improving clinical effectiveness and risk control in chronic pain management: the berkshire county...
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Improving Clinical Effectiveness and Risk Control in Chronic Pain
Management:The Berkshire County Experience
Ronald F. Hayden, MDAnn E. McDonald, MN
John F. Rogers, EsqAlex N. Sabo, MD
Berkshire Health Systems, Inc.Pittsfield, Massachusetts
Disclosure
The content of this presentation does not relate to any product of a commercial interest. Therefore, there are no relevant financial relationships to disclose for:
Ronald F. Hayden, MDAnn E. McDonald, MN
John F. Rogers, EsqAlex N. Sabo, MD
Factors Fueling Berkshire Community Pain Management
Program
Ann E. McDonald, MNBerkshire Community Pain Management
ProjectBerkshire Health Systems, Inc.
Berkshire County—Including Area Hospitals And
Cities
Berkshire County Surface TranquilityBerkshire County Surface Tranquility
2005 Massachusetts Opioid Poisoning CasesRates per 100,000, by Town
Rates per 100,000 population (quintiles)00.01 - 18.0118.02 - 41.6341.64 - 62.7362.74- 225.51
2005
000.01 - 18.0118.02 - 41.6341.64 - 62.7362.74- 225.51
Rates per 100,000 population (quintiles)
Sub-surface TremorsSchedule II Opioid Poisonings Per 100,000
BMC has > 40 survived overdoses annually, mostly oxycodone and hydrocodone combinations
Sub-surface TremorsSchedule II Opioid-related
HospitalizationsPer 100,000 – 2005
Sub-surface TremorsSchedule II Opioid-related
HospitalizationsPer 100,000 – 2005
Sub-surface TremorsUnintentional overdose death rates by state,
2006 – over 16,000 deaths annually
1.1-8.4 8.5-11.4 11.5-19.4
Rate per 100,000 population
9.5
8.4
7.6
4.9
8.0
3.1
1.1
4.0
4.5
9.9
6.9
10.7
7.5
10.0
15.4
6.9
19.4
7.7
8.3
10.2
14.2
7.9
6.210.8
15.3
6.4
7.6
16.1
11.0
11.5
9.8
14.1
12.1
18.6
11.6
12.5
10.4
12.5
11.0
16.5
9.9
NH 9.4VT 10.0MA 13.0RI 15.2CT 10.0NJ 8.6DE 8.6MD 12.3DC 16.4
8.9
Len Paulozzi, MD, MPH, Centers for Disease Control and Prevention, 2009
MA – 2006 – 13 2005 – 10.6 2002 – 9.2
Sub-surface TremorsRelationship Between Opioid Sales And Drug
Poisoning Mortality
LJ Paulozzi, GW Ryan , American Journal of Preventive Medicine, 2006
MA
• Increasing reliance on pain specialists for chronic pain medication management instead of PCPs
• Pharma industry information suggesting +2 million Schedule II doses in 2005 in Berkshire County
• Schools and law enforcement reporting increased discovery of diverted pain medication prescribed by local providers
• DA concern about pain medication abuse and opioids as gateway to heroin use
• Anecdotal evidence of “doctor shopping”
• Addiction specialists seeing greater use of analgesics
Sub-surface TremorsSub-surface Tremors
Doses of Schedule II Opioids Dispensed in
Berkshire County: 1996-2008
Doses of Schedule II Opioids Dispensed in
Berkshire County: 1996-2008
0
500,000
1,000,000
1,500,000
2,000,000
2,500,000
3,000,000
3,500,000
578,309
661,987748,463
1,057,2791,250,047
1,533,6001,806,831
2,175,883
2,489,265
2,851,4432,936,420
3,094,9113,168,950
Fiscal Year 1996-2008
To
tal D
os
es
Dis
pe
ns
ed
1996-2005 an increase of 18% annually
2006-2008 inc 4% yr
Magnitude of Local Pain Management
Risk Control IssueEstimated ratio of
Schedule II to Schedule III and IV opioids is 1:4.4
3,168,950 Schedule II opioid pills in 2008
Total 13,943,380 opioid pills prescribed
103.3 tabs per each of 135,000 residents
MDPH Prescription Monitoring Program, 2009
Schedule II Opioid Prescriptions in Berkshire County 1996-2008
Schedule II Opioid Prescriptions in Berkshire County 1996-2008
60,000
50,000
40,000
30,000
20,000
10,000
0
Pre
scri
pti
on
Nu
mb
ers
FY 1996-2008
Schedule II Prescriptions per Individual in Berkshire County: 1996-
2008
Schedule II Prescriptions per Individual in Berkshire County: 1996-
2008
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
2.22
2.362.43
2.602.69
2.793.02 3.21
3.39
3.33 3.253.19
3.03
Fiscal Years 1996-2008
Es
tim
ate
d p
res
cri
pti
on
s/ i
nd
ivid
ua
l
4.00
3.50
3.00
2.50
2.00
1.50
1.00
0.50
0.00Fiscal Years 1996-2008
Esti
mate
d p
rescri
