McLaren/Hurley/Genesys - FLINT 2011
Clinical Challenges in
Prescribing Controlled
Substances:
Prescribing to
Balance Risk and
Access
Medical/Legal Cases
William R. Morrone DO, MS, FACOFP, DAAPM
Medical Director, Hospice of Michigan CT 101
Consulting Faculty Department of Psychiatry
Assistant Director of Family Medicine @
Synergy Medical Education Alliance
Michigan State University
Central Michigan University
DrMorrone.com





Home
About Me
Medical/Legal
Media Appearances
Contact Us
Home
Welcome to DrMorrone.com. In my world, forensic science, medicine,
teaching, law, criminal justice investigation and toxicology explain mystery
and discover truth. Universal scientific principles often uncover mystery.
What is truth? What is Justice? Sometimes, making complex medical
facts simple honest sound bites, is the only true justice. Teaching and
knowledge are the only weapons against fear and ignorance.
As a practicing physician, teacher, forensic scientist, research scientist,
medical examiner, toxicologist, addictionologist and social advocate, I have
sought simple truth to help, heal or comfort others for 24 years. Over that
period of time, I have watched medical knowledge undergo exponential &
dramatic growth, most recently in areas of drug
development and DNA application. I have attempted
to bring natural justice to every level of “complex
science and medicine” that has been too long-winded
in the past.
This website is to declare my interests as a forensic
scientist, toxicologist, real-world practicing physician,
and medical-legal consultant. I hope to share this with
colleagues and students as well as those who seek
my services to explain, teach and investigate.
Bring me your mystery.
Sincerely,
William R. Morrone, DO, MS, ACOFP, CCD
For Medical/Legal Consulting
For Media Appearances
Dr. William R. Morrone
Belladonna Medical Consultants
Lois Katz Public Relations, LLC
Phone: 609-936-0014
Email: Lois3153@aol.com
Phone: 989-928-3566
Fax: 989-891-9199
Credit and disclosure
• I am inspired by and
credit Michael Wissel,
R.Ph at the Michigan
Department of
Community Health,
(MDCH Power Point) &
the raw MAPS data
(2007).
• Dr. Morrone is or has
been a teaching
advocate for RBInc.
Conflicts:
there is no justice only more laws.
Opine, Disclosure &
Conflict of Interest
Dr. Morrone has been a paid teaching advocate for
Rickett Benkiser (Suboxone, Frank’s “Red Hot”
(Louisiana) cayenne pepper sauce & French’s
Mustard
I may be biased.
Today’s
Financial
disclosure
NOBODY IS
PAYING ME TO
USE DRUG
COMPANY
SLIDES.
I am hopelessly
original.
• Dr. Morrone has been a guest with:
•
•
•
•
•
•
•
•
•
•
•
State of Michigan, MDCH - HIV/AIDS Council
Nancy Grace CNN Headline News Network
Rita Cosby MSNBC Nightly News Journal
Bill O’Reilly “Radio Factor” WOR 710 AM
Bill O’Reilly “O’ Reilly Factor” FOX News
Channel
Shepard Smith “STUDIO B” FOX News Channel
Kim Guifoyle FOX News Channel
Neil Cavuto’s “YOUR WORLD” FOX News
Catherine Crier Court TV
Geraldo Rivera FOX News “@Large”
Happening Now AM FOX News Channel
•
•
•
•
•
•
•
•
•
•
BOARD CERTIFIED FAMILY MEDICINE from ACOFP.
BOARD CERTIFIED PAIN MGMNT from AAPM.
BOARD CERTIFIED CLINICAL DENSITOMITRIST.
AM. COLLEGE OF FORENSIC EXAMINERS INSTITUTE.
Michigan Assn. Medical Examiners
AMERICAN ACADEMY of PAIN MEDICINE
AMERICAN ACADEMY of PAIN MANAGEMENT (AAPM)
INTERNATIONAL SOCIETY of CLINICAL DENSITOMETRY
MICHIGAN CONSORTIUM for OSTEOPOROSIS
CANADIAN HOSPICE and PALLIATIVE CARE ASSOCIATION
(CHPCA).
