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PAT/T 21 Drug Misuse Management in the Acute Hospital Setting Guidelines This procedural document supersedes: PAT/T 21 v.1 – Guidelines for the Management of Patients with Drug Misuse in the Acute Hospital Setting. Did you print this document yourself? The Trust discourages the retention of hard copies of policies and can only guarantee that the policy on the Trust website is the most up-to-date version. If, for exceptional reasons, you need to print a policy off, it is only valid for 24 hours. Author/reviewer: (this version) Shane Peagram – Drug and Alcohol Liaison Nurse Specialist DRI Date written/revised: July 2013 Approved by: Policy Approval and Compliance Group on behalf of the Patient Safety Review Group Date of approval: 9 October 2013 Date issued: 17 October 2013 Next review date: October 2016 Target audience: Trust wide Page 1 of 63 v.2 PAT/T 21 v.2 Amendment Form Please record brief details of the changes made alongside the next version number. If the procedural document has been reviewed without change, this information will still need to be recorded although the version number will remain the same. Version 2 Date Issued 17 October 2013 Summary of changes General restructuring of contents to improve access and flow of subject material. Contents presented to reflect National Drug Policy focus on Recovery. (DOH 2010) Clinical governance framework incorporating NICE QS23 (2012) New content - General guidance on prescribing by substance of misuse. New content – Equity and diversity issues for Assessment. New content – inclusion of contact details for Trust child Protection Nurses and Doncaster and Bassetlaw social services departments. New content – Methadone Pharmacology. New content – Buprenorphine Pharmacology New content – Patients own supplies, linked to PAT/MM1B v.4 New content – Pain management. Major revision – Discharge planning, to reflect need for TTA doses of OST at weekends and holidays. New content – APPENDIX 3 ICD 10 Dependency diagnosis. (WHO 1992) Revised content – Summary card – amended to reflect updated discharge planning arrangements. Page 2 of 63 Author S. Peagram PAT/T 21 v.2 Contents Section 1 Page No 6 INTRODUCTION 2 PURPOSE 6 3 DUTIES AND RESPONSIBILITIES 6 GENERAL GUIDANCE Overview Rationale for prescribing Prescribing considerations Exceptional circumstances PRESCRIBING BY SUBSTANCE - OVERVIEW Opiates Benzodiazepines Alcohol Stimulants Cannabis New psychoactive substances ASSESSMENT Overview Equity and diversity Aims of a full assessment Urine screening Opiate withdrawal syndrome Opiate intoxication Drug using parents Cardiac assessment EXISTING COMMUNITY METHADONE / BUPRENORHINE PATIENTS Pre prescribing checks Out of hours Missed doses Administration ILLICIT OPIATE (HEROIN) USING PATIENTS Overview Precautions Choosing and appropriate opioid substitute Risk factors METHADONE PHARMACOLOGY Peak plasma concentration Peak clinical effects Duration of action (half life) Metabolism Excretion Dosing 8 8 8 9 9 9 9 10 10 10 11 11 11 11 11 12 12 13 14 15 16 16 4 4.1 4.2 4.3 4.4 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 7 7.1 7.2 7.3 7.4 8 8.1 8.2 8.3 8.4 9 9.1 9.2 9.3 9.4 9.5 9.6 Page 3 of 63 16 17 17 18 18 18 18 19 20 21 21 21 21 21 22 22 PAT/T 21 9.7 9.8 10 10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.9 11 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 12 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 12.9 13 13.1 13.2 13.3 13.4 13.5 13.6 13.7 13.8 13.9 13.10 13.11 13.12 14 14.1 14.2 14.3 14.4 Equivalence Tolerance METHADONE INDUCTION PROCESS – NEW STARTER Indication Precautions Contraindications Investigations Principles of safe induction Dosing Administration Risk factors Other points to consider BUPRENORPHINE PHARMACOLOGY Peak plasma concentration Peak clinical effects Duration of action (Half life) Metabolism Excretion Dosing Equivalence Tolerance BUPRENORPHINE INDUCTION PROCESS – NEW STARTER Indication Precautions Contraindications Investigations Principles of safe induction Dosing Dosing Administration Risk factors for overdose Buprenorphine + Naloxone (Suboxone) Precipitated withdrawal OPIOD DETOXIFICATION Overview Consent Unsuitable populations Opiods and alcohol Opioids and benzodiazepines Methadone or Buprenorphine Lofexidine Clonidine Dihydrocodeine Other symptomatic medications Lofexidine dosing Lofexidine regime RELAPSE PREVENTION PRESCRIBING (NALTREXONE) Benefits Risks Investigations Dosing Page 4 of 63 v.2 22 22 23 23 23 23 23 24 24 25 25 25 26 26 26 26 26 26 26 26 27 27 27 27 27 28 28 28 28 29 29 29 30 30 30 30 31 31 31 31 32 32 32 32 33 34 34 34 34 34 PAT/T 21 v.2 14.5 15 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9 15.10 16 16.1 16.2 16.3 16.4 16.5 17 17.1 17.2 17.3 17.4 18 Loss of tolerance GENERAL MANAGEMENT Ward management Drug related deaths Reducing drug related deaths Dealing with emergency overdose Sleeplessness Patients own supplies Pregnancy Mental capacity Illicit opiate use on top of prescribed medication Drug misusers not admitted to hospital and not in treatment PAIN MANAGEMENT Overview Methadone and pain Buprenorphine (subutex / Suboxone) and pain Naltrexone and pain Peri operative pain DISCHARGE PLANNING TTO - Existing community patient Caution TTO - New starter Caution TRAINING / SUPPORT 35 35 35 35 36 37 37 37 38 38 38 39 39 39 41 42 42 43 43 43 44 44 44 45 19 45 20 MONITORING COMPLIANCE WITH THE PROCEDURAL DOCUMENT DEFINITIONS 21 EQUALITY IMPACT ASSESSMENT 46 22 ASSOCIATED TRUST PROCEDUAL DOCUMENTS 46 23 REFERENES 46 APPENDICIES: Appendix 1 Clinical Governance Framework – Clinical Guidelines 2007 Appendix 2 NICE quality standard 23 Appendix 3 Cardiac assessment and monitoring for methadone prescribing Appendix 4 ICD-10 Diagnostic Guidelines “Dependency” Appendix 5 Methadone assessment prior to administration of methadone Appendix 6 Methadone Safety Care Plan Appendix 7 Safer Injecting Care Plan Appendix 8 Methadone summary card Page 5 of 63 45 49 50 51 53 54 56 58 60 PAT/T 21 1. v.2 INTRODUCTION These guidelines are intended for both medical and nursing staff to act as a resource in the management of patients with drug misuse issues when prescribing for maintenance or detoxification. The main source of evidence used within these guidelines is taken form the ‘Drug Misuse and dependence – UK Guidelines on Clinical Management, (2007) and should be read in conjunction with, Guidance on methadone and buprenorphine for the management of opioid dependence (NICE) ; Drug misuse: opioid detoxification (NICE) ; Naltrexone for the management of opioid dependence (NICE); Guidance for the use of substitute prescribing in the treatment of opioid dependence in primary care (RCGP 2011): “Medications in Recovery – Re-orientating Drug Dependence Treatment” (NTA 2012). 2. PURPOSE The purpose of these guidelines is to offer a comprehensive structure that will provide treatments within the context of the National Drug Strategy 2010’s overarching aims to: Reduce illicit and other harmful drug use: and Increase the numbers recovering from their dependence “Our ultimate goal is to enable individuals to become free from their dependence” [DOH 2010] 3. DUTIES AND RESPONSIBILITIES 3.1 DOCTORS’ RESPONSIBILITIES It is acknowledged that drug misusers have the same entitlement as other patients to the services provided by the National Health Service and it is the responsibility of all Doctors to provide care for both general health needs and drug-related problems, whether or not the patient is ready to withdraw from drugs. [DOH, 1999] All doctors must provide medical care to a standard, which could be reasonably, expected of a clinician in their position. The focus for the clinician treating a drug misuser is on the patients themselves. However, the impact of their drug misuse on other individuals – especially dependant children – and on communities should be taken into consideration. [DOH, 2007] 3.2 PRESCRIBERS’ RESPONSIBILITIES It is the responsibility of the prescriber (Doctor, NMP) to identify the purpose of prescribing e.g. maintain the continuity of existing community prescribing [sec 7] or to initiate new prescribing [sec 8]. Page 6 of 63 PAT/T 21 v.2 In either case the prescriber must ensure that an adequate assessment has been carried out prior to prescribing. [sec 6] Where continuity of community prescribing is the goal; Confirmation of Drug, dose and time last taken should be established and documented. [sec 7.1] Missed doses and appropriate actions should be documented. [sec7.3] Discharge arrangements including Drug , dosage , take home quantities and date of next community prescribing agreed with the responsible community prescriber and documented. [sec17] Where initiation of treatment is the goal; Attention must be paid to the aim of treatment – stabilisation – abstinence – detoxification [sec 8] The choice of treatment [sec 8.3] Discharge arrangements [sec 17] NOTE: While it is important to liaise with the relevant community Drug Team regarding ongoing treatments it is worth noting that their operational policies may be different from our own. In the event that a scenario should arise which is not covered within these guidelines the first point of contact should be the Drug and Alcohol Clinical Nurse Specialist – Shane Peagram (DRI Blp 1491) Valerie Wood (BDGH Blp 2417) Methadone and buprenorphine should only be prescribed following liaison with the community drug team and there is a documented plan for continuation of treatment upon discharge. 3.3 NURSES’ RESPONSIBILITES It is the responsibility of nursing staff to ensure the safe administration of medicines as per PAT/MM 1. For existing community methadone / buprenorphine patients; Confirmation of Drug, dose and time last taken should be established and documented. [sec 7.1] Missed doses and appropriate actions should be documented. [sec7.3] Page 7 of 63 PAT/T 21 v.2 Discharge arrangements including Drug, dosage, take home quantities and date of next community prescribing agreed with the responsible community prescriber and documented. [sec 17] For new treatments; The presence of an opiate withdrawal syndrome should be assessed [sec 6.5] and documented. [Appendix 5] Where Methadone is prescribed, the Methadone Assessment Prior to Administration checks are completed [sec 6.6] and documented. [Appendix 5] Methadone and buprenorphine should only be prescribed following liaison with the community drug team and there is a documented plan for continuation of treatment upon discharge. 3.3 PATIENT RESPONSIBILITIES It is the patients responsibility to provide details of current treatment, prescriber and dispensing arrangements including any missed doses. Patients in possession of community dispensed medication must inform nursing staff. 4. GENERAL GUIDANCE 4.1 OVERVIEW Problematic drug users experience increased rates of morbidity and mortality due to their substance misuse, and although drug misuse exists in every sector of society, it is most prevalent in areas of social deprivation where individuals are more likely to experience poorer health outcomes, independent of substance misuse. (RCGP 2011) Generally, there is a greater prevalence of certain illnesses amongst the drug-misusing population, including viral hepatitis, bacterial endocarditis, HIV, tuberculosis, septicaemia, pneumonia, deep vein thrombosis, pulmonary emboli, abscesses and dental disease. (DOH 1999) 4.2 RATIONALE FOR PRESCRIBING For many people, prescribed treatment is an important part of their recovery journey. It is a component of a broader recovery-orientated system of health and social care and support that harnesses the full range of individual, social and community assets. Before deciding to prescribe, the clinician should be clear as to what the functions of prescribing are. A prescription can: Page 8 of 63 PAT/T 21 v.2 Maintain current community prescribing. or Reduce or prevent withdrawal symptoms from illicit drugs Offer an opportunity to stabilise drug intake and lifestyle whilst breaking with previous illicit drug use and associated unhealthy behaviours Promote a process of change in drug taking and high risk behaviour Help maintain contact and offer opportunity to work with the patient Achieve abstinence 4.3 PRESCRIBING CONSIDERATIONS Current community treatment plan The overall treatment plan for the individual client National and Locally agreed protocols The clinicians experience and competencies Discussion with member of a multi-agency team Advice, where necessary from a specialist in drug misuse Methadone and buprenorphine should only be prescribed following liaison with the community drug team and there is a documented plan for continuation of treatment upon discharge. 