Charlene M. Dewey, M.D., M.Ed., FACP Associate Professor of Medical Education and Administration Associate Professor of Medicine Co-Director, Center for Professional Health Vanderbilt University.

Transcript Charlene M. Dewey, M.D., M.Ed., FACP Associate Professor of Medical Education and Administration Associate Professor of Medicine Co-Director, Center for Professional Health Vanderbilt University.

Charlene M. Dewey, M.D., M.Ed., FACP

Associate Professor of Medical Education and Administration Associate Professor of Medicine Co-Director, Center for Professional Health Vanderbilt University Medical Center September 2011

 Which doctor is at risk of mis-prescribing?

 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.

Be the end of the session participants will be able to: 1.

Discuss the CPD use/misuse epidemic in the US and TN Apply proper prescribing rules from the practitioner’s manual in their individual and office practices Identify behaviors associated with drug seekers

Introduction: the CPD problem CSA Proper prescribing practices – using the PM  Individual  Office Q&A Summary

 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

 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

 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

 Americans = 4.6% of world’s population  Use 66% of world’s illicit drugs  Use 80% of global opioid supply  Use 99% of global hydrocodone supply 2006 National Survey on Drug Abuse and Health, SAMHSA

 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

 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 pharmacies  drug theft  prescription 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).

SAMHSA 2006 4% <1%

9% 19% 56%

Given free from a friend or relative

Given by a single doctor

Bought from a friend or relative Bought from stranger/dealer Internet

 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

 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

“

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

 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

 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 The prevention, detection, and investigation of the

diversion of controlled substances

from legitimate channels

 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!

 Monitors: 1.

Diversion to Illicit Use Self Others Maintenance of addictions Latrogenic addictions  Five (5) schedules  I-V  Addictive potential  Rules on schedule IIs http://www.justice.gov/dea/concern/narcotics.html

Schedule 1 Substance 1-Methyl-4-phenyl-4 propionoxypiperidine DEA Number Non Narcotic 9661 Gama Hydroxybutyric Acid (GHB) 2010 Heroin Lysergic acid diethylamide Marijuana Myrophine Psilocybin 9200 7315 7360 9308 7437 N N N N Other Names MPPP, synthetic heroin GHB, gama hydroxybutyrate, sodium oxybate Diacetylmorphine, diamorphine LSD, lysergide Cannabis, marijuana Constituent of "Magic mushrooms"

Amobarbital Amphetamine Cocaine Codeine Fentanyl Hydrocodone Hydromorphone Meperidine Methadone Methadone intermediate Methamphetamine 2125 N 1100 N 9041 9050 9801 9193 9150 9230 9250 9254 1105 N Methylphenidate Morphine Opium, raw Oxycodone Oxymorphone Pentobarbital Phencyclidine 1724 N 9300 9600 9143 9652 2270 N 7471 N Schedule II Amytal, Tuinal Dexedrine, Biphetamine Methyl benzoylecgonine, Crack Morphine methyl ester, methyl morphine Innovar, Sublimaze, Duragesic dihydrocodeinone Dilaudid, dihydromorphinone Demerol, Mepergan, pethidine Dolophine, Methadose, Amidone Methadone precursor Desoxyn, D-desoxyephedrine, ICE, Crank, Speed Ritalin MS Contin, Roxanol, Duramorph, RMS, MSIR Raw opium, gum opium OxyContin, Percocet, Tylox, Roxicodone, Roxicet, Numorphan Nembutal PCP, Sernylan

Anabolic steroids Barbituric acid derivative Schedule III 4000 2100 Butalbital 2100 Codeine combination product 90 mg/du 9804 N "Body Building" drugs N Barbiturates not specifically listed N Fiorinal, Butalbital with aspirin Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine Hydrocodone combination product 15 mg/du Lysergic acid Chlordiazepoxide Clonazepam Clorazepate Dexfenfluramine Dextropropoxyphene dosage forms Diazepam Dichloralphenazone Diethylpropion Lorazepam Lormetazepam Modafinil Pentazocine Temazepam Triazolam Zaleplon Zolpidem 9806 7300 2744 2737 2768 1670 9278 2765 2467 1610 2885 2774 1680 9709 2925 2887 2781 2783 Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia ++ N LSD precursor N Librium, Libritabs, Limbitrol, SK-Lygen N Klonopin, Clonopin N Tranxene N Redux Darvon, propoxyphene, Darvocet, Dolene, Propacet N Valium, Valrelease N Midrin, dichloralantipyrine N Tenuate, Tepanil N Ativan N Noctamid N Provigil N Talwin, Talwin NX, Talacen, Talwin Compound N Restoril N Halcion N Sonata N Ambien, Stilnoct,Ivadal

Practitioner’s Manual

An 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

What constitutes schedule I or other schedules assignments for drugs?

