Disclosures. Target Audience. A Focus on Local, Regional and Global Tools for Caring for Clients with Opioid Addictions

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1 Disclosures A Focus on Local, Regional and Global Tools for Caring for Clients with Opioid Addictions Dana Murphy-Parker, MS, CRNP, PMHNP-BC, CARN-AP Carmel Clancy, PhD, RN, BSc (Hons), FPH The International Nurses Society on Addictions Dana Murphy-Parker, MS, CRNP, PMHNP-BC, CARN AP No Disclosures Carmel Clancy No Disclosures September 28, Target Audience PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training (SECSAT). The overarching goal of PCSS-O is to offer evidence-based trainings on the safe and effective prescribing of opioid medications in the treatment of pain and/or opioid addiction. Our focus is to reach providers and/or providers-in-training from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators. For more information visit: For questions pcss-o@aaap.org Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department 3 of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

2 PCSS-O Colleague Support Program Educational Objectives PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications. PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management. Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties. The mentoring program is available at no cost to providers. For more information on requesting or becoming a mentor visit: Listserv: A resource that provides an Expert of the Month who will answer questions about educational content that has been presented through PCSS-O project. To join pcss-o@aaap.org. 5 At the conclusion of this activity participants should be able to: Incorporate updates of ASAM s Press Conference and Stakeholder Summit held in Washington, D.C. on September 2, Discuss ASAM s National Practice Guideline for the Use of Medications, pocket guide, mobile phone application, slide deck and future educational opportunities. Increase knowledge of online networking tools, specifically wikis and their role in building international co-operation from diverse cultural communities in the area of addiction Share initial lessons from GAaP s first 6 months of operation: planning and set up Explore with participants the challenges and possibilities particularly focusing on the impact of such methodology on achieving wider engagement on a global public health issue and enhancing interprofessional learning. 6 Definitions: No doubt, this is a Medical Disorder: A Neurobiological Disorder What is this about? ASAM defines addiction as a primary, chronic disease of brain reward, motivation, memory, and related circuitry, with a dysfunction in these circuits being reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) states Substance Use Disorder is a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues using the substance despite significant substance-related problems. Opioid use disorder (OUD) include. Opioid Use Disorder Opioid Intoxication Opioid Withdrawal Other Opioid-Induced Disorders Unspecified Opioid-Related Disorders 7 The ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use The ASAM National Practice Guideline is the 1st to include all FDA-approved medications in single document 8

3 Why is this so important? 9 12

4 Journal of Addictions Medicine (2015) Psychosocial Treatment in Conjunction With Medications for the Treatment of Opioid Use Disorder Just published: Kampman, K. & Jarvis, M. (2015). American Society of Addiction Medicine (ASAM) National Practice Guidelines for the Use of Medications in the Treatment of Addiction Involving Opioid Use. Journal of Addiction Medicine, 9 (5). September/October A review of the literature on the efficacy of psychosocial treatment to be used in conjunction with Medication Assisted Treatment (MAT) of opioid use disorder was conducted. The review was partially funded by National Institute of Drug Abuse (NIDA). Methodology of this review can be found with the ASAM journal article previously mentioned. A full article on the literature review will be published in a subsequent Journal of Addiction Medicine edition. 1 Categories covered in the National Practice Guidelines Assessment Diagnosis Treatment 15 ASSESSMENT The first clinical priority should be given to identifying and making appropriate referral for any urgent or emergent medical or psychiatric problem(s), including drug-related impairment or overdose. Completion of the patient s medical history should include screening for concomitant medical conditions, including infectious diseases (hepatitis, HIV, and TB), acute trauma, and pregnancy. (The leading causes of death in people using opioids for nonmedical purposes are overdose and trauma). A physical examination should be completed as a component of the comprehensive assessment process. The prescriber (the clinician authorizing the use of a medication for the treatment of OUD) may conduct this physical examination him/herself, or, in accordance with the ASAM Standards1, ensure that a current physical examination is contained within the patient medical record before a patient is started on a new medication for the treatment of his/her addiction. Initial laboratory testing should include a complete blood count, liver function tests, and tests for hepatitis A, B, C and HIV. Testing for TB and sexually transmitted infections should also be considered. Hepatitis A and B vaccination should be offered, for those who are pregnant and the general population. 16

