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Recognition and Management of Prescription Opioid Failure and Abuse in the Primary Care Setting

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Recognition and Management of Prescription Opioid Failure and Abuse in the Primary Care Setting

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    1. “Recognition and Management of Prescription Opioid Failure and Abuse in the Primary Care Setting” William Morris, MD Medical Director Janus of Santa Cruz

    4. Give my back ground as to how I came to be interested in the topic of the dark side of opioid use in chronic pain.Give my back ground as to how I came to be interested in the topic of the dark side of opioid use in chronic pain.

    5. Chronic Pain: Burden of Disease 9 in 10 Americans regularly suffer from pain Each year approx 50 million Americans suffer from chronic pain Chronic pain is the most common cause of chronic disability Almost 1/3 of Americans will suffer from chronic pain at some point in their lives Chronic pain is a huge medical problem, and I don’t want to give the impression that opioids should never be used for its treatment. Like in STAR WARS – the force of OPIOIDS has a good side as well as a dark side.Chronic pain is a huge medical problem, and I don’t want to give the impression that opioids should never be used for its treatment. Like in STAR WARS – the force of OPIOIDS has a good side as well as a dark side.

    6. Overview Process for prescription of opioids for chronic non-cancer pain Opioid “failures” excessive side effects inadequate analgesia Opioid “misuse” = opioid-related aberrant behaviors Clarification of terminology Recognizing and responding to aberrant opioid-related behaviors The reason for keeping in mind an “overview” of the process, is so that we know where we are going. How will we arrive where we want to go without knowing where we are going? I would argue that there is 3 main ways that opioids can fail our patients (note – patients don’t fail, opioids fail our patients) I find I can keep 3 things in mind at any one time, no more…. Dr. Krebs called ORABs “opioid misuse”The reason for keeping in mind an “overview” of the process, is so that we know where we are going. How will we arrive where we want to go without knowing where we are going? I would argue that there is 3 main ways that opioids can fail our patients (note – patients don’t fail, opioids fail our patients) I find I can keep 3 things in mind at any one time, no more…. Dr. Krebs called ORABs “opioid misuse”

    7. Clinical Guidelines for Opioid Use in Chronic Pain 2010: American Society of Anesthesiologists – http://journals.lww,com/anesthesiology/Fulltext/2010/04000/Practice_G 2010: Drug Enforcement Agency – www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html uideline_for_Chronic_Pain_Management_13.aspx 2009: Institute for Clinical Systems Improvement – www.icsi.org/pain_chronic_assessment_and_management_of_14399/pain_chronic_assessment_and_management_of_guideline.html 2009: Journal of Pain – www.jpain.org/article/S1526-5900(08)00831-6/fulltext 2004: Federation of State Medical Boards of the United States – www.fsmb.org/pdf/2004_grpol_controlled_substances.pdf 2003: Veterans Administration Guideline – www.healthquality.va.gov/cot/cot_fulltext.pdf Following guidelines improves care and patient safety, reduces liability risksFollowing guidelines improves care and patient safety, reduces liability risks

    8. Summary Process for Prescription Opioids

    9. Decision Phase – Are Opioids Needed? Pain is moderate to severe Pain has significant impact on function and quality of life Non-opioid therapies have failed

    10. Decision Phase- Are Opioid Benefits > Risks? Strongest risk factors for abuse History of substance abuse personally/family Psychiatric comorbidity: severe depression/anxiety History of drug-related crime Regular contact with high risk group (substance abusers) History of Sexual abuse – preadolescent Smokers This should be an overriding theme in treatment of patients with opioids>>>> it is unethical to continue treatment when in your opinion, benefits are outweighed by risks> Genetics may account for 40-60% of risk of addiction.This should be an overriding theme in treatment of patients with opioids>>>> it is unethical to continue treatment when in your opinion, benefits are outweighed by risks> Genetics may account for 40-60% of risk of addiction.

    11. Decision for Opioids - Benefit > Risk? (cont.) Risk assessment tools: www.emergingsolutionsinpain.com Opioid Risk Tool: Webster LR and Webster RM. Pain Medicine.2005;6;432-42 Screener and Opioid Assessment for Patients with pain – Revised (SOAPP-R): Butler et al. Journal of Pain. 2008;9:360-72 Collateral information: family, friends, physicians, pharmacists CURES report This should be an overriding theme in treatment of patients with opioids>>>> it is unethical to continue treatment when in your opinion, benefits are outweighed by risks COLLATERAL INFO: Family, pharmacist,This should be an overriding theme in treatment of patients with opioids>>>> it is unethical to continue treatment when in your opinion, benefits are outweighed by risks COLLATERAL INFO: Family, pharmacist,

    12. Opioid Risk Tools ORT: scores to place in low, mod, high risk Family Hx of substance abuse Personal Hx of Substance abuse Hx of preadolescent sexual abuse Psych disease (depression separate) Age, Sex SOAPP-R: 24 ?’s self admin 1-4 scale totaled e.g: “How often do you feel bored?” “How often have you been sexually abused?” “How often have you felt impatient with your doctors?” Can be one element of risk assessment Neither extensively validated ORT; asks SA Hx by ETOH, illegal, prescription differently weighted by sex Incorporates age, preaDOLESCENT SEX ABUSE, Psych disease, depression separately Can be one element of risk assessment Neither extensively validated ORT; asks SA Hx by ETOH, illegal, prescription differently weighted by sex Incorporates age, preaDOLESCENT SEX ABUSE, Psych disease, depression separately