• MICHIGAN CH. of AMERICAN SOCIETY OF ADDICTION
MEDICNE.
• AMERICAN SOCIETY of ADDICTION MEDICINE
Global Objectives
•
•
•
•
•
•
•
•
Legal Case history
License options
Reduced risk documentation
Prescription monitoring (MAPS)
Exit strategy – buprenorphine
Methadone good and bad
Drug testing
Red Flags
Meeting objectives
• Apply clinical guidance for safe and
appropriate opioid prescribing.
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
• Describe red flags of opioid use
including exit strategies for changes
in treatment plans.
GOALS for your FUTURE
• Advances in Understanding
Opioid Analgesics and Risk.
• Patient Screening, Assessment
and Managing Risk.
• Clinical Issues, Methadone LAW
& the Regulatory Environment.
111111111111111
% Rx Drug Crime by DEA (2005)
Organized efforts to thwart you!
Laws? Which one? Why are they
important? What about changes?
•
•
•
•
Federal law (CFR: Code of Fed. Regulations)
State law
Standard of care
DEA and MDCH
Federal laws on controlled substances
21 C.F.R. § 1306.01 Scope of Part 1306
21 C.F.R. § 1306.02 Definitions
21 C.F.R. § 1306.03 Persons entitled to issue prescriptions
21 C.F.R. § 1306.04 Purpose of issue of prescription
21 C.F.R. § 1306.05 Manner of issuance of prescriptions
21 C.F.R. § 1306.06 Persons entitled to fill prescriptions
21 C.F.R. § 1306.07 Administering or dispensing of narcotic drugs
21 C.F.R. § 1306.11 Requirement of prescription
21 C.F.R. § 1306.12 Refilling prescriptions
21 C.F.R. § 1306.13 Partial filling of prescriptions
21 C.F.R. § 1306.14 Labeling of substances and filing of prescriptions
21 C.F.R. § 1306.21 Requirement of prescription
21 C.F.R. § 1306.22 Refilling of prescriptions
21 C.F.R. § 1306.23 Partial filling of prescriptions
21 C.F.R. § 1306.24 Labeling of substances and filing of prescriptions
21 C.F.R. § 1306.25 Transfer between pharmacies of prescription
information for Schedules III - V controlled substances for refills
21 C.F.R. § 1306.26 Dispensing without prescription
Federal Regulations
Section 1306.01 Scope of Part 1306.
Rules governing the issuance, filling and filing
of prescriptions pursuant to section 309 of the
Act (21 U.S.C. 829) are set forth generally in
that section and specifically by the sections of
this part.
•
Pain and Symptom Management for Health Care Professionals
•
Welcome to the portion of the Pain and Symptom Management website devoted to information
for both Michigan health care providers and health policy professionals. This part of the website
will provide health care professionals with state and national guidelines, Michigan legislation,
educational links and various articles and publications related to pain and symptom management.
Health Professionals are also likely to find this website's link to the Advisory Committee
on Pain and Symptom Management of interest.
•
State and National Guidelines Click here for: state and national guidelines for pain and symptom
management
Palliative Care Click here for: Information about chronic disease and cancer-related palliative care
Links to Pain and Symptom Management Information Click here for: Links to Pain and Symptom
Management Information
Pain & Symptom Management State Legislation Click here for: information about state legislation
pertaining to pain and symptom management
End of Life Care Click here for: pain management during the final days of life
Publications and Articles Click here for: publications/articles about pain/symptom management
•
•
•
•
Another
Book
IMPORTANT
• LEARNER OBJECTIVE #1
• Apply clinical guidance for safe
and appropriate opioid
prescribing.
