Managing Risk - Identifying Issues in

the Workplace April 10-12, 2012

Walt Disney World Swan Resort

Accepted Learning Objectives: 1.  Identify the signs and symptoms of drug

addiction.

2.  Describe the proper procedure for employers to take when they suspect substance abuse in their employees.

3.  Explain the potential liabilities faced by employers who do not address substance abuse issues within the workplace.

Disclosure Statement

•  Det. Ryan Buzzini has disclosed no relevant, real or apparent personal or professional financial relationships.

•  Phil Walls has disclosed that he will discuss the off-label use of drugs such as Actiq and Fentora that create a high risk environment for developing addiction.

“Doctors pour drugs, of which they know little, for diseases, of which we know less,

Into patients—of which we know nothing.”

—Voltaire

•  From 1991 to 2009, prescriptions for opioid analgesics increased almost threefold, to over 200 million.

•  Overdoses attributed to prescription painkillers killed nearly 15,000 people in the U.S. in 2008, more than three times as many as in 1999.

Prescription opioid overdose is now the second leading cause of accidental death in the U.S., killing more people than heroin and cocaine combined.

In Worker’s Compensation

“The abuse of prescription opioids has become a grave personal risk to injured workers, a disruptive force in the lives of those close to claimants harmed by abuse, and a cost concern to other stakeholders in the United States workers’ compensation system.”

Joint statement of ACOEM and IAIABC

•  Temporary disability payments are 3.5 times higher when opioids are prescribed

•  A study of 17 states found that many physicians who prescribed narcotics to injured workers were not using recommended tools to monitor use, abuse and diversion

Drug Use Statistics

•  80% of the world’s supply of opioids is consumed in the US

•  99% of the world’s supply of hydrocodone is consumed in the US

•  2/3 of the world’s supply of illicit substances are consumed in the US

Manchikanti, L. National Drug Control Policy and Prescription Drug Abuse: Facts and Fallacies. Pain Physician. 10:399-424, 2007.

Search Results: “undertreatment of pain”

April 15, 2011 “Despite Awareness, Undertreated Cancer Pain Persists”

July 5, 2011 “Pain Common but Undertreated”, www.medscape.com

July 11, 2011 “Case Report: Undertreatment of Pain in a 40-Year-Old Woman”, Psychiatry Weekly

ETC.

Commonly Prescribed Drugs (from all payer types)

Atorvastatin

Amoxicillin

Hydrocodone Comb.

Oxycodone Comb.

Propoxyphene Comb.

Tramadol and Comb.

Codeine Comb.

Oxycodone

Other Opioids

Fentanyl

Morphine

Number of Prescriptions (in millions) IMS 2005

Drug Enforcement Administration

– Bureau of Prohibition 1927-1930 – Bureau of Narcotics 1930-1968 – Bureau of Narcotics and Dangerous Drugs

(BNDD) 1968-1973 – Drug Enforcement Administration 1973

Role of the DEA

– Controlled Substances • Narcotics vs. Opioids •  Illicit drugs • Diversion of prescription drugs

– Schedules – level based on potential for abuse and addiction

– Addiction vs. Tolerance

Controlled Substances •  Schedule II

– Rx cannot be phoned or faxed to pharmacy

– Rx cannot be refilled •  Schedule III, IV and V

– Rx may be phoned or faxed to pharmacy. Fax must originate from doctor’s office.

– Rx may be refilled if authorized by MD up to 5 times within 6 months of the date Rx was ‘written’ (all other prescriptions expire after 12 months).

Schedule II Examples •  Actiq (oral transmucosal fentanyl citrate,

OTFC) •  Avinza (morphine sulfate) •  Dolophine, Methadose (methadone) •  Duragesic (fentanyl patches) •  Embeda (morphine sulfate and naltrexone) •  Fentora (OTFC) •  Kadian (morphine sulfate) •  OxyContin (oxycodone)

Schedule III and IV •  Darvocet N 100 (propoxyphene napsylate

and APAP) •  Tylenol #3 (codeine with acetaminophen) •  Vicodin/Lortab/Lorcet (hydrocodone with

APAP) •  Talwin (pentazocine with naloxone) •  Ativan (lorazepam) •  Klonopin (clonazepam) •  Valium (diazepam) •  Xanax (alprazolam)

Schedule V

•  Codeine containing cough syrups •  Certain paregoric formulations

Tolerance

•  Tolerance is 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

•  Tolerance develops at different rates, in different people, to different effects

Physical Dependence

•  A 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

Addiction Concensus Medical Definition

•  “A primary, chronic neurobiological disease with genetic, psychosocial and environmental factors influencing its development and manifestation”

From AAPM, APS, ASAM Definitions Related to the Use of Opioids for the Treatment of Pain. Available at: http://www.ampainsoc.org/advocacy/opioids2.htm.

