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8/25/2015
Opioid Safe Prescribing: Intro
to the TN Guidelines
Steven J Baumrucker, MD, FAAHPM, FAAFP
Associate Editor in Chief, The American Journal of Hospice and Palliative Medicine
Assistant Clinical Professor, ETSU College of Medicine, LMU/DCOM College of Osteopathic Medicine
System Medical Director, Hospice and Palliative Medicine, Wellmont Health System
• Timely and appropriate treatment for pain
• Improves
• Ability to function
• Quality of life
• Intended to support clinicians in treatment of chronic pain
• Avoiding
• Addiction
• Adverse outcomes
Purpose of the Guidelines
• MEDD
• PO “Morphine Equivalent Daily Dose”
• CSMD
• “Controlled Substances Monitoring Database”
Some Baseline
Information
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• Defined as pain lasting longer than 90 days
• Requires and interdisciplinary process
• Many non-opioid modalities
• Physical therapy
• Psychology
• Non opioid medications
• Steroids
• Anticonvulsants
• Antidepressants
• SNRI
Chronic Pain
• In 2011, TN was second in the country for opioid scrips
• Unintentional overdose
• Increased 250% from 2001 to 2011
• Eclipsed MVA, Homicide, Suicide in 2010
• Neonatal Abstinence Syndrome grew 10-fold 2001-2011
• Five fold increase in Worker’s Comp cases for opioid
abuse
• Chronic pain still needs treatment
• 116 million US adults suffer from chronic pain
Why Is This Necessary?
• Acute and chronic pain
• Among the most common reasons
• For physician visits
• For taking medication
• For work disability
• Affects
• physical and mental functioning
• Quality of life
• Productivity
Pain
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Porter and Jick Letter
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• Opioid Addiction is “rare in pain patients”
• Physicians allow patients to suffer needlessly because of
“opiophobia”
• Opioids are safe and effective for chronic pain
• Opioid therapy can be easily discontinued
Industry Influenced
“Education”
5th Vital Sign
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Rate of Rx Painkiller Sales, Deaths and Substance
Abuse Treatment Admissions (1999-2010)
Source: National Vital Statistics System
• Top 1% of States that sell prescription pain medications
• Top 10 for deaths by overdose
• Unintentional Drug overdose
• Number one cause of death in TN
• Over motor vehicle accidents, homicides
• Peak age 40-49
• Providers prescribed 17 opioid scrips per capita
• National average=12
TN Ranks Highly in…
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Improve Symptoms
Improve Functioning
Improve Quality of Life
Minimize adverse effects, including death
Minimize addiction
Long Term Goals of Pain
Management
• Not applicable to
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End of life care
Acute pain
Emergency Room
Hospital Patients
• Not meant to
• Dictate medical decision-making
• “Generally Accepted” guidelines and not “absolutes”
• Providers have flexibility to deal with exceptional cases
• “Occasional deviation for appropriate reasons is to be expected”
What the Guides are Not
• Prescription by another provider is not a reason to
continue opioids
• Reasonable non-opioid treatments should be tried
• All newly pregnant women should have UDS
• Discuss birth control to prevent unintended pregnancy in
every woman of child-bearing age
• Document Hx, PE, Database prior to starting opioids
• “Chronic pain shall not be treated [with opioids] through
telemedicine.”
Key Principles
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• H&P
• Nature, intensity, past and current Rx
• Comorbid conditions
• Effect on FUNCTION
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Work
Relationships
Sleep
Recreation
Initial Steps Prior to
Opioid Therapy
• Evaluate for conditions that may result in adverse events
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Age
COPD
OSA
DM
CHF
Renal Failure
• Morphine
Co-Morbid Conditions
• Initial, condition-appropriate physical exam
• Confirm diagnosis?
Physical Exam
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• Consider screening for
• Depression
• Anxiety
• Current or past substance abuse
• Address these in the treatment plan
Screening for Mental
Health
• Scoring: Count the points and total the score.
• The possible range is 0-27.
• Minimal depression 0-4 may not need depression treatment
• Mild depression 5-9 Physician uses clinical judgment
• Moderate depression 10-14 Physician uses clinical
judgment
• Moderately severe depression 15-19
• Severe depression 20-27 Warrants treatment for depression,
using antidepressant, psychotherapy and/or a combination
of treatment.
Scoring the PHQ-9
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• Will be addressed later today!
Risk Assessment Tools
• Review of prior records DIRECTLY RELATED to
patient’s CHRONIC PAIN CONDITION
• Just saying “I have arthritis” is not sufficient
• Prescribers have had difficulty justifying some diagnoses
before the BME
• “Well, they TOLD me they had cancer.”
