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Sarah J. Payne, MS, PharmD, BCPS

Assistant Professor, UNT System College of Pharmacy

The Opioid Epidemic

Learning Objectives

1. Describe the prescription painkiller epidemic.

2. State the DEA Scheduling Class for hydrocodone as of October 2014.

Opioid Prescriptions in the US

www.cdc.gov/vitalsigns/opioid-prescribing/

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Opioid Use by Age

www.drugabuse.gov

Deaths from Opioid Painkillers

www.drugabuse.gov

What Can Be Done?

• Federal Government• Support states development of programs and policies

• Supply healthcare providers with guidance

• Increase access to mental health services

• Reclassification of controlled substances• Hydrocodone to CII

www.cdc.gov/vitalsigns/opioid-prescribing/

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What Can Be Done?

• State Governments• ↑ use of prescription drug monitoring & substance abuse

treatment

• Create policy relating to use of pain medications

• Assess effectiveness of health programs

www.cdc.gov/vitalsigns/opioid-prescribing/

What Can Be Done?

• Healthcare Providers• Identify patients who might be misusing drugs

• Use effective treatments for substance abuse

• Discuss risks and benefits of pain treatment

• Follow best practices• Screening for substance abuse and mental health problems

• Avoid combinations of painkillers and sedatives, if possible

• Prescribe lowest effective dose and specific quantity needed

www.cdc.gov/vitalsigns/opioid-prescribing/

What Can Be Done?

• Everyone• Avoid taking painkillers other than prescribed

• Dispose of medications properly

• Help prevent misuse and abuse

• Get help for substance abuse problems• 1-800-662-HELP

www.cdc.gov/vitalsigns/opioid-prescribing/

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Jon C. Sivoravong, D.O.Associate Professor and

Vice Chair for Clinical Affairs Department of Family Medicine-UNTHSC

March 2015

Understand acute and chronic pain

Understand abuse, addiction and aberrant behaviors

Describe the frame work for opioid prescription

Able to locate Prescription Access in Texas website

Able to write schedule II prescription

Goals and objectives

No issue more polarizing than management of chronic pain

Spectrum of belief on treatment ranges from those who believe narcotics should never be prescribed who believe narcotics best therapeutic option

1:4 American suffers from chronic pain

Treatment of nonmalignant chronic pain in primary setting

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No issue more polarizing than management of chronic pain

Spectrum of belief on treatment ranges from those who believe narcotics should never be prescribed who believe narcotics best therapeutic option

1:4 American suffers from chronic pain

Treatment of nonmalignant chronic pain in primary setting

Nociceptive Pain RA, Gout, Osteoarthritis

Neuropathic Pain Diabetic peripheral neuropathy, post herpetic

neuralgia

Sensory Hypersensitivity Fibromyalgia

Three Main types of pain pathophysiology

Nociceptive Pain RA, Gout, Osteoarthritis

Neuropathic Pain Diabetic peripheral neuropathy, post herpetic

neuralgia

Sensory Hypersensitivity Fibromyalgia

Three Main types of pain pathophysiology

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Nociceptive Pain RA, Gout, Osteoarthritis

Neuropathic Pain Diabetic peripheral neuropathy, post herpetic

neuralgia

Sensory Hypersensitivity Fibromyalgia

Three Main types of pain pathophysiology

Unpleasant sensory and emotional experience

associated with actual or potential tissue damage or described in terms of such damage

does not require nociception, as pain is emotional experience.

Pain:

International Association for the Study of Pain (IASP) - 1994

Unpleasant sensory and emotional experience

associated with actual or potential tissue damage or described in terms of such damage

does not require nociception, as pain is emotional experience.

Pain:

International Association for the Study of Pain (IASP) - 1994

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Short or appropriate duration (usually <2 wk.)

Specific pathology

Treatment obvious

Useful in getting person to physician

Generally does not interfere with function

Acute pain

Short or appropriate duration (usually <2 wk.)

Specific pathology

Treatment obvious

Useful in getting person to physician

Generally does not interfere with function

Acute pain

Persist longer than 3 or 6 month Persist longer beyond the normal healing process Occurs after acute injury or have no apparent cause May spread beyond the original site Appears to serve no biological purpose Moderate to severe intensity Limits physiologic function and Psychological and emotional

activities Reduce quality of life Refractory to treatment.

