should be sought from colleagues or through communication with the Specialist Pain Service. An observer who is external to the therapeutic relationship between prescriber and patient may feel concern relating to the prescribing seen within their field of practice. This may include other General Practitioners, hospital staff, custody or prison staff, pharmacists, specialist nurses, family members etc. Where an external party identifies a concern relating to potentially inappropriate prescribing it is recommended that such a concern is raised in a sensitive manner. This allows an external party to undertake an objective consideration of the situation. This may involve communication with the prescriber involved, examination of patient records, and an offer of supportive assistance, if such is required, to remedy the situation. It is likely that most such concerns will be easily allayed once the complete picture is known; however, any such concern should be raised and treated seriously via communication with the Specialist Pain Service. THERAPEUTIC CHOICES‘The goal of treatment should be to reduce pain sufficiently to allow engagement with rehabilitation and the restoration of useful function. ‘Supported Self Management (non-drug options)Many patients with persistent pain find that the conventional medical approach alone, principally involving the use of medicines, is not effective in providing adequate pain relief or sufficient improvement in function. Other interventions, therefore, are of great importance in order to achieve positive outcomes. Supported self-management is a recognised intervention for persistent pain and a core driver of reform in health and social care in Scotland. It does not seek to cure, but it describes a set of approaches which help patients feel able to live well on their terms, manage their condition and minimise the impact the pain has on their everyday life.It includes a spectrum of support that helps someone to learn about their condition, acknowledge the impact it has on their life, make changes and identify areas where they require support. Support for self-management is designed to enhance these strengths and help people to feel in control and able to manage well in their everyday life. Non-pharmacological therapies can ameliorate persistent pain while posing substantially less risk to patients. In some instances, these other therapies may result in measurably better outcomes than medication, particularly opioids. These options include:Understanding pain educationEvidence suggests that providing patients with an improved understanding of persistent pain through education can reduce pain interference via re-conceptualising their attitudes and beliefs.Activity management educationAdvise and encourage the patient to stay active in a sensible and sustainable manner to reduce flare ups (‘pacing’). Education should be provided on planning, prioritising and pacing of activityGraded activity:Graded activity should be encouraged in activities of daily living and exercise. This approach starts slow, with the challenge rating increasing over the course of time. This has been shown to improve patient’s confidence and compliance to activity.Goal setting;Goal setting has been shown to be a powerful way for people to improve quality of life and sense of control. It is important that goals are meaningful and based around the patient’s own values. Flare-up managementFlare-up refers to a period of intense pain which is felt more severely than the day to day persistent pain. Education for patients on recognising the warning signs and developing a response plan can reduce the incidence and impact of flare-ups in patient’s lives.Exercise therapy;There is strong evidence for the benefits for physical exercise and activity as part of the management of persistent pain and this is highlighted within SIGN 136. Exercise has one of the strongest recommendations in the SIGN Guideline. Exercise should involve strengthening, flexibility, endurance and balance.Advice alone may be insufficient to enable patients to adhere to an exercise programme and so appropriate structured exercise may improve adherence eg. supervised exercise sessions or individualised exercises in group settings or provision of a home exercise programme. Examples of potentially suitable exercise options include:PilatesYogaT’ai ChiWalkingSwimmingWeight management;Weight management techniques encompass long-term lifestyle strategies that promote healthy eating and daily physical activity. Effective weight management strategies consider not only weight loss toward a goal weight but also the maintenance of a healthy body weight over time.Weigh to goLEAN ProgrammeDieteticsManaging mood/emotionsIt is important to explain to patients that it’s normal for pain to affect mood and vice-versa, and that relaxation, mindfulness and pleasurable activity can help counter distress. Useful tools include the Pain Toolkit and Scottish Moodjuice website. Leaflets are available regarding stress and relaxation. Further support may need to be considered depending on the patient’s level of emotional distress and may be accessed through a referral to psychology services.Psychological therapiesThe two principal types of psychological treatment utilised for the management of persistent pain are cognitive behavioural therapy (CBT) and behaviour therapy. Both focus on helping people to change behaviour that maintains or worsens pain, disability, distress and catastrophic thinking; CBT also directly addresses the thoughts and feelings that are a problem for people with persistent pain. Psychological therapies can help people with persistent pain reduce negative mood (depression and anxiety), disability, catastrophic thinking, and in some cases, pain. These therapies may be offered as ‘stand-alone’ in some settings or may be available only as part of a treatment programme. Sleep hygiene;As persistent pain develops, patients may develop poor sleeping habits without conscious awareness. These habits may include such things as: varying the time that one goes to bed and awakens in the morning; taking naps during the day; staying in bed most of the day; or engaging in stressful or stimulating activities.A wide variety of different techniques and sleep aids promote a normal, high-quality night's sleep leading to full alertness and energy during the day. The following interventions are not evidence based, and are therefore not offered through the NHS, but may be of interest for some patients to pursue themselves: TENS therapy;acupuncture;thermotherapy and cryotherapymassage and manual therapyHealthcare professionals should signpost patients to self help with written as well as web based information resources:Athena: Patient-accessible: websites provide a useful aid at any point in the patient pain journey. Self management resources should be considered to complement other therapies in the treatment of patients with persistent pain. They may be used from an early stage of a pain condition and continue as part of a long term management strategy1. Pharmacotherapy (drug options)There is individual variation in individuals’ requirement for analgesia and treatment should be tailored to the individual’s needs. There should be a full discussion with the patient regarding the likelihood of a benefit with the drug options and the variability in response along with the more common significant adverse effects. There should be an acknowledgement that the pain may never entirely resolve. Other issues such as the ability of patients to work, operate machinery, or drive whilst taking analgesics should also be considered. MILD PAIN Simple Analgesia Regular paracetamol and a NSAID (if not contraindicated)MODERATE PAIN Simple Analgesia Regular paracetamol and a NSAID if not contra-indicated should be continued. They can have an opioid sparing effect. + Weak opioidSEVERE PAIN Simple Analgesia Regular paracetamol and a NSAID if not contra-indicated should be continued. They can have an opioid sparing effect. + Strong opioid* .