Transcript presentation here.

SCWEA Meeting
Charleston, SC
Feb 27, 2011
Appropriate Opioid Management
Matthew Foster, PharmD
Clinical Pharmacy Manger, PMSI
1
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
2
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
3
Medication Management of Chronic Pain


Choice of initial agent dependent upon type of pain
present
World Health Organization pain ladder commonly used
3. Opioid for moderate to
severe pain +/Non-Opioid +/- Adjuvant
Increased or
Persisting Pain
2. Opioid for mild to moderate pain
+/- Non-Opioid +/- Adjuvant
1. Non-Opioid
4
Common Medications in Pain Management




Non-steroidal ant-inflammatory drugs (NSAIDs)
 Ibuprofen (Motrin), Naproxen (Aleve), Celecoxib (Celebrex)
Narcotic Analgesics
 Short-acting
– Oxycodone-Acetaminophen (Percocet), hydrocodoneacetaminophen (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)
5
Use of Narcotics and Other Drug Classes in the
First Year after Injury
Early use of narcotics decreasing
Other medication classes being used to treat early injuries more commonly
70%
64%
60%
59%
58%
50%
50%
52%
46%
40%
2008
30%
27%
29%
2009
30%
2010
20%
8%
10%
9%
10%
0%
Narcotics
NSAIDs
SMR
Dermatologics
6
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
80.00%
70.00%
60.00%
50.00%
Antidepressants
Analgesics - Narcotics
Anti-inflammatory
40.00%
Anticonvulsant
Skeletal Muscle Relaxants
30.00%
Dermatological
20.00%
10.00%
0.00%
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10
7
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
8
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%)

9
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
10
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…
11
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)
12
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)

13
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 hrs
1-3 days
1-2 days
1-4 days
Acetaminophen
1-10 hrs
1-2 days
Cocaine
1-8 hrs
1-4 days
14
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
15
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?!!
16
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?!

17
Treatment Plans and Documentation

Aside from the dates, can
you make anything out of
this?
18
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
19
Prescriptions


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!
ePrescribing
 Securely send the prescription
to the (registered) pharmacy
of choice
 Not valid for C-II prescriptions
(yet)
20
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
21
New York Treatment Guidelines
■ 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
22
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
23
Scripts Rx (South Carolina)
24
FDA Propoxyphene Market Recall

500
Codeine-APAP
(Tylenol #3)
400
Hydrocodone-APAP
(Vicodin)
350
300
Oxycodone-APAP
(Percocet)
250
Propoxyphene
200
Propoxyphene-APAP
150
Tapentadol
(Nucynta)
100
Tramadol (Ultram)
50
0
week -6
week -5
week -4
week -3
week -2
week -1
week +1
week +2
week +3
week +4
week +5
week +6
Number of Prescriptions per Week
450
Tramadol-APAP
(Ultracet)

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)
25
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
26
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

27
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
28
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
29
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.
30
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/
31
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
32
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
33
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
34
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
35
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
36
Forging Prescriptions
With today’s technology, it isn’t
difficult 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

37
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
38
Narcotic diversion mug shots
39
Thank you, celebrities, for being positive role
models!!
40
41