4.4 EXCEPTIONAL CIRCUMSTANCES Only in exceptional circumstances should the decision be made to offer substitute medication without specialist advice being sought i.e. a drug misuser presenting with opioid withdrawal in late pregnancy a patient with serious concomitant physical or psychiatric illness where withdrawal is complicating the clinical problems someone who is opioid-dependent and demonstrating withdrawal. Indeed, in such circumstances it is vital that the doctor fulfils their responsibilities by ensuring adequate assessment and appropriate management that facilitates the retention of the patient in treatment. (DOH, 1999). 5 PRESCRIBING BY SUBSTANCE - OVERVIEW 5.1 OPIATES Heroin users are the largest single group in treatment and use an especially tenacious, habit forming drug in the most dangerous ways. (NTA 2012) Page 9 of 63 PAT/T 21 v.2 There is robust evidence showing that Opiate Substitution Therapy can significantly improve outcomes for most opioid dependent people. Treatment can reduce symptoms of dependence, and being in treatment can help to reduce associated difficulties. OST allows people the time, space and platform to make meaningful choices. OST: Prevents people dropping out of treatment. Suppresses illicit use of heroin. Reduces crime. Reduces the risk of BBV transmission Reduces risk of death. Exiting treatment prematurely can harm individuals, especially if it leads to relapse, which is also harmful to society. Coming off OST can lead to greater risk of relapse, BBVs and overdose; and that treatment orientated to rapid abstinence produces worse outcomes than treatment initially orientated to maintenance. (National Drug Strategy 2010) Prescribing options – Methadone [sec 9] Buprenorphine [sec 11] Detoxification [sec 13] 5.2 BENZODIAZEPINES Benzodiazepines prescribed for benzodiazepine dependence should be at the lowest possible dose to control dependence and doses should be reduced as soon as possible. It is common to consolidate Benzodiazepine use to a single preparation i.e. Diazepam and divide doses evenly. Prescribing options – Diazepam [BNF] Benzodiazepines should only be prescribed following liaison with the community drug team and there is a documented plan for continuation of treatment upon discharge. 5.3 ALCOHOL Acute alcohol withdrawal syndrome is a medical emergency and requires timely and appropriate intervention to prevent potentially life threatening complex symptoms. Prescribing options – Chlordiazepoxide, Lorazepam, Diazepam, Midazolam For guidance on alcohol withdrawal management refer to PAT/T 25 5.4 STIMULANTS There are no licenced pharmacological treatments to eliminate the symptoms of withdrawal from stimulants (including cocaine). Page 10 of 63 PAT/T 21 v.2 Prescribing options – There is limited evidence supporting the use of Dexamphetamine in the treatment of habitual amphetamine use. Treatment should only be considered by experienced practitioners within specialist drug treatment settings. Short term symptomatic relief of agitation with Anxiolytics may be considered i.e. Diazepam. [BNF] For psychosis short term management with Antipsychotics i.e. Haloperidol. 5.5 CANNABIS There are no licenced pharmacological treatments to eliminate the symptoms of withdrawal from cannabis. Short term symptomatic relief of agitation or insomnia with Anxiolytics may be considered i.e. Diazepam. [BNF] 5.6 NEW PSYCHOACTIVE SUBSTANCES New psychoactive substances (NPS) so called “designer drugs” or “legal highs” such as Mephadrone present a unique challenge as users might not know exactly which compound has been taken as many are sold under a variety of brand names. Prescribing options – no substitute medications, consider symptomatic relief. In all cases of acute intoxication or poisoning TOXBASE should be consulted 6 ASSESSMENT 6.1 OVERVIEW Good assessment is essential to the continuing care of the patient. (DOH 2007), Furthermore, “Assessment for recovery aims to deliver an informed understanding of the person’s wishes, substance use, and the severity and complexity of clinical and other problems: and it needs to identify their strengths and key obstacles to their recovery.” (NTA 2012) 6.2 EQUITY AND DIVERSITY All assessments should be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English. People who need a comprehensive assessment should have access to an interpreter or advocate if needed. Page 11 of 63 PAT/T 21 v.2 6.3 AIMS OF A FULL ASSESSMENT A comprehensive assessment should consider both drug use and resources for recovery and include: treating the emergency or acute problem confirming the person is taking drugs (history, examination and drug testing) (Table 1) assessing the degree of dependence (Table 2, 3 and 4 ) assessing physical and mental health identifying social assets, including housing, employment, education and support networks assessing risk behaviour including domestic violence and offending determining the person's expectations of treatment and desire to change determining the need for substitute medication obtaining information on any dependent children of parents who misuse drugs, and any drug-related risks to which they may be exposed. (Table 5 ) The clinician must ensure that an adequate assessment has been made before prescribing substitute opioids or controlled drugs. 6.4 URINE SCREENING Urine analysis should be regarded as an adjunct to the history and examination in confirming drug use, and should be obtained at the outset of prescribing and randomly throughout treatment (request Full Drug Screen). Results should always be interpreted in the light of clinical findings, as false negatives and positives can occur. If results do not correspond to the patient’s history, repeat the urine toxicology test before taking any action, as laboratory errors can occur. If the urine test is negative for opioids, and there is no evidence of opioid withdrawal symptoms; the drug misuser is very unlikely to be physically dependent on opioids and needs to be reassessed in the light of this. Table 1 – Drug detection times Drug Or Its Metabolite(s) Amphetamine/amfetamines, including methylamphetamine and MDMA Benzodiazepines Ultra-short-acting[half-life 2h] [e.g. midazolam] Short-acting [half-life 2-6h] [e.g. triazolam] Intermediate-acting [half-life 6-24h] [e.g. temazepam, Page 12 of 63 Duration of Delectability 2 days 12 hours 24 hours 2-5 days PAT/T 21 chlordiazepoxide] Long-acting [half-life 24h] [e.g. diazepam, nitrazepam] Buprenorphine and metabolites Cocaine metabolite Methadone [maintenance dosing] Codeine, dihydrocodeine, morphine, propoxyphene [heroin is detected in urine as the metabolite morphine] Cannabinoids Single use Moderate use [three times a week] Heavy use [daily] Chronic heavy use [more than three times a day] v.2 7 or more 8 days 2 – 3 days 7 – 9 days 48 hours 3 – 4 days 5 – 6 days 20 days up to 45 days Detection times are only approximate and highly dependant upon dose, frequency, route of administration and urine excretion and concentration. 6.5 OPIATE WITHDRAWAL SYNDROME The onset of physical withdrawal symptoms is a key characteristic of opiate dependency and there presence is required to establish a diagnosis. Table 2 – Opiate Withdrawal Syndrome Signs and Symptoms Drug craving, anxiety, drug – seeking Yawning, sweating, running nose, lacrimation Increase in above signs and: Dilated pupils, goose-flesh, tremors, hot/cold flushes, aching bones/muscles, loss of appetite, abdominal cramps and irritability Increase in intensity of above and: Insomnia, increased blood pressure, low grade fever, increased respiration, increased pulse rate, restlessness, nausea and vomiting Increase in intensity of above and Weight loss, diarrhoea, weakness, febrile, foetal position (curled up on a surface), increased blood sugar Page 13 of 63 Heroin 6 hours 8 hours 12 hours Methadone 34-48 hours 48-72 hours 18-24 hours 24-36 hours 364days 36-4days PAT/T 21 Table 3 – Opiate Withdrawal Syndrome Objective signs of opiate withdrawal Yawning Coughing Sneezing Runny nose Lacrimation Raised blood pressure Increased pulse Dilated pupils Cool, clammy skin Diarrhoea Nausea Fine muscle tremor v.2 Subjective signs of withdrawal Restlessness Irritability Anxiety [The signs above may also be useful objective signs] Sleep disorders]depression Drug craving Abdominal; cramps Source: Ghodse (1998) The use of a clinical tool such as the Short opiate Withdrawal Scale is recommended to establish the presence of a physical withdrawal syndrome. The Short Opiate Withdrawal Scale is include as part of the Methadone Assessment Prior to Administration Tool [ Appendix 5 ]. 6.6 OPIATE INTOXICATION Mortality rates amongst Opiate users are 12 x higher than their none opiate using peers, and rise to 22 x higher for Intravenous drug users. The ability to identify and respond to acute opiate intoxication is key to maintaining patient safety. (DOH 2007) Table 4 - Opioid Intoxication SIGNS Euphoria/Relaxation Constricted pupils (pinned) Drowsiness Slurred speech Unsteady gait Smell (alcohol) SYMPTOMS Feelings of well-being Poor attention/concentration Slurred speech Methadone Pre Administration checklist and assessment The Methadone Pre Administration checklist needs completing by the person dispensing the initial dose (nurse, doctor or pharmacist) the same person should also assess patient, [sec 3.2,3.3] completing the pre administration checklist. [Appendix 5] The assessment should ensure that the patient is not showing evidence of intoxication due to opioids, alcohol or other drugs. (Table 4) Page 14 of 63 PAT/T 21 v.2 Patients who appear intoxicated with CNS depressant drugs should not be given their usual dose of methadone but be reassessed at a later time when they are no longer intoxicated. If intoxication mild the patient may be given a delayed or reduced dose but only after being reviewed by the prescriber. The Pre Administration Methadone Assessment Checklist needs completing prior to every dose [Appendix 5] 6.7 DRUG USING PARENTS A third of drug misusers in treatment have child care responsibilities. NTA (2009) Table 5 – Child Protection Considerations The following should be taken into consideration: Effect of drug misuse on functioning, for example, intoxication, agitation Effect of drug seeking behaviour, for example, leaving children unsupervised, contact with unsuitable characters. Impact of parent’s physical and mental health on parenting How drug use is funded, for example, sex working, diversion of family income. Emotional availability to children Effects on family routines, for example, getting children to school on time Other support networks, for example, family support. Ability to access professional support Storage of illicit drugs, prescribed medication and drug-using paraphernalia With consent, information should be gathered from other professionals If risk of significant harm to a young person is found, involve other professionals according to local child protection requirements. Referral to Social Services in Doncaster – 01320 736636 Referral to Social Services in Bassetlaw – 01777 716161 For more information or advice about Child Protection Policies and Procedures within BDGH contact Safeguarding Team, Named Nurse for Children on ext 4090. PAT/PS 10 - Safeguarding and Promoting the Welfare of Children. Page 15 of 63 PAT/T 21 v.2 6.8 CARDIAC ASSESSMENT Methadone and QT prolongation The Medicines and Health Care Product Regulatory Agency [MHRA] recommended in 2006 ‘’that patients with the following risk factors to QT interval prolongation are carefully monitored whilst taking Methadone: heart or liver disease, electrolyte abnormalities, concomitant treatment with CVP 3A4 inhibitors, or medicines to cause QT interval prolongation. In addition any patient requiring anymore than 100mg of methadone per day should be closely monitored. Further information is included in the product information.’’ Clinicians must make a balanced judgement for each patient according to the MHRA guidance [and any later expansion or revision] Monitoring, will usually include checking other medications, general monitoring of cardiovascular disease, liver function tests and urea and electrolytes. As the risk factors for the QT interval prolongation increase, e.g. high methadone dose or multiple risk; clinicians will need to consider ECGs. The MHRA recommendation, suggests that an ECG might be considered before induction onto methadone, or before increases in methadone dose and subsequently after stabilisation – at least with doses over 100 mg per day and in those with substantial risk. [APPENDIX 3] 7 EXISTING COMMUNITY METHADONE / BUPRENOPHINE PATIENTS Good communication between hospital and community team is essential to ensure safe management of the admission and discharge of existing community treatment. 