Transcript Prescription Monitoring Programs

"Managing Difficult Issues Regarding
Patient Prescription Drug Abuse: An
Educational Program for Emergency
Physicians"
Maine ACEP Chapter Grant
Project Coordinator Michael Gibbs
and Tamas Peredy, MD
Program Description
• Maine ACEP proposes to hold five three-hour educational
programs for Maine’s emergency physicians on the issue of
patient diversion of drugs for street use over the course of
the 18-month grant period in 2009/2010 at various rural
locations across the state.
• Objectives
– 1. Increase clinician awareness of the issues surrounding opioid
misuse including risk of oligoanalgesia, factors that may identify high
risk patients and rights and responsibilities of law enforcement
reporting.
– 2. Increase enrollment in the Maine’s Electronic Web-based
Prescription Monitoring Program.
– 3. Share evidence-based Pain Management Policies and Protocols.
Conference Speakers
• Maine ACEP
– Michael Gibbs, MD, FACEP Tamas Peredy, MD, FACEP
• Maine Medical Association
– Gordon Smith, ESQ, Andrew MacLean, ESQ
• Maine OSA/Prescription Monitoring Program
– Daniel Eccher, MPH, Stacey Chandler, Anne Rogers, M Ed,
• Maine DEA
– Officers Chris Gardner, James Pease, Lowell Woodman,
Kevin Cashman, Gerry Baril
Special Thanks to
• Anna Bragdon
– Chapter Executive, MACEP
• Maine Medical Center
– Hannaford Center for Safety, Innovation and
Simulation
• Marcella Sorg, PhD
– Margaret Chase Smith Policy Center
– University of Maine
• Scott Kemmerer, MD
– Immediate Past President MACEP
Conference Sites
• Pilot Programs:
– Portland 10/16/2008
– Bangor 3/12/2009
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Augusta/Waterville 3/31/2011
Orono 4/12/2011
Lewiston/Auburn 4/21/2011
Topsham 4/27/2011
Biddeford 4/28/2011
Hannaford Center for Safety,
Innovation and Simulation
• Department of Medical Education
• 4 Case scenarios
– 1) Ankle Fx in chronic pain pt, 2) Forged script with back
pain pt, 3) Migraine HA in drug seeker and 4) Dental pain
with and without brief assessment
• Appeared in Scenarios
– Tamas Peredy, MD Michael Gibbs, MD
– Shelly Chipman, Todd Dadaleares and Susie Lane
Challenge
• Increased dispensation of opioids coupled
with changing societal attitudes towards
prescription opioids has contributed to our
current pandemic of non-medical pain
reliever misuse.
Response
• To develop a balanced approach to the
proper distribution of pain medication to
those in need while developing safeguards
that reduce the amount of diversion.
General Articles
• McLellan AT, Turner B, Prescription Opioids,
Overdose Deaths and Physician Responsibility,
JAMA, 300(22): 2672-2673.
• MacCarberg BH, Balancing Patient Needs and
Provider Responsibilities in the use of Opioids,
P&T Digest, 32-38, 2006.
• Woodcock J, A Difficult Balance – Pain
Management, Drug Safety and the FDA, NEJM,
361(22): 2105-2107.
Societies
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American College of Emergency Physicians
American Society of Interventional Pain Physicians
International Association for the Study of Pain
American Pain Society
American Academy of Pain Medicine
Oligoanalgesia in the Emergency
Department
Excerpts from Presentation #1
Developed by Michael Gibbs, MD
Human Beings Are Good
A Lot Of Them Come
To The ED With Pain
It Is Our Job To
Alleviate Pain & Suffering
We Don’t Do A Very
Good Job!
Barriers to Adequate Analgesia
• Lack of Medical Provider Education
• Non-existence of Pain Treatment Quality Management
Programs
• Lack of ED Pain Treatment Efficacy Studies (including
pediatric, geriatric…)
• Clinician’s attitudes about addiction, drug-seeking
• Opiophobia – safety concerns relative to other modalities
• Unappreciated cultural and gender differences in pain
reporting
• Racial and ethnic stereotyping
Rupp T, Inadequate Analgesia in Emergency Medicine, Ann Emerg Med 43(4): 494-503, 2004
Millard WB, Grounding Frequent Flyers, Not Abandoning Them: Drug Seekers in the ED, Ann Emerg Med 49(4): 2007.
