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The Prescription <strong>Dr</strong>ug Overdose Epidemic<br />

and the Role <strong>of</strong> <strong>PDMP</strong>s in Stopping It<br />

<strong>Len</strong> <strong>Paulozzi</strong>, MD, MPH<br />

National <strong>Center</strong> for Injury Prevention and Control<br />

<strong>Center</strong>s for Disease Control and Prevention<br />

National <strong>Center</strong> for Injury Prevention and Control<br />

Division <strong>of</strong> Unintentional Injury Prevention<br />

1


The Public Health Model<br />

New or<br />

Persistent<br />

Problem<br />

Identified<br />

Remediable<br />

Risk Factors<br />

Identified<br />

Surveillance<br />

and<br />

Assessment<br />

Interventions<br />

Developed<br />

and Tested<br />

for Efficacy<br />

Proven<br />

Interventions<br />

Tested for<br />

Effectiveness<br />

2


Early surveillance data failed to detect a<br />

problem: DAWN 1990-1996, (Joranson, 2000)<br />

3


Perhaps because some data was left out:<br />

DAWN 1990-1998 data available when<br />

Joranson et al (2000) published<br />

4


Identifying the problem <strong>of</strong> prescription drug<br />

overdoses: First report, North Carolina, 2002<br />

5


Identifying the problem <strong>of</strong> prescription drug<br />

overdoses: Second Report, Maine, 2002<br />

6


Rate <strong>of</strong> unintentional drug overdose death in<br />

the United States, 1970-2007<br />

Death rate per 100,000<br />

10<br />

9<br />

8<br />

7<br />

6<br />

5<br />

4<br />

3<br />

2<br />

1<br />

0<br />

'70 '72 '74 '76 '78 '80 '82 '84 '86 '88 '90 '92 '94 '96 '98 '00 '02 '04 '06<br />

7


Number <strong>of</strong> <strong>of</strong> drug-induced deaths deaths compared compared with with other types<br />

<strong>of</strong> deaths, US, 1999-2006<br />

other types <strong>of</strong> deaths, US, 1999-2006<br />

8


Unintentional overdose deaths involving opioid<br />

analgesics now exceed the sum <strong>of</strong> deaths<br />

involving heroin or cocaine<br />

Number <strong>of</strong> deaths<br />

14,000<br />

12,000<br />

10,000<br />

8,000<br />

6,000<br />

4,000<br />

2,000<br />

0<br />

Opioid analgesic<br />

Cocaine<br />

Heroin<br />

'99 '00 '01 '02 '03 '04 '05 '06 07<br />

Source: National Vital Statistics system, multiple cause <strong>of</strong> death dataset<br />

9


Unintentional overdose deaths involving opioid<br />

analgesics parallel per capita sales <strong>of</strong> opioid<br />

analgesics in morphine equivalents <strong>by</strong> year,<br />

U.S., 1997-2007<br />

14000<br />

12000<br />

10000<br />

8000<br />

6000<br />

4000<br />

2000<br />

0<br />

Number <strong>of</strong><br />

Deaths<br />

'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07<br />

*<br />

Opioid sales (mg/<br />

person)<br />

800<br />

700<br />

600<br />

500<br />

400<br />

300<br />

200<br />

100<br />

0<br />

Source: National Vital Statistics System, multiple cause <strong>of</strong> death dataset, and DEA ARCOS<br />

* 2007 opioid sales figure is preliminary.<br />

10


Opioid-analgesic-related death rates in 1999-2004<br />

and opioid analgesic prescription rates in 2002<br />

among men, Kentucky (<strong>PDMP</strong> data courtesy <strong>of</strong><br />