pti
on
s /
ind
ivid
ual
Questionable Opioid Activity in Berkshire County: 1996-2008
Questionable Opioid Activity in Berkshire County: 1996-2008
0
20
40
60
80
100
120
140
160
39
51
4539
53
76
58
64
89
83
95
94
139
Fiscal Years 1996-2008
# o
f In
div
idu
als
wit
h Q
ue
sti
on
ab
le A
cti
vit
y
Fiscal Years 1996-20080
20
40
60
80
100
120
140
160
# o
f In
div
idu
als
wit
h Q
uesti
on
ab
le
Acti
vit
y
Linear Relationship Between Opioids Dispensed
and. . .
Linear Relationship Between Opioids Dispensed
and. . .• Deaths – tripled in the US between 1999 and 2007, now more than 1000 deaths each month in US
• Overdoses – major culprit is oxycodone, most are unintentional and occur in relatively young individuals
• Hospitalizations – secondary to rescue and treatment of addiction, risk of addiction after treatment for several months or longer is 35% (BMJ, 2011)
• Impaired Lifestyle – isolation, loss of function, motivation
• Worse Outcomes - most commonly studied in LBP, leading to high rates of long term disability
Prescriber Role in Both Proper Control and Misuse
Alex N. Sabo, MDBMC Department of Psychiatry and Behavioral
SciencesBerkshire Health Systems, Inc
18
Project ThesisProject Thesis
• Health care entities and clinicians uniquely situated to lead effort among community-based stakeholders to:– Improve quality/availability of care for
patients with chronic pain through provider and patient education with adoption of strategies to improve safety in prescribing
– Improve individual and public health and safety by reducing misuse and diversion of prescription pain medication
– Reduce expense of care, productivity loss and other societal costs of dependence and addiction through prevention and early identification
Twin Project GoalsTwin Project GoalsAssuring safe and effective treatment of those suffering from acute
and chronic pain in Berkshire County while preventing individual and
community harm from misuse and diversion
of prescribed pain medication
Participating Community Organizations
Participating Community Organizations
Community Treatment Providers: Physicians and other cliniciansDentistsPharmacies
Criminal Justice: MA Probation ServicesBC Sheriff’s Office BC District Attorney Police Departments BC Drug Task Force
Community Stakeholders:Public and private schoolsThree community coalitions
Massachusetts Dept of Public Health: Drug Control Program Prescription Monitoring Program
Academic Affiliations:Brandeis University Tufts University
First Barrier to Safe Prescribing: Lack of Effective Communication
Silo’d Treatment and Communication
Criminal Justice System
Substance Abuse
Providers
Emergency Medicine Providers
Mental Health Providers
Pain Providers
Primary Care Providers
Community Agencies:
Schools
Regulatory Agencies: DPH
Goal: An Integrated Community Program Optimize treatment planning
and EMR communication
Berkshire County Community Pain
Management
Primary Care
Mental Health
Emergency Medicine
Pain Specialist
MA DPH PMP
23
Pain Care Resource Manual Tools
• Universal Precautions– Clarify expectations– Improve patient care and patient safety– Reduce stigma– Contain risk
• Diagnosis and Treatment Algorithms– Reinforce evidence-based medicine in pain
management• Opioid Medication & Risk Information• Treatment Agreements
– Medication benefits and risk informed consent document
– Treatment goals and expectations set– One prescriber/one pharmacy– Appropriate communication among all co-
managers of care
Pain Care Resource Manual Tools
• Urine Drug Screening Advice and Forms – 3x annually– Liquid chromatograph/mass spectrometry
technology added in 3Q 2008– Improves patient safety by identifying non-
compliance– Aids prescriber risk assessment
• Opioid Risk Screening Tools: SOAPP & COMM
• Multidisciplinary Assessment Program Description
• Regulatory Information• Community Resources, including
substance abuse services
Key Project Components
• Provider Education– Pain Care Resource Manual
– Encouragement of BioPsychoSocial Model for Addressing Persistent Pain
