The Use of Prescription Medications in the World of Litigation

Chapter Twenty – 8854T
Workers’ Compensation Section
The Use of Prescription Medications in the World of
Litigation
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Course Summary
This session addresses the new legislation regarding: physicians dispensing medications, the
high costs of drugs highlighting issues of both perspectives (carrier from a literal standpoint,
claimant’s from a medical standpoint), detox and rehab issues, “experimental” drugs and
whether they should be paid for, chronic pain patients and alternative options to narcotics.
Panelists:
Hon. Geoffrey Dlin (Ret.)
Krasno, Krasno & Onwudinjo, P.C.
Hon. Tina Maria Rago
Workers Comp. Office of Adjudication
Megan Dougherty, Esq.
The Chartwell Law Offices, LLP
Dr. Gregory H. Pharo
Pharo Pain Management Associates, P.C.
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Pain Management
GREGORY H. PHARO, D.O.
PHARO PAIN MANAGEMENT ASSOCIATES, P.C.
215-925-0986
[email protected]
OCTOBER 17, 2015
Bio & Disclaimer
y Gregory H. Pharo, D.O.
y Board Certified: ABA, ABA subspecialty Pain Medicine
y Anesthesiology and Pain Medicine
y Active Clinical Practice in Pennsylvania Hospital and Chestnut Hill Hospital
y No outside funding, no grants, no support from industry
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Objectives
y Recognize pain management as the discipline of medicine devoted to the
diagnosis and treatment of pain
y Recognize the proper use of Urine Drug Screen in the management of opioid
patients
y Compounding Medication
y Recognize current treatment guidelines
Pain ….. What is it?
y Both a symptom and a disease
y An unpleasant sensory and emotional experience (always subjective)
associated with actual or potential tissue damage, or described in terms of
such damage IASP-94
y Many report pain in the absence of tissue damage or any likely
pathophysiological cause; usually this happens for psychological reasons
but is no way to distinguish their experience from that due to tissue damage
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Opioids - ACOEM
y The use of opioids is well accepted in treating cancer pain, where nociceptive
mechanisms are generally present due to ongoing tissue destruction, expected survival
may be short, and symptomatic relief is emphasized more than functional outcomes.
y In chronic non-malignant pain, by contrast, tissue destruction has generally ceased…
Expected survival in chronic pain is relatively long and return to a high level of function is
a major goal of treatment. Therefore, approaches to pain developed in the context of
malignant pain may not be transferable to chronic non-malignant pain.
Opioids - ACOEM
y Opioids are generally not the best choice of medication for controlling neuropathic pain.
Tricyclic's and anticonvulsants should be tried first.
y In most cases, analgesic treatment should begin with acetaminophen, aspirin, and
NSAIDs. While maximum efficacy is modest, they may reduce pain sufficiently to permit
adequate function.
y When these drugs do not satisfactorily reduce pain, opioids for moderate to moderately
severe pain may be added to (not substituted for) the less efficacious drugs.
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Opioids - ACOEM
y Routine use of opioids for treatment of chronic non-malignant pain
conditions Not Recommended (C)
y Use for Myofascial pain, fibromyalgia, tender points, trigger points Not
Recommended (I)
y Opioids are recommended for select patients with chronic LBP, chronic
persistent pain, neuropathic pain, or CRPS - (I)
Nonetheless …
The 䇾Push䇿 for Opioids
y The recognition that opioid therapy can relieve pain and improve mood and functioning in
many patients with chronic pain led pain experts to recommend that such patients not be
denied opioids.
y Consequently, opioids have been used extensively, with arguments that physicians
should be encouraged to prescribe opioids because they are indispensable for the
treatment of pain and suffering, because uncontrolled pain may have deleterious physical
effects.
Trescot, A. M., S. E. Glaser, et al. (2008). "Effectiveness of opioids in the treatment of chronic non-cancer pain." Pain Physician 11(2
Suppl): S181-200.
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Nonetheless …
The 䇾Push䇿 for Opioids
y The recognition that opioid therapy can relieve pain and improve mood and functioning in
many patients with chronic pain led pain experts to recommend that such patients not be
denied opioids.
y Consequently, opioids have been used extensively, with arguments that physicians
should be encouraged to prescribe opioids because they are indispensable for the
treatment of pain and suffering, because uncontrolled pain may have deleterious physical
effects.