KASPER)<br />

11


Estimated numbers <strong>of</strong> ED visits for misuse or<br />

abuse <strong>of</strong> drugs <strong>by</strong> drug type, DAWN,<br />

United States, 2008<br />

Source: <strong>Dr</strong>ug Abuse Warning Network<br />

12


Age-specific rates <strong>of</strong> ED visits for nonmedical use <strong>of</strong><br />

opioid analgesics (OAs) and benzodiazepines (BZDs) ---<br />

DAWN, United States, 2004 and 2008<br />

MMWR June 18, 2010


Past month nonmedical use <strong>of</strong> prescription pain<br />

relievers <strong>by</strong> age group, NSDUH, 2002-2009<br />

18-25<br />

12-17<br />

12+


Past year initiates for specific illicit drugs<br />

among persons aged 12 or older –<br />

NSDUH 2008


Most recent source used <strong>by</strong> past year nonmedical<br />

users <strong>of</strong> pain relievers aged 12 or older,<br />

NSDUH, 2009<br />

NSDUH summary <strong>of</strong> national findings, 2009<br />

16


Health outcomes related to opioid analgesics,<br />

United States, 2007-2009<br />

>11,499<br />

~1,854,000<br />

Deaths: NVSS 2007; Treatment admissions are for primary use <strong>of</strong> opioids, TEDS data, 2008;<br />

ED visits are DAWN 2008; Abuse/dependence and nonmedical use past month are NSDUH 2009<br />

17


The Public Health Model<br />

New or<br />

Persistent<br />

Problem<br />

Identified<br />

Remediable<br />

Risk Factors<br />

Identified<br />

Surveillance<br />

and<br />

Assessment<br />

Interventions<br />

Developed<br />

and Tested<br />

for Efficacy<br />

Proven<br />

Interventions<br />

Tested for<br />

Effectiveness<br />

18


The Public Health Model<br />

New or<br />

Persistent<br />

Problem<br />

Identified<br />

Remediable<br />

Risk<br />

Factors<br />

Identified<br />

Surveillance<br />

and<br />

Assessment<br />

Interventions<br />

Developed<br />

and Tested<br />

for Efficacy<br />

Proven<br />

Interventions<br />

Tested for<br />

Effectiveness<br />

19


Top Three Opioids in Overdose Deaths<br />

State Year <strong>of</strong> Deaths 1st 2nd 3rd <br />

North Carolina 2001 Meth 80 Oxy 41 Hydro


Characteristics <strong>of</strong> unintentional pharmaceutical<br />

overdose deaths,<br />

West Virginia, 2006<br />

Characteristic No. (%)<br />

History <strong>of</strong> substance abuse 231 (78.3)<br />

Other mental illness 126 (42.7)<br />

Any rx drug involved with no prescription 186 (63.1)<br />

Nonmedical route <strong>of</strong> administration 66 (22.4)<br />

5+ prescribers <strong>of</strong> controlled substances/yr 63 (21.4)<br />

Previous overdose 50 (16.9)<br />

Total 295 (100.0)<br />

Sources: Hall et al, JAMA, 2008 and Toblin et al, J Clin Psych, 2010<br />

21


Characteristics <strong>of</strong> unintentional drug overdose<br />

deaths, Ohio, 2006-8<br />

Characteristic %<br />

Filled prescriptions from an average <strong>of</strong> five<br />

prescribers/year over 3 years among deaths <strong>of</strong><br />

patients in state <strong>PDMP</strong> (N=1,047)<br />

No prescription in the <strong>PDMP</strong> for an opioid among<br />

prescription opioid-related deaths (N=508)<br />

No prescription in the <strong>PDMP</strong> for methadone<br />

among methadone-related deaths (N=157)<br />

16<br />

25<br />

71<br />

Source: Ohio Department <strong>of</strong> Health at www.healthyohioprogram.org/diseaseprevention/dpoison/drugdata.aspx<br />