Identify the schedule for each of the following:  Marijuana; morphine; heroin; codeine; LSD; opium; amphetamine; cocaine How often do you renew your DEA registration and what happens if you move?

Which schedules can be refilled?

Can you fax CPD prescriptions?

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

 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)

 Schedule III:  <15mg of hydrocodone (Vicodin ® & Lortab®)  <90mg of codeine  Benzodiazepines  Sleep aids  Marinol  Schedule IV:  narcotics (propoxyphene)  Schedule V:  <200mg of codeine/100 ml or g (Robitussin AC® & Phenergan with codeine®)

 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

 Example: Patient: Wanna Findasucker Address: 1 Skid Row Way Today 2011  Drug name  Strength  Dosage form  Quantity (# and written)  Indication  Directions  # of refills Hydrocodone/Acetamenophin 5/500 mg 1 tab po q4 hrs PRN pain Disp: #20 tabs (Twenty Tabs) – NO REFILLS Dispense as written Suremakes M. Feelgood, M.D.

Dr Suremakes Me Feelgood Any Practice, USA 1-800-cal-ford Substitution  Pt full name & address  Physician name, address & DEA #  Manually signed DEA Practitioners Manual 2006; pg. 18

 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 time DEA Practitioners Manual 2006 ed.

 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.

 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.

 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.

 Follow the CSA – PM guidelines  Train nurses/office managers to recognize the drug-seeking pt  Place copy of DEA regulations in office waiting  room Set new pt rules – E.g.: No CPD on first visits  Scan photo ID for every pt with CPD use  Use PDMP for all pts: http://prescriptionmonitoring.state.tn.us

https://prescriptionmonitoring.state.tn.us

 Use the 4 step approach for EVERY new patient  Implement full SBIRT for all (+) screens of SU  Assess the 4 A’s on EVERY f/u visit  Provide patient info on drug use, dependence, and abuse  Set minimum documentation standards  System for reporting drug diversion – contact DEA field office regarding suspicious prescription activities

 Step 1:  Workup (Hx & PE) Pain scale Labs, studies, etc.

 Appropriate screening Individual Family  Step 3:  Develop plan of care – WHO & Adjuvants  Informed consent  Reassessment criteria  Step 2:  Full SBIRT – if a screen (+)  Step 4:  Document   PACT (Presenting complaint; Additional information; Confirm diagnosis; Therapeutic decision) 4 A’s – f/u visits

Table 3: Definition and Components of SBIRT S

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 RT

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)

Referral to Treatment

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



Screening tools



NIAA



CAGE



MAST



T-ACE



Pittsburg*



AUDIT



CRAFT



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



Motivational Interviewing

MSO 4 SR/ Fentanyl patch, with MSO 4 IR (etc.) for breakthrough Oxycodone Hydrocodone Codeine

Freedom from pain

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

Pain persisting or increasing

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

Pain persisting or increasing

NSAIDs Acetaminophen Nonopiod +/- Adjuvant

Pain

MD Consult L.L.C. http://www.mdconsult.com

Bookmark URL:

/das/book/view/14899700/959/I366.fig/top

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

 Analgesia  Activities  Adverse Events  Aberrancy Created by the VUMC FPWC Prescribing Policy Team. Dewey, Jackson, Mullins, Garriss, Gregory and Gregg, 2010.

 Something you didn’t expect…  Early refill  (+) or (-) UDS  Failed contract  Other



Physical dependence and tolerance are

normal

physiological consequences of extended opioid therapy for pain and are

not the same as addiction

Use Tolerance Dependence Pseudoaddiction ≠ Abuse Addiction

1. Four Step Approach 2. Proper Prescribing 1. 1 & 2 above 2. CPD Agreement 3. UDS 4. PDMP 5. Adjuvant Trx 1. 1 & 2 above 2. CPD Agreement, UDS, PDMP, Adj Trx 3. Referrals

Transient-passing through Feigns physical or psychological problems Pressures the physician for a particular drug or multiple refills of a prescription Red flags in presentation and PE findings Assertive personality/demanding/overacting

Ref: Pocket card

Unwilling to provide references/medical records No PCP

Cutaneous signs of drug use Has no interest in diagnosis

10.

Rejects all forms of treatment that do not involve narcotics