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The Prescription Drug Epidemic:
           Pills, Addictions, Deaths.
                What To Do About it?

     Michael M. Miller, MD, FASAM, FAPA




                    33rd Annual Behavioral Health &
                    Addictive Disorders Conference
                          U.S. Journal Training, Inc.
                                 February 14, 2012
Michael M. Miller, MD, FASAM, FAPA
mmiller@rogershospital.org


Medical Director, Herrington Recovery Center (HRC)
Rogers Memorial Hospital
Oconomowoc, Wisconsin

Associate Clinical Professor
University of Wisconsin School of Medicine and Public Health
Associate Clinical Professor
Medical College of Wisconsin, Dept of Psychiatry & Behavioral Health
Past President and Board Chair
Wisconsin and American Societies of Addiction Medicine
At-Large Director
American Board of Addiction Medicine
Rogers treats children, adolescents
and adults with:
• Anxiety disorders
• Mood disorders
• Eating disorders
• Substance-use disorders



                       800-767-4411
                     rogershospital.org
Psychiatry (MD, DO)

(General, Adult, Child/Adolescent, Geriatric, Forensic, Addictio
n)

A medical specialty of physicians devoted to the diagnosis
and treatment of mental disorders, using
psychotherapy, medications, and other somatic therapies
Clinical Psychology (PhD, PsyD)

A mental health discipline in which individuals with a doctoral
degree in psychology from an accredited professional school
of psychology (the scientific study of the behavior of
individuals and their mental processes) evaluate and treat
children, adolescents, and adults using clinical
interviews, psychological testing, and various
individual, group, couples and family therapies.
Addiction Medicine:

The specialty of medicine devoted to
diagnosis, treatment, prevention, education, epidemiology, res
earch, and public policy advocacy regarding addiction and
other substance-related health conditions
How to Identify a Physician Recognized for
Expertise in the Diagnosis and Treatment of
Addiction and Substance-related Health
Conditions (ASAM Public Policy Statement)
www.asam.org/HowToIdentifyaPhysicianRecognizedforExpertness.html
www.asam.org/HowToIdentifyaPhysicianRecognized
forExpertness.html

• Completion of a residency/fellowship in Addiction
  Medicine or Addiction Psychiatry
• Certification in Addiction Medicine by the American Society
  of Addiction Medicine (ASAM)
• Subspecialty certification in Addiction Psychiatry by the
  American Board of Psychiatry and Neurology (ABPN)
• A Certificate of Added Qualification in Addiction Medicine
  conferred by the American Osteopathic Association (AOA)
• Board Certification in Addiction Medicine by the
  American Board of Addiction Medicine (ABAM)
Scope of Practice for Addiction Medicine
Physicians (ABAM)
The addiction medicine physician provides medical care within
the bio-psycho-social framework for persons with addiction,
for the individual with substance-related health conditions,
for persons who manifest unhealthy substance use, and for
family members whose health and functioning are affected by
someone‘s substance use or addiction.
Scope of Practice for Addiction Medicine
Physicians (ABAM)
The addiction medicine physician is specifically trained in a
wide range of prevention, evaluation and treatment modalities
addressing substance use and addiction in ambulatory care
settings, acute care and long-term care facilities, psychiatric
settings, and residential facilities.

Addiction medicine specialists often offer treatment for
patients with addiction or unhealthy substance use who have
co-occurring general medical and psychiatric conditions.
Prelude

• Pain and addiction are both commonly experienced
  conditions.
• General medical physicians, e.g. those in primary care or in
  emergency department settings, are called upon to treat
  patients with pain complaints and/or with substance use
  disorders—but they have had inadequate training in
  medical school and residency to address these
  presentations.
Prelude

• There was great concern in the 1990s that physicians were
  overly/unnecessarily hesitant to prescribe opioid
  analgesics, even to patients with cancer, even to patients
  who were terminal.
• A response was a public policy initiative to work with
  professional societies, licensure boards, and accreditation
  agencies to promote ‗balance‘ in opioid prescribing.
Prelude

• A result was a major increase in recognition of pain as a
  focus of clinical care, but also a major increase in the
  number of opioid prescriptions written
• Pain Medicine has expanded as a medical specialty, but
  specialists/subspecialists are unable to meet the demand
  for care—thus, patients on chronic opioid analgesic therapy
  present to emergency departments and 1° care, presenting
  new kinds of challenges
Prelude

• There has also been an increase in recognition of
  substance use issues as a focus of clinical care
• Addiction Medicine has expanded as a medical
  specialty, but specialists/subspecialists are unable to meet
  the demand for care; there has been a push to train
  generalists to become prescribers of buprenorphine and
  naltrexone, and patients methadone, Suboxone®
  (buprenorphine) and Vivitrol® (naltrexone) present to
  emergency departments and primary care—presenting new
  kinds of challenges
Prelude

• Physicians who specialize in the treatment of pain and
  those who specialize in the treatment of addiction have
  been struck with how under-recognized these conditions
  have been in general medical settings – in response, there
  have been efforts to improve the recognition of these
  treatable states, so that suffering can be minimized and
  functioning enhanced, for individuals and for populations.
Inadequacy of docs to evaluate/
manage pain

• Too few specialists in Pain Med
• Inadequate training on basic concepts of management
• Many patients
• Docs flooded with ‗demand‘ and ‗entitlement mentality‘
Inadequacy of docs to evaluate/
manage addiction

• Too few specialists in Addiction Med
• Inadequate training on basic concepts of management
• Many patients – most unrecognized
• Docs flooded with ‗med-seeking patients‘ and patients with
  ‗dysfunctional behaviors‘
• Docs, like the public, often don‘t distinguish between
  addiction and ‗unauthorized substance use‘
Under-responding to pain…

• Comprehensive Cancer Center, UW-Madison
• Pain Policy Project – UW-Madison
• Survey of cancer patients, domestically and internationally
• Survey of State Medical Board practice
• Attention to ―opioiphobia‖ on the part of docs
• Education to docs re: pain and pain meds
• Policy changes at FSMB and JCAHO – a call for ―balance‖
Joint Commission Standard PC.01.02.07 ―The hospital
assesses and manages the patient's pain‖

Rationale for the Standard:
• Patients can expect that their health care providers will ask
  them about whether they have pain. When pain is identified
  the individual is assessed based on his or her clinical
  presentation and in accordance with the
  care, treatment, and services provided by the organization.
Joint Commission Pain Standard

Evidence of Performance:
1 The hospital conducts a comprehensive pain assessment that is
  consistent with its scope of care, treatment, and services and the
  patient‘s condition. (See also PC.01.02.01, EP 2; RI.01.01.01, EP 8)
2 The hospital uses methods to assess pain that are consistent with the
  patient‘s age, condition, and ability to understand.
3 The hospital reassesses and responds to the patient‘s pain, based on
  its reassessment criteria.
4 The hospital either treats the patient‘s pain or refers the patient for
  treatment.
There have been efforts
to improve the case-finding
by docs of cases of pain

     The Joint Commission Standard
       ―Pain as the 5th vital sign‖
PAIN ASSESSMENT: THE FIFTH VITAL SIGN
California Assembly Bill 791 was signed into law by Governor Gray
Davis, to be effective January 1, 2000.

Section 1254.7 was added to the Health and Safety Code (HSC) as part
of this bill. HSC 1254.7 reads:
(a) It is the intent of the Legislature that pain be assessed and treated
    promptly, effectively, and for as long as pain persists.
(b) Every health facility licensed pursuant to this chapter shall, as a
    condition of licensure, include pain as an item to be assessed at the
    same time as vital signs are taken. The health facility shall insure that
    pain assessment is performed in a consistent manner that is
    appropriate to the patient.
The pain assessment shall be noted in the patient‟s chart in a manner
consistent with other vital signs.
PAIN ASSESSMENT: THE FIFTH VITAL SIGN
California Assembly Bill 791 was signed into law by Governor Gray
Davis, to be effective January 1, 2000.

This legislative mandate is consistent with state and federal concerns regarding
appropriate pain management for all persons. The Veterans Administration has
adopted similar policies, referring to pain as the fifth vital sign.

In 1994, the BRN adopted a pain management policy for RN practice and pain
management curriculum guidelines for nursing programs. Both of these
documents include a standard of care for California RNs of assessing pain and
evaluating response to pain management interventions using a standard pain
management scale based on patient self-report. Nursing programs need to
integrate pain as the fifth vital sign into their curriculum and health facilities
need to educate staff regarding pain management. It is now required that all
health care staff record pain assessment each time that vital signs are recorded
for each patient.
Measuring Pain as the 5th Vital Sign Does
Not Improve Quality of Pain Management

• Mularski RA, White-Chu F,Overbay D, Miller, L, Asch
  SM, Ganzini L.
• Journal of General Internal Medicine 21(6): 607–612.
  (2006)
Over-responding to pain…

• Joint Commission standard: a ―right‖ to pain mgmt?
• Proliferation of interventional pain clinics
• Proliferation of opioid prescribing and ―pill mills‖
• Under-attention to non-interventional approaches, non-
  opioid pharmacotherapy, non-pharmacological therapy
• Expanding incidence of
  diversion, misuse, overdose, mortality, and cases of
  addiction
How did we get here?

• More prescribers
  – Explosion of prescribing by primary care
• More milligrams
  – Availability of new drug formulations: MS
    Contin, OxyContin, fentanyl in patch form
• More patients
  – Aging population: more aches/pains
  – Successful expansion of markets by direct-to-consumer
    advertising
Increasing Use of Prescribed Opioids




Manchikanti & Singh 2008
Slide thanks to Marv Seppala, MD, Hazelden Foundation
Retail Sales of Opioid Medications
  (grams of medication 1997-2005)


                                 1997                2005          % of Change
   Methadone                   518,737            5,362,815           933%
   Oxycodone                  4,449,562          30,628,973           588%
   Fentanyl Base                74,086             387,928            423%
   Hydromorphone               241,078             781,287            244%
   Hydrocodone                8,669,311          25,803,544           198%
   Morphine                   5,922,872          15,054,846           154%
   Meperidine                 5,765,954           4,272,520           -26%
   Codeine                   25,071,410          18,960,038           -24%

http:www.deadiversion.usdoj.gov/arcos/retail_drug_summary/index.html
Table thanks to Marv Seppala, MD, Hazelden Foundation
Annual Numbers of New Nonmedical Users of
Psychotherapeutics: 1965-2000




2001 National Household Survey on Drug Abuse
http://www.oas.samhsa.gov/NHSDA/2k1NHSDA/vol1/toc.htm#v1

Thanks to Marv Seppala, MD, Hazelden Foundation
Scope of the Problem
• Between 1992 and 2003:
  – U.S. population increase of 14%
  – No. people abusing controlled prescription drugs jumped 81%
      2x > than marijuana        5x > than cocaine    60x > than heroin
• Prescription pain medications (Opioids) are now the 4th most abused
  substances in the U.S.
  – Behind marijuana, alcohol, and tobacco
• Misuse of painkillers represents 3/4 of the overall problem of
  prescription drug abuse
• Prescription medications are now the leading cause of accidental
  death for ages 18-34
Drug Enforcement Administration www.justice.gov/dea

Thanks to Marv Seppala, MD, Hazelden Foundation
Persons Admitted for Addiction Treatment are
More Often Having Diagnoses of Opioid Use Disorder

• The proportion of all SUD treatment admissions where
  opioid analgesic abuse or dependence is
  mentioned, increased more than four-fold between 1998
  and 2008.
• The proportion of SUD treatment admissions for persons
  ages 12-24 where opioid analgesic abuse or dependence is
  mentioned, increased more than eight-fold between 1998
  and 2008.
Emergency Department Visits




 DAWN Data 1995 - 2005
Treatment Admissions for Pain Medications

• The proportion of all substance abuse treatment
  admissions (that reported any pain medication abuse)
  increased more than four-fold between 1998 and 2008.
• The increase in those age 12-24 increased approximately
  eight-fold.
―Non-Medical Use‖ of Prescription Opioids
• Where are these medications coming from?
  How many patients who had an overdose ever had a legitimate
  prescription for the medication they overdosed on?
• What do persons report is the source of the prescription opioids
  that they‘re using?
  – Their own doctor?
  – A family member who got it from their own doctor?
  – A friend who got it from their own doctor?
  – A dealer?
  – Multiple sources?
The ―One Doctor‖ Source for
Prescription Drugs
• According to NSDUH 2008 data, only 1 in 20 nonmedical
  users (4.3%) of prescription pain relievers got them from a
  drug dealer.
• In most cases, prescription drugs obtained for nonmedical
  purposes originated from a single doctor – rather than from
  multiple sources (the Rx could have been written for
  them, or could have been obtained from a different
  ―legitimate patient‖ of a single prescriber who authorized it
  in the course of routine medical/dental practice)
JAMA Article April 2011 plus editorial by
Volkow and McLellan
From 1991 to 2009, prescriptions for opioid analgesics
increased almost threefold, to over 200 million. According to
the Drug Abuse Warning Network system, which monitors
drug-related emergency department visits and drug-related
deaths, emergency room visits related to the nonmedical use
of pharmaceutical opioids has doubled between 2005 and
2009.
JAMA Article April 2011 plus editorial by
Volkow and McLellan
• The sample included 79.5 million prescriptions dispensed in
  the United States during 2009, which represent almost 40
  percent of all the opioid prescriptions filled nationwide.
• Most abusers report getting these medications from friends
  and relatives who had been prescribed opioids, or they are
  abusing their own medications.
• The records show that approximately 56 percent of
  painkiller prescriptions were given to patients who had filled
  another prescription for pain from the same or different
  providers within the past month.
JAMA Article April 2011 plus editorial by
Volkow and McLellan
• Nearly 46 percent of opioid prescriptions were given to
  patients between ages 40 and 59, and most of those
  were from primary care providers.
• Nearly 12 percent of opioids prescribed were to young
  people aged 10-29. Dentists were the main prescribers
  for youth aged 10-19 years old.
It‘s not just diversion and misuse
It‘s O.D.s and Overdose Deaths
Accidental Deaths Due to Prescribed Opioids

• Between 1999 and 2002:
   – The number of opioid analgesic poisonings on death
     certificates increased 91.2%
   – Heroin poisonings increased 12.4%
   – Cocaine poisonings increased 22.8%
• 2007: The second leading cause of injury/death (after motor vehicle
  accidents)
• 2009: The number of deaths secondary to prescription drugs was 4
  times the number due to illicit drugs.