– County-wide Medical Conferences: 2005, 2006, 2009-10
– Introduction of Content into Residency Program Training
– Education of entire care team, including MAs and practice administrators, through biannual meetings on implementation
Key Project Components
• Integration of Care
– Information Technology: Optimizing EMR– Monthly Multidisciplinary Treatment Planning
Conferences– Integrated Pain Treatment Pilot Program – CBT
and Yoga– Psychologist Added to the Pain Treatment
Program– Wrap-around Buprenorphine Treatment– Residency QI program to measure and improve
use of quality of care tools• Community Assistance and Awareness
• Safe Medication Disposal Initiatives
• Partnerships with MA DPH and Research Institutions
Information Technology Tools
• Flag Electronic Medical Records – Co-management issues with opioid medication
• Existence of chronic pain and medication contracts are noted in Patient Summary Screen
• Substance Use Alerts on Aberrant Behavior are noted in Patient Summary Screen; history/risk of abuse
• Automatic system for maintaining currency of contract notation
• Create Pain Management Plan note to allow more effective co-management of care
• Identify “doctor shoppers” through multiple prescribers/visits
• Study e-Prescribing of Controlled Substances in ambulatory setting
• Track individual cases and assemble aggregate outcomes
Monthly Multidisciplinary Treatment Conference
• Goal: Efficiently communicate coordinated treatment plan for challenging patients across provider network
• Plan identified in EHR problem list as “Pt Specific Treatment Plan (See MTP 01/01/11)”
• Participants include:– Interventional Pain Physicians– ED Chair– Psychiatrist with addiction specialty– Psychologist– Ideally – PCPs, neurologists, rheumatologists
and mental health providers already involved in care
Community Assistance and Awareness:
Parent Education: 1/5
Community Assistance and Awareness:
Partnership with Criminal Justice SystemCollaboration with District Attorney’s Office • Measure local opioid poisonings and deaths,• Annual “State of the Streets” report • 3 Drug Take Back Programs
Facilitation of Pre- and Post-trial Substance Abuse treatment
Berkshire Partnership in Care Program• Pilot program with Probation Services in central and
southern county to better manage care of probationers at risk for prescription medication abuse
The “Oxy” Free ED: An New Approach to Prescribing Controlled Substances in the BHS
Emergency Departments
Ronald F Hayden, MD, FACEPBMC Department of Emergency Medicine
Berkshire Health Systems, Inc.
Characteristics Of All EDs That Create Environment of Opioid
Prescribing Risk
Characteristics Of All EDs That Create Environment of Opioid
Prescribing Risk• Open continuously• Often no existing physician-patient
relationship• Fragmented connection to primary
prescriber• Patients become aware of variance
in prescribing patterns, plan visits• Busy environment, easier to write
script than start education on safety
Why an Oxy Free ED?Why an Oxy Free ED?
• The “Oxy Free ED” –a much needed concept to help EDs manage care effectively but also cope an epidemic of opiate misuse, addiction and death occurring over past 15 to 20 years.
• Need to prescribe analgesics in manner consistent with the medical evidence, mindful of individual and social risk.
• The statistics speak for themselves . . .
Sources of Opioid AnalgesicsSources of Opioid Analgesics
Setting Type % Distribution
Emergency department 39%
Primary care office 31%
Medical specialty office 13%
Surgical specialty office
10%
Hospital outpatient department
7%
36
Source: National Center for Health Statistics. Medication therapy in ambulatory medical care: United States, 2003-04
Goals of Oxy-Free ED
• For acute pain complaints: apply accepted guidelines to effectively treat pain but avoid medications that pose risk of diversion, abuse and addiction.
• For chronic pain complaints: clarify the role of the ED at presentation, emphasizing coordinated care, information sharing, drug screening and concern for addiction and other risk issues.
