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SCWEA MeetingCharleston, SCFeb 27, 2011

Matthew Foster, PharmD

Clinical Pharmacy Manger, PMSI

Appropriate Opioid Management

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Overview

Medication use for treatment of chronic pain Adverse effects of narcotics (abuse/addiction) Appropriate pain management for narcotics Legislative efforts for appropriate pain management Pharmaceutical industry efforts for appropriate pain management Patient activities to subvert appropriate pain management

monitoring

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Top Injuries in Workers Compensation

Most patients enter the workers’ compensation system due to some type of physical injury

Physical injuries often require treatment for pain Most common injuries include

Sprains, strains Burns Lacerations, punctures, amputations

Therefore, treatment of pain is major issue in workers compensation

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Medication Management of Chronic Pain

Choice of initial agent dependent upon type of pain present

World Health Organization pain ladder commonly used

Increased or Persisting Pain

1. Non-Opioid

2. Opioid for mild to moderate pain +/- Non-Opioid +/- Adjuvant

3. Opioid for moderate to severe pain +/- Non-Opioid +/- Adjuvant

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Common Medications in Pain Management Non-steroidal ant-inflammatory drugs (NSAIDs)

Ibuprofen (Motrin), Naproxen (Aleve), Celecoxib (Celebrex) Narcotic Analgesics

Short-acting – Oxycodone-Acetaminophen (Percocet), hydrocodone-

acetaminophen (Vicodin, Lortab), tramadol (Ultram) Long-acting

– Oxycodone (Oxycontin), fentanyl (Duragesic), Morphine (Kadian, Avinva, MS Contin, Embeda)

Topical Analgesics Topical NSAIDs

– Diclofenac (Voltaren Gel, Pennsaid, Flector patches) Topical Anesthetics

– Lidocaine patch (Lidoderm) Adjuvants

– Duloxetine (Cymbalta), Pregabalin (Lyrica)

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Use of Narcotics and Other Drug Classes in the First Year after Injury

Early use of narcotics decreasingOther medication classes being used to treat early injuries more commonly

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Use of Medications by Class in Workers’ Comp

Early use decreased, but in those claimants needing continued treatment of chronic pain conditions, narcotic use INCREASES

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Opioid Analgesics: Adverse Effects

Physical Dependence “…a state of adaptation that is manifested by a drug class-specific

abstinence syndrome following abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist”

Also occurs in antihypertensives and steroids Not a problem when dosage tapered during discontinuation

Pseudo-addiction “…patient behaviors that may occur when pain is under-treated” NOT the same as addiction May appear to be drug-seeking Behaviors will subside when optimal pain control achieved

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Opioid Analgesics: Adverse Effects

Addiction “…a primary, chronic, neurobiologic disease, with genetic,

psychosocial, and environmental factors influencing its development and manifestations”

“…impaired control over drug use, compulsive use, continued use despite harm and craving”

Prevalence uncertain in chronic pain patients One study only occurred in about 2% of enrolled patients– Probably closer to general rate of additions in society (7-11%)

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Prevalence of Narcotic use

Across the country, there is an increase in the number of ER visits due to non-medical use of narcotics

Up to 89% of abused prescription drugs are diverted from legally written prescriptions

In 1994-2004, there was a 550% increase in unintentional drug overdose mortality

Problem isn’t just with narcotic prescribing, but with how they are used once in the hands of the public

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Narcotics Prevalence in Society

Narcotics commonly used to treat pain

Issues with safety of NSAIDs (Vioxx, Bextra, etc) drove higher use of narcotics in treatment of injuries

Issues with safety of antiinflammatory drugs in elderly (cardiovascular complications) drove increase in use in elderly for treatment of pain

Even in animals…

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What prescribers should be doing to conduct appropriate pain management

Enact treatment plans Documentation of results of patient response

Continued maintenance of therapy and reassessment Conduct pill counts to ensure compliance Periodic monitoring through drug testing (urine or blood)

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Taking control of your prescribing

Tips for doctors on how to avoid doctor shoppers and drug diverters

– Keeping control of their prescription pads– Limit the ability of employees to have access privileges to

prescription pads, office dispensing machines■ Patient activities to watch out for

– Patients allergic to everything but one specific drug– Patients with all the right answers about pain thresholds, while

taking large quantities of pain medications– Cash patients– Travellers (live >50 miles away)– Puppeteering (bring in family member and direct choice of

drugs)

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Drug Testing Testing methods available