    13. Controlled Substance Utilization Review and Evaluation System – “CURES” Office of state Attorney General http://ag.ca.gov/bne/cures.php Online “Prescription Drug Monitoring Program” generates “patient activity report” Initial register online at: http//ag.ca.gov/bne/cures.php Then must submit written application with notarized copies of DEA and medical licenses, govt. issued ID

    14. Decision Phase – Goals and Conditions of Opioid Rx Goals Analgesia Improved function: physical, social, vocational and recreational Ask question what can patient realistically hope to be able to do that they cannot do now? Important to realize that the evidence for opioid efficacy mostly comes from survey and uncontrolled case series, therefore each patient is his/her “n of 1” trial.

    15. Decision Phase – Goals and Conditions of Rx (cont.) Conditions of Rx “universal precautions” Treatment agreement - verbal or written? Informed consent/education One prescriber/one pharmacy Visit frequency No early refills Pill counts? Urine tox screens? Not that there is no good evidence that opioid agreements are helpful or harmfulNot that there is no good evidence that opioid agreements are helpful or harmful

    16. Urine Drug Tests - An Objective Tool Shows patient is taking what they are prescribed and not other substances Data shows clinicians are not very good at identifying patients who are compliant. Urine tox screens are an objective tool. Takes some personal interaction skills to avoid alienating patients, as mutual trust is important to the therapeutic relationship.Data shows clinicians are not very good at identifying patients who are compliant. Urine tox screens are an objective tool. Takes some personal interaction skills to avoid alienating patients, as mutual trust is important to the therapeutic relationship.

    17. Decision Phase – Goals and Conditions for Rx Exit plan - mutually agreed upon criteria Lack of adequate analgesia Lack of adequate functional improvement Persistent, intolerable side effects Aberrant behaviors Emphasize that it has to remain your judgement as to whether the benefit > risk. If not, opioids will no longer be prescribed.Emphasize that it has to remain your judgement as to whether the benefit > risk. If not, opioids will no longer be prescribed.

    18. Implementation Phase Dose initiation and titration How long is long enough? [2 months] How much is too much? [200mg daily oral morphine equiv dose] Higher doses – refer to specialty pain clinic Ballantyne, JC and Mao, JM. Opioid Therapy for Chronic Pain. NEJM.2003;349:1943-53 Management of side effects

    19. Outcomes Phase – When Goals are Met: Monthly med renewal visits Document pain score and side effects Treat side effects Tox screen if indicated Comprehensive Reassessment visits Q 3-6 months The “4 A’s” Analgesia? Activity? Acceptable SE profile? Aberrant behaviors? “collateral” information remains important

    20. Outcome Phase – The Dark Side of Opioids When goals are not met try to clarify why…. If SEs, sometimes can be managed. If pain initially better, then effectiveness wanes, consider progression of disease or tolerance as etiology Some pain are “relatively” resistant to opioids, but only relatively so – higher doses may be effective, but also may lead to more SE’s When goals are not met try to clarify why…. If SEs, sometimes can be managed. If pain initially better, then effectiveness wanes, consider progression of disease or tolerance as etiology Some pain are “relatively” resistant to opioids, but only relatively so – higher doses may be effective, but also may lead to more SE’s

    21. Opioid-induced Hyperalgesia vs. Opioid Toxicity Opioid-Induced Hyperalgesia Anesthesia/pain literature Setting of chronic, non-terminal pain syndromes Continued poor pain control despite moderate opioid doses (>200mg/day) Diffuse pain, out of previous distribution Absence of neuroactivation Absence of dehydration, renal failure RX: dose reduction and opioid rotation (NMDA antagonists?) Opioid toxicity Palliative Care/oncologic literature Increase in pain despite rapid titration Allodynia, hyperalgesia Signs of neuroactivation: myoclonus, delirium Dehydration, renal failure RX: opioid rotation with marked reduction in dose, benzos, hydration?

    22. “Confusing Panopoly of Terms and Definitions” Addiction Habituation Dependence Substance abuse Substance dependence Substance misuse Physical dependence Psychological dependence DSM-IV currently uses term “substance dependence” - have to have physical withdrawal - but someone s=who is in receovery can have no physical withdrawal any longer, yet remain addicted with strong cravingsDSM-IV currently uses term “substance dependence” - have to have physical withdrawal - but someone s=who is in receovery can have no physical withdrawal any longer, yet remain addicted with strong cravings

    23. Evolution of Terminology Liaison Committee on Pain and Addiction (LCPA) American Pain Society American Academy of Pain Medicine American Society of Addiction Medicine 1991-2001 created consensus definitions

    24. LCPA Consensus Definitions “Addiction” favored over “dependence” Clear separation of concepts of physical dependence, tolerance, and addiction Addiction as a chronic disease Utility of distinguishing addiction from other forms of aberrant drug behavior

    25. Tolerance “a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time”

    26. Physical Dependence “a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid does reduction, decreasing blood level of the drug, and/or administration of an antagonist.”