Addictive Behaviors

•  Addictive behaviors include one or more of the following: –  Impaired control over drug use – Compulsive use – Continued use despite harm (physical,

mental, and/or social) – Craving

Savage SR, et al. J Pain Symptom Manage. 2003;26(1):655–667. [Evidence Level C]

Opioid Effects: Analgesia and Reward

•  General –  Analgesia –  Altered mood –  Decreased anxiety –  Respiratory depression –  (-) GI motility –  Cough suppression –  Miosis –  Pruritus, nausea,

vomiting Clinical Manual Addiction

Psychopharmacology, 2005.

•  Reinforcing effects

- Reduce anxiety

- Decrease boredom

- Decrease aggression

- Increase self-esteem

Pseudoaddiction

•  Behaviors that may occur when pain is inadequately treated

•  Patients may become focused on obtaining medications

•  May seem to be drug-seeking •  Behaviors resolve when pain is

appropriately treated

Diversion

•  The use of a legitimately prescribed medication for illicit or illegitimate purposes—perhaps with the intent to sell or distribute

•  Examples – Stolen, altered, or forged prescriptions – Trading for profit on medication from others – Scams

Aberrant Behavior vs Abuse

Total Pain Population

Aberrant Behavior: 40%

Abuse: 20%

Addiction: 2%–5%

Webster LR, Webster RM. Pain Med. 2005;6:432–442; Webster LR, et al. Pain Med. 2005;6:432–442.

What about Schedule I?

•  Highest potential for abuse and addiction

•  No approved medical use

•  Cocaine (CS II) •  Heroin •  Marijuana •  Methamphetamine

FDA Panel Votes Against Requiring Prescriptions For

Medicines Containing Dextromethorphan.

NBC Nightly News (9/14) reported that in "a decision that surprised some people late this afternoon," and "despite an alarming number of teenagers who are using common over-the-counter medicines to get high," a FDA panel "considering whether or not to recommend a prescription to buy them has decided that it is not a good idea for now."

Red Flags In Screening/Early Therapy

•  Little or no relief using opioid therapy in acute/sub-acute phases

•  Diagnosis identified as one that hasn’t been shown to have good success using opioids, i.e. unidentifiable pain or pain associated with physiological factors

•  Patient request of opioid medication, with inconsistencies in history, presentation, behaviors or physical findings

•  Inappropriate use of opioids within first 30 days of therapy

Daily Equivalent Morphine Dosage (MED)

•  Computed utilizing dosages of all opioid and opioid-containing medication taken during a 24-hour period

•  120 mg MED threshold as an indicator of risk

•  Patients receiving 100 mg or more per day MED had a 9-fold increase in overdose risk – most were medically serious, 12% were fatal

MED (cont.)

National Council of Self-Insurers

•  Early data show the 120 mg MED guideline has played a part in reducing injured-worker deaths caused by the dramatic rise in opioid prescribing

Best Practices •  Full evaluation of medical history and physical

examination •  Determine the lowest effective dose

•  Set and agree upon goals. Use Pain Treatment Agreement

•  Use Step Therapy approach

•  Actively monitor with Urine Drug Screening (UDS)

The purpose of UDS is to reveal not only the presence of illicit substances, but also the absence of the prescribed medication

•  Stop use if pain is not at least partially relieved

Urine Drug Screening

•  Start with baseline and determine risk level with ORT, then repeat randomly based on level of risk

Long Term Use? •  Routine use not recommended for chronic pain

syndromes

•  Can be carefully prescribed for select patients who have not responded to other therapies

•  Can be effective if improvement can be documented in:

reduced pain better quality of life functional improvement appropriate medication use minimal side effects

•  Periodically re-assess benefit-risk ratio

Risk Reduction Strategies

•  Treatment plan with clearly defined objectives

•  Use a written Pain Treatment Agreement to clarify proper medication practices and expectations for relief

Risk Reduction Strategies •  Use a risk screening

tool such as the Current Opioid Misuse Measure (COMM) to assess how medication is being used

•  Monitor compliance with periodic Urine Drug Screening

•  Periodically decrease dosage and try alternate therapies to reduce potential for abuse or dependence

Evaluating Continued Use •  Use 4 A’s of ongoing monitoring:

Analgesia – Is there documented pain relief? Activities of daily living – Normal function returning, not

just a patient-reported decrease in pain? Adverse side effects – Are they minimal and tolerable? Aberrant drug-taking behaviors – Are there “red flags”?

