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MEDICATIONS OF CONTROVERSYChallenges, Risks and Strategies

Alan Lembitz M.D.COPIC

Disclosure

I have no relevant financial relationships to disclose

Risks

OverviewToday we are going to talk about:

Safe prescribing practices

Scope of Problem

Tools- PDMP, Agreements, Consents,

Screening Tools, Diagnostic Tools,

Documentation

PART 1

OPIOIDS

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Being a medical caregiver means putting your self in suffering’s way

Rita Charon M.D.

CDC declares painkillers at epidemic levels

Opioids, Anxiolytics and Sedatives

Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999-2010)

SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009

Distribution of Opioid Users

Controlledchronic pain

“All the rest”uncontrolled painpseudo-addiction

Addictionabuse

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Overview

Top Reasons for paid claims in Primary Care:

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2 Improper treatment of known medical condition

Delay or failure to diagnose (65+%)

3 Medication Errors

Risk by diagnosis

Heads Hearts Bellies Bugs- Severe Infectious

Diseases Failure to DX CA Underappreciated

severity of trauma

COPIC data

OxyContin in increasing doses beginning at ½ tabTID (20 mg) and increasing to 80mg tabs 6 per dayin 4 doses – These are the complete notes

Opiates

Opiates from poppies

Sumerians isolated opium from 3000 B.C.

Given with hemlock to put people to death

China 800 AD Europe 1300

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Opiates

In 1806 Serturner isolated the morphine alkaloid and named it after the god of dreams, Morpheus

Heroin detailed for cough medicine in 1898

Works thru at least 4 receptors throughout the body

Profound effect is the mu receptor CNS

Controlled Substances Act in 1970 DEA enforces

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Be sure of the DX

Pain out of proportion to findings

? FX

? Necrotizing fasciitis

Vascular, inc. mesenteric

Compartment syndrome

Don’t miss the CA

Pain diagrams

Accuracy of diagnosis Symptom magnification Objective pre-

procedure, or pre-treatment functionality

Objective post-procedure or post-treatment assessment of functionality

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Addiction vs. tolerance vs. dependence

Addiction

Compulsive use causing personal harm

Psychological dependence

Rare in terminally ill or pain management

Usually preexisting abuse

Physical dependence

Abstinence syndrome think French connection

Not psychologic addiction

Decrease dose 50% Q 3 days

Tolerance

Decreased effectiveness

over time

Actually rare - if more needs there may be a

reason

Don’t label a tolerant patient

addicted

Addiction

A maladaptive pattern of substance use leading to impairment or distress, but has not met the criteria for Substance Dependence, having ≥ 1 of the following:

Recurrent substance use resulting in failure to fulfill major role obligations at work, home, school

Recurrent substance use in situations in which it is physically hazardous

Recurrent substance-related legal problems Continued substance use despite having

persistent or recurrent problems caused by the substance use

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Opioid addiction risk factors

Biggest risk factor is a personal or family history of drug/ETOH abuse

Journal of pain v109 pg 113-130 2009

Psych problems

Poor coping skills

Sexual abuse

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Faces of addiction

Genetics

Pathogenesis

Precipitants

Environmental determinants

Gender specifics

Complications

Relapse-Remission

Criteria of chronic illness

Key to identifying alcohol abuse

ASK

• CAGE: cut back, annoying, guilt, eye opener

• Drinks per week: 7 or 14?• Binge per year: 5 (4)?

SOAPP

Biggest risk factor is a personal or family history of drug/ETOH abuse

Journal of pain v109 pg 113-130 2009

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Overdose- accidental vs. intentional

It’s about the documentation

Evaluate for coexisting psych problem

Tip of the iceberg potential

ACTIONS MUST MATCH THE DOCUMENTATION

DEA

Responsible prescribing

Regulation increasing

Stings

Documentation

Pharmacist is the trigger work with them

Street value

Drug Estimated Street Cost

Oxycodone $5-10/ pill

Oxycodone ER $1/mg

Vicodin 5/500 $3-5/ pill

Percocet $5-10/ pill

Methadone $25

Xanax $3-5/ pill

Fentanyl $1/ mcg

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Dilaudid 4mg #240

Street value of this Rx: $7,000plus

No addressNo datePmNo legitimatepurpose

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Prescription Drug Monitoring Program

Powerful tool

Use it don’t lose it

Password sacred

Notification

Which of the following is NOT appropriate for a pain agreement?