Trescot, A. M., S. E. Glaser, et al. (2008). "Effectiveness of opioids in the treatment of chronic non-cancer pain." Pain Physician 11(2
Suppl): S181-200.
The Result …..
y The prevalence of opioid prescriptions ned in recent years due to national quality
improvement initiatives requiring assessments and treatment of pain
y Although widely viewed as helpful in managing moderate to severe acute pain and
cancer pain, controversial for treatment of CNMP as ned prescriptions have not been
accompanied by health improvements for back or neck pain
y Increased rates of abuse & drug diversion
y Management of CNMP with long-term high-dose opioids particularly controversial …..
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Physician Decisions to
Prescribe Opioids (Turk)
y When all variables entered into logistic regression model, only observed pain
behaviors showed a significant association with opioid prescriptions.
y Physicians' practice in prescribing of opioids appears to be influenced most
by patients' nonverbal communications of pain, distress, & suffering
independent of objective findings
Turk, D. C. and A. Okifuji (1997). "What factors affect physicians' decisions to prescribe opioids for chronic non-cancer pain patients?"
Clin J Pain 13(4): 330-6.
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Opioids – Adverse Effects
y Issues of dependence, addiction & diversion are becoming
increasingly prominent.
y Also are seeing more serious adverse events such as respiratory
depression & death with use of Actiq® fentanyl buccal tablets for
break-through pain.
y Drug deaths from opioids serious & increasing issue.
Do They Provide Benefit?
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2004 Systematic Review –
Opioids in CNCP
y Oral opioids vs. placebo for 4D – 8 wks. 6/15 trials had an open label follow-up of 6-24
months.
y Mean Ļ in pain intensity in most • 30% with opioids (but not for MS pain)
y About 80% experienced • one adverse event; only 44% of 388 patients on open label
treatments still on opioids at 7 and 24 months.
y The short-term efficacy of opioids was good in both neuropathic and musculoskeletal pain
conditions but only a minority of patients in these studies went on to long-term
management with opioids.
Kalso, E., J. E. Edwards, et al. (2004). "Opioids in chronic non-cancer pain: systematic review of efficacy and safety." Pain 112(3):
372-80.
2005 Narrative Review
Opioids & Quality of Life
y 11 studies (6 RCT, 5 observational) evaluating QoL in pts receiving long-term treatment
with opioids
{
{
Quality of RCTs mixed; 1 high, remaining mod - low quality
Long-term use defined as > 4-6 weeks
y Concluded: evidence suggests that 䇾long-term treatment with opioids can lead to
significant improvements in functional outcomes, including QoL, in patients with CNMP䇿
y Methodological short-comings only support recommendations for further more rigorous
investigations.
Devulder, J., U. Richarz, et al. (2005). "Impact of long-term use of opioids on quality of life in patients with chronic, non-malignant
pain." Curr Med Res Opin 21(10): 1555-68.
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Opioid Use & Abuse
y Therapeutic opioid use and abuse coupled with the nonmedical use of other
psychotherapeutic drugs has shown an explosive growth in recent years and has been a
topic of great concern and controversy.
y Americans = 4.6% of the world's population, but consume 80% of the global opioid
supply, 99% of the global hydrocodone supply; 2/3 world's illegal drugs.
Manchikanti, L. and A. Singh (2008). "Therapeutic opioids: a ten-year perspective on the complexities and complications
of the escalating use, abuse, and nonmedical use of opioids." Pain Physician 11(2 Suppl): S63-88.
Criteria for Initiation
y No evidence of significant psychopathology or an elevated risk of abuse, addiction, or
adverse outcome. Not absolute contraindications to opioid Rx, but their presence
requires the practitioner to take added precautions by ning patient education & degree
of opioid usage monitoring & control.
y Must be a clear understanding that opioids are to be used for a limited term in the first
instance, that their use is contingent upon certain obligations or goals being met by the
patient, e.g., return-to-work, and the patient understands that there may be drug
screening to ensure compliance.
