Opioid Therapy in Pain Management: Minimizing Risk and Improving Outcomes Nancy Wiedemer,MSN,CRNP Pain Management Coordinator Philadelphia VA Medical Center nancy.wiedemer@med.va.gov The goal of this presentation is to answer the question: How can we balance the mandate to treat pain (following standard of care which includes opioids) with the public health problem of abuse and the disease of addiction? Objectives : • Define pain including a primer on neurobiological mechanisms of the disease of pain, assessment and treatment within a biopsychosocial framework • Define addiction including the spectrum of substance misuse/abuse/ addiction as it relates to opioid therapy for pain management • Present a model for clinical practice Substance Abuse Disorder Barriers to use of opioids for treatment of chronic pain • Threat of regulatory scrutiny • Concerns about causing addiction or diversion • Increased time required for documentation and follow-up • Minimal to no education in basic training programs ( in nursing and medicine) in pain management and especially opioid prescribing Confusion about prevalence of addiction and definition/diagnosis of addiction Prevalence of Addiction • General Population 3-16 % (Zacny et al,2003) • Chronic Pain Population 3.2%-18% (Fishbain et al 1992) • Hospitalized Population 19-25 % (Savage,2003) • Trauma Population 40-62% (Doherty, 2000) Prevalence of Pain in Addiction • Chronic pain in addiction – MMT patients • 61.3% (Jamison 2000) • 80% (Rosenblum, Joseph et al 2003) – (severe 37%) – Substance abuse tx inpatients • 78% (Rosenblum, Joseph et al 2003) – (severe 24%) Prevalence of Addiction • The good news is…. The end of the 20th century brought with it more aggressive pain management • The bad news is… A rise in prescription opioid abuse Prevalence of Addiction • 97-02 ? prescription opioid abuse increased from 5.75% to 9.85% (Gilson et al,2004) • Prescription opioid abuse is the 2nd largest type of illicit drug abuse second only to marijuana and ahead of cocaine and heroin (SAMHSA,2005) • SAMHSA 2005 survey ? prescription opioids are the first drugs tried ( in 2.1m in 2005) ahead of marijuana and nearly equal to number of new initiates to smoking Problem: Lack of clear definition of terms • WHO 1952 ? Addiction / Habituation • WHO 1957 ? Psychic dependence / physical dependence • WHO 1964 ? Drug dependence • WHO 1993 ? Substitution of “withdrawal syndrome” for physical dependence • ICD-10 ? Dependence Syndrome • DSM- IV ? Substance Dependence • Other frequently used terms: Drug Seeking , substance abuse, chemical dependency, prescription drug abuse DSM-IV Substance Dependence (Addiction) ? Tolerance ? Physical dependence/withdrawal ? Used in greater amounts or longer than intended ? Unsuccessful attempts to cut down or discontinue ? Much time spent pursuing or recovering from use ? Important activities reduced or given up ? Continued use despite knowledge of persistent physical or psychological harm “ Definitions Related to the Medical Use of Opioids: Evolution toward Universal Agreement” Savage et al, J of Pain and Symptom Management, 2003;26:655-667. Consensus Document: The American Academy of Pain Medicine,The American Pain Society, The American Society of Addiction Medicine, 2001 Definitions • Physical Dependence • Tolerance • Abuse • Addiction • Withdrawal syndrome in response to abrupt dose reduction • Pharmacologic property, dose may need to be increased to maintain effect • The intentional misuse of a medication for nonpresribed effects ( e.g. mood alteration) • Chronic neurobiologic disorder characterized by loss of control, craving, compulsive use despite harm Pseudoaddiction • Aberrant behavior that seems similar to addiction, but is due to unrelieved pain • Behavior stops once the pain is relieved, often through an increase in the opioid dose. • Misunderstanding of this phenomenon may lead the clinician to inappropriately label the patient an “addict” Addiction • A primary, chronic, neurobiologic disease with