Is it Pain? Is it Addiction? Or is it Both?

Is it Pain? Is it Addiction?

Or is it Both?

Carol P. Curtiss, MSN, RN-BC

Disclosure Information  Advisory Board and Speakers’ Program, Archimedes Pharmaceuticals  Consultant and Case Managers Speakers’ Program, Genentech Pharmaceuticals

Learning Objectives  Identify current issues related to the intersection of pain and addiction  Differentiate among physical dependence, tolerance, addiction and pseudoaddiction  Identify assessment tools and techniques to minimize risk and optimize pain care  Discuss strategies for effective pain control in persons with addiction disorders

Blueprint for Transforming Pain ‌approaching pain at both the individual and the broader population levels will require a transformation in how Americans think and act individually and collectively regarding pain and suffering. We believe this transformation represents a moral and national imperative‌..

IOM, 2011 – preface, iv

Unrelieved Pain: The Problem • Major public health problem • 100 million in U.S. live with chronic pain – Greater than diabetes, heart disease and cancer combined

• Costs U.S. > $600 billion each year • Under-treatment occurs in every clinical setting and for all types of pain Institute of Medicine Committee on Advancing Pain Research, Care and Education. Relieving Pain in America: A Blueprint for transforming Prevention, Care, Education & Research. Washington, D.C.: National Academies Press, 2011

Is it Pain?

• An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage • Whatever the experiencing person says it is, existing whenever the person says it does International Association for the Study of Pain (IASP) definition of pain. http://www.iasp-pain.org/AM/Template.cfm?Section=Pain_Definitions .

Accessed June 1, 2012.; McCaffery M. Nursing practice theories related to cognition, bodily pain, and man-environment interactions. Los Angeles: University of California at Los Angeles Students’ Store, 1968: 95.

Pain‌ How should someone look?

How should someone act?

Substance Use Disorders: The Problem  Major public health problem  40-60% vulnerability may be genetic  Increased risk: – Mental illness – Poverty – Poor parental support – Availability of drugs – Use at an early age Substance Abuse and Mental Health Services Administration, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.

Prevalence of Substance Use Disorders U.S. General Population – 8.7% of general population age 12 or older classified with substance dependence or abuse • Alcohol 15 million • Illicit drugs 4.2 million • 20.5 million needed treatment but did not receive it.

• Number of people receiving treatment for non-medical pain reliever use more than doubled from 2002-2010

Substance Abuse and Mental Health Services Administration, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.

Addiction/Substance Use Disorders: Populations with Pain  Reported prevalence rates vary depending on definition used and population studied • 0-39% when tobacco is included

 Prevalence does not appear greater than in general population except in patients with a current or past history of substance abuse or psychiatric co-morbidities

Fleming MF et al. Substance use disorders in a primary care sample receiving daily opioid therapy. J Pain. 2007; 8(7): 573-582.

Is it Addiction?  A primary chronic disease of brain reward, motivation, memory and circuitry  Leading to characteristic biological, psychological, social and spiritual manifestations.  Reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors American Society of Addiction Medicine, Public Policy Statement. 2011. http://www.asam.org/docs/publicy-policy-statements/1definition_of_addiction_short_411.pdf?sfvrsn=0 Accessed June 1, 2012

Addiction is characterized by…  Inability to Abstain  Impairment in Behavioral control  Craving (for drugs or rewarding experiences)  Diminished recognition of significant problems  A dysfunctional Emotional response

American Society of Addiction Medicine Public Policy Statement: Definition of Addiction, 2011

Use despite harm  Decreased level of functioning  Negative mood changes  Persistent over-sedation  Distortion of thinking  Diminished quality of life  Addiction is a disease of behavior as depression is a disease of mood

Addiction: A Chronic Illness  Pathologic basis  Known risk factors  Predictable course  Treatments with known efficacy exist – Require behavior changes – More successful outcomes when treatment is on-going

 Expect remissions, exacerbations, relapse – Increased risk with stress

Addiction, diabetes, HTN, asthma  Comparable etiology & course • Genetic heritability • Environmental factors • Personal choice

 Common treatment issues • Adherence, early drop-out, relapse

 Non-compliance/relapse predictors • Poverty • Lack of family support • Psychiatric co-morbidity

McLellan AT, et al. JAMA. 2000;284:1689-95

Addiction How should someone look?

How should someone act?

Myth  I can easily tell who is a legitimate pain patient and a patient who is “drug seeking”

A diagnosis of addiction REQUIRES a plan for treatment

True or False?