ED Patient
With “Pain”
Prescribe
Correct
Incorrect
Don't
Prescribe
Correct
Incorrect
WHAT IS THE COST OF BEING
WRONG?
Oligoanalgesia Articles
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Todd KH, Samaroo N, Hoffman JR, Ethnicity as a Risk Factor for Inadequate Emergency
Department, JAMA, 269: 1537-1539, 1993.
Todd KH, Deaton Cm D’Adamo AP et al, Ethnicity and Analgesic Practice, Ann Emerg
Med, 35(1): 11-16, 2000.
Pletcher MJ, Kertesz SG, Kohn MA et al, Trends in opioid prescribing by race/ethnicity for
patients seeking care in US emergency departments. JAMA. 299:70-78, 2009.
Jones JS, Johnson K, McNinch M, Age as a Risk Factor for Inadequate Analgesia in the
Emergency Department, Am J Emerg Med, 14:157-160, 1996.
Brown JC, Klein EJ, Lewis CW, Emergency Department Analgesia for Fracture Pain, Ann
Emerg Med, 42(2): 197-205, 2003.
Rupp T, Delaney KA, Inadequate Analgesia in Emergency Medicine, Ann Emerg Med
43(4): 494-503, 2004.
Alexander J, Manno M, Underuse of Analgesia in Very Young Pediatric Patients with
Isolated Painful Injuries Ann Emerg Med, 41(5):617-622, 2003.
Goldman RD, Crum D, Bromberg R et al, Analgesia Administration for Acute Abdominal
Pain in the Pediatric Emergency Department, Pedi Emerg Care, 22(1):18-21, 2006.
Pines JM, Hollander JE, Emergency Department Crowding is Associated with Poor Care
for Patients with Severe Pain, Ann Emerg Med 51(1): 1-5, 2008.
Decosterd I, Hugli O, Tamches E et al, Oligoanalgesia in the Emergency Department, Ann
Emerg Med, 50(4): 462-471, 2007.
Duignan M, Dunn V, Barriers to Pain Management in Emergency Departments, Emerg
Nurse, 15(9): 30-34, 2008.
Chan L, Winegard B, Attitudes and Behaviors Associated with Opioid Seeking in the
Emergency Department, J Opioid Manage, 3(5): 244-248, 2007.
Pandemic of Prescription
Misuse
Excerpts from Presentation #2
Developed by Tamas Peredy
Opioid
Prescriptions
• Overall opioids
– 1997 50.7 M grams
– 2006 115.3 M grams
• 1997-2006
– Methadone ↑1117%
– Oxycodone ↑732%
– Hydrocodone ↑244%
ARCOS
Non-medical Use of Prescription
Drugs
• NSDUH 2006
– 20.4 M (8.3% population) current illicit drug users
• 14.8 M (6%) THC
• 7 M (2.8%) Prescription Drugs
– 5.2 M pain relievers
• 2.4 M cocaine, 1 M hallucinogens
2008
Drug Diversion
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Doctor shopping
Wrote fake prescription
Internet pharmacy $4B
Stolen from doctor’s office/pharmacy
Illicit script from Prescriber
80% from one doctor
1. Reported Methods of Obtaining
‘Its nice to share’
all
those who met
definition of dependent/abuser
Emergency Department Visits
• Drug Abuse Warning Network (DAWN) 2005
• 1.3 M visits drug use/misuse
– 196,000 visits opioids (↑24% since 2004)
– >2/3rds multiple drugs
Suicides are included,
and are about 15% of
these totals.
