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An Overview of Suboxone and Its Relevance to the Inner City Health Program M.R. is a patient that has been with the Inner City Health Program for approximately six months. She is a chronic user of heroin and morphine, and satisfies the criteria for opioid dependence. In the last few years, she has been on and off of methadone. She finds it difficult to attend her regular methadone appointments and often uses morphine or heroin bought on the street on top of her methadone, putting her at risk for overdose. Currently, she is presenting to the health care team because she is “tired of it all, tired of being dope-sick, tired of going out every morning to look for drugs.” She has been off of methadone for two weeks though she continues to want maintenance treatment. Her methadone provider is on holiday for the next two weeks, and in the meantime she is requesting opioid from the health care team. Suboxone is considered as a potential treatment option. Introduction Opioid dependence is a major individual and public health issue. It is known that opioid addiction put patients at risk for other diseases as well, such as HIV, hepatitis C, and tuberculosis.i In addition, chronic opioid dependence by definition impairs functioning on social, political, and economic levels. At the Inner City Health Program, staff are witness to the devastating medical and psychosocial effects of opioid dependence on a daily basis. Regardless of how abstinence is achieved, opioid dependence is considered a chronic illness. Few people remain abstinent after detoxifcation, and we have few effective strategies for preventing relapse. It is well known in the literature that maintenance therapy is more effective than detoxification therapy in treating opioid dependence. In maintenance therapy compared to detoxification, patients are more likely to stay in the program, less likely to take other opioids, display decreased criminal activity, and have a decreased rate of HIV transmission.ii Currently in Canada, the only maintenance therapy for opioid dependence covered by Ontario Drug Benefits is methadone. Unfortunately, in Ottawa, we face long waiting lists for patients to enter into treatment with methadone. In addition, as the example above of patient M. R. illustrates, not all patients are as suitable as others for long-term methadone treatment. Suboxone is a new combination pill with buprenorphine and naloxone that was recently approved in Canada for the treatment of opioid dependence. This drug is not yet covered under Ontario Drug Benefits, and costs $90-460 per month plus dispensing fees. There is hope that this medication will soon be covered by Ontario Drug Benefits, as it is currently under review. Some patients in Canada have been using Suboxone because it is covered under their private drug plan, or they are willing to pay because the cost is less than the opioids they are currently buying in the street. While funding is currently a barrier, the efficacy of suboxone, its safety profile, and its prescription model that is easily amenable to primary care shows great promise. In the United States, regulation that has allowed physicians to prescribe suboxone in their outpatient offices has expanded the availability of opioid dependence treatment significantly.iii This paper will provide an introduction to suboxone and its use in primary care in the hope that this medication may one day expand the availability of effective and safe opioid dependence treatment in Ottawa through primary care agencies such as the Inner City Health Project. Pharmacology Suboxone is made by Schering-Plough Canada and comes in formulations of buprenorphine 2mg with naloxone 0.5mg and buprenorphine 8mg with naloxone 2mg. Buprenorphine is the opioid component of the combination pill. Pharmacologically, buprenorphine is a partial mu-opioid receptor agonist and a kappa receptor antagonist.iv As a partial agonist at the mu-opioid receptor, buprenorphine only partially stimulates this receptor to produce opioid-like effects. This means it produces milder sensations of euphoria, sedation, analgesia, and less respiratory depression, hypotension, nausea, constipation, and papillary constriction than other opioids. By contrast, heroin, methadone, morphine, and oxycodone are full agonists at the mu-opioid receptor. The partial agonist effect on the mu-opioid receptor leads to a “ceiling effect” property of buprenorphine, where increasing the dose of buprenorphine has little to no physical effects.v This reduces suboxone’s potential for abuse and makes it safer in overdose.vi In addition, buprenorphine has a very high affinity for the mu-opioid receptor, and thus blocks the effect of other opioid agonists.vii Therefore, if another opioid agonist is taken with buprenorphine it will have little effect, and taking buprenorphine while on another opioid agonist can precipitate withdrawal. This makes patients on suboxone less likely to abuse other opioids. Finally, the tight adherence of buprenorphine to the mu-opioid receptor is associated with a slow dissociation from that receptor, leading to a longer duration of action than other opioids (except methadone, which has the longest duration of action).viii According to the manufacturer, the half-life of buprenorphine is thirty-seven hours.ix However, in practice there is inter-individual variation such that the half-life is twentyfour to sixty-nine hours.x As would be expected, the effective plasma concentration in individual patients at any one time on any given dose is therefore difficult to predict.xi It starts to work within half and hour to an hour and peaks at one to four hours. The duration of action is dose dependent, being up to twelve hours at low doses and up to two to three days at higher doses. Unlike methadone, which can take weeks to titrate, suboxone reaches a steady state after three to seven days.xii The slow dissociation of buprenorphine also creates a milder withdrawal syndrome compared to other opioids, including methadone.xiii Finally, buprenorphine acts as antagonist at the kappa-opioid receptor, which theoretically may have antipsychotic and antidepressant effects. However, there have not been studies that show that this is a clinically relevant effect of buprenorphine in the literature. Naloxone, the other component of suboxone, is a competitive opioid antagonist at the mu, kappa, and sigma receptors.xiv Naloxone does not have clinical effects when administered sublingually for two reasons: naloxone is poorly absorbed by the sublingual route, and buprenorphine has a much longer half life than naloxone.xv However, when injected, it can precipitate withdrawal. Thus, in one study, it was found that of those