1. All patients who go through withdrawal are addicted.

2. Patients who take doses higher than the package insert are likely addicted 3. Patients who are demanding about pain management are likely addicted 4. Patients who ask for medications by name are likely addicted

What is NOT Addiction!  Physical dependence  Tolerance  Pseudoaddiction

Physical Dependence  Biologic phenomenon  State of adaptation that is manifested by a drug-class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist American Pain Society, American Society of Addiction Medicine, American Academy of Pain Medicine. Consensus: Definitions related to the use of

opioids in pain treatment, 2001.

 Normal, expected physiologic response  By itself, it has NO relation to addiction – Taper off med to manage the problem – Opioids by ~ 10% per day, slower with high doses

Tolerance: biologic adaptation  Exposure to drug induces changes that result in diminution of one or more of the drug’s effects over time ASAM, APS, AAPM Consensus, 2001

 This is NOT addiction – Clinically not relevant in most cases – With substance use disorders • Higher doses may be needed • May be opioid-induced hyperalgesia

Tolerance: Management  With new unrelieved pain, assess, assess, assess – New disease progression?

– Other causes?

– Changes in condition?

– Changes in activity

 Persons with substance use disorders may need higher doses for pain management than others

Pseudo-addiction • Anger, escalating demands for more or different medications  Caused by undertreatment of pain  Clinician misidentifies as drug-seeking behavior.

• Not a diagnosis, rather a description of a clinical interaction • Behavior ceases with adequate pain relief • This is NOT addiction Weissman DE, Haddox JD. Pain. 1989;36:363-6.: APS, ASAM, AAPM, Consensus Statement, 2001

Unintentional Deaths, 1999-2007

CDC Public Health Grand Rounds 2.18.2011; National Vital Statistics System. http://wonder.cdc.gov, multiple cause dataset

Sources of Non-medical Users of Opioids in the U.S., 2009 4% 20%

Prescribed to Someone Else Prescribed to User 76%

Other

CDC Grand Roundtable 2.18.11. Data from Natl Survey on Drug Use and Health. Summary of national findings, 2008-2009. http://www.oas.samhsa.gov

The Challenge

Appropriate and timely pain management

Prevention of misuse, abuse, and diversion

Patient & Family Education  Risks of unrelieved pain  Importance of taking medications as instructed  What to report and to whom  Risks of opioid therapy – Self and others

 Safe storage – Total possession of medication at all times – Locked boxes/safes

 Safe disposal – Household strategies – Take-back programs

New Formulations: Oral Opioids  Abuse deterrent formulations – Physical barriers to tampering – Agonist/antagonist formulations – Aversion components – Pro-drugs – New options under study • Opioid attached to polymer that prevents drug from binding to cell receptors until drug reaches the small intestines. There tyrosine (digestive enzyme) activates the molecule and releases the opioid. Trypsin is not present in the blood stream.

Waters, Nature Medicine. 17(8), 2011. p905.www.pallimed.org/2010/12/opioids-on-chopping-block.html

Risk Evaluation and Mitigation Strategy (REMS) Already here for some opioids and coming for others

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

REMS Overview  What is a REMS? – Risk Evaluation and Mitigation Strategy (REMS) – FDA mandated (FDA Amendments Act of 2007) – Management strategy to prevent serious risk of a drug – Ensure that only appropriate patients receive drug

 When is a REMS required?

– FDA determines if needed before or after approval – When necessary to ensure that benefits of the drug outweigh the risk

Components of REMS  Package inserts  Medication guides  Communication plan – Letters to health care providers – Other dissemination strategies

 Elements to ensure safe use  Implementation system to monitor and evaluate each specific REMS

Elements to Ensure Safe Use 1. Specific training or experience for prescribers of drugs with REMS 2. Special certification for pharmacists and others who dispense the drug 3. Dispensing limited to specific settings 4. Patient prequalification 5. Written informed consent by patients 6. Patient education and monitoring 7. Registry?

REMs and Clinical Practice Advantages    

Education of providers Education of patients & families Appropriate selection of patients Can document and track prescribing

Disadvantages  Requires action by the provider in order to prescribe  May decrease access to meds by patients due to failure of provider to enroll  May increase fears among patients regarding opioids  May shift prescribing to opioids without REMs

Persistent Pain: Responsible Opioid Prescribing  Patient evaluation – Careful selection

 Written treatment plan  Informed consent and agreement to treat  Periodic review  Referral and patient management  Documentation  Compliance with laws and regulations Fed. of State Medical Boards Model Policy for the Use of Controlled Substances in the Treatment of Pain, 2004.

Universal Precautions in Pain Management 1. History, physical and diagnosis 1.

2.

3.

4.

5.

6.

Diagnostics as needed

Psychological assessment & risk evaluation Risks, benefits, informed consent Treatment agreement & clear written goals Assessment of pain intensity & function pre and post intervention Appropriate trial of medications & exit strategy Gourley D & Heit H. Universal precautions: a matter of mutual trust and responsibility.

Pain Medicine.2006. 7(2): 210-211.

