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 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 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

9.96.9

10.7

7.5

10.0

15.4

6.9

19.4

7.7

8.3

10.214.2

7.9

6.210.815.3

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 Tremors

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

Tota

l Dos

es D

ispe

nsed

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

60,000

50,000

40,000

30,000

20,000

10,000

0

Pres

crip

tion

Num

bers

FY 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

Estim

ated

pre

scrip

tions

/ ind

ivid

ual

4.00

3.50

3.00

2.50

2.00

1.50

1.00

0.50

0.00 Fiscal Years 1996-2008

Esti

mat

ed p

resc

ript

ions

/ind

ivid

ual

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

# of

Indi

vidu

als

with

Que

stio

nabl

e A

ctiv

ity

Fiscal Years 1996-20080

20

40

60

80

100

120

140

160

# o

f Ind

ivid

uals

wit

h Q

uest

iona

ble

Acti

vity

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 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 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

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

ProvidersPain

ProvidersPrimary

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• 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 % DistributionEmergency 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 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, EsqVice 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

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• 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• 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

Prescribers

Pharmacists

LicensingBoardsLawEnforcementOthersInternet based

5,500 report requests per week<5 second response time

Est. 1999CS Dispensers: 1500Scripts 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 is491,050 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

Average Monthly Cost of CarePre-treatment:

$5258During 1st year of treatment:

$1566During 2nd year of treatment:

$700

Carlen Robinson, 32

August 9, 1973 - November 11, 2005