Inside the FSMB
Responsible Opioid Book
•
•
•
•
•
•
•
Patient evaluation, including risk assessment
Treatment plans - incorporate functional goals
Informed consent and prescribing agreements
Periodic review and monitoring of patients
Referral and patient management
Documentation & Compliance: state/federal law
Scott M. Fishman, M.D., is a leading pain clinician
Standard of Care Update
Andrea Trescott, et. al.
Pain Physician. 2006; 9: 1-40
ISSN 1533-3159
“Opioid Guidelines in the
Management of Chronic NonCancer Pain”
Good and Balanced Office Visit for Pain
UDS
E&M
H&P
Visit
Rx
This is where physicians get in trouble.
UDS
H&P
Visit
Who most likely killed Marilyn?
•
•
•
•
FBI & CIA because she was a communist?
Secret Service to protect Jack Kennedy?
Bobby Kennedy to protect Jack Kennedy?
Marilyn (suicide) to protect Jack Kennedy?
• A psychiatrist gave “chloral
hydrate” (IV) and an internist
gave “Nembutal®” (sodium
pentobarbital schedule II) and
they didn’t talk to each other?
HIGH END USERS = HIGH RISK
•
•
•
•
•
•
•
INTERNAL MEDICINE
FAMILY MEDICINE
PAIN CLINIC
URGENT CARE
PSYCHIATRIST
NEUROLOGIST
EMERGENCY DEPARTMENT
DEA: Five schedules
• I: no accepted medical use (LSD, MDMA,
marijuana, PCP, DMT)
• II: limited use/high abuse (opioid, cocaine,
amphetamine, secobarb, pentobarb)
restrictions on prescribing & no refills
• III: most opiate combos w/ASA or APAP
and anabolic steroids.
• IV: benzodiazepines for anxiety or sleep
• V: codeine cough syrup & Lyrica
Definitions to Set the Stage.
• 1. Administer: I.V.,
oral or other route
in the office.
• 2. Prescribe: paper
or fax or eRx.
• 3. Dispense: Pt
leaves with the
medicine.
WARNING:
•
•
•
•
The following information is public domain.
http://www.deadiversion.usdoj.gov
Click on icon “cases against doctors”
No names were changed and the following
is not intended to be perjorative, only
educational examples of case law that are
already in the public domain.
U.S. v Rosen 582F. 2d 1032
(5th circuit court 1978)
• Inordinately large quantity of opioid Rx
• No physical exam
• Physically advised patients to use multiple
pharmacies to avoid tracking
• Physician issued Rx knowing it was going to
be delivered to others
• No logical relationship of Rx to Diagnosis
7/13/2007: Virginia Appeals Judge Brinkema
sentenced Dr. Wm. Hurwitz to 4 years.
The judge said that Hurwitz's practice was legitimate
medicine that saved patients' lives and that medical
literature increasingly supports his theories
on the property of massive drug doses to
treat patients in chronic pain. "An increasing
body of respectable medical literature and expertise
supports those types of high-dosage, opioid
medications," the judge said……..then the judge
added, “Hurwitz undermined his cause by
ignoring that some patients were clearly
drug dealers.”
• Dr. Joseph Guenther, convicted
04/18/2007 (Louisiana)
• Illegally dispense and distribute
Schedule III and IV substance
prescriptions not medically
necessary or were issued for
overlapping treatment periods for
the same medical condition.
• 10 months state prison; 3 years of
supervision and a $40,000.00 fine.
• Dr. Calie Herpin, convicted 04/06/2006
(Texas)
• Conspiracy to fraud; illegal distribution
of a controlled substance; 2,500 gal of
promethazine w/ codeine and 1,765,000
dosage units of hydrocodone/APAP;
prescriptions generated without a
doctor-patient relationship (phone book)
• 120 months (10 years) in state prison
followed by 3 years supervision.
• $ 12.9 million in restitution to CMS
• Dr. William R. Lockridge (internet)
(DEA administrative action); immediate
suspension; registration was
inconsistent with the public interest.
21 U.S.C. §§ 824.
• Dr. Lockridge issued 350 prescriptions
for controlled substance on a single
day from his home in FL without a FL
state license.