• Remember, another prescriber writing pain medications is
not in itself justification to continue them
Records Review
• Women of child-bearing age and reproductive capacity
• Should be asked about the possibility of pregnancy at each
visit
• Use of contraception should be discussed
• Referral to high risk OBGYN considered
• (We’ll cover “Women’s Issues” later in the day)
Pain Medications and
Pregnancy
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• “There shall be the establishment of a current diagnosis
that justifies a need for opioid medications.”
Establish a Diagnosis
• “The prescriber shall assess the patient’s risk for misuse,
abuse, diversion and addiction.”
• The prescriber should obtain a urine drug screen
• The prescriber shall check the Controlled Substances
Database (tncsmd.com)
• The prescribing of opioids shall take risk assessment
information into account
Assessment of Risk for
Abuse
• Primary goal of treatment should be clinically significant
improvement in function.
• Treatment plan must also
• Include other treatments beyond opioids
• Pharmacological and non-pharmacological
• Provider should make reasonable attempts to implement this plan
• Counsel the patient
• Goal is to increase function and reduce pain
• NOT eliminate pain
• “documentation of this discussion shall be included in the medical
record.”
Goals for Treatment
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Initiating Opioids
For Management of Chronic Non-Malignant Pain
• Maximum of 4 breakthrough doses/day
• If more are needed, simply document why
• Methadone shall be prescribed only by a pain medicine
specialist
• Prescribers shall not prescribe buprenorphine for chronic
pain
• If opioid >= 120mg PO Morphine Equivalents/day
• A mental health professional must assess necessity for any
concomitant benzodiazepine prescriptions
• Should treatment deviate from the guidelines
• Simply document the reasons in the medical record
Key Principles
• Short acting
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Incident pain
Acute pain
Short-term treatment
Mild pain
• Long acting
• Less of a peak effect
• Chronic pain requiring round the clock dosing
• ONE long-acting, ONE short-acting
• Short-acting MEDD should never be more than 50-100% of
the long-acting.
Basics of Opioid Therapy
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• Sustained release Morphine
• 30mg PO BID
• Breakthrough dose
• Immediate Release morphine
• 7.5 – 15mg PO QID prn
• LA = 60 MEDD
• SA = 30-60 MEDD
Example
Morphine
Oxycodone
Oxymorphone
Hydromorphone
Calculating MEDD
• Patient is on Opana ER 20mg PO BID and
Hydromorphone 4mg PO QID prn
• MEDD=
• 40mg PO OPANA x 30mg PO Morphine/10mg PO Opana
• = 120mg PO Morphine/day
• 16 mg PO dilaudid x 30mg PO Morphine/7.5mg PO
dilaudid
• = 64mg PO Morphine/day
• TOTAL MEDD
• = 64+120 = 184 mg PO Morphine/day
Example
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• Initiation should be presented as a therapeutic trial
• Opioid naïve?
• Use lowest dose and titrate to effect
• INFORMED CONSENT must be obtained
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See sample informed consent
Risks, alternatives and benefits
Likelihood of dependence, risk of oversedation
Pregnancy
Risk of impaired motor skills, addiction and death
• Written treatment agreement
Upon Initiating Opioids
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Reasons for discontinuation of controlled substances
Practice policy on “early refills”
Policy on lost prescriptions
Use of one pharmacy
Periodic drug testing
Female patients will tell the provider if they want to avoid
unintended pregnancy and if they become pregnant
• See sample treatment agreement
Written Treatment
Agreement
• Practitioners may provide a bridge of opioids
• For up to 6 months
• While assessment process is carried out
• No provider is obligated to continue opioid therapy that
has been initiated by another provider
• If the initial evaluation does not support opioid use
• Discussion about risk and possible treatment of withdrawal
• Document with clinical reasoning for cessation
Opioid Bridge
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• Providers must continually monitor patients for signs of
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Abuse
Misuse
Diversion
Improvement of underlying condition
• Document improvement in
• Physical Functioning
• Psychosocial Functioning
• Drug Screening should be done twice a year (minimum)
Reassessment
Treatment with Opioids
Key principles
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Chronic opioid therapy should be handled by a single provider
Prescriptions should be filled in a single pharmcy
Use the lowest effective dose
NO MORE THAN ONE SHORT-ACTING OPIOID
Document “The Five As”
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Analgesia
Activities of Daily Living
Adverse effects
Aberrant behavior
Affect
Key Principles
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• State recommends that patients on >100 MEDD should be
referred to a pain specialist
• Consultation vs management
• If not done, document why
• Monitor patients for abuse
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UDS at least twice a year
Document pill counts
Check the CSMD
Ongoing risk assessment
• Stop opioid therapy if the risks outweigh the benefits
• Taper if indicated
Ongoing Therapy
• Any time the risks outweigh the benefits therapy should
be discontinued
• Discontinuation poses risk for withdrawal
• Nausea, vomiting, piloerection, diaphoresis, myalgia
• Acute post withdrawal syndrome
• Depression, malaise, fatigue, lasting up to two YEARS
• Benzodiazepine withdrawal can be fatal
• Low dose opioids  low risk for withdrawal
• Responsibility of the current provider to address this
issue
Tapering Protocol
• Conservative:
• 10% reduction per week
• Moderate
• 25% reduction every 4 days
• Aggressive
• 25-50% reduction daily
• TN Dept of Health does not recommend any specific
protocol
• Adjuvant medication
• Clonidine 0.1mg q6h or 0.1mg TD q24h
• Hypotension and anticholinergic effects
Weaning Opioids
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• If recent UDS shows no opioids in system weaning is not
necessary
• If drug diversion is suspected, further prescribing is not
indicated.