5 Diagnosis Symptoms of Opioid Intoxication Other clinicians may diagnose OUD, but confirmation of the diagnosis by the provider with prescribing authority, and who recommends medication use, must be obtained before pharmacotherapy for OUD commences. OUD is primarily diagnosed on the basis of the history provided by the patient and a comprehensive assessment that includes a physical examination. Validated clinical scales that measure withdrawal symptoms may be used to assist in the evaluation of patients with OUD: Examples include; The Objective Opioid Withdrawal Scale (OOWS)a The Subjective Opioid Withdrawal Scale (SOWS)a The Clinical Opioid Withdrawal Scale (COWS)a Visit www. GuidelineCentral.com/OUD for calculators Drooping eyelids Constricted pupils Reduced respiratory rate Scratching (due to histamine release) Head nodding Urine drug testing during the comprehensive assessment process, and frequently during treatment, is recommended Withdrawal Signs Treatment Setting Yawning Rhinorrhea OOWS SOWS COWS Piloerection (observe arm) Perspiration Lacrimation Tremor (hands) Mydriasis Hot and cold flushes Restlessness Vomiting Muscle twitches Abdominal cramps Anxiety I feel anxious. I feel like yawning. I m perspiring. My eyes are tearing. My nose is running. I have goose flesh. I am shaking. I have hot flashes. I have cold flashes. My bones and muscles ache. I feel restless. I feel nauseous. I feel like vomiting. Pulse Sweating Restlessness Pupil size Bone or joint aches Rhinorrhea Tearing GI upset Tremor of outstretched hands Yawning Anxiety or irritability Gooseflesh skin 19 Clinicians should consider the patient s preferences, past treatment history, and treatment setting when deciding between the use of methadone, buprenorphine, and naltrexone in the treatment of addiction involving opioid use. The treatment setting described as Level 1 treatment in the ASAM Criteria may be a general outpatient location such as a clinician s practice site. The setting as described as Level 2 in the ASAM Criteria may be an intensive outpatient treatment or partial hospitalization program housed in a specialty addiction treatment facility, a community mental health center, or another setting. The ASAM Criteria describes Level 3 or Level treatment respectively as a residential addiction treatment facility or hospital. The venue in which treatment is provided is as important as the specific medication selected. 20

6 Treatment Setting, con t FDA Approved Medications for Opioid Use Disorder Opioid Treatment Programs offer daily supervised dosing of methadone, and increasingly of buprenorphine. Naltrexone can be prescribed in any setting by any clinician with the authority to prescribe any medication. In accordance with federal law (21 CFR ), Office-Based Opioid Treatment (OBOT), which provides medication on a prescribed weekly or monthly basis, is limited to buprenorphine. Clinicians should consider a patient s psychosocial situation, co-occurring disorders, and risk of diversion when determining whether Opioid Treatment Programs (OTP) or OBOT is most appropriate. OBOT may not be suitable for patients with active alcohol use disorder or sedative, hypnotic, or anxiolytic use disorder (or who are in the treatment of addiction involving the use of alcohol or other sedative drugs, including benzodiazepines or benzodiazepine receptor agonists). It may also be unsuitable for persons who are regularly using alcohol or other sedatives but do not have addiction or a specific substance use disorder related to that class of drugs. The prescribing of benzodiazepines or other sedative-hypnotics should be used with extreme caution in patients who are prescribed methadone or buprenorphine for the treatment of an OUD 21 Methadone Buprenorphine (In ASAM s pocket guide, reference to buprenorphine is for the combination buprenorphine/naloxone formulations. If the single reference is made to buprenorphine, it is referred to as buprenorphine monoproduct. Naltrexone, both the oral and the injectable (Vivitrol) Naloxone The Guideline Committee recommends the inclusion of clonidine as a practice to support opioid withdrawal. Clonidine is not FDA-approved for the treatment of opioid withdrawal but it has been extensively used off-label for this purpose. Clonidine may be used orally or transdermally at doses of mg every 6 8 hours with a maximum dose of 1.2 mg daily to assist in the management of opioid withdrawal symptoms. Its hypotensive effects often limit the amount that can be used. Clonidine can be combined with other non-narcotic medications targeting specific opioid withdrawal symptoms such as benzodiazepines for anxiety, loperamide for diarrhea, acetaminophen or nonsteroidal anti-inflammatory medications (NSAIDs) for pain, and ondansetron or other agents for nausea. 22 Venue for Treatment Setting Current Prescribers for Buprenorphine Opioid Treatment Programs offer daily supervised dosing of methadone, and increasingly of buprenorphine. Naltrexone can be prescribed in any setting by any clinician with the authority to prescribe any medication. In accordance with federal law (21 CFR ), Office-Based Opioid Treatment (OBOT), which provides medication on a prescribed weekly or monthly basis, is limited to buprenorphine. Clinicians should consider a patient s psychosocial situation, cooccurring disorders, and risk of diversion when determining whether Opioid Treatment Programs (OTP) or OBOT is most appropriate. Time Frame Past 30 days Past 60 days Past 90 days Last year Current 30 patient certified ,037 20,722 % 100 patient certified 68.% 15 60% 65.6% 67.1% 67.9% ,89 9,801 % Total 31.6% % % 1,388 32,9%,526 30, % 23 2