JAMA 2003

Chronic pain -70 million sufferer 2003

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Persist longer than 3 or 6 month Persist longer beyond the normal healing process Occurs after acute injury or have no apparent cause May spread beyond the original site Appears to serve no biological purpose Moderate to severe intensity Limits physiologic function and Psychological and emotional

activities Reduce quality of life Refractory to treatment.

JAMA 2003

Chronic pain -70 million sufferer 2003

Pain is usually undertreated due to multiple cause Decision to give opioids is difficult when patient is not an ideal candidate Prescriptions must be individualized (medical, psychiatric and hsx response) Prescriber may occasionally be misled by patients who divert or misuse Prescribers have obligation to understand the risks, and management of

addictive disease. Prescribers who persistently fail to treat addiction is poor medical practice Prescribers who fail to prescribe opioids when use is indicated is also poor

medical practice Providers traditionally receive little or no education about pain

management or treatment of addition.

American Academy of Pain Medicine 2004

Rights and Responsibilities of prescribers of Opioids

Prescription drug abuse

Most abused

OpioidsCNS depressant

anxiety and sleep disorders

Stimulants ADHD and Narcolepsy

Young people

1 in 5 teenager Most popular drugs Hydrocodone 18% Oxycodone 10% ADHD drugs 10%

National Institute of Drug Abuse. 2005 Partnership for drug free America 2007

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Memory-Addiction- Reward Pathway (in a nutshell)

VTA and NAC - reward pathway Dopamine

Opioid receptors Frontal cortex and limbic system

High Dopamine released- trigger High Glutamate release in memory pathway

Hypermemory state - embedded in cortex

Stress: “fuel to the fire of addiction”

Stress causes individuals to search for solutions; in modern era, solutions often involve use of pharmacologic agents

Patients with unclear pathology start on chronic pain

pathway and see many physicians who offer different “right answers” but inadequate care this leads to anxiety and depression

45% of patients have depressed and anxiety disorder by time they see specialist in chronic pain

Chronic pain — research suggests primarily an emotional disorder

Common Clinical pathway:

Verbalization: pain becomes patient’s life Populations at risk: women 40 to 49 yr. of age

Depression: can prevent patient’s ability to discriminate pain level assessment — questionnaires (e.g., Beck Depression Inventory)

Hostility: clinician must set boundaries on hostile behaviors

Manipulative: centered on obtaining narcotics

Drug abuse: usually not patients’ intent

Clinical Characteristics of chronic pain patients

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The use of any substance for nontherapeutic purpose

or the use of medication for purposes other than those for which the agent is prescribed.

Drug abuse

The use of any substance for nontherapeutic purpose

or the use of medication for purposes other than those for which the agent is prescribed.

Drug abuse

A primary chronic neurobiological disease

influenced by genetics, psychosocial, and environmental factors.

It is characterize by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving.

Addiction

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A primary chronic neurobiological disease

influenced by genetics, psychosocial, and environmental factors.

It is characterize by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving.

Addiction

Abuse vs Addiction:

Abuser

Stressors influential in Abusers

Abusers or heavy abusers behave as if addicted when under severe stress

Addiction Behavior uncontrolled

without means of modulation

Substance escalate steadily under normal circumstances in absence of stress

Eventually, substance becomes solution to every form of emotional discomfort

Chronic pain patient vs

Addicted patient

Chronic pain

Medication use not out of control

Medication improve quality of life

Is concerned about physical problem

Follow agreement for opioids

Frequently has leftover

Addicted Out of control Medication diminished

quality of life Increase medication use

despite adverse effects Unaware of or denial about

problem as a result from drug treatment

Does not follow agreement Does not have leftover, loses

prescriptions, always has a story

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Chronic pain pt.

Aberrant Behavior, Abuse and Addiction

Addiction 2-5%

Abuser 20%

Aberrant Behavior 40%

Webster, Pain Med. 2005

All addicted people are abusers, but not all abusers are addicted

Chronic pain pt.