• If any circumstance is thought to constitute more risk to
the patient or community than the potential for
withdrawal, no additional opiates should be prescribed.
REMEMBER
Applicable TN Statutes
• If detected, provider must report to law enforcement
• Form is located at:
• http://bit.ly/1bPjSiT
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Fax directly to 423 267 8983
Or scan and email to: [email protected]
Simply starts a process
Enters patient into a database looking for other “red flags”
Doctor Shopping
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• No specific penalty for failing to report.
• Protection from liability
• A health care provider, or any person under the direction of
the health care provider or any entity that assumes the
responsibility of reporting for the provider who furnishes
any information in good faith is immune from liability if a
complaint, report, information, or record is furnished to a
law enforcement agency.”
• item (d) in 53-11-309.
Penalty for Not Reporting
(TN Guidelines)
• TennCare has its own rules, however
• “All managed care …providers …shall advise the office of
TennCare inspector general immediately when …fraud is
being…committed.”
• Any person … making a complaint … is immune from civil
liability.
• Providers …shall advise the Medicaid fraud control unit (MFCU)
• “…failure to report such fraud shall be subject to a civil penalty
of not more than ten thousand dollars ($10,000) for each finding
to be assessed by the office of TennCare inspector general.”
Reporting “Fraud” for
TennCare Patients
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• “…knowingly, willfully and with the intent to deceive,
failing to disclose to a … health care provider …that the
person has received either the same controlled substance
or a prescription for the same controlled substance, or a
controlled substance of similar therapeutic use …from
another practitioner within the previous thirty (30) days
and the person used TennCare to obtain the benefits.”
Definition of Fraud in this
Context -- (TennCare)
Tennessee Laws
• The TNBME does not have a list of “bad” drugs
• Nor a “magic formula” for dosage/admin
• Does have an expectation of the following
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Proper indication
Monitoring
Follow up, reassessment
Rationale for continuing or modifying therapy
No “Bad” Drugs
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• Pain patient’s bill of rights
• Does NOT apply to acute pain Rx
• Right to opiates IF patient, physician concur
• Medically necessary dose of opiates may be used
• Defense to disciplinary action by board
• Physician right to prescribe even for abusers, addicts for
pain
• REPEALED by House and Senate in 2015
Intractable Pain Act 2001
• Effective January 1, 2012, all pain management clinics
must be registered with the State.
• Link to application: http://health.state.tn.us/Downloads/PH4151.pdf
• Link to rules: http://state.tn.us/sos/rules_all/2011/1200-3401.20110930.pdf
Pain Management Clinics
• privately-owned facility
• provides pain management services to patients
• majority of whom are issued a prescription for opioids,
benzodiazepine, barbiturates, or carisoprodol, for more than 90
days within 12-month period
• Does not include suboxone (separate requirements)
Do you need to register?
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(1) A medical or dental school
(2) A hospital including any outpatient facility or
clinic of a hospital;
(3) Hospice services as defined in S 68-1 1-201;
(4) A nursing home as defined in S 68-11-201;
(5) A facility maintained or operated by this state; or
(6) A hospital or clinic maintained or operated by the federal
government.
Does Not Apply To
 Practitioners at uncertified clinics may be fined $1000 per
day by their board
 Clinic itself can be fined $1000 a day for not meeting
legal requirements
Inspections/Complaints
• [email protected]
• 423 923 1522
Contact Dr Baumrucker
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