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Edwin W. Lojeski, D.O.

Chief Anesthesia Service

Boise VAMC

� None

� Identify benefit of opioid treatment in chronic pain.

� Identify risks to patients from chronic opioid treatment.

� Understand risk mitigation strategies to be used in patients on chronic opioid treatment.

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“as to disease, make it a habit of two things- to do good, or at least do no

harm” Hippocrates

RISK BENEFIT

� Risk is the potential loss (an undesirable outcome) resulting from a given action, activity and/ or inaction

Benefit something that has a good effect or promotes well-being.

� Acute pain- Opioids are often very helpful in the treatment of acute pain conditions (trauma/surgery).

� Chronic pain- Opioids can be helpful but there is a lack of evidence for effectiveness and the “evidence for the benefits has remained controversial and insufficient”.

� Federation of State Medical Boards, Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain, July 2013

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� Opioids do help in some chronic pain patients.

� A trial of opioid therapy for chronic pain should only be considered after failure of other treatment options.

� Generally, improvement with chronic opioid therapy is about a 30% decrease in pain when they are helpful.

� Patient

� Provider

� Society

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� Medical management of chronic pain claims have been increasing.

� In 2008, 17% of chronic pain cases involved medical management.

� Death from opioid rotation.

� MVA due to prescription opioids.

� Overdose related to non compliance with guidelines.

� Iatrogenic addiction.

� Lack of informed consent.

� Prescription opioids caused 11,499 deaths in 2007, more than cocaine and heroin combined.

� Prescription pain medications are the second most prevalent type of abused drug after marijuanna.

� Admissions to substance abuse treatment programs increased 400% from 1998-2008.

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� Prescription drug abuse is the fastest growing drug problem in the U.S.

� In an attempt to better treat patient pain, practitioners have greatly increased their rate of opioid prescribing.

� 1997, drug distribution was 96 mg morphine equivalents per person.

� By 2007, it was 700 mg per person (increase 7 times)

� Many providers under-appreciate the risk of opioids and frequently exaggerate the benefitsof high dose chronic opioid treatment.

� It is critical to define the populations at greatest risk to develop and implement effective interventions.

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� Age

� Dose- greater than 100 mg morphine equivalents (ME) per day.

� Patients with underlying lung disease.

� Patients with underlying liver disease.

� Patients with comorbid substance use disorder.

� Patients on benzodiazepines.

� Patients with comorbid mental health disorder.

� Literature shows a consistent increase risk for opioid misuse for younger patients.

� Persons aged 18-30 showed a 4-5 fold increased risk for opioid misuse compared to persons 65 and older(Sullivan, Ballantyne. Arch Intern Med/ Vol 172(#5), Mar 2012:433-4).

� Older patients often have more medical comorbidities, altered pharmacokinetics and pharmacodynamics that can increase their risk.

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� Estimated annual overdose rates:

� 0.2% < 20 ME mg day

� 0.7% 50-99 ME mg day

� 1.8% > 100 ME mg day

� 88% of identified OD were non fatal but required hospitalization.

� Higher in patients over 65, history of sub abuse treatment or a history of depression.

� Highest risk after prescription refill of new prescription.

Opioid Prescriptions for Chronic Pain and Overdose (Ann Intern Med, Jan 2010)

� “It is much more important to know what sort of patient has a disease than what sort of disease the patient has.”

� Sir William Osler

� Structured evidence based review of all studies available on the development of abuse/addiction and ADRB in chronic pain patients exposed to COT.

� Abuse/addiction grouping calculated abuse/addiction rate 3.27%

� Preselected for no previous history 0.19%

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BIOLOGICAL PSYCHIATRIC

� Age < 45

� Gender

� Family history of prescription drug or ETOH abuse (genetic and environmental)

� Cigarette smoking

� Substance use disorder

� Preadolescent sexual abuse (in females)

� Major psychiatric disorder (eg, personality disorder, anxiety or depressive disorder, biploardisorder)

� Social

� Prior Legal problems

� History of MVA

� Poor family support

� Involvement in a problematic subculture

� Life stressors

� Key principle prior to starting a patient on chronic opioid therapy is determining a patient’s risk of abuse/harm.