who had injected suboxone, eighty percent had a “bad experience,” and the same study found that the buprenorphine and naloxone combination of suboxone had less than half the street value of buprenorphine alone.xvi Thus, the addition of naloxone to the buprenorphine makes suboxone less attractive as a drug of abuse. The combination pill of buprenorphine with naloxone has been shown to be equally effective to buprenorphine alone in treating opioid dependence.xvii Prescribing 1. USES Buprenorphine is used to treat opioid dependence through maintenance or withdrawal therapy. On at least one occasion, it has also been successfully used to reverse a heroine overdose.xviii However, reversal of overdose is an off-label use of buprenorphine. One study looking at opioid-addicted youth found that, over a twelve week period, maintenance therapy with suboxone was more effective than detoxification treatment with suboxone including better retention in treatment (p<0.001), less opioid use (p<0.001), less injecting (p<0.001), and less nonstudy addiction treatment (p<0.001).xix This reflects studies in the adult population, which have determined that the most effective treatment for opioid dependence is maintenance therapy plus counseling.xx Suboxone has been prescribed at Centre for Addiction and Mental Health (CAMH) in Toronto since about 2003.xxi Thirty thousand prescriptions for suboxone were written in Ontario in the first six months of 2009.xxii Thus, there is experience within this province in suboxone, and organizations such as CAMH are available for support. Buprenorphine’s analgesic potency is about twenty-five to forty times greater than morphine.xxiii This is important in terms of estimating the dose of suboxone a patient will need, however, currently it is recommended that for safety reasons, all patients be started at the low dose of 4mg of suboxone and tapered up. 2. ADVERSE EFFECTS Adverse effects of suboxone are dose-related and similar to other opioids, including constipation, headache, sedation, euphoria, sweating, nausea, insomnia, and orthostatic hypotension. Serious adverse events in studies include elevated LFTs in 4.4%, depression including suicidal ideation or suicide attempt (2.6%), infection (1.0%), accident (1.0%), abscess (0.9%), chest pain (0.6%), and GI issues (0.5%); these occurred in patients on high doses, and most could be attributed to some other cause than suboxone, such as those with raised LFTs mostly had hepatitis, and those with depression were all at one centre so may have been a centre-specific phenomenon.xxiv Suboxone can also induce withdrawal, as it displaces other opioids in the patient’s system due to its strong association to the mu-opioid receptor. Symptoms of withdrawal include muscle and joint pains, restlessness, irritability, nausea, vomiting, diarrhea, and insomnia. Signs of withdrawal are diaphoresis, rhinorrhea, piloerection, tachycardia, hypertension. Suboxone can also cause hepatic abnormalities, and it is wise to do baseline liver function tests and subsequent tests every three to six months for monitoring.xxv While theoretically patients with hepatic disease would clear buprenorphine less efficiently, limited data suggest that clinically no dose adjustments are required in patients with hepatic disease.xxvi Suboxone is well tolerated in patients with renal failure. Buprenorphine has been used in France since about 1996, for maintenance therapy. Overall, the safety profile has been excellent, however, there have been at least twenty deaths attributable to overdose by parentaral use while taking other CNS depressants (these deaths were in patients taking buprenorphine without the nalaxone combination).xxvii When overdose does occur, either with suboxone alone or in combination with other respiratory depressants, the respiratory depression may be prolonged and more difficult to treat with naloxone due to buprenorphine’s high affinity for the mu-opioid receptor.xxviii Even where there are milder symptoms, patients may need to be admitted to hospital for monitoring, as symptoms of overdose can persist for twelve to twenty-four hours.xxix Certainly, suboxone does represent a hazard to pediatric patients, and can lead to significant centreal nervous system and respiratory depressant effects.xxx Care should be taken to ensure that any take-home doses are stored away from children in child-proof containers, and patients should be counseled in this regard. 3. INTERACTIONS WITH OTHER MEDICATIONS Buprenorphine is metabolized by P450(CYP)3A4 in the liver to the active metabolite nubuprenorphine.xxxi This notable in terms of possible adverse effects when suboxone is prescribed with other medications. Inducers of CYP3A4, which would decrease the buprenorphine level, include phenytoin, carbamazepine, phenobarbital, and rifampin. Inhibitors, which would increase the buprenorphine level, include ketoconazole, fluvoxamine, erythromycin, indinavir, saquinavire. For patients who are HIV positive, it is important to note that suboxone interacts less with HART medications than methadone. 4. PRESCRIBING In terms of detailed information on how to prescribed suboxone for maintenance treatment, please see the prescribing algorithm (see Appendix A). To use suboxone for detoxification, induction of suboxone should be achieved until withdrawal symptoms are under control. The dose can then be tapered over three to ten days or longer.xxxii If naltrexone management is to be used after suboxone tapering, it should not be started for at least seven days after the last dose of suboxone.xxxiii A longer tapering schedule does not appear to improve outcomes in withdrawal treatment.xxxiv Besides a physician and nurses to prescribe and administer suboxone, a suboxone program requires other interdisciplinary team members. As is emphasized in the prescribing algorithm, when used for maintenance therapy prescriptions of suboxone should be accompanied by a full program including counseling. Counseling should focus on behaviour modification, social reintegration, coping skills, and motivation.xxxv On-site urine drug screening is very valuable, whether carried out by a lab technician or a nurse. A strong working relationship with a pharmacy that has experience with methadone or suboxone is an asset. Frequent communication between the pharmacist and the rest of the health care team is key in terms of safety. A debate that is logistically relevant to Inner City Health is whether or not patients must always be observed when taking suboxone. One RCT showed that retention in the maintenance program and heroin use were not significantly different between groups that were observed taking suboxone and those that were unobserved.xxxvi At the same time, unobserved dosing was