CDC: Epi to Policy April 22, 2013Atlanta, GA

CONSIDERATIONS ON THE USE OF PRESCRIPTION MONITORING PROGRAMS BY PRESCRIBERS,

PHARMACISTS, & PUBLIC HEALTH DEPARTMENTS

The Warren Alpert Medical School of Brown University

Traci C. Green, PhD, MScDirector of Public Health Research & Methodology, Inflexxion, Inc.

Assistant Professor of Emergency Medicine & EpidemiologyThe Warren Alpert School of Medicine at Brown University, Rhode Island Hospital

Disclosures: Traci C. Green

The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: Employment at Inflexxion, Inc.,

Funding: CDC National Center for Injury Prevention and Control, 5R21CE001846-02 and 1R21CE002165-01; National Institute on Drug Abuse, 1R21DA029201-02A1

Inflexxion at a Glance

• Founded in 1989 – over 85 employees

• Science based programs in the areas of:

Pharmaceutical Risk Management

Pain treatment, self-management, & education

Prescription drug abuse

Substance abuse/behavioral health evaluation & treatment

College student health

• Over $80 million over the last 18 years in US National Institutes of Health (NIH) research support

NAVIPPRO Program

aims

To present a conceptual model of PMP use & overdose risk

To contrast PMP use between two states, Connecticut and Rhode Island, with different PMP accessibility

To report data on use of PMPs in medical, pharmacy practice, including responses to suspected diversion or “doctor shopping”

To reflect how overdose is represented in PMP materials & resources, contrast with PMP use laws

BACKGROUND

DRUG POISONING (overdose) is the leading cause of adult injury death in Rhode Island (RI), Connecticut (CT) and 28 other states

More fatal drug poisonings involve PRESCRIPTION OPIOIDS than other illicit drugs. Two-thirds of RI and CT overdoses involve prescription opioids

PRESCRIPTION MONITORING PROGRAMS (PMPs) can influence risks associated with abuseable medications, exist in 49 states

PRESCRIBERS & PHARMACISTS are on the “front lines” of the prescription opioid abuse epidemic Motivated to use PMPs to detect diversion, help reduce “dr. shopping”

(Fass 2011; Ulbrich 2010)Limited data exist on effects of PMP use on MEDICAL,

PHARMACY PRACTICE

“DR. SHOPPING”: indicator of addiction, help seeking, overdose risk (Hall et al., 2008; Martyres et al.,2004)

Multiple comorbidities, histories of trauma, interpersonal violence, PTSD Coprescribed other CNS depressants Higher prevalence of substance use disorder (SUD) Greater likelihood of complex pain condition(s) More often opioid therapy, multiple opioids, multiple providers Housing stability/residence

Denial of medications may contribute to poor health outcomes: initiation, illicit use, riskier use, overdose (Fibbi et al, 2012)

Complicated data, complicated patients

Where are overdoses highest?

Death Rates for Drug Overdose by State, 2010Death Rates for Drug Overdose by State, 2010

3.4 - 10.9* 10.9* - 13.9 14.0 - 28.9

Age-adjusted rate per 100,000 population

10.0

9.6

7.8

8.6

10.6

6.3

3.4

6.7

7.3

13.9

11.8

11.4

9.6

14.4

13.2

15.0

23.8

11.8

10.9

11.4

19.4

10.7

6.812.7

23.6

10.9

12.9

16.9

14.6

16.1

12.9

16.9

15.3

28.9

13.1

17.5

10.4

16.4

17.0

20.7

11.6

NH 11.8VT 9.7MA 11.0RI 15.5CT 10.1NJ 9.8DE 16.6MD 11.0DC 12.912.5

Footnote: *10.9 is in two ranges due to rounding. HI is 10.88 while WI is 10.94

PAINKILLERS SOLD BY STATE PER 10,000 PEOPLE (2010)

Risk Factors for Unintentional Opioid Poisoning

Change in TOLERANCE using ALONE, by oneself MIXING opioids with other central nervous

system depressing substances (alcohol, benzodiazepines)