– Urine stand alone kits■ Stand alone kits test for limited drugs, potential false

positives■ Kits only test for a limited set of drugs

■ Urine test alone can only test for recent use of a drug, not current use or compliance with therapy

■ Blood tests■ Much more accurate; no false positives

Substance Blood Urine

Opiates 1-24 hrs 1-4 days

Carisoprodol meprobamate

1-10 hrs1-3 days

1-2 days1-4 days

Acetaminophen 1-10 hrs 1-2 days

Cocaine 1-8 hrs 1-4 days

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Treatment plans and documentation Example of documentation to justify the treatment plan

Define the role of all medications Treatment plan of current and future medications Plan for follow-up

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Treatment Plans and Documentation

Example of a sheet to help the prescriber assess all aspects of narcotic management

Great tool, but only as good as the information it provides What’s the plan?!!

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Treatment Plans and Documenation

Example of documentation with inappropriate follow through

Notes state drug test is negative for all meds, BUT the prescriber still goes ahead and writes for Percocet and Duragesic

– If it isn’t in the patient, where is it, exactly?

– What do you expect of that next drug screen?

– Did pharmacy records support these results?!

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Treatment Plans and Documentation

Aside from the dates, can you make anything out of this?

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What is being done Legislatively to ensure appropriate pain management

Prescription pads/ ePrescribing Texas legislation for ODG formulary NY Pain Guidelines State Monitoring programs FDA updates

Removal of propoxyphene products from the market Dose limitations for acetaminophen products

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Prescriptions

ePrescribing Securely send the

prescription to the (registered) pharmacy of choice

Not valid for C-II prescriptions (yet)

Prescription pads can be bought with tamper resistant technology Security watermarks, colored

backgrounds, etc Still only as good as security

to keep that pad out of patient’s hands!

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Texas ODG Formulary

House Bill 7 mandated Texas enact a closed formulary system for workers’ compensation

Decision to use the Official Disability Guidelines (ODG) as the source for deciding what is allowed for treatment of injured workers

Pros Cons

Requires utilization review prior to an insurer having to cover a medication that is not on formulary

Utilization review ~$120 per occurrence; some of these medications are only $10-20 per Rx

Helps reduce use of inappropriate medication use for treatment of pain

Guidelines are mainly focused on treatment of chronic pain and injuries, not necessarily ancillary conditions (psyche issues, infections, etc)

Common overused medications addressed (Soma, Oxycontin, etc)

Common Medications require authorization that are appropriate in short term treatments

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■ Implements new treatment guidelines for medical care – back, neck, shoulder and knee – based upon ACOEM national guidelines

– Medical providers must adhere to treatment guidelines and recommendations; can deviate for emergency care if variance from guidelines is approved

– Some treatments (even recommended by guidelines) require prior authorization; for prior authorization, providers must fill out a C-4 Authorization form

– Treatment guidelines also contain recommendations for drug therapy and prescribing of medications by treating doctors

– Aimed at length and legitimacy of narcotics and steroids– Sets optimum durations and steps for use of specific drugs

New York Treatment Guidelines

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Prescription Drug Monitoring Program

Goals/Objectives of having a PDMP Support access to legitimate medical use of controlled

substances Identify and deter or prevent drug abuse and diversion Facilitate and encourage the identification, intervention with

and treatment of persons addicted to RX drugs Inform public health initiatives through outlining of use and

abuse trends and Educate individuals about PDMPs and the use, abuse and

diversion of and addiction to RX drugs Prescription information from pharmacies, outpatient clinics,

prescriber offices sent to a central data store Allow health care practitioners to get a snapshot of controlled

substance use by their claimant

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Scripts Rx (South Carolina)

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FDA Propoxyphene Market Recall

Propoxyphene (Darvocet, Darvon) removed from Market November 2010

Of those claimants receiving propoxyphene before the recall

– 12% were acute injuries and most likely didn’t require further treatment

– 50% switched to other short-acting opioids (Tylenol #3, Ultram, Vicodin, etc.)