7.1 PRE PRESCRIBING CHECKS Prior to prescribing Methadone or Buprenorphine the following safety checks need confirming and documenting. Drug type and strength (i.e. Methadone 1mg/1ml) Daily dose Pick up frequency (daily , 3 x weekly, 2 x weekly, weekly) Community Pharmacy Date last collected Missed doses [sec7.3] Prescribing agency / keyworker Amount and whereabouts of any community supplies brought to hospital by the patient. [sec15.6] Page 16 of 63 PAT/T 21 v.2 Information provided by the patient may not be reliable and needs corroborating with the community pharmacy and community drug team and documenting. Liaise with the community prescriber as early as possible so that the community prescriber can cancel the existing community prescription and be prepared to recommence the prescription on discharge of the patient. 7.2 OUT OF HOURS Where there is evidence of acute opioid withdrawal and it is not possible to corroborate the patients information i.e. outside of pharmacy hours, Bank holidays etc., Opioid Substitution Therapy medications can be prescribed with the following precautions. Assess the patient [Section 6] Evidence onset of withdrawal syndrome using Short Opiate Withdrawal Scale. [Appendix 5] Methadone 1mg/1ml (PRN) 5 – 10mg 4hrly Max 40mg in 24 hrs Methadone Assessment Prior to Administration checklist to be completed prior to every dose. [Appendix 5] TO BE INCLUDED ON RE PRINT AMMEDMENT Confirm community dose at earliest possible opportunity and review patient in light of findings. CAUTION Patients presenting out of hours in receipt of existing community opiate substitution therapy may have been dispensed advanced supplies for Weekends and Bank Holidays. This may be in their possession. Patients do not always disclose this information on admission. Every effort should be made to establish the whereabouts of patients own supplies and reassure the patient that continuity of treatment will be maintained throughout admission and upon discharge. [sec3.2 sec 3.3 sec15.6] 7.3 MISSED DOSES OST is reIf patient has missed OST doses, for whatever reason, they will need to be reassessed for intoxication and withdrawal before OST administration is recommenced. [sec 6.5] [sec 6.6] Where patients miss OST doses they may use illicit opiates or other drugs including central nervous system depressants such as alcohol and benzodiazepines. When OST doses are missed for 3 days or more days, tolerance to opioids may be reduced placing patients at increased risk of overdose when introduced. Page 17 of 63 PAT/T 21 v.2 Table 6 – Action to be taken in the event of Missed doses Number of days missed Action to be taken One day No change in dose Two days If no evidence of intoxication administer normal dose. Three days Administer half dose in discussion with prescriber. Four days Patient must see prescriber. Recommencement at 40mg half dose which ever is the lower. Five days or more Regard as a new medication. (Australian Gov, 2000) 7.4 ADMINISTRATION In order to maintain patient safety and reduce drug related deaths [sec 15.3] an assessment of intoxication [sec 6.6] is required prior to administration. The Drug and Alcohol Service Methadone Assessment Prior to Administration Checklist [Appendix 5] needs completing immediately before each administration. 8 ILLICIT OPIATE (HEROIN) USING PATIENTS 8.1 OVERVIEW Patients who are physically dependent on opioids may need OST to relieve the distressing symptoms of opiate withdrawal whilst in hospital. Failure to address the patients dependency may result in continued used of illicit opioids i.e. heroin within the ward environment or premature discharge from hospital. 8.2 PRECAUTIONS Do not give in to undue pressure to prescribe immediately. Take time to assess the patient. Remember a patient who is experiencing withdrawal symptoms may not be able to co-operate fully with medical or surgical treatment. A patient suffering from abstinence withdrawal will present with objective and subjective withdrawal. [See tables 2 and 3] For safety’s sake rely more on objective signs of opioid withdrawal.[see tables 2 and 3] Page 18 of 63 PAT/T 21 v.2 Poly-drug and alcohol misusers may develop multiple withdrawal syndromes and hospital doctors will need to differentiate these to prioritise treatment. Methadone may initially mask alcohol and benzodiazepine withdrawal symptoms. Exercise particular care in cases of respiratory disease, head injury and liver diseases. It is important to be extremely careful when prescribing additional drugs such as sedatives. It may be necessary, in some cases, to contact the relevant pain control team for further advice on improving pain control. If a urine test is negative for opioids and there is no evidence of opiate withdrawal symptoms, the drug misuser is very unlikely to be physically dependent on opiates and should be reassessed in the light of this. It is not appropriate to offer OST to patients who do not meet the diagnostic criteria for opioid dependency. [Appendix 4] If there is doubt about the degree of dependence it is advisable and safer to withhold prescribing of substitute medication initially and observe the patient until the physical manifestations of opioid withdrawal are evident.[Armstrong, 2003] 8.3 CHOOSING THE APPROPRIATE OPIOID SUBSTITUTE Opioid substitution Therapy should only be considered following liaison with the community drug services. Appropriate arrangements for exit prescribing will need to be in place to ensure a seamless transfer of care back into to community The clinical need for prescribing should always be paramount [sec 4.2] [sec 5.1] [Appendix 4] Methadone and buprenorphine are both approved for the treatment and prevention of withdrawals from opioids. Both are approved for maintenance and detoxification programmes (NICE 2007a) NICE recommends the ‘if both drugs are equally suitable, methadone should be prescribed as the first choice.” because: Its clinical effectiveness is supported by extensive research. It alleviates opioid withdrawal symptoms. It is taken orally, thus reducing the risk of injection. The dose can be carefully titrated to the optimal level. Blood levels can be kept stable, thus eliminating post dose euphoria and pre dose withdrawal. Page 19 of 63 PAT/T 21 v.2 However a patient may express a preference, in which case the following needs to be considered; Level of opioid use Safety, for example likelihood of diversion and overdose risk Patient experience with both illicit and prescribed medications, treatment history and response Patient preference Retention and treatment compliance The prescriber’s experience with different medications Need to take opiate analgesia in the case of Buprenorphine Opioid substitution Therapy should be commenced in accordance with the principles of safe induction [sec 10.5] 8.4 RISK FACTORS Extra caution should be exercised and benefits and risks assessed when prescribing methadone or buprenorphine in the following situations. Concurrent use of other sedating drugs or medications: full agonists and especially methadone have been associated with sedation, respiratory depression and coma when used in conjunction with central nervous system depressants such as alcohol, benzodiazepines, barbiturates, neuroleptics and tricyclic antidepressants. Monamine oxidase inhibitors (MAOI’s) need to be avoided with methadone because of potential risk of central nervous system hyperexcitation (hyperthermia, deliriumk etc) which has been noted with pethidine but never, so far, with methadone. This occurs with buprenorphine, but with much less effect. However both alcohol and benzodiazepine use is common in those requesting opioid treatment and should not be regarded as an absolute contraindication. Medical conditions complicating opioid use: as with other opioids, they should be used cautiously in individuals with recent head injury, acute abdominal conditions, severe respiratory, hepatic or renal disease. Patients suffering with chronic pain: where opioid analgesia is indicate, patients should normally be given appropriate doses of additional opioid analgesia on top of that required for the management of dependence. [sec 16] People with severe mental illness: this group may have limited capacity to provide informed consent. Medications that effect methadone levels: some medications have a significant effect on methadone levels; for example, rifampicin may require a doubling or trebling of methadone dose and can precipitate severe withdrawal. Methadone is excreted more rapidly by urine acidifiers, e.g. ascorbic acid, so can significantly reduce methadone levels. Urine alkalinisers such as sodium bicarbonate, reduce excretion and so may increase methadone levels. For further details, see appendix 1 in the British National Formulary (BNF) Page 20 of 63 PAT/T 21 v.2 Transfer of patients on more than 30mg of methadone to buprenorphine: this is more likely to be associated with precipitated withdrawal and should only be attempted after consultation with a specialist or experienced prescriber. History of cardiac arrhythmias or abnormal ECG: Caution is required when using methadone, [Appendix 3] 9 METHADONE PHARMACOLOGY 9.1 PEAK PLASMA CONCENTRATION Four hours after regular oral administration (Range two to six hours) 9.2 PEAK CLINICAL EFFECTS Two to six hours post oral dose (two to four hours first dose) It takes four to five days for methadone tissue plasma levels to stabilise, though accumulation continues beyond this, finally reaching a steady state after ten days. Once a steady state is achieved, variations in blood concentrations are small. 9.3 DURATION OF ACTION (HALF LIFE) The length of time it lasts in the body varies. Single dose; shorter half life than maintenance dosing 12 – 18 hours means 15 hours. First few days between 13 and 112 hours mean 37 hours. Because of its cumulative effect until steady state is reached, methadone induction should be a cautious and gradual process. Elimination half life is normally 20 – 37 hours but can range up to 91 hours for some individuals; its rate of clearance from the body can vary by a factor of almost 100. Optimal doses are usually between 24 – 36 hours. 9.4 METABOLISM Well absorbed from the gastrointestinal tract into the blood stream Well distributed in body fats Metabolised through the liver via cytochrome P450 sub family of enzymes, thus susceptible to pharmacokinetic interactions with drugs that inhibit or induce liver enzymes. Binds well to plasma proteins and to lungs, liver and kidney tissues. Varies enormously in different people and widely different doses of methadone are needed to create the same serum methadone level. Page 21 of 63 PAT/T 21 v.2 9.5 EXCRETION Excreted in the faeces and urine; urinalysis is useful only in confirming if being taken, but not establishing the dose. 9.6 DOSING While research evidence suggests that optimal doses for most people lie between 60 and 120 mg some people will need more and some people will need less due to a range of individual factors such as size, gender, age, other health problems and metabolic clearance rates. Doses between 10 and 120mg may exert clinical effects for 24 to 36 hours; low doses exert clinical effects for only a few hours. 9.7 EQUIVALENCE Direct equivalence to street heroin is difficult to estimate, as purity of street heroin can vary 9between20 and 60%). One gram of street heroin is usually very roughly equivalent to 50 to 80mg methadone. Direct equivalence of methadone and buprenorphine and vice versa is difficult to estimate, as the pharmacological properties of the two agents are not identical and it is not a linear relationship. When comparing the efficacy of maintenance doses, 50 to 80mg methadone is approximately as effective as 12 to 16mg buprenorphine in reducing heroin use and retaining patients in treatment. When comparing the equivalence of methadone to injectable pharmaceutical diamorphine, half lives must be taken into consideration. This is not a linear relationship, so equivalence can vary from a methadone: diamorphine relationship of 1:3 (or even 1:1 for very low doses) to around 1:5 for high doses of diamorphine (e.g. 120mg methadone is equivalent to between 360 and 600mg of injectable diamorphine). 