ILLNESS

(Sporer 2007, Binswanger 2007, Green 2012)

effects on overdose risk

Drugs prescribed, #, type, dose

Risk reduction counseling

Abuse detected

Drugs dispensed

(licit)

Detect abuse, Doctor

shopping/diversion

(illicit)

Inappropriate prescription

(errors)

Closing narcotics investigations

Diversion, rogue prescribers, pill mill

detection

Law enforcement intelligence

PMP Pharmacists

Prescribers

Law Enforcement

Public health/Safety dept.

Target public health

measures

Trend Awareness

Disciplinary actions

RARx Study-PMP as public health tool in Rx opioid overdose risk reduction Online survey of prescribers, pharmacists in RI, CT Data linkage, spatial analysis, case-control 12 week rapid assessment and response on nonmedical

prescription opioid use & overdose, July-August 2011 3 non-urban sites, 2 New England states Community advisory boards in both states 195 key informant interviews with systems, interactors, community informants

(opioid users, dealers, chronic pain patients, families of overdose survivors)

PMPU Study—local health impacts of PMP use Local PMP use effects on Supply, Demand, Harm Data linkage: street drug price, initiation of heroin, nonmedical use, circulating medications 7 states: 5 with active PMPs, 2009-2012 analysis Survey of PMPs on overdose-specific programming, framing

two studies

Controlled substance data from licensed pharmacies, electronically uploaded, securely stored in a central database

CT Maintained by Dept of Consumer Protection, Drug Control Division Operational since July 2008 Registered health profs licensed to prescribe/dispense controlled substances Schedule II-V prescriptions Electronic queries, patient report generated in seconds Health professional queries outnumber law enforcement queries

RI Maintained by Dept of Health, Board of Pharmacy Cannot be directly accessed or queried by health profs Inquiries made indirectly by phone, email, fax, mail Schedule II and III medications Patient report receipt may take hours to weeks Law enforcement, investigative queries outnumber health prof queries

Rarx: CT & RI PMP

Anonymous surveys emailed to CT, RI licensed prescribers, pharmacists

Items from literature, PMP staff input Current SA/MH practices, counsel on overdose risk, Rx

opioid storage+disposal, PMP use, barriers to PMP use, addressing dr. shopping/diversion

Data collected March-August 2011; 3 reminder emails Respondents: PMP registered users, prescribers (n=1385),

pharmacists (n=306) Analyses By state pharmacy practice, PMP use; PMP user comparisons

on responses to suspected dr. shopping/diversion

Rarx Pmp surveys: Methods

Rarx PMP Survey Findings: prescribers

Most use PMP reports to screen for abuse, complement patient care

Primary means of diagnosing drug abuse is “professional judgment”

When concerned about “dr. shopping”/diversion, PMP users significantly more likely than non-users to: Screen for drug abuse, conduct urine screens, refer to another provider,

refer to substance abuse treatment Revisit pain treatment agreements Less likely to do nothing (ignore it) Fewer calls to law enforcement to intervene

Little patient counseling on overdose, risk factorsIndirect not direct influence on overdose risk

Green et al., How Does Use of a Prescription Monitoring Program Change Medical Practice?Pain Medicine July 2012

Direct & indirect effects on overdose risk

Drugs prescribed, #, type, dose

Risk reduction counseling

Abuse detected

Drugs dispensed

(licit)

Detect abuse, Doctor

shopping/diversion

(illicit)

Inappropriate prescription

(errors)

Closing narcotics investigations

Diversion, rogue prescribers, pill mill

detection

Law enforcement intelligence

PMP Pharmacists

Prescribers

Law Enforcement

Public health/Safety dept.