* NOTE – Strong opioids are not recommended for the management of pain in certain long term conditions, such as: headache; neuropathic pain; fibromyalgia; undiagnosed pain; functional pain syndromes etc, irrespective of the severity of the pain experienced.Simple Analgesia – paracetamol and NSAID; alone or combination therapy Paracetamol – OralParacetamol is well tolerated and provides effective analgesia for mild to moderate pain. It may have an opioid sparing effect and should continue to be given when opioids are required. Paracetamol - Oral (SPC)It is generally considered the first line analgesic of choice, with the standard dose being 1g four times a day. Dosing is more effective at regular intervalsIn patients with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition or dehydration the maximum dose must not exceed 3g daily. In severe renal impairment (creatinine clearance ≤30ml/min) doses should not be given more frequently than every 6 hours. There is no specific advice on the use of oral paracetamol in adults of low body weight (<50kg). Consider a dose reduction or an increased interval between doses in these patients (eg 500mg 4 times daily)Paracetamol can be given rectally, however speed of onset is slower than oral administration and absorption is variable. Over dosage is dangerous as it may cause hepatic damage which may not be apparent for four to six days. The code of practice for the safe use of intravenous (IV) paracetamol is available at (f).pdf and may contain useful guidance and information.Non Steroidal Anti-Inflammatory Drugs (NSAIDs) - OralIn single doses, NSAIDs have similar analgesic efficacy to paracetamol. In regular doses they have a greater analgesic and anti-inflammatory action. They may be useful alone or in combination with paracetamol (eg. in osteoarthritis of hip or knee)NICE recommend that if an NSAID is needed, use ibuprofen (1200 mg a day or less) or naproxen (1000 mg a day or less). Use the lowest effective dose and the shortest duration of treatment necessary to control symptoms. effects of NSAIDs include gastro-intestinal (GI) discomfort, nausea, bleeding and ulceration, hypersensitivity reactions (including rashes, angioedema and bronchospasm), fluid retention and renal failureIbuprofen – oral (SPC)Ibuprofen has the lowest risk of GI side effects and should generally be the first line drug.Doses of 400mg every 4-6hours up to a maximum of 1200mg per day are typical and recommended although divided doses up to a maximum of 2400mg per day may be used. Naproxen – oral (SPC)Preferred second line NSAID where additional anti-inflammatory and analgesic effect is required.A greater risk of GI side effects than ibuprofenTypical dosages are 250-500mg in divided doses (usually twice daily) up to 1000mg per day.Diclofenac – oral (SPC)Diclofenac has greater anti-inflammatory action than ibuprofen but an intermediate risk of GI side effects Advice from the MHRA states the cardiovascular risk with diclofenac is similar to that of the selective COX-2 inhibitors4. Consistent with COX-2 inhibitors, diclofenac is now contraindicated in those with: ischaemic heart disease; peripheral arterial disease; cerebrovascular disease; or established congestive heart failureTypical dosages of 75-150mg in two or three divided doses.Mefenamic Acid – oral (SPC)Mefenamic acid is indicated for the treatment of dysmenorrhoeaTypical dose is 500mg in three divided ical NSAID Should be considered in the treatment of patients with persistent pain from musculo-skeletal conditions, particularly in patients who cannot tolerate oral NSAIDs Ibuprofen gel (SPC) or Ketoprofen gel (SPC) are first line options.Gastrointestinal adverse events with topical NSAIDs are less frequent than with oral NSAIDs1.Notes for Prescribing NSAIDsUse NSAIDs with caution in the elderly and patients with cardiac, renal or hepatic impairment Avoid in dehydrated patients and caution when prescribed with angiotensin antagonists, angiotensin converting enzyme inhibitors and diureticsNSAIDs are contra-indicated in patients with a history of hypersensitivity to aspirin or any other NSAID, in severe cardiac failure or in patients with previous or active peptic ulceration Consider a proton pump inhibitor for patients at risk of GI adverse effects (includes patients >60 years, smokers, dyspepsia, patients on steroids or anti-coagulants) See ADTC 134: Use of Acid Inhibitors Policy In Adults aged 16-years and over (link).All NSAIDs are associated with a small increased risk of thrombotic events (myocardial infarction and stroke). It is recommended that the lowest effective dose is prescribed and long term use is periodically reviewed NSAIDS and Asthma NSAIDs may induce bronchospasm in a small number of asthmatic patients. This occurs in approximately 10-15% of asthmatics and is associated with the combination of asthma, chronic rhinitis and nasal polyps. Most asthmatic patients can tolerate NSAIDs Avoid if history of severe asthma, previous worsening of symptoms associated with NSAIDs or history of chronic rhinitis/nasal polyps NSAIDs are contraindicated in patients who have previously known hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or Urticaria, allergic disease) in response to (NSAIDs)COX-2 NSAIDs do not appear to induce bronchospasm COX-2 Inhibitors – oralSelective cyclo-oxygenase-2 inhibitors (COX-2) NSAIDs have a lower incidence of serious upper GI side-effects although this benefit is lost when the patient is also on aspirin. There is very limited evidence of any benefit compared to the combined use of non-selective NSAIDs and Proton Pump Inhibitors.COX-2 NSAIDs are associated with an increased risk of thrombotic events (e.g. myocardial infarction and stroke) and should not be used in preference to non-selective NSAIDs except when specifically indicated (i.e. for patients at particularly high risk of developing upper GI side-effects) and after assessing their cardiovascular risk. Celecoxib (SPC)Typical dosages are 100-200mg once or twice daily. The maximum recommended dose is 200mg twice daily (400mg daily)In the absence of an increase in therapeutic benefit after two weeks at maximum tolerated dose other therapeutic options should be considered.Antidepressant Drugs - oralNefopam (SPC)Nefopam is not a formulary recommendation in Ayrshire and ArranFor persistent pain the Scottish Intercollegiate Guidelines Network (SIGN) stated that ‘The evidence identified on the use of nefopam for chronic pain relief is not sufficient to support a recommendation’. In inflammatory arthritis a Cochrane systematic review concluded ‘based on 3 small trials, which were all at high risk of bias, there is weak evidence that nefopam and capsaicin are superior to placebo in reducing pain in patients with RA, but both are associated with a significant side effect profile’ A Cochrane review looked at single dose oral nefopam for acute postoperative pain in adults. With the authors concluding ‘In the absence of evidence of efficacy for oral nefopam in acute postoperative pain, its use in this indication is not justified. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies are lacking, use in other indications should be evaluated carefully…’ RubefacientsRubefacients act by counter-irritation. Pain, whether superficial or deep-seated, is relieved by any method that itself produces irritation of the skin. Topical rubefacient preparations may contain nicotinate and salicylate compounds, essential oils, capsicum, and camphor. The evidence available does not support the use of topical rubefacients in acute or chronic musculoskeletal pain.Capsaicin PreparationsCapsaicin Cream 0.025% (SPC)A preparation containing capsaicin 0.025% can be considered as an adjunct in hand or knee osteoarthritis It may need to be used for 1–2 weeks before pain is of FormBottom of FormOpioidsNotes on prescribing opioidsOver the last few decades, the use of opioids in persistent non-cancer pain management has increased despite a lack of evidence to support this change in practice. Potential reasons for this include new preparations and formulations of opioids and changes in patient expectations, medical practice and societal attitudes. There has been an epidemic of deaths in the US related to prescription opioids. The situation in the UK is currently thought to be less critical but there is growing cause for concern.The Faculty of Pain Medicine has provided advice (Opioids Aware) on the prescribing of opioids12. It is summarised as follows:Opioids are very good analgesics for acute pain and for pain at the end of life but there is little evidence they are helpful for long term pain.A small proportion of people may obtain good pain relief with opioids in the long term if the dose can be kept low and especially if their use is intermittent (however it is difficult to identify these people at the point of opioid initiation).The risk of harm increases substantially at doses above an oral morphine equivalent of 120mg/day, but there is no increased benefit.If a patient is using opioids but is still in pain, the opioids are not effective and should be discontinued, even if no other treatment is available.Persistent pain is very complex and if patients have refractory and disabling symptoms, particularly if they are on high opioid doses, a very detailed assessment of the many emotional influences on their pain experience is essential.Weak Opioids - oralWeak opioids should be added to simple analgesia when pain is classed as moderate. Additional information relating to the prescribing of opioids can be found in the section below (link) Codeine (SPC)The preferred first choice weak opioid.It is a prodrug which is variably metabolised to morphine. 1 in 10 patients will not metabolise codeine to morphine resulting in poor analgesia Doses are typically 30-60mg every 4-6 hours when necessary up to a maximum dose of 240mg daily.Dihydrocodeine (SPC)An alternative to codeine which may be effective in patients who do not metabolise codeine. Doses are similar to codeine.Tramadol (SPC)Tramadol may also be considered in patients who do not tolerate codeine. It may cause less constipation than codeine so may be preferable for patients where this may be problematic despite appropriate laxative prescribing. Adverse effects of tramadol may include nausea and dizziness, hallucinations, confusion and convulsions. Care should be taken in patients with epilepsy and patients on other medicines which can lower the seizure threshold (eg. ciprofloxacin) The home office has reclassified Tramadol as a schedule 3 controlled drug. Prescriptions are required to adhere to Controlled Drug prescription writing regulations. Quantities must be stated in words and figures. The Prescription is valid for 28 days only. Safe storage and register keeping will not be required.Tramadol may be classified in some instances as a ‘strong’ opioid, despite equivalence of its potency to codeine, possibly due to additional SNRI activity and side-effects/abuse potential.An initiation dose is usually 50mg with subsequent dosage titrated according to pain severity and individual response – the lowest dose providing effective pain control is advocated. Doses of 50-100mg every 4-6 hours may be appropriate with a total daily maximum dose of 400mg except in special clinical circumstances. Notes for prescribing of weak opioidsIf pain is not controlled using one weak opioid (plus SIMPLE ANALGESIA), switch to an alternative weak opioid instead of adding an additional weak opioid. Weak opioids should be stopped in patients taking a strong opioid (eg morphine) on a long term basisInitial prescribing of opioids should be for a trial period with a review and reassessment within four weeks. Strong Opioids – oral and transdermalStrong opioids should be added to simple analgesia to replace weak opioids when pain is classed as moderate. Additional information relating to the prescribing of opioids can be found in the section below (link). Strong opioids are not recommended for the management of pain in certain long term conditions, such as: fibromyalgia; undiagnosed pain or functional pain syndromes, irrespective of the severity of the pain experienced.Initial prescribing of opioids should be for a trial period with a review and reassessment within four weeks. Realistic outcomes of treatment should be agreed at the outset and if these are not met discontinuation should be considered. There is no convincing evidence that different strong opioids at equivalent doses are more effective than morphine and dose escalation beyond 120mg of morphine equivalent per day with any agent is unlikely to be helpful in non-cancer pain. Opioids administered at regular intervals in the management of patients with non-palliative pain may increase tolerance and reduce effect. Use of more flexible intermittent dosing regimens using immediate release preparations (alone or in combination with modified release preparations) may be justified in some circumstances to improve pain response. Morphine – oral (SPC)NHS Ayrshire & Arran formulary first choice for a strong opioid. There is no convincing evidence for the superiority of any other opioid agent at equivalent doses. Doses of immediate-release preparations are determined according to the severity of the pain and previous opioid analgesic dose and are given every 4-6 hours. Maximum dose of 120mg per day. Modified release formulations are available; with Zomorph? the preferred brand in Ayrshire and Arran.Oxycodone – oral (SPC)Oxycodone is considered to be twice as potent as morphine per mg dose. Restricted to initiation by: Palliative Care; Acute Pain team and Persistent Pain Team. Prescribed by the Orthopaedics speciality for short durations in specific clinical situations including: Analgesia for patients aged 65 years and over who have sustained a fragility fracture (ADTC287)Enhanced recovery programme from arthroplasty (ADTC136) Doses of immediate-release preparations are determined according to the severity of the pain and previous opioid analgesic dose and are given every 4-6 hours. Maximum dose of 60mg per day (equivalent to 120mg morphine)A modified release formulation is available however this is reserved for use in those whom controlled release morphine sulphate is ineffective or the side effects not tolerated9. Oxycodone should be prescribed by brand (from May 2014) to improve patient safety and minimise prescribing and administration errors.Shortec? capsules for immediate release preparations Longtec? tablets for modified release preparations) Buprenorphine - transdermal (SPC)The Scottish Medicines Consortium has advised (January 2017) that buprenorphine transdermal patches are accepted for restricted use