Aberrant Behavior, Abuse and Addiction

Addiction 2-5%

Abuser 20%

Aberrant Behavior 40%

Webster, Pain Med. 2005

All addicted people are abusers, but not all abusers are addicted

Addiction PseudoaddictionOther psychiatric disorder Anxiety, major depression Personality disorders, antisocial

Encephalopathy Psychosocial or emotional issues Recreational

Differential for aberrant behavior

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Relative severity - egregious Quantity - multiple Persistence - recurrence Purpose - deliberate misuse Time consuming nature - health care resource

Aberrant behavior classification

Behaviors predictive of addiction

Lesser Aggressive complaining for

higher dose Drug hoarding Request specific drugs Multiple prescriber Unsanctioned dose escalation

1-2x Unapproved use of drug to treat

another symptom Reporting psychiatric drug

related effects Occasional impairment

More Selling prescription drugs Forgery Stealing Injecting oral formulation Obtaining drugs from nonmedical

source Multiple prescription loss Concurrent abuse of related illegal

drugs Multiple dose escalations despite

warning Repeat episodes of gross

impairment

Portenoy. J Pain Symptoms Management 1996

1. Overwhelming time spend on opiates discussion after a

3rd visit.

2. Pattern of early refill (3 or more) or dose escalation.

3. Multiple phone calls to the office.

4. Pattern of lost, spilled or stolen prescriptions.

5. Multiple source of opiates.

Expert 5 point checklist for drug abuse

Webster, Avoiding Opioid Abuse while managing pain. Sunrise river press 2007

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Careful observation and documentation of drug

aberrant behavior should be charted in chronic pain patients like any clinical data such as hemoglobin A1c in diabetic patients and blood pressure reading on hypertensive patients.

Documentations

Narcotic prescription needs to be highly structured policy

Specific guidelines Pain contract, UDS, refills, multidisciplinary team approach

1: Assess Risk - consider non opioids first Assess patient’s risk for aberrant behaviors Assess the patient for psychological disorders Review your state’s prescription monitoring program Conduct a baseline urine drug test

2: Select Agent – Consider the patient’s general condition, medical status, and prior opioid experience After deciding on an agent, consider an abuse-deterrent opioid

3: Dialogue with patient Discuss treatment expectations Review written treatment agreement

4: Monitor Treatment – Regularly assess the “4 A’s” Analgesia: Activity: Adverse effects: Aberrant behavior:

A Framework for Appropriate Opioid prescribing

Addiction severity index Self or interview 200 item 1hr

Alcohol use Disorder identification Test Self or interview 10 item 2 minutes

Structure interview DSM-IV interview 30-60 min

CAGE interview 4 item <1 min

Case Adapted to include drugs interview 4 items <1 min

Two item conjoint screening tool interview 2 items <1 min

Screener and Opioid Assessment for Patients with Pain (SOAPP)

Self or interview 24 items 10 min

Prescription Drug use Questionnaire interview 42 items 20 min

RAFFT Self 5 items about 1 min

Drug Abuse Screening Test self 20 items 5 min

Michigan Alcohol Screening Test Self or interview 25 items 15 min

Screening Instrument for Substance Abuse Potential

interview 5 Items about 1 min

Substance abuse Subtle Screening Inventory

self 1 page 15 min

Severity of opiate Dependence Questionnaire

self 21 items about 5 min

Opioid Risk Tool self 5 items 1 min

Risk Tools

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Webster LR, Webster R. Predicting aberrant behaviors in Opioid-treated patients: preliminary validation of the Opioid risk tools. Pain Med. 2005; 6(6): 432

Authorized users can search the last 365-days worth

of prescription dispensing history for Schedule II – V controlled substances, 24-hours a day, seven-days a week, including patient prescription history and physician’s own prescribing information.

PAT is a secured, online prescription monitoring program

https://www.texaspatx.com/login.aspx

Prescription Access in Texas (PAT)

Hydrocodone Combination Products (HCPs) have

been moved from Schedule III controlled substances to the more-restrictive Schedule II, effective on Oct. 6, 2014.

The U.S. Drug Enforcement Administration’s rescheduling of HCPs as Schedule II Controlled Substances will increase the restrictions on prescribing and dispensing practices for HCPs.