22


Risk factors for opioid poisoning/abuse among<br />

privately insured patients,<br />

Maine, last quarter <strong>of</strong> 2006<br />

Behavior during<br />

3 month period<br />

Odds Ratio<br />

(95% confidence<br />

interval)<br />

Use <strong>of</strong> 3+ pharmacies for opioids 1.96 (1.66-2.33)<br />

Rapid opioid dose escalation 1.59 (1.33-1.89)<br />

1+ early refill <strong>of</strong> an opioid<br />

prescription<br />

6.52 (5.39-7.89)<br />

12+ opioid prescriptions in 3 months 2.12 (1.73-2.61)<br />

Source: White et al, Am J Managed Care, 2009;15:897<br />

23


Combined opioid and sedative-hypnotic use<br />

increases risk <strong>of</strong> serious overdose events<br />

Group Health Consort Study, 1997-2005, Dunn et al, 2010<br />

24


High opioid daily dosage increases risk <strong>of</strong><br />

serious overdose events<br />

Group Health Consort Study, 1997-2005, Dunn et al, 2010<br />

25


Non-medical use per 10,000 retail<br />

prescriptions <strong>by</strong> drug, DAWN, 2004 – 2006<br />

* Includes all formulations<br />

Source: National estimates from DAWN, 2004-2006; Verispan VONA<br />

Presentation <strong>by</strong> <strong>Dr</strong>. Catherine Dormitzer to the Anesthetic and Life Support <strong>Dr</strong>ugs and <strong>Dr</strong>ug Safety and Risk<br />

Management Advisory Committees, May 5, 2008<br />

26


Non-medical use per 10,000 retail prescriptions,<br />

oxycodone <strong>by</strong> release type, DAWN, 2004-2006<br />

Sources: National estimates from DAWN, 2004-2006; Verispan VONA<br />

Anesthetic and Life Support <strong>Dr</strong>ugs and <strong>Dr</strong>ug Safety and Risk Management Advisory Committees, May 5,<br />

2008<br />

27


Possible remediable risk factors include:<br />

q Use without a prescription<br />

q Doctor/pharmacy shopping<br />

q Early refills and dose escalation<br />

q Combined use <strong>of</strong> prescription opioids and sedativehypnotics<br />