9.8 TOLERANCE Develops at different speed in different individuals, can change in individuals over time and develops differently for different effects. With long term use, and in response to continued exposure of the brain to opiates, neuro adaptation occurs and involves changes in nerve and receptor function. Level of heroin use is not the only factor in determining the final dose of substitution that will be required. Patients react differently: some will need more and some will need less than others using the same amount of heroin. RCGP 2011 Guidance for the use of substitute prescribing in the treatment of opioid dependence in primary care. Page 22 of 63 PAT/T 21 v.2 METHADONE INDUCTION PROCESS – NEW STARTERS 10 Opioid substitution Therapy should only be considered following liaison with the community drug services. Appropriate arrangements for exit prescribing will need to be in place to ensure a seamless transfer of care back into to community 10.1 INDICATION Methadone, an opioid agonist, can be substituted for opioids such as diamorphine, preventing the onset of withdrawal symptoms; it is itself addictive and should only be prescribed for those who are physically dependent on opioids.. It is available in several preparations, Liquid , Injection and Tablet, and strengths 1mg/1ml – 5mg/1ml – 10mg/1ml – 25mg/1ml – 50mg-1ml The most common and preferred form used for the treatment of opioid dependency is METHADONE mixture 1mg/1ml Status – Schedule 2 Controlled Drug 10.2 PRECAUTIONS Poly drug use – alcohol, benzodiazepines Respiratory insufficiency Severe Hepatic dysfunction Renal impairment Opiate naive QT elongation 10.3 CONTRAINDICATIONS Acute respiratory depression Raised intracranial pressure Comatose patient 10.4 INVESTIGATIONS Establish dependence [Appendix 4] Establish withdrawal [appendix 5] Page 23 of 63 PAT/T 21 v.2 10.5 PRINCIPLES OF SAFE INDUCTION Delay the first dose of methadone until the patient is experiencing features of opioid withdrawal (this typically means at least 8 hours after last heron use, 24 hours after last methadone use). Objective withdrawal symptoms [table5] are assess using the Short Opioid Withdrawal Score [Appendix 5] and should be completed at least 4-hourly. NEVER give more than 10mg (Methadone Mixture 1mg/1ml) as an initial dose to patients not receiving a methadone prescription in the community. Do not exceed more than 40 mgs of methadone in the first 24-hour period. The patient should be reminded that that although there will be a 4-hourly objective assessment of withdrawal signs and symptoms, should they request a review of their medication the assessment can be brought forward by 2 hours: Whereby an objective assessment of opioid withdrawal can determine; if a further 5 – 10 mg methadone is thought necessary. Consultation with the prescribing team will be required. Always complete a methadone assessment form prior to administration of methadone. [See Appendix 5] NEVER give methadone to a patient already intoxicated with opioids or other drugs including alcohol. After the initial induction [over 2 – 4 days] allow time for methadone levels to reach a steady state [and so minimise the risk of an excessive cumulative increase in the blood levels in the early days of treatment], then reassess and give the medication as a supervised daily dose. Where doses need to be increased, the increments should be no more than 10 mg per day and no more than 30 mg per week week. 10.6 DOSING Table 7 – Methadone Induction Dosing DAY DRUG Day 1 Methadone 1mg/1ml Day 2 Methadone 1mg/1ml Day 3 Methadone 1mg/1ml DOSING DAILY MAX 5 – 10mg PRN 2 - 4 hrly in 40mg response to symptoms Day 1 total as a single dose + 50mg additional 5-10mg STAT Day 2 total as a single dose + 60mg additional 5-10mg STAT Page 24 of 63 PAT/T 21 Day 4 Methadone 1mg/1ml v.2 Day 3 total as a single dose + 70mg additional 5-10mg STAT 10.7 ADMINISTRATION In order to maintain patient safety and reduce drug related deaths [sec 15.3] an assessment of intoxication [sec 6.6] is required prior to administration. The Drug and Alcohol Service Methadone Assessment Prior to Administration Checklist [Appendix 5] needs completing immediately before each administration. 10.8 RISK FACTORS Deaths during methadone titration are rare but most occur in the first two to three days. Over 20% of all methadone deaths in treatment take place within two weeks of commencement of prescribing and most occur during sleep. Risk of overdose is increased by low opioid tolerance, too high an initial dose, too rapid increases and concurrent use of other drugs, particularly alcohol, benzodiazepines and antidepressants. Daily assessment, using supervised consumption is the best safeguard to prevent undetected over sedation in a patient. Methadone patients should be informed of the ‘increasing effects of a dose’ as steady state is achieved, so that they do not excessively ‘top up’ with street drugs. A number of factors can alter methadone plasma levels, including gastric emptying, pregnancy and liver metabolism, which can increase risk of overdose. 10.9 OTHER POINTS TO CONSIDER During induction, psychological factors and psychiatric morbidity / illness need to be taken into consideration on the premise that depression may contribute to suicidal ideation. Clinical experience and some published data (though not randomised controlled trials) suggest that psychiatric conditions, including major depression and psychosis, sometimes respond to appropriate methadone dosing. In patients with co-morbidity good control of opioid dependence leads to stability and improvements in mental health. Page 25 of 63 PAT/T 21 11 v.2 BUPRENORPHINE PHARMACOLOGY 11.1 PEAK PLASMA CONCENTRATION 90 to 150 minutes after regular sublingual administration. 11.2 PEAK CLINICAL EFFECTS One to four hours post sublingual dose. It takes three to four days for buprenorphine plasma levels to stabilise. 11.3 DURATION OF ACTION (HALF LIFE) Related to dose. Low dose (e.g. 2 to 4mg) may exert clinical effects for only a few hours, up to a maximum of 12 hours, because receptor occupancy will be minimal and plasma concentrations suboptimal. Higher doses (e.g. 16 to 32mg) can exert effects for up to 48 to 72 hours. Optimal doses are usually between 24 and 36 hours. Elimination half life is between 20 and 37 hours. 11.4 METABOLISM Principally in the liver via two hepatic pathways: glucuronide conjugation and Ndealkylation by the cytochrome P450 enzyme system. The tablets are administered sublingually because it has poor bioavailability. It is inactivated by gastric acid and has a high first pass metabolism. 11.5 EXCRETION Excreted in the faeces and urine; urinalysis is useful only in confirming if being taken, but not establishing the dose. 11.6 DOSING Maintenance is between 8 and 32mg daily but the blockade dose (dose where the effects of additional opioids are markedly reduced) is maximal above 16mg daily. 11.7 EQUIVALENCE Direct equivalence of methadone and buprenorphine and vice versa is difficult to estimate, as the pharmacological properties of the two agents are not identical and it is not a linear relationship. Page 26 of 63 PAT/T 21 v.2 When comparing the efficacy of maintenance doses, 50 to 80mg methadone is approximately as effective as 12 to 16mg buprenorphine in reducing heroin use and retaining patients in treatment. 11.8 TOLERANCE Develops at different speed in different individuals, can change in individuals over time and develops differently for different effects. With long term use, and in response to continued exposure of the brain to opiates, neuro adaptation occurs and involves changes in nerve and receptor function. Level of heroin use is not the only factor in determining the final dose of substitution that will be required. Patients react differently: some will need more and some will need less than others using the same amount of heroin. RCGP 2011 Guidance for the use of substitute prescribing in the treatment of opioid dependence in primary care. BUPRENORPHINE INDUCTION PROCESS – NEW STARTER 12 Opioid substitution Therapy should only be considered following liaison with the community drug services. Appropriate arrangements for exit prescribing will need to be in place to ensure a seamless transfer of care back into to community 12.1 INDICATION Buprenorphine is a sublingual tablet licensed for the treatment of opioid dependence in individuals over the age of 16 years of age. It is available in the following doses – 0.4 mg, 2 mg, and 8 mg. Status - Schedule 3 Controlled Drug 12.2 PRECAUTIONS Poly-drug use especially benzodiazepines Chronic pain Severe psychiatric illness Methadone maintenance at doses higher than 40 mgs 12.3 CONTRAINDICATIONS Pregnancy Breast feeding Severe hepatic/respiratory disease Page 27 of 63 PAT/T 21 v.2 12.4 INVESTIGATIONS Establish opioid dependency Liver function test Pregnancy test 12.5 DOSING The purpose of the induction is to establish the patient on a safe dose of Buprenorphine that prevents opioid withdrawals, reduces the need to take additional illicit opioids and keep side effects to a minimum. It is usual to start on a low dose and increase rapidly until a stabilizing dose is reached. Before the commencement of buprenorphine, a full explanation should be given to the patient covering the properties of the drug, it effects, the induction period and the possible side effects. Understanding that the first 3 days are usually the worst is very helpful to the patient, especially when explaining precipitated withdrawal and the need for compliance to the treatment programme. (RCGP, 2004) 12.6 ADMINISTRATION In order to maintain patient safety and reduce drug related deaths [sec 15.3] an assessment of intoxication [sec 6.6] is required prior to administration. The Drug and Alcohol Service Methadone Assessment Prior to Administration Checklist [Appendix 5] needs completing immediately before each administration. 12.7 PRINCIPLES OF SAFE INDUCTION Delay the first dose of buprenorphine until patient is experiencing features of opioid withdrawal (this typically means at least 8 hours after last heroin use, 24 to 48 hours after last methadone use) Commence with an initial dose of between 4 and 8 mgs Rapidly titrate the dose on subsequent days according to clinical response (daily increases of up to 4 mgs are possible) Buprenorphine are administered sublingually, therefore it is important that the patient is observed the entire period that it takes the tablet to dissolve, and then be given a full glass of water to drink. Table 8 - Suggested buprenorphine induction regime for the ward setting DAY MORNING EVENING DAY 1 4 mgs 4 mgs DAY 2 8 mgs 4 mgs DAY 3 16 mgs Subsequent days Continue as above Page 28 of 63 PAT/T 21 v.2 12.8 RISK FACTORS FOR OVERDOSE Low opioid tolerance, Use of CNS depressant drugs, including alcohol, There is also a risk of increased precipitating withdrawal, if insufficient time is left before administering buprenorphine in patients who have: Recently used heroin, particularly at higher doses, Recently consumed long-acting opioids such as methadone 12.9 BUPRENORPHINE + NALOXONE (SUBOXONE) A new form of buprenorphine has been developed that includes the opioid antagonist naloxone (buprenorphine: naloxone 4:1) in a combined sublingual tablet. This new form is for use at the same buprenorphine dose (the current 8 mg sublingual buprenorphine being considered as the same therapeutic dose as the new combination of 8 mg buprenorphine plus 2 mg naloxone). It has been presented as a new product, under the trade name Suboxone®, and received product approval for addiction treatment throughout the European Union in December 2006. The rationale is that, when taken sublingually as intended, the naloxone has very low bioavailability and does not diminish the therapeutic effect of the buprenorphine. However, if injected, the naloxone has high bioavailability and is liable to precipitate withdrawal in an opioid-dependent patient, therefore discouraging further misuse. If taken intranasally, the effect of the naloxone appears to be variable. The combination tablet is therefore expected to provide the same therapeutic benefit while preventing or reducing the liability for misuse. Clinical experience with this new combination product is, at the time of publication, extremely limited in the UK, and it is too early to indicate the relative positions of these two versions of buprenorphine. NOTE – This medication is not included in the Trust formulary; but is widely prescribed within the community setting To ensure minimum delay in treatment for the patient generic buprenorphine (Subutex) can be prescribed as an alternative to Suboxone at an equivalent dose. 12.10 PRECIPITATED WITHDRAWAL Precipitated withdrawal occurs in someone commencing buprenorphine who has recently taken heroin (less than 6 hours previously) or methadone (less than 24 hours previously). It is caused by the high affinity of buprenorphine displacing other opioids e.g. methadone, heroin from opioid receptors, but having less opioid activity (partial agonist). This rapid reduction in the opioid effects can be experienced as precipitated withdrawal, Page 29 of 63 PAT/T 21 v.2 typically occurring 1 to 3 hours after the first buprenorphine dose, peaking in severity over the first 3 to 6 hours, the gradually subsiding. If it occurs, reassure the patient and offer symptomatic treatment such as Lofexidine e.g. 400 – 600 mcg 8 hourly, as appropriate, if withdrawal symptoms are severe. Do not prescribe more buprenorphine until opioid withdrawal symptoms have settled. 