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Contraindications
y History of alcohol or other substance abuse, or a history of chronic, high-dose
benzodiazepine use (or active use)
y Off work for more than six months
y Severe personality disorder or untreated mood or psychotic disorders (e.g., depression).
y Decreased physical or mental function with continued opioid use.
y Addictive behaviors
Red Flag 1
y Ultra-short acting Opioids
Actiq®-lollipop,
Fentora®-bucal film
Subsys®-sublingual spray
y Transmucosal Preparations
y Near equivalent to Intravenous
y Indicated for Cancer Patients Only
y NO INDICATION FOR CHRONIC PAIN
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Red Flag
y Actiq® deaths over 127
y Cephalon™ $425M fine from Dept. of Justice
y 䇾ER on a stick䇿
y TIRF-REMS
y Transmucosal Immediate Release Fentanyl- Risk Evaluation and Mitigation
Strategy
y NO INDICATION FOR CHRONIC PAIN
Urine Drug Screen
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Urine Drug Screening
y Routine use for ALL patients on chronic opioids Recommended (C) as can identify
aberrant opioid use & other substance use that otherwise is not apparent to the treating
physician.
y Frequency – Baseline, randomly 2 - 4 X/yr. & at termination. Should also be performed
䇾for cause䇿 (e.g., suspicion of misuse, accidents or injuries, DUI, premature Rx
renewals, self-directed dose changes, lost or stolen prescriptions, using > 1 provider for
Rx, non-pain use of meds, excessive alcohol use, missed appts, hoarding or selling of
medications).
y Standard urine drug/toxicology screening processes should be followed (consult a
qualified MRO)
Drug Screening & Opioids
y Retrospective analysis of data from 470 pts. who had urine screening at a pain
management program.
y 45% of the pts. + abnl urine screens. 20% + illicit substance in their urine, 14% additional
drug; 10.2% missing drug.
y Confirm past findings that random urine toxicology screens among patients prescribed
opioids for pain reveal a high incidence of abnormal findings.
Michna, E., R. N. Jamison, et al. (2007). "Urine toxicology screening among chronic pain patients on opioid therapy: frequency and
predictability of abnormal findings." Clin J Pain 23(2): 173-9.
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Drug Screening & Opioids
y Failed urine drug screens of 89 patients in an interventional pain management practice
were analyzed. The results showed that 55% were not taking the prescribed opioid,
whereas 39% were taking opioids which were not prescribed. In addition, 46% of the
patients were using illicit drugs.
y Conclusion: Urine drug screens can be very useful in identifying illicit drug use, &
ascertaining if pts are not taking the opioid as prescribed or taking other opioids which
have not been prescribed.
Atluri, S. and G. Sudarshan (2003). "Evaluation of abnormal urine drug screens among patients with chronic non-malignant pain
treated with opioids." Pain Physician 6(4): 407-9.
Urine Drug Screens
y ACOEM recommends random UDS 2-4 times per year. The Official Disability Guidelines offer more explicit recommendations.
y
y
y
y
y
y
y
First, they recommend a risk profile assessment before initiating opioid therapy. Based upon the results of that risk profile, the
proposed frequency is set:
Low risk: screen at 6 mos and annually thereafter
Moderate risk: screen 2-3 times/year
High risk: as often as monthly
Claims Eval assisted one of its clients by performing a random audit of UDS charges.
Audit found that 90% of the submitted charges were not medically necessary.
Providers were routinely screening for 20-30 reagents for initial screening, followed by confirmatory testing on all of those
reagents – regardless of the initial results.
ODG also only recommends confirmatory testing of inconsistent results. As a result of discussions with our clients – coupled
with our audit results, you will see UDS decisions being written to comply with evidence-based guidelines, certifying a random
10 panel screen with confirmatory testing of inconsistent results only. Frequency of testing will be dictated by the risk profile
as well as the documentation of notation of aberrancies.
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On-Going, Long-Term
y Prescriptions from a single practitioner
y Ongoing review and documentation of pain relief, functional status, appropriate
medication use, and side effects
y Frequent follow-up at least every 2 to 4 weeks may be necessary to titrate dosage and
assess clinical efficacy.
y Ongoing effort to gain improvement of social and physical function as a result of pain
relief,
y Use of a long acting opioid for maintenance of pain relief & a short acting opioid for ltd
rescue use when pain > level routinely seen*
Unfortunately ….