Machikanti 2007 MMWR 7/8/11
Slide thanks to Marv Seppala, MD, Hazelden Foundation
Opioid Deaths are #1 Rx Drug Deaths
Prescription Opioid O.D. Deaths Outpace Heroin Deaths
The CDC used death certificates to determine that there were 45,000
traffic accident deaths in 2006 and about 39,000 drug-induced deaths—
pooled US data
Responding to the epidemic
• Return to restrictive prescribing practices and opiophobia
• Training of prescribers re: reasonable limits on numbers of
  doses/refills authorized
• Recognition of data on efficacy: what really is ‗best
  practice‘?
• Making medication formulations more safe
• Practices to better manage supplies in the community
  – Lock Your Meds, Take Back your meds, safe disposal of
    medication supplies
Responding to the epidemic

                   The White House Office of National
                       Drug Control Policy (ONDCP)


 ―EPIDEMIC: RESPONDING TO AMERICA‘S PRESCRIPTION
                DRUG ABUSE CRISIS‖

http://whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf
ONDCP Strategy on PDA

• Education: patients, parents, youth, and health care
  professionals
• Monitoring: Prescription Drug Monitoring Programs
  (PDMPs), multi-state data-sharing
• Rx Disposal
• Enforcement
Responding to the epidemic
• Controlled Substances Workgroup (CSW), Prevention
  Committee, Wisconsin State Council on Alcohol and Other Drug
  Abuse (SCAODA)
• California
  http://www.adp.ca.gov/Director/pdf/Prescription_Drug_Task_Force.pdf
• Ohio
  http://www.odh.ohio.gov/features/odhfeatures/drugod/drugoverdose.aspx
• Maryland
  http://www.oag.state.md.us/Reports/PrescriptionDrugAbuse.pdf
• Washington State
• Medical Society of Georgia Foundation
ONDCP Strategy on PDA:
Health Provider Education
• Work with Congress to amend Federal law to require practitioners
  (such as physicians, dentists, and others authorized to prescribe)
  who request DEA registration to prescribe controlled substances to
  be trained on responsible opioid prescribing practices as a
  precondition of registration. This training would include assessing
  and addressing signs of abuse and/or dependence.
  (ONDCP/FDA/DEA/SAMHSA)

• Require drug manufacturers, through the Opioid Risk Evaluation and
  Mitigation Strategy (REMS), to develop effective educational
  materials and initiatives to train practitioners on the appropriate use
  of opioid pain relievers. (FDA/ONDCP/SAMHSA)
ONDCP Strategy on PDA:
Health Provider Education
• Federal agencies that support their own healthcare systems will
  increase continuing education for their practitioners and other
  healthcare providers on proper prescribing and disposal of
  prescription drugs. (VA/HHS/IHS/DOD/BOP)

• Work with appropriate medical and healthcare boards to
  encourage them to require education curricula in health
  professional schools (medical, nursing, pharmacy, and dental)
  and continuing education programs to include instruction on the
  safe and appropriate use of opioids to treat pain while
  minimizing the risk of addiction and substance abuse
Prescription Drug Monitoring Programs
(PDMP)
• The National All Schedules Prescription Electronic Reporting
  (NASPER) Act, was signed into law on August 11, 2005
   – Authorized $60 million to establish or improve state-run
     Prescription Drug Monitoring Programs (PDMP) which analyze
     prescription data
   – The Department of Justice and SAMHSA continue to fund grants
• PDMP can identify individuals, physicians, or pharmacies that have
  unusual patterns suggesting drug diversion, abuse, or doctor
  shopping
Prescription Drug Monitoring Programs
(PDMPs)

• The National All Schedules Prescription Electronic Reporting
  (NASPER) Act, was signed into law on August 11, 2005
   – Authorized $60 million to establish or improve state-run
     Prescription Drug Monitoring Programs (PDMP) which analyze
     prescription data
   – The Department of Justice and SAMHSA continue to fund grants
• PDMP can identify individuals, physicians, or pharmacies that have
  unusual patterns suggesting drug diversion, abuse, or doctor
  shopping
Responding to the epidemic
PDMPs
1. What is a prescription drug monitoring program (PDMP)?
   According to the National Alliance for Model State Drug Laws
   (NAMSDL), a PDMP is a statewide electronic database which collects
   designated data on substances dispensed in the state. The PDMP is
   housed by a specified statewide regulatory, administrative or law
   enforcement agency. The housing agency distributes data from the
   database to individuals who are authorized under state law to receive the
   information for purposes of their profession.

2. Does the Drug Enforcement Administration (DEA) oversee PDMPs?
   The DEA is not involved with the administration of any state PDMP.

 Q&A on webpage of DEA‘s Office of Diversion Control
 http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm
Responding to the epidemic
PDMPs
3. What are the benefits of having a PDMP?
   The overview provided by NAMSDL clearly identifies the benefits of a
   PDMP: as a tool used by states to address prescription drug
   abuse, addiction and diversion, it may serve several purposes such as:
   – 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 prescription 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 prescription drugs.
Responding to the epidemic
PDMPs
4. Which states currently have a PDMP?
   According to the Alliance of States with Prescription Monitoring
   Programs, (www.pmpalliance.org) as of October 16, 2011, 37 states have
   operational PDMPs that have the capacity to receive and distribute
   controlled substance prescription information to authorized users. Eleven
   states) and one U.S. territory (Guam), have enacted legislation to establish
   a PDMP, but are not fully operational.
PDMPs

• In 1992 only 10 states had a PDMP
  – In 1998, California created its Controlled Substance Utilization
    Review and Evaluation System (CURES). 7500 pharmacies and
    158,000 prescribers report information and can review patient
    medications.
• Now 43 states have operational PDMPs in place
• Only 3 states – Kentucky, Nevada & Utah – routinely
  provide their information proactively to physicians
• Rarely is data from Methadone Clinics (Opioid Treatment
  Programs, OTPs) included in a state‘s PDMP database!
ONDCP Strategy on PDA:
Proper Drug Disposal
• While the administrative process to establish the DEA medication disposal
  rule is underway,19 DEA and other Federal agencies shall conduct
  additional take-back activities. Information about the take-back events shall
  be distributed to local anti-drug coalitions and other organizations (chain
  pharmacies, boards of pharmacies, boards of medicine, environmental
  agencies, etc). (DEA/ONDCP)
• Once DEA regulations on controlled substance prescription drug disposal
  have been established, develop and execute a robust public education
  initiative to increase public awareness and provide education on new
  methods of safe and effective drug return and disposal. (ONDCP/
  EPA/DEA/FDA/CDC/HHS/SAMHSA/NIDA)
• Once DEA regulations have been established, engage PhRMA and others
  in the private sector to support community-based medication disposal
  programs. (ONDCP/FDA/DEA/HHS/CDC/ SAMHSA/EPA)
Responding to the epidemic
Public Eduation


Partnership for a Drug Free America
  www.drugfree.org


Preventing Teen Abuse of Prescription Drugs
• FACT SHEET
Wisconsin State Council on AODA


SCAODA Prevention Committee
Controlled Substances Workgroup (CSW)
http://scaoda.state.wi.us/docs/prevandspfsig/FINAL01032012
   CSWReport.pdf
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Fostering Healthy Youth
• Recommendation 1: Support communities to foster healthy
  youth.


Priority Area: Community Engagement & Education
• Recommendation 2: Launch a public outreach and education
  campaign.
• Recommendation 3: Support community coalitions as the vehicle
  through which communities will successfully prevent and reduce
  prescription drug diversion, abuse and overdose deaths.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Health Care Policy and Practice
• Recommendation 4: Mandate education and training health care
   professionals.
• Recommendation 5: Ensure that chronic pain sufferers have safe and
   consistent access to care.
• Recommendation 6: Establish standard prescribing practices for urgent
   care and emergency departments.
• Recommendation 7: Develop standard screening methodologies for
   drug-testing labs to use in detecting the presence of drugs to include all
   commonly misused opioids, benzodiazepines, psychostimulants, and
   related agents, and assure that drug-testing methodologies used in
   clinical settings and in post-mortem settings (including the State Crime
   Lab system) are aligned in order to generate the most consistent and
   useful data.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Health Care Policy and Practice
• Recommendation 8: Develop a standard set of treatment protocols
  for Opioid Treatment Programs (OTPs).
• Recommendation 9: Establish guidelines to reduce the diversion of
  prescription drugs by those who handle prescription medications in
  the course of their daily work.
• Recommendation 10: Equip health care providers and first
  responders to recognize and manage overdoses.
• Recommendation 11: The Wisconsin Dental Association and
  Wisconsin Dental Examining Board should endorse the findings of
  the Tufts Health Care Institute Program on Opioid Risk Management
  and the School of Dental Medicine, Tufts University.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Prescription Medication Distribution
• Recommendation 12: Convene a work group to develop
  recommendations to increase security measures in the dispensing of
  prescriptions for controlled substances.
• Recommendation 13: Implement a system to ensure that, for
  controlled substance prescriptions, patients are identified in a
  manner similar to photo identification as required to obtain
  pseudoephedrine.
• Recommendation 14: Support a system that increases security and
  traceability of controlled substances from manufacturer to patient.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Prescription Medication Disposal
• Recommendation 15: Establish a coordinated statewide system for
  providing secure, convenient disposal of consumer medications from
  households.
• Recommendation 16: Integrate medication collection with the
  Wisconsin Drug Repository.
• Recommendation 17: Create an infrastructure for the destruction of
  drugs in compliance with state and federal environmental regulations.
• Recommendation 18: Identify the causes for prescription drug waste
  and implement proactive solutions.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Prescription Medication Disposal
• Recommendation 19: Identify a sustainable means for funding
  collection and disposal in cooperation with key stakeholders including
  pharmaceutical producers, local governments, law enforcement,
  waste management companies, health care providers, pharmacies
  and consumers.
• Recommendation 20: Establish a system for effective disposal of
  consumer medications in all care programs and facilities which
  complies with state and federal waste management laws.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Prescription Medication Disposal
• Recommendation 21: Establish regulations that would permit
  registered nurses employed by home health agencies and
  hospices to transport unused medications, including controlled
  substances, to designated drug drop-off and disposal facilities, so
  that when patient medications are no longer needed, such nurses
  are allowed by law to assist in their safe destruction.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Law Enforcement and Criminal Justice
• Recommendation 22: Build bridges between law enforcement and
  community-based prevention efforts.
• Recommendation 23: Make drugged driving a priority issue.
• Recommendation 24: Support drug courts.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Surveillance System
• Recommendation 25: Design and implement an electronic
  Prescription Drug Monitoring Program (PDMP).
• Recommendation 26: Develop a community early warning and
  monitoring system that tracks use and problem indicators at the local
  level.
• Recommendation 27: Develop a community monitoring and early
  warning and monitoring system that tracks overdoses at the local
  level.
• Recommendation 28: Improve consistency in reporting drug use and
  abuse across the state.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Early Intervention, Treatment & Recovery
Across Lifespan
• Recommendation 29: Establish guidelines to screen for
  substance use in all health care settings.
• Recommendation 30: Promote and support evidence-based
  screening and early intervention for mental health and substance
  abuse.
Responding to the epidemic: Wisconsin State Council
Controlled Substances Workgroup Recommendations

Priority Area: Early Intervention, Treatment & Recovery
Across Lifespan
• Recommendation 31: Integrate high quality medication
  management and psychosocial interventions for substance use
  disorders so that both are available to consumers as their
  conditions indicate.
• Recommendation 32: Make addiction treatment and recovery
  support services available both on a stand-alone and integrated
  basis with primary health care services, as well as in other
  relevant community settings.
STRETCH!
Responding to the epidemic

• Community Coalitions (CADCA, others)
• Education of Patients by Prescribers
• Education of Prescribers re: best practices
• Better Data
  – Mortality statistics
  – Accurate death certificates
  – Accurate toxicology at time of death; aligning drug testing
    procedures for the living and the dead
Responding to the epidemic

• Better disposal of unused supplies
  – If they‘re there, keep ‗em locked
  – If they‘re not needed, bring them to safe collection site
  – Change laws/procedures to allow for well-recognized legal
    collection sites
What about ―going upstream‖ from
treatment, to PREVENTION?

