Opioid Management

Ashok Kumar MD FACP.Associate Professor

Dept of Internal MedicineSanford Medical School

UNDERSTAND THE EXTENT OF UNINTENTIONAL EXCESSIVE USE OF OPIOIDS IN OUR PRACTICE AND ABUSE BY PATIENTS

Analyze the risk versus benefit of high dose opioid use in chronic non-cancer pain (CNCP)

Discuss implementation of an opioid surveillance program targeted at patients currently receiving high dose opioids

LEARN SAFE UTILIZATION OF OPIOIDS IN PAIN MANAGEMENT

PRESENTATION OBJECTIVE

TREATMENT GOAL

Reduce abuse and overdose of opioids and other controlled prescription drugs while ensuring patients with pain are safely and effectively treated.

22,134 prescription drug overdose deaths in 2010◦ Opioid analgesics

75% of Rx overdose deaths (16,651) 76% increase in opioid overdose deaths than in 1999

(4,030 deaths)◦ Other medication classes highly associated with

overdose deaths Benzodiazepines Antidepressants Antipsychotics

2012 CDC Update

Develop and Test

Prevention Strategies

Identify Risk and Protective

Factors

Define the Problem

Ensure Widespread

Adoption

The Public Health Approach to Prevention

Rates of Opioid Overdose Deaths, Sales, and Treatment Admissions, United States, 1999–2010

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100

1

2

3

4

5

6

7

8

Opioid Sales KG/10,000 Opioid Deaths/100,000Opioid Treatment Admissions/10,000

Year

Rate

CDC. MMWR 2011. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm60e1101a1.htm?s_cid=mm60e1101a1_w. Updated with 2009 mortality and 2010 treatment admission data.

National Data◦ Nearly 15,000 people die yearly from Rx opioid

overdoses Deaths now outnumber motor vehicle accidents Deaths outnumber combined deaths from heroin plus

cocaine◦ Enough opioid analgesics were prescribed in 2010

to treat every adult around the clock for 1 month in the U.S.

◦ The excessive use of opioid analgesics has now been labeled an “epidemic”

Background, Relevance, & Importance

CDC. Vital Signs. Novermber 2011. Available from: http://www.cdc.gov/vitalsigns

Motor Vehicle Traffic, Poisoning, and Drug Poisoning (Overdose) Death RatesUnited States, 1980–2010

NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.

1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 20100

5

10

15

20

25

Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose)

Year

Dea

ths

per

100,

000

popu

lati

on

Deaths Related to Drug Overdoses

CDC. Vital Signs. November 2011. Available from: http://www.cdc.gov/vitalsigns

Opioid Prescriptions Dispensed by Retail Pharmacies—United States, 1991–2011

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

0

50

100

150

200

250

76 78 80 86 91 96 100109

120131

139 144 151 158169

180192

201 202210

219

Year

Num

ber

of P

resc

ript

ions

(in

mill

ions

)

IMS Vector One. From “Prescription Drug Abuse: It’s Not what the doctor ordered.” Nora Volkow National Prescription Drug Abuse Summit, April 2012. Available at http://www.slideshare.net/OPUNITE/nora-volkow-final-edits.

2012 MOST RX PRESCRIPTIONS QUANTITY QUANITIY/RX

Hydrocodone/APAP 295,073 16,675,025 57Zolpidem 102,625 3,293,422 32Lorazepam 86,333 4,083,256 47Clonazepam 74,990 4,625,870 62Alprazolam 58,837 3,417,895 58Methylphenidate 50,964 2,297,922 45Amphetamine 46,547 2,075,441 45Oxycodone/APAP 44,966 2,753,411 61Oxycodone 42,852 3,533,264 82APAP/Codeine 37,527 1,439,872 40

TOP 10 CONTROLLED SUBSTANCES IN SD BY NUMBER OF DOSES DISPENSED : 2012

Trends for Drug Use and Death

CDC. Vital Signs. November 2011. Available from: http://www.cdc.gov/vitalsigns. Goodman, F. THE TALK. Opioid Trial Exit Strategy. VA PBM December 18,2012.