13 OPIOID DETOXIFICATION 13.1 OVERVIEW Detoxification should be a readily available treatment option for people who are opioid dependent and have expressed an informed choice to become opioid abstinent. 13.2 CONSENT In order to obtain informed consent, staff should give detailed information to service users about detoxification and the associated risks, including: the physical and psychological aspects of opioid withdrawal, including the duration and intensity of symptoms, and how these may be managed the use of non-pharmacological approaches to manage or cope with opioid withdrawal symptoms the loss of opioid tolerance following detoxification, and the ensuing increased risk of overdose and death from illicit drug use that may be potentiated by the use of alcohol or benzodiazepines the importance of continued support, as well as psychosocial and appropriate pharmacological interventions, to maintain abstinence, treat comorbid mental health problems and reduce the risk of adverse outcomes (including death). 13.3 UNSUITABLE POPULATONS With a medical condition needing urgent treatment In police custody, or serving a short prison sentence or a short period of remand; Who have presented to an acute or emergency setting; the primary emergency problem should be addressed and opioid withdrawal symptoms treated, with referral to further drug services as appropriate. For women who are opioid dependent during pregnancy, detoxification should only be undertaken with caution. For people who are opioid dependent and have comorbid physical or mental health problems, these problems should be treated alongside the opioid dependence. Page 30 of 63 PAT/T 21 v.2 13.4 OPIOIDS AND ALCOHOL If the person is alcohol dependent, alcohol detoxification should be offered. This should be carried out before starting opioid detoxification in a community or prison setting, but may be carried out concurrently in an inpatient setting. For alcohol detoxification refer to PAT/T 25. 13.5 OPIOIDS AND BENZODIAZEPINES If the person presenting for opioid detoxification is also benzodiazepine dependent, healthcare professionals should consider benzodiazepine detoxification. When deciding whether this should be carried out concurrently with, or separately from, opioid detoxification, healthcare professionals should take in to account the persons preference and the severity of dependence for both substances. 13.6 METHADONE – BUPRENORPHINE Methadone or Buprenorphine can be offered as the first line treatment in oioid detoxification. When deciding between these medications, healthcare professionals should take in to account: Whether the service user is receiving maintenance treatment with methadone or buprenorphine; if so, opioid detoxification should normally be started with the same medication. The preference of the service user Detoxification can be achieved through regular 1 – 2 x weekly dose reductions not usually more than 10% of the total daily dose. Symptomatic relief of withdrawal symptoms may also be required. [sec 13.10] 13.7 LOFEXIDINE Lofexidine may be considered for people: Who have made an informed and clinically appropriate decision not to use methadone or buprenorphine for detoxification. Who have made an informed and clinically appropriate decision to detoxify within a short time period With mild or uncertain dependence (including young people). See section [sec 13.11] [sec 13.12] 13.8 CLONIDINE Clonidine should not be used routinely for opioid detoxification. Page 31 of 63 PAT/T 21 v.2 13.9 DIHYDROCODEINE Dihydrocodeine should not be used routinely for opioid detoxification. 13.10 OTHER SYMPTOMATIC MEDICATIONS Diarrhoea – loperamide 4 mg immediately followed by 2 mg after each loose stool for up to five days; usual dose 6-8 mg daily, maximum 16 mg daily. Nausea, vomiting, may also be useful for stomach cramps – metoclopramide 10 mg eight hourly or prochlorperazine 5 mg three times a day or 12.5 mg intramuscularly 12-hourly. Stomach cramps – buscopan 20mgs qds Agitation and anxiety, sleeplessness – diazepam (oral) up to 5-10 mg three times daily when required (or zopiclone 7.5 mg at bedtime for patients who have been dependent on benzodiazepines). In severe cases of anxiety and agitation, obtain suitable psychiatric advice from an addiction psychiatrist or the on-call duty psychiatrist. Muscular pains and headaches – paracetamol, aspirin and other non-steroidal anti-inflammatory drugs. Topical rubefacients can be helpful for relieving muscle pain associated with methadone withdrawal. 13.11 LOFEXIDINE CONSIDERATOINS Lofexidine is a non-opioid alpha-adrenergic agonist and is not a controlled drug. It is licensed for the management of symptoms of opioid withdrawal but is being used much less frequently. Lofexidine comes as a 200mcg tablet and the effect lasts only a few hours. The treatment course is between 7–10 days with doses starting at 800 micrograms daily and rising to a maximum of 2.4 mg in divided doses. The dose is then reduced over subsequent days. Reported side effects of Lofexidine are dry mouth and mild drowsiness. Patients sometimes complain of a metallic taste in their mouth and that their urine smells of yeast. There is a risk of bradycardia and hypotension hence pulse and blood pressure need to be monitored. There is also a risk of rebound hypertension when treatment with lofexidinbe ends. Use lofexidine with caution in-patients with cardiac disease, cerebrovascular accidents, and chronic renal failure. The safety in pregnant and breastfeeding women has not been established. Sedation is increased with concomitant use of alcohol or central nervous system depressants and overdose can result in hypotension, bradycardia, sedation and coma. Page 32 of 63 PAT/T 21 v.2 It is most likely to be successful for patients who are using small amounts of opioids or have uncertain dependence, and those with shorter drug use or treatment histories. Lofexidine can be used in patients whom it is clinically appropriate and in those who have made a decision not to be detoxified using methadone or buprenorphine. In every case the patient needs to be carefully assessed and selected, should make and informed choice and want to stop using opiates. There is an increased risk of overdose amongst patients returning to illicit opioid (heroin) use following a period of abstinence. 13.12 LOFEXIDINE REGIME Before commencing a patient on Lofexidine, it is advisable to obtain a baseline blood pressure (BP) reading and pulse (P); then measure the BP and P prior to administration of medication. Lofexidine should be discontinued if the blood pressure drops significantly i.e. if diastolic falls below 60 and pulse rate fall below 55 beats per minute. Table 9 – Procedure for induction of Lofexidine DAY 1 All opioids stopped, record withdrawal symptoms using Short Opioid Withdrawal Scale (A Check BP/Pulse Commence lofexidine regime as shown above Check BP/Pulse 30 minutes post dose If BP/Pulse stable continue Lofexidine 0.2mg q.d.s If diastolic BP falls below 60, pulse rate falls below 55 beats per minute or if client develops physical symptoms e.g. dizziness or fainting then omit the next Lofexidine dose and seek medical advice. DAY 2 Chart withdrawal symptoms Check BP/Pulse Lofexidine as per regime Symptomatic treatment as required DAY 3 - 6 As day 2 DAY 7 No further medication unless objective withdrawals present. If observed 0.2mgs q.d.s May be considered with a reduction of 1 tablet daily. Table 10 - Lofexidine regime DAY 1 DAY 2 08.00 14.00 18.00 22.00 2 3 2 2 2 2 2 3 Page 33 of 63 TOTAL TABLETS (200 micrograms) 8 10 PAT/T 21 DAY 3 DAY 4 DAY 5 DAY 6 DAY 7 3 3 3 2 0 3 3 2 2 0 3 3 2 2 0 3 3 3 2 0 v.2 12 12 10 8 0 Additional short-term medication for symptoms such as stomach cramps and diarrhoea may be required. Withdrawal symptoms can be monitored using the Short Opiate Withdrawal Scale [Appendix 5], which provides a comparison over time. 14 RELAPSE PREVENTION PRESCRIBING 14.1 BENEFITS Naltrexone is an opioid antagonist which, when taken regularly, blocks opiate receptors within the brain thus preventing a former opiate user from experiencing the effects of opioids. It can be helpful following detoxification in enabling a patient to maintain abstinence. In the UK naltrexone is only licensed for use orally. Before considering commencement of naltrexone, the patient needs to be fully informed of the effects, side effects and risks of naltrexone so that they are able to make an informed choice. 14.2 RISKS There is a risk of fatal overdose should the patient attempt to ‘override” the opioid blockade with illicit drug use. 14.3 INVESTIGATIONS Due to the potentially hepatotoxic nature of naltrexone, liver function tests should be conducted before and during naltrexone treatment. 14.4 DOSING Naltrexone is a long-term therapy and will need to be continued via a community service on discharged. Appropriate arrangements for exit prescribing will need to be put in place to ensure a seamless transfer of care back into the community before the patient is discharged. Page 34 of 63 PAT/T 21 v.2 Following a negative urine or oral fluid test for opioids the patient is given a single dose of naltrexone (25 mg) orally Observe the patient for any withdrawal or other ill effects. If the patient does not experience any withdrawal a 50 mg. dose may be given the next day The usual maintenance dose is then 50 mg a day 14.5 LOSS OF TOLERANCE The patient should be warned of the risk of drug overdose on leaving hospital, due to loss of tolerance. Accidental overdose is often due to reduction in tolerance after period of abstinence (e.g. release from prison, discharge from rehabilitation or hospital).[ACMD, 2000] Appropriate written support information should be given to the patient to refer to on discharge, alongside a good, effective explanation of the literature to ensure understanding and informed choice. See DRUG RELATED DEATHS [sec 15.2] [sec 15.3] 15 GENERAL MANAGEMENT 15.1 WARD MANAGEMENT A risk assessment to should be completed to determine the risks to patient, staff, public and the environment. To avoid illicit drug use on the ward: ingestion of medication should be observed; freedom to wander the hospital should be controlled; visitors should be limited and regular urine samples should be taken. Consideration should be given to placing the patient’s bed close to the nursing station to facilitate observation Some opioid users abuse other drugs. Concurrent dependence on alcohol and sedative drugs (e.g. benzodiazepines/barbiturates) can cause severe withdrawal symptoms and may require stabilisation on a sedative drug of the same class (e.g. diazepam, chlordiazepoxide, phenobarbitone) Reassurance that any existing community treatment will be continued on admission. 15.2 DRUG RELATED DE ATHS Rates of recorded drug-related deaths among UK drug misusers are among the highest in Europe. The four main causes of drug-related deaths are: overdose suicide Page 35 of 63 PAT/T 21 v.2 accidents physical health complications of drug misuse Drug-related overdoses are most commonly caused by opioid drugs (heroin or methadone) and often involve the use of other depressant drugs like alcohol and benzodiazepines. Drug overdose remains the second most common cause of years of life lost in young men. Drug-related deaths are especially high in the first weeks following release from prison. Those at most risk have a history of injecting drug use immediately prior to entry to prison, and a long history of opioid dependence or poly-drug dependence (Farrell and Marsden, 2005). Mortality in the first few weeks of OST is significantly elevated, as it is in the weeks after leaving treatment. (Cornish et al 2010) Strang Clinicians have an important role in minimising the risks of all four causes of drug-related deaths among drug misusers and the risks of death to others due to diversion or due to unsafe storage of prescribed medication. 