• Reducing availability of prescription drugs for diversion
  (and misuse, and overdose)?
• By educating physicians and dentists to prescribe less
  often, to authorize smaller supplies, to have fewer
  refills, and to monitor all patients on such medications?
• By educating parents as to their role in keeping drug
  supplies locked away and safe?
Responding to the epidemic
Prevention Strategies: “Lock Up Your Meds”
• ―You are the Key‖
• National Family Partnership: www.nfp.org

The responsible parties are:
  • PARENTS and GRANDPARENTS
  • PHYSICIANS who can educate parents about their role
www.nfp.org
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• Logos
• Leave Behind Card
• Sponsor solicitation slides
• Parent Guide Brochure
http://mccrearyrecord.com/x316477008/
Are-you-an-Accidental-Dealer
Are you an ‗Accidental Dealer‘?
• Operation UNITE launches prescription awareness
  campaign
• By JANIE SLAVEN News Editor The McCreary County Record
  Tuesday January 25, 2011, 01:05 PM EST
• WHITLEY CITY — A University of Kentucky study has shown
  rural teenagers in Kentucky are 26 percent more likely to abuse
  prescription drugs than those living in urban areas.
The CDC is Paying Attention
Data from the National Vital Statistics System Mortality File:
• From 1999 through 2006, the number of fatal poisonings
  involving opioid analgesics more than tripled from 4,000 to
  13,800 deaths.
• Opioid analgesics were involved in almost 40% of all poisoning
  deaths in 2006. .
• In about one-half of the deaths involving opioid
  analgesics, more than one type of drug was specified as
  contributing to the death, with benzodiazepines specified with
  opioid analgesics most frequently.
• In 15 states, opioid deaths exceed highway traffic deaths
New Policy Initiative: Washington State
• Interagency Guideline on Opioid Dosing for Chronic Non-
  Cancer Pain
• The Washington State Medical Quality Assurance
  Commission (MQAC)
• http://www.wsma.org/medical_professionalism/clinicalresou
  rces.cfm#painPain_Management_Guidelines
• Effective 7.1.11 for DOs, DPMs, DDSs, nurses and
  osteopathic PAs
• Effective 1.2.12 for MDs and their PAs
Responding to the epidemic
―Washington State Guidelines‖
• Requirements re: patient evaluation and periodic review
• Requirements re: signed informed consent, written
  treatment plans, and written ―treatment agreements‖
• Mandatory consultation for any patient that is receiving >
  120 mg morphine equivalent dose (MED), with certain
  exemptions
Equivalent Dose (mg) Chart
Doses equal to    Dose (mg) per 24 hr
Morph 10mg IM     IV/IM                 PO/PR

Codeine           130                   200
Fentanyl          0.1                   N/A
Fentanyl Patch*   (mcg/hr*) =           *16.7
Hydrocodone       N/A                   30
Hydromorphone     1.5                   7.5
Levophanol        2                     4
Meperidine        75                    300
Methadone         10                    20
Morphine          10                    20
Nalbuphine        10                    N/A
Oxycodone         N/A                   30
Pentazocine       60                    180
Propoxyphene      N/A                   130
Sufentanil        0.01-0.02             N/A
Tramadol          N/A                   (?) 150
Summary: the POLICY side

• States and their Medical Licensing Boards are involved, as
  well as the FSMB
• The CDC is involved
• The federal treatment agencies are involved
  (SAMHSA/CSAT)
• The federal research agencies are involved (NIDA)
• The federal policy agencies are involved
  (the White House ―Drug Czar‘s Office‖)
Responding to the epidemic
CDC



http://www.cdc.gov/media/pressrel/2010/s100603.htm?s_cid=media
   rel_s100603
• CDC Statement Regarding the Misuse of Prescription Drugs
   (Press Release, June 3, 2010)
• November 2011
   http://www.cdc.gov/vitalsigns/PainkillerOverdoses/
   Prescription Painkiller Overdoses in the US
CDC Vital Signs, November 2011
Related Pages
• Vital Signs: Overdoses of Prescription Opioid Pain Relievers–United States, 1999–
  2008 (link to come): Morbidity and Mortality Weekly Report (MMWR)
• CDC Feature- Prescription Painkiller Overdoses in the U.S.
• Prescription Painkiller Overdoses in the U.S. – What You Need to Know
  [PODCAST - 1:15 minutes]
• Sobredosis de medicamentos recetados para el dolor en los EE. UU.: Lo que usted
  necesita saber [PODCAST - 1:39 minutes]
• Prescription Painkiller Overdoses in the U.S. – What You Need to Know [PSA - 0:60
  seconds]
• Policy Impact: Prescription Painkiller Overdoses
• Unintentional Poisoning
• Home and Recreational Safety
CDC Vital Signs, November 2011
Related Pages: On Other Web Sites
• The White House - Office of National Drug Control Policy
• SAMSHA – Substance Abuse and Mental Health Services
  Administration
• Drug Enforcement Administration – Office of Diversion Control
• National Institute on Drug Abuse – Prescription Medications
• U.S. Food and Drug Administration - Drugs Information
• MedlinePlus - Pain Relievers
• MedlinePlus - Prescription Drug Abuse
The Interface of Policy and Practice
• If not enough pain is recognized, and not enough pain is
  treated, is that an ―imbalance‖?
• If regulators/criminal justice are trying to control supplies
  and penalize physicians, is that ―imbalance‖?
• If not enough addiction is recognized, if he addictive
  potential of prescription drugs is under-appreciated, is that
  ―imbalance‖?
What can we do in the meantime?
• There are patients with pain
• There are patients who engage in ―non-medical use‖ of
  pain meds
• There are patients who develop addiction


What can happen in the clinical world to restore balance …
and so that we won‟t have “more pain patients” becoming
translated into “more addiction patients” and “more coroners‟
cases”?
So, what would ―real balance‖
 in clinical care look like?

• Clear understanding of pain
• Clear understanding of addiction and the range of substance
  use conditions
• Balance in prescribing practices--no one is
  stigmatized, excluded, under-treated
• Improved pharmacotherapy of pain and pharmacotherapy of
  addiction
So, what would ―real balance‖
in clinical care look like?

• Clear understanding of pain
• Clear understanding of addiction and the range us
  substance use conditions
• Balance in prescribing practices
• Improved pharmacotherapy of pain and pharmacotherapy
  of addiction
Pain: Clinical Definition


―Whatever the patient states it is unless proven
otherwise by poor adherence to the agreed
upon medical regimen.‖

     – Fishman, et al, Journal of Pain and Symptom
       Management, Vol. 20 (2000)
Acute Pain vs. Chronic Pain
• Acute Pain
  – Sudden onset, usually sharp in quality
  – Serves as a warning of disease or a threat to the body
  – Multiple causes: Broken bones, cuts, burns, surgery, infection…
• Chronic Pain
  – Persists, lasting longer than 3-6 months
  – Serves no useful purpose; may continue after healing of an injury
  – Assumes control of the individual

(Slide thanks to Marv Seppala, MD, Hazelden Foundation)
Chronic Pain Syndrome

• Intractable pain of more than 6 months duration
• Marked alteration in behavior, restriction in daily activities
• Excessive use of medication and medical services
• No clear relationship to organic disorder - multiple
  nonproductive tests/treatments/surgeries


Office of Disabilities, Social Security Administration
Chronic Pain by the Numbers

• 116 million people in the U.S. suffer from chronic pain
• Low back pain is the most common type, affecting 28% of
  the population
• Knee pain is second at 20% of the population



IOM Report
Relieving Pain in America
Characteristics of Patients
Referred to Pain Management
(or is this a list of characteristics of patients referred for
Addiction Management?)
• Report high level of psychological distress
• Display high levels of psychopathology
• Report high levels of functional impairment
• Have work / M.V.A. related injuries
• Frequent use of health care system
• Complain of constant pain
• Have had prior surgery (ies) for pain
• Are using narcotic medications
Chronic Pain Syndrome:
Common Presentation
• Mood disturbance
  (irritable, depressed, anxious, angry)
• Sleep disturbance
• Physical deconditioning
• Work, vocational, financial, legal issues
• Weight changes
• Psychiatric illness
• Alcohol or other drug misuse/addiction
Slide: courtesy of Marv Seppala, MD, Hazelden Foundation
Pain Complaints

• The pain is an appropriate/legitimate response to
  injury/illness/pathophysiology.
• The complaint has a legitimate/organic bases but is an
  amplification of appropriate/legitimate distress.
• The complaint represents a psychiatric disorder rather than
  somatic injury/illness
• The complaint is a manifestation of an addictive disorder.
Psychiatric States in which Pain Complaints
can be Manifest
• Major depression with somatization
• Major depression with psychosis
• Conversion disorder
• Psychogenic pain disorder
• Somatization disorder
• Anxiety disorder
• Borderline personality, histrionic personality, narcissistic
  personality, antisocial personality
• Munchausen‘s syndrome (factitious disorder)
Manifestation of an addictive disorder
• Addiction—out-of-control use; deterioration of functioning
  over time; continued substance use despite adverse
  consequences; the substance becomes the central
  reinforcer in the person‘s life; use in order to experience
  euphoria or too feel ―normal‖
• Often diagnosed longitudinally in the pain patient (the more
  meds you give, the worse the patient looks and gets, cf.
  pain disorder where the more meds you give, the better the
  patient functions (ideally)
• Withdrawal—often seen in addiction, but sometimes
  present without addiction; ‗normal‘ physiological process
Is it Addiction or Pseudoaddiction?

• Pseudoaddiction: a syndrome of maladaptive behavior
  indicating not true addiction, but at attempt on the part of
  the patient to obtain relief of under-treated pain
• Preoccupation, seeking supplies, phone calls between
  refills, ER visits, and even doctor-shopping and securing
  illicit supplies, can indicate pseudoaddiction
Is it Addiction or Pseudoaddiction?

• Addiction: taking more meds leads to decrease in
  function
• Pseudoaddiction: taking adequate dose of opioids
  improves function and ends pattern of maladaptive
  behaviors

REMEMBER: it’s not the medication that’s pathological;
opioids are not intrinsically evil!
Addiction vs. Pseudoaddiction

• Addiction is diagnosed prospectively: Aberrant behavior
  worsens despite the best attempts at a rational treatment
  plan by the physician

• Pseudoaddiction is diagnosed retrospectively: Aberrant
  behavior normalizes with a rational treatment plan.
Pathological Pattern of Use =
Misuse, Non-Medical Use
• Stealing scripts, forging scripts, altering scripts, calling in
  scripts
• Using via alternate route of administration
• Using for an indication other than the intended, e.g., for
  relief of depression/ anxiety/insomnia/‘stress‘ vs. pain
• Amplifying or fabricating symptoms in order to obtain
  additional supplies
Medication Seeking

• Conscious manipulation of healthcare professional
  – For others
  – For sale
  – For self - cases of opioid addiction
• Seeking supplies for ―relief use‖
  ― Treatment of anxiety
  ― Treatment of depression
  ― Treatment of withdrawal
Medication Seeking

• Seeking supplies for treatment of general medical condition
  not actually present
  – Somatization disorder
  – Psychogenic pain disorder
• Pseudo addiction – seeking medication because of under
  treatment of legitimate injury/illness
Aberrant Drug-Related Behaviors
More Predictive                               Less Predictive
• Selling Prescription Drugs                  • Aggressive complaining about the
• Prescription forgery                          need for higher doses
• Stealing or ―borrowing‖ drugs from          • Drug hoarding during periods of
  another patient                               reduced symptoms
• Injecting oral formulations                 • Requesting specific drugs
• Obtaining prescription drugs from non-      • Prescriptions from other physicians
  medical sources                             • Unsanctioned dose escalation
• Concurrent abuse of related illicit drugs   • Unapproved use of a drug
• Multiple, unsanctioned dose                 • Reporting psychic effects not intended
  escalations                                   by the physician
• Repeated episodes of lost
  prescriptions                                  Portenoy 1996
Assessing Aberrant Behavior
What does it mean?
• Aberrant behavior may mean out of control use of a drug,
  which is a symptom of addiction
• Aberrant behavior may suggest inadequate pain
  management
• ―Aberrant Behavior‖ by a pain patient is not, in and of itself,
  not diagnostic; it must be interpreted and addressed in the
  clinical context
True ―Medication Seeking‖
• Patient demands one agent only, claims nothing else
  works.
• Patient is impatient and speaks only of meds—not of non-
  medication approaches, not even of his/her symptoms
• Patient returns again and again seeking early supplies, with
  odd stories (lost/missing).
• Patient requests more of the agent even when manifesting
  impairment from use (sedated, ataxic, incoherent).
Danger Signs of Abuse / Addiction
Ask: ―Have you ever….‖
• Had a problem with prescription drug use?
• Been treated for addiction to prescription drugs?
• Taken __ in doses greater than your doctor ordered?
• Taken __ in a way [route of admin.] different than Rx‘d?
• Taken any __ even if it was [impairing your function]?
• Taken __ for a reason other than what the medicine was
  intended for, e.g., a pain med for anxiety/sleep?
• Gotten a ‗high‘ from taking __, and then taken it in order to get
  that high? [can be energy boost not just euphoria]
Danger Signs of Abuse / Addiction
Ask: ―Have you ever….‖
• Used some __ from a friend/family member‘s supplies?
• Obtained __ from more than one doctor at once, without the
  other doctor‘s knowledge/permission?
• Made up a symptom in order to get a prescription?
• Over-stated a symptom in order to get a prescription?
• Bought any supplies from a non-medical source?
• Taken any __ from someone‘s medicine cab./ purse?
• Altered a prescription? Forged /called in a Rx?
• Stolen any __? Stolen a prescription pad?
―Red Flags‖ to look for