DEATHS FROM UNINTENTIONAL OVER DOSE OF MEDICATIONS ARE INCREASING OVER

THE YEARS

PROBLEM

Develop and Test

Prevention Strategies

Identify Risk and Protective

Factors

Define the Problem

Ensure Widespread

Adoption

The Public Health Approach to Prevention

High Risk Populations People taking high daily doses of opioids People who “doctor shop” People using multiple abusable substances like

opioids, benzodiazepines, other CNS depressants, illicit drugs

Low-income people and those living in rural areas Medicaid populations People with substance abuse or other mental

health issues

White AG, Birnbaum HG, Schiller M, Tang J, Katz NP. Analytic models to identify patients at risk for prescription opioid abuse. Am J Managed Care 2009;15(12):897-906. Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA 2008;300(22):2613-20. Paulozzi LJ, Logan JE, Hall AJ, et al. A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia. Addiction 2009;104(9):1541-8. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011;305(13):1315-1321.

Middle-aged adults◦ Men: higher risk

People living in rural areas◦ Twice as likely to overdose on Rx painkillers

Whites and Native Americans◦ Most likely ethnicities to overdose

1 in 10 Native Americans report using opioid analgesics for nonmedical purposes in 2010

Large percentage of VA Black Hills patients

Patient Population Most at Risk

CDC. Vital Signs. November 2011. Available from: http://www.cdc.gov/vitalsigns

WHEN DOES THE RISK OUTWAY BENEFIT?

Three studies have assessed dose cutoffs for safety◦ Bohnert et al. Association Between Opioid

Prescribing Patterns and Opioid Overdose-Related Deaths. 2011

◦ Dunn et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010

◦ Gomes et al. Opioid Dose and Drug-Related Mortality in Patients With Nonmalignant Pain. Arch Intern Med. 2011

High Opioid Dose and Overdose Risk

1 - 19 mg/d 20 - 49 mg/d 50 - 99 mg/d ≥100 mg/d0

2

4

6

8

10

12

Morphine MG Equivalent Dose

Adju

sted

Haz

ard

Rati

o

Dunn et al. Opioid prescriptions for chronic pain and overdose. Ann Int Med 2010;152:85-92.

1.00 1.19

3.11

11.18

* Overdose defined as death, hospitalization, unconsciousness, or respiratory failure.

Doses over 50 mg ME daily◦ Increased risk for overdose or death

Doses over 100 mg ME◦ Further elevation in risk of overdose or death

Doses above 100 mg ME daily where risk elevates the most?◦ Doses greater than 200 mg ME daily provide the

most risk◦ Unknown what dose above 200 infers highest risk

Risk of death and overdose-related adverse events is highly associated with total daily dose

Summary of Study Safety Information

Bohnert et al. Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths. 2011Dunn et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010Gomes et al. Opioid Dose and Drug-Related Mortality in Patients With Nonmalignant Pain. Arch Intern Med. 2011

The Public Health Approach to Prevention

Develop and Test

Prevention Strategies

Identify Risk and Protective

Factors

Define the Problem

Ensure Widespread

Adoption

BLACK HILLS VA INITIATIVE

VA Black Hills◦ Highest utilizer of oxycodone SA in VISN 23◦ 2nd highest utilizer of long-acting opioids in VISN 23

VISN 23 ◦ 4th highest user of oxycodone SA

August 2012 VA Black Hills dispensing numbers (for perspective)◦ 136,128 opioid analgesic tablets dispensed

Does not include: Any codeine formulation Cough syrup Fentanyl patches

◦ 77,000 tablets containing oxycodone ◦ 6500 tablets of oxycodone SA

VA Black Hills Specific Information

200-400 400-600 601-800 801-1000 1001 or more

0

5

10

15

20

25

30

35

4035

12

3 42

32

11

13 2

Jan-13

Apr-13

Morphine Equivalents

Num

ber

of P

atie

nts

Contraband-Sales, Manufactur-ing; 7

Contraband-Drug Possession; 3

Forgery-Counterfeiting; 1

Fraud; 2

Information Joint Lawen-forcement Investigation; 1

Non-Criminal-Information; 10

Non-Criminal-Joint Law Officer Assist; 1

Non-Criminal-Staff Assist; 6

Larceny-Theft;Actual Drug Theft-Controled Substance; 12

HEALTH CARE l Defining EXCELLENCE in the 21st Century

BHVAPD Drugs 2012

American Pain Society

American Society of Interventional Pain Physician

s

VA/DoD Guidelin

es

Canadian Pain

Guidelines

High dose:

200 mg morphin

e equivalents (ME)

daily

Opioid Analgesic Dosing: What is high dose?

30

Focus on patients receiving oxycodone SA◦ Convert to alternative analgesics as

appropriate Eliminate new prescribing of oxycodone SA

◦ It is a nonformulary agent ◦ Utilize other analgesics

Focus on patients receiving greater than 200mg ME daily◦ Dose reduction to less than or equal to 200

mg ME daily

Identified as Next Steps by VISN CMO

Minneapolis VA◦ 200 mg ME daily◦ Believed that other VAs have gone to this cutoff as well

Orlando VA◦ Currently seeking P&T for approval of 200 mg ME daily

cutoff State of Washington

◦ 120 mg ME daily For doses over 120 mg ME daily, Patient must

Demonstrate improved functionor

Seek pain consultation

What Cutoffs Have Others Used?

VA DIRECTOR SENT A LETTER TO ALL PATINTS ABOUT THE ISSUE OF OPIOD USE IN THE VA FOR CHRONIC PAIN , AND THE ASSOCIATED INCREASED RISKS INCLUDING DEATH

POSTERS AT VA ENTERANCE AND AT PATIENT WAITING AREAS

PROVIDER EDUCATION

ELECTRONIC TEMPLATE CREATED FOR DOSE REDUCTION

PROCESS IMPLEMENTED

Chart review assessed patients receiving oxycodone SA◦ Excluded patients with active cancer

Chart review assessed patients receiving ≥ 200 mg ME daily◦ Excluded patients with active cancer

Provided education regarding safety◦ High dose opioid analgesic use for CNCP

Opioid analgesic tapering and oxycodone SA conversions

Current Processes

Random decrease in dose without patient education at a face to face encounter

STRATEGIES THAT WAS NOT EFFECTIVE

Prescription Drug Monitoring Programs (PDMPs)

Operational in 42 states

Focus PDMPs on Patients at highest

risk of abuse and overdose

Prescribers who clearly deviate from accepted medical practice

Implement PDMP best practices

CAUTION FEDERAL PRACTIONERS CAN GET DATTA ON

PRESCRIPTIOS FROM PRIVATE SECTOR BUT NOT THE OTHER WAY AROUND

PRACTIONERS CAN CALL VA TO GET PRESCRIPTION INFORMATION ON VA PATIENTS.

Patient Review and Restriction Programs(aka “Lock-In” Programs)

Applies to patients with inappropriate use of controlled substances

1 prescriber and 1 pharmacy for controlled substances

Improve coordination of care and ensure appropriate access for patients at high risk for overdose

Evaluations show cost savings as well as reductions in ED visits and numbers of providers and pharmacies

Appropriate uses of pain medication

Risk/benefit framework

Screening tools Epidemiology of

prescription drug abuse

Expectations of opioid treatment

Universal precautions approach

Treatment agreements

Signs of possible abuse vs. under-treatment of pain

Discontinuing treatment/proper disposal

Safe Prescribing for Pain

Clinical Guidelines Improve prescribing and treatment Basis for standard of accepted medical

practice for purposes of licensure board actions

Several consensus guidelines available Common themes among guidelines

Adverse events and death associated with opioid analgesic use have increased substantially over the past 20 years

Risk of opioid-related adverse events increases with dose

◦ Doses greater than 50 mg ME daily show elevated risk◦ Highest risk appears to be in those on more than 200 mg ME daily

Risk stratify your patient population on opioids

Implement a structured stepwise program to reduce dose in patients on high dose

Conclusion