Improving Clinical Effectiveness and Risk
Control in Chronic Pain Management:
The Berkshire County Experience
Ronald F. Hayden, MD
Ann E. McDonald, MN
John F. Rogers, Esq
Alex 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, MD
Ann E. McDonald, MN
John F. Rogers, Esq
Alex N. Sabo, MD
Factors Fueling Berkshire Community Pain
Management Program
Ann E. McDonald, MN
Berkshire Community Pain Management Project
Berkshire Health Systems, Inc.
Berkshire County—
Including Area Hospitals And Cities
Berkshire County Surface Tranquility
Sub-surface Tremors
Schedule II Opioid Poisonings Per 100,000
2005 Massachusetts Opioid Poisoning Cases
Rates per 100,000, by Town
2005
Rates per 100,000 population (quintiles)
Rates per
0 100,000 population (quintiles)
0.01
0 - 18.01
18.02
00.01 -- 41.63
18.01
41.64
62.73
18.02 - 41.63
62.74- 225.51
41.64 - 62.73
62.74- 225.51
BMC has > 40 survived overdoses annually, mostly
oxycodone and hydrocodone combinations
Sub-surface Tremors
Schedule II Opioid-related Hospitalizations
Per 100,000 – 2005
Sub-surface Tremors
Unintentional overdose death rates by state, 2006 –
over 16,000 deaths annually
11.6
7.6
10.4
1.1
4.5
9.8
6.9
6.9
4.9
4.0
16.1
12.5
7.6
9.9
16.5
8.0
8.3
3.1
12.1
9.5
10.0
11.5
18.6
10.8
7.5
14.2
19.4
11.0
15.3
6.2
10.2
14.1
11.0
8.9
10.7
8.4
NH
VT
MA
RI
CT
NJ
DE
MD
DC
7.7
7.9
MA – 2006 – 13
2005 – 10.6
2002 – 9.2
15.4
12.5
9.9
Rate per 100,000 population
6.4
1.1-8.4
Len Paulozzi, MD, MPH, Centers for Disease Control and Prevention, 2009
8.5-11.4
9.4
10.0
13.0
15.2
10.0
8.6
8.6
12.3
16.4
11.5-19.4
Sub-surface Tremors
Relationship Between Opioid Sales And Drug Poisoning Mortality
MA
LJ Paulozzi, GW Ryan , American Journal of Preventive Medicine, 2006
Sub-surface Tremors
• 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
Doses of Schedule II Opioids Dispensed in
Berkshire County: 1996-2008
3,500,000
3,094,911
3,168,950
3,000,000
Total Doses Dispensed
2,851,443
2,936,420
2,500,000
1996-2005 an increase of 18% annually
2,000,000
2,489,265
2,175,883
1,806,831
1,533,600
1,500,000
1,057,279
1,250,047
1,000,000
661,987
748,463
500,000
578,309
0
Fiscal Year 1996-2008
2006-2008 inc 4% yr
Magnitude of Local Pain Management
Risk Control Issue
Estimated 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
60,000
Prescription Numbers
50,000
40,000
30,000
20,000
10,000
0
FY 1996-2008
Schedule II Prescriptions per Individual in
Berkshire County: 1996-2008
Estimated prescriptions /individual
Estimated prescriptions/ individual
4.00
4.00
3.39
3.50
3.50
3.02 3.21
2.79
3.00
3.00
2.60
2.50
2.50
2.00
2.00
2.36
3.25
3.19
2.69
2.43
2.22
1.50
1.50
1.00
1.00
0.50
0.50
0.00
0.00
3.33
Fiscal Years
Fiscal
Years1996-2008
1996-2008
3.03
Questionable Opioid Activity in Berkshire County: 1996-2008
Questionable Activity
with Questionable
Individualswith
# of
Activity
Individuals
# of
160
160
140
140
139
120
120
95
100
100
89
94
76
80
80
64
51
60
60
40
40
53
58
39
45
39
20
20
00
FiscalYears
Years 1996-2008
1996-2008
Fiscal
83
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, MD
BMC Department of Psychiatry and Behavioral Sciences
Berkshire Health Systems, Inc
18
Project 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 Goals
Assuring
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
Community Treatment Providers:
Physicians and other clinicians
Dentists
Pharmacies
Criminal Justice:
MA Probation Services
BC Sheriff ’s Office
BC District Attorney
Police Departments
BC Drug Task Force
Community Stakeholders:
Public and private schools
Three 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
Criminal
Justice
System
Regulatory
Agencies:
DPH
Community
Agencies:
Schools
Substance
Abuse
Providers
Silo’d Treatment
and
Communication
Primary
Care
Providers
Emergency
Medicine
Providers
Mental
Health
Providers
Pain
Providers
Goal: An Integrated Community Program
Optimize treatment planning and EMR communication
Primary
Care
MA DPH
PMP
Berkshire
County
Community
Pain
Management
Pain
Specialist
Mental
Health
Emergency
Medicine
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 comanagement 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 System
Collaboration 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, FACEP
BMC Department of Emergency Medicine
Berkshire Health Systems, Inc.
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?
• 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 Analgesics
Setting Type
Emergency department
Primary care office
% Distribution
39%
31%
Medical specialty office
Surgical specialty office
Hospital outpatient
department
13%
10%
7%
Source: National Center for Health Statistics. Medication therapy in
ambulatory medical care: United States, 2003-04
36
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 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
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 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 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 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 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 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 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 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 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 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, Esq
Vice President and General Counsel
Berkshire Health Systems, Inc
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 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 PatientDirected 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 ongoing education (“new community ethic”)
• Enrollment in PMP Single Patient Look-up
• ED provider prescribing modifications
Early Signs of Project Impact
Increased 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 Impact
Increased 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 Impact
Increased Use of Prescription Monitoring Program
The Kentucky PMP Experience
Est. 1999
CS Dispensers: 1500
Scripts annually: 8.2 million
Prescribers
Pharmacists
92%
1% 1%
3% 3%
Internet based
5,500 report requests per week
<5 second response time
Licensing
Boards
Law
Enforcement
Others
Early Signs of Project Impact:
Slowing Annual Increase in Total Schedule II Doses
Slope-1.2%
Slope-10%
Slope-3.69%
Slope-18%
Slope- 9%
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)
90%
80%
70%
p<0.05
60%
50%
80%
40%
30%
20%
42%
10%
0%
Pretreatment
(Measured as return to work or school)
After Treatment Was Initiated
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
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