Check the patient‘s chronic pain management history for
these ―Red Flags‖ that might point to potential problems:
• Excessive use of medications
• Lack of progress in physical therapy
• Diagnosis of addictive illness including nicotine
• Prior injuries/chronic pain condition
• Failure to follow up on or irregular attendance with
  providers for therapy or medical appointments
There are various types of pain,
and various terms to describe them
• Somatic or visceral pain
  – Eudynia
• Neuropathic pain
  – Maldynia
• Acute pain and chronic pain
  – Acute injury/inflammation
  – Pain associated with terminal conditions
  – Chronic non-cancer pain
There are various types of pain,
and various terms to describe them
• Psychological pain
• Physical pain
• Nociceptive pain
• Other pathological pain states
  – Hyperalgesia
  – Allodynia
  – Phantom-limb pain
How to approach

• Somatic/visceral/nociceptive pain:
  – Responds well to opioids, NSAIDS, ASA/Tylenol, and probably
    sedatives
• Neuropathic pain:
  – Responds poorly to opioids, well to tricyclics, anticonvulsants
    (gabapentin, carbamazepine), Lyrica, Cymbalta
• Depression with physical symptoms:
  – Responds well to SSRIs, TCADs, anticonvulsants, and somewhat
    to anxiolytics
How to approach

• Hyperalgesia responds well to reducing opioids
• Psychogenic pain/somatoform disorders require
  psychotherapy and a long-term relationship; they do not
  respond well to opioids or other general pharmaco-
  therapies, and patients are at risk as well for overuse of
  benzo‘s
• Patients with borderline personality, histrionic personality
  may have somatic pain
So, what would ―real balance‖
in clinical care look like?
• Clear understanding of pain

• Clear understanding of addiction and the
  range us substance use conditions
• Balance in prescribing practices
• Improved pharmacotherapy of pain and pharmacotherapy
  of addiction
Range of Conditions
                      Or, looked at another way:
•   Use               • Use
•   Misuse
•   Risky Use         • Unhealthy Use
•   Problem Use        –   ‗heavy drinking‘
                       –   ‗non-medical use‘
•   ‗Abuse‘
                       –   ‗use despite consequences‘
•   Addiction
                       –   ‗binge drinking‘
•   Disability         –   ‗harmful use‘ (IVDU)
•   Death
                      • Addictive Use
Addiction is only one of the
Substance-Related Disorders
• Addiction (DSM-IV Substance Dependence)
• Problem Use (DSM-IV Substance Abuse)
• Intoxication States
• Withdrawal States
• Substance-Induced Medical Problems
• Substance-Induced Psychiatric Problems
• Health Problems linked to Secondary Use
Terminology is complicated
and not consistent
Addiction vs. dependence

Addiction vs. pseudoaddiction

Dependence vs. abuse

Physical vs. psychological
―Physical Dependence‖ =
Tolerance and Withdrawal
Repeated administration of opioids that activate the mu
receptor results in dose-dependent physical dependence and
opioid tolerance
Physical dependence and tolerance manifest as characteristic
withdrawal signs and symptoms (the opioid withdrawal
syndrome) upon (1) reduction or cessation of opioid
use/administration or (2) the administration of an antagonist or
a partial agonist in a person with established tolerance
What is Addiction?
• Substance use (= reward, relief, from alcohol/drugs/behaviors)
• Use behaviors and procurement behaviors persist despite problems
  due to use
• Return to use after periods of abstinence, despite previous problems
• Inability to consistently control use
• Preoccupation with use/procurement; salience of use-related
  behaviors
• Cognitive changes (over-valuation, de-valuation, minimization/denial)
• Enhanced cue responsiveness via conditioning and generalization
The Definition of Addiction
(ASAM, AAPM, APS – 2001)

• Addiction: a primary, chronic, neurobiological disease, with
  genetic, psychosocial, and environmental factors influencing its
  development and manifestations. It is characterized by
  behaviors that include one or more of the following: impaired
  control over drug use, compulsive use, continued use despite
  harm, and craving.

• Physical Dependence: a state of adaptation that is manifested
  by a drug class specific withdrawal syndrome that can be
  produced by abrupt cessation, rapid dose reduction, decreasing
  blood level of the drug, and/or administration of an antagonist.
Addiction

Its onset and progression (genesis and pathogensis)
result from genetic, psychosocial, and environmental/
cultural influences
Addiction

New Definition from
American Society of Addiction Medicine


www.asam.org/DefinitionofAddiction-LongVersion.html
Addiction

Results from interactions among
• Agents
• Biology
• Context
             »Substances
             »Hosts
             »Environments
Opioids don‘t cause opioid addiction

Addiction arises due to interactions among agents
(e.g., opioids), vulnerable hosts (persons with increased
genetic risks or psychiatric comorbidities), and
environments (stresses, drug availability, cultural issues).
Prescription Opioid
Use/Misuse/Addiction
   Nathaniel Katz, MD,
   Tufts University School of Medicine
   Presentation at APA Meeting 2006
Katz‘s data
• 33-45% of persons with opioid use disorder report that their first
  supply was a prescription from a physician
• Rates of co-morbid SUD in chronic pain patients is 20-40%
• Most prescription opioid abusers obtain drugs from either their own
  prescriptions or from prescriptions written for family members of
  friends
• A significant minority of prescription opioid abusers were not at
  apparent high risk prior to first exposure
• Katz, in Clinical Journal of Pain 18:S76 2002: 21% of persons with
  no ‗aberrant behaviors‘ have a urine drug test positive.
Katz‘s data
We are lacking data so we can have a more intelligent discussion.
Data submitted for publication by Katz et al.:
• Opioids dispensed per year USA: 190 mil prescriptions, 9.5 billion
  doses
• Non medical users in last year (NSDUH) = 11 million people
• 430 million non-medical use days
• Minimum of 430 million abused doses (only 1/day)
• Ratio of Non-medical use days to Medical use days = 0.22.
Why a Person with Addiction Would Seek
Drugs for Their Own Use

• To produce euphoria

• To manage an acute opioid withdrawal syndrome

• To relieve post-acute opioid withdrawal symptoms
So, what would ―real balance‖
in clinical care look like?

• Clear understanding of pain
• Clear understanding of addiction and the range us
  substance use conditions

• Balance in prescribing practices
• Improved pharmacotherapy of pain and pharmacotherapy
  of addiction
Clinical Management:
So, how DO we prescribe ‗properly‘?
Management

• Treat acute pain as acute pain
• Give thoughtful consideration to the likelihood that a non-
  opioid (e.g., NSAID) may be effective
• If authorizing an opioid write for only a reasonable number
  of doses, and if you have no established relationship with
  the patient, no refills
Management

• If it‘s chronic pain, are you sure that opioids will make a
  long-term difference?
• Might we all change our thinking, and if we do use opioids
  when ‗chronic pain‘ is clearly the problem, might we
  envision only a short-term trial and make this clear to the
  patient?
• Place the prescribing of opioids into a context, including
  treatment agreements and monitoring
Management

• Is there a ―treatment agreement‖ or ―pain contract‖ in
  place?
  – Are you operating within the parameters of the treatment
    agreement?
  – Are you operating outside of the parameters of the treatment
    agreement?
• What is the patient ―being held to‖ and what is the
  prescriber ―being held to‖
Provider Obligations
• Keep clear records of # of pills authorized per office visit, number
  of refills, date that the authorization is expected to last until
• Monitor clinical progress: keep clear records of the patient‘s
  response to treatment
   – Symptom reduction
   – Functional impairment
• Utilize collaterals to validate patient self-reports
• Monitor adherence and non-adherence via drug testing
• If the patient violates the contract, do you do what the contract
  says you will do in response to that?
Management
• ‗Lost supplies‘
  – listen to story; your response is a judgment call
  – fill for 1-2 days only: get management back in the hands of the
    regular Rx-er
• ‗Violated contract / loss of provider‘
  – listen to story; your response is a judgment call
  – fill for 1-2 days only: get management back in the hands of the
    PCP
  – you don‘t have to given an opioid; you can respond to the
    patient‘s loss of regular / legitimate opioid supplies, and offer to
    manage any acute withdrawal
Management:
Tips for Prescribers

• Maybe the most therapeutic thing you
  can do is not to give an opioid
• RECALL: the WAY you do this is a key
• Be THERAPEUTIC: You are a
  Physician, not a prosecutor or jail deputy
  !
So, what would ―real balance‖
in clinical care look like?

• Clear understanding of pain
• Clear understanding of addiction and the range us
  substance use conditions
• Balance in prescribing practices

• Improved pharmacotherapy of pain
  and pharmacotherapy of addiction
Managing Acute Pain without Opioids


• NSAIDs
• Acetaminophen
• Flexeril / Skelaxin / Baclofen
• Think before prescribing Fiorinal
  – it‟s not a „pain medicine‟, it‟s a BARB
Managing Chronic Pain without Opioids


• TCAD‘s
• Cymbalta
• Lyrica
• Neurontin and other anticonvulsants
Managing Pain With Opioids

   Short-acting, adequate potency
   Long-acting (Levodromeran)
   Methadone for Pain
Methadone

• Excellent pain control, long acting
• Increasingly used because of low cost (Medicare Part D;
  any managed pharmacy benefit plan)
• Can be LETHAL
• Must ―start low, go slow‖
• Starting dose in methadone clinics / OTP‘s
• Starting dose in pain practice / primary care
Equivalent Dose (mg) Chart
Doses equal to    Dose (mg) per 24 hr
Morph 10mg IM     IV/IM                 PO/PR

Codeine           130                   200
Fentanyl          0.1                   N/A
Fentanyl Patch*   (mcg/hr*) =           *16.7
Hydrocodone       N/A                   30
Hydromorphone     1.5                   7.5
Levophanol        2                     4
Meperidine        75                    300
Methadone         10                    20
Morphine          10                    20
Nalbuphine        10                    N/A
Oxycodone         N/A                   30
Pentazocine       60                    180
Propoxyphene      N/A                   130
Sufentanil        0.01-0.02             N/A
Tramadol          N/A                   (?) 150
Managing Opioid Withdrawal without focusing
on managing pain

• Maybe the acute problem isn‘t the underlying pain
  condition, but the symptoms resulting from a cutting off of
  opioid analgesic supplies
• Traditional methods: clonidine and supplemental agents;
  Ultram® can be used but that is associated with drug-
  linking and diversion among addicts
Do treat acute pain

• Even if patient has history of addiction

• Even if patient is on methadone

• Even if patient is on Suboxone (this probably requires use
  of fentanyl)
  – But the first intervention should be to divide the dose of Suboxone
    or methadone

• Even if the patient is on naltrexone (Vivitrol)
Do your best to not use opioids to treat
‗psychic pain‘
• Is it really depression you‘re treating?

• Is it really anxiety you‘re treating?

• Is it really a somatoform disorder you‘re treating?
Buprenorphine

• OBOT—office based opioid treatment
• Special DEA registration of the provider
• Clinics are not regulated, prescribers are
• Sublingual tablets, but use of new ―film‖ can reduce
  diversion
Buprenorphine

• It IS AN OPIOID – it is a ―partial agonist‖ at the mu opioid
  receptor (the ―morphine‖ receptor)
• Thus, it can treat pain, in the absence of addiction
  – Buprenex
  – Butrans
  – Suboxone, Subutex
• While special DEA registration is required of the provider
  who prescribes for addiction, no special DEA registration is
  required when prescribing for pain management only
• It can treat pain and addiction in the patient who has both
Intrinsic Activity: Full Agonist (Morphine), Partial
Agonist (Buprenorphine), Antagonist (Naloxone)
                 100

                  90                            Full Agonist
                                                (Morphine)
                  80

                  70
Intrinsic Activity 60
                                                Partial Agonist
                  50                            (Buprenorphine)
                  40

                  30

                  20

                  10
                                         Antagonist (Naloxone)
                   0
                        -10   -9    -8     -7      -6      -5     -4

                              Log Dose of Opioid
Responding to the Epidemic

• Treat Opioid Addiction with Buprenorphine!
 Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone
 Treatment for Prescription Opioid Dependence
 A 2-Phase Randomized Controlled Trial
 Roger D. Weiss, MD; Jennifer Sharpe Potter, PhD; David A. Fiellin, MD; Marilyn Byrne, MSW; Hilary S.
 Connery, MD, PhD; William Dickinson, DO; John Gardin, PhD; Margaret L. Griffin, PhD; Marc N.
 Gourevitch, MD, MPH; Deborah L. Haller, PhD; Albert L. Hasson, MSW; Zhen Huang, MS; Petra
 Jacobs, MD; Andrzej S. Kosinski, PhD; Robert Lindblad, MD; Elinore F. McCance-Katz, MD; Scott E.
 Provost, MSW; Jeffrey Selzer, MD; Eugene C. Somoza, MD, PhD; Susan C. Sonne, PharmD; Walter
 Ling, MD

 Arch Gen Psychiatry. Published online November 7, 2011.
 doi:10.1001/archgenpsychiatry.2011.121
Now available in a sublingual film

• Generic buprenorphine is available, but not recommended
• Still, many hurdles to overcome re: stigma,
  misunderstandings, discrimination
• Limitations of access
  – ‗off formulary‘
  – ‗caps‘ on daily doses, monthly doses, duration of therapy, via
    Medicaid and private insurers/PRMs
Suboxone® Film (sub-lingual)
Pharmacotherapy Approaches to Opioid
Dependence
Agonist Maintenance Treatment
• Methadone (full agonist)
• Buprenorphine (partial agonist)


Antagonist Maintenance Treatment
• Naltrexone (oral = ReVia®)
• Naltrexone (long-acting injectable = Vivitrol®)
Herrington Recovery Center
Thank you!