– 38% apparently did not continue on anything (but may be too early to tell)

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Dose limits for Acetaminophen Products

Over next three years, FDA mandates that the acetaminophen component of combination products be limited to no more than 325 mg

Goal is to reduce potential toxicity of cumulative dose of acetaminophen exceeding 4 grams per day

Product Acetaminophen dose

Max doses per day before exceeding 4 grams acetaminophen

Vicodin ES 750 mg 5 tablets

Vicodin HP 660 mg 6 tablets

Vicodin, Tylox 500 mg 8 tablets

Percocet 650 mg 6 tablets

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What is being done by the industry to ensure appropriate pain management

Abuse resistant formulations Reformulations of existing products– Oxycontin

REMS New drugs/formulations for getting patients “detoxed”

Suboxone, Subutex

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Abuse Resistant Formulations

Embeda Sustained release morphine beads Beads also contain naloxone pellets When Embeda is crushed or chewed, pellets are

opened releasing naloxone which counteracts effects of morphine and other narcotics

Acurox “Oxycontin + niacin” When crushed, release niacin (uncomfortable flushing

reaction Able to be mostly averted by taking an aspirin first

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Oxycontin Reformulation

Oxycontin released version with “harder shell”

Went through FDA as a reformulation, not as an “abuse resistant” formulation

Crushed tablets are chunkier, and less able to be used for snorting or injecting

Also helps extend out Oxycontin patent for when generics will be possible in 2012

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REMS (Risk Evaluation and Mitigation Strategy)

September 2007 - Food and Drug Administration Amendments Act (FDAAA)

REMS may be required at any stage of the product lifecycle Manufacturer:

120 days to submit REMS for a marketed drug Must be part of NDA for new drug

FDA has issued an outline of specific elements that have to be included in the proposed document. Medication guide Communication plan Elements to assure Safe use Implementation plan Timetable for submission of assessments.

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Suboxone/Subutex

Buprenorphine (Subutex) and Buprenorphine-Naloxone (Suboxone) used in the outpatient management of narcotic dependence to “detoxify” a patient off of narcotics

Physicians with additional training can prescribe buprenorphine products in effort to wean a patient off of narcotics Buprenorphine provides analgesic effects as well as blocks

other narcotics effects Allows outpatient management of narcotic addiction program, as

opposed to inpatient treatment programs or methadone clinics Goal is to get the patient completely off of narcotics, not just

substitute one for another via medically supervised withdrawal http://buprenorphine.samhsa.gov/

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What are the patients doing to block efforts at appropriate pain management and monitoring strategies

Doctor shopping Pain clinics/pill mills Cheating urine drug tests Rent a pill Forged prescription pads

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Doctor/Pharmacy Shopping

Going to different prescribers or pharmacies, under same or other identities, in order to get multiple prescriptions for narcotics Able to obtain “legitimate” prescriptions, as well as find those

doctors that aren't so diligent in their prescribing practices Shoppers often work in groups

Track where they had successes and failures

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Pill Mills

Prevalent in Florida, Texas Signs of a pill mill:

Accept cash only No physical exam is given No medical records or x-rays are needed You get to pick your own medicine, no questions asked You are directed to "their" pharmacy They treat pain with pills only You get a set number of pills and they tell you a specific date to

come back for more They have security guards There may be huge crowds of people waiting to see the doctor

Efforts under way to legislatively stop these from occurring

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Beating the Urine Tests

Multiple commercial products available to attempt to mask results of urine tests

Availability of clean urine (synthetic or real!) Don’t forget the delivery device!

– Urinator, Wizzinator Refusal for testing

Religious grounds, moral grounds, etc Knowing the false positives for office based tests

Opioids -> fluroquinolone antibiotics (Levaquin) Benzodiazepine -> oxaprozin (NSAID) Amphetamines -> Vick’s inhaler

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Rent a Pill

When prescribers demand claimant submit to drug counts (random or not), claimant must bring in their prescription bottles Quantity left should match up to prescribed dose Example

– 60 Oxycontin, twice daily, dispensed 2/15; patient asked to bring in bottle for pill count at office visit on 2/28

– 2/28 minus 2/15 = 13 days x 2 tabs/day =26 should be gone– Bottle should have 34 (+/- one) remaining

Rent a Pill operations have supplies of various products and from multiple manufacturers (so your pills look alike) Pay a fee to rent the pills for your office visit

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Forging Prescriptions

With today’s technology, it isn’tdifficult to create a forged prescription pad

– There are multiple avenues to create and edit your own prescription pads online

– Replace prescribers phone number with another number

– Cut the pad down to the correct size

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Summary

Narcotics are still a very important tool in pain management, but must be prescribed and monitored appropriately

When inappropriate activity occurs, prescribers should take appropriate actions

Legislative efforts have been enacted to crack down on inappropriate narcotic prescribing

Pharmaceutical options for treating pain in high risk patients Prescribers must be aware of issues of inappropriate use of

narcotics

Tomorrows lecture will get more into these issues of how insurers can work with their pharmacy benefit manager to uncover high risk and/or inappropriate use of narcotics

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Narcotic diversion mug shots

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Thank you, celebrities, for being positive role models!!

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