Texas Department of Public Safety

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(A) the date the prescription is issued

(B) the controlled substance prescribed(C) the quantity of controlled substance prescribed, shown:

(i) numerically, followed by the number written as a word (ii) numerically, if the prescription is electronic;

(D) the intended use - the diagnosis (E) the practitioner's name, address, and DEA number (F) the name, address, and date of birth or age of the person(G) if the prescription is issued to be filled at a later date under

481.074(d-1), the earliest date on which a pharmacy may fill the prescription;

(f) Not more than one prescription may be recorded on an official prescription form, except as provided by rule adopted under §481.0761.

Each official prescription form or electronic prescription used to

prescribe a Schedule II controlled substance must contain:

Dilemmas in treatment of

Chronic nonmalignant pain: Lack appreciation between acute

and chronic

Use extended-release opioids (immediate-release agents may act as trigger)

Emotional pain even in breakthrough pain

Patients must stop “chasing their pain”

Need to minimize effects on dopaminergic pathway

Opioid limits: keep patients below

high-dose level 100-120 mg of morphine

equivalents per 24-hr period * <60 mg recommended if

possible

Rotate long-term opioid use,

agents and lower dose

*Dunn KM, et. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92.

http://www.rethinkopioids.com/medication-options-of-chronicpain

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A physiologic state caused by regular use of an

opioid in which increased doses are needed to maintain the same effect.

In patients with “analgesic tolerance,” increased doses of the opioid are needed to maintain pain relief

Tolerance

A physiologic state characterized by abstinence

syndrome (withdrawal) if treatment with an opioid is stopped or decreased abruptly or an opioid antagonist is administered.

It is an expected result of opioid therapy and does not by itself equal addiction

Physical Dependence

A syndrome characterized by symptoms that include

sweating, tremor, vomiting, anxiety, insomnia, and muscle pain. caused by reduction in the opioid dose or opioid antagnonist.

It can be avoided by carefully tapering the opioids dosage and monitoring the patient.

American Academy of pain medicine American pain Society American society of addiction medicine

Abstinence Syndrome

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Prosecutors' three-year investigation of Limbaugh began

after he publicly acknowledged being addicted to pain medication and entered a rehabilitation program. They accused Limbaugh of "doctor shopping," or illegally deceiving multiple doctors to receive overlapping prescriptions, after learning that he received about 2,000 painkillers, prescribed by four doctors in six months, at a pharmacy near his Palm Beach mansion. Limbaugh, who pleaded not guilty Friday, has steadfastly denied doctor shopping. Black said the charge will be dismissed in 18 months if Limbaugh complies with court guidelines.

Rush Limbaugh Arrested On Drug ChargesApril 28, 2006

Senate Bill 406, effective Nov. 1, 2013, allows Mid-Level

Practitioners to add Schedule 2 and 2N. E-prescribing capability for Schedule II prescriptions was

implemented October 2013. Texas Administrative Code 13.73 Exceptions to Use of

Form. (a) An official prescription form is not required for a medication order written for a patient who is admitted to a hospital at the time the medication order is written and filled. (1) A practitioner may dispense or cause to be dispensed a Schedule II controlled substance to a patient who: (A) is admitted to the hospital; and (B) will require an emergency quantity of a controlled substance upon release from the hospital.

Mid Level, E-Prescribing, exceptions

American Pain Society/American Academy of Pain Medicine http://www.sciencedirect.com/science/article/pii/S1526590008008316 Department of Veterans Affairs/Department of Defense http://www.va.gov/painmanagement/docs/cpg_opioidtherapy_fulltext.

pdf Federation of State Medical Boards http://library.fsmb.org/book/ Utah Department of Health http://www.dopl.utah.gov/licensing/forms/OpioidGuidlines.pdf Washington State Agency Medical Directors’ Group http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf

http://www.rethinkopioids.com/guidelines

Guidelines and templates

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C H R I S T O P H E R J O R D A N , D O , F A C O I

M A R C H 1 8 , 2 0 1 5

U N T H S C G R A N D R O U N D S

Pain Management in Oncology

Identifying Pain

There are many tools useful for identifying patients with cancer-related pain

Verbal Patient

Literate

Illiterate

Non-verbal Patient

Dementia

ICU patient

Anticipating Pain

Pre-Procedural—pain is expected in many different procedures in Oncology, (bone marrow aspiration and biopsies, radiation, mediport placement and/or access, wound care, line placement, port access, LP, skin biopsies, etc…) as well as other maneuvers, such as transportation