Target public health

measures

Trend Awareness

Disciplinary actions

Overdose risk identified, counseled

Initiate/refer to drug treatment

Rarx Results: pharmacist PMp use

•Lack of awareness•No/limited internet access•Report delay•Employer doesn’t require it•Employer doesn’t permit it

Screening for abuse Professional judgment (80%-90%), PMP report (CT: 79%, RI: 22%), ask

directly

No differences by state or PMP use on patient counseling topics on prescribed Rx opioids

Coingestion risks Addiction Unauthorized dose escalations Sharing medications Overdose symptoms Disposal Storage Nothing/does not counsel patient (12%-20%)

Rarx Results: PMPs changing pharmacy practice?

Detecting “dr. shopping” Similar % RI & CT pharmacists used insurance rejection (77.9%),

professional judgment (73.1%), and verifying the prescription and prescriber (68.6%) check PMP (CT: 67%, RI: 7%, p<0.001)

Views of PMP: helps reduce diversion, prescription opioid abuse in their state, in their practice

PMP users in CT had most positive view of PMP effectsCT pharmacists had more positive view of PMP than RI pharmacists

Rarx Results: pmp use changing pharmacy practice?

RARx Results: pmp use changingpharmacy practice?

Responses to suspected diversion/“dr shopping”Typical PMP user actions vs. typical non-user actions (ref)

aOR [95% CI]Contact the patient’s physician(s) (if known)

0.86 [0.21, 3.47]

Discuss the concerns with the patient

0.48 [0.25, 0.92]

Refer the patient back to provider 1.50 [0.79, 2.86]Refuse to fill the prescription 0.63 [0.30, 1.30]State out of stock of the drug 0.27 [0.12, 0.60]Counsel the patient on potential overdose risk

0.59 [0.27, 1.27]

Refer the patient to substance abuse treatment

1.29 [0.25, 6.53]

Ask the patient to leave the pharmacy

0.46 [0.17, 1.29]

Notify law enforcement 0.81 [0.33, 2.01]

Direct & indirect effects on overdose risk

Drugs prescribed, #, type, dose

Risk reduction counseling

Abuse detected

Drugs dispensed

(licit)

Detect abuse, Doctor

shopping/diversion

(illicit)

Inappropriate prescription

(errors)

Closing narcotics investigations

Diversion, rogue prescribers, pill mill

detection

Law enforcement intelligence

PMP Pharmacists

Prescribers

Law Enforcement

Public health/Safety dept.

Target public health

measures

Trend Awareness

Disciplinary actions

Overdose risk identified, counseled

Initiate/refer to drug treatment

Overdose risk identified, counseled

Compared Emergency provider (EP) prescribing decisions before, after review of PMP data (Baehren et al., 2010) Changed prescribing behavior for 41% (of 179 cases): 61% fewer/no

opioids, 39% more opioids than originally planned

Online survey of EPs, presented index, suspicious patient cases (Grover et al, 2012) Fair-moderate agreement on patient drug seeking based on high # of

prescribers or high # of prescriptions (PMP-like data) No differences attendings vs. residents: PMP use not clinical differences

Compared EP impression of “drug seeking behavior”: clinical evaluation vs actual PMP data (Weiner et al., under review) 544 patients, 38 providers, 2 EDs, patients with pain complaint Only Fair agreement (k=.3), low PPV= 41.2% Prescribing plan change for 9.5% at discharge: 3% no opioids, 6.5%

opioids previously unplanned Predictors of EP suspicion vs. PMP cutoff underscore emphasis placed on

clinical impression

PMP use in the Emergency department

• How do PMPs talk about overdose? What tools are available to PMP users to reduce the risk of fatal overdose? How do states with mandatory PMP use/registration laws differ?

