The Proper Prescribing of Controlled Prescription Drugs

1. The Proper Prescribing of Controlled Prescription Drugs 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

2. Introduction • Which doctor is at risk of mis-prescribing?

3. 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.

4. Objectives Be the end of the session participants will be able to: • 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

5. Agenda • Introduction: the CPD problem • CSA • Proper prescribing practices – using the PM • Individual • Office • Q&A • Summary

6. 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

7. 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

8. 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

9. Introduction • 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

10. 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

11. 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 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).

12. Introduction 4% <1% 9% 56% 19% SAMHSA 2006

13. 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

14. 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

15. 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

16. The DEA

17. 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.

18. 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: • 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

19. 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!

20. Controlled Substances Act (CSA) • Monitors: • Diversion to Illicit Use • Self • Others • Maintenance of addictions • Latrogenicaddictions • Five (5) schedules • I-V • Addictive potential • Rules on schedule IIs http://www.justice.gov/dea/concern/narcotics.html

21. Examples: Schedule I Drugs

22. Examples: Schedule II Drugs

23. Examples: Schedule III Drugs

24. DEAOffice of Diversion Control 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

25. Test Your Knowledge • 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

26. 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)

27. Answers: 1 • 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®)

28. 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

29. Patient: Wanna Findasucker Address: 1 Skid Row Way Today 2011 Hydrocodone/Acetamenophin 5/500 mg 1 tab po q4 hrs PRN pain Disp: #20 tabs (Twenty Tabs) – NO REFILLS Suremakes M. Feelgood, M.D. Dispense as written Dr Suremakes Me Feelgood Any Practice, USA 1-800-cal-ford Substitution 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 DEA Practitioners Manual 2006; pg. 18

30. 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 time DEA Practitioners Manual 2006 ed.

31. 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.

32. 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.

33. 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.

34. Office Practices • 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.ushttps://prescriptionmonitoring.state.tn.us

35. Office Practices • 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

36. Circumscribed Medical Illness

37. Four Step Approach • 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 • Step 1: • Workup (Hx & PE) • Pain scale • Labs, studies, etc. • Appropriate screening • Individual • Family • Step 2: • Full SBIRT – if a screen (+)

38. SBIRT

39. SBIRT • Screening tools • NIAA CAGE • MAST AUDIT • T-ACE CRAFT • Pittsburg* • Have you ever or do you currently use ___________ (tobacco, marijuana, ETOH, crack, cocaine, speed/amphetamines, other street drugs, CPD)? • Motivational Interviewing SBIRT

40. Freedom from pain Opiod for moderate-severe pain +/- Nonopiod +/- Adjuvant MSO4 SR/ Fentanyl patch, with MSO4 IR (etc.) for breakthrough Pain persisting or increasing Opiod for mild-moderate pain + Nonopiod +/- Adjuvant Oxycodone Hydrocodone Codeine Pain persisting or increasing Nonopiod +/- Adjuvant NSAIDs Acetaminophen Pain Adjuvant Treatments MD Consult L.L.C.   http://www.mdconsult.com Bookmark URL: /das/book/view/14899700/959/I366.fig/top

41. Adjuvant Therapies • Exercise/PT • TCAs • Gabapentin (Neurontin) • Pregabalin (Lyrica) • Valproate (Depakote) • TENS unit • Bisphosphonates • Accupuncture • Chiropractor • Neutraceuticals

42. 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.

43. Aberrancy • Something you didn’t expect… • Early refill • (+) or (-) UDS • Failed contract • Other

44. 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 Use Tolerance Dependence Pseudoaddiction ≠ Abuse Addiction

45. Boundaries and Practice Four Step Approach Proper Prescribing 1 & 2 above CPD Agreement UDS PDMP Adjuvant Trx 1 & 2 above CPD Agreement, UDS, PDMP, AdjTrx Referrals

46. Suspect Drug-Seeking Behavior

47. Drug Seeking Behaviors • 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

48. Drug Seeking behaviors • Unwilling to provide references/medical records • No PCP • Cutaneous signs of drug use • Has no interest in diagnosis • Rejects all forms of treatment that do not involve narcotics Ref: Pocket card

49. 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

50. Q&A