q Higher daily prescribed opioid dosages<br />

q Use <strong>of</strong> specific opioids or formulations, eg,<br />

methadone or extended-release formulations<br />

q Nonmedical route <strong>of</strong> administration, eg, injection<br />

28


The Public Health Model<br />

New or<br />

Persistent<br />

Problem<br />

Identified<br />

Remediable<br />

Risk Factors<br />

Identified<br />

Surveillance<br />

and<br />

Assessment<br />

Interventions Developed and Tested for<br />

Efficacy<br />

Proven<br />

Interventions<br />

Tested for<br />

Effectiveness<br />

29


State prescription drug monitoring programs<br />

VT<br />

WA*<br />

OR<br />

NV<br />

CA<br />

MT<br />

ID<br />

WY<br />

UT<br />

CO<br />

AZ NM<br />

ND<br />

MN<br />

SD<br />

WI<br />

NE<br />

IA<br />

IL<br />

KS<br />

MO<br />

OK<br />

AR<br />

MS<br />

NY<br />

MI<br />

PA<br />

OH<br />

IN<br />

WV<br />

VA<br />

KY<br />

NC<br />

TN<br />

SC<br />

GA<br />

AL<br />

ME<br />

NH<br />

MA<br />

RI<br />

CT<br />

NJ<br />

DE<br />

MD<br />

DC (no PMP)<br />

AK<br />

TX<br />

LA<br />

FL<br />

Operational <strong>PDMP</strong>s<br />

HI<br />

Enacted <strong>PDMP</strong> legislation, but<br />

program not yet operational<br />

*Washington has temporarily suspended its PMP operations<br />

due to budgetary constraints.<br />

Research is current as <strong>of</strong> July 16, 2010<br />

30


Single-copy, serialized paper prescription<br />

forms


Changes with special prescription forms<br />

during the 1980s<br />

32


Pain clinic laws: LA, TX, and FL<br />

33


Doctor shopping laws<br />

34


Medicaid programs to reduce doctor<br />

and pharmacy shopping<br />

500+<br />

clients<br />


Changes in mean daily dosage <strong>of</strong> opioid<br />

analgesics among Medicaid clients after<br />

enrollment for inappropriate use, WA,<br />

2006<br />

36


Emergency Department Programs to<br />

Manage <strong>Dr</strong>ug-Seeking Patients<br />

37


ED visits per year <strong>by</strong> 40 patients making frequent<br />

visits before and after regional program initiation,<br />

Spokane hospitals, 2006-2007<br />

38


Guidelines or laws<br />

aimed at reducing<br />

opioid dosage<br />

Washington State limits<br />

narcotic doses<br />

____<br />

ENGROSSED SUBSTITUTE HOUSE BILL 2876<br />

__________________________________________<br />

___<br />

AS AMENDED BY THE SENATE<br />

Passed Legislature - 2010 Regular Session<br />

State <strong>of</strong> Washington 61st Legislature 2010<br />

Regular Session<br />

By House Health Care & Wellness (originally<br />

sponsored <strong>by</strong><br />

Representatives Moeller, Green, and Morrell)<br />

39


Other interventions underway<br />

q Dispensing laws, eg, those requiring identification <strong>of</strong><br />

the person getting the prescription<br />

q Laws requiring physical exams before prescribing<br />

q Prescription limits, eg, number <strong>of</strong> days<br />

q Harm reduction programs, including naloxone<br />

q Good Samaritan Acts or laws ensuring immunity<br />

from prosecution<br />

q <strong>Dr</strong>ug take-back programs<br />

40


<strong>PDMP</strong> data is critical in evaluating<br />

interventions<br />

Examples <strong>of</strong> Intervention<br />

<strong>PDMP</strong> improvements<br />

Single-copy serialized or<br />

tamper-resistant forms<br />

Doctor shopping & pain clinic<br />

laws<br />

Medicaid patient restriction<br />

programs<br />

Clinical guidelines or<br />

mandates<br />

<strong>PDMP</strong> Data Can Evaluate:<br />

Changes in drug use, prescriber use <strong>of</strong> the<br />

system<br />

Changes in use and inappropriate use with<br />

form changes<br />

Rates <strong>of</strong> behaviors and prevalence <strong>of</strong> clinics<br />

with extraordinary volumes<br />

When linked to Medicaid enrollment, whether<br />

Medicaid programs induce clients to pay out<strong>of</strong>-pocket<br />

Average daily dosage and other prescribing<br />

patterns and report request rates<br />

Changes in drug formulation Rates <strong>of</strong> use and inappropriate use per 10,000<br />

prescriptions <strong>by</strong> formulation<br />

41


Advantages <strong>of</strong> using <strong>PDMP</strong> data in evaluation<br />

• High level <strong>of</strong> drug detail, including formulation,<br />

prescriber, and dispenser identifications<br />

• Timeliness better than most other data sources<br />

• Baseline has already been collected<br />

• Statistical power, i.e., large enough numbers to detect<br />

small changes<br />

• Use <strong>of</strong> rates per 10,000 prescriptions avoids<br />

confounding <strong>by</strong> changes in drug use<br />

• Longitudinal linkage <strong>of</strong> patient and provider data<br />

• Costs lower than use <strong>of</strong> commercial rx data


The Public Health Model<br />

New or<br />

Persistent<br />

Problem<br />

Identified<br />

Remediable<br />

Risk Factors<br />

Identified<br />

Surveillance<br />

and<br />

Assessment<br />

Interventions<br />

Being<br />

Developed<br />

and Tested<br />

for Efficacy<br />

You are<br />

here<br />

Proven<br />

Interventions<br />

Tested for<br />

Effectiveness<br />

43


Thank You<br />

National <strong>Center</strong> for Injury Prevention and Control<br />

Division <strong>of</strong> Unintentional Injury Prevention

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