THE PROPER PRESCRIBING OF

CONTROLLED PRESCRIPTION

DRUGSCharlene M. Dewey, M.D., M.Ed., FACP

Associate Professor of Medical Education and AdministrationAssociate Professor of Medicine

Co-Director, Center for Professional HealthVanderbilt University Medical Center

September 2011

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INTRODUCTION Which doctor is at risk of mis-prescribing?

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GOALS The purpose of the session is to provide

learners with an overview of the CPD epidemic and review guidelines on proper prescribing and office practices based on the CSA and the practitioner’s manual.

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OBJECTIVESBe the end of the session participants will be able to:

1. Discuss the CPD use/misuse epidemic in the US and TN

2. Apply proper prescribing rules from the practitioner’s manual in their individual and office practices

3. Identify behaviors associated with drug seekers

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AGENDA1. Introduction: the CPD problem

2. CSA

3. Proper prescribing practices – using the PMIndividualOffice

4. Q&A

5. Summary

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INTRODUCTION Substance abuse, including controlled

prescription medication, is the nation's number one health problem affecting millions of individuals

Rate of controlled prescription drug (CPD) abuse - almost doubled from 7.8 million to 15.1 million in the past decade (1992 to 2003)

Adults >18 is up by 81%

Manchikanti L, et al. 2005; Substance Abuse 2001; Bollinger LC 2005. 2006 National Survey on Drug Abuse and Health, SAMHSA

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INTRODUCTION Rate has nearly tripled in the teenage

population Children aged 12 -17:

abusing CPD more than adults rate estimated at 212%

New drug users of prescription opioids = 2.4 million Marijuana (2.1 million); Cocaine (1.0 million)

Total abusing > those abusing cocaine, hallucinogens, heroin, and inhalants combined!

Manchikanti L, et al. 2005; Substance Abuse 2001; Bollinger LC 2005. 2006 National Survey on Drug Abuse and Health, SAMHSA

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INTRODUCTION More “new users” tried opioids for non-medical

reasons in the past year than any other illicit drug CDC:

Opioid prescription painkillers cause more drug overdose deaths than cocaine and heroin combined

Increased ER visits Increased accidental deaths Health care costs = millions of dollars annually

DEA Practitioners Manual 2006 ed.; Manchikanti L, et al. 2005; Substance Abuse 2001; Bollinger LC 2005. 2006 National Survey on Drug Abuse and Health, SAMHSA

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INTRODUCTION Americans = 4.6% of world’s population

Use 66% of world’s illicit drugsUse 80% of global opioid supplyUse 99% of global hydrocodone supply

2006 National Survey on Drug Abuse and Health, SAMHSA

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INTRODUCTION TN #2 in nation in rate of prescription drug

use Hydrocodone is #1 drug 2.8% of all prescriptions (More than Lipitor,

Nexium) Death rate from accidental drug poisoning in

TN is 26% above national average Rx for top 5 narcotics rose 90% nationwide

from 1997-2005 (The largest increase in any state)

Increase was 206% in TN

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INTRODUCTION Prescription drug diversion is simply the

deflection of prescription drugs from medical sources into the illegal market.

Physicians remain the #1 provider of CPD

Sources: doctor shopping illegal internet pharmaciesdrug theftprescription forgery illicit prescribing by physicians

U.S. Department of Justice, Drug Enforcement Administration, Prescription Accountability Resource Guide, September 1998. http://www.deadiversion.usdoj.gov/pubs/program/rx_account/index.html (5 January 2004).

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INTRODUCTION

Given free from a friendor relative

Given by a singledoctor

Bought from a friend orrelative

Bought fromstranger/dealer

Internet

SAMHSA 2006

19%56%

4% <1%

9%

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INTRODUCTION

Up to 43% of physicians DO NOT ask about controlled prescription drug abuse when taking a patient's health history.

Only 19% received any medical school training in identifying prescription drug diversion

Only 40% received training on identifying prescription drug abuse and addiction

Bollinger et al, 2005

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INTRODUCTION

Many are not trained to effectively handle drug-seeking patients

“Confrontational Phobia”- a term used to describe physicians’ reluctance to say “no” to a patient, thus making physicians an “easy target for manipulation.”

Bollinger et al, 2005

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SUBSTANCE ABUSER

“Obviously, doctors don’t like to give you controlled substances easily but if you’re

aggressive and persistent enough…and can talk a good enough game, I don’t know how

they could not give it to you. I mean they’re in the health field and they’re caring people and

they’re trying to take care of their patients’ individual needs.”