15.3 REDUCING DRUG RELATED DEATHS The 2007 Clinical Guidelines suggest that clinicians can help to reduce drug-related deaths in their patients by: identifying and assessing patients at greatest risk of drug-related death. providing education and training to drug misusers and their families on the risks of overdose and how to respond effectively advising drug misusers of the dangers of combining drugs, especially alcohol and benzodiazepines. educating drug misusers that the use of methadone, outside its medical purpose, is extremely dangerous. educating new patients starting on methadone and buprenorphine on the risks of loss of tolerance. using supervised consumption, especially in the early stages of methadone and buprenorphine treatment, adjusting dispensing frequency according to risks. requiring that patients moving on to take home methadone and buprenorphine provide details of satisfactory home storage arrangements and recording these in the patient’s notes, especially when children are in the home. conducting or arranging for mental health assessments in patients who present a suicide risk. making use of local specialist support and referral in complex cases, such as cases of polypharmacy requiring specialist review. Contributing to effective care pathways between hospital and community services. Page 36 of 63 PAT/T 21 v.2 15.4 DEALING WITH EMERGENCY OVERDOSE Treat opioid overdose with standard resuscitation techniques and with the use of naloxone. Naloxone is given 0.4-2.0 mg parenterally (IV/IM/SC) and this can be repeated after every 3–4 minutes, up to a maximum dose of 10 mg. It is important to remember the half-life of naloxone is much shorter than methadone and other opioids. This fact should be made clear to patients, particularly in A&E and in other situations where the patient may leave the hospital suddenly. Patients should be helped to understand that they are at risk of re-emergence of life-threatening sedation when the naloxone wears off. Given that some patients may find it difficult to cope with the precipitated discomfort that can occur on administering naloxone, and may choose to leave, it is important that they are helped to understand this risk. To accommodate the above recommendations the following care plans need to be completed prior to discharge: Methadone Safety Care Plan [Appendix 6] Safer Injecting Care Plan [Appendix 7] 15.5 SLEEPLESSNESS There is recognition that sleeplessness can present a management problem. It has to be appreciated by the patient and the team that sleeplessness is a feature of opioid withdrawal and therefore as the titration of methadone progresses there will be a limited need for night sedation. This minimises the over reliance of sedative medication which is dependence producing. Night sedation should not be considered in the first 2 –3 days of stabilisation. The use of benzodiazepines should be actively discouraged unless there is evidence of concurrent benzodiazepine dependence. However should the insomnia persist in exceptional circumstances Nitrazepam 5-10 mgs may be given at the discretion of the medical team and at the first appropriate opportunity discontinue the medication. 15.6 PATIENTS OWN SUPPLIES PAT/MM 1B v.4 POLICY FOR THE SAFE AND SECURE HANDLING OF MEDICINES PART B Controlled Drugs “6.10 Patient’s Own Medicines Patient’s own Controlled Drugs that are brought on a ward or department that stock CDs shall normally be destroyed in that ward or department following procedure in Section 7.15.” Page 37 of 63 PAT/T 21 v.2 Any community methadone / buprenorphine brought to hospital on admission must not be returned to the patient. Take home supplies should be issued to maintain continuity of community treatment and prevent accumulation of doses whilst in hospital. Liaison with the community drug team is essential. The ward to inform the patient’s GP and community pharmacy of any methadone / buprenorphine that may have been accrued by the patient in the community setting during their admission. 15.7 PREGNANCY The number of women misusing drugs has increased considerably in the past 30 years, and many are of childbearing age. [DOH, 1999]. Any patient found to be pregnant and misusing drugs will require a sensitive approach and every opportunity taken to encourage them into mainstream service. Sudden withdrawal of opioids should not be encouraged during pregnancy because of the risks to the mother and baby. Advised take the lowest amount of drug needed to avoid withdrawal, in the safest way [e.g. smoke rather than inject] Offer urgent referral to drug services / specialist midwife. Where appropriate initiate methadone prescribing [section 3] SUBOXONE is not suitable for treatment during pregnancy 15.8 MENTAL CAPACITY For patients with impaired mental capacity refer to the trust policy in relation to the mental capacity act (PAT/PA 19) 15.9 ILLICIT DRUG USE ON TOP OF PRESCRIBED MEDICATION At the beginning of treatment, people may not have decided to become immediately abstinent and may not have agreed their level of need and the full package of care. They may continue to use illicit opiods albeit at a reduced amount. If there is evidence of regular additional heroin use concurrent with a methadone prescription, limiting heroin use solely by admission may result in, heroin being brought on to the ward, or the patient discharging themselves prematurely. In these circumstances, advice should be sought from the community prescriber regarding any adjustments that might be needed to the existing methadone daily dose. Discuss and Document concerns and risk of overdose with patient. Page 38 of 63 PAT/T 21 v.2 Consider increasing the dose - no more than 10mg per day no more than 30mg above starting dose in a week. [sec 10.6] Complete Methadone Assessment Prior to Administration. [Appendix 5] Review daily. If little or no improvement results from the current treatment interventions they may need to be adapted then reviewed again. This can help ensure treatment remains dynamic and responsive to need. Identifying “little or no improvement” is important but must take into account continued harm reduction benefits and the prevention of deterioration. (NTA 2012). 15.10 DRUG MISUSERS NOT ADMITTED TO HOSPITAL AND NOT IN TREATMENT Where patients receive care in departments and do not require admission it is inappropriate to initiate treatment, however; Attendance at A&E or admission into hospital may present a window of opportunity to put drug misusers in touch with other services and consider their drug misuse. (DOH 2007) On discharge, the following information should be given as a minimum: 16 General health promotion advice, Contacts for further help (such as needle exchange services, drug treatment services or self-help groups), Advice on preventing overdose, Advice on reducing the risk of blood-borne virus infection and its consequences (including support for hepatitis B vaccination). This information is available from local drug treatment services. PAIN MANAGEMENT 16.1 OVERVIEW Pain is subjective and person defined; it is always unpleasant. It can be acute, which is a protective warning, predictable and responding well to treatment OR chronic, tending to be continuous, of moderate to high severity for more than six months and in contrast unpredictable. Pain can be affected by fears, age, gender, culture, previous experience of either self or significant others. A history of substance use including alcohol, is commonly linked with chronic anxiety and chronic depression, which may negatively affect a patients experience of pain. Chronic pain affects between 10 – 15% of the general population rising to between 30 and 50% of substance misusers. Page 39 of 63 PAT/T 21 v.2 Pain in people who use drugs is common, complex and often forgotten and poorly treated. Up to 25% of people who use opioids say they start opiates because of pain. Under-treatment is common and is often based on misconceptions. There are a number of reasons why individuals who are drug dependent may have greater than expected needs regarding pain relief: Compared to those who are not dependent, the presence of a drug misuse syndrome seems to worsen the experience of pain – hyperalgesia. Drug misusers have a low tolerance of non-pharmacological interventions to achieve pain control. By nature of their condition, drug misusers have frequent episodes of intoxication, and withdrawal, which may alter the intensity of the pain experience. Virtually all forms of addiction are associated with sleep disturbance and this is a well established exacerbating factor in chronic pain. Depression and anxiety are common features in addiction and these have an important influence on the pain experience. Drug misusers are more likely to suffer from accidental and non accidental injury, and medical complications related to their drug use. This places them at high risk from physical problems that may require analgesia. When a known substance misuser presents with a need for analgesia A full substance misuse and medication history should be taken. This can be used to check for drug interactions and to assist with choice and appropriate analgesic. The accurate assessment of contemporaneous treatment for addiction is also mandatory as many of these treatments have important implications for the use of opioid medications. It is important to discuss the patients use of alcohol as this has specific relevance to the experience of and management of pain. Pain symptoms must be properly evaluated including relevant investigations and taking note of potential contributors to the patients experience of pain. If non pharmacological interventions are known to have utility for the pain condition described they should be offered to the patient, with a clear explanation of why such interventions are likely to help. Similarly non opioid medications should be used where supported by evidence, again with clear discussion of the rationale for any drug used. Page 40 of 63 PAT/T 21 v.2 There is little published guidance for management of patients who have chronic pain requiring opioid therapy, and who currently exhibit aberrant behaviour which may indicate misuse or addiction, or have a history of substance misuse. Nevertheless, some general principles may be applied: The therapeutic regimen should be selected with the risk of aberrant drug related behaviours in mind i.e. short acting opioids are widely acknowledged to have greater abuse potential than long acting or sustained release preparations. The prescriber must communicate clearly with the patient about setting reasonable expectations or goals for therapy and bout the necessity to frequently assess the progress towards these goals. This must include a regular review of the prescription. The process of building trust between the clinician and the patient should include a candid discussion of acceptable and unacceptable behaviour. The results of such a discussion should be written down and given to the patient. This may take the form of a treatment contract although this is not required by law. Be aware of the various potential presentations and drug seeking behaviour. Refer patient to, or seek advice from, a pain specialist or substance misuse specialist at an early stage where appropriate. Treatment decisions need to made in compliance with pertaining laws and regulations. Response to treatment including degree of pain control and progress towards agreed goals needs to be assessed frequently. Patients already tolerant to a long term illicit or prescription opiates taken for addiction will derive little analgesic effect from their regular dose. If the patient needs opiate analgesia these drugs will have to be prescribed in addition to any existing prescribed regimen. 