y Most chronic pain visits last ” 15 minutes
y Issues in the management of chronic non-cancer pain are substantially
different from those involved in palliative care of cancer pain due to
differences in expected survival, age, life circumstances, and feasibility of
long term close monitoring in most care settings (primary or specialty
practice)
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Compliance with Guidelines
y 䇾When the necessary resources of time, personnel and multidisciplinary
rehabilitation are not available, physicians tend to bypass the principles
outlined in the guidelines and comply with patients䇻 demands for increased
opioid doses, even when treatment goals are not achieved.䇿
Ballantyne, J. C. and J. Mao. (2003, November 13, 2003). "Opioid Therapy for Chronic Pain." N Engl J Med
Compounding Cream
y History: Ancient times
y Used plants, herbs, roots to make ointments
y Appeared in the US in the 1800’s
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Compounding Creams
y 5 Fold increase last 5 years in WC
y
2006, California’s workers’ compensation system was billed $10 million for compound creams, according to Alex Swedlow, a
researcher with the California Workers’ Compensation Institute, which tracks the industry. By 2013, Swedlow said, the amount had
ballooned to $145 million – a 14-fold increase.
y Prices have increased dramatically
y In the past decade alone, Tricare's annual costs for compound prescriptions has risen from $5 million to $514 million.
y And in just the first two months of 2015, Tricare has paid $434 million for the medications, mainly for pain treatments.
y Compound medications make up less than 0.5 percent of the total number of Tricare prescriptions but account for more
than 20 percent of total pharmacy costs, according to defense officials.
y Sterile compounded drugs have increased
Compounded creams
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Compounding creams
Compounding Creams
Advantages
y Topically application to site of injury
y Decreased systemic absorption
y Decreased side effects
y Multiple ingredients could simplify
y Easier for those who can’t swallow
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Compounding Creams
y The cost associated with compounding medications has skyrocketed over the past
two years. For patients, the prescription price for a compounded medication has risen
more than tenfold on average: from $90 to $1,100 per prescription. Payers have felt
similar pain – in Q1 2012, Express Scripts clients spent about $28 million on
compounded medications, while just two years later, the quarterly spend was $171
million.
y What’s going on here? Do more patients need compounded medications? Absolutely
not.
y - See more at: http://lab.express-scripts.com/insights/drug-options/closing-thecompounding-loophole#sthash.6nuydbSj.dpuf
Compounding Creams
y Ensure patients who need compounds will receive compounds
y Evaluate all compound ingredients to identify needless cost and waste
y Actively and regularly manage the use of compounded medications
y Target, or block, more than 1,000 ingredients (bulk powders) whose prices have been
greatly inflated but that provide no additional clinical benefit
http://lab.express-scripts.com/insights/drug-options/closing-the-compoundingloophole#sthash.6nuydbSj.dpuf
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Compounding Creams
y MEDROX PATCH
y ACTIVE INGREDIENTS
y Menthol
y Capsaicin
5.00%
0.0375%x
y Zostrix HP
y Tiger Balm
Compounding Creams
y Medrox Rx– Manufactured for: Pharmaceutica North America Package size:
y
y
y
y
120 grams (4 oz.) tube NDC: 45861-0005-01
AWP: $3.125/gram or $375.00 for a 120 gram tube
Note: the percent is the number of grams of the active ingredient per 100 grams
of inert cream/gel
Compare the actual production costs as quoted by a private label OTC
pharmaceutical manufacturer for a Medrox like product: $4.91
http://www.comptoday.com/Newsletters/2014%20Q1%20Newsletter.pdf
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Compounding Cream
y Medi-Derm
y Manufactured for Two Hip Sales and Consulting, LLC Package size: 120
grams (4 oz.) tube
NDC: 76074-0120-01
AWP: $3.24167/gram or $389.00 for a 120 gram tube
y Note: the percent is the number of grams of the active ingredient per 100 grams
of inert cream/gel