much more cost effective.xxxvii Even more convenient for patients and prescribers is that suboxone can be dispensed less frequently than once daily, down to thrice weekly, once the patient is on a stable dose and this does not appear to decrease efficacy.xxxviii Comparison to Methadone Buprenorphine is as effective as methadone in treating opioid dependence.xxxix This has been well established, and clearly gives suboxone an important role in alleviating the methadone provider shortage. When used for withdrawal from opioids, a Cochrane review concluded that more data is required, but current studies indicate that withdrawal from buprenorphine may be more successful than withdrawal from methadone.xl Certainly, compared to clonidine or lofexidine, buprenorphine is more effective in reducing the symptoms of withdrawal, and patients on buprenorphine treatment are more likely to stay in treatment and to complete withdrawal treatment.xli Suboxone is easier to prescribe than methadone. It takes a few days to one week to titrate suboxone to an effective dose, whereas methadone titration can take weeks.xlii Similarly, suboxone is can be more easily and quickly tapered than methadone.xliii According to a Cochrane review, the severity of withdrawal from buprenorphine and methadone are the same, but withdrawal may resolve more quickly with buprenorphine.xliv Suboxone has been shown to be safer in overdose than methadone.xlv This is very significant, as the risk of overdose is so high amongst methadone users. For patients at high risk of overdose, such as the patient case at the beginning of this paper of M. R., suboxone may be a better choice. However, it must be remembered that if suboxone is combined with other respiratory depressants, such as alcohol or benzodiazepines, it can still be fatal secondary to respiratory depression. When suboxone is prescribed at maximal doses, it may not always be sufficient for patients who use high doses of opioid daily. In this case, the recommendation is to switch treatment to methadone, which can be titrated to a higher dose than suboxone.xlvi For patients who use very high amounts of opioid, the best treatment may still be methadone if you anticipate they will not be able to achieve full remission on suboxone. For pregnant patients, methadone is still the gold standard of treatment. Suboxone can be prescribed in any outpatient office. The CPSO does have guidelines for physicians prescribing suboxone that recommend that physicians have experience with addictions and education in suboxone before prescribing it (see Appendix B). For many patients, such as those at Inner City Health, it is more convenient for them to receive suboxone from their primary practitioner rather than having a special addictions doctor, which is required for methadone. This allows for them to receive more holistic care. Office-based treatment has many other advantages, including reduced stigma, increased availability, more flexibility to cater to individual patients’ needs, and limiting of patients’ contact with other drug addicted patients.xlvii Conclusion Suboxone holds a lot of promise as an alternative to methadone that can be prescribed within the Inner City Health framework. It is safe, effective, and relatively easy to manage and prescribe. However, there are a few obstacles that can be expected in implementing a suboxone maintenance and/or detoxification program. Firstly, maintenance treatment is by definition long-term, even lifelong, and patients at Inner City Health are with the program for variable periods of time. Practitioners that are willing to take on these patients when they leave the Inner City Health Program and continue their suboxone treatment will have to be set-up before therapy can start. In addition, the demands of supervised dosing and frequent dosing and urine drug screening may prove to be heavy demands on already hard worked staff at Inner City Health. On the other hand, the advantages of the Inner City Health set-up for prescribing suboxone are many. Maintenance and withdrawal treatment should always be accompanied by supportive counseling and attention to all of the social determinants of health – areas in which Inner City Health excels with its dedicated nursing and support staff that know the patients well. Inner City Health also has ample experience in addictions and concurrent disorders that they can bring to prescribing this new therapy. As with any new medication, there will be a learning curve if suboxone is introduced to the Inner City Health Program. Please access the below resources for more information and continued support. Further training: • SAMHSA training module: http://buprenorphine.samhsa.gov/tip43_curriculum.pdf • SAMHSA guidelines: http://buprenorphine.samhsa.gov/Bup_Guidelines.pdf i Bridge TP, Fudala PJ, Herbert S, Leiderman DB. Safety and health policy considerations related to the use of buprenorphine/naloxone as an office-based treatment for opiate dependence. Drug Alcohol Depend. 2003 May 21;70(2 Suppl):S79-85. ii Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. iii Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. iv Schering-Plough Canada I. SuboxoneTM Product Monograph. 2007. v Walsh SL, Preston KL, Stitzer ML, et al. Clinical pharmacology of buprenorphine: Ceiling effects at high doses. Clin Pharmacol Ther 1994;55:569-580. vi Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. Cicero TJ, Inciardi JA. Potential for abuse of buprenorphine in office-based treatment of opioid dependence. N Eng J Med 2005;353:1863-1865 vii Schering-Plough Canada I. SuboxoneTM Product Monograph. 2007. viii Schering-Plough Canada I. SuboxoneTM Product Monograph. 2007. ix Schering-Plough Canada I. SuboxoneTM Product Monograph. 2007. x Elkader A, Sproule BA. Buprenorphine: Clinical pharmacokinetics in the treatment of opioid dependence. Clinical Pharmacokinetics 2005;44:661-680. xi Chiang CN, Hawks RL.Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Drug Alcohol Depend. 2003 May 21;70(2 Suppl):S39-47. xii Schering-Plough Canada I. SuboxoneTM Product Monograph. 2007. xiii Isaac P, Janecek E, Kalvik A, Sproute B. Buprenorphine: a new treatment for opioid dependence. Pharmacy Connection 2008; CAMH. xiv Helm II S, Trescot AM, Colson H, et al. Opioid antagonists, partial agonists, and agonists/antagonists: the role of office-based detoxification. Pain Physician 2008;11:225-235. xv Chiang CN, Hawks RL.Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Drug Alcohol Depend. 2003 May 21;70(2 Suppl):S39-47. xvi Alho H, Sinclair D, Vuori E, Holopainen A. Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. Drug Alcohol Depend. 2007 Apr 17;88(1):75-8. xvii Chiang CN, Hawks RL.Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Drug Alcohol Depend. 