• Failure to maintain patient records
and drug dealing behavior constituted
conduct that threatened public health
& safety.
Licenses & registrations
• Medical license (State)
• DEA registration (Federal)
• Addiction treatment (state/federal/pharmacy)
• Multiple locations and multiple licenses
Tamper Resistant-Deterrent Based
Naltrexone
Core
Prescribing controlled substances
• Arabic and English numerical terms
30 (thirty)
• One Schedule II allowed per script
• No stamps
Prescribing controlled substances
•
•
•
•
Telephone refill for schedule III to V.
Manually sign and not pre or post date.
Schedule II valid 60 days after written
Up to 3 months allowed on schedule II with
“Do not fill until” dates
Prescribing controlled substances
• Use schedule II for chronic and end of life pain
– There are exceptions
– Duragesic (fentanyl) is not for post-op or sprains
• Document work up of pain patients and follow
up consults, labs, physical therapy or analgesics.
• No physician disciplined for treating
chronic pain or end of life patients
correctly (DEA FAQ web site).
Controlled
substance logic
and/or chronic
pain
documentation
can lower your
risk because it is
more than just a
progress note.
IMPORTANT TOOLS
• LEARNER OBJECTIVE # 2
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
Reduced risk documentation
•
•
•
•
•
•
•
Pain-O-Gram
Visual analog (Wong-Baker faces)
Zung depression inventory
Injury and medication history
DAST (drug addiction)
Disability index
Goals
Opioid Treatment Agreement
http://www.lni.wa.gov/ClaimsIns/Files/OMD/agreement.pdf. Accessed March 2010.
What are the
characteristics
of physicians
who have been
targeted by the
authorities?
U.S. v Rosen 582F. 2d 1032
th
(5 circuit court 1978)
• Inordinately large quantity of opioid Rx
• No physical exam
• Physically advised patients to use multiple
pharmacies to avoid tracking
• Physician issued Rx knowing it was going to
be delivered to others or used differently
• No logical relationship of Rx to Diagnosis
Example: Doctor ABC
NO MAPS and Medical records all same length
• No labs, PT-OT, referrals, or diagnostics
• Used multiple long acting schedule 2’s
• Local pharmacies stop honoring scripts
• Dr. ABC started dispensing Vicodin at office.
• One Rx q 6 minutes in a 40 hour week
• 20,000 Rx for Narcotics per year is high risk.
• 1.7 million units per 18-24 months
• No NSAID or muscle relaxer, No adjuvant
IMPORTANT TOOLS
• LEARNER OBJECTIVE # 2
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
What is MAPS?
• Michigan Automated Prescription System
• Prescription monitoring systems 37/50 states
• MAPS requires pharmacists, vets, dispensing
doctors to electronically report all controlled
substances dispensed in schedules 2-5
• No methadone clinic reports data
• No VA Hospitals report data
MAPS: Dr. Morrone Patient H.G.
•
•
•
•
•
•
•
Pelvic pain, IBD, Scoliosis, assault from carjack
120 Vicoden ES, i po q 6 hours and Pentasa
60 Vicodin ES 7 days later
60 Vicodin ES 7 days later
60 Vicodin ES 7 days alter
120 Vicodin ES 3 days later
420 Vicodin in a month = 14-15 per day or
she is selling them ( what do you think? )
MCLA 333.7333a Access to MAPS
• Health professional boards investigations
• Employee or agent of Department (MDCH)
• State, federal or municipal employee or agent
whose duty is to enforce drug laws (5%)
• State operated Medicaid programs
• Practitioner (80%) or pharmacist (15%) who
certifies info is for treatment of bona fide current
patient
• Info used for bona fide drug related criminal
investigatory or evidentiary purposes
IMPORTANT TOOLS
• LEARNER OBJECTIVE # 2 and #3
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
• Describe red flags of opioid use
including exit strategies for
changes in treatment plans.