~A 52-year-old drug abusing patient interviewed in the CASA study

Bollinger et al, 2005

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THE DEA

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DRUG ENFORCEMENT ADMINISTRATION (DEA)

The mission of the DEA is to:Enforce the controlled substances laws

and regulations of the United States and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances.

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CONTROLLED SUBSTANCES ACT (CSA)

Controlled Substances Act of 1970 (CSA) Assigned legal authority for the regulation of

controlled substances (illicit and licit)

Responsibility is two-fold:1. Ensuring that adequate supplies are available

to meet legitimate domestic medical, scientific, and industrial needs

2. The prevention, detection, and investigation of the diversion of controlled substances from legitimate channels

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CONTROLLED SUBSTANCES ACT (CSA)

Providers must be registered Registration can be suspended/revoked by

the Attorney General if a registrant: Materially falsified any application filed Been convicted of a felony Had his/her state license or registration suspended,

revoked, or denied by competent state authority Committed such acts as would render his

registration inconsistent with the public interest Been excluded (or directed to be excluded) from

participation in a program pursuant to section 1320a-7(a) of title 42 = Medicare Fraud!

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CONTROLLED SUBSTANCES ACT (CSA)

Monitors:1. Diversion to Illicit Use

- Self- Others

2. Maintenance of addictions

3. Latrogenic addictions Five (5) schedules

I-V Addictive potential Rules on schedule IIs

http://www.justice.gov/dea/concern/narcotics.html

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EXAMPLES: SCHEDULE I DRUGS

Schedule 1

Substance DEA Number Non Narcotic

Other Names

1-Methyl-4-phenyl-4-propionoxypiperidine

9661   MPPP, synthetic heroin

Gama Hydroxybutyric Acid (GHB)

2010 N GHB, gama hydroxybutyrate, sodium oxybate

Heroin 9200   Diacetylmorphine, diamorphine

Lysergic acid diethylamide 7315 N LSD, lysergide

Marijuana 7360 N Cannabis, marijuana

Myrophine 9308    

Psilocybin 7437 N Constituent of "Magic mushrooms"

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EXAMPLES: SCHEDULE II DRUGS

Schedule IIAmobarbital 2125 N Amytal, Tuinal Amphetamine 1100 N Dexedrine, Biphetamine Cocaine 9041   Methyl benzoylecgonine, Crack Codeine 9050   Morphine methyl ester, methyl morphine Fentanyl 9801   Innovar, Sublimaze, Duragesic Hydrocodone 9193   dihydrocodeinone Hydromorphone 9150   Dilaudid, dihydromorphinone Meperidine 9230   Demerol, Mepergan, pethidine Methadone 9250   Dolophine, Methadose, Amidone Methadone intermediate 9254   Methadone precursor Methamphetamine 1105 N Desoxyn, D-desoxyephedrine, ICE, Crank,

Speed Methylphenidate 1724 N Ritalin Morphine 9300   MS Contin, Roxanol, Duramorph, RMS, MSIR Opium, raw 9600   Raw opium, gum opium Oxycodone 9143   OxyContin, Percocet, Tylox, Roxicodone,

Roxicet, Oxymorphone 9652   Numorphan Pentobarbital 2270 N Nembutal Phencyclidine 7471 N PCP, Sernylan

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EXAMPLES: SCHEDULE III DRUGS

Schedule IIIAnabolic steroids 4000 N "Body Building" drugs Barbituric acid derivative 2100 N Barbiturates not specifically listed Butalbital 2100 N Fiorinal, Butalbital with aspirin Codeine combination product 90 mg/du 9804   Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine

Hydrocodone combination product 15 mg/du

9806   Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia ++

Lysergic acid 7300 N LSD precursor Chlordiazepoxide 2744 N Librium, Libritabs, Limbitrol, SK-Lygen Clonazepam 2737 N Klonopin, Clonopin Clorazepate 2768 N Tranxene Dexfenfluramine 1670 N Redux Dextropropoxyphene dosage forms 9278   Darvon, propoxyphene, Darvocet, Dolene,

Propacet Diazepam 2765 N Valium, Valrelease Dichloralphenazone 2467 N Midrin, dichloralantipyrineDiethylpropion 1610 N Tenuate, Tepanil Lorazepam 2885 N Ativan Lormetazepam 2774 N Noctamid Modafinil 1680 N Provigil Pentazocine 9709 N Talwin, Talwin NX, Talacen, Talwin Compound Temazepam 2925 N Restoril Triazolam 2887 N Halcion Zaleplon 2781 N Sonata Zolpidem 2783 N Ambien, Stilnoct,Ivadal

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DEAOFFICE OF DIVERSION CONTROL