within NHS Scotland for the treatment of persistent non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia in elderly patients (over 65 years). Prescribing by brand name (Butec?) is recommended10 to avoid confusion.Given the nature of buprenorphine as a partial agonist the dose given must reflect previous opioid history as well as general condition and medical status of the individual. Initiation at the lowest dose of 5 micrograms/hour is recommended. Fentanyl – transdermal (SPC) Fentanyl is restricted to patients with very stable persistent painSublingual tablets/lozenges are restricted to Palliative Care team initiation only. Transdermal patches are only to be used in patients who are intolerant of morphine or cannot swallow. Dose must be determined according to the severity of the pain and previous opioid analgesic dose. The dose given by the 25?g/hour patch is approximately equivalent to 90mg - 134mg of oral morphine per day. Great care must be taken in titration and use should be restricted to opioid tolerant individuals. It may take upwards of 24hours for initial peak serum levels following application, up to six days to achieve equilibrium following dose change and over 20hours for serum levels to drop by 50% following patch removal. Tapentadol – oral (SPC) Specialist use only and non-formularyThe Scottish Medicines Consortium has accepted modified release tapentadol for restricted use in the treatment of severe persistent pain which can be adequately managed only with opioid analgesics11. It is restricted to patients in whom morphine sulphate modified release has failed to provide adequate pain control or is not tolerated. Additional factors to consider when prescribing opioidsInitiation of opioids Opioid therapy should be added to other treatments for persistent pain only when the expected benefits for both pain and function are likely to outweigh the substantial risks inherent in their use. Initial prescribing of opioids should be for a trial period (with a review and reassessment within four weeks). The trial duration and outcomes of treatment such as reduction in pain score (30%), improvement in sleep pattern and improvement in functional ability should be agreed with the patient at the outset. It should be clearly explained that if improvement outcomes are not realised - ie. the pain is poorly opioid sensitive – that the medication will be stopped. Dose escalation is rarely helpful.It should also be explained that if the trial is successful the patient may be taking the drug for many years and patients should be given information about possible short and long-term side effects.Some individuals presenting to secondary care services with either acute exacerbations of persistent pain or those with persistent painful symptoms following surgery are started on opioids to facilitate their discharge from hospital. These individuals should have their pain assessed by an experienced professional. The decision to start long term opioid therapy should be considered carefully by the prescriber, the patient and his/her carers and other members of the healthcare team. It is helpful to supplement discussions regarding treatment with written information. Patients can be offered the Faculty of Pain Medicine patient information leaflet available at . Unfortunately this document understates the risks of dependence and addiction. The BNF states that the development of psychological and physical dependence is rarely a problem with therapeutic use. This advice could be considered outdated. A systematic review estimated problematic prescribed opioid misuse between 21% and 29%, with rates of addiction between 8% and 12%5. Opioids are not recommended for long term use in patients with:sleep apnoea; no improvement with previous use of opioids; headache;non-specific low back pain;fibromyalgia;unexplained pain. Opioid dose and adjustmentsPain treatment with opioids should start with a low dose and increase every 2 weeks until required pain relief has been achieved or side effects are intolerable, or until 60mg twice daily of morphine sulphate (modified release) - or equivalent - is reached. It may be useful to reassess the patient’s progress weekly during this titration period. The doses of opioid used for persistent non-cancer pain in published trials equate to less than 180mg morphine equivalent in 24 hours (Oxycodone 90mg or transdermal fentanyl 50micrograms/hour). The US Department of Health6 suggested a maximum of 90-120 morphine equivalents in 24 hours. Overdose risk increases in a dose–response manner, at least doubling at 50 to 99 morphine milligram equivalents (MME) per day and increasing by a factor of up to nine at 100 or more MME per day, as compared with doses of less than 20 MME per day. Overall, 1 in 550 patients started on opioid therapy died of opioid-related causes a median of 2.6 years after the first opioid prescription; the proportion was as high as 1 in 32 among patients receiving doses of 200 MME or higher.26 If patients do not achieve useful relief of pain symptoms at doses up to 120 morphine milligram equivalent in 24 hours the pain can be considered to be poorly opioid sensitive, the opioid trial can be deemed to have failed and the opioid withdrawn. There is little convincing evidence to support the effectiveness of alternative opioids where an appropriate dose of one has shown little improvement. Equivalent doses of opioid analgesics8The following tables give some guidance for approximately equianalgesic doses of various opioid agents.Variable guidance is given regarding dose equivalence of opioids so close monitoring of the patient is required following any titration or conversion so that dose adjustments can be made if necessaryDose conversions should typically be rounded down by 25%. There is an opioid dose conversion tool at . Conversion to methadone is not recommended for non-specialists. 72-hour Fentanyl patches are approximately equivalent to the following 24-hour doses of oral morphine8? morphine salt 45?mg daily≡fentanyl ‘12’ patchmorphine salt 90?mg daily ≡fentanyl ‘25’ patchmorphine salt 180?mg daily* ≡fentanyl ‘50’ patchmorphine salt 270?mg daily*≡fentanyl ‘75’ patchmorphine salt 360?mg daily*≡fentanyl ‘100’ patch?* Note – strengths marked in red exceed the recommended 120mg/day maximumAdverse effects Patients should be advised about adverse effects and the likelihood of their occurrence before starting treatment. 80% of patients taking opioids will experience at least one adverse effect and should be managed actively with antiemetics, laxatives and antihistamines as appropriate. The most common adverse effects are: constipation nausea somnolence itching dizziness vomiting Tolerance to some adverse effects develops within the first few days of initiating treatment; pruritis and constipation tend to persist. Patients using intermittent dosing schedules might not become tolerant to adverse effects. Patients are at risk of respiratory depression when there has been a major change in dose, formulation or route of administration. Accidental overdose is the commonest cause of respiratory depression. Particular caution is necessary for patients taking more than one class of sedative medication and in those with pre-existing disorders of respiratory control, such as obstructive sleep apnoea.Drug DrivingIn 2015 the UK government introduced legislation in England and Wales regarding driving while impaired by drugs. Eight medicines (6 benzodiazepines, morphine and methadone) and 8 ‘illegal’ drugs were included, specifying threshold limits for each. The Scottish Government plans to introduce similar legislation by 2019 although it is already illegal to drive in Scotland while impaired by drugsA professional guidance document on the legislation is available at: Individuals prescribed medications which may impair their capacity to drive should made be aware of the potential issue by drawing attention to the Patient Information Leaflet and, if appropriate, explaining the possibility. Patients should not drive if they feel drowsy, dizzy, unable to concentrate, unable to readily make decisions, or if they have blurred or double vision. If an individual drives whilst impaired in this manner, even if they are taking their medicine as prescribed, they are breaking the law. The Road Traffic Act requires licence holders or applicants to inform the DVLA of ‘any disability likely to affect safe driving.’ Persistent pain conditions or the use of sedating analgesics may affect capacity to drive safely. The DVLA website provides comprehensive information for professional on all situations which may affect a person’s ability to drive. ()Where there is a concern that an individual is driving unsafely prescribers should make patients aware that they may inform the DVLA of the situation if the patient fails to do so themselves. (The General Medical Council provides guidance on this issue: ) Long term effects of OpioidsLong term administration of opioids is associated with endocrine impairment in men and women resulting in hypogonadism and adrenal insufficiency. These can lead to amenorrhoea, reduced libido, infertility and depression in women and erectile dysfunction and diminished libido in men. Opioids have been shown to impair the immune system in animal and human studies but the clinical relevance of this is unknown. Prolonged use of opioids is recognised as causing opioid induced hyperalgesia, a state of abnormal pain sensitivity. The long term use of opioids is associated with an increased incidence of falls and fractures. duration of opioid treatment following surgery was the strongest predictor of opioid abuse among individuals with no history of misuse or ongoing opioid use25. Each additional week of opioid treatment increased the risk of dependence or overdose by nearly 20 percent.25De-escalation and Detoxification from OpioidsThere are circumstances where it may be desirable, appropriate or necessary to reduce a dose of prescribed opioid medication with a view to assessing the dose/benefit relationship at a lower dose or to achieve complete cessation of the opioid. The principles of tapering and detoxification are similar for most dependence-forming agents although the specific symptoms of withdrawal and timescales may vary. The circumstances where dose reduction (de-escalation) or drug cessation (detoxification) of opioid medications may be necessary are varied and will depend upon each unique set of circumstances, however, they may include:Lack of efficacy – the pain is not sensitive to opioids. Agreed treatment goals not achieved – where a minimum standard of improvement, either in pain or function, is not seen. Current dose is excessive – the pain may not be opioid-sensitive and resultant dose escalation may have led to doses significantly in excess of those considered appropriate with little increase of positive effect compared to potential negative impacts. Intolerable side-effects or risk of harmAdverse drug effects such as sedation, CNS depression or constipation may be causing suffering or impact which does not compare favourably with the positive effect of the drug. Use of concomitant CNS depressants such as benzodiazepines, gabapentinoids or alcohol may significantly increase risk of harm and alter the balance of risk factors. Certain medical conditions may increase risk such as the development of COPD increasing the risks of respiratory depression. Concerns over abuse or diversionProblematic opioid misuse and development of addiction may lead to escalating doses or use inconsistent with pain. This may manifest as deception and manipulation to increase or ensure supply. Diversion of prescribed medication to others, potentially for financial profit, is also a possible reason to consider cessation.Tapering SchedulesThe principle of tapering is to gradually remove a drug’s effect at a rate which can be managed without undue stress upon the impacted physiological systems. Withdrawal symptoms from CNS depressants are prompted by rebound over-excitation of the previously depressed physiology and range from unnoticeably mild to intolerably severe. The rate of reduction is a factor of both increments and timescale – ie. the size of each drop and how long between drops - and can be adjusted according to individual patient need. There is limited evidence regarding faster or slower rates of withdrawal, much depends upon the individual physiology of the patient, the original dose, the duration of action of the drug and the effects of other drugs present. This also does not consider psychological impacts of withdrawal, merely the physical elements. A commonly advised tapering schedule for opioids is a 10% dose reduction at weekly intervals. It is typical to recalculate the 10% reductions again at 50-60% of the original dose to reduce the increments of reduction in the later portion of the programme. If a patient is experiencing significant or severe intolerable withdrawal effects following a dose reduction an additional recalculation of the dose increment may be helpful. A more gradual tapering schedule of 5-10% reduction every two weeks has also been found to be useful in those struggling with withdrawal effects. An alternative approach is to recalculate the dose drop at each increment, thus reducing the dose by approximately 10% of the former dose each time. This is more complex at the outset; however it has the benefit of smoothing the reduction process, particularly at the lower doses, making significant withdrawal less likely. An example of the two 10% approaches - the sustained 10% reduction and a recalculated 10% tapering schedule - for a starting dose of 640mg a day is attached in Appendix 1. A useful option to consider may be to transfer the patient to an alternative opioid drug for the purpose of dose reduction and tapering. This may give an opportunity to reduce the daily dose by 25-30% due to incomplete cross-tolerance. Typically longer-acting agents also reduce the impact of between-dose withdrawal phenomena. A formulation with small dose increments further reduces the likelihood of patient suffering. An example of a useful titration agent might be the modified-release formulations of morphine.For patients experiencing significant difficulty during the dose reduction and tapering process it is useful to have the possibility of a ‘pause’ or temporary plateau included within the process. In this case a static dose would continue for an appropriate period, perhaps one or two reduction cycles in length, to allow the issue to pass. Whether it is withdrawal symptoms, anxiety or negative life circumstance; such a temporary slowing is supportive of individual patient circumstance without introducing the possibility of re-increasing the dose.The challenges associated with dose reduction and potentially cessation may be due to: patient resistance; patient addiction; patient dependence (and associated withdrawal syndrome); a lack of feasible alternative options and a lack of certainty around the process. It is important to take account of patient needs but it is also important to understand what is in the best interests of the patient medically