             Michael M. Miller, MD, FASAM, FAPA
             Medical Director
             Herrington Recovery Center

             262-646-1056
             mmiller@rogershospital.org
Rogers treats children, adolescents
and adults with:
• Anxiety disorders
• Mood disorders
• Eating disorders
• Substance-use disorders



                       800-767-4411
                     rogershospital.org

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Prescription Drug Epidemic: Pills, Addictions, Deaths. What To Do About it

  • 1. The Prescription Drug Epidemic: Pills, Addictions, Deaths. What To Do About it? Michael M. Miller, MD, FASAM, FAPA 33rd Annual Behavioral Health & Addictive Disorders Conference U.S. Journal Training, Inc. February 14, 2012
  • 2. Michael M. Miller, MD, FASAM, FAPA mmiller@rogershospital.org Medical Director, Herrington Recovery Center (HRC) Rogers Memorial Hospital Oconomowoc, Wisconsin Associate Clinical Professor University of Wisconsin School of Medicine and Public Health Associate Clinical Professor Medical College of Wisconsin, Dept of Psychiatry & Behavioral Health Past President and Board Chair Wisconsin and American Societies of Addiction Medicine At-Large Director American Board of Addiction Medicine
  • 3. Rogers treats children, adolescents and adults with: • Anxiety disorders • Mood disorders • Eating disorders • Substance-use disorders 800-767-4411 rogershospital.org
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  • 5. Psychiatry (MD, DO) (General, Adult, Child/Adolescent, Geriatric, Forensic, Addictio n) A medical specialty of physicians devoted to the diagnosis and treatment of mental disorders, using psychotherapy, medications, and other somatic therapies
  • 6. Clinical Psychology (PhD, PsyD) A mental health discipline in which individuals with a doctoral degree in psychology from an accredited professional school of psychology (the scientific study of the behavior of individuals and their mental processes) evaluate and treat children, adolescents, and adults using clinical interviews, psychological testing, and various individual, group, couples and family therapies.
  • 7. Addiction Medicine: The specialty of medicine devoted to diagnosis, treatment, prevention, education, epidemiology, res earch, and public policy advocacy regarding addiction and other substance-related health conditions
  • 8. How to Identify a Physician Recognized for Expertise in the Diagnosis and Treatment of Addiction and Substance-related Health Conditions (ASAM Public Policy Statement) www.asam.org/HowToIdentifyaPhysicianRecognizedforExpertness.html
  • 9. www.asam.org/HowToIdentifyaPhysicianRecognized forExpertness.html • Completion of a residency/fellowship in Addiction Medicine or Addiction Psychiatry • Certification in Addiction Medicine by the American Society of Addiction Medicine (ASAM) • Subspecialty certification in Addiction Psychiatry by the American Board of Psychiatry and Neurology (ABPN) • A Certificate of Added Qualification in Addiction Medicine conferred by the American Osteopathic Association (AOA) • Board Certification in Addiction Medicine by the American Board of Addiction Medicine (ABAM)
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  • 11. Scope of Practice for Addiction Medicine Physicians (ABAM) The addiction medicine physician provides medical care within the bio-psycho-social framework for persons with addiction, for the individual with substance-related health conditions, for persons who manifest unhealthy substance use, and for family members whose health and functioning are affected by someone‘s substance use or addiction.
  • 12. Scope of Practice for Addiction Medicine Physicians (ABAM) The addiction medicine physician is specifically trained in a wide range of prevention, evaluation and treatment modalities addressing substance use and addiction in ambulatory care settings, acute care and long-term care facilities, psychiatric settings, and residential facilities. Addiction medicine specialists often offer treatment for patients with addiction or unhealthy substance use who have co-occurring general medical and psychiatric conditions.
  • 13. Prelude • Pain and addiction are both commonly experienced conditions. • General medical physicians, e.g. those in primary care or in emergency department settings, are called upon to treat patients with pain complaints and/or with substance use disorders—but they have had inadequate training in medical school and residency to address these presentations.
  • 14. Prelude • There was great concern in the 1990s that physicians were overly/unnecessarily hesitant to prescribe opioid analgesics, even to patients with cancer, even to patients who were terminal. • A response was a public policy initiative to work with professional societies, licensure boards, and accreditation agencies to promote ‗balance‘ in opioid prescribing.
  • 15. Prelude • A result was a major increase in recognition of pain as a focus of clinical care, but also a major increase in the number of opioid prescriptions written • Pain Medicine has expanded as a medical specialty, but specialists/subspecialists are unable to meet the demand for care—thus, patients on chronic opioid analgesic therapy present to emergency departments and 1° care, presenting new kinds of challenges
  • 16. Prelude • There has also been an increase in recognition of substance use issues as a focus of clinical care • Addiction Medicine has expanded as a medical specialty, but specialists/subspecialists are unable to meet the demand for care; there has been a push to train generalists to become prescribers of buprenorphine and naltrexone, and patients methadone, Suboxone® (buprenorphine) and Vivitrol® (naltrexone) present to emergency departments and primary care—presenting new kinds of challenges
  • 17. Prelude • Physicians who specialize in the treatment of pain and those who specialize in the treatment of addiction have been struck with how under-recognized these conditions have been in general medical settings – in response, there have been efforts to improve the recognition of these treatable states, so that suffering can be minimized and functioning enhanced, for individuals and for populations.
  • 18. Inadequacy of docs to evaluate/ manage pain • Too few specialists in Pain Med • Inadequate training on basic concepts of management • Many patients • Docs flooded with ‗demand‘ and ‗entitlement mentality‘
  • 19. Inadequacy of docs to evaluate/ manage addiction • Too few specialists in Addiction Med • Inadequate training on basic concepts of management • Many patients – most unrecognized • Docs flooded with ‗med-seeking patients‘ and patients with ‗dysfunctional behaviors‘ • Docs, like the public, often don‘t distinguish between addiction and ‗unauthorized substance use‘
  • 20. Under-responding to pain… • Comprehensive Cancer Center, UW-Madison • Pain Policy Project – UW-Madison • Survey of cancer patients, domestically and internationally • Survey of State Medical Board practice • Attention to ―opioiphobia‖ on the part of docs • Education to docs re: pain and pain meds • Policy changes at FSMB and JCAHO – a call for ―balance‖
  • 21. Joint Commission Standard PC.01.02.07 ―The hospital assesses and manages the patient's pain‖ Rationale for the Standard: • Patients can expect that their health care providers will ask them about whether they have pain. When pain is identified the individual is assessed based on his or her clinical presentation and in accordance with the care, treatment, and services provided by the organization.
  • 22. Joint Commission Pain Standard Evidence of Performance: 1 The hospital conducts a comprehensive pain assessment that is consistent with its scope of care, treatment, and services and the patient‘s condition. (See also PC.01.02.01, EP 2; RI.01.01.01, EP 8) 2 The hospital uses methods to assess pain that are consistent with the patient‘s age, condition, and ability to understand. 3 The hospital reassesses and responds to the patient‘s pain, based on its reassessment criteria. 4 The hospital either treats the patient‘s pain or refers the patient for treatment.
  • 23. There have been efforts to improve the case-finding by docs of cases of pain The Joint Commission Standard ―Pain as the 5th vital sign‖
  • 24. PAIN ASSESSMENT: THE FIFTH VITAL SIGN California Assembly Bill 791 was signed into law by Governor Gray Davis, to be effective January 1, 2000. Section 1254.7 was added to the Health and Safety Code (HSC) as part of this bill. HSC 1254.7 reads: (a) It is the intent of the Legislature that pain be assessed and treated promptly, effectively, and for as long as pain persists. (b) Every health facility licensed pursuant to this chapter shall, as a condition of licensure, include pain as an item to be assessed at the same time as vital signs are taken. The health facility shall insure that pain assessment is performed in a consistent manner that is appropriate to the patient. The pain assessment shall be noted in the patient‟s chart in a manner consistent with other vital signs.
  • 25. PAIN ASSESSMENT: THE FIFTH VITAL SIGN California Assembly Bill 791 was signed into law by Governor Gray Davis, to be effective January 1, 2000. This legislative mandate is consistent with state and federal concerns regarding appropriate pain management for all persons. The Veterans Administration has adopted similar policies, referring to pain as the fifth vital sign. In 1994, the BRN adopted a pain management policy for RN practice and pain management curriculum guidelines for nursing programs. Both of these documents include a standard of care for California RNs of assessing pain and evaluating response to pain management interventions using a standard pain management scale based on patient self-report. Nursing programs need to integrate pain as the fifth vital sign into their curriculum and health facilities need to educate staff regarding pain management. It is now required that all health care staff record pain assessment each time that vital signs are recorded for each patient.
  • 26. Measuring Pain as the 5th Vital Sign Does Not Improve Quality of Pain Management • Mularski RA, White-Chu F,Overbay D, Miller, L, Asch SM, Ganzini L. • Journal of General Internal Medicine 21(6): 607–612. (2006)
  • 27. Over-responding to pain… • Joint Commission standard: a ―right‖ to pain mgmt? • Proliferation of interventional pain clinics • Proliferation of opioid prescribing and ―pill mills‖ • Under-attention to non-interventional approaches, non- opioid pharmacotherapy, non-pharmacological therapy • Expanding incidence of diversion, misuse, overdose, mortality, and cases of addiction
  • 28. How did we get here? • More prescribers – Explosion of prescribing by primary care • More milligrams – Availability of new drug formulations: MS Contin, OxyContin, fentanyl in patch form • More patients – Aging population: more aches/pains – Successful expansion of markets by direct-to-consumer advertising
  • 29. Increasing Use of Prescribed Opioids Manchikanti & Singh 2008 Slide thanks to Marv Seppala, MD, Hazelden Foundation
  • 30. Retail Sales of Opioid Medications (grams of medication 1997-2005) 1997 2005 % of Change Methadone 518,737 5,362,815 933% Oxycodone 4,449,562 30,628,973 588% Fentanyl Base 74,086 387,928 423% Hydromorphone 241,078 781,287 244% Hydrocodone 8,669,311 25,803,544 198% Morphine 5,922,872 15,054,846 154% Meperidine 5,765,954 4,272,520 -26% Codeine 25,071,410 18,960,038 -24% http:www.deadiversion.usdoj.gov/arcos/retail_drug_summary/index.html Table thanks to Marv Seppala, MD, Hazelden Foundation
  • 31. Annual Numbers of New Nonmedical Users of Psychotherapeutics: 1965-2000 2001 National Household Survey on Drug Abuse http://www.oas.samhsa.gov/NHSDA/2k1NHSDA/vol1/toc.htm#v1 Thanks to Marv Seppala, MD, Hazelden Foundation
  • 32. Scope of the Problem • Between 1992 and 2003: – U.S. population increase of 14% – No. people abusing controlled prescription drugs jumped 81% 2x > than marijuana 5x > than cocaine 60x > than heroin • Prescription pain medications (Opioids) are now the 4th most abused substances in the U.S. – Behind marijuana, alcohol, and tobacco • Misuse of painkillers represents 3/4 of the overall problem of prescription drug abuse • Prescription medications are now the leading cause of accidental death for ages 18-34 Drug Enforcement Administration www.justice.gov/dea Thanks to Marv Seppala, MD, Hazelden Foundation
  • 33. Persons Admitted for Addiction Treatment are More Often Having Diagnoses of Opioid Use Disorder • The proportion of all SUD treatment admissions where opioid analgesic abuse or dependence is mentioned, increased more than four-fold between 1998 and 2008. • The proportion of SUD treatment admissions for persons ages 12-24 where opioid analgesic abuse or dependence is mentioned, increased more than eight-fold between 1998 and 2008.
  • 34. Emergency Department Visits DAWN Data 1995 - 2005
  • 35. Treatment Admissions for Pain Medications • The proportion of all substance abuse treatment admissions (that reported any pain medication abuse) increased more than four-fold between 1998 and 2008. • The increase in those age 12-24 increased approximately eight-fold.
  • 36. ―Non-Medical Use‖ of Prescription Opioids • Where are these medications coming from? How many patients who had an overdose ever had a legitimate prescription for the medication they overdosed on? • What do persons report is the source of the prescription opioids that they‘re using? – Their own doctor? – A family member who got it from their own doctor? – A friend who got it from their own doctor? – A dealer? – Multiple sources?
  • 37. The ―One Doctor‖ Source for Prescription Drugs • According to NSDUH 2008 data, only 1 in 20 nonmedical users (4.3%) of prescription pain relievers got them from a drug dealer. • In most cases, prescription drugs obtained for nonmedical purposes originated from a single doctor – rather than from multiple sources (the Rx could have been written for them, or could have been obtained from a different ―legitimate patient‖ of a single prescriber who authorized it in the course of routine medical/dental practice)