Universal Precautions (cont’d)

7. Regular reassessment of goals 8. Regular assessment of 4 A’s – Analgesia – ADLs – Aberrant behavior – Adverse effects 9. Periodic review of diagnosis, including addictive disorders 10. Documentation

Patient Evaluation  Assess, assess, assess  Pain, pain relief, the effects of pain on the person, the person  ASK: – Personal or family history of substance use disorder

 Identify and document goals of care – What do you hope to do with this treatment that you can’t do now?

 Document, document, document

Assessment: Tips  Be nonjudgmental  Explain importance of information  Assume use: – how often do you use?

 Estimate high quantities: – do you drink about a quart (or case) a day?

 ? Feelings of impending withdrawal  Be aware of stages of change  Use established assessment tools

Screening: Principles of Risk Management  Stratify risk  Structure treatment commensurate with risk  Assess drug-related behaviors over time  Respond to aberrant drug-related behaviors  Document, communicate and educate

Adapted from: Portenoy RK. www.thelancet.com 377: June 25, 2011

Stratify Risk  Universal precautions – Ask about ETOH, drug/tobacco use, contact with drug culture – PMP

 Risk evaluation tools – Screener and Opioid Assessment for Patient with Pain - revised (SOAPP-R) – Opioid Risk Tool calculator (ORT) – Current Opioid Misuse Measure (COMM) – CAGE-AID ORT: http://www.painbalance.org/opioid-risk-tool-calculator-ort-1245284765 SOAPP-R and COMM: http://www.painedu.org

CAGE AID

Brown & Rounds. Wisconsin Medical Journal. 1995;94(3):135-140.

Screener & Opioid Assessment for Patients with Pain, revised (SOAPP®-R) – 24 item, paper/pencil survey for those considering opioid therapy – Used to determine level of monitoring for long-term opioid therapy • High risk > 22 • Moderate risk 10-21 • Low risk < 9

– Not intended to screen out patients – May over-identify those at low risk www.painedu.org. Accessed June 1, 2012

Opioid Risk Tool (ORT)  Low risk – 0-3 points

 Moderate risk – 4-7 points

 High risk – > 8 points

Webster et al. Pain Med. 2005;6:432

Current Opioid Misuse Measure (COMM)  17 item patient self-assessment

– for those who are currently on long term opioid therapy

 S/S intoxication, emotional volatility, poor response to medications, addiction, healthcare use patterns, problematic medication behavior  NOT used prior to therapy Meltzer et al. Pain. 2011;152:397-402.

Is it Pain, Addiction, or Both?  Assess, assess, assess, assess – Prescription monitoring programs carefully

 Look at the whole person  Ask about substance use history  Look at the situation  Look at old records  Interview patient  Interview family

Behaviors & Addiction Less predictive  Anxiety or depression over recurrent symptoms  Hoard medications  Take someone else’s  Aggressively complain  Request specific drug – worry over change  Use more than recommended  Use opioid for other sx  Drink etoh, tobacco for pain

More predictive  Bought meds on street  Stole for meds  Tried to obtain meds from > 1 source; seeing >1 clinician at once w/o them knowing  Performed sex for drugs/$$  Stole drugs from others  Prostituted others for $$/drug  Rx forgery  Sold prescription drugs Fishman, Responsible Opioid Prescribing. 2nd ed.

Washington DC, Waterford Life Science. 2012: 31

Chronic Pain or Addiction?

Chronic Pain

Addiction

 Medication use

 Medication use

– Not out of control – Improves QOL

 Desire to decrease meds with adverse affects  Concerned about physical problem  Follows agreements  Frequently has leftover meds

– Out of control – Impairs QOL – Continues despite A/Es

    

Unaware/in denial of any problems Doesn’t follow agreement Doesn’t have leftover med Loses prescriptions Always has a story…

Fishman S. Responsible Opioid Prescribing. 2nd ed. Washington DC, Waterford Life Science, 2012: 30

Risk Management (cont’d)  Structure treatment commensurate  Assess drug-related behaviors with risk over time – High risk = > structure  Document the 4 A’s plus 1 – Use PMP data – with caution – Use urine drug screens with knowledge

 Treatment agreements – Mutual responsibilities

– Analgesia – ADLs – Adverse events – Aberrant behavior – Achieving goals of care

Common Elements of Treatment Agreements

 Clear written goals of care  Willing to participate in other therapies  One prescriber/one pharmacy for pain meds  Medication taken as prescribed –No escalation of dose (includes change in frequency of dosing), sharing, altering medications (chewing)

Common Elements of Treatment Agreements

 No early refills, on weekends/off hours  No illicit substances  Toxicology screening  Pill/patch counts  Side effects of medications provided  Ongoing evaluation plan