    27. Addiction “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

    28. Addiction “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

    29. Addiction “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

    30. Addiction “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

    31. Addiction “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

    32. Aberrant Opioid-Related Behaviors Examples of non-addiction aberrant behaviors: Noncompliance Diversion Seeking euphoria Medical “coping” Pseudoaddiction How do we understand behaviors such as diversion? seeking a “high”? Pseudoaddiction?How do we understand behaviors such as diversion? seeking a “high”? Pseudoaddiction?

    34. Behaviors LESS indicative of addiction Anxiety over symptoms Med hoarding Taking other’s meds Requesting a specific med Openly getting meds from other providers Complaints about needing higher dose Behaviors MORE indicative of addiction Buying street drugs Illegal activities Multiple lost or stolen meds Prescription forgery Injection or snorting meds Performed sex for drugs Resistance to med change despite SEs

    35. Aberrant Opioid-Related Behavior Survey Tools Addiction Behaviors Checklist Wu, et al. J. Pain Symp Manage. 2008;32(4):342-51. Clinician considers presence of behaviors since last visit and within current visit e.g. ran out of meds early? Reports worsening relationship with family? Current Opioid Misuse Measure Butler, et al. Pain. 2007;130:144-56. 17 questions asked of patient with 0-4 response

    36. 2 to 5 % felt to have addiction as characterized by the “4 Cs” Control (impaired) Compulsive (use) Continued (use despite harm) Craving 2 to 5 % felt to have addiction as characterized by the “4 Cs” Control (impaired) Compulsive (use) Continued (use despite harm) Craving

    37. Personal Observations from Dealing with Challenging Patients Assuming opioids = only way to Rx severe pain Multiple opioids of same type High doses without pain specialist input Continued dose escalation despite lack of significant improvement Absence of weighing benefit against risk Assuming aberrant behaviors = addiction These patients without exception are miserable folk, with little to call a life: pain, little function and few relationships WE CAN DO BETTER BY THESE PATIENTS!These patients without exception are miserable folk, with little to call a life: pain, little function and few relationships WE CAN DO BETTER BY THESE PATIENTS!

    38. Having the Conversation Clearly lay out my concerns – I first focus on lack of analgesia and side effect Then discuss specific examples of aberrant opioid-related behaviors Present your assessment that risk of harm is greater than benefit If I have relationship with patient, I focus on my wanting the best for them If first visit, I focus on my ethical obligation to “do no harm” Refer back to opioid agreement if you have one Keep in min, DOPAMINE IS A STRONG DRIVING FORCE! I like to picture what I am doing is like jumping onto a wild stallion – he will do everything he can to buck me off – I just need to hold on with the strength that comes from wanting what is best for the patient until the wild animal of addiction comes under control. Keep in min, DOPAMINE IS A STRONG DRIVING FORCE! I like to picture what I am doing is like jumping onto a wild stallion – he will do everything he can to buck me off – I just need to hold on with the strength that comes from wanting what is best for the patient until the wild animal of addiction comes under control.

    39. Having the Conversation (cont.) “It doesn’t make sense to keep doing something that is more likely to harm you than help you, does it?” I acknowledge that this is not an easy problem to deal with Don’t back them into a corner - I remind them; My diagnosis could be wrong I would not be offended if they transferred care to another physician I will not abandon them. Keep in min, DOPAMINE IS A STRONG DRIVING FORCE! I like to picture what I am doing is like jumping onto a wild stallion – he will do everything he can to buck me off – I just need to hold on with the strength that comes from wanting what is best for the patient until the wild animal of addiction comes under control. Keep in min, DOPAMINE IS A STRONG DRIVING FORCE! I like to picture what I am doing is like jumping onto a wild stallion – he will do everything he can to buck me off – I just need to hold on with the strength that comes from wanting what is best for the patient until the wild animal of addiction comes under control.

    40. Having the Conversation (cont.) I offer choice around how opioids are tapered, not if they will be tapered, with as much flexibility as is safe. Try to decide: tapering because of addiction or because of opioid side effects and/or failure? Addiction should include in the care plan referral for recovery treatment Addiction may require medication assisted treatment: methadone or buprenorphine Keep in min, DOPAMINE IS A STRONG DRIVING FORCE! I like to picture what I am doing is like jumping onto a wild stallion – he will do everything he can to buck me off – I just need to hold on with the strength that comes from wanting what is best for the patient until the wild animal of addiction comes under control. Keep in min, DOPAMINE IS A STRONG DRIVING FORCE! I like to picture what I am doing is like jumping onto a wild stallion – he will do everything he can to buck me off – I just need to hold on with the strength that comes from wanting what is best for the patient until the wild animal of addiction comes under control.

    41. Insanity: doing the same thing over and over again and expecting different results - Albert Einstein

    43. janussc.org To get copies of all the talks go onto Janus’ website in a few days and they will be availbleTo get copies of all the talks go onto Janus’ website in a few days and they will be availble

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