and to pursue the most appropriate, effective and safe treatment possible. If reduction or cessation of opioid medication is warranted then it is appropriate to pursue this goal. NEUROPATHIC PAINNeuropathic pain arises as a direct consequence of a lesion or disease affecting the somatosensory system. It is diagnosed on clinical findings. Typical descriptive terms include shooting, stabbing, electric shock, burning, tingling, tight, numb, prickling, itching and pins and needles. There may also be hyperalgesia or allodynia. There are many causes including painful diabetic neuropathy, pain after surgery and postherpetic neuralgia.Pharmacotherapy (drug options)FIRST LINEAmitriptylineSECOND LINEGabapentinDuloxetine (only for Diabetic Peripheral Neuropathic Pain)THIRD LINEPregabalinCapsaicin Topical Patch (only for specialist hospital use)Lidocaine Topical Patch (only for Post-Herpetic Neuralgia)SIGN 136 recommends amitriptyline as a licensed first line medicine in neuropathic pain dependent on clinical preference and patient factors. Gabapentin may be considered If the initial treatment is not effective or not tolerated. Pregabalin is an alternative in patients who have found no benefit from, or not tolerated, amitriptyline or Gabapentin. Capsaicin cream may be considered for patients with localised neuropathic pain who cannot tolerate oral treatment.A combination of these therapies is often used in neuropathic pain. There is insufficient evidence to recommend which combinations should be offered to which patients.Tricyclic Anti-Depressants (TCADs) - oralAmitriptyline - Oral (SPC)Amitriptyline is the first line agent for use in neuropathic pain. Amitriptyline is licensed for this indication and should be considered for the treatment of patients with neuropathic pain (except HIV related pain)1 or fibromyalgia. SIGN 1361 recommends that TCADs should not be used in the treatment of persistent low back pain. A low starting dose of amitriptyline10mg daily should be considered for initiation with 10-25mg increases every 3-7 days as tolerated. Recommended doses are 25mg –75mg daily (higher doses could be considered in consultation with the specialist pain service). The analgesic effect is normally seen after 2 -4 weeks of appropriate dosing.Maximum peak effect is typically around 4 hours following oral dose however this may be longer in some cases (6-8hours) and so doses taken around 7pm may be appropriate to avoid morning sedation. Imipramine (SPC) or Nortriptyline (SPC) – OralImipramine or nortriptyline are sometimes considered as an alternative if satisfactory pain reduction is obtained but the patient is unable to tolerate amitriptyline. These drugs are unlicensed for this indication and are not included within the NHS Ayrshire and Arran formulary.The use of imipramine or nortriptyline TCADs in neuropathic pain is sometimes countenanced based upon historical use and clinical prerogative. This is an unlicensed indication which is termed “off label” and refers to licensed medicines used out with the terms of the specific Marketing Authorisation, including dose, indication and contra indication. “Off-label” use is an unlicensed use of a licensed medicine. Informed consent should be obtained and documented. Please refer to NHS Ayrshire & Arran Code Of Practice for Medicines Governance Section 9 (b) for further information on the off-label use of medicines at:(b).pdfOther Anti-Depressant Drugs - oralDuloxetine – Oral (SPC)Duloxetine is accepted for restricted use for the treatment of diabetic peripheral neuropathic pain in adults by the Scottish Medicines Consortium17. Duloxetine was shown to relieve peripheral neuropathic pain compared with placebo in patients with diabetes. SIGN recommends that duloxetine (60mg/day) should also be considered for the treatment of patients with fibromyalgia or osteoarthritis1. Duloxetine capsules at 60mg – 120mg daily are the duloxetine preparation that is the licensed for diabetic peripheral neuropathic pain. An alternative formulation of duloxetine is licensed for stress urinary incontinence with a different dosing schedule. It should be initiated by prescribers experienced in the management of diabetic peripheral neuropathic pain as 2nd or 3rd line therapy. If an adequate response is not seen 8 weeks after initiation – it should be discontinued. Anti-Epileptic Drugs (Gabapentinoids) - oralDrugs for the treatment of epilepsy have historically been used for the treatment of neuropathic pain and the gabapentinoid drugs, Gabapentin and Pregabalin, are the latest agents being engaged for this purpose. Gabapentinoids, when used appropriately, have been shown to be effective for some patients in the management of neuropathic pain. The table below provides the number needed to treat (NNT) and number needed to harm (NNH) for both drugs.DrugNNTNNHPregabalin7.7 (95% CI 6.5-9.4)13.9 (95% CI 11.6-17.4)Gabapentin6.3 (95% CI 5.0-8.3) and8.3 (95% CI 6.2-13) for ER preparations25.6 (95% CI 15.3-78.6) and 31.9 (95% CI 17-230) for ER preparationsClinical evidence of efficacy in patients with peripheral neuropathic pain who are refractory to other treatment was based on open-label, uncontrolled, non-randomised studies, with small patient numbers and different methodologies. The Cochrane Collaboration review of antiepileptic drugs for neuropathic pain and fibromyalgia concluded that:Gabapentin and pregabalin showed good evidence of efficacy in painful diabetic sensory neuropathy and post herpetic neuralgiaPregabalin showed good evidence of efficacy in central neuropathic pain and fibromyalgiaThey further concluded that the number-needed-to-treat to achieve a 50% reduction in pain was between four and ten, indicating that most patients derived no mon side effects of both drugs include dizziness, drowsiness and balance issues. Caution should be shown when initiating gabapentinoids in patients with compromised respiratory function or neurological disease, renal impairment or concomitant use of CNS depressants.It is important that practices monitor gabapentinoid prescriptions both in the individual patient and at practice level. More frequent reviews are recommended during initiation eg monthly. The medicine should be stopped if no improvement is seen. Subsequent review should take place at least annually, more frequently in high risk patients and those who are having their dose changed (increased or decreased). Many patients whose pain is well controlled manage to successfully reduce their dose of gabapentinoids, and they should be supported in trying to do this.Gabapentinoids are not licensed for non-neuropathic pain, nor is there any evidence to support their use. Warning of potential misuse and dependence The use of either gabapentin or pregabalin can lead to addiction and dependence and these medicines may be misused or diverted16. In light of these issues around misuse and addiction and involvement of these drugs in drug-related deaths the Advisory Council for the Misuse of Drugs (ACMD) and the British Medical Association (BMA) have recommended additional controls over Pregabalin and Gabapentin. The UK Government is expected to reclassify Pregabalin and Gabapentin as Controlled Drugs in the near future. Prescribers should be aware of the risk of dependence misuse and diversion as well as the potential benefits of these drugs.Practitioners should be able to identify and manage misuse if it arises as a result of prescribing.Prescribe with caution for patients with a known or suspected propensity to misuse, divert or become dependent on drugs.Less harmful alternatives may be