� There are a number of validated tools available to help assess a patients risk of opioid abuse.

� Ideally they are simple, validated and identify abuse potential prior to initiating COT.

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� 1) Opioid Risk Tool- ORT

� 2)Screener and Opioid Assessment for Patients with Pain- SOAPP

� 3) Diagnosis, Intractability, Risk and Efficacy Score- DIRE

� Self administered.

� Brief, 5 questions, easy to score.

� Validated in pain populations.

� Provides excellent discrimination for patients with low risk (<3) vs high risk (>= 8) scores.

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Opioid Risk Tool

Patient's Sex

Mark each box

that applies

Item

Score

1) Family History of Substance Abuse:

Alcohol 0

Illegal Drugs 0

Prescription Drugs 0

2) Personal History of Substance Abuse

Alcohol 0

Illegal Drugs 0

Prescription Drugs 0

3) Age (Mark Box if 16-45) 0

4) History of Pre-adolescent Sexual Abuse 0

5) Psychological Disease

5a) Attention Deficit Disorder 0

Obsessive Compulsive Disorder

Bipolar

Schizophrenia

5b Depression 0

Total 0

*Total Score Risk Category

Low Risk 0-3

Moderate Risk 4-7

High Risk > or = 8

Male Female

* Score is SEX dependent

Convert To Prog Note Text

� Best psychometrics of any measure designed to predict aberrant behavior before therapy is begun.

� Self administered, 24 and 14 questions forms.

� Possibly better for high-risk populations (time).

� Physician administered, 7 items.

� Easy to use, takes <2 minutes

� Designed for PCP

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Characteristic Low Risk Moderate Risk

High Risk

Substance abuse

Never Past Current

Smoking Never Past Current

FH of addiction

None Past Current

Psych No Major Current Significant

H/O sex abuse

No N/A Yes

Positive UDS Neg Int pos Pos

Dose MED ≤ 40 40-120 >120

ORT 0-3 4-7 8+

SETTING MONITORING

� PCP

� PCP plus consultation

� Pain Management Clinic

� UDS frequency

� Frequency of face to face visits

� Frequency of tools

� Hyperalgesia

� Hypogonadism

� Sedation

� Respiratory depression

� Falls (elderly)

� Immunosurpression

� Cognitive impairment

� Constipation

� Nausea/Vomiting

� Pruritis

� Central Sleep Apnea

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� Borrowed from infectious disease.

� Impossible for the health care professional to reliably assess the risk of infectivity during an initial assessment of the patient.

� We have to apply an appropriate minimum level of precaution to all patients to reduce the risk of transmission of infection.

� Also, impossible to reliably predict the risk of opioids during a initial assessment so same principles apply.

� 1) Diagnosis with appropriate differential.

� 2) Psychological assessment (risk of addictive disorders)

� 3) Informed consent.

� 4) Treatment agreement.

� 5) Pre and Post intervention assessment of pain level and function.

� 6) Appropriate trial of opioid therapy

� 7) Reassessment of pain score and level of function.

� 8) Regularly assess the “4A’S” of pain medicine (analgesia, activity, adverse effects, aberrant behavior).

� 9) Periodically review pain diagnosis and comorbid conditions, including addictive D/O.

� Documentation.

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� Conduct a comprehensive review, including risk stratification.

� Counsel and obtain informed consent.

� Individualize treatment.

� Evaluate potential causes for repeat dose escalations, wean or taper if necessary

� Periodically reassess the patient.

� Anticipate, identify and treat opioid associated adverse events.

� Integrate nonopioidtherapies as adjunctive treatment.