7 The TREAT ACT Obama Administration Makes Big Announcement Addressing Heroin Epidemic Introduced in July, 201 by Senator Edward J. Markey (D-Massachusetts) introduced the Recovery Enhancement for Addiction Treatment (TREAT ACT). This bill will increase the number of patients that qualified physicians could treat for opioid dependency and, for the first time, allow certain nurse practitioners and physician assistants to treat patients by allowing other prescribers to prescribe buprenorphine. This legislation is supported by: The American Medical Association The American Society of Addictions Medicine The American Association of Nurse Practitioners The International Nurses Society on Addictions Rundio, A (2015). Landmark legislation to expand treatment for heroin and prescription drug addiction. Journal of Addictions Nursing,26 (3), pp This past spring, Sen. Edward Markey (D-Mass.) and Sen. Rand Paul (R-Ky.) introduced legislation that would raise the first-year cap from 30 patients to 100 and offer nurse practitioners and physician assistants the ability to prescribe the medication. After one year, doctors could seek to remove the cap entirely Buprenorphine, a Partial Agonist Buprenorphine, con t Opioid-dependent patients should wait until they are experiencing mild to moderate opioid withdrawal before taking the first dose of buprenorphine to reduce the risk of precipitated withdrawal. Generally, buprenorphine initiation should occur at least 6 12 hours after the last use of heroin or other short-acting opioids, or 2 72 hours after their last use of long-acting opioids such as methadone. Induction of buprenorphine should start with a dose of 2 mg. Dosages may be increased in increments of 2 mg. Clinicians should observe patients in their offices during induction. However, home buprenorphine induction may be considered. Home-based induction is recommended only if the patient or prescribing physician is experienced with the use of buprenorphine. Buprenorphine doses after induction and titration should be, on average, 8 mg per day. However, if patients are continuing to use opioids, consideration should be given to increasing the dose by 8 mg (daily doses of mg or higher). The FDA approves dosing to a limit of 2 mg per day, and there is limited evidence regarding the relative efficacy of higher doses. In addition, the use of higher doses may increase the risk of diversion. When considering a switch from buprenorphine to naltrexone, 7 1 days should elapse between the last dose of buprenorphine and the start of naltrexone to ensure that the patient is not physically dependent on opioids prior to starting naltrexone. When considering a switch from buprenorphine to methadone, there is no required time delay since the addition of a full mu-opioid agonist to a partial agonist does not typically result in any type of adverse reaction. Patients who discontinue agonist therapy and resume opioid use should be made aware of the risks associated with an opioid overdose, and especially the increased risk of death