preferred first-line eg. amitriptyline.Daily or weekly dispensing in patients considered to be at risk should be consideredGabapentin – Oral (SPC)Gabapentin is licensed for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post herpetic neuralgia, and is the gabapentinoid of choice in Ayrshire and Arran.Treatment should be initiated with a low dose and titrated gradually up according to patient response and tolerability. Typical titration involves increasing 300mg per day for the first three days and then by 300mg increments every 2-3 days.Typical therapeutic doses vary between 900mg and 3600mg per day split into three separate doses per day although twice daily dosing is often used in some settings for neuropathic pain without apparent issue.Treatment should be stopped if the patient has not shown sufficient benefit within 8 weeks of reaching the maximally tolerated therapeutic dose. Pregabalin – Oral (SPC)Pregabalin is accepted for restricted use within NHS Scotland for the treatment of peripheral neuropathic pain in adults by the Scottish Medicines Consortium14. Pregabalin may be considered in patients who have not achieved adequate pain relief from, or have not tolerated, first and second line treatments for peripheral neuropathic pain. Dosing is based on individual patient response and tolerability.The initial dose for most patients is 75mg twice daily. The dose may be increased to 300mg per day after 3-7 days and again to the maximum of 600mg per day after an additional 7 days. Most patients require a total daily dose of at least 300mg to obtain analgesia. Switching between gabapentin and pregabalinWhere it is considered necessary to do so there is guidance and information available at and Detoxification from GabapentinoidsThere are circumstances where it may be desirable, appropriate or necessary to reduce a dose of prescribed gabapentionoid medication with a view to assessing the dose/benefit relationship at a lower dose or to achieve complete cessation of the medication. The principles of tapering and detoxification are similar for most dependence-forming agents and so the information on page 24 ‘De-escalation and Detoxification from Opioids’ may be useful.Both gabapentin and pregabalin doses should normally be gradually reduced to minimise symptoms of withdrawal and allow assessment of response. The following principles may be useful:A trial of dose reduction cessation (or potentially cessation) should be undertaken, following a period of stabilityA suggested reduction regime for analgesic use would be: Gabapentin – reduce at maximum daily rate of 300mg every week Pregabalin - reduce at maximum daily rate of 50-100mg every week In high risk patients, or those who experience significant challenge during the reduction, it may be useful to temporarily halt reduction for a short period (one or two weeks), in preference to re-escalating the dose.Rapid reduction to stop is justified if there is clear evidence of attempts to divert or obtain illicit supplies of gabapentin or pregabalin In practice, reduction regimes may be adjusted depending on individual response and degree of associated risk. Capsaicin preparations – topical Capsaicin Topical Cream 0.075% (SPC)A capsaicin 0.075% cream is recommended for the relief of painful diabetic neuropathy.apply sparingly 3–4 times daily (not more often than every 4 hours) for 8 weeks then reviewCapsaicin Topical Patch 179mg (8%) (SPC)Licensed for the treatment of peripheral neuropathic pain in non-diabetic patients neuralgia in patients who have not achieved adequate pain relief from, or who have not tolerated conventional first and second-line treatments.Hospital Use OnlyContact Specialist Pain Team for advice as specific training is requiredAnaesthetic preparations - topicalLidocaine 5% medicated plaster This preparation is accepted for restricted use within NHS Scotland for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia) by the Scottish Medicines Consortium18. It is restricted to use in patients who are intolerant of first-line systemic therapies for post-herpetic neuralgia or where these therapies have been ineffective. SIGN 136 states Versatis is the treatment of choice for patients who prefer a topical treatment for postherpetic neuralgia A trial period of one month is appropriate. There are only limited comparative data available for lidocaine plasters. The comparative clinical effectiveness remains unclear. They are not recommended for low back pain or fibromyalgia. Prescribing of this agent should be reviewed at all opportunities in both Primary and Secondary care.Condition Specific CareLow Back Pain/SciaticaIn November 2016 NICE published a guideline on the management of low back pain and sciatica19.Summary:Exclude specific causesConsider using risk stratification eg STarT Back toolProvide information and continue normal activitiesConsider group exercise programmeDo not offer corsets, belts, orthotics, rocker sole shoes, traction, acupuncture, ultrasound, PENS, TENS or interferential therapyConsider psychological therapy using cognitive behavioural approach as part of treatment package with exercisePromote return to workDo not offer paracetamol alone Consider NSAIDs (combined with paracetamol), taking risk factors into accountConsider a weak opioid if an NSAID is not tolerated or is ineffectiveDo not offer opioids routinely for acute back painDo not offer opioids for persistent back painDo not offer selective serotonin reuptake inhibitors, serotonin–norepinephrine reuptake inhibitors, tricyclic antidepressants or anticonvulsants for low back painFibromyalgiaThe European League Against Rheumatic Disease (EULAR) produced a revision of their guideline providing recommendations for the management of Fibromyalgia in 2015 20Overarching principlesOptimal management requires prompt diagnosis. Full understanding of fibromyalgia requires comprehensive assessment of pain, function and psychosocial context. It should be recognised as a complex and heterogeneous condition where there is abnormal pain processing and other secondary features. In general, the management of Fibromyalgia should take the form of a graduated approach.Management of fibromyalgia should aim at improving health-related quality of life balancing benefit and risk of treatment that often requires a multidisciplinary approach with a combination of non-pharmacological and pharmacological treatment modalities tailored according to pain intensity, function, associated features (such as depression), fatigue, sleep disturbance and patient preferences and comorbidities; by shared decision-making with the patient. Initial management should focus on non-pharmacological therapies.Evidence base for Specific recommendationsNon-pharmacological management Strength of recommendation for this interventionAerobic and strengthening exercise StrongCognitive behavioural therapies WeakMulticomponent therapies WeakDefined physical therapies: acupuncture or hydrotherapy WeakMeditative movement therapies (qigong, yoga, tai chi) and mindfulness-based stress reduction WeakPharmacological management Strength of recommendation for this interventionAmitriptyline (at low dose) WeakDuloxetine or milnacipran WeakTramadol WeakPregabalinWeakSpecial Patient GroupsElderly patients Advice on the assessment of pain in elderly people is available21. Advice on prescribing in the elderly is available at . These highlight the challenges of prescribing for this group including a higher risk of adverse reactions and interactions, higher sensitivity to many drug groups including opioids and NSAIDs. Owing