Total Drug Deaths
Maine
200
150
100
50
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Total Drug Deaths 34
54
66
60
90
166 153 162 176 167 154
Maine Medical Examiner’s Office: 429% increase in drug deaths 1997-2006
Crude rate per 100,000
8
U.S. Crude Death Rate:
Unintentional Drug Overdose
63%
7
6
5
4
3
2
1
0
'70 '72 '74 '76 '78 '80 '82 '84 '86 '88 '90 '92 '94 '96 '98 '00 '02 '04
Year
Source: NVSS, CDC WONDER, Paulozzi, 2008
Number of deaths
Unintentional Poisoning Deaths
by Specific Drug Type
US1999-2005
9000
8000
7000
6000
5000
4000
3000
2000
1000
0
prescription opioid
cocaine
heroin
'99
'00
'01
'02
'03
'04
'05
Year
Paulozzi, LJ. Budnitz, DS. Xi, Y
Increasing deaths from opioid analgesics in the United States
Pharmacoepidemiol Drug Saf. 2006 Sep;15(9):628-31
Epidemiology Articles
• Paulozzi LJ, Ryan GW, Opioid Analgesics ad Rates of
Fatal Drug Poisoning in the US, Am J Prev Med, 31(6):
506-511, 2006.
• Bailey JE, Campagna E, Dart RC et al, The Under
recognized Toll of Prescription Opioid Abuse on Young
Children, Ann Emerg Med, 2008.
• Hall AJ, Logan JE, Toblin RL et al, Patterns of Abuse
Among Unintentional Pharmaceutical Overdose
Fatalities, JAMA, 300(22): 2613-2620, 2008.
• McCabe SE, Cranford JA, Boyd CJ et al, Motives,
Diversion and Routes of Administration Associated with
Non-Medical Use of Prescription Opioids, Addict Behav,
32: 562-575, 2007.
Opioid Addiction Therapy
History
• Harrison Narcotic Act 1914
– Webb vs. United States 1919
• Physicians could not prescribe narcotics for addiction
• Methadone
– Treatment for Opioid began 1964 (NYC)
– Narcotic Addict Treatment Act 1974
• Federal Regulation SAMHSA CSAT
– ~15% addicts in a program, 150,000 participants
• Drug Addiction Treatment Act Oct 2000
– Schedule II, III, IV medications for the detoxification or maintenance of
opioid dependency
• FDA approval buprenorphine (+/- naloxone) Oct 2002
– Schedule III drug for detoxification or maintenance of opioid dependency
– Office-based Opioid Treatment (OBOT)
Fudala PJ et al NEJM 2003
Figure 2 Tolerance versus opioid-induced hyperalgesia
•Chronic Pain
•Tolerance
•Hyperalgesia
•Dependency (risk of withdrawal)
Crofford, L. J. (2010) Adverse effects of chronic opioid therapy for chronic musculoskeletal pain
Nat. Rev. Rheumatol. doi:10.1038/nrrheum.2010.24
Methadone Pharmacology
• Mu agonist, NMDA agonist
• Usual dosing 60-120 mg/ once per day
– High dose protocols (Strain, Shinderman)
• Analgesic action 4-8 hrs
• Elimination half-life 8-59 hrs
• Major metabolite
– EDDP metabolite
• QT prolongation (Black Box Warning) Krantz Ann Inter
Med 2002
Methadone Unintended Deaths
• Nationally (FDA warning 2006)
*ED visits
41,000 in 2005
↑659% 1999-2005
– # scripts ↑700% 1998-2006
– Deaths 790 in 1999 → 3849 in 2004 (↑468%)
• 82% unintentional (most polydrug e.g. benzos)
– Increase not related to MMTP
• Locally
– Vermont 17→79 2001-2006 Shapiro 2007
– Maine 23→67 2001-2006 Sorg 2007
Coben JH Am J Prev Med 2006
SAMHSA Substance Abuse Treatment Advisory, Spring 2009
Martin TC Curr Drug Safety 2011
Buprenorphine Pharmacology
• Partial mu agonist
– May induce withdrawal in dependent patients
• High mu affinity
• Elimination half-life 4-5 hours
• Analgesic ceiling ~32 mg/day
• Usual dosing 4-16 mg/day BID
Sporer KA Ann Emerg Med 2004
Acute Pain Management in Chronic
Pain Patients
• Re-emphasize non-pharmaceutical and nonopioid treatments
• Do not vary long-acting opioid dosing
– methadone or fentanyl patch dose
• Buprenorphine frequency or dose may be
increased to q6 or up to 32 mg/day
• Titrate a short-acting opioid
• Rapid referral or re-check to reduce quantity
dispensed
Chronic Pain Articles
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Savage SS, Kirsch KL, Passik SD, Challenges in Using Opioids to Treat Pain in
Persons with Substance Use Disorders, Addict Sci Clin Pract, 4-25, 2008
Martin TC, Rocque M, Accidental and Non-Accidental Ingestion of Methadone and
Buprenorphine in Childhood, Curr Drug Safe, 6(1): 1-5, 2011.
