Post on 05-Feb-2016
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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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