to the increased susceptibility of the elderly to the side effects of NSAIDs the following recommendations are made:for osteoarthritis, soft-tissue lesions, and back pain, first try measures such as weight reduction (if obese), warmth, exercise, and use of a walking stick;for osteoarthritis, soft-tissue lesions, back pain, and pain in rheumatoid arthritis, paracetamol should be used first and can often provide adequate pain relief;alternatively, a low-dose NSAID (e.g. ibuprofen up to 1.2?g daily) may be given;for pain relief when either drug is inadequate, paracetamol in a full dose plus a low-dose NSAID may be given;if necessary, the NSAID dose can be increased or an opioid analgesic given with paracetamol;Elderly patients often have an altered response to pain and analgesia drugsConcurrent medication increases the possibility of drug interactions. Most non-drug options remain suitable for older adults. Opioid dosing requirements are typically lower in elderly individualsElderly patients may be more at risk of opioid adverse effects such as confusion, falls and fracturesTricyclic antidepressants can be useful in the elderly but their use is limited by side effectsNon Steroidal Anti-Inflammatory Drugs (NSAIDs) should be used with caution as there is a higher risk of renal impairment, cardiac problems and gastric irritation. Do not give multiple NSAIDs at the same time.Prophylaxis of NSAID-induced peptic ulcers may be required if continued NSAID treatment is necessary see, NSAID-associated ulcers under Peptic ulceration. See also: (‘ADTC134: Use of Acid Inhibitors Policy In Adults aged 16-year s and over’ ( ).Female patients of reproductive age/pregnant/breastfeedingAdvice on prescribing in pregnancy is available at 23 During the first trimester drugs can produce congenital malformations (teratogenesis), and the period of greatest risk is from the third to the eleventh week of pregnancy.During the second and third trimesters drugs can affect the growth or functional development of the foetus, or they can have toxic effects on foetal tissues.For most prescribing the lowest possible dose should be used for the shortest possible time and only if the potential benefit outweighs the riskParacetamol is not known to be harmful. NSAIDs should be avoided in the third trimester. Acute withdrawal of opioids should be avoided because it can cause foetal death24. Secure Environment Patients / Prisoners The secure custodial environments, such as Prisons and Police Custody Suites, introduce additional challenges and restrictions around the provision of healthcare to patients in these settings. The majority of the population within the secure environment settings (though not all) are accustomed to using illicit and prescribed drugs to ameliorate or treat symptoms and perceived wants and needs. Time spent in custody may be used to encourage lifestyle and behaviour changes to improve prisoner health, however, the prevalence of drug-seeking and misuse within the prison and police custody environments necessitates many differences in the provision of healthcare and pharmacological treatment. Previous history of substance use, mental and physical health issues are common within the prison and reporting of pain or painful conditions is similarly prevalent. The majority of agents utilised for analgesia have additional value within custody for their psychotropic or sedating properties and are liable to drug-seeking activity and subsequent diversion and misuse. Security considerations and the safety and wellbeing of the incarcerated patients mean that prescribing for various conditions, particularly pain and mental health issues, must be considered through an additional filter of custodial setting specific requirements. In practice this may mean the selection of therapies and dose forms which may not be consistent with those used in community, for example modified release formulations to allow supervision. There is no expectation that these would be continued in community post-release and it is anticipated that the community practitioner would review and alter prescribed treatments to their community equivalents. The document ‘Safer Prescribing in Prisons’ provides a useful background to the subject:()As well as a review of all prescribing on entry to the prison, an additional facet of custodial care is the increased scrutiny and monitoring of medication use compared to that typically available within the community. As an outcome of these differences there are frequently occasions where a custodial prescriber reduces the dose or ceases prescribing of an existing medication either due to lack of efficacy, use outwith licensed indication or due to evidence of diversion or non-compliance. When patients are liberated into the care of community practitioners it is therefore essential to consider whether discontinued medication is essential and appropriate to resume. AbbreviationsADTC Ayrshire and Arran Drug and Therapeutics CommitteeEULAR European League against Rheumatic DiseaseFM FibromyalgiaNICE National Institute for Health and Care ExcellenceNSAID Non-steroidal Anti-inflammatory DrugsPENS Percutaneous Electrical Nerve StimulationSIGN Scottish Intercollegiate NetworkTCAD Tricyclic Antidepressant DrugTENS Transcutaneous Electrical Nerve StimulationAppendix 1 – 10% Taper Schedule – Comparing ApproachesReferences1. SIGN 136 Management of Chronic Pain December 2013 2. Guidance on the Management of Pain in Older People Journal of the British Geriatrics Society 2013 vol 42 suppl 1 . . . Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis Vowles KE et al Pain: April 2015 - Volume 156 - Issue 4 - p 569–5766. US Dept of Health – Centres for Disease Control and Prevention – March 2016 – Checklist for Prescribing Opioids for Chronic Pain7. Burden of disease is often aggravated by opioid treatment of chronicpain patients: Etiology and prevention Breivik H and Stubhaug Auden PAIN 155 (2014) 2441–24438. . Scottish Medicines Consortium. Oxycodone prolonged release tablets (Oxycontin?) for the treatment of severe non-malignant pain requiring a strong opioid. SMC no. 197/05. August 2005. Accessed May 2013 via 10.. . . NICE Clinical Guideline 173 Neuropathic Pain – pharmacological management November 2013 14. Scottish Medicines Consortium. Pregabalin for peripheral neuropathic pain in adults. SMC no 157/05. April 2009. Accessed May 2013 via . Gabapentin for Chronic Neuropathic Pain and Fibromyalgia in adults (review) Moore RA, Wiffen PJ, Derry S, Toelle T, Rice ASC The Cochrane Collaboration 2014 issue 4 . Medicines optimisation in long-term pain Key therapeutic topic Published: 16 January .uk/guidance/ktt2117. Scottish Medicines Consortium. Duloxetine for diabetic peripheral neuropathic pain in adults. SMC no. 285/06. August 2006. Accessed May 2013 via 18. Scottish Medicines Consortium. Lidocaine 5% medicated plaster (Versatis?) for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia). SMC no. 334/06. July 2008. Accessed May 2013 via 19. NICE Guideline 59: Low Back pain and sciatica in over 16s: assessment and management .uk/guidance/ng5920. Macfarlane GJ , Kronisch C , Dean LE et al EULAR revised recommendations for the management of Fibromyalgia. Ann Rheum Dis 2017;76:318–28.21. The assessment of pain in older people: UK National Guidelines Age and aging 2018;47:i1-i2222. . . . Brat et al 2018. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study BMJ 2018; 360 (accessed 16/8/18)26 Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: . ................
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