8 Methadone Methadone, con t Methadone is a treatment option recommended for patients who are physiologically dependent on opioids, able to give informed consent, and who have no specific contraindications for agonist treatment when it is prescribed in the context of an appropriate plan that includes psychosocial intervention. The recommended initial dose ranges for methadone are from mg with reassessment in 3 hours, and a second dose not to exceed 10 mg on the first day if withdrawal symptoms are persisting. The usual daily dosage of methadone ranges from mg. Some patients may respond to lower doses, and some patients may need higher doses. Dosage increases in 5 10 mg increments applied no more frequently than every 7 days (depending on clinical response) are necessary to avoid over-sedation, toxicity, or even iatrogenic overdose deaths. The administration of methadone should be monitored because unsupervised administration can lead to misuse and diversion. OTP regulations require monitored medication administration until the patient s clinical response and behavior demonstrates that the prescribing of non-monitored 29 doses is appropriate. Switching from methadone to another medication for the treatment of OUD may be appropriate if the patient experiences intolerable side effects or is not successful in attaining or maintaining treatment goals through the use of methadone. Patients switching from methadone to buprenorphine in the treatment of OUD should be on low doses of methadone prior to switching medications. Patients on low doses of methadone (30 0 mg per day or less) generally tolerate transition to buprenorphine with minimal discomfort, whereas patients on higher doses of methadone may experience significant discomfort in switching medications. Patients switching from methadone to oral naltrexone or extended-release injectable naltrexone must be completely withdrawn from methadone and other opioids, before they can receive naltrexone. The only exception would apply when an experienced clinician receives consent from the patient to embark on a plan of naltrexone-facilitated opioid withdrawal management. Patients who discontinue agonist therapy with methadone or buprenorphine and then resume opioid use should be made aware of the risks associated with opioid overdose, and especially the increased risk of death. 30 Naltrexone, an Opioid Antagonist Medication Naltrexone, con t Naltrexone is a recommended treatment in preventing relapse in OUD. Oral formula naltrexone may be considered for patients where adherence can be supervised or enforced. Extended-release injectable naltrexone (Vivitrol) may be more suitable for patients who have issues with adherence. Oral naltrexone should be taken daily in 50 mg doses, or 3 times weekly in two 100 mg doses followed by one 150 mg dose. Extended-release injectable naltrexone should be administered every weeks by deep intramuscular injection in the gluteal muscle at a set dosage of 380 mg per injection. There is no recommended length of treatment with oral naltrexone or extended-release injectable naltrexone. Duration depends on clinical judgment and the patient s individual circumstances. Because there is no physical dependence associated with naltrexone, it can be stopped abruptly without withdrawal symptoms. Switching from naltrexone to methadone or buprenorphine should be planned, considered, and monitored. Switching from an antagonist such as naltrexone to a full agonist (methadone) or a partial agonist (buprenorphine) is generally less complicated than switching from a full or partial agonist to an antagonist because there is no physical dependence associated with antagonist treatment and thus no possibility of precipitated withdrawal

9 Naloxone, an Opioid Antagonist Medication Naloxone should be given in case of opioid overdose. Naloxone can and should be administered to pregnant women in cases of overdose in order to save the mother s life. The Guideline Committee, based on consensus opinion, recommends that patients who are being treated for OUD and their family members/significant others be given prescriptions for naloxone. Patients and family members/significant others should be trained in the use of naloxone in overdose. The Guideline Committee, based on consensus opinion, recommends that first responders such as emergency medical services personnel, police officers, and firefighters be trained in and authorized to administer naloxone. Naloxone injection Evzio (auto-injector) 0. mg/0. ml For emergency treatment of overdose Narcan, generic (various) Opioid depression, diagnosis of suspected opioid overdose, Naloxone There is not yet an FDA-approved intranasal formulation. There are only kits made available to deliver the injectable formulation intranasally WHO UK The Guidelines review the use of medicines such as methadone, buprenorphine, naltrexone and clonidine in combination with psychosocial support in the treatment of people dependent on heroin or other opioids. Based on systematic reviews of the literature and using the GRADE approach to determining evidence quality, the guidelines contain specific recommendations on the range of issues faced in organizing treatment systems, managing treatment programmes and in treating people dependent on opioids edition New guidelines coming out in early 2016 Addresses management of opi 35 36