• Reduce the unnecessary volume of
prescription opioids in our community…thereby reduce death, overdose and addiction
Principles of “Oxy” Free EDPrinciples of “Oxy” Free ED
• Acute pain should be treated promptly and appropriately:– Most often non opioid analgesics or schedule III opioids
are sufficient– If opioids prescribed, limit discharge medications– If possible, direct communication with primary doctor,
including record of visit• Acute exacerbations of chronic pain: Appropriate
for treatment in ED? – When urgent treatment necessary—urine drug screen and
contact with primary doctor before any prescriptions (limited) are given.
• Chronic pain is multifactorial; opioids only small part of care plan– Opioids often not indicated or appropriate– ED management of one small component of overall
treatment regimen often ineffective or dangerous• Writing unnecessary opioid script is easy,
addressing issue is harder.
BHS Emergency Department Guidelines for the Management of
Chronic Pain Complaints
BHS Emergency Department Guidelines for the Management of
Chronic Pain Complaints
We Care: To improve your safety and the quality of your care, the BHS Emergency Departments will follow these guidelines in prescribing medication for the treatment of pain.
First PrincipleFirst Principle
Pain is a significant medical condition warranting prompt attention and intervention for its relief in the most effective and safest manner feasible:
• The Emergency Departments will promptly and effectively address complaints of acute and chronic pain of all patients and, when drugs are appropriate, provide the right drug in the right dosage and for the right duration.
Second PrincipleSecond Principle
To prevent the risks of uncoordinated care, one provider should manage all opioids (narcotics) prescribed for chronic pain:
• Opioid medications have risks associated with dosage and interaction with other medications, therefore, it is critical to patient safety that one provider coordinate all prescribing. Any exception will require urine drug screen and direct contact with your regular doctor.
Third PrincipleThird Principle
• To avoid the risks associated with the administration of injectable opioids, we will rarely provide these medications for the treatment of chronic pain:• Pain specialists discourage the use of
pain medication shots for the treatment of chronic pain as they lead to increase tolerance to the these medications.
Fourth PrincipleFourth Principle
In order to avoid the risks of overmedication and other misuse, we will not provide replacement prescriptions that are lost, destroyed or stolen.
• Any necessary replacement prescription must be obtained from the original prescribing doctor.
Fifth PrincipleFifth Principle
Long-acting or controlled-release opioids (such as OxyContin, oxycodone, fentanyl patches and methadone) are designed to be part of plan for managing chronic pain. We will not prescribe them for managing a chronic pain complaint. These medications need a primary care or pain specialist supervision.
• We can assist in managing acute pain either with non-opioid treatment or a short course of opioid medication in appropriate situations.
Sixth PrincipleSixth Principle
In order to better assure safe, effective coordination of care, we will share relevant information with doctors involved in caring for the patient.
• We will appropriately share information with your doctors.
Seventh PrincipleSeventh Principle
Patients with complex pain conditions often require treatment by many specialists. These patients are best managed with a coordinated plan of care. This care plan improves safety and effectiveness.
• We may develop a patient treatment plan on your condition and record this in the medical record.
Summary and RationaleSummary and Rationale
The Departments will rarely prescribe those medications most associated with abuse or addiction: e.g., Percocet, OxyContin, Dilaudid, MS Contin, Duragesic (fentanyl).
The Oxy Free EDThe Oxy Free ED
• Do the right thing and provide acute pain relief promptly and in proportion to injury using a short course of medications.
• Reduce dependence, addiction and overdose risk with less opportunity for diversion and non-medical use.
• Reduce the high utilization of the ED for chronic pain complaints and engage primary physicians and pain specialists.
• Improve better outcomes for patient, family and the community.
Key Legal Issues ∆
Early Signs of Berkshire Project Impact
John F. Rogers, EsqVice President and General Counsel
Berkshire Health Systems, Inc
Key Legal Issues Key Legal Issues
• Patient Privacy and HIPAA Basics– Most states recognize that duty of
confidentiality exception in cases of serious danger to patient or others
• Narrower exception in psychiatric care (Tarasoff cases)
– Implied consent in co-management of care– HIPAA Privacy Rule
• OCHA• NOPP• TOP • Crime on Premises
– Federally funded treatment programs (“Part 2 Facilities”)
Key Legal IssuesKey Legal Issues
• Privacy Exception: Reporting Crime on Premises– All states have laws similar to M.G.L. c.
94, §33 making it a crime to:
“knowingly or intentionally acquire or obtain possession of a controlled substance by means of forgery, fraud, deception or subterfuge, including but not limited to forgery or falsification of a prescription or non-disclosure of a material fact…..”