16.2 METHADONE AND P AIN Give the usual methadone maintenance dose to address the persons baseline opioid requirements. If an opioid analgesic is appropriate for the patients condition, a non-methadone opioid may be co prescribed in addition to the patients usual methadone dose. It is not necessary to “rationalise” the patients entire opioid requirements to one drug. Relatively high doses of opioids at short interval may be needed because of tolerance. Morphine is the preferred opioid agonist. It is usually necessary to give a dose that is at least the dose that would be given to a person not on substitute drug maintenance treatment. It is not possible to Page 41 of 63 PAT/T 21 v.2 predict how much extra dose will be required. Increased sensitivity to pain or cross tolerance will often necessitate higher or more frequent doses. Avoid partial agonist / antagonist drugs should for patients receiving methadone as withdrawal may be precipitated. 16.3 BUPRENOPRHINE (SUBUTEX / SUBOXONE) AND PAIN Patients taking high dose Buprenorphine as substitution therapy may be relatively refractory to opioid prescribed for analgesia. See specialist advice. Management could follow any of the following options. Try NSAIDs and paracetamol If the pain will be of short duration, continue buprenorphine maintenance therapy and titrate a short acting opioid agonist. Because higher doses of full opioid agonist analgesics may be required in a person taking buprenorphine, be cautious if the person’s buprenorphine therapy is abruptly discontinued, as sedation and respiratory depression may occur. Alternatively, divide the daily dose of buprenorphine and administer every 6-8 hours (although this not a licensed use of subutex) However if opioid tolerance has developed, additional opioid analgesia may be required. Discontinue buprenorphine and treat with an opioid analgesic by titrating the dose to avoid withdrawal and then to achieve analgesia. Both sustained release and immediate release morphine may be used. Convert back to buprenorphine using the initiation and stabilisation protocol. If the person is in hospital, buprenorphine can be stopped and methadone maintenance and opioid analgesic used, but close observation is essential and naloxone should be immediately available. The person may be changed back to buprenorphine before discharge. Advice should be sought from the Acute Pain Team on bleep 1449 (at DRI) or 3107 (at BDGH) or the on-call anaesthetist outside office hours. 16.4 NALTREXONE AND PAIN Naltrexone is an opiate antagonist with no agonist properties and will totally block the effects of substantial doses of opioid analgesics. People taking Naltrexone should be aware of the potential problems and the need to alert clinicians. Discontinuation of naltrexone produces very few signs and symptoms, but long term use increases the concentration of opioid receptors in the brain and produces a temporary exaggeration of response to the subsequent administration of opioid analgesics. If unexpected or severe pain should occur, then intravenous paracetamol, high dose nonsteroidal anti inflammatory drugs, and local anaesthetics are effective. Ketamine is an effective analgesic and may be useful. There is no information available about whether Tramadol would be useful. Minor or intermediate elective surgery: discuss with the person and their community drug team the possibility of management of the pain with none opioid Page 42 of 63 PAT/T 21 v.2 analgesics versus the risk of relapse if naltrexone is withdrawn and opioid analgesics used. Naltrexone should be withdrawn 48-72 hours before the surgery is due to take place. Major surgery, with expected severe post operative pain: naltrexone should be discontinued 72 hours beforehand. Expect a degree of resistance to opioid analgesics, although there may be increased sensitivity. 16.5 PERI OPERATIVE PAIN Methadone may be given as per the patient’s usual requirements within 2 hours before surgery, as per clear fluids policy. (PAT/T 24) The anaesthetist will need informing of the amount and time of the last methadone dose given. It may be necessary to omit or delay Buprenorphine dosing to prevent either opioid blockade or precipitated withdrawal effects. 17 DISCHARGE PLANNING Every effort is taken to minimise the need for take home supplies upon discharge from hospital, however, there are times such as weekends and Bank holidays when it is necessary to provide take home doses in order to maintain continuity of care. It is essential to liaise with the Community Drug Team as part of discharge planning to establish a plan which minimises both the potential for duplicate prescribing or a medication shortfall. 17.1 TTO – EXISTING COMMUNITY PATIENT It is normal Community Substance Misuse Team practice for methadone / buprenorphine patients receive weekend supplies to take away to allow for pharmacy closed days. Some patients will routinely receive “take home” supplies in the community i.e. 3 x weekly (mon / wed / fri), twice weekly or weekly. For these well establish patients the risks from providing take home supplies upon discharge from hospital is generally considered to be low, whereas failure to maintain continuity of treatment could result in withdrawal and illicit drug use which may pose a greater risk to health. In order to manage the safe transition from inpatient to community care the following checks need to carried out, documented in the patient notes and communicated to the Community Drug Team. Current drug and dose Date and time last taken Reason for giving TTO Amount of take home medication supplied Page 43 of 63 PAT/T 21 v.2 Date of next required community dosing For patients receiving weekly supplies of methadone in the community the decision to issue large amounts of TTO medication should only be taken in conjunction with DALNS. 17.2 CAUTION The JAC default for TTA medication is 28 days. Ensure you have amended JAC according to the patients individual plan. A handwritten INTERIM DISCHARGE NOTIFICATION for (HMR 2a) needs completing in addition to the JAC TTA request. 17.3 TTO - NEW STARTERS TTO supplies are not routinely given to patients initiated in hospital. Extra safeguards are required when discharging patients who where not receiving OST on admission as Mortality in the first few weeks of OST is significantly elevated (Cornish et al 2010) Every effort should be taken to minimise the need for take home methadone dosing, for “new starters” and additional steps should be considered to prevent discharge at weekends or public holidays which would require the need for take home dosing. Where it is not possible to prevent a discharge requiring take home dosing, it is essential to liaise with the Community Drug Team to establish a plan which minimises both the potential for double prescribing or the patient experiencing an interruption to treatment. In order to manage the safe transition from inpatient to community care the following checks need to carried out, documented and communicated to the relevant Community Drug Team. Current drug and dose Date and time last taken Date of next required community dosing. Inform the patient of overdose risks from opiates, Benzodiazepine and Alcohol. Methadone safety care plan. [Appendix 6] 17.4 CAUTION The JAC default for TTA medication is 28 days. Ensure you have amended JAC according to the patients individual plan. A handwritten INTERIM DISCHARGE NOTIFICATION for (HMR 2a) needs completing in addition to the JAC TTA request. Page 44 of 63 PAT/T 21 v.2 TTA supplied in line with PAT/MM 1A. 18 TRAINING/ SUPPORT The nurse or healthcare worker in charge of a department is responsible for ensuring that their staff are competent in the management of patients with substance misuse problems. In the case of medical staff the consultant is responsible. The Drug and Alcohol Liaison Nurse Specialist services at Doncaster Royal Infirmary and Bassetlaw District General Hospital provide “in house” training support via Specific Study Days, ward based sessions or on a 1:1 case specific supervision basis. 19 MONITORING COMPLIANCE WITH THE PROCEDURAL DOCUMENT What is being Monitored 20 Were pre prescribing checks carried out and documented Were discharge / TTO plans explicit Were Methadone Pre administration checklists used Were Methadone Safety care Plans used Were Safer injecting care plans used Who will carry out the Monitoring How often How Reviewed/ Where Reported to DALNS / Pharmacist / Ward Managers Annual Audit Annual Audit Report in conjunction with Clinical Audit DALNS / Ward Managers Annual Audit Annual Audit Report in conjunction with Clinical Audit DEFINITIONS ACMD – Advisory Council on the Misuse of Drugs BDGH – Bassetlaw District General Hospital BNF – British National Formulary DALNS – Drug and Alcohol Liaison Nurse Specialist DOH – Department of Health DRI – Doncaster Royal Infirmary OST – Opioid Substitution Therapy ECG – Electro Cardio Gram NICE – National Institute for Clinical Excellence NMP – Non Medical Prescriber NTA – National treatment Agency PRN – Pro Re Nata (latin “as the occasion arises”) RCGP – Royal College General Practitioners TTA – To Take Away WHO – World Health Organization Page 45 of 63 PAT/T 21 21 v.2 EQUALITY IMPACT ASSESSMENT An Equality Impact Assessment (EIA) has been conducted on this procedural document in line with the principles of the Equality Analysis Policy (CORP/EMP 27) and the Fair Treatment For All Policy (CORP/EMP 4). The purpose of the EIA is to minimise and if possible remove any disproportionate impact on employees on the grounds of race, sex, disability, age, sexual orientation or religious belief. No detriment was identified. A copy of the EIA is available on request from the HR Department. 22 ASSOCIATED TRUST PROCEDURAL DOCUMENTS PAT/T 25 - Guidelines for the Management of Alcohol issues in the Acute General Hospital Setting. PAT/MM 1B - POLICY FOR THE SAFE AND SECURE HANDLING OF MEDICINES PART B Controlled Drugs PAT/MM 1A - Policy for the Safe and Secure Handling of Medicines Part A PAT/.PA 19 - Mental Capacity Act 2005 Policy and Guidance PAT/PS 10 - Safeguarding and Promoting the Welfare of Children PAT/T 24 - Pre-operative fasting guidelines. 23. REFERENCES 1. Advisory Council on the Misuse of Drugs (2000) Reducing Drug Related Deaths. A Report by the Advisory Council on the Misuse of Drugs. HMSO London 2. Armstrong, D., Phillips T.(2003) Management of Patients with Opiate Dependency on Medical / Surgical Wards – Guidelines, Hull& East Riding Community Mental Health NHS Trust 3. Arizona Centre for Education and Research on Therapeutics. Drugs that Prolong the Qt Interval and/or Induce Torsades de Pointes Ventricular Arrhythmia. www.torsades.org 4. Australian Government (2003) National Strategy. Clinical Guidelines for Procedures for the use of Methadone Maintenance Treatment of Opioid Dependency. Australia 5. Botstein P (1993) Is QT Interval Prolongation Harmful. A Regulatory Perspective. Amer J Cardiology 1993; 72 (6): 50B-52B Page 46 of 63 PAT/T 21 v.2 6. Capelhorn J and Drummer OH (1999) Mortality Associated with New South Wales Methadone 7. Cornish et al (2010) Risk of death during and after opiate substitution treatment in primary care: prospective observational study in UK General Practice Research Database. BMJ 341: c5475. doi: 10.1136 8. Programs in (1994): lives lost and saved. Medical Journal of Australia 170, 104–109. 9. UK health departments (1999) Drug Misuse and Dependence – Guidelines on Clinical Management. London: The Stationery Office. 10. Department of Health, (1999b) National Service Frameworks for Mental Health: Modern Standards and Service Models. Department of Health 11. Department Of Health, [2005].National Treatment Agency for Substance Misuse – Models of Care for Drug Misuse. London, HMSO 12. Department of Health. (2007) Drug Misuse and Dependence – Guidelines on Clinical Management. London: The Stationery Office 13. Drug Strategy (2010) Reducing demand, restricting supply, building recovery: supporting people to live a drug free life. 14. EAEMP (2001) Public Statement on the Recommendation to Suspend the Marketing Authorisation for ORLAAM (Levacetylmethadol) in the European Union. London: European Agency for the Evaluation of Medicinal Products. 15. Farrell M and Marsden J (2005) Drug-related Mortality Among Newly Released Offenders 1998-2000. London: Home Office, on-line report 40/05. 16. Haigney MC, Alam S, Tebo S, Marhefka G, Elkashef A, Kahn R, Chiang CN, Vocci F and 17. Cantilena L (2006) Intravenous Cocaine and QT Variability. J Cardiovasc Electrophysiol. 17(6):610-6. 18. Ghodse, A.H. (2002) Drugs and addictive behaviour: A guide to treatment. 3rd edition. Blackwell Science. Oxford. 19. Lipski J, Stimmel B and Donoso E (1973) The Effect of Heroin and Multiple Drug Abuse on the 20. Electrocardiogram. Am Heart J 1973;86 (5);663-668. 