  • 38. JAMA Article April 2011 plus editorial by Volkow and McLellan From 1991 to 2009, prescriptions for opioid analgesics increased almost threefold, to over 200 million. According to the Drug Abuse Warning Network system, which monitors drug-related emergency department visits and drug-related deaths, emergency room visits related to the nonmedical use of pharmaceutical opioids has doubled between 2005 and 2009.
  • 39. JAMA Article April 2011 plus editorial by Volkow and McLellan • The sample included 79.5 million prescriptions dispensed in the United States during 2009, which represent almost 40 percent of all the opioid prescriptions filled nationwide. • Most abusers report getting these medications from friends and relatives who had been prescribed opioids, or they are abusing their own medications. • The records show that approximately 56 percent of painkiller prescriptions were given to patients who had filled another prescription for pain from the same or different providers within the past month.
  • 40. JAMA Article April 2011 plus editorial by Volkow and McLellan • Nearly 46 percent of opioid prescriptions were given to patients between ages 40 and 59, and most of those were from primary care providers. • Nearly 12 percent of opioids prescribed were to young people aged 10-29. Dentists were the main prescribers for youth aged 10-19 years old.
  • 41. It‘s not just diversion and misuse It‘s O.D.s and Overdose Deaths
  • 42. Accidental Deaths Due to Prescribed Opioids • Between 1999 and 2002: – The number of opioid analgesic poisonings on death certificates increased 91.2% – Heroin poisonings increased 12.4% – Cocaine poisonings increased 22.8% • 2007: The second leading cause of injury/death (after motor vehicle accidents) • 2009: The number of deaths secondary to prescription drugs was 4 times the number due to illicit drugs. Machikanti 2007 MMWR 7/8/11 Slide thanks to Marv Seppala, MD, Hazelden Foundation
  • 43. Opioid Deaths are #1 Rx Drug Deaths Prescription Opioid O.D. Deaths Outpace Heroin Deaths
  • 44. The CDC used death certificates to determine that there were 45,000 traffic accident deaths in 2006 and about 39,000 drug-induced deaths— pooled US data
  • 45. Responding to the epidemic • Return to restrictive prescribing practices and opiophobia • Training of prescribers re: reasonable limits on numbers of doses/refills authorized • Recognition of data on efficacy: what really is ‗best practice‘? • Making medication formulations more safe • Practices to better manage supplies in the community – Lock Your Meds, Take Back your meds, safe disposal of medication supplies
  • 46. Responding to the epidemic The White House Office of National Drug Control Policy (ONDCP) ―EPIDEMIC: RESPONDING TO AMERICA‘S PRESCRIPTION DRUG ABUSE CRISIS‖ http://whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf
  • 47. ONDCP Strategy on PDA • Education: patients, parents, youth, and health care professionals • Monitoring: Prescription Drug Monitoring Programs (PDMPs), multi-state data-sharing • Rx Disposal • Enforcement
  • 48. Responding to the epidemic • Controlled Substances Workgroup (CSW), Prevention Committee, Wisconsin State Council on Alcohol and Other Drug Abuse (SCAODA) • California http://www.adp.ca.gov/Director/pdf/Prescription_Drug_Task_Force.pdf • Ohio http://www.odh.ohio.gov/features/odhfeatures/drugod/drugoverdose.aspx • Maryland http://www.oag.state.md.us/Reports/PrescriptionDrugAbuse.pdf • Washington State • Medical Society of Georgia Foundation
  • 49. ONDCP Strategy on PDA: Health Provider Education • Work with Congress to amend Federal law to require practitioners (such as physicians, dentists, and others authorized to prescribe) who request DEA registration to prescribe controlled substances to be trained on responsible opioid prescribing practices as a precondition of registration. This training would include assessing and addressing signs of abuse and/or dependence. (ONDCP/FDA/DEA/SAMHSA) • Require drug manufacturers, through the Opioid Risk Evaluation and Mitigation Strategy (REMS), to develop effective educational materials and initiatives to train practitioners on the appropriate use of opioid pain relievers. (FDA/ONDCP/SAMHSA)
  • 50. ONDCP Strategy on PDA: Health Provider Education • Federal agencies that support their own healthcare systems will increase continuing education for their practitioners and other healthcare providers on proper prescribing and disposal of prescription drugs. (VA/HHS/IHS/DOD/BOP) • Work with appropriate medical and healthcare boards to encourage them to require education curricula in health professional schools (medical, nursing, pharmacy, and dental) and continuing education programs to include instruction on the safe and appropriate use of opioids to treat pain while minimizing the risk of addiction and substance abuse
  • 51. Prescription Drug Monitoring Programs (PDMP) • The National All Schedules Prescription Electronic Reporting (NASPER) Act, was signed into law on August 11, 2005 – Authorized $60 million to establish or improve state-run Prescription Drug Monitoring Programs (PDMP) which analyze prescription data – The Department of Justice and SAMHSA continue to fund grants • PDMP can identify individuals, physicians, or pharmacies that have unusual patterns suggesting drug diversion, abuse, or doctor shopping
  • 52. Prescription Drug Monitoring Programs (PDMPs) • The National All Schedules Prescription Electronic Reporting (NASPER) Act, was signed into law on August 11, 2005 – Authorized $60 million to establish or improve state-run Prescription Drug Monitoring Programs (PDMP) which analyze prescription data – The Department of Justice and SAMHSA continue to fund grants • PDMP can identify individuals, physicians, or pharmacies that have unusual patterns suggesting drug diversion, abuse, or doctor shopping
  • 53. Responding to the epidemic PDMPs 1. What is a prescription drug monitoring program (PDMP)? According to the National Alliance for Model State Drug Laws (NAMSDL), a PDMP is a statewide electronic database which collects designated data on substances dispensed in the state. The PDMP is housed by a specified statewide regulatory, administrative or law enforcement agency. The housing agency distributes data from the database to individuals who are authorized under state law to receive the information for purposes of their profession. 2. Does the Drug Enforcement Administration (DEA) oversee PDMPs? The DEA is not involved with the administration of any state PDMP. Q&A on webpage of DEA‘s Office of Diversion Control http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm
  • 54. Responding to the epidemic PDMPs 3. What are the benefits of having a PDMP? The overview provided by NAMSDL clearly identifies the benefits of a PDMP: as a tool used by states to address prescription drug abuse, addiction and diversion, it may serve several purposes such as: – 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 prescription 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 prescription drugs.
  • 55. Responding to the epidemic PDMPs 4. Which states currently have a PDMP? According to the Alliance of States with Prescription Monitoring Programs, (www.pmpalliance.org) as of October 16, 2011, 37 states have operational PDMPs that have the capacity to receive and distribute controlled substance prescription information to authorized users. Eleven states) and one U.S. territory (Guam), have enacted legislation to establish a PDMP, but are not fully operational.
  • 56. PDMPs • In 1992 only 10 states had a PDMP – In 1998, California created its Controlled Substance Utilization Review and Evaluation System (CURES). 7500 pharmacies and 158,000 prescribers report information and can review patient medications. • Now 43 states have operational PDMPs in place • Only 3 states – Kentucky, Nevada & Utah – routinely provide their information proactively to physicians • Rarely is data from Methadone Clinics (Opioid Treatment Programs, OTPs) included in a state‘s PDMP database!
  • 57. ONDCP Strategy on PDA: Proper Drug Disposal • While the administrative process to establish the DEA medication disposal rule is underway,19 DEA and other Federal agencies shall conduct additional take-back activities. Information about the take-back events shall be distributed to local anti-drug coalitions and other organizations (chain pharmacies, boards of pharmacies, boards of medicine, environmental agencies, etc). (DEA/ONDCP) • Once DEA regulations on controlled substance prescription drug disposal have been established, develop and execute a robust public education initiative to increase public awareness and provide education on new methods of safe and effective drug return and disposal. (ONDCP/ EPA/DEA/FDA/CDC/HHS/SAMHSA/NIDA) • Once DEA regulations have been established, engage PhRMA and others in the private sector to support community-based medication disposal programs. (ONDCP/FDA/DEA/HHS/CDC/ SAMHSA/EPA)
  • 58. Responding to the epidemic Public Eduation Partnership for a Drug Free America www.drugfree.org Preventing Teen Abuse of Prescription Drugs • FACT SHEET
  • 59. Wisconsin State Council on AODA SCAODA Prevention Committee Controlled Substances Workgroup (CSW) http://scaoda.state.wi.us/docs/prevandspfsig/FINAL01032012 CSWReport.pdf
  • 60. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Fostering Healthy Youth • Recommendation 1: Support communities to foster healthy youth. Priority Area: Community Engagement & Education • Recommendation 2: Launch a public outreach and education campaign. • Recommendation 3: Support community coalitions as the vehicle through which communities will successfully prevent and reduce prescription drug diversion, abuse and overdose deaths.
  • 61. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Health Care Policy and Practice • Recommendation 4: Mandate education and training health care professionals. • Recommendation 5: Ensure that chronic pain sufferers have safe and consistent access to care. • Recommendation 6: Establish standard prescribing practices for urgent care and emergency departments. • Recommendation 7: Develop standard screening methodologies for drug-testing labs to use in detecting the presence of drugs to include all commonly misused opioids, benzodiazepines, psychostimulants, and related agents, and assure that drug-testing methodologies used in clinical settings and in post-mortem settings (including the State Crime Lab system) are aligned in order to generate the most consistent and useful data.
  • 62. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Health Care Policy and Practice • Recommendation 8: Develop a standard set of treatment protocols for Opioid Treatment Programs (OTPs). • Recommendation 9: Establish guidelines to reduce the diversion of prescription drugs by those who handle prescription medications in the course of their daily work. • Recommendation 10: Equip health care providers and first responders to recognize and manage overdoses. • Recommendation 11: The Wisconsin Dental Association and Wisconsin Dental Examining Board should endorse the findings of the Tufts Health Care Institute Program on Opioid Risk Management and the School of Dental Medicine, Tufts University.
  • 63. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Prescription Medication Distribution • Recommendation 12: Convene a work group to develop recommendations to increase security measures in the dispensing of prescriptions for controlled substances. • Recommendation 13: Implement a system to ensure that, for controlled substance prescriptions, patients are identified in a manner similar to photo identification as required to obtain pseudoephedrine. • Recommendation 14: Support a system that increases security and traceability of controlled substances from manufacturer to patient.
  • 64. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Prescription Medication Disposal • Recommendation 15: Establish a coordinated statewide system for providing secure, convenient disposal of consumer medications from households. • Recommendation 16: Integrate medication collection with the Wisconsin Drug Repository. • Recommendation 17: Create an infrastructure for the destruction of drugs in compliance with state and federal environmental regulations. • Recommendation 18: Identify the causes for prescription drug waste and implement proactive solutions.
  • 65. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Prescription Medication Disposal • Recommendation 19: Identify a sustainable means for funding collection and disposal in cooperation with key stakeholders including pharmaceutical producers, local governments, law enforcement, waste management companies, health care providers, pharmacies and consumers. • Recommendation 20: Establish a system for effective disposal of consumer medications in all care programs and facilities which complies with state and federal waste management laws.
  • 66. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Prescription Medication Disposal • Recommendation 21: Establish regulations that would permit registered nurses employed by home health agencies and hospices to transport unused medications, including controlled substances, to designated drug drop-off and disposal facilities, so that when patient medications are no longer needed, such nurses are allowed by law to assist in their safe destruction.
  • 67. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Law Enforcement and Criminal Justice • Recommendation 22: Build bridges between law enforcement and community-based prevention efforts. • Recommendation 23: Make drugged driving a priority issue. • Recommendation 24: Support drug courts.
  • 68. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Surveillance System • Recommendation 25: Design and implement an electronic Prescription Drug Monitoring Program (PDMP). • Recommendation 26: Develop a community early warning and monitoring system that tracks use and problem indicators at the local level. • Recommendation 27: Develop a community monitoring and early warning and monitoring system that tracks overdoses at the local level. • Recommendation 28: Improve consistency in reporting drug use and abuse across the state.