10 Primary Care Setting - UK Australia GAaP History and Background Some of the GAaP members Although established formally in May 201 the origins and idea for GAaP have been around a long time, primary through ongoing collaboration between Dana Murphy-Parker and Carmel Clancy since 1998 GAaP has been initially supported via small grants via Middlesex University founding members of GAaP are drawn from UK, USA, Brazil and New Zealand 39 Presentation title 3 0 Presentation title

11 Drexel University GAaP USA Middlesex University GAaP UK University San Paolo GAaP Brazil Who is GAaP Nordland Hospital, GAaP Norway NCETA, GAaP Australia Potential members coming online GAaP China GAaP Israel GAaP Ireland GAaP S. Korea GAaP Japan Universiteti Planetari I Tiranes GAaP Albania Matua Raki GAaP New Zealand Structure Each country has an identified GAaP Co-ordinating Centre e.g. GAaP USA is Drexel University (contact person Dana Murphy-Parker dam355@drexel.edu) The Co-ordinating Centre has a responsibility to set up a GAaP Country Reference Group these groups must be interdisciplinary, members should have a background in addiction, and be representative of different types of facilities e.g. universities; practice; policy; research etc The GAaP co-ordinating centers meet online employing the use of a WIKI platform and Skype 1 2 Presentation title Our Vision for GAaP Explore addiction issues across countries e.g. policies; service user lived experience; treatment comparing differences and similarities Raise the profile of addiction including an aspect of activism Establish joint workforce guidelines standardization of preparation for professionals working in the field of addiction - Getting it into the Water Supply Provide a virtual room for everyone to enter to discuss the issues as outlined above Become a knowledge Hub Become a vehicle/platform to transfer best practice or 3 Middlesex explore University what good looks like To provide a platform communication tool to raise awareness and explore brief interventions; psychosocial issues; pharmacology To be a global online classroom A place to increase curiosity/increasing competencies directly in the field A community of practice and a resource tool, which can be sliced in different ways An Intersection between policy/clinical/academic communities A global knowledge network finding synergies

12 Key Strategic Areas Practice Education Research Policy Workforce Planning Methodology for staying connected & working together Wiki (online network community) Jointly delivered on-line courses Off line linking e.g. conferences; staff & student exchanges 5 6 It is not without its challenges First major project Slow burner Techno issues access issues; variation in level of members expertise The world clock I m awake, you re asleep! Finding the time Funding issues and volunteer syndrome MOOC (Massive Open Online Course) Falling Down Older People and Problematic Substance Use Course release/ teaching starts on 7 th of March until 10 April Presentation title 8

13 Broad Learning Outcomes for MOOC 1. To explore problematic substances use in relation to older people and their carers through current research, practice and service user and carers perspectives. 2. To promote awareness of current challenges when working with problematic substance use in ageing contexts for practitioners working with problematic substance use and for those working in ageing services who may not have a detailed knowledge of this issue. 3. To identify the scope of the issue within an international and national context and to identify the need for further knowledge, skills, service development and partnerships as well as future research and guidance in order to meet these challenges 9. References ASAM (2015). National Practice Guidelines and Associated Products at Press Conference and Stakeholder Summit on September 2, Retrieved at Website, Department of Health (England) and the devolved administrations (2007). Drug Misuse and Dependence: UK Guidelines on Clinical Management. London: Department of Health (England), the Scottish Government, Welsh Assembly Government and Northern Ireland Executive. Guidance for the use of substitute prescribing in the treatment of opioid dependence in primary care. Available at : Rundio, A (2015). Landmark legislation to expand treatment for heroin and Journal of Addictions Nursing,26 (3), pp prescription drug addiction. World Health Organization (WHO) (2009). Guidelines for psychosocially assisted pharmacological treatment of persons dependent on opioids. Retrieved at: 50