Practitioner’s ManualAn Informational Outline of the

Controlled Substances Act

2006 Edition

DEA remains committed to the 2001 Balanced Policy of promoting pain relief & preventing abuse of pain medications.

http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html

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TEST YOUR KNOWLEDGE1. What constitutes schedule I or other

schedules assignments for drugs?2. Identify the schedule for each of the

following: Marijuana; morphine; heroin; codeine;

LSD; opium; amphetamine; cocaine

3. How often do you renew your DEA registration and what happens if you move?

4. Which schedules can be refilled?5. Can you fax CPD prescriptions?

DEA Practitioner’s Manual 2006; pg. 5-6 & 9-11 & 21-22

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ANSWERS: 1 Schedule I: no accepted medical use in the

US; therefore, cannot be prescribed, administered or dispensed for medical use; no evidence of safety; high potential for abuse

Schedule II-V: some accepted medical use and can be prescribed, administered, or dispensed for medical use; High potential for abuse; descending order (II > III > IV >V)

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ANSWERS: 1 Schedule III:

<15mg of hydrocodone (Vicodin® & Lortab®)

<90mg of codeineBenzodiazepinesSleep aidsMarinol

Schedule IV: narcotics (propoxyphene)

Schedule V:<200mg of codeine/100 ml or g (Robitussin

AC® & Phenergan with codeine®)

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ANSWERS: 2-5 Schedule I: marijuana; heroin; LSD Schedule II: morphine; codeine*; opium; cocaine;

amphetamine Renew DEA registration q3 years Sent 45 days prior to expiration Sent to address on file; will not be forwarded If you don’t receive it w/in 30 days, call 800-882-9539 Relocating: modify application on-line @:

www.DEAdivision.usdoj.gov Schedules II: cannot be refilled on the Rx Schedules III-V: can be refilled on the prescription Up to 5 times w/in 6 mo Fax: in urgent/emergent situations

- printed version within 7 days or mandatory reporting

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PROPER PRESCRIBING PRACTICES

Example: Drug name Strength Dosage form Quantity

- (# and written) Indication Directions # of refills Pt full name & address Physician name, address & DEA # Manually signed

Dr Suremakes Me FeelgoodAny Practice, USA

1-800-cal-ford

Patient: Wanna FindasuckerAddress: 1 Skid Row Way

Today 2011

Hydrocodone/Acetamenophin 5/500 mg1 tab po q4 hrs PRN painDisp: #20 tabs (Twenty Tabs) – NO REFILLSDispense as written Substitution

Suremakes M. Feelgood, M.D.

DEA Practitioners Manual 2006; pg. 18

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PROPER PRESCRIBING PRACTICES

Federal courts expect a “legitimate medical purpose in the usual course of professional practice”

Must Do’s: DO prescribe for legitimate medical reasons DO document history & physical examination DO screen for substance abuse – SBIRT DO use proper prescription writing techniques DO keep prescription blanks in a safe place where

they cannot be stolen DO use ONLY 1 tamper-resistant prescription pad

at a timeDEA Practitioners Manual 2006 ed.

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PROPER PRESCRIBING PRACTICES

DO use electronic prescriptions when possible DO give informed consent to EVERY patient DO require for ALL chronic pain pts:

- Signed “CPD agreement”- Random or routine urine drug screens- Check PDMP on every visit

DO keep meticulous records DO require pt to use one pharmacy DO know/communicate with the pharmacist(s)

DEA Practitioners Manual 2006 ed.

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PROPER PRESCRIBING PRACTICES

Must AVOID: AVOID prescribing controlled drugs at intervals

inconsistent with legitimate medical treatment* AVOID large quantities of CPD* AVOID large numbers of prescriptions issued*

(*compared to other physicians) AVOID warning patients to fill prescriptions at

different drug stores AVOID prescribing drugs when there is NO

relationship between the drugs prescribed and condition being treated.

DEA Practitioners Manual 2006 ed.

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PROPER PRESCRIBING PRACTICES

Never Do’s: NEVER issue prescriptions to patients known to

divert drugs NEVER issue prescriptions in exchange for sexual

favors, money, or gifts NEVER prescribe CPD for family members NEVER use prescription blanks for writing notes NEVER sign blank prescriptions and leave with

others

DEA Practitioners Manual 2006 ed.