genetic, psychosocial and environmental factors influencing its development and manifestions • Characterized by behaviors that include one or more of the following: – Continued use despite harm (adverse Consequences) – Impaired Control over use (Compulsive use) – Preoccupation with use for non-pain relief purposes (Craving) ASAM, APS, AAPM Neurobiology of Addiction • Neurobiologic underpinings of : – Craving – Relapse – Choice – Control • Enduring vulnerability to relapse Initiation of Addiction • Repeated limbic reward induces reorganization/ permanent changes in the vulnerable ? Neuroplasticity • Drive state results similar to thirst, hunger, sex, maternal nurturing ? Dysregulation of adaptive behavioral response • Not all who use for reward become addicted • Vulnerability differs: biogenetic basis 3 Stages of Addiction Behavioral Characteristics of End-Stage Addiction • Craving • Relapse • Reduced ability to suppress drug seeking Drug Reward • Some drugs and dosing regimens induce greater reward than others – Rapidity of increase in blood level – Magnitude of blood level – Specific receptor effects – Periodicity of effects: intermittent vs stable Disease of Addiction • Causes – Biogenetic predisposition – Behaviors contribute • Drug use • Psychosocial factors • Course: remissions and exacerbations • Cure not possible • Control of the disease – Avoid drug use – Psychosocial interventions – Medications Diabetes, Hypertension, Asthma • Causes – Biogenetic predisposition – Behaviors often contribute • Diet, lack of exercise, smoking, other lifestyle • Psychosocial factors • Course: remissions and exacerbations • Cure not possible • Control of the disease – Dietary changes, exercise – Psychosocial interventions – Medication McClellan, Lewis, O’Brien, Keber, JAMA 2000 Treatment Adherence Addiction • With appropriate treatment, one year 40-60% fully abstinent • Adherence poorest among – Low socioeconomic groups – Poor family and social support – Psychiatric co-morbidity McClellan, Lewis, O’Brien, Keber, JAMA 2000 Treatment Adherence Other Chronic Diseases Addiction • A primary, chronic, neurobiologic disease with genetic, psychosocial and environmental factors influencing its development and manifestions • Characterized by behaviors that include one or more of the following: – Continued use despite harm (adverse Consequences) – Impaired Control over use (Compulsive use) – Preoccupation with use for non-pain relief purposes (Craving) ASAM, APS, AAPM Assessing and Interpreting ”Behaviors” • Recognition that there is a range of behaviors that may be considered problematic in patients treated with opioids for pain • The term “Aberrant Drug Taking Behaviors” has emerged in the literature in the last decade as a descriptor for the broad rane of behaviors that require assessment and interpretation Spectrum of Drug Misuse • Self medication: mood, sleep, memories “chemical copers” • Medication of others, sharing • Diversion for profit – Criminal business – Support medication costs • Recreation: euphoria, rush high • Addictive use Monitoring Aberrant Drug-Related Behaviors • Aggressive complaining • Drug hoarding • Requesting specific drug • Acquiring drugs from other medical sources • Unsanctioned dose escalation once or twice • Unapproved use of the drug to treat other symptoms • Reporting of psychic effects not intended by clinician • Occasional impairment Monitoring Aberrant Drug-Related Behaviors • Selling prescription drugs • Forging prescriptions • Steeling or “borrowing” drugs from another person • Injecting oral formulations • Obtaining prescription drugs from nonmedical source • Loosing Rx repeatedly • Concurrent abuse of related illicit drugs • Multiple dose escalations despite warnings • Repeated episodes of gross impairment or dishevelment Differential Diagnosis of aberrant drug-related behavior • Addiction • Under-treated pain (Pseudoaddiction) • Other psychiatric disorders( eg. Borderline personality disorder) • Mild encephalopathy • Family disturbances • Criminal intent - diversion Opioids in Clinical Practice Risk Management Strategies to Maintain Patient Safety and Minimize Abuse Risk Management Strategies • Practice policies that are standardized and applicable to ALL patients include: > Diagnostic workup for pain generator/mechanism > Assessment of co-morbid psychiatric conditions > Targeted treatment > Are opioids appropriate ? > Screening to identify patients at risk for opioid misuse/abuse/addiction Risk Management Strategies • Practice policies that are standardized and applicable to ALL patients include: > Informed consent and treatment agreements > Single provide/practice responsible for prescribing > Urine Drug Testing > Monitoring and Documentation Implications for Practice Opioid Treatment Agreement Implications for Practice Opioid Treatment Agreement “From an ethical standpoint, the discriminatory implementation of opioid contracts may potentially violate patients’ rights to fair and equal treatment.” Arnold, RM, et al, JAMA 2006 Monitoring Aberrant Drug-Related Behaviors: Urine Drug Testing • Important tool for assessing aberrant behaviors and monitoring safety of treatment • Consistent Policy ? Why test Who to test When to test What will you do with abnormal results • UNDERSTAND the TECHNOLOGY ? Methods used in your lab ? Drugs analyzed ? Detection cut-off ? Detection period for metabolites ? What test to order Assessing and interpreting aberrant drug-taking behaviors Assessing and interpreting aberrant drug-taking behaviors • For the diagnosis of addiction, we are looking for a persistent pattern of: > Compulsive use > Craving > Impaired control What does this all mean for the clinician who is managing pain ? • Goal – Relieve pain and improve function • If opioids are in the mix – Decrease risk of substance misuse/abuse/diversion – Identify emerging disease of addiction – Treat individuals with the disease of addiction whose disease state requires opioids What does this all mean for the clinician who is managing addiction ? • Goal – Promote/maintain recovery and improve function • Can opioids be considered for pain management ? The Opioid Renewal Clinic: A Primary Care Managed Approach to Opioid Therapy in Chronic PainPationts at risk for substance abuse Background and Significance Incorporating Consensus Guidelines into Primary Care Practice at PVAMC • Chronic Narcotic Use Policy 1998 • Chronic Opioid Use Policy 2000 Major Principles > One Provider responsible for Rx > Use of Opioid Treatment Agreement > Urine Drug Screening > Documentation • More consistent analgesia • Fewer mini-withdrawals or rebound reactions • More tolerance to adverse effects • Better sleep ==> better daytime function • Less euphoria, abuse, addiction, and diversion (Savage 1999, Copton & Athanasos, 2003) The Problem: • Guidelines and policies available but “they take too much time “ ! • Reluctance of PCPs, who care for the majority, to prescribe opioids • Concern about diversion, abuse, addiction and regulatory scrutiny, particularly in a high risk population • Prescribing opioids without assessment and without monitoring treatment outcomes The Problem: • The Oxycontin Media Blitz • Visit from the Investigator General • Pharmacy Budget “crisis” $ 237,830 – 6 month (in 2001) cost of Oxycontin The Need: • Cost-effective strategies to support PCPs’ management of these patients. Action plan: • Focus group meetings with PCPs • Review of Literature for guidelines and evidenced-based strategies The Opioid Renewal Clinic: A Primary Care, Managed Approach to Opioid Therapy in Chronic Pain Patients at Risk for Substance Abuse A Nurse Practitioner and Clinical Pharmacist managed service at the Philadelphia VA Medical Center Opioid Therapy and Aberrant Drug-Related Behaviors Addressing aberrant drug-related behavior --> Proactive strategies <-- • Know laws and regulations • Assess and document behaviors comprehensively • Possess a range of strategies to respond to aberrant behaviors • Structure therapy to match perceived need • Integrative Tx Plan b/t Addiction and Medicine (Savage,1999 Portenoy, 2003; Compton &Athanasos, 2003;Gourlay & Heitt, ) Opioid Renewal Clinic Goals: 1) Facilitate appropriate treatment for each patient - opioid therapy if indicated and/or - addiction treatment 2) Improve PCP confidence in prescribing opioids 3) Improve monitoring and documentation 4) Provide cost-effective care by decreasing miss-utilization of resources Opioid Renewal Clinic: Services • Assist with opioid titration and rotation • Assist with management of challenging patients requiring structured prescribing and monitoring of long-term opioid therapy – Patients with aberrant drug related behaviors r/o substance misuse vs pseudoaddiction vs addiction – Patients with h/o addiction, recent addiction, active addiction Opioid Renewal Clinic Services Examples of strategies: • Opioid Treatment Agreement ? Second Chance Agreement • Frequent visits • Prescribing opioids on a short term basis (i.e. weekly or bi-weekly) • Periodic urine drug testing • Pill counts • Co-management with addiction services Opioid Renewal Clinic: Procedure • Consult from PCP • Elligibilty Workup and pain dx Opioid Treatment Agreement Baseline urine drug test • THE PCP CONTINUES TO BE RESPONSIBLE TO PRESCRIBE OPIOIDS Opioid Renewal Clinic: Procedure • Initial Appointment with clinical pharmacist > Assessment and documentation > Review current treatment plan including opioids > Review/introduce Opioid Treatment Agreement > Patient Education Documentation – Opioid Renewal Note Opioid Treatment Plan Provider/Team: Diagnosis: Level of Analgesia (Pain Scale –NRS) Average: Best: Worse: Goal: Functional Ability: Adverse Drug Effects/Side Effects: Current Medications: Aberrant Behavior: Recommendations/Comments: Opioid Renewal Clinic: Procedure For routine monthly renewals > Calls taken Monday and Tuesday 5 days ahead for pick-up 10 days ahead for mail > Telephone assessment of 4 As > PCP notified to forward Rx > Clinical pharmacist monitors adherence including ordering urine drug testing Outcome Measures PCPs variables: • Increase in use of the Opioid Treatment Agreement • Increase in Urine Drug Testing by PCPs • Satisfaction with the program Patient variables: • Adherence to the Opioid Treatment Agreement • Reduction of inappropriate clinical visits and contacts Outcome Measures Pharmacy budget goals: • Decrease Oxycontin use to 3 % of all opioids prescribed Results Aberrant behavior 366 (47%) • UDT + for illegal drugs or unprescribed drugs • UDT negative for prescribed drugs • Overusing prescribed opioids No Aberrant Behavior 418 (53 %) • Opioid rotation or titration • H/O of recent substance abuse • Conflicts with providers • Part-time clinicians- referred for assistance with monthly monitoring Results (n= 784) 366 (47%) Documented aberrant behavior • Resolution of aberrant behavior • Discharge from ORC n=101 (28 %) self-discharged n= 86 (23 %) ORC discharged • Referred for addiction therapy • Consistently negative UDT weaned from opioids • Undeclared – still monitoring • 147 (40.2%) • 187 (51 %) • 24 (6.6 %) • 7 (1.9 %) • 1 ( 0.3%) Results (n= 784) 418 (53%) no documented aberrant behaviors Adherence to Opioid Treatment Agreement – 100 % Increase in Urine Drug Testing Increase in use of Opioid Treatment Agreements Comments from PCP Satisfaction Survey • “This program has made my life and my patients life easier. It gives me time to address all the other important health care issues during the visit.” • “Before this service, patients seeking opioids would disrupt the delivery of care .” • “It has helped me to improve my relationship with my chronic pain patients.” Impact on Practice Structured approach to opioid prescribing: • Facilitates treatment of high risk patients with opioids • Assists in making the diagnosis of addiction ? there is no diagnostic test for addiction ? diagnosis is made prospectively Impact on Practice • Eliminates prejudice Who needs more structure ???? Do we know up front ? • Structure can be tightened