Urine Drug Screening  Pros

– Generally considered most effective biologically-based method for determining presence/absence of most drugs

• Screening (immunoassay) • Confirmatory (gas chromatography-mass spectrometry GC-MS or high performance liquid chromatography HPLC)

– Relative ease of sampling; inexpensive, simple testing – Longer detection period for parent drug and/or its metabolite(s) than serum testing

 Cons

– Immunoassays may cause false-positive and false-negative results, causing misinterpretation – Clinicians must understand what to order (thresholds, tests) • Must know drugs and metabolites to interpet

– Clinicians may be unprepared to address unanticipated results

False Positives  Nasal decongestants  Ibuprofen  Synthetic PCN  OTC nasal decongestants  Meperidine  Amitriptyline  Quinine  OTC nighttime cold/ sleep meds  Diazepam  Diphenhydramine

False + amphetamines False + marijuana False + cocaine False + opiates False + opiates False + opiates False + opiates False + methadone False + PCP False + PCP

Drug Testing Service, Department of Health & Human Services, Substance Abuse and Mental Health, Division of Workplace Program, San Diego Reference Laboratory Toxicology Lab Technical Brief, Dr. Joseph Grass Ph.D.

Ongoing Assessment  Pain assessment – Analgesia, Activities of daily living (function) – Aberrant behavior, Adverse events

 Medication review, plan review  PMP review P/E, mental health assessment  Progress toward goals of care – “What are you doing now that you weren’t doing before?”

People with Addictive Disease & Pain  Right to treatment with dignity, respect and same quality as all others – Balance between pain relief and inappropriate use

 Nurses well positioned and obligated to advocate for pain management in patients who are…

– Actively using, in therapy, in recovery American Society for Pain Management Nursing, 2002

 Assess both pain and addiction history  Differentiate between undertreatment & addiction

www.store.samhsa.gov Download or hard copies for free with standard shipping United States, Substance Abuse & Mental Health Services Administration (SAMHSA)

Treating Pain in People with Substance Use Disorders  Universal precautions  Tighten the structure to match risk – Setting of care – Selection of treatment – Supply of medications – Supports for recovery – Supervision & monitoring

Savage, Kirsh & Passik. Addiction Science & Clinical Practice; June 2008

• • •

• • •

Careful, ongoing assessment Multidisciplinary approach Larger doses of medication may be required • Requests often perceived as addiction • Do not withhold/reduce opioids with severe pain Develop a plan that addresses pain, functional impairment and psychological symptoms Closely monitor Patient and family education

Interface of Addiction and Pain  Distinguish among those with remote history of substance abuse, persons on methadone or buprenorphine maintenance, and the active user  Early consultation with team  Provide non-opioid therapy  Apply current principles of opioid therapy  Use a written treatment agreement for out-patient Krupnick SL, MEDSURG Nsg, November/December, 18(6): 381-384, 2009

Both pain and addiction?  Active user – Acute pain: • Higher doses, sometimes  pain perception, team approach, nonjudgmental, once pain is controlled, discuss options for help

– Chronic pain: • Opioids not likely appropriate

 In recovery/remote history • Discuss plan & proposed meds, risks of unrelieved pain, risks of relapse, involve family/supports, intensify recovery programs, respect wishes, CBT, non-pharmacologic interventions

Acute Pain Management  Plan in advance, if possible – Treat pain, prevent withdrawal first, then offer help with substance use disorder.

– Doses may need to be higher than “normal” – Involve patient in team planning – Use non-pharmacologic strategies, adjuvant meds. Avoid mixed agonists, antagonists – Schedule medications or PCA – Plan for discharge, taper meds as healing takes place Savage, Kirsh & Passik. Addiction Science & Clinical Practice; June 2008

Chronic Pain & Addiction

(SAMHSA, 2012)

 Chronic non-cancer pain & addiction frequently co-occur  Both have many shared patterns – Abnormal neural processing at the periphery and CNS – Mediated by genetics and environment – Significant behavioral components – Harmful consequences if not treated – Often require multi-faceted treatment

Both pain and addiction?

(SAMHSA, 2012)

 In methadone maintenance program (MMP) – Collaborate with MMP for pain management, continue daily methadone dose for addiction, add more frequent dosing of methadone for pain or use another analgesic.

 On buprenorphine – Contact buprenorphine prescriber for collaboration, use divided doses for pain or stop & add another analgesic

Consequences of Under Treatment of Pain in People with Addictive Disorders  Fear of worsening the addiction leads to withholding or reducing meds  Relapse may be a consequence of under treatment  Patient may “self-medicate” if pain is not adequately managed  Hospital/provider hopping = suboptimal health care model

â&#x20AC;&#x153;Failure to treat pain brushes perilously close to intentionally inflicting it.â&#x20AC;?

David Morris, The Culture of Pain, 1991