•  Return to work?

•  Prescriptions obtained from a single practitioner

•  Prescriptions filled by a single pharmacy

Other Standards to Maintain

•  Use of a pain diary

•  Continuing UDS

•  Documentation of misuse

When To Stop Treatment

Indicators should be well documented and include: •  Level of function – if no overall improvement, stop

therapy

•  Continuing pain with intolerable adverse effects – side effects may outweigh benefits

•  Serious non-adherence in the way the patient takes medication or in the manner it’s obtained

•  Evidence of diversion, forgery, stealing or motor vehicle accident related to opioids or other illicit drugs

•  Repeated violations of medication contract or evidence of abuse/addiction

Risk Reduction is Key

Carefully balancing of benefits and risks is essential in the treatment of injured workers

FDA Actions

• Focus on reducing overall risk with long-acting and extended-release opioids

• REMS – require manufacturers to provide prescriber training materials covering use, risks of misuse and potential for abuse/addiction

• Encouraging development of abuse deterrent formulations more difficult to alter in order to get immediate release

When Should Your PBM Take Action?

•  2 or more long-acting opioids •  Multiple pharmacies •  Multiple prescribers •  High dose opioids •  Opioid prescription for known substance abuser •  Injectable opioids for non-cancer patents •  Frequent physician changes within same specialty •  Prescribing patterns outside of pain management

or REMS guidelines

Principles of Chronic Opioid Maintenance for Pain:

•  Try aggressive rehabilitative approaches which aim to restore function and reduce reliance on medications

•  Ensure other treatment options have been maximized •  Consider opioid therapy as an adjunct; sole opioid therapy is

rarely successful •  Base regimen on long-acting opioids •  Ensure careful and regular follow-up •  Be prepared to wean and discontinue if treatment goals are

not met •  Careful evaluation of patient/Maintain good documentation Ballantyne JC and LaForge KS, Opioid dependence and

addiction during opioid treatment of chronic pain, Pain. 2007;129:235-255.

•  In actuality, the panel supports restricting the use of opioids

•  The rejection was because the panel did not think REMS for opioids was strong enough to actually control the use of these drugs

•  The panel voted 25 to 10 against the FDA plan, with the primary reason for dissension being that the plan did not require training for physicians that prescribe these drugs.

NY Times Headline July 23, 2010: “FDA Panel Opposes Plan to Tighten Use of Painkillers”

•  Effective March 25, 2008 as part of the Food and Drug Administration Amendments Act of 2007

•  Provides the FDA with the authority to order REMS for any drug or biological with significant toxicity levels or demonstrable risk factors.  Not limited to opioids.

•  REMS should ensure that the benefits of a drug outweigh the risks.

Risk Evaluation and Mitigation Strategies (REMS)

•  Medication guide or patient package insert

•  Communication plan for healthcare providers

•  Elements to assure safe use (ETASU)

Note: Not all drugs require all three components.

Three components to a REMS program

•  Dispense drugs through specific distribution channels

•  Require specific training or certification in order to prescribe

•  Develop registry for patients •  Mandatory time sensitive reports of

patient responses to treatment

For drugs requiring ETASU:

Update on Implementation of Opioids REMS

•  The central component of the Opioid REMS is an education program for prescribers so that LA/ER opioid drugs can be prescribed and used safely. FDA expects the training to be conducted by accredited, independent continuing education (CE) providers.

•  On November 4, 2011, FDA announced the availability for public comment of a draft "Blueprint."

http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm163647.htm

Blueprint

•  Prescribers should establish goals for therapy and continuously evaluate pain as well as functioning level and quality of life.

•  Prescribers should be aware of the existence of Patient Provider Agreements (PPAs), although FDA is not requiring their use.

http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf

PPAs

– PPAs are documents signed by both prescriber and patient at the time an opioid is prescribed. PPAs can help ensure patients understand the goals of treatment, the risks, and how to use the medications safely. •  Utilizing PDMPs to identify potential abuse

where available •  Understanding the role of drug testing and

performing drug screens as indicated •  Screening and referring for substance abuse

treatment when indicated

List of TIRF Medicines Available Only through the TIRF REMS Access Program

•  ABSTRAL® (fentanyl) sublingual tablets •  ACTIQ® (fentanyl citrate) oral

transmucosal lozenge •  FENTORA® (fentanyl citrate) buccal

tablet •  LAZANDA® (fentanyl) nasal spray •  ONSOLIS® (fentanyl buccal soluble

film)

http://www.fda.gov/downloads/Drugs/DrugSafety/