y Compare the actual production costs as quoted by a private label OTC
pharmaceutical manufacturer for a Medi-Derm like product: $4.76
Compounding Creams
y Dendracin
y Combination of Zostrix HP(capsaicin) and Icy Hot(menthol and methyl
acetylsalicylic acid
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Compounding Cream
y
y
y
y
y
y
y
y
y
y
ketamine HCl 15%; ketoprofen 10%; gabapentin 6%; baclofen 2%;
cyclobenzaprine HCl 2%; ethoxy diglycol; Lipopen Plus
flurbiprofen 20%, diclofenac 10% in a cream base
ketamine HCl 10%; gabapentin 6%; lidocaine 10%; bupivacaine HCl 3%;
amitriptyline HCl 10%; diclofenac sodium 5%; cyclobenzaprine HCl 2%
amantadine 10%; diclofenac 3%; cyclobenzaprine 2%; gabapentin 8%; tramadol 5%;
lidocaine 5%; diethylene glycol monoeth; PCCA Emulsifix-205 base; PCCA Lipoderm base
diclofenac 30%; cyclobenzaprine 2%; gabapentin 8%; tramadol 5%; lidocaine 5%;
capsaicin 0.05%, menthol 10%, camphor 5% PCCA Lipoderm Base
Lidocaine 5%, bupivacaine 2%, prilocaine 2% in cream base
Compounding Creams
y Compound Script Fax: PLEASE INCLUDE PATIENT DEMO SHEET AND FRONT/BACK OF PATIENT
y
y
y
y
INSURANCE CARD WITH THIS SCRIPT
Patient Full Name
____________________________________________________________DOB__________/_________/_______
__ Address: __________________________________________________ Best Contact Phone ( )__ _____ )__________________ City: ___________________ State: _______ Zip: ______________ Allergies:
Workers Compensation? Y_______ N ______ HMO / PPO? Y______ N ______ Diagnosis Code:
________________________________
Claims of efficacy
FOR OFFICE USE RXS
*Please remember prescriber information below with signature.
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Compounding Creams
y NEUROPATHIC
y 2 or 3 muscle relaxants
y Ketamine 10%, Baclofen 2% Cyclobenzaprine 2% Flurbiprofen 10%, Gabapentin 6%, Lidocaine 2%
y RSD/CRPS-Trigeminal Neuralgia-Phantom Limb Pain-Developing Neuropathy
y Ketamine 10%, Clonidine 0.2%, Gabapentin 6%, Imipramine 3%, Mefenamic Acid 3%, Lidocaine 2%
y Chemotherapy Induced Peripheral Neuropathy-Diabetic Peripheral Neuropathy
y Ketamine 10%, Baclofen 2%, Gabapentin 6%, Imipramine 3%, Nifedipine( )__?) 2%, Lidocaine 2%
Compounded Creams
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Compounding Cream
NECC
y In 2012, 64 people died nationwide from a fungal meningitis they contracted
after receiving steroid injections produced by a large compound manufacturer,
New England Compounding Center.
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Compounding Medications
y Musculoskeletal Pain-Inflammation
y Ketamine 10%, Gabapentin 6%, Baclofen 2%, Cyclobenzaprine 2%, Lidocaine 2%, Flurbiprofen 10%
y Radiculopathy-Fibromyalgia
y Ketamine 10%, Baclofen 2%, Cyclobenzaprine 2%, Diclofenac 3%, Gabapentin 6%, Lidocaine 2%
y Myofascial Pain Syndromes - TMJ
y Flurbiprofen 10%, Baclofen 2%, Cyclobenzaprine 2%, Gabapentin 6%, Orphenadrine 5%, Tetracaine 2%
y Myofascial Pain-Post Laminectomy-Greater Neuropathic Components
y Ketamine 10%, Baclofen 2%, Cyclobenzaprine 2%, Flurbiprofen 10%, Gabapentin 6%, Lidocaine 2%
Compounding Creams
Disadvantage
y Not all ingredients needed
y Costs
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Compounding Creams
Summary
y Compounds have not been proven to be more effective than commercial preps
y Manufactured drugs are approved by FDA
y Using compounds pose risk to patients
Compounding Creams
Summary
y Compounds are often not medically necessary
y Pharmacy regulation varies by states
y Expense
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Spinal Interventional Techniques Guidelines by
ASIPP 2013
Pain Physician 201366,6%1
Lumbar Radicular Pain - Interlaminar ESI
Lateral Position
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Lumbar EpidurographyLateral view
Lumbar Radicular Pain - Transforaminal ESI
(LTESI)
Nerve root filling with
partially into epidural space
Nerve root filling after
contrast injection
Digital subtraction image-Live fluoroscopy
(LTESI)
Contrast injection for left
L5-S1 Transforaminal
Digital subtraction view:
epidural & vascular
contrast pattern
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Single Stage Neuroplasty
CPT code 62264
y One single charge established by
Medicare
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Multiple Codes
y Seven separate charges