Francine Goodman, PharmD, BCPS

1
VA National Opioid Pain Care Agreement

• Francine Goodman, PharmD, BCPS
• Clinical Pharmacy Specialist
• VA Pharmacy Benefits Management Services
• Co-chair, Pharmacy Work Group
• Project Leader, National Opioid Pain Care
  Agreement
• National Pain Management Strategy Coordinating
  Committee

2
What Are Treatment Agreements?

• Tools for
• Clarifying the parameters of opioid treatment in
  the context of a comprehensive and individualized
  treatment plan
• Fostering open communication
• Promoting safe and efficacious use of opioids
• Providing education, reasonable obligations, and
  realistic expectations

3
What Are Treatment Agreements?

• Signed treatment agreements can serve as
  documentation of informed consent discussions.
• They are NOT written informed consents.
• VAs standardized treatment agreement National
  Opioid Pain Care Agreement (OPCA)

4
Where We Are

• Limited Supportive Evidence
• Poor-quality clinical studies
• Extensive expert support
• Variable usage of Opioid Agreements
• 80 of facilities use OAs 20 dont
• Multiple versions
• Content
• Tone
• Reading levels
• Different locations
• Disparity in enforcement

My way or the highway
5
Evolution of the National OPCAGoals
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Evolution of the National OPCACompleted Steps
Changed to Directive (11/07) Reviewed by field
(1/08) Incorporated field OAs (9/08) Edited by Pt
Education Panel (11/08)
Prepared by Pain PWG Based on Portlands OA
(7/07)
Start (11/06)
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Evolution of the National OPCAOngoing and
Future Steps
Submit for VACO concurrence Post THE Model OPCA
Obtaining consensus (2/09?) Piloting OPCA and PI
Guide (6/09?)
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Other Plans

• Patient Education
• MyHealtheVet
• Provider Education
• Time management strategies
• Communication techniques

9
National OPCA Policy (Draft)

• It is VHA policy that providers MUST
• discuss and review the national Opioid Pain Care
  Agreement to patients who are expected to receive
  daily opioid therapy for 3 or more consecutive
  months for the treatment of chronic pain (unless
  exemptions apply)
• 2) provide a copy of the Agreement to the
  patient and
• enter a copy of the signed Opioid Pain Care
  Agreement in the electronic chart in the Clinical
  Warnings section of CPRS for consistency and easy
  retrieval.
• Exemptions the pain is related to active
  malignancy or the patient has an advanced illness
  where provision of comfort care is the primary
  goal (i.e., palliative or hospice care).

10
National OPCA Policy (Draft) Refusal to Sign

• The patient is free to refuse to sign the
  Agreement.
• Refusal to sign does not automatically disqualify
  the patient for opioid therapy and is not
  necessarily an indication that it is unsafe to
  prescribe opioids.
• If a patient refuses to sign or follow the
  national Opioid Pain Care Agreement, the VHA
  provider will decide on a case-by-case basis
  whether to prescribe opioids to the patient,
  based on their professional judgment about the
  benefits and risks to the patient. Such
  discussions, decisions, and rationale will be
  documented by the provider.

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National OPCA (Draft)

• Partnership for the Safe and Effective Use of
  Opioids for Pain Control An Agreement to
  Participate
• (5 pages)
• Things the patient should know about opioid
  therapy (8 items)
• Patient responsibilities (15 items)
• Additional agreements (free text)
• Signatures Patient and Provider

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Patient Information Guide (Draft)

• What You Need to Know About VA Opioid Pain Care
• (13 pages)

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National OPCA Work Group

• IT / iMED / CPRS Robert Silverman, Raymond
  Frazier, Loren Stevenson
• General Counsel Eric Raun
• Ethics Kenneth Berkowitz
• Hospice Palliative Care Scott Shreve
• Hematology / Oncology Paulette Mehta
• Primary Care / Pain Robert Kerns, Mac
  Gallagher, Nancy Wiedemer, Francine Goodman,
  Stephen Eraker, Lisa Knoff, Matt Bair, Michael
  Clark, Jack Rosenberg, Beverly Rashad, Anthony
  Mariano, Mitchell Nazario, Diana Higgins, Sue
  Millar, Karl Frohm, Michael Mangione, Tim Lee
• Patient Education Panel Pam Hebert, Charlene
  Stokamer, Janette Elliott
• Provider Education Anne Turner, Robert Sproul

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Focus of Work Group Discussions

• Language / Tone / Content
• Informed Consent vs. Treatment Agreement
• Patient Rights and Patient / Public Safety
• Open communication
• Shared decision making
• Clinician judgment and responsibilities
• Education - Patient and Provider

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Significance of the National OPCA

• Thorough and exhaustive critical review and
  iterative consensus -building
• First national large-scale effort to standardize
  opioid treatment agreement
• IMPACT -gt Implementation of the VA-OPCA Policy
  will affect many Veterans and Providers

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IMPACT

• Primary Care Providers 6700
• 4400 FTEEs
• Veterans in Primary Care 4.6 million
• 
  FY 08 FY 09 (through July)
• Total outpatient Rx 4,438,696 4,393,534
• Rx for all CN101 971,613
  949,467
• RX for gt 3 months 378,422
  380,157

All numbers represent unique patients
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Summary

• The VA Opioid Pain Care Agreement (OPCA),
  Directive, and Patient Information Guide
• aim to enhance the safety and effectiveness of
  opioid pain care of veterans
• will standardize opioid treatment agreements,
  their utilization, availability, and
  documentation
• support respect for patients and their right to
  autonomous, informed participation and shared
  decision-making
• have been (and still is being) extensively
  vetted, meticulously reviewed, and painstakingly
  word-smithed
• will be models for the nation