Patient “red flags”
ALL failure to comply is to be seen as a problem
requiring investigation:
• Evidence of fraud or deception = termination
• Lost or early refills = investigate
• Dr. shopping, inappropriate urine toxicology =
termination/investigation.
• Clearly contacting all present or past physicians is
mandated. Patients agree or termination.
• Change intervals from monthly to every two
weeks or weekly when patients continually
run out of medication early.
Scripts Reported in 2003-2006 by
MDCH on the MAPS
• 2003:
• 2004:
• 2005:
• 2006:
12,498,338
13,689,728
14,355,989
15,989,785
• Hydro/APAP
4,596,486
28.74 %
Michigan MAPS requests
• Requests for 2005 averaged over 200 daily.
• Majority are physicians
• Request for 2006-2007 average over 400 daily.
• 100% online after May 1st 2008
Percent Increase in scheduled
drugs by year (source MAPS)
Schedule
2004
2005
2006
II
15.8
7.7
21.0
III
11.6
5.3
10.7
IV
9.4
1.1
10.3
V
2.2
9.2
34.2
total
9.5
4.8
11.4
12.7
13.2
Hydrocodone 16.2
IMPORTANT TOOLS
• LEARNER OBJECTIVE #3
• Describe red flags
of opioid use
including exit
strategies for
changes in
treatment plan
• Do not feel
boxed in.
Exit Strategy
• Methadone only MMT clinic
• Schedule II
• Buprenorphine OBOT
• Schedule III
• Experimental tramadol/clonidine
• Nonscheduled
Exit strategy when narcotics are out of
control – refer out or Buprenorphine
•
•
•
•
•
•
Opioid dependence
Heroin user (6-MAM)
+20 Vicodin per day
Snorting OxyContin
Doctor shopping
Follow up on O.D.
Buprenorphine
• Only FDA approved medication to
treat opioid dependence OBOT.
• Covered on Medicaid (CMS) and
any prior authorization needs a
counselor’s name and license
number to link behavioral
modification with medication.
DATA 2000
• Drug Abuse and Treatment Act of 2000 allows
waivered physicians to treat opioid
dependence in the office.
• Office based substance abuse treatment with
buprenorphine
– Buprenorphine (Subutex®)
– Buprenorphine with Naloxone (Suboxone®)
• Street I.V. buprenorphine mixed with I.V.
benzodiazepines = abused in France.
SchIII
DETOX
Special DEA registration
• Issued a DEA registration starting with
XS1234567 if your original was AS1234567
• Eight hours of training or dvd & on-line test
• Initially limited to 30 patients, increased to
100 patients after one year
• Records subject to same confidentiality as
methadone and alcohol treatment records
• Title 42 of the CFR
Michigan Buprenorphine Rx’s
• Suboxone (all strengths)
– Scripts written in 2006: 51,252
– Scripts written in 2005: 25,798
– Scripts written in 2004: 11,919
Prescriptions Reported on MAPS
(Michigan Buprenorphine Only)
Suboxone 8/2 - ( % increase over the year before )
• 2003 - 140
• 2004 - 6,919
( 4,842 % )
• 2005 - 17,359
( 150 % )
• 2006 - 36,252 ( 108 % )
Update DATA 2000
• Office based substance abuse treatment with
buprenorphine (OBOT)
• Law changed in December 2006 and now
allows practitioner after one year of
experience to treat up to 100 patients
Methadone
facts:
the good and
the bad
Methadone
METHADONIA
• All inexperienced physicians
should be initiated and
mentored on the use of
methadone for pain.
• Chart documentation on
prescriptions and patient
education should be detailed
and clear……dose slow.
Schedule II MAPS methadone info
•
•
•
•
2003:
2004:
2005:
2006:
72,172 scripts
109,869 increase of 52%
131,524 increase of 20%
162,736 increase of 22%
• Medicaid now requires prior approval for
Oxycontin and not for methadone; there will
be a transfer due to this formulary issue.