2003 May 21;70(2 Suppl):S39-47. xviii Welsh C, Sherman SG, Tobin KE. A case of heroin overdose reversed by sublingually administered buprenorphine/naloxone (Suboxone). Addiction. 2008 Jul;103(7):1226-8. xix Woody GE, Poole SA, Subramaniam G, Dugosh K, Bogenschutz M, Abbott P, Patkar A, Publicker M, McCain K, Potter JS, Forman R, Vetter V, McNicholas L, Blaine J, Lynch KG, Fudala P. Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial. JAMA. 2008 Nov 5;300(17):2003-11. xx Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. xxi Isaac P, Janecek E, Kalvik A, Sproute B. Buprenorphine: a new treatment for opioid dependence. Pharmacy Connection 2008; CAMH. xxii Silversides, A. Ontario takes aim at painkiller abuse. CMAJ 2009; 181(8):E141. xxiii Sporer KA. Buprenorphine: A primary for emergency physicians. Ann of Emerg Med 2004;43(5):580583 xxiv Bridge TP, Fudala PJ, Herbert S, Leiderman DB. Safety and health policy considerations related to the use of buprenorphine/naloxone as an office-based treatment for opiate dependence. Drug and Alcohol Depend 2003;70(suppl):S79-S85 xxv Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. xxvi Bridge TP, Fudala PJ, Herbert S, Leiderman DB. Safety and health policy considerations related to the use of buprenorphine/naloxone as an office-based treatment for opiate dependence. Drug and Alcohol Depend 2003;70(suppl):S79-S85 xxvii Bridge TP, Fudala PJ, Herbert S, Leiderman DB. Safety and health policy considerations related to the use of buprenorphine/naloxone as an office-based treatment for opiate dependence. Drug and Alcohol Depend 2003;70(suppl):S79-S85 xxviii Isaac P, Janecek E, Kalvik A, Sproute B. Buprenorphine: a new treatment for opioid dependence. Pharmacy Connection 2008; CAMH. xxix Sporer KA. Buprenorphine: A primary for emergency physicians. Ann of Emerg Med 2004;43(5):580583 xxx Schwarz KA, Cantrell FL, Vohra RB, Clark RF. Suboxone (buprenorphine/naloxone) toxicity in pediatric patients: a case report. Pediatr Emerg Care. 2007 Sep;23(9):651-2. xxxi Elkader A, Sproule BA. Buprenorphine: Clinical pharmacokinetics in the treatment of opioid dependence. Clinical Pharmacokinetics 2005;44:661-680. xxxii Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. xxxiii Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. xxxiv Orman JS, Keating GM. Buprenorphine/Naloxone: a review of its use in the treatment of opioid dependence. Drugs 2009;69(5):577-607. xxxv Collins GB, McAllister MS. Buprenorphine maintenance: A new treatment for opioid dependence. Cleveland Clinic Journal of Medicine 2007;74(7):514-520. xxxvi Bell J, Shanahan M, Mutch C, Rea F, Ryan A, Batey R, Dunlop A, Winstock A. A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphinenaloxone for heroin dependence. Addiction. 2007 Dec;102(12):1899-907. Epub 2007 Sep 3. xxxvii Bell J, Shanahan M, Mutch C, Rea F, Ryan A, Batey R, Dunlop A, Winstock A. A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphinenaloxone for heroin dependence. Addiction. 2007 Dec;102(12):1899-907. Epub 2007 Sep 3. xxxviii Orman JS, Keating GM. Spotlight on buprenorphine/naloxone in the treatment of opioid dependence. CNS Drugs. 2009 Oct 1;23(10):899-902. xxxix West SL, O’Neal KK, Graham CW. A meta-analysis comparing the effectiveness of buprenorphine and methadone. J of Subst Abuse 2000;12:405-414 Ling W, Wesson DR. Clinical efficacy of buprenorphine: Comparisons to methadone and placebo. Drug Alcohol Depend 2003;70(suppl):S49-S57 xl Gowing L, Ali R, White JM. Buprenorphine for the management of opioid withdrawal. The Cochrane Library: John Wiley & Sons Ltd; 2009, issue 4. xli Gowing L, Ali R, White JM. Buprenorphine for the management of opioid withdrawal. The Cochrane Library: John Wiley & Sons Ltd; 2009, issue 4. xlii Isaac P, Janecek E, Kalvik A, Sproute B. Buprenorphine: a new treatment for opioid dependence. Pharmacy Connection 2008; CAMH. xliii Isaac P, Janecek E, Kalvik A, Sproute B. Buprenorphine: a new treatment for opioid dependence. Pharmacy Connection 2008; CAMH. xliv Gowing L, Ali R, White JM. Buprenorphine for the management of opioid withdrawal. The Cochrane Library: John Wiley & Sons Ltd; 2009, issue 4. xlv Robinson SE. Buprenorphine-containing treatments. Place in the management of opioid addiction. CNS Drugs 2006;29: 697-712. xlvi Isaac P, Janecek E, Kalvik A, Sproute B. Buprenorphine: a new treatment for opioid dependence. Pharmacy Connection 2008; CAMH. xlvii Bridge TP, Fudala PJ, Herbert S, Leiderman DB. Safety and health policy considerations related to the use of buprenorphine/naloxone as an office-based treatment for opiate dependence. Drug and Alcohol Depend 2003;70(suppl):S79-S85 Appendix A: Suboxone Protocol for Ottawa Inner City Health This protocol is adapted from the following: 1. the online educational module for Suboxone CMEi 2. CPSO policy on buprenorphine hydrochlorideii 3. CAMH toolkit for buprenorphine and methadone providersiii Training for nurses and nurse practitioners: 1. nurses should have experience and training in opioid addictions 2. complete the online suboxone CME training program at www.suboxonecme.ca 3. attend a clinical observership for one day methadone clinics to become familiar with the current treatment of chronic opioid dependence Initial Assessment: Identifying patients who may benefit from suboxone and gathering patient information 1. History a.) inquire about substance use, directly inquiring about each substance: - opioids - stimulants, sedatives, cannabis - alcohol - tobacco - buprenorphine, methadone b.) for each substance that is used: - age at first use - quantity, frequency, routes of administration, time of last use - whether withdrawal symptoms have been experienced - consequences of use: job, family, legal - the stage of change the patient is in regarding quitting the substance (see Prochaska’s Stages of Change below) - past attempts at treatment c.) past medical history: - all chronic conditions, past hospitalizations, surgeries - HIV/Hepatitis status - ask whether immunized against Hepatitis A and B - if IVDU, ask about complications such as abscesses, endocarditis, septic arthritis - obstetrics and gyne history: LMP, regularity of periods, birth control, pregnancies, births - psychiatric history: anxiety, depression, mania, psychosis, eating disorders, personality disorders, suicide attempts, suicidal ideation d.) medications: - document all medications, asking in particular about prescription antipsychotics, sleeping agents, anxiolytics - e.) f.) g.) h.) i.) if on methadone, document length of treatment, number of relapses, S/E of treatment, attempts at overdose on methadone, use of other opioids while on methadone - inquire about allergies to medications social history: - housing situation, including