Transcript Green_PMP
CONSIDERATIONS ON THE USE OF
PRESCRIPTION MONITORING
PROGRAMS BY PRESCRIBERS,
PHARMACISTS, & PUBLIC HEALTH
DEPARTMENTS
Traci C. Green, PhD, MSc
Director of Public Health Research & Methodology,
Inflexxion, Inc.
Assistant Professor of Emergency Medicine & Epidemiology
The Warren Alpert School of Medicine at Brown University,
Rhode Island Hospital
The Warren Alpert Medical
School of Brown University
CDC: Epi to
Policy
April 22, 2013
Atlanta, GA
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 ef fects of PMP use on MEDICAL, PHARMACY
PRACTICE
COMPLICATED DATA,
COMPLICATED PATIENTS
“DR. SHOPPING”: indicator of addiction, help seeking,
overdose risk (Hall et al., 2008; Mar tyres 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)
WHERE ARE OVERDOSES HIGHEST?
Death Rates for Drug Overdose by State, 2010
13.1
12.9
10.4
3.4
7.3
12.9
11.8
10.9
6.3
15.0
8.6
6.7
20.7
15.3
10.0 14.4
16.9
10.6
7.8
13.9
16.1
28.9
12.7
9.6
17.0
6.8
23.6
11.4
16.9
17.5
19.4
23.8
14.6
12.5
11.4
11.8
NH
VT
MA
RI
CT
NJ
DE
MD
DC
11.8
9.7
11.0
15.5
10.1
9.8
16.6
11.0
12.9
10.7
9.6
13.2
16.4
11.6
10.9
Age-adjusted rate per 100,000 population
3.4 - 10.9*
10.9* - 13.9
Footnote: *10.9 is in two ranges due to rounding. HI is 10.88 while WI is 10.94
14.0 - 28.9
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
Risk reduction
counseling
Drugs prescribed,
#, type, dose
Target public
health
measures
Trend
Awareness
Abuse
detected
Drugs
dispensed
(licit)
Prescribers
Public health/
Safety dept.
Disciplinary
actions
PMP
Pharmacists
Law
Enforcement
Closing narcotics
investigations
Law enforcement
Diversion, rogue
intelligence
prescribers, pill mill
detection
Detect abuse,
Doctor
shopping/
diversion
(illicit)
Inappropriate
prescription
(errors)
TWO STUDIES
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
RARX: CT & RI PMP
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 repor t 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 repor t receipt may take hours to weeks
Law enforcement, investigative queries outnumber health prof queries
RARX PMP SURVEYS: METHODS
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 SURVEY
FINDINGS: PRESCRIBERS
Green et al., How Does Use of a Prescription Monitoring Program Change Medical Practice?
Pain Medicine July 2012
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 factors
Indirect not direct influence on overdose risk
DIRECT & INDIRECT EFFECTS ON OVERDOSE RISK
Initiate/refer to
drug treatment
Risk reduction
counseling
Drugs prescribed,
#, type, dose
Target public
health
measures
Trend
Awareness
Abuse
detected
Drugs
dispensed
(licit)
Prescribers
Public health/
Safety dept.
Disciplinary
actions
PMP
Pharmacists
Law
Enforcement
Closing narcotics
investigations
Overdose risk
identified,
counseled
Law enforcement
Diversion, rogue
intelligence
prescribers, pill mill
detection
Detect abuse,
Doctor
shopping/
diversion
(illicit)
Inappropriate
prescription
(errors)
RARX RESULTS: PHARMACIST PMP USE
90
80
CT
70
RI
Percent (%)
60
50
40
30
20
10
0
Ever use
Past year >=weekly use Interested in using PMP
•Lack of awareness
•No/limited internet access
•Report delay
•Employer doesn’t require it
•Employer doesn’t permit it
RARX RESULTS: PMPS CHANGING
PHARMACY PRACTICE?
Screening for abuse
Professional judgment (80%-90%), PMP report (CT: 79%, RI: 22%), ask
directly
No dif ferences 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: PMP USE 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 ef fects
CT pharmacists had more positive view of PMP than RI pharmacists
RARX RESULTS: PMP USE CHANGING
PHARMACY PRACTICE?
Responses to suspected diversion/“ dr shopping”
Contact the patient’s physician(s) (if known)
Discuss the concerns with the patient
Typical PMP user actions vs. typical
non-user actions (ref)
aOR [95% CI]
0.86 [0.21, 3.47]
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
Refer the patient to substance abuse
treatment
Ask the patient to leave the pharmacy
0.59 [0.27, 1.27]
1.29 [0.25, 6.53]
Notify law enforcement
0.81 [0.33, 2.01]
0.46 [0.17, 1.29]
DIRECT & INDIRECT EFFECTS ON OVERDOSE RISK
Initiate/refer to
drug treatment
Risk reduction
counseling
Drugs prescribed,
#, type, dose
Target public
health
measures
Trend
Awareness
Abuse
detected
Drugs
dispensed
(licit)
Prescribers
Public health/
Safety dept.
Disciplinary
actions
PMP
Pharmacists
Law
Enforcement
Closing narcotics
investigations
Overdose risk
identified,
counseled
Law enforcement
Diversion, rogue
intelligence
prescribers, pill mill
detection
Detect abuse,
Doctor
shopping/
diversion
(illicit)
Inappropriate
prescription
(errors)
Overdose risk
identified,
counseled
PMP USE IN THE
EMERGENCY DEPARTMENT
Compared Emergency provider (EP) prescribing decisions before,
after review of PMP data ( B a eh ren et a l . , 2 010 )
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
( G rover et a l , 2 01 2 )
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 ( We in er et a l . , un de r rev i ew )
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
FRAMING THE PROBLEM: PMP &
OVERDOSE MENTIONS P R E LI M INARY F I ND I NG S
• 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
PMP WEBSITE CONTENT
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
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”
www.ncdhhs.gov/MHDDS
AS/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
PMP USE & NALOXONE LAWS
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 prescription
Law 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
users
Naloxone
prescribers
PMP
users
Naloxone
prescribers
www.orpdmp.com
DISCUSSION
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 ef ficient, 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?
RECOMMENDATIONS
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
MAT: suboxone, methadone
Distribution of naloxone to
laypersons
Thank you!
[email protected]
[email protected]
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A . Wa l l ey et a l . O p i o i d o v e r d o s e r a te s a n d i m p l em e n t a t i o n o f o v e r d o s e e d u c a t i o n a n d
n a s a l n a l oxo n e d i s t r i b ut io n i n M a s s a c h us et t s : i n te r r up te d t i m e s e r i e s a n a l y s i s B M J
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