Do not use Methadone unless you are
very comfortable with it.
Document reasons
clearly for using
methadone:
•
•
•
•
•
Hospice
Allergies
Formulary
Diagnosis
MMTs
Pharmacologics
• Efficacy greater than
morphine
• Full Mu-opioid agonist
• Inhibits reuptake of
5HT and NE.
• NMDA antagonist
resulting in additional
analgesia
Methadone
• Synthetic opioid discovered by Nazi’s in 1939.
• Emerged in 1963-66 as addiciton treatment.
• Initially use limited to addiction. Restricition
was removed in 1976. All physicians with DEA
registration and state license may prescribe
for anlagesia.
• Methadone for addiction in MMTs only.
Methadone Pharmacokinetics
• Metabolized in liver NO active
metabolites (EDDP).
• Elimination half life of about 22
hours but varies in each person.
• Duration 8-12 hours with
repeated dosing.
• Minimal renal excretion
primarily fecal excretion.
Methadone Pharmacokinetics
• Lipophilic & bioavailability > 90%
• Morphine bioavailability 20-30%
• Methadone tissue binding dominates over
binding to plasma proteins. Methadone
accumulates in tissue with repeated dosing
which acts as a reservoir (Dole & Kreek 1973).
Analgesia similar to morphine
•
•
•
•
•
•
Once daily dose for opioid addiction (MMT only)
Liquid used mostly for addiction and HOSPICE
15 mg morphine equal to 5 to 10 mg methadone
150 mg morphine equal to 30 mg methadone
Suitable for pain when there is morphine allergy
Slow onset helps avoid establishing
reward behaviors that can occur
with fast acting short duration
opioids
Methadone Dosing
• Package insert advised dosage of 2.5 to 10mg every 3-4
hours as needed
• 40-50 mg/day can be deadly for new patient
• FDA black box warning
• 18 deaths - Kent county, 11 deaths - Bay
County (2006)
• 2003 DAWN data from ME’s in Detroit identified 64
deaths from methadone
• Benzos found in 74% of deaths related to methadone
• Marked drowsiness (side effect) add methylphenidate
• Duration of analgesia about 8 hours (6 to 10 hours)
Medical Examiner Report
Kent Co. 2006 OD Deaths
•
•
•
•
•
•
•
5 alcohol
4 heroin
10 cocaine
18 methadone
21 narcotic
1 antidepressant
7 other (polypharmacy)
IMPORTANT TOOLS
• LEARNER OBJECTIVE # 2 and #3
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
• Describe red flags of opioid use
including exit strategies for
changes in treatment plans.
DRUG TESTING
WeeksMonths
Hours-Days
Urine testing
• Pain management “Basic” test is the “HHS5”
“Federal Five” and includes “opiates”
• (THC, cocaine , opiate, PCP & amphetamine)
• Will not identify synthetics such as
methadone fentanyl or meperidine
• May not include semisynthetics such as
hydrocodone and oxycodone unless
thresholds eliminated and GC or MS
performed
Only 8 % of primary care
use urine drug toxicology
Opiate testing
• Natural opioids : morphine and codeine;
heroin shows up as 6-MAM & morphine
• Lab should use GC or MS to separate and
identify individually. Cannot determine dosage
from urine testing if RIA only.
• Methadone treatment centers have additional
federal privacy protections under CFR 42
which includes alcohol and predates HIPAA.
Exempt from MAPS
heroin
a
Natural
Semi-synthetic
Synthetic
(from opium 100%)
(derived from opium)
(man made)
Codeine
Hydrocodone
Meperidine
Morphine
Hydromorphone
Fentanyl
Thebaine
Oxycodone
Propoxyphene
Oxymorphone
Methadone
Buprenorphine
•
•
•
•
•
•
•
•
•
Ameritox
Quest
Warde
Sparrow
Ford
DMC
U of M
Spectrum
Metro
• Qualitative Analysis
• Patient self-reporting is unreliable and behavior observation
unreliable
• Cornell University: doctors unable to detect patients misusing
medications up to 90% of the time, and mistakenly identify
compliant patients as those who abuse medication
• Prescription Monitoring Program
• Tracks prescriptions written - does not address patient compliance
• Urine Drug Testing
• Determines the presence or absence of a drug (positive/negative)
• Easy to “beat”, resulting in false negatives
• Quantitative Test
• Identifies quantitative levels and metabolites
• Does not provide clinical perspective for the data
People are going to try to cheat us.