whether patient lives with other drug users - whether the patient lives with or cares for children - employment - drug coverage - domestic violence - high risk activities such as unprotected sex, sharing needles, impaired driving - legal issues - current social supports and likelihood of patient accessing them effectively family history of substance abuse obtain collateral hx, only if consent from the patient is given, by contacting family/friends and obtaining past medical records consider completing a standardized tool, such as the baseline Maudsley Addiction Profile (available online for free at http://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_346_MAP.pdf ) for a good initial assessment, see the sample form used at CAMH in Toronto (see Toolkit item A) Actions depending on above: • if not immunized for Hepatitis A and B, offer this to patient • if of childbearing age and no desire for pregnancy, counsel regarding birth control • begin process of optimizing chronic medical conditions • according to need for housing and social support, refer patient to appropriate social services • consider involving CAS if children are involved for protection and support • consider filling out MOT form regarding concerns about impaired driving if patient discloses impaired driving • consider suboxone only if patient meets DSMIV criteria for opioid dependence, not simply opioid use or abuse: - DSMIV Criteria for substance dependence: maladaptive pattern of substance use leading to clinically significant impairment or distress as manifested by ≥3 occurring at any time in the same 12 month period: tolerance (need for increased amount to achieve intoxication or diminished effect with same amount of substance) withdrawal/use to avoid withdrawal taken in larger amount or over longer period than intended persistent desire or unsuccessful efforts to cut down - • if patient has opioid dependence, consider suggesting suboxone only if the patient is in the contemplation or planning stage of quitting; if pre-contemplative, refer for further counseling - • • • • • • excessive time to procure, use substance, or recover from its effects important interests/activities given up or reduced continued use despite physical/psychological problem caused/exacerbated by substance Prochaska’s stages of change: precontemplation contemplation preparation action maintenance termination (see the excellent American Family Physician review article on the stages of change available for free at http://www.aafp.org/afp/20000301/1409.html) if using opioids along with sedatives such as benzodiazepines and alcohol, the patient is not safe to use suboxone until they cease using sedatives due to the increased risk of respiratory depression, coma, and even death pregnant patients should be referred for methadone HIV positive patients should be referred for suboxone because there are less interaction with HAART compared to methadone counsel patient regarding their choice of methadone vs suboxone if eligible for both if using methadone, the patient is not eligible to switch to suboxone if methadone treatment is progressing well. In communication with the patient’s methadone provider, consider a change to suboxone only if: - the patient is experiencing significant side effects from methadone - the patient is at risk of overdose - the patient is using other opioids on top of methadone regularly - the patient is failing methadone treatment i.e. relapsing very often - the patient has been informed and understands that the methadone needs to be tapered first and this will take time currently suboxone is not covered by ODSB, and if the patient does not have drug coverage, they would need to be willing and able to afford $90-460 a month for suboxone 2. Physical Exam a.) vital signs b.) general appearance - euphoria/dysphoria - motor retardation - slowed/slurred/pressured speech c.) d.) e.) f.) g.) h.) i.) j.) k.) - sedation - affect consider MMSE head and neck - cervical lymph nodes - evidence of thrush cardiac - murmurs - indications of endocarditis: splinter hemorrhages in nails, janeway lesions respiratory - signs of pneumonia, COPD, TB abdominal - signs of chronic liver disease: jaundice, hepatosplenomegaly, ascites, pedal edema, asterixis, palmar erythema, leukonycia, spider nevi, gynecomastia, testicular atrophy pelvic: consider pap test and/or STI screening if indicated peripheral vascular dermatological - skin and soft tissue infections - evidence of IVDU - evidence of Kaposi’s sarcoma neurological - pupils - gait - observe for tremor: action, intention, rest - cerebellar testing: tandem gait, finger-to-nose, heel-to-shin, dysdiadokinesis 3. Investigations a.) baseline bloodwork: CBC with differential, creatinine, urea, electrolytes, LFTs b.) urine pregnancy test c.) urine toxicology screening d.) offer and counsel regarding HIV, hepatitis B and C, and syphilis testing e.) consider Mantoux test if risk factors f.) consider CXR if querying TB, aspiration pneumonia g.) consider ECG if on methadone to identify prolonged QT interval Action on above: refer to physician with results of physical exam and investigations. Managing Treatment Initiation: Follow-up in the first two months of treatment 1. obtain a copy of the written contract signed by the patient and physician (see Toolkit item B for a sample contract); review terms of contract with patient as needed 2. the first dose of suboxone should be administered by a physician who then follows that patient for the next 24hrs (see Initiation of Suboxone Appendix C) - observation of withdrawal symptoms within the first 45-90min after the administration of suboxone indicates precipitated withdrawal and requires physician management to manage withdrawal symptoms with non-opioid, non-sedating agents - observation of withdrawal symptoms 5-24hrs after the first dose of suboxone indicates inadequate dosage of suboxone and requires physician management to increase suboxone 3. the physician will monitor dosage of suboxone and may increase the dose incrementally with the suboxone dose never exceeding 24mg SL OD 4. daily administration of suboxone - confirm the patient’s identity - the sublingual tablet takes 2-10min to dissolve; observe the patient in a private area to ensure the entire dose is taken - record the time and date of the dose in a patient log - withhold dose if patient displays signs of intoxication and contact the physician - do not replace a dose of suboxone, even if the patient swallows or vomits it 5. missed doses of suboxone - if misses <3 days of suboxone therapy, document reason for missing and continue at regular dose - if misses >3 days of suboxone therapy, needs full reassessment by physician and re-induction with suboxone 6. urine drug