  • 69. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Early Intervention, Treatment & Recovery Across Lifespan • Recommendation 29: Establish guidelines to screen for substance use in all health care settings. • Recommendation 30: Promote and support evidence-based screening and early intervention for mental health and substance abuse.
  • 70. Responding to the epidemic: Wisconsin State Council Controlled Substances Workgroup Recommendations Priority Area: Early Intervention, Treatment & Recovery Across Lifespan • Recommendation 31: Integrate high quality medication management and psychosocial interventions for substance use disorders so that both are available to consumers as their conditions indicate. • Recommendation 32: Make addiction treatment and recovery support services available both on a stand-alone and integrated basis with primary health care services, as well as in other relevant community settings.
  • 72. Responding to the epidemic • Community Coalitions (CADCA, others) • Education of Patients by Prescribers • Education of Prescribers re: best practices • Better Data – Mortality statistics – Accurate death certificates – Accurate toxicology at time of death; aligning drug testing procedures for the living and the dead
  • 73. Responding to the epidemic • Better disposal of unused supplies – If they‘re there, keep ‗em locked – If they‘re not needed, bring them to safe collection site – Change laws/procedures to allow for well-recognized legal collection sites
  • 74. What about ―going upstream‖ from treatment, to PREVENTION? • Reducing availability of prescription drugs for diversion (and misuse, and overdose)? • By educating physicians and dentists to prescribe less often, to authorize smaller supplies, to have fewer refills, and to monitor all patients on such medications? • By educating parents as to their role in keeping drug supplies locked away and safe?
  • 75. Responding to the epidemic Prevention Strategies: “Lock Up Your Meds” • ―You are the Key‖ • National Family Partnership: www.nfp.org The responsible parties are: • PARENTS and GRANDPARENTS • PHYSICIANS who can educate parents about their role
  • 76. www.nfp.org • Affiliates Alert • TVAds • Radio Ads • Multimadia Slide Show • Communication Gap • MEDucation Kit • Logos • Leave Behind Card • Sponsor solicitation slides • Parent Guide Brochure
  • 77. http://mccrearyrecord.com/x316477008/ Are-you-an-Accidental-Dealer Are you an ‗Accidental Dealer‘? • Operation UNITE launches prescription awareness campaign • By JANIE SLAVEN News Editor The McCreary County Record Tuesday January 25, 2011, 01:05 PM EST • WHITLEY CITY — A University of Kentucky study has shown rural teenagers in Kentucky are 26 percent more likely to abuse prescription drugs than those living in urban areas.
  • 78. The CDC is Paying Attention Data from the National Vital Statistics System Mortality File: • From 1999 through 2006, the number of fatal poisonings involving opioid analgesics more than tripled from 4,000 to 13,800 deaths. • Opioid analgesics were involved in almost 40% of all poisoning deaths in 2006. . • In about one-half of the deaths involving opioid analgesics, more than one type of drug was specified as contributing to the death, with benzodiazepines specified with opioid analgesics most frequently. • In 15 states, opioid deaths exceed highway traffic deaths
  • 79. New Policy Initiative: Washington State • Interagency Guideline on Opioid Dosing for Chronic Non- Cancer Pain • The Washington State Medical Quality Assurance Commission (MQAC) • http://www.wsma.org/medical_professionalism/clinicalresou rces.cfm#painPain_Management_Guidelines • Effective 7.1.11 for DOs, DPMs, DDSs, nurses and osteopathic PAs • Effective 1.2.12 for MDs and their PAs
  • 80. Responding to the epidemic ―Washington State Guidelines‖ • Requirements re: patient evaluation and periodic review • Requirements re: signed informed consent, written treatment plans, and written ―treatment agreements‖ • Mandatory consultation for any patient that is receiving > 120 mg morphine equivalent dose (MED), with certain exemptions
  • 81. Equivalent Dose (mg) Chart Doses equal to Dose (mg) per 24 hr Morph 10mg IM IV/IM PO/PR Codeine 130 200 Fentanyl 0.1 N/A Fentanyl Patch* (mcg/hr*) = *16.7 Hydrocodone N/A 30 Hydromorphone 1.5 7.5 Levophanol 2 4 Meperidine 75 300 Methadone 10 20 Morphine 10 20 Nalbuphine 10 N/A Oxycodone N/A 30 Pentazocine 60 180 Propoxyphene N/A 130 Sufentanil 0.01-0.02 N/A Tramadol N/A (?) 150
  • 82. Summary: the POLICY side • States and their Medical Licensing Boards are involved, as well as the FSMB • The CDC is involved • The federal treatment agencies are involved (SAMHSA/CSAT) • The federal research agencies are involved (NIDA) • The federal policy agencies are involved (the White House ―Drug Czar‘s Office‖)
  • 83. Responding to the epidemic CDC http://www.cdc.gov/media/pressrel/2010/s100603.htm?s_cid=media rel_s100603 • CDC Statement Regarding the Misuse of Prescription Drugs (Press Release, June 3, 2010) • November 2011 http://www.cdc.gov/vitalsigns/PainkillerOverdoses/ Prescription Painkiller Overdoses in the US
  • 84. CDC Vital Signs, November 2011 Related Pages • Vital Signs: Overdoses of Prescription Opioid Pain Relievers–United States, 1999– 2008 (link to come): Morbidity and Mortality Weekly Report (MMWR) • CDC Feature- Prescription Painkiller Overdoses in the U.S. • Prescription Painkiller Overdoses in the U.S. – What You Need to Know [PODCAST - 1:15 minutes] • Sobredosis de medicamentos recetados para el dolor en los EE. UU.: Lo que usted necesita saber [PODCAST - 1:39 minutes] • Prescription Painkiller Overdoses in the U.S. – What You Need to Know [PSA - 0:60 seconds] • Policy Impact: Prescription Painkiller Overdoses • Unintentional Poisoning • Home and Recreational Safety
  • 85. CDC Vital Signs, November 2011 Related Pages: On Other Web Sites • The White House - Office of National Drug Control Policy • SAMSHA – Substance Abuse and Mental Health Services Administration • Drug Enforcement Administration – Office of Diversion Control • National Institute on Drug Abuse – Prescription Medications • U.S. Food and Drug Administration - Drugs Information • MedlinePlus - Pain Relievers • MedlinePlus - Prescription Drug Abuse
  • 86. The Interface of Policy and Practice • If not enough pain is recognized, and not enough pain is treated, is that an ―imbalance‖? • If regulators/criminal justice are trying to control supplies and penalize physicians, is that ―imbalance‖? • If not enough addiction is recognized, if he addictive potential of prescription drugs is under-appreciated, is that ―imbalance‖?
  • 87. What can we do in the meantime? • There are patients with pain • There are patients who engage in ―non-medical use‖ of pain meds • There are patients who develop addiction What can happen in the clinical world to restore balance … and so that we won‟t have “more pain patients” becoming translated into “more addiction patients” and “more coroners‟ cases”?
  • 88. So, what would ―real balance‖ in clinical care look like? • Clear understanding of pain • Clear understanding of addiction and the range of substance use conditions • Balance in prescribing practices--no one is stigmatized, excluded, under-treated • Improved pharmacotherapy of pain and pharmacotherapy of addiction
  • 89. So, what would ―real balance‖ in clinical care look like? • Clear understanding of pain • Clear understanding of addiction and the range us substance use conditions • Balance in prescribing practices • Improved pharmacotherapy of pain and pharmacotherapy of addiction
  • 90. Pain: Clinical Definition ―Whatever the patient states it is unless proven otherwise by poor adherence to the agreed upon medical regimen.‖ – Fishman, et al, Journal of Pain and Symptom Management, Vol. 20 (2000)
  • 91. Acute Pain vs. Chronic Pain • Acute Pain – Sudden onset, usually sharp in quality – Serves as a warning of disease or a threat to the body – Multiple causes: Broken bones, cuts, burns, surgery, infection… • Chronic Pain – Persists, lasting longer than 3-6 months – Serves no useful purpose; may continue after healing of an injury – Assumes control of the individual (Slide thanks to Marv Seppala, MD, Hazelden Foundation)
  • 92. Chronic Pain Syndrome • Intractable pain of more than 6 months duration • Marked alteration in behavior, restriction in daily activities • Excessive use of medication and medical services • No clear relationship to organic disorder - multiple nonproductive tests/treatments/surgeries Office of Disabilities, Social Security Administration
  • 93. Chronic Pain by the Numbers • 116 million people in the U.S. suffer from chronic pain • Low back pain is the most common type, affecting 28% of the population • Knee pain is second at 20% of the population IOM Report Relieving Pain in America
  • 94. Characteristics of Patients Referred to Pain Management (or is this a list of characteristics of patients referred for Addiction Management?) • Report high level of psychological distress • Display high levels of psychopathology • Report high levels of functional impairment • Have work / M.V.A. related injuries • Frequent use of health care system • Complain of constant pain • Have had prior surgery (ies) for pain • Are using narcotic medications
  • 95. Chronic Pain Syndrome: Common Presentation • Mood disturbance (irritable, depressed, anxious, angry) • Sleep disturbance • Physical deconditioning • Work, vocational, financial, legal issues • Weight changes • Psychiatric illness • Alcohol or other drug misuse/addiction Slide: courtesy of Marv Seppala, MD, Hazelden Foundation
  • 96. Pain Complaints • The pain is an appropriate/legitimate response to injury/illness/pathophysiology. • The complaint has a legitimate/organic bases but is an amplification of appropriate/legitimate distress. • The complaint represents a psychiatric disorder rather than somatic injury/illness • The complaint is a manifestation of an addictive disorder.
  • 97. Psychiatric States in which Pain Complaints can be Manifest • Major depression with somatization • Major depression with psychosis • Conversion disorder • Psychogenic pain disorder • Somatization disorder • Anxiety disorder • Borderline personality, histrionic personality, narcissistic personality, antisocial personality • Munchausen‘s syndrome (factitious disorder)
  • 98. Manifestation of an addictive disorder • Addiction—out-of-control use; deterioration of functioning over time; continued substance use despite adverse consequences; the substance becomes the central reinforcer in the person‘s life; use in order to experience euphoria or too feel ―normal‖ • Often diagnosed longitudinally in the pain patient (the more meds you give, the worse the patient looks and gets, cf. pain disorder where the more meds you give, the better the patient functions (ideally) • Withdrawal—often seen in addiction, but sometimes present without addiction; ‗normal‘ physiological process
  • 99. Is it Addiction or Pseudoaddiction? • Pseudoaddiction: a syndrome of maladaptive behavior indicating not true addiction, but at attempt on the part of the patient to obtain relief of under-treated pain • Preoccupation, seeking supplies, phone calls between refills, ER visits, and even doctor-shopping and securing illicit supplies, can indicate pseudoaddiction
  • 100. Is it Addiction or Pseudoaddiction? • Addiction: taking more meds leads to decrease in function • Pseudoaddiction: taking adequate dose of opioids improves function and ends pattern of maladaptive behaviors REMEMBER: it’s not the medication that’s pathological; opioids are not intrinsically evil!
  • 101. Addiction vs. Pseudoaddiction • Addiction is diagnosed prospectively: Aberrant behavior worsens despite the best attempts at a rational treatment plan by the physician • Pseudoaddiction is diagnosed retrospectively: Aberrant behavior normalizes with a rational treatment plan.
  • 102. Pathological Pattern of Use = Misuse, Non-Medical Use • Stealing scripts, forging scripts, altering scripts, calling in scripts • Using via alternate route of administration • Using for an indication other than the intended, e.g., for relief of depression/ anxiety/insomnia/‘stress‘ vs. pain • Amplifying or fabricating symptoms in order to obtain additional supplies
  • 103. Medication Seeking • Conscious manipulation of healthcare professional – For others – For sale – For self - cases of opioid addiction • Seeking supplies for ―relief use‖ ― Treatment of anxiety ― Treatment of depression ― Treatment of withdrawal
  • 104. Medication Seeking • Seeking supplies for treatment of general medical condition not actually present – Somatization disorder – Psychogenic pain disorder • Pseudo addiction – seeking medication because of under treatment of legitimate injury/illness
  • 105. Aberrant Drug-Related Behaviors More Predictive Less Predictive • Selling Prescription Drugs • Aggressive complaining about the • Prescription forgery need for higher doses • Stealing or ―borrowing‖ drugs from • Drug hoarding during periods of another patient reduced symptoms • Injecting oral formulations • Requesting specific drugs • Obtaining prescription drugs from non- • Prescriptions from other physicians medical sources • Unsanctioned dose escalation • Concurrent abuse of related illicit drugs • Unapproved use of a drug • Multiple, unsanctioned dose • Reporting psychic effects not intended escalations by the physician • Repeated episodes of lost prescriptions Portenoy 1996
  • 106. Assessing Aberrant Behavior What does it mean? • Aberrant behavior may mean out of control use of a drug, which is a symptom of addiction • Aberrant behavior may suggest inadequate pain management • ―Aberrant Behavior‖ by a pain patient is not, in and of itself, not diagnostic; it must be interpreted and addressed in the clinical context
  • 107. True ―Medication Seeking‖ • Patient demands one agent only, claims nothing else works. • Patient is impatient and speaks only of meds—not of non- medication approaches, not even of his/her symptoms • Patient returns again and again seeking early supplies, with odd stories (lost/missing). • Patient requests more of the agent even when manifesting impairment from use (sedated, ataxic, incoherent).