Toombs JD, Kral LA, Methadone Treatment for Pain States, Am Fam Phys, 71(7):
1353-8, 2005.
Wolff K, Characterization of Methadone Overdose, Therapeu Drug Monitor, 24(4):
457-470, 2002.
Fudala PJ, Bridge TP, Herbert S et al, Office-Based Treatment of Opioid Addiction
with SL Buprenorphine and Naloxone, NEJM, 349(10): 949-958, 2003.
Berg ML, Idrees U, Ding R et al, Evaluation of the Use of Buprenorphine for Opioid
Withdrawal in an Emergency Department, Drug Alco Depend, 2006.
Bell JR, Butler B, Lawrence A et al, Comparing Overdose Mortality Associated with
Methadone and Buprenorphine Treatment, Drug Alco Depend, 104: 73-77, 2009.
Sporer KA, Buprenorphine: A Primer for Emergency Physicians, Ann Emerg Med,
43(5): 580-584, 2004.
Maine Prescription Monitoring
Program
Excerpts from Presentation #3
Developed by Daniel Eccher, MPH
Top Five Rx Drugs of Abuse
Drug Name
Tablets Dispensed
Hydrocodone/APAP
26.4 million
Oxycodone HCl
17.3 million
Oxycodone/APAP
10.6 million
Alprazolam
9.2 million
Diazepam
4.0 million
PMP Data, SFY 2009. According to the Maine Drug Enforcement
Agency, these drugs are the top 5 of concern for law enforcement.
How to register as a Requester
1. Go to: http://www.maine.gov/pmp
2. Click on “RxSentry Data Requester Forms”
link.
3. Download appropriate Registration Form.
4. Fill it out, sign it in front of a Notary Public,
have them notarize it, and mail it to OSA at
the address on the form.
Questions: (207) 287-2595
Sub-account User Registration
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Go to www.maine.gov/pmp.
Click on “RxSentry Data Requester
Forms” link.
Download “Sub-account User Form.”
Fill it out; prescriber signs middle; subaccount user-to-be signs in front of a
Notary Public; then, send original form to
OSA at address on form.
Registration Statistics
PMP Articles
• Fishman SM, Papazian JS, Gonzalez S et al, Regulating
Opioid Prescribing Through Prescription Monitoring
Programs, Am Acad Pain Med, 5(3): 309-324, 2004.
• Reisman RM, Shenoy PJ, Atherly AJ et al, Prescription
Opioid Usage and Abuse Relationships, Subst Abuse Res
Treat, 3: 41-51, 2009.
• Baehren DF, Marco CA, Droz DE et al, A Statewide
Prescription Monitoring Program Affects Emergency
Department Prescribing Behaviors, Ann Emerg Med, 56(1):
19-23, 2010.
• Todd KH, Pain and Prescription Monitoring Program in the
Emergency Department, Ann Emerg Med , 56(1): 24-26,
2010.
ED Pain Management Guidelines
Excerpts from Presentation #4
Developed by Tamas Peredy
Chronic Pain Ambulatory Care
Guidelines (Universal Precautions)
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Evaluation
Risk Assessment
Controlled Substance Prescribing Contract
Prescription Monitoring Program
Drug Education
– Addiction (4C’s), Dependency, Tolerance
• Adherence monitoring
– Pill counts
– Urine drug screening
Fundamental Goals
– ‘Fifth vital sign’ (0-10 scale) JCAHO 2001
• One-dimensional
• Best used to assess therapeutic success
– Identify cause or causes
• Objective testing, if needed
• Therapy may begin simultaneously
– Treatment
• Expedience/Titration
• Individual benefit versus risks (balance)
• Background: environmental costs
ACEP Board of Directors Statement 2009
FSMB Published Statement 2004
Multidisciplinary Treatment
Modalities
• Physical
– Heat/ice, immobilization, massage, acupuncture
• Psychobehavioral
– Relaxation, biofeedback, sleep management,
cognitive restructuring
• Interventional
– Blocks, stimulators
• Medications
– APAP, NSAIDS, topical therapy, Adjuncts, Opioids
ED Pain Metric
• Inclusion:
– Age range: all
– Complaint: pain
– Acuity: < 1 week
• Exclusion:
– Unstable vital signs
– Clear indications for emergent transfer to:
• L&D, Cath Lab, Operating Room
ED Flow
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Triage Evaluation of Pain (PQRST) and implementation of non-pharmacological
measures within 15 minutes
– Positioning, ice, immobilization
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Assess medications, allergies, mental status, respiratory status, circulation and
gastrointestinal complaints (nausea, vomiting)
Pain VAS
– 1-3 minor
• Initiate APAP or NSAID
– 4-10 major
• Obtain urine specimen
• Check PMP
• Ask if patient can wait 30 minutes for medications to work?