screening - performed twice weekly to weekly - do not observe the patient voiding; to test for adulteration of urine, check that urine is at body temperature and pH is 4.5-8 7. supportive counseling 8. monitoring for adverse events, which are most commonly due to withdrawal or agonist effects: Location Body as a Whole Cardiovascular System Digestive System Central Nervous System (CNS) Musculoskelet al System Metabolism Common Adverse events (≥5%) Headache, pain, withdrawal syndrome, infection, back pain, flu syndrome, abdominal pain, accidental injury, asthenia, chills, fever Vasodilation Constipation, nausea, vomiting, diarrhea, dyspepsia, tooth disorder Insomnia, depression, anxiety, nervousness, somnolence, dizziness, paresthesia Myalgia Peripheral Edema and Nutritional Disorders Respiratory System Skin Rhinitis, pharyngitis, increased cough Sweating 9. Report adverse events to Health Canada 10. continue to optimize other medical conditions 11. continue to offer social supports Action depending on above: • inform physician if you suspect diversion of suboxone • inform physician of every positive drug screen • inform physician if you suspect adulteration of urine drug screens • inform physician of missed doses of suboxone • inform physician of adverse effects Managing Long-Term Treatment: Follow-up during the maintenance period of treatment 1. administration of suboxone - the physician may start to dose suboxone every other day or three times a week once a stable dose has been achieved 2. tapering suboxone should be done by a physician (see Tapering of Suboxone, Appendix D). During tapering, it is important to monitor: - whether the patient is using other opioids or other drugs - medical condition - psychiatric condition - psychosocial functioning 3. urine drug screening - urine drug screening should continue on a weekly basis until there has been six months of negative screens - after six months of negative screens, start screening biweekly and consider monthly screening 4. continue to optimize other medical conditions 5. continue to offer social supports Action depending on above: • inform physician if you suspect diversion of suboxone • inform physician of every positive drug screen Managing Withdrawal: Follow narcotic withdrawal protocol Action for above: contact patient’s physician prescriber of Suboxone i CPC Healthcare Communications for Scherling-Plough Canada. Suboxone Education Program. Accessed at www.suboxonecme.ca on Feb 24th 2010. ii CPSO. Buprenorphine Hydrochloride for the Treatment of Opioid Dependence. 2007. Accessed at http://www.cpso.on.ca/policies/policies/default.aspx?ID=1826 on Feb 26th 2010. iii CAMH. The CAMH Toolkit for Buprenorphine and Methadone Providers. Accessed at http://www.camh.net/Publications/Resources_for_Professionals/clinic_toolkit_methadon e/clinic_toolkit_methadone.html on Feb 25th 2010. Appendix B: CPSO Physician Requirements to Prescribe Suboxone Physician training recommendations by the CPSOi: a.) physicians do not need to complete a section 56 methadone exemption1 from Health Canada to prescribe suboxone, but the CPSO recommends that physicians obtain one b.) the CPSO recommends the following training: - successful completion of a prescribing course in buprenorphine that provides appropriate training for treating opioid dependency - completion of a one-day clinical observership of an opioid-dependency practice e.g. where methadone and/or buprenorphine are currently prescribed - ongoing CME in opioid-dependency treatment and/or addiction medicine c.) there are no guidelines currently for suboxone by the CPSO; physicians are expected to refer to the 2005 Methadone guidelines d.) buprenorphine is a narcotic, therefore its prescription must comply with the Controlled Drugs and Substances Act i CPSO. Buprenorphine Hydrochloride for the Treatment of Opioid Dependence. 2007. Accessed at http://www.cpso.on.ca/policies/policies/default.aspx?ID=1826 on Feb 26th, 2010. Appendix C: Initiation of Suboxone Maintenance Therapy This protocol is adapted from the following: 1. the online educational module for Suboxone CMEi 2. CPSO policy on buprenorphine hydrochlorideii 3. CAMH toolkit for buprenorphine and methadone providersiii 1. arrange for early morning dosing of suboxone so that withdrawal symptoms can be monitored through the day 2. do a urine toxicology screen prior to initiation 3. ensure the patient has taken no sedatives recently and reinforce the danger of taking sedatives with suboxone 4. consider relative and absolute contraindicaions: a.) relative contraindications: benzodiazepine use b.) absolute contraindications: breastfeeding, pregnancy c.) other opioids should not be used for analgesic relief, as they will not be effective and this may result in the patient overdosing 5. consider type of opioid addiction: - if the patient is taking heroin or other short-acting opioids, suboxone should not be started until at least 4hrs after the last dose of opioid and preferably once withdrawal symptoms have begun to present themselves - if the patient is taking methadone, the dose of methadone should be tapered to 30mg per day first and then suboxone should not be started until at least 24hrs after the last dose of methadone and preferably once withdrawal symptoms have begun to present themselves -> this should be done in consultation with the patient’s methadone prescriber 6. prescriptions must specify the following: - date - doctor’s name, address, prescribing number - name of drug - dosage in numbers and words - start and end dates - days to be observed and days for carries - patient’s name and address - pharmacy name – as the patient should always be using the same pharmacy for safety and so the physician can communicate with their pharmacist - physician’s signature and full name - no refills are allowed - a new prescription must be written if the patient is switching pharmacies 7. start every patient on a 4mg SL dose of suboxone as a starting dose 8. observe the patient taking suboxone sublingually until the medication has fully dissolved 9. see patient approximately 90min after administering the first dose -> if experiencing withdrawal symptoms, this is precipitated withdrawal - reassure the patient that these symptoms will resolve within a few hours - emphasize that using another opioid will not alleviate symptoms and will interfere with the induction process - offer non-sedating, non-opioid symptomatic treatments e.g. anti-emetics, clonidine, NSAIDs, anti-diarrheals 10. be available to the patient in the next 24hrs if they should start to experience withdrawal symptoms that start after the first 4hrs of treatment, as this is indicative of acute withdrawal and a higher dose of suboxone is needed - reassure the patient that