or loosened based on the patient’s behavior • Preserves the therapeutic relationship Conclusion • Opioids should be considered for treatment of chronic noncancer pain within a comprehensive individualized treatment plan • Appreciate the potential for toxic side effects ? including substance abuse & diversion ? the DEA • Implement policies to safeguard yourself, your practice and PATIENTS who suffer from chronic pain. Conclusion Develop a practice policy that sets boundaries and is implemented with consistency, empathy and respect CASES 57 yo male. Chronic low back pain started in 1960’s after thrown out of a jeep in VN. • Worked as a Philadelphia Police Officer until age of 50 • Now active in community. Lives with wife and 3 daughters • Admits to cocaine and speed “ for 1-2 years 25 years ago • Pain has been worsening and interferes with functioning • Dx: spinal stenosis • PCP prescribing appropriate multimodal TX. • Opioids added to regimen. Did well • Referred to ORC because of UDT positive for Cocaine Aberrant Behavior: 10/20/06: wnl 09/22/06: wnl 09/08/06: wnl 08/11/06: wnl 07/28/06: +unprescribed morphine ( trace) -pt denies 07/14/06: wnl 06/30/06: wnl 06/23/06: +COCAINE 06/09/06: Urine drug screen not taken until 6/23/06??? 05/12/06: wnl 04/14/06: wnl 03/31/06: wnl 03/17/06: wnl 03/03/06: wnl 02/04/06: wnl 01/03/06: wnl 12/22/05: +COCAINE 12/19/05: + COCAINE 34 yo male presented for Initial Visit in Primary Care at the Phila VA. He is transferring from the Bedford MA VA. He says that he is moving back home to Phila and will be living with his parents. • Chief complaint is chronic low back pain from service connected injury. He reported having lumbar fusion 4 years ago and continues with pain. • He says he has been treated with methadone and ran out yesterday. He reports being prescribed 30 mg q 8 hours What would you do ? Summary from Primary Care Initial Visit Note: (Information retrieved from remote VA records) • Positive for cannibus and cocaine on 2/2005 • Signed another pain contract at Bedford VA • Reported stolen meds 11/15/2005, 3/13/2006, 6/13/2006 • Pt also screened positive for cannibus on 10/2005 • His last Bedford PMD indicated (10/2005) giving patient "one last chance, after reviewing appropriate behavior on prescription opiates.” • Pt subsequently screened positive for cannibus on 2/2006 • Bedford VA psychiatry note 7/06 indicates pt lost his prison guard job due to "drugs" and was required to take urine drug screens at Lowell sheriff's department. Patient presented to Pain Service office after PCP declined to prescribe methadone requesting that we prescribe it. More info: • s/p L5-S1 fusion in 2003 • Pain continued after surgery – “ deep burning pain in center of back” • Oxycontin was continued after surgery by neurosurgery group, then a Pain Center • Lost his job, then lost insurance • Transferred care to Bedford VA in 2005 > switched to methadone for pain management • Acknowledges that Bedford VA notes look bad but states that his girlfriend had the drug problem • Pain Service prescribed a 3 day supply of methadone and scheduled an Addiction consult • Urine Drug Test was obtained and was positive for methadone Addiction Evaluation • ASSESSMENT: While history is suggestive, there is no way of proving addiction at this time. His explanations of aberrancies seem plausible to me. • PLAN: Suggest ongoing monitoring for substance abuse. If there is any more aberrant behavior, the dx is made, but I would suggest controlled prescription of methadone as a therapeutic trial. Aberrant Behavior 10/24/06: WNL 10/12/06: WNL 10/3/06: WNL 9/19/06: WNL 9/12/06: WNL 7/26/06: WNL ( positive only for methadone) • The patient requested help with weaning from methadone. He successfully weaned himself within a month and is currently managing on Ibuprofen and working out daily. He started a house painting business and is planning on taking advantage of VA vocational rehabilitation to go to school. • But wait…. There is more to this story if we have time….