Minnesota Vikings
•
•
•
•
Wizzinator $150.00
2 urine packs $30.00
2 heating pads $4.00
Overnight ship $29.50
• Total $213.50
The best one out there.
Frauding toxicology is big business
Drug is stored in hair cuticle.
What is the policy for fraud in urine
testing for a federal employment?
W
MRO POLICY
Fraud on your urine test……is the
same as refusing to test.
• You are not hired.
• You stand down.
• You are suspended or fired.
• Medical Review Officer (MRO) isn’t
a doctor-patient relationship.
Protecting yourself and patients
•
•
•
•
•
Limit staff allowed to telephone refills
Safe (locked) for controlled substances
Don’t leave Rx pads out
Security paper – as of 2008
Don’t sign blank prescriptions
High Risk Patients
High
Risk
Patients
TEXAS PAIN PHYSICIAN
Law requires that physician ask patient about
Rx use and record response in medical record.
(no drug testing any visit)
(56 y/o White F with OA, LBP, GI bleed hx)
VISIT #1-10 mg OxyContin: Rx filled, takes ii
instead of i now and then.
VISIT #2-40 mg OxyContin: never filled and
the physician never asked about the Rx.
VISIT#3-80 mg OxyContin: took two & died.
IMPORTANT TOOLS
• LEARNER OBJECTIVE # 2 and #3
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
• Describe red flags of opioid use
including exit strategies for
changes in treatment plans.
Protecting yourself and patients
•
•
•
•
Do not exceed the dose ordered.
Do not exceed the dose frequency.
Do not mix with out talking to PCP.
If you take it off schedule you may end up in
the Emergency Dept. or worse yet, you may
surely die.
• If you need more chronic pain treatment,
come back and see your doctor.
“Red Flags”
• ALL failure to comply is to be seen as a
problem requiring investigation.
• Evidence of fraud or deception,
• Lost or early refills,
• Doctor shopping,
• Inappropriate urine toxicology = termination.
• Clearly contacting all present or past
physicians is mandated. Patients agree or get
terminated.
• Change intervals: monthly to every two weeks
or weekly when patients continually
run out of medication early.
More “Red Flags”











Overly complimentary patient
Shows up for the initial consult on chronic pain prescriptions
with no referral, records, and is “running out of medications”
When no prescription is issued on the initial visit, the patient
usually gets angry
Cash patient with no referral
Lost prescriptions
Multiple missed visits/irresponsible behavior
History of Substance Abuse Disorder
Knows what they like (Vicodin ES® vs. Vicodin HP®) or has an
unusual knowledge of controlled substances
Wants Rx called in (outside of regular hours, i.e., after 5pm)
Must have the brand name (DAW)
Not interested in an extended physical examination or
diagnosis with Patient Education time.
Protecting yourself and patients
• Respond to “Red Flags”
• Print a MAPS for all new and narcotic pts.
• Keep accurate records & treatment
agreements.
• Contracts, urine screen chronic pain patients
• Avoid Vicodin type analgesics for “chronic”
pain patients
• Know issues associated with methadone
Medical Legal
Issues & Case
Studies
#1.
• Patient states he was at a party on Saturday
night and everyone else was smoking but he
never smoked a single joint.
• Specimen collected 2 days after claimed
passive exposure.
• THC Lab cut off limit = 30 ng/mL
• Violation - you may keep or discharge.
• Document unambiguous counseling.