  • 108. Danger Signs of Abuse / Addiction Ask: ―Have you ever….‖ • Had a problem with prescription drug use? • Been treated for addiction to prescription drugs? • Taken __ in doses greater than your doctor ordered? • Taken __ in a way [route of admin.] different than Rx‘d? • Taken any __ even if it was [impairing your function]? • Taken __ for a reason other than what the medicine was intended for, e.g., a pain med for anxiety/sleep? • Gotten a ‗high‘ from taking __, and then taken it in order to get that high? [can be energy boost not just euphoria]
  • 109. Danger Signs of Abuse / Addiction Ask: ―Have you ever….‖ • Used some __ from a friend/family member‘s supplies? • Obtained __ from more than one doctor at once, without the other doctor‘s knowledge/permission? • Made up a symptom in order to get a prescription? • Over-stated a symptom in order to get a prescription? • Bought any supplies from a non-medical source? • Taken any __ from someone‘s medicine cab./ purse? • Altered a prescription? Forged /called in a Rx? • Stolen any __? Stolen a prescription pad?
  • 110. ―Red Flags‖ to look for Check the patient‘s chronic pain management history for these ―Red Flags‖ that might point to potential problems: • Excessive use of medications • Lack of progress in physical therapy • Diagnosis of addictive illness including nicotine • Prior injuries/chronic pain condition • Failure to follow up on or irregular attendance with providers for therapy or medical appointments
  • 111. There are various types of pain, and various terms to describe them • Somatic or visceral pain – Eudynia • Neuropathic pain – Maldynia • Acute pain and chronic pain – Acute injury/inflammation – Pain associated with terminal conditions – Chronic non-cancer pain
  • 112. There are various types of pain, and various terms to describe them • Psychological pain • Physical pain • Nociceptive pain • Other pathological pain states – Hyperalgesia – Allodynia – Phantom-limb pain
  • 113. How to approach • Somatic/visceral/nociceptive pain: – Responds well to opioids, NSAIDS, ASA/Tylenol, and probably sedatives • Neuropathic pain: – Responds poorly to opioids, well to tricyclics, anticonvulsants (gabapentin, carbamazepine), Lyrica, Cymbalta • Depression with physical symptoms: – Responds well to SSRIs, TCADs, anticonvulsants, and somewhat to anxiolytics
  • 114. How to approach • Hyperalgesia responds well to reducing opioids • Psychogenic pain/somatoform disorders require psychotherapy and a long-term relationship; they do not respond well to opioids or other general pharmaco- therapies, and patients are at risk as well for overuse of benzo‘s • Patients with borderline personality, histrionic personality may have somatic pain
  • 115. So, what would ―real balance‖ in clinical care look like? • Clear understanding of pain • Clear understanding of addiction and the range us substance use conditions • Balance in prescribing practices • Improved pharmacotherapy of pain and pharmacotherapy of addiction
  • 116. Range of Conditions Or, looked at another way: • Use • Use • Misuse • Risky Use • Unhealthy Use • Problem Use – ‗heavy drinking‘ – ‗non-medical use‘ • ‗Abuse‘ – ‗use despite consequences‘ • Addiction – ‗binge drinking‘ • Disability – ‗harmful use‘ (IVDU) • Death • Addictive Use
  • 117. Addiction is only one of the Substance-Related Disorders • Addiction (DSM-IV Substance Dependence) • Problem Use (DSM-IV Substance Abuse) • Intoxication States • Withdrawal States • Substance-Induced Medical Problems • Substance-Induced Psychiatric Problems • Health Problems linked to Secondary Use
  • 118. Terminology is complicated and not consistent Addiction vs. dependence Addiction vs. pseudoaddiction Dependence vs. abuse Physical vs. psychological
  • 119. ―Physical Dependence‖ = Tolerance and Withdrawal Repeated administration of opioids that activate the mu receptor results in dose-dependent physical dependence and opioid tolerance Physical dependence and tolerance manifest as characteristic withdrawal signs and symptoms (the opioid withdrawal syndrome) upon (1) reduction or cessation of opioid use/administration or (2) the administration of an antagonist or a partial agonist in a person with established tolerance
  • 120. What is Addiction? • Substance use (= reward, relief, from alcohol/drugs/behaviors) • Use behaviors and procurement behaviors persist despite problems due to use • Return to use after periods of abstinence, despite previous problems • Inability to consistently control use • Preoccupation with use/procurement; salience of use-related behaviors • Cognitive changes (over-valuation, de-valuation, minimization/denial) • Enhanced cue responsiveness via conditioning and generalization
  • 121. The Definition of Addiction (ASAM, AAPM, APS – 2001) • Addiction: a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. • Physical Dependence: a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
  • 122. Addiction Its onset and progression (genesis and pathogensis) result from genetic, psychosocial, and environmental/ cultural influences
  • 123. Addiction New Definition from American Society of Addiction Medicine www.asam.org/DefinitionofAddiction-LongVersion.html
  • 124. Addiction Results from interactions among • Agents • Biology • Context »Substances »Hosts »Environments
  • 125. Opioids don‘t cause opioid addiction Addiction arises due to interactions among agents (e.g., opioids), vulnerable hosts (persons with increased genetic risks or psychiatric comorbidities), and environments (stresses, drug availability, cultural issues).
  • 126. Prescription Opioid Use/Misuse/Addiction Nathaniel Katz, MD, Tufts University School of Medicine Presentation at APA Meeting 2006
  • 127. Katz‘s data • 33-45% of persons with opioid use disorder report that their first supply was a prescription from a physician • Rates of co-morbid SUD in chronic pain patients is 20-40% • Most prescription opioid abusers obtain drugs from either their own prescriptions or from prescriptions written for family members of friends • A significant minority of prescription opioid abusers were not at apparent high risk prior to first exposure • Katz, in Clinical Journal of Pain 18:S76 2002: 21% of persons with no ‗aberrant behaviors‘ have a urine drug test positive.
  • 128. Katz‘s data We are lacking data so we can have a more intelligent discussion. Data submitted for publication by Katz et al.: • Opioids dispensed per year USA: 190 mil prescriptions, 9.5 billion doses • Non medical users in last year (NSDUH) = 11 million people • 430 million non-medical use days • Minimum of 430 million abused doses (only 1/day) • Ratio of Non-medical use days to Medical use days = 0.22.
  • 129. Why a Person with Addiction Would Seek Drugs for Their Own Use • To produce euphoria • To manage an acute opioid withdrawal syndrome • To relieve post-acute opioid withdrawal symptoms
  • 130. So, what would ―real balance‖ in clinical care look like? • Clear understanding of pain • Clear understanding of addiction and the range us substance use conditions • Balance in prescribing practices • Improved pharmacotherapy of pain and pharmacotherapy of addiction
  • 131. Clinical Management: So, how DO we prescribe ‗properly‘?
  • 132. Management • Treat acute pain as acute pain • Give thoughtful consideration to the likelihood that a non- opioid (e.g., NSAID) may be effective • If authorizing an opioid write for only a reasonable number of doses, and if you have no established relationship with the patient, no refills
  • 133. Management • If it‘s chronic pain, are you sure that opioids will make a long-term difference? • Might we all change our thinking, and if we do use opioids when ‗chronic pain‘ is clearly the problem, might we envision only a short-term trial and make this clear to the patient? • Place the prescribing of opioids into a context, including treatment agreements and monitoring
  • 134. Management • Is there a ―treatment agreement‖ or ―pain contract‖ in place? – Are you operating within the parameters of the treatment agreement? – Are you operating outside of the parameters of the treatment agreement? • What is the patient ―being held to‖ and what is the prescriber ―being held to‖
  • 135. Provider Obligations • Keep clear records of # of pills authorized per office visit, number of refills, date that the authorization is expected to last until • Monitor clinical progress: keep clear records of the patient‘s response to treatment – Symptom reduction – Functional impairment • Utilize collaterals to validate patient self-reports • Monitor adherence and non-adherence via drug testing • If the patient violates the contract, do you do what the contract says you will do in response to that?
  • 136. Management • ‗Lost supplies‘ – listen to story; your response is a judgment call – fill for 1-2 days only: get management back in the hands of the regular Rx-er • ‗Violated contract / loss of provider‘ – listen to story; your response is a judgment call – fill for 1-2 days only: get management back in the hands of the PCP – you don‘t have to given an opioid; you can respond to the patient‘s loss of regular / legitimate opioid supplies, and offer to manage any acute withdrawal
  • 137. Management: Tips for Prescribers • Maybe the most therapeutic thing you can do is not to give an opioid • RECALL: the WAY you do this is a key • Be THERAPEUTIC: You are a Physician, not a prosecutor or jail deputy !
  • 138. So, what would ―real balance‖ in clinical care look like? • Clear understanding of pain • Clear understanding of addiction and the range us substance use conditions • Balance in prescribing practices • Improved pharmacotherapy of pain and pharmacotherapy of addiction
  • 139. Managing Acute Pain without Opioids • NSAIDs • Acetaminophen • Flexeril / Skelaxin / Baclofen • Think before prescribing Fiorinal – it‟s not a „pain medicine‟, it‟s a BARB
  • 140. Managing Chronic Pain without Opioids • TCAD‘s • Cymbalta • Lyrica • Neurontin and other anticonvulsants
  • 141. Managing Pain With Opioids Short-acting, adequate potency Long-acting (Levodromeran) Methadone for Pain
  • 142. Methadone • Excellent pain control, long acting • Increasingly used because of low cost (Medicare Part D; any managed pharmacy benefit plan) • Can be LETHAL • Must ―start low, go slow‖ • Starting dose in methadone clinics / OTP‘s • Starting dose in pain practice / primary care
  • 143. Equivalent Dose (mg) Chart Doses equal to Dose (mg) per 24 hr Morph 10mg IM IV/IM PO/PR Codeine 130 200 Fentanyl 0.1 N/A Fentanyl Patch* (mcg/hr*) = *16.7 Hydrocodone N/A 30 Hydromorphone 1.5 7.5 Levophanol 2 4 Meperidine 75 300 Methadone 10 20 Morphine 10 20 Nalbuphine 10 N/A Oxycodone N/A 30 Pentazocine 60 180 Propoxyphene N/A 130 Sufentanil 0.01-0.02 N/A Tramadol N/A (?) 150
  • 144. Managing Opioid Withdrawal without focusing on managing pain • Maybe the acute problem isn‘t the underlying pain condition, but the symptoms resulting from a cutting off of opioid analgesic supplies • Traditional methods: clonidine and supplemental agents; Ultram® can be used but that is associated with drug- linking and diversion among addicts
  • 145. Do treat acute pain • Even if patient has history of addiction • Even if patient is on methadone • Even if patient is on Suboxone (this probably requires use of fentanyl) – But the first intervention should be to divide the dose of Suboxone or methadone • Even if the patient is on naltrexone (Vivitrol)
  • 146. Do your best to not use opioids to treat ‗psychic pain‘ • Is it really depression you‘re treating? • Is it really anxiety you‘re treating? • Is it really a somatoform disorder you‘re treating?
  • 147. Buprenorphine • OBOT—office based opioid treatment • Special DEA registration of the provider • Clinics are not regulated, prescribers are • Sublingual tablets, but use of new ―film‖ can reduce diversion
  • 148.
  • 149. Buprenorphine • It IS AN OPIOID – it is a ―partial agonist‖ at the mu opioid receptor (the ―morphine‖ receptor) • Thus, it can treat pain, in the absence of addiction – Buprenex – Butrans – Suboxone, Subutex • While special DEA registration is required of the provider who prescribes for addiction, no special DEA registration is required when prescribing for pain management only • It can treat pain and addiction in the patient who has both
  • 150. Intrinsic Activity: Full Agonist (Morphine), Partial Agonist (Buprenorphine), Antagonist (Naloxone) 100 90 Full Agonist (Morphine) 80 70 Intrinsic Activity 60 Partial Agonist 50 (Buprenorphine) 40 30 20 10 Antagonist (Naloxone) 0 -10 -9 -8 -7 -6 -5 -4 Log Dose of Opioid
  • 151. Responding to the Epidemic • Treat Opioid Addiction with Buprenorphine! Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence A 2-Phase Randomized Controlled Trial Roger D. Weiss, MD; Jennifer Sharpe Potter, PhD; David A. Fiellin, MD; Marilyn Byrne, MSW; Hilary S. Connery, MD, PhD; William Dickinson, DO; John Gardin, PhD; Margaret L. Griffin, PhD; Marc N. Gourevitch, MD, MPH; Deborah L. Haller, PhD; Albert L. Hasson, MSW; Zhen Huang, MS; Petra Jacobs, MD; Andrzej S. Kosinski, PhD; Robert Lindblad, MD; Elinore F. McCance-Katz, MD; Scott E. Provost, MSW; Jeffrey Selzer, MD; Eugene C. Somoza, MD, PhD; Susan C. Sonne, PharmD; Walter Ling, MD Arch Gen Psychiatry. Published online November 7, 2011. doi:10.1001/archgenpsychiatry.2011.121
  • 152. Now available in a sublingual film • Generic buprenorphine is available, but not recommended • Still, many hurdles to overcome re: stigma, misunderstandings, discrimination • Limitations of access – ‗off formulary‘ – ‗caps‘ on daily doses, monthly doses, duration of therapy, via Medicaid and private insurers/PRMs
  • 154. Pharmacotherapy Approaches to Opioid Dependence Agonist Maintenance Treatment • Methadone (full agonist) • Buprenorphine (partial agonist) Antagonist Maintenance Treatment • Naltrexone (oral = ReVia®) • Naltrexone (long-acting injectable = Vivitrol®)
  • 156. Thank you! Michael M. Miller, MD, FASAM, FAPA Medical Director Herrington Recovery Center 262-646-1056 mmiller@rogershospital.org
  • 157. Rogers treats children, adolescents and adults with: • Anxiety disorders • Mood disorders • Eating disorders • Substance-use disorders 800-767-4411 rogershospital.org