Sufficient time and discussion with patients and family are important to plan analgesics (topical, local, and/or systemic therapy) as well as anxiolytic therapy

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Pain Assessment

There are many different factors involved in assessment of pain, and each one is helpful to identifying the best possible treatment of pain

-cancer itself

-treatment and/or procedures

-coincidental (arthritis, etc…)

Pathophysiology—nociceptive, neuropathic, visceral, effective, behavioral, cognitive

The Pain Experience

Location, referral pattern, and pain radiation

Intensity—last 24 hrs and current (rest, movement)

Interference with activities**

Timing

Description or quality of pain

Aggrevating and alleviating factors

Current treatment plan (both pharmacologic and non-pharmacologic)

Response to current therapy

The Pain Experience (cont)

Breakthrough pain

Prior pain therapies

Special issues relating to pain—family and patient understanding, meaning and consequences of pain, patient goals, cultural, spiritual and religious beliefs toward pain medications, potential for abuse/misuse

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Pain Management

First, its necessary to distinguish pain as an oncologic emergency or non-emergency

Then, determination of pain medications is necessary based on patients being narcotic naïve or tolerant.

Then, rating the pain 0-10 on numeric or picture scales, or using non-verbal pain scales, is necessary to establish severity of pain

Pain management (cont)

In patients experiencing pain <7 on 10 point scale, opiates should be a consideration up front, and adjuvant analgesics should be considered cautiously, as some can have adverse effects in both opiate naïve and opiate tolerant patients, though the dosages may differ significantly.

Caution should be used in both so dangerous side effects (respiratory depression, etc…) can be avoided and titration should be rapid.

Pain Management (cont)

Once adequate pain control is achieved with short acting opioids, and the goal of therapy should be the highest level of pain control with the least amount of side effects, if pain is adequately controlled with short acting opioids, whether alone or in combination with other anagesics, then would keep patient on the current dosages

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Pain Management (cont)

If pain medication levels are adequate to achieve short term pain control, but are not sufficient for the prescribed period of time, then addition of longer acting medications is prudent here

Long-acting medications should be prescribed to take around the clock and not prn and should not be used for the short term control of pain. Dosages should be equivalent to the shorter acting medications for the prescribed time periods of the shorter acting medications, though the length of action of longer acting medications will generally be longer (12-72 hours depending on medications)

Breakthrough pain

Defined as pain that develops between doses of medication, whatever the interval is. Generally, when patients have these levels of pain, they should be on long-acting medications and have short acting combination agents for short term, break through pain control

Example: MS Contin Q12 hours ATC, followed by Norco Q4-6 hours prn breakthrough pain

Breakthrough pain

If breakthrough pain is severe and frequent, short acting pain medication is necessary and rapid titration of these medications are necessary to achieve short term pain control. Once these short acting doses are known, then increasing the dose of long acting medications would be appropriate

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Other pain management options

If pain is confined to one area, narcotic and non-narcotic topical agents may be appropriate. These are beneficial because of local control with significantly less systemic effects.

Limitations: not for generalized pain. Require compounding pharmacy expertise typically.

Other pain management options (cont)

Injections—often, if pain is located in one area where a nerve block or local pain medications are appropriate, these can achieve very high levels of pain control (ex. Celiac plexus block in patients with pancreatic cancer)

Pain pumps—inserted to deliver continuous pain medication, typically to a specific nerve area to achieve adequate pain control

Other pain management options (cont)

Pain management consultation—practitioners specializing in pain management can assist significantly in the management of pain in patients with cancer and should be considered when unable to adequately control pain with medication prescriptions

Psychiatric consultation—in patients with psychiatric disorders, such as depression, pain can be significantly exacerbated by the underlying condition and prescription of psychiatric medications as adjunct therapies should be considered. Also, patients without underlying conditions can certainly have depression secondary to their cancer diagnosis and this should ALWAYS be a consideration in pain management

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Goal

Regardless of pain site, and tolerance or naivety to opioids, the threshold for using opioid pain medication in patients with cancer should be low, as pain relief is the goal of therapy to keep patients from suffering and to remain active in their daily lives as much as possible. The best dose of pain medication is the dose that relieves the most pain but with the least amount of side effects of pain medication