– Yes, give APAP 1g, NSAID ibuprofen 10 mg/kg plus Oxycodone 0.1 mg/kg
» Reassess 30 minutes, notify provider
– No, give fentanyl 1 mg/kg up to 100 mcg IV
» Reassess 10 minutes, notify provider
– Provider assessment within 1 hour
• Secondary intervention or documentation of exclusion criteria
– Complete pain relief, Disingenuous pain, etc..
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Metric
– %secondary assessment within 30-60 min
– %achieved pain relief 50% or greater
Acute pain
15 minutes
Triage
Assessment
Pain VAS 1-3
Pain VAS 4-10
Contraindications
to PO medication
Give APAP 1g
and/or
No contraindications
to PO medication
Give APAP 1g PO
and/or
Give fentanyl
1 mcg/kg IV
Ibuprofen 10 mg/kg
Ibuprofen 10 mg/kg PO
60 minutes
30 minutes
Secondary
Assessment:
Goal Pain reduction 50%
PMP check
Secondary
Assessment:
Goal Pain reduction 50%
Documentation of outliers
30 minutes
Secondary
Assessment:
Goal Pain reduction 50%
Risk Assessment Tools (screening tools)
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ABD Addiction Behavior Checklist
CAGE-AID
COMM Current Opioid Misuse Measure
CRAFFT
– Car, relax, alone, forgetfulness, friend tolf you to quit, trouble with law
• DIRE
– Diagnosis, intractability, risk, efficacy
• SISAP Screening Instrument for Substance Abuse Potential
SOAPP
– CAGE plus mood, legal problems, personal, friend and family Hx
substance abuse, psychological problems, treatment and treatment
failure
• ORT (opioid risk tool)
– Personal and family Hx substance abuse, age, social factors,
psychological diseases
Urine Drug Screen
• Rarely impacts acute medical care
• Opioids (cutoffs, threshold)
– Typically detection of codeine, hydrocodone,
hydromorphone, morphine, heroin (diacetylmorphine)
– Variable cross reactivity with oxycodone
• Special assays required for
– Methadone, buprenorphine, oxycodone, fentanyl
Minimum Documentation
• Past visits resulting in opioid scripts (recurrence)
• Past failures of non-opioid pain relieving treatments
• History of drug use including alcohol and tobacco
– Past treatment for drug problems
• Family situation (including relations with substance
abuse)
• Outpatient resources (primary care doctor)
Vukmir RB, Drug Seeking Behavior, Am J Drug Alco Abuse, 30(3): 551-575, 2004.
125th Maine Legislature First Regular Session LD 1501
ED Pain Management Articles
• Wilsey B, Fishman S, Rose JS et al, Pain Management
in the ED, Am J Emerg Med, 22(1): 51-57, 2004.
• McIntosh SE, Leffler S, Pain Management After
Discharge From the ED, Am J Emerg Med, 22(2): 98100, 2004.
• Tamches E, Buclin T, Hugli O et al, Acue Pain in Adults
Admitted to the Emergency Room: Development and
Implementation of Abbreviated Guidelines, Swiss Med
Weekly, 137: 223-227, 2007.
• Rasor J, Harris G, Using Opioids for Patients with
Moderate to Severe Pain, JAOA, 107(9) S5: ES4-10,
2007.