• Make sure you have a narcotic contract in
place.
• Plan 4 to 6 urine toxicology tests per year.
• The patient will likely self discharge.
#2.
• Patient states he is taking Percocet ® and
regularly eats Zender’s poppy seed streusel,
kolache, and poppy seed bagels every day.
• Morphine is 3,150 ng/mL and the 6monoacetylmorphine (6-MAM) is negative.
• Documentation at the pharmacy show a valid
current Rx for 5mg Percocet® i-ii po q 8 hours.
Czechoslovakian poppy seed kolache
#3.
• The patient states that he was taking Tylenol®
with codeine at the time of the drug test and
gives a history of acute back pain & a visit to
Bay Medical Center’s E.R.
• Morphine is 6,350 ng/mL
• Codeine is 17,340 ng/mL
• 6-MAM is negative
• The donor supplies a valid Rx for a codeine
product.
• O.K.
#4.
• Patient claims to have had some old bottles of
cough syrup & stuff and took them this
weekend. He is a 3rd shift baker at Tim
Horton’s & was ill.
• Morphine was 2,500 ng/mL
• Codeine was 3,800 ng/mL
• 6-MAM was negative
• Old bottles of Robitussin & Donnagel are
supplied.
• O.K.
#5. Mr. J.D.
• A patient denies using cocaine but claims that
cocaine was used as a topical anesthetic prior
to an ENT endoscopic procedure.
• Specimen donor returns with hospital
documentation to verify cocaine was used in
endoscopy 10 days prior.
• Violation – I would totally stop narcotics.
• You may or may not keep the patient but must
verify or document unambiguous counseling.
• Urine drug toxicology 4 to 6 times per year.
• Look for other signs of diversion.
• Patient will likely self discharge.
• Remember he denied cocaine (lies??)
#6. Ms. W.
• Patient comes to your Urgent Care at 7:59 pm
(1959 EST) just one minute before you close.
• It is the day before a 3 day weekend holiday.
• It is a very cold November Thursday night.
• There is a snow storm starting.
• It appears the patient is not wearing a bra.
• She wearing a very low cut snug sweater top
and no coat. Heavy perfume.
continued
• She hears you’re a “good doctor” and says her
doctor’s office is closed.
• She is out of OxyContin 80 mg she needs 6
a day for 7 days to get to her doctor. It must
be DAW only because generics don’t work &
this patient is allergic to all NSAIDs.
• Your qualitative in-office $25.00 UDS shows
(-) oxy and (+) cocaine, morphine & 6-MAM.
Remember Eliott Spitzer
• Send her to Emergency
Department. This is
nothing but trouble.
• Do not try to treat this,
unless you are an AAAP
admitting psychiatrist
with an inpatient facility.
• $ 1,400 street value.
Resources at the State of Michigan
• Department of Community Health
• Bureau of Health Professions
• www.michigan.gov/healthlicense
Health Investigation Division
• mapsinfo@michigan.gov
• http://sso.state.mi.us/
SUMMARY
•
•
•
•
•
•
•
•
Legal Case history
License options
Low risk documentation
Prescription monitoring
Exit strategy – buprenorphine
Methadone good and bad
Drug testing
Red Flags
Today’s objectives page
• Apply clinical guidance for safe and
appropriate opioid prescribing.
• Implement risk assessment
documentation tools regarding
appropriate patient selection.
• Describe red flags of opioid use
including exit strategies for changes
in treatment plans.
References
•
•
•
•
•
•
•
•
1 complete pain consult
1 MDCH Power Point
1 county medical examiner report
4 books
5 DEA/DOJ case law examples
6 websites
6 clinical urine toxicology studies
17 federal laws
Call any time.
 Director of Hospice and Palliative Care:
Hospice of Michigan - 989.790.7352.
 Assistant Director Family Medicine:
Synergy Medical Alliance - 989.583.6800.
24 hour Answering Service:
989.891.8979
Any question. Any medicine.
william.morrone@sbcglobal.net
t