• December 2012-March 2013, systematically reviewed PMP websites • 44 states w/active PMPs , 3 w/enacted PMP legislation, inactive

programs • Specific mentions/materials on site pages• Searched: “overdose”, “death”, “poisoning”, “naloxone”, “narcan”• Content: practical instructions, program goals, mission

statement, regulations, training materials, informational pamphlets, FAQs

• Mentions coded for thematic similarities, location on website

Framing the problem: pmp & overdose mentions preliminary findings

PMP website content

OD mentions

OD related provider tools

Mandatory usage & registration laws (n=3) KY, MA, TN

0 0

Mandatory usage only (n=9) CO, DE, LA, NY, NC, NV, OH, OK, WV

3 0

Home page: "To reduce morbidity and mortality from unintentional drug overdoses”

Link to legislation: "to address the problems of widespread drug abuse and the resulting overdose deaths”

PMP website content by use laws

www.ncdhhs.gov/MHDDSAS/controlledsubstance/

PMP website content by use laws

OD mentions

OD related provider tools

Mandatory usage & registration laws (n=3) KY, MA, TN

0 0

Mandatory usage only (n=9) CO, DE, LA, NY, NC, NV, OH, OK, WV

3 0

Mandatory registration only (n=5)AZ, ME, NH, NM, UT

3 1

UT regulation: for every acute hospital poisoning/overdose involving a prescribed controlled substance, law mandates notification of practitioners who may have prescribed controlled substance to patient, send PMP & hospital report to prescriber

Intent: encourage discussions with patient related to poisoning/overdose , advise on future prevention, make decisions regarding future prescriptions written for patient

Naloxone is an opioid overdose antidote & is standard treatment in the pre-hospital setting

Community-wide distribution of naloxone is associated with overdose mortality reductions of 27-46%

188+ community based programs, trained 50,000+, with 10,000+ reversals

Naloxone only available by prescriptionLaw is a key driver of accessibility to naloxone

Encourage prescribing/appropriate use of naloxone Provide limited immunity if call 911 in overdose NM (2001), NY, IL, WA, CA, RI, CT, MA

Pmp use & Naloxone laws

PMP users

Naloxone prescribers

PMP users

Naloxone prescribers

www.orpdmp.com

Prescribers: How to change, sustain PMP use to directly & indirectly reduce overdose risk?

Pharmacists: Why avoidance of talking with patient about PMP report? How to improve this situation, expand therapeutic use of PMP patient report in the pharmacy?

EPs: How to promote efficient, therapeutic use of PMP in ED setting?

Public health/safety: How can the PMP/data be used to directly reduce, raise awareness of overdose risk? How can we better coordinate use of available tools?

Discussion

CDC ONDCP FDA

PRIMARY PREVENTION

Use PMPs, insurance to combat “dr. shopping”

Tracking, monitoring: operational PMPs, inter-state data sharing

Legislation/enforcement of pill mill laws, Rx fraud

Target “unscrupulous” health professionals, pill mills, “dr shopping”

EBM, CMEs to improve safer prescribing*complex pain, pain-SA hx

Mandatory education for controlled substance prescribers

Class-wide REMS, voluntary provider education

Patients, parents education

Medication “take-backs” / drop boxes

ADFs

SECONDARY & TERTIARY PREVENTION

Distribution of naloxone to laypersons, 1st responders

Distribution of naloxone to laypersons

MAT: suboxone, methadone

Recommendations

Thank you!

tgreen@inflexxion.comtraci.c.green@gmail.com

references

Surveillance-related TC Green, R Black, JM Grimes-Serrano, SH Budman, SF Butler. Typologies of Prescription

Opioid Use in a Large Sample of Adults Assessed for Substance Abuse Treatment. PLoS ONE (6(11): e27244). http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0027244

SF Butler, SH Budman, A Licari, TA Cassidy, K Lioy, J Dickinson, JS Brownstein, JC Benneyan, TC Green, N Katz. National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO™): A real-time, product-specific, public health surveillance system for monitoring prescription drug abuse. Pharmacoepidemiology and Drug Safety 2008.

JS Brownstein, TC Green, T Cassidy, SF Butler. Geographic Information Systems and Pharmacoepidemiology: Using spatial cluster detection to monitor local patterns of prescription opioid abuse. Pharmacoepidemiology and Drug Safety 2010; 19(6):627-37.