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OFFICE PRACTICESFollow the CSA – PM guidelinesTrain nurses/office managers to recognize the

drug-seeking ptPlace copy of DEA regulations in office waiting

roomSet new pt rules – E.g.: No CPD on first visitsScan photo ID for every pt with CPD useUse PDMP for all pts: http://prescriptionmonitoring.state.tn.us

https://prescriptionmonitoring.state.tn.us

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OFFICE PRACTICESUse the 4 step approach for EVERY new patient Implement full SBIRT for all (+) screens of SUAssess the 4 A’s on EVERY f/u visitProvide patient info on drug use, dependence,

and abuseSet minimum documentation standardsSystem for reporting drug diversion – contact

DEA field office regarding suspicious prescription activities

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FOUR STEP APPROACH Step 1:

Workup (Hx & PE)- Pain scale- Labs, studies, etc.

Appropriate screening- Individual- Family

Step 2: Full SBIRT – if a

screen (+)

Step 3: Develop plan of care

– WHO & Adjuvants Informed consent Reassessment

criteria

Step 4: Document PACT (Presenting complaint;

Additional information; Confirm diagnosis; Therapeutic decision)

4 A’s – f/u visits

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SBIRT

Table 3: Definition and Components of SBIRTS Screening – Screening patients at risk for substance

abuse; inquiring about family history of addiction; using screening tools such as the NIAA 1-question screening tool for alcohol use, AUDIT, CAGE, CRAFT for adolescents, etc.

BI Brief Intervention - Establish rapport with pt; ask permission; raise subject; explore pros/cons; explore discrepancies in goals; assess readiness to change; explore options for change; negotiate a plan for change-(motivational interviewing)

RT Referral to Treatment – For patients responding positively to the screening tests, refer to AA, drug addiction clinic, pain clinic, counseling, etc.

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SBIRT Screening tools

NIAA CAGEMAST AUDITT-ACE CRAFTPittsburg*

Have you ever or do you currently use ___________ (tobacco, marijuana, ETOH, crack, cocaine, speed/amphetamines, other street drugs, CPD)?

Motivational Interviewing

SBIRT

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MD Consult L.L.C.   http://www.mdconsult.com Bookmark URL: /das/book/view/14899700/959/I366.fig/top

Nonopiod +/- Adjuvant

Opiod for mild-moderate pain + Nonopiod +/- Adjuvant

Opiod for moderate-severe pain +/- Nonopiod +/- Adjuvant

Pain persisting or increasing

Pain persisting or increasing

Freedom from pain

Pain

NSAIDsAcetaminophen

OxycodoneHydrocodoneCodeine

MSO4 SR/ Fentanyl patch, with MSO4 IR (etc.) for breakthrough

ADJUVANT TREATMENTS

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ADJUVANT THERAPIES Exercise/PT TCAs Gabapentin (Neurontin) Pregabalin (Lyrica) Valproate (Depakote) TENS unit Bisphosphonates Accupuncture Chiropractor Neutraceuticals

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CHRONIC PAIN:F/U ASSESSMENT – 4 A’S

Analgesia Activities Adverse Events Aberrancy

Created by the VUMC FPWC Prescribing Policy Team. Dewey, Jackson, Mullins, Garriss, Gregory and Gregg, 2010.

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ABERRANCY Something you didn’t expect…

Early refill (+) or (-) UDSFailed contractOther

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FOLLOW UP – 4 A’S Physical dependence and tolerance are

normal physiological consequences of extended opioid therapy for pain and are not the same as addiction

UseTolerance

DependencePseudoaddictio

n≠ Abuse

Addiction

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BOUNDARIES AND PRACTICE

1. 1 & 2 above2. CPD Agreement3. UDS4. PDMP5. Adjuvant Trx

1. 1 & 2 above2. CPD Agreement,

UDS, PDMP, Adj Trx3. Referrals

1. Four Step Approach2. Proper Prescribing

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SUSPECT DRUG-SEEKING BEHAVIOR

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DRUG SEEKING BEHAVIORS

1. Transient-passing through

2. Feigns physical or psychological problems

3. Pressures the physician for a particular drug or multiple refills of a prescription

4. Red flags in presentation and PE findings

5. Assertive personality/demanding/overacting

Ref: Pocket card

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DRUG SEEKING BEHAVIORS

6. Unwilling to provide references/medical records

7. No PCP

8. Cutaneous signs of drug use

9. Has no interest in diagnosis

10. Rejects all forms of treatment that do not involve narcotics

Ref: Pocket card

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PROPER PRESCRIBING

“Its not what you prescribe, but how well you manage the patient’s care, and document that care in legible

form, that is important.”

First distributed by Minnesota BME in 1990, then taken by the North Carolina BME and then adopted by the Tennessee BME

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Q&A

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SUMMARY CPD epidemic is real and is costly to pts and

our community Physicians are the #1 reason for excess

CPD on the streets Apply proper prescribing rules from the

practitioner’s manual into individual and office practices

Be on guard for drug seekers and know the proper procedure to take if identified