A) No diversion allowed

B) May request a tox screen at any time

C) Notify us by Thursday if scripts are lost or destroyed

D) Can only go to 1 pharmacy

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Opioid agreements

An Agreement not a Contract

May specify one pharmacy

Treaters may discuss DX and RX

No diversion Danger of abrupt

withdrawal Pregnancy

Urine or Serum tox screens may be a condition of the agreement.

Lost, wet, left, stolen not acceptable excuses

Compliance with scheduled appointments and referrals

Breach may result in termination, cessation of therapy or referral to addiction specialist

Long-term consent

Indications

Risks

Prohibition of activity if impaired

Withdrawal

Addiction definition and potential

Physical Dependence

Tolerance and Possible Increases in dosages or reduction in effect

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Align your partners

Clear discussion of philosophy

Pain agreements help guide your partners

A covering prescriber on a routine script- little risk

CMB – red flags

Chronic narcotics without cause

No formal relationship

No physical exam

Suggest different pharmacies

Prescribe for sex or sharing

Prescribe to family

Example of the office visit notes

OxyContin 40mg 2-bidDilaudid 8mg qidSoma 1 qid

DEA examplesNew patient:Prescribed Dilaudid4 mg #240 plusXanax

Do you believe this doctordid an exam of the head,

heart and lungs?

Hassle factors

HIPAA

Records release

Labeling addict can be an issue

Weekend and night calls

Always

Contact the previous physician

Ask the patient about previous alcohol and drug use, or psychiatric or drug related hospitalizations.

Document a thorough and thoughtful exam

Consider a drug screen

PART 2

MEDICAL MARIJUANA

RECREATIONAL MARIJUANA

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SCOPE OF MMJ

Numbers of registrants

Characteristics of registrants Age Primary Dx

The Dispensaries

MAJOR QUESTIONS TO CONSIDER

Do I certify for MMJ? Informed ConsentScreen for contraindicationsKnow and review the scienceFollowing CMB regulations

Bona fide physician patient relationship Diagnosis established by history and examination Documentation Recommendation for follow-up

Practical Logistics- forms and registry

MAJOR QUESTIONS TO CONSIDER

My patient is on MMJ registry and actively using, does this change my practice and prescribing for them?

MAJOR QUESTIONS TO CONSIDER

What if my patient was inappropriately certified for the registry?CMB unprofessional conduct- license and duty to reportSpecific clinical examples

Minors Psychiatric contraindications Occupations involving public safety

MAJOR QUESTIONS TO CONSIDER

Do I have vicarious liability if I certify, or if I know my patient is using MMJ, or if they are taking opioids, etc?Chart documentation of discussion Informed consent is a process, but a form may be required if

significant risk and non-compliance with recommendations

DRIVING UNDER INFLUENCE

Law Enforcement considerations

Available testing and reliability

SPECIAL SITUATIONS

Physicians who personally are on the registry CPHP CMB COPIC

SUMMARY

Certifying my own patients- how to do this in compliance and consistent with sound medical practice

What to do about your patient who someone else certified for the registry

What about other physicians who certify out of compliance with sound practice

Vicarious liabilityDUI is not just alcohol

Boundaries- Are your issue

Boundary discussions are often about your own conflict

Can be you or the patient with the problem

Discuss what your concern is

Boundaries—Providers role

Clarify boundaries

And negotiate

I don’t give unlimited narcotics but I want to help you. What can we work out….

My role is to help people not just give out narcs…

Can we come up with a short term plan today and then work on something long term?

Do you accept the challenge?

Do you choose to work with this patient?

It is OK to say no

Send a letter 30 days

Taper schedule

Withdrawal and ? refer

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The good news

Most lawsuits result in defense judgments or verdicts.

Most patient complaints to plaintiffs’ attorneys do not result in lawsuits

Most CMB complaints do not result in discipline

Pain assessments, agreements, consents, documentation and consults help greatly

Our challenge

"....in the sufferer, let me see only the human being” –

Maimonides, 13th Century

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I appreciate your feedback.

Alan Lembitz M.D.VP, COPIC

Patient Safety and Risk Management

Thank you

Any questions?