� Consider PRN therapy for breakthrough pain

� 2013 Model Policy on the use of Opioid Analgesics in the Treatment of Chronic Pain.

� The goal is a guideline for “assessing physicians’ management of pain, determine whether opioid analgesics are used in a manner that is both medically appropriate and in compliance with applicable state and federal laws and regulations”.

� 57 of 70 Medical Boards have adopted similar/verbatim language.

� Pain management is important.

� Opioids may be necessary for pain relief.

� Use of opioids for other than medical purpose poses a risk to the individual and society.

� Physicians have a responsibility to minimize potential for abuse and diversions.

� Physicians may deviate from recommended treatment based on good cause.

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� Not meant to constrain or dictate medical decision making.

� “inadequate attention to initial assessment to determine if opioids are clinically indicated and to determine the risks associated with their use in a particular individual with pain.”

� “There are significant risks associated with opioids and therefore benefits and must outweight the risks.”

� Inadequate evaluation to determine risk.

� Inadequate monitoring during use.

� Inadequate attention to patient education and informed consent.

� Unjustified dose escalation without adequate attention to risks or alternative treatments.

� Excessive reliance on opioids.

� Not making use of tools for risk mitigation.

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� 1. Evaluation of the patient.

� 2. Treatment plan.

� 3. Informed consent and agreement for treatment.

� 4. Periodic review.

� 5. Consultation.

� 6. Medical records.

� 7. Compliance with laws and regulations.

FSMBS

Universal Precautions in Pain

APS/AAPM

� Preparation is the best approach.

� Mail intake questionnarie.

� Prompted chart notes.

� Templated notes/dictations.

� Document completely.

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� History and PE.

� Diagnostic tests.

� Pain Diagnosis

� Evaluation and consultation-consider psychosocial.

� Treatment objectives.

� Informed consent-written.

� Treatment Agreement.

� Medications.

� Risk Assessment/Periodic review.

� Experts recommend.

� Evidence is weak in reducing opioid misuse.

� Typically check for evidence of opiate, alcohol, benzodiazepines, cocaine, marijuana, amphetamine and barbiturate use.

� Some opiates may need to be specifically requested (oxycodone, fentanyl, methadone).

� Purpose is to identify aberrant behavior.

� Discover undisclosed drug use and/or abuse.

� Verify compliance with treatment.

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� Low risk by ORT Periodic 1/yr

� Moderate risk by ORT Regular 2/yr

� High Risk by ORT Frequent 3-4/yr

� Aberrant Behavior At time of visit

� Negative for opioid(s) you prescribed.

� Positive for amphetamine/methamphetamine.

� Positive for cocaine or metabolites.

� Positive for drug (benzodiazepines, opioids, etc) that you did not prescribe or have knowledge of.

� Positive for alcohol.

� Experts recommend using and becoming standard of care (FSMBs, VA/DOD).

� Evidence for their effectiveness is weak in decreasing opioid misuse.

� Allows you to have a conversation about risk/benefits, set limits, define responsibilities, set expectations.

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� Patients agree to comply fully with all aspects of treatment.

� Prohibit use of alcohol, other sedating medications and illegal drugs.

� Agree not to drive until sedation resolved.

� One prescriber.

� UDS.

� Agree to keep schedule appointments.

� PDMP is a statewide electronic database which collects designated data on controlled substances dispensed in the state.

� Agency distributes data to individuals who are authorized under state law to receive the information.

� DEA is not involved.

� Each state controls who will have access and for what purpose.

� Support access to legitimate medical use of controlled substances.

� Identify and prevent drug abuse and diversion.

� Facilitate the identification, intervention and treatment of persons addicted to prescription drugs.

� Identify use and abuse trends in a population.

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� Opioids can be effective in chronic pain.

� They have significant risks.

� Must do a risk assessment.

� Need informed consent.

� Approach as a trial and stop if no effect.

� Documentation is important.