Nonmedical Use of Prescription opioids: Trends TC Green, EF Donnelly. Preventable death: Accidental drug overdose in Rhode Island.

Medicine & Health Rhode Island. 2011; 24(11): 341-343. M Yokell, TC Green, S Bowman, M McKenzie, JD Rich. Opioid overdose prevention and

naloxone distribution in Rhode Island. Medicine & Health Rhode Island. 2011; 94 (8): 240-242. TC Green, LE Grau, HW Carver, M Kinzly, R Heimer. Epidemiologic and geographic trends in

fatal opioid intoxications in Connecticut, USA: 1997-2007. Drug and Alcohol Dependence 2011 Jun 1;115(3):221-8.

RARx TC Green, MR Mann, SE Bowman, N Zaller, X Soto, J Gadea, C Cordy, P Kelly, PD Friedmann.

How does use of a prescription monitoring program change pharmacy practice? Journal of the American Pharmacy Association (in press)

N Zaller, MA Yokell, TC Green. Pharmacists’ and injection drug users’ attitudes toward take-home naloxone: challenges and opportunities. Substance Use and Misuse (in press).

TC Green, SE Bowman, M Ray, N Zaller, R Heimer, P Case. Collaboration or coercion? Partnering to Divert Prescription Opioid Medications. Journal of Urban Health (in press)

TC Green, SE Bowman, N Zaller,M Ray, P Case, R Heimer. Barriers to medical provider support for prescription naloxone as overdose antidote for lay responders. Substance Use and Misuse (in press)

TC Green, MR Mann, SE Bowman, N Zaller, X Soto, J Gadea, C Cordy, P Kelly, PD Friedmann. How does use of a prescription monitoring program change medical practice? Pain Medicine (e-pub 2012 Jul 30.)

TC Green, N Zaller, S Bowman, JD Rich, PD Friedmann. Revisiting Paulozzi et al.’s “Prescription Drug Monitoring Programs and Death Rates from Drug Overdose”. Letter. Pain Medicine 2011; 12 (6): 982-985.

M Yokell, N Zaller, TC Green, M McKenzie, J Rich. Intravenous use of illicit buprenorphine/naloxone to reverse an acute heroin overdose. Journal of Opioid Management. January/February 2012; 63-66.

Naloxone & Good Samaritan law-related Davis, Corey S., Webb, Damika and Burris, Scott C., Changing Law from Barrier to

Facilitator of Opioid Overdose Prevention (April 17, 2013). Available at SSRN: http://ssrn.com/abstract=2252624

C. Banta-Green, “Washington’s 911 Good Samaritan Overdose Law: Initial Evaluation Results,” November 2011, available at <http://adai.uw.edu/pubs/infobriefs/ADAI-IB-2011-05.pdf> (last visited January 8, 2013).

N. Dasgupta, C. Sanford, S. Albert, and F. Brason, “Opioid Drug Overdose: A Prescription for Harm and Potential for Prevention,” American Journal of Lifestyle Medicine 4, no. 1 (2010): 32-37, at 34.

A. Walley et al., “Opioid Overdose Prevention with Intranasal Naloxone among People Who Take Methadone,” Journal of Substance Abuse Treatment 44, no. 2 (2013):241-247.

TC Green, LE Grau, R Heimer. Distinguishing signs of opioid overdose and indication for naloxone: An evaluation of six overdose training and naloxone distribution programs in the United States. Addiction 2008.

“Naloxone OD Prevention Laws Map,” available at <http:// lawatlas.org/> Centers for Disease Control and Prevention, “Community-Based Opioid Overdose

Prevention Programs Providing Naloxone – United States, 2010,” Morbidity and Mortality Weekly Report 61, no. 6 (2012): 101-105.

A. Walley et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysisBMJ 2013;346:f174 doi: 10.1136/bmj.f174 (Published 31 January 2013). http://www.bmj.com/content/346/bmj.f174.pdf%2Bhtml