Attempts to commit a crime are also a crime.
Key Legal Issues
• Patient Autonomy and Limits of Patient- Directed Care– Most states recognize the patient
right to give/withhold consent ≠ right to inappropriate or futile care, care outside boundaries of accepted medical practice
• Liability Coverage
Early Signs of Project Impact: Adoption of Best Practices
• 750 Pain Contracts posted in EMR from 11 Practices
• Steadily increasing volume of Urine Drug Screens
• 166 prescribers participating in EPCS study
• Prescriber and administrator enthusiasm for on-going education (“new community ethic”)
• Enrollment in PMP Single Patient Look-up
• ED provider prescribing modifications
Early Signs of Project ImpactIncreased Use of Prescription Monitoring
Program
Early Signs of Project ImpactIncreased Use of Prescription Monitoring
Program• Prescription Monitoring Program
authorized in 48 states, operating in 35 – Pharmacies transmit prescribing data
to state repository—either public health or public safety
– Operated on state-by-state basis• First in 1972 (PA); 36 added since 2000• Limited interconnectivity• National All Schedules Prescription
Electronic Reporting Act of 2005—– Unfunded 2006-2008; $2M in 2009 and
2010 (grants in 13 states– Would annually collect 673 million
prescriptions from 65,000 DEA-registered pharmacies accessible by 1.2 million DEA-registered prescribers
Early Signs of Project ImpactIncreased Use of Prescription Monitoring
Program
Early Signs of Project ImpactIncreased Use of Prescription Monitoring
Program• PMPs Originally Funded through
Department of Justice– Law enforcement focus: “doctor shopping”,
prescription forgery, indiscriminate prescribing– Many state PMPs housed in law enforcement
agencies– Data base not used to target subjects for
investigation and only available to law enforcement in connection with existing investigation concerning specific prescribers or customers
• More Current Approach, Including NASPER Focuses on Public Health Potential of PMPs
Early Signs of Project ImpactIncreased Use of Prescription Monitoring
Program
Early Signs of Project ImpactIncreased Use of Prescription Monitoring
Program
Prescribers
Pharmacists
LicensingBoardsLawEnforcementOthers
Internet based
5,500 report requests per week
<5 second response time
Est. 1999
CS Dispensers: 1500
Scripts annually: 8.2 million
The Kentucky PMP Experience
92%
3%1% 1%
3%
Early Signs of Project Impact:Slowing Annual Increase in Total Schedule
II Doses
Slope-10%
Slope-18%
Slope-3.69%
Slope- 9%
Slope-1.2%
2008 PMP data showed statistically significant reductions in scripts per pt and doses per script.
Early Signs of Project Impact: Providers Beginning to Limit Prescriptions and
Doses Per Prescription
The difference between the 05-08 projected total doses and the recorded 05-08 total doses is
491,050 doses.
Early Signs of Project Impact: Program Success with Coordinated,
Planned Care(Buprenorphine Wrap Around Program)
Pretreatment After Treatment Was Initiated0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
42%
80%
p<0.05
(Measured as return to work or school)
Early Signs of Project Impact: Individual Patient Success with Coordinated,
Planned Care
• Single male, 30’s• College graduate• Unemployed 4
years• Chronic pain
syndrome• 3 + Berkshire
doctors providing opioids and benzodiazepines
• 28 hospital visits in 33 months
• Family terrified he will die
• Began drinking age 8
• Misusing opioids > 10 years
• Polysubstance dependence
• Multiple overdoses; near fatal experiences
• Multiple suicide attempts
• Variety of dangerous behaviors involving police
Early Signs of Project Impact: Individual Patient Success with Coordinated,
Planned Care
• Care coordinated with Emergency Department, Psychiatry and Substance Abuse Services
• Admitted to inpatient psychiatry unit• Tapered off opioids and benzodiazepines• Multiple family and treatment meetings • Seamless transfer to buprenorphine wrap-
around program
Early Signs of Project Impact: Individual Patient Success with
Coordinated, Planned Care
Early Signs of Project Impact: Individual Patient Success with
Coordinated, Planned Care
Average Monthly Cost of Care
Pre-treatment:$5258
During 1st year of treatment:$1566
During 2nd year of treatment:$700
Carlen Robinson, 32
August 9, 1973 - November 11, 2005