21. MHRA (2006) Current Problems in Pharmacovigilance, vol 31 May 2006. London: Medicines and Healthcare products Regulatory Agency 22. NTA (2012) Medications in recovery – re orientating drug dependence treatment. Page 47 of 63 PAT/T 21 v.2 23. NICE (2007a) Methadone and Buprenorphine for the Management of Opioid Dependence. Technology appraisal 114. London: National Institute for Health and Clinical Excellence. 24. NICE (2007b) Drug Misuse: Opiate Detoxification. NICE clinical guideline 52. London: National Institute For Health and Clinical Excellence. 25. NICE (2007c) Naltrexone for the Management of Opioid Dependence. NICE technology appraisal guidance 115. London: National Institute for Health and Clinical Excellence 26. NICE (2012) Quality Standards for Drug Use Disorders. QS23. National Institute for Clinical Excellence. 27. Royal College of General Practitioners, (2004). Guidance for the use of buprenorphine for the treatment of opioid dependence in primary care. 28. Royal College of General Practitioners, (2011). Guidance for the use of substitute prescribing in the treatment of opioid dependence in primary care. 29. Rawson, RA et al. (1997) Naltrexone and Behaviour Therapy for Heroin Addiction. National Institute for Drug Abuse Research Monograph Series p26-43 30. Schmittner J, Schroeder JR, Epstein DH and Preston KL (2004) QT Interval Increased After Single Dose of Lofexidine. BMJ 329: 1075. 31. Zador D & Sunjic S (2000) Deaths in Methadone Maintenance Treatment in New South Wales, Australia, 1990-1995. Addiction 95:77-84. 32. National Treatment Agency Media Release (2009) Moves to provide greater protection to children living with drug addicts. 33. World Health Organisation. (1992). ICD-10 Classifications of Mental and Behavioural Disorder: Clinical Descriptions and Diagnostic Guidelines. Geneva. World Health Organisation 34. Joint Formulary Committee (2007). British National Formulary. London: British Medical Association and Royal Pharmaceutical Society of Great Britain. Page 48 of 63 PAT/T 21 v.2 APPENDIX 1 CLINICAL GOVERNANCE Clinicians working with drug misusers must be appropriately competent, trained and supervised. Effective, safe and responsive services for drug misusers will usually involve clinicians working together and with others in teams in primary care, in secondary care or both. The setting in which health professionals work in treating drug misuse will affect the clinical governance mechanisms that needs to be in place. Those working in relative isolation must ensure they have an opportunity to discuss and review their work with colleagues in the field, to remain good and up-to-date practice Service should be provided consistent with national guidance and principles, and in line with the evidence base. The expansion of non-medical prescribing has implications for drug misuse treatment and care and clinical governance. A timely and regular audit and review should be in place. Patients must be involved in their own treatment. Carers of adults can be involved in patients’ treatment, usually with the patients, consent Taken from Drug misuse and Dependence - UK Guidelines on Clinical management (2007 Page 49 of 63 PAT/T 21 v.2 APPENDIX 2 NICE Quality Standards (QS23) – Drug misuse and dependence Statement 1. People who inject drugs have access to needle and syringe programmes in accordance with NICE guidance. Statement 2. People in drug treatment are offered a comprehensive assessment. Statement 3. Families and carers of people with drug use disorders are offered an assessment of their needs. Statement 4. People accessing drug treatment services are offered testing and referral for treatment for hepatitis B, hepatitis C and HIV and vaccination for hepatitis B. Statement 5. People in drug treatment are given information and advice about the following treatment options: harm-reduction, maintenance, detoxification and abstinence. Statement 6. People in drug treatment are offered appropriate psychosocial interventions by their keyworker. Statement 7. People in drug treatment are offered support to access services that promote recovery and reintegration including housing, education, employment, personal finance, healthcare and mutual aid. Statement 8. People in drug treatment are offered appropriate formal psychosocial interventions and/or psychological treatments. Statement 9. People who have achieved abstinence are offered continued treatment or support for at least 6 months. Statement 10. People in drug treatment are given information and advice on the NICE eligibility criteria for residential rehabilitative treatment. NICE (2012) Page 50 of 63 PAT/T 21 v.2 APPENDIX 3 Cardiac assessment and monitoring for methadone prescribing [2007 Clinical Guidelines, p98] A2.1 Drug-induced prolongation of the QT interval The QT interval is measured on an ECG* from the beginning of the QRS complex (caused by contraction of the ventricular mass) until the end of the T wave (caused by the return of the ventricular mass to the resting state). The QT corrected (QTc) interval is the QT interval (in milliseconds) corrected for heart rate using a standard formula (for example, Bazett’s formula: QTc (ms) = QT (ms) / RR½ – QT divided by the square root of the R-R interval). QTc calculators are available on the internet. The QTc interval is a useful indicator of risk of polymorphic ventricular tachycardias, or torsade de pointes which can be fatal. QTc interval prolongation beyond normal limits (440 ms for men and 470 ms for women) is associated with increased risk of cardiac arrhythmias and sudden death, especially above 500 ms (Botstein, 1993). Various psychotropic medications have recently been identified as causing QT prolongation and sudden death. In the past decade, this has become the most common reason for a drug to be withdrawn from the market. In the drug treatment field, this was the reason for levacetylmethadol (LAAM or ORLAAM) being withdrawn (EAEMP, 2001). A2.2 Methadone and risk of QT prolongation Methadone may prolong the QTc interval and induce torsade de pointes (Lipski et al., 1973). However increases in QTc interval following methadone induction may not exceed specified thresholds (440 ms in adult males and 470 ms adult females). Findings in relation to the effect of methadone dose have been varied but recently there have been a number of case reports of patients on high-dose methadone experiencing QT prolongation and torsade de pointes. Reducing or stopping methadone was followed by reduction in the QT interval. Cocaine has been shown to increase QT intervals acutely (Haigney et al., 2006). Other confounding factors may be the use of antipsychotic and tricyclic antidepressants (www.torsades.org; Schmittmer et al., 2004). In summary, the evidence, as currently available, points towards methadone as a risk factor for QT prolongation and torsade de pointes, with a possible dose-dependent action. A2.2.1 MHRA guidance 2006 In May 2006 the Medicines and Healthcare Products Regulatory Agency (MHRA) drew attention to reports in Europe and elsewhere which “highlighted the risk of QT prolongation in patients taking methadone, especially at high doses”. The MHRA recommended that: “patients with the following risk factors for QT interval prolongation are carefully monitored whilst taking methadone: heart or liver disease, electrolyte abnormalities, concomitant treatment with CYP 3A4 inhibitors, Page 51 of 63 PAT/T 21 v.2 or medicines with the potential to cause QT interval prolongation in addition any patient requiring more than 100 mg of methadone per day should be closely monitored.” (MHRA, 2006). A2.3 Patient consent and information The patient should be fully informed of the available evidence, the reasons for the clinical assessment and fully involved in the decision making process for their treatment. A patient information leaflet may be useful to inform the patient of the available evidence. A2.4 Clinical assessment of patients on methadone maintenance A standard physical health assessment and physical examination should be carried out on all patients entering methadone maintenance treatment. For patients already in methadone treatment, the clinical assessment should cover assessment of heart or liver disease, concomitant treatment with CYP 3A4 inhibitors, other drugs with the potential to cause QT interval prolongation and the presence of electrolyte abnormalities. Please also refer to the general section on clinical assessment for drug misuse patients before proceeding. [see section 1] A2.5 Clinical assessment of patients when initiating methadone At present, the decision to perform an ECG prior to commencing methadone treatment should be based on a risk-benefit analysis. A baseline ECG should be considered in patients with evidence of heart or liver disease, concomitant treatment with CYP 3A4 inhibitors, use of other QTc prolonging drugs or electrolyte abnormalities. If QT prolongation is detected, alternatives to methadone should be considered, and other QTc risk factors (such as cocaine use) should be reassessed. It is important that the patient is fully informed and involved in the decision making process. 98 A2.6 Summary Methadone may be a risk factor for QT prolongation and torsade de pointes with a possible dose-dependent action. The MHRA recommends monitoring for patients on high dose methadone (>100 mg daily) and with other QT interval prolongation risk factors where appropriate. Patients should be fully informed of the reasons for the clinical assessment and involved in the decision making process for their treatment. Screening before commencing methadone treatment is not currently advocated but may be considered. Any QT prolongation needs full investigation, consideration of specialist referral, identification of options for QT risk factor modification as well as ongoing ECG monitoring. NOTE Clinicians wanting to refresh their understanding of ECGs might start with Hampton JR (2003). The ECG Made Easy, 6th edition. London: Churchill Livingstone. Page 52 of 63 PAT/T 21 v.2 APPENDIX 4 CLINICAL DIAGNOSIS ICD-10 Clinical description A cluster of physiological, behavioural, and cognitive phenomena in which the use of a substance or a class of substances takes on a much higher priority for a given individual than other behaviours that once had greater value. A central descriptive characteristic of the dependence syndrome is the desire (often strong, sometimes overpowering) to take psychoactive drugs (which may or may not have been medically prescribed), alcohol, or tobacco. There may be evidence that return to substance use after a period of abstinence leads to a more rapid reappearance of other features of the syndrome than occurs with nondependent individuals. ICD-10 Diagnostic guidelines A definite diagnosis of dependence should usually be made only if three or more of the following have been present together at some time during the previous year: A strong desire or sense of compulsion to take the substance; Difficulties in controlling substance-taking behaviour in terms of its onset, termination, or levels of use; A physiological withdrawal state when substance use has ceased or have been reduced, as evidenced by: the characteristic withdrawal syndrome for the substance; or use of the same (or closely related) substance with the intention of relieving or avoiding withdrawal symptoms; Evidence of tolerance, such that increased doses of the psychoactive substance are required in order to achieve effects originally produced by lower doses (clear examples of this are found in alcohol- and opiate-dependent individuals who may take daily doses sufficient to incapacitate or kill nontolerant users); Progressive neglect of alternative pleasures or interests because of psychoactive substance use, increased amount of time necessary to obtain or take the substance or to recover from its effects; Persisting with substance use despite clear evidence of overtly harmful consequences, such as harm to the liver through excessive drinking, depressive mood states consequent to periods of heavy substance use, or drug-related impairment of cognitive functioning; efforts should be made to determine that the user was actually, or could be expected to be, aware of the nature and extent of the harm WHO (1992) Page 53 of 63 PAT/T 21 APPENDIX 5 Page 54 of 63 v.2 PAT/T 21 Page 55 of 63 v.2 PAT/T 21 APPENDIX 6 Page 56 of 63 v.2 PAT/T 21 Page 57 of 63 v.2 PAT/T 21 APPENDIX 7 Page 58 of 63 v.2 PAT/T 21 Page 59 of 63 v.2 PAT/T 21 APPENDIX 8 Page 60 of 63 v.2 PAT/T 21 Page 61 of 63 v.2 PAT/T 21 Page 62 of 63 v.2 PAT/T 21 Page 63 of 63 v.2