Legal and Law Enforcement Issues
associated with Opioid Dispensing
Excerpts from presentation #5
Developed by Gordon Smith, EVP, MMA
207-622-3374, ext. 212
[email protected]
Maine State Law
• §1109. Stealing drugs
• 1. A person is guilty of stealing drugs if the person
violates chapter 15, section 353, 355 or 356-A knowing
or believing that the subject of the theft is a scheduled
drug, and it is in fact a scheduled drug, and the theft is
from a person authorized to possess or traffick in that
scheduled drug.
• [ 2003, c. 1, §9 (AMD) .]
• 2. Stealing drugs is:
• A. A Class C crime if the drug is a schedule W, X or Y
drug; or [2001, c. 419, §21 (NEW).]
• B. A Class D crime if the drug is a schedule Z drug.
[2001, c. 419, §21 (NEW).]
Searching for Balance
• Practitioners have a legal & ethical duty to
effectively diagnose & manage pain
• Practitioners must be aware of federal & state
laws governing the prescription of controlled
substances for pain management & must keep
them in mind when developing treatment plans
• Following medically-based, peer reviewed, &
nationally-recognized guidelines, documenting
good faith prior exams, & outlining the
parameters of treatment plans will put you in the
best position to defend enforcement actions
• Following BOLIM Rule Chapter 21 essential
State Law Aimed at Preventing
Diversion
• Joint Rule Chapter 21, Use of Controlled
Substances for Treatment of Pain
• MDEA Rule Chapter 1, Requirements of Written
Prescriptions of Schedule II Drugs (with printer &
waiver lists)
• Board of Pharmacy Rule Chapter 19, Receipt
and Handling of Prescription Drug Orders
• An Act to Facilitate Communication between
Prescribers & Dispensers of Prescription
Medication (P.L. 2003, Chapter 483; effective
9/13/03) – Prescription Monitoring Program
Health Information Privacy Laws &
Diversion
• 22 M.R.S.A. sec. 1711-C, Confidentiality of health care
information (Maine’s privacy statute, effective 2/1/00)
• 45 C.F.R. Parts 160 & 164, Standards for Privacy of
Individually Identifiable Health Information (the HIPAA
privacy rule, effective 4/14/03)
• FAQ: What disclosure to law enforcement officials is
permitted under these privacy laws?
– Is there any recognized privacy interest in criminal activity?
– Can practitioner disclose facts about patient conduct that
suggest diversion without disclosing PHI?
• L.D. 1425, An Act to Facilitate the Reporting of the Crime
of Acquiring Drugs by Deception (P.L. 2007, Chapter
382; effective 9/20/07)
Amendment to Crime of Acquiring
Drugs by Deception
• L.D. 1425 amends 17-A M.R.S.A. sec. 1108, Acquiring
drugs by deception, as follows:
– 6. A prescribing health care provider, or a person acting under
the direction or supervision of a prescribing health care provider,
who knows or has reasonable cause to believe that a person is
committing or has committed deception may report that fact to a
law enforcement officer. A person participating in good faith in
reporting under this subsection, or in participating in a related
proceeding, is immune from criminal or civil liability for the act of
reporting or participating in the proceeding.
Medical Marijuana
• Maine Medical Marijuana Act: passed by referendum in
1999; repealed & replaced by referendum in 2009;
amended by legislature in 2010
• Expanded list of “debilitating medical conditions”
• Role of physician: may, but is not required to, provide
“written certification” of eligibility
• Issues of informed consent
– Uncertain status under federal law: AG Holder statement
– Drug regulatory concerns: not FDA-approved; don’t “prescribe”
or “dispense”
– Potential exposure to claims of negligence: unregulated drug;
may not know strength or impurities
• Is this at odds with our concern about Maine’s drug
problem?
Legal Articles
• Lawrence LL, Legal Issues in Pain Management: Striking
a Balance, Emerg Med Clin N Am, 23: 573-584, 2005.
• Goldenbaum DM, Christopher M, Gallagher RM et al,
Physicians Charged with Opioid Analgesic-Prescribing
Offenses, Pain Med, 9(6): 737-747, 2008
• Fishbain DA, Lewis JE, Gao J et al, Alleged Breaches of
“Standards of Medical Care” in a Patient Overdose
Death, Am Acad Pain Med, 10(3): 565-572, 2009.
• Model Policy for the Use of Controlled Substances for
the Treatment of Pain, Federation of State Medical
Boards.