the dose of suboxone will be titrated up - may provide another 4mg SL dose of suboxone in the first 24hrs 11. titration of suboxone dose - maximum dose of suboxone is 24mg SL OD - less opioid use and better treatment retention at doses >16mg SL OD - example of a monitored induction from suboxone training program: Day 1 2 3 4 5 6+ - • • • i Potential Regime 4 mg 6 mg 8 mg 10 mg 12 mg Dose titration stops once patient is stable and not experiencing withdrawal. Daily Dose 8 mg 4-10 mg 6-12 mg 8-14 mg 10-16 mg 16-18 mg during initiation, monitor the patient on a daily basis once the dose of suboxone has stabilized, the patient may choose to have every other day or three times weekly dosing of suboxone every other day dosing: every other day twice the individually titrated dose is given, never exceeding more than 24mg SL OD three times weekly dosing: Monday and Wednesday twice the individually titrated dose is given, and Friday three times the individually titrated dose is given, never exceeding more than 24mg SL OD in the first two months of therapy, take-home doses are only allowed on weekends and statutory holidays after at least two months of therapy, can consider take-home doses of suboxone ensure the patient has a safe place to store the medication consider specifying childproof packaging on the prescription missed doses: <3 days of maintenance therapy missed -> continue on same dose, reassess stability, document reasons for missing doses >3 days of maintenance therapy missed -> fully reassess the patient, begin induction again CPC Healthcare Communications for Scherling-Plough Canada. Suboxone Education Program. Accessed at www.suboxonecme.ca on Feb 24th 2010. ii CPSO. Buprenorphine Hydrochloride for the Treatment of Opioid Dependence. 2007. Accessed at http://www.cpso.on.ca/policies/policies/default.aspx?ID=1826 on Feb 26th 2010. iii CAMH. The CAMH Toolkit for Buprenorphine and Methadone Providers. Accessed at http://www.camh.net/Publications/Resources_for_Professionals/clinic_toolkit_methadone/clinic_toolkit_m ethadone.html on Feb 25th 2010. Appendix D: Tapering of Suboxone 1. determine the likelihood of success that the patient will remain drug-free after tapering by first addressing poor prognostic factors: - continues to use other opioids or other drugs - unstable medical condition - unstable psychiatric condition - poor psychosocial functioning - continues to be surrounded by same environment or elements of the same environment they associate with using 2. patients who are pregnant and likely to use again should not have their suboxone tapered 3. the patient must be fully informed about the process of tapering, and expectations must be discussed 4. a plan should be made for increasing monitoring and assessments 5. if the tapering is gradual, which can take up to one year, the patient should not need supplementary medications 6. have a plan for post-tapering treatment options e.g. long-term counseling, psychiatric follow-up, medical follow-up 7. to taper, according to the Suboxone education module: Daily Dose >16 mg 4-16 mg Progressively reduce dose by: 2-4 mg/week 2 mg/week Addiction Medicine First Assessment Form 1 Client Data Name: _______________________________________ MRN: ___________ Date: _______________ DOB: ________/________/_____ ___ Age: _____ Phone : ( ) ______________________ Address: ___________________________________________________________________________ ODB#: __________________________ Family Physician: ___________________________________ Specialist(s): _______________________________________________________________________ Referral Source: _________________________ Physician’s Phone: ( ) _______________________ Emergency Contact Name: __________________________ Phone: ( ) _______________________ 2 Confidentiality Please review the following information with the client, answer any questions he or she may have about confidentiality and ask for a signature. Everything that you tell the clinic staff is confidential except under the following circumstances, when we must report something you tell us to the appropriate authority: • If we suspect that a child is being abused or neglected, it is the law that we report this information. • If you reveal to the staff that you intend to harm another person, we are obliged to protect that person by notifying the appropriate authority. • If a court subpoenas your chart we must release it to the party that requests it. • If you become suicidal or homicidal, or are unable to take care of yourself due to a psychiatric condition, you might be held against your will to be assessed by a psychiatrist. • If it is suspected that you are unable to drive a car due to a medical condition (which includes intoxication from alcohol or drugs), we are obliged to notify the Ministry of Transportation of this and may confiscate your car keys. • Certain infectious diseases, when detected, must be reported to the Public Health Department. Examples include tuberculosis and HIV. Confidentiality has been explained to me and my questions about it have been answered to my satisfaction. ______________________________ Client Signature ___________ Date 1 3 Profile (age, marital status, living arrangements, occupation, children) ______________________________________________________________________ ______________________________________________________________________ 4 Reason for Referral ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ 5 History of Primary Substance Use What is/are the client’s substance(s) of choice? ______________________________________________________________________ ______________________________________________________________________ Describe the characteristics of use (amount, frequency of use [now, 1st use, 1st regular use], route, whether substance is prescribed): ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Does the client use alone or with others? ______________________________________________________________________ **For EtOH or benzo abuse only: Is there a history of withdrawal seizures? If so, how often? What is date of last seizure? ________________________________________ ____________________________________________________________________ What medical complications of drug use has the client experienced? ______________________________________________________________________ 2 ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Which treatment is desired? ______________________________________________________________________ Why is the client coming for help now? ______________________________________________________________________ Indicate below what other drugs of abuse the client has used or currently uses. Drug Opioids Amount Route Pattern / Duration Last Use Ethanol Tobacco THC Sedatives Cocaine Stimulants Hallucinogens/GHB Solvents 6 Substance Use Treatment 3 Describe the current and/or planned treatment. ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Describe any past treatment or detox the client has undergone for substance use. ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ 7 High-Risk Behaviour Does the client’s behaviour include yes no impaired driving? ________________________________________________________________ IV drug use / sharing of paraphernalia / blood transfusions / tattoos? yes no ________________________________________________________________ unprotected sex? yes no ________________________________________________________________ possibility of pregnancy? yes no ________________________________________________________________ Date of client’s last HIV test:_____________ Last Hep B/C test:_______________ Other comments on high-risk behaviour: ____________________________________ _____________________________________________________________________ 4 8 Consequences of Substance Use Describe the major consequences of the client’s substance use. ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ 9 Medical History Describe the client’s past medical history. ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ List any medications that are currently prescribed to the client. Name:_______________________ Dose: ____________ Frequency: ___________ Name:_______________________ Dose: ____________ Frequency: ___________ Name:_______________________ Dose: ____________ Frequency: ___________ Name:_______________________ Dose: ____________ Frequency: ___________ Name:_______________________ Dose: ____________ Frequency: ___________ List any OTC medications the client currently uses. Name:_________________________Dose: ______________Frequency: ___________ Name:_________________________Dose: ______________Frequency: ___________ 5 Describe any allergies the client has. _____________________________________________________________________ _____________________________________________________________________ 10 Psychiatric History Psychiatric diagnosis:_______________________________________________ _____________________________________________ Year: ____________ Psychiatrist: ________________________________________________________ Hospitalizations (date, duration and diagnosis): _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ Is the client currently suicidal? yes no __________________________________________________________________ Does the client have a history of suicide attempts? yes no __________________________________________________________________ 11 Legal Problems Describe any legal problems that have resulted from the client’s substance use. ______________________________________________________________________ ______________________________________________________________________ Does the client have a history of being violent? yes no ______________________________________________________________________ 6 ______________________________________________________________________ 12 Relevant Family History Describe any history of addictions and/or mental health problems in the client’s family. ____________________________________________________________________ ____________________________________________________________________ 13 DSM-IV Criteria Please review these statements with reference to the client’s primary substance of choice and check off those to which the response is “yes”: In the last 12 months, Do you need more and more of the drug you are using to get the same effect? Describe what symptoms you experience if you suddenly stop taking the drug. ______________________________________________________________ ______________________________________________________________ Do you frequently take more drugs then you planned, or use a drug for longer than you had planned to? Have you had many unsuccessful attempts to cut down on your drug use? Do you spend a lot of your day getting, using and recovering from the effects of drugs? Have you given up work, social activities or other things you used to do because of your drug use? Do you keep taking drugs despite the harm and problems their use is causing you? 7 14 Examination BP: _____/_____ HR: ______ RR:______/min. Temp:______ °C Ht: ____cm Wt: ____kg Orientated? yes Smell of ethanol? yes no no Breathalyzer result: ___________ Mental status: _______________________________________________________ ___________________________________________________________________ ENT:__________________________________________________________________ Neuro:________________________________________________________________ Chest:________________________________________________________________ CVS:_________________________________________________________________ Abd:__________________________________________________________________ Skin:__________________________________________________________________ Tattoos? yes Tracks? yes Piercing? yes no ____________________________________________ no ____________________________________________ no ____________________________________________________________ Stigmata of liver disease? yes no _____________________________________ Other:_________________________________________________________________ 15 Problem List 1. ______________________________________________ 2. ______________________________________________ 3. ______________________________________________ 4. ______________________________________________ 5. ______________________________________________ 6. ______________________________________________ 8 16 Plan Describe the treatment plan. _____________________________________________ ____________________________________________________________________ ____________________________________________________________________ Describe the psychosocial support plan. ____________________________________ ____________________________________________________________________ ____________________________________________________________________ What laboratory tests are suggested? CBC INR ALT bilirubin albumin creatinine UDS HBsAg HCAb HIV BHCG anti-HBsAg AST GGT TB Other: _________________________________________________________ Examination done by: _____________________________ ________________________ ____________ Physician’s Name Physician’s Signature Date © 2008 Centre for Addiction and Mental Health, Toronto, Canada. Permission is granted for this document to be adapted as appropriate, copied and distributed for use by health professionals in the treatment of opioid dependence. All other rights are reserved. This document is available for download as part of the OpiATE Project Toolkit: please visit methadonesaveslives.ca. 9