Enabling Electronic Prescribing and Enhanced Management of Controlled Substances

Slide Presentation from the AHRQ 2008 Annual Conference

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On September 8, 2008, Grant M. Carrow, made this presentation at the 2008 Annual Conference. Select to access the PowerPoint® presentation (510 KB).

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Slide 1

Enabling Electronic Prescribing and Enhanced Management of Controlled Substances

Grant M. Carrow, Ph.D.
Massachusetts Department of Public Health
Bureau for Health Care Safety and Quality Drug Control Program
AHRQ Annual Conference
September 8, 2008

Slide 2

Project Collaborators

• MA Department of Public Health, Drug Control Program.
• DrFirst, Inc., Rockville, MD.
• Brandeis University, Heller School for Social Policy and Management.
• Berkshire Health Systems, Inc.
• U. S. Department of Justice, Drug Enforcement Administration.
• Supported by a grant from the U.S. Agency for Healthcare Research and Quality.

Slide 3

Project Team

Adele Audet, RPh, DPH
Arnold Bilansky, RPh, DPH
Michael B. Blackman, MD, MBA, Berkshire Health Systems, Inc.
Grant M. Carrow, PhD, DPH, Principal Investigator
Nancy Coffey, U.S. Drug Enforcement Administration
John L. Eadie, MPA, DPH
Peter N. Kaufman, MD, DrFirst
Stephen J. Kelleher, Jr., MHA, FACHE, Project Manager
MeeLee Kim, BA, Brandeis University
Peter Kreiner, PhD, Brandeis University
Ann McDonald, RN, MN, BHS & Project Liaison
Lee Panas, MS, Brandeis University
Cindy Parks Thomas, MSPH, PhD, Brandeis University
Stan Walczyk, RPh, O'Laughlin's Pharmacy & DPH Formulary Comm.

Slide 4

Agenda

• Project Purpose and Method.
• Background.
• Project Specific Aims.
• Protocol.
• Preliminary Findings.
• Expected Outcomes.

Slide 5

Project Purpose and Method

• Encourage the expansion, adoption and diffusion of e-prescribing, a key component of health information technology (IT) and electronic health records, to improve medication management by ambulatory care clinicians at the point-of-care.
• Test and demonstrate the safety, security, quality and effectiveness of electronic transmission of prescriptions for federally controlled medications in the ambulatory care setting.

Slide 6

Background: Challenges Unique to EPCS

• Currently there is a lack of approved security standards for the electronic prescribing of controlled substances (EPCS).
• Security standards for EPCS are a unique challenge because of the need to prevent pharmaceutical (or drug) diversion.

Slide 7

Background: Challenges (continued)

• Pharmaceutical (or drug) diversion is the channeling of licit controlled substances or other pharmaceuticals for illegal purposes or abuse.
• Diversion may include, but is not limited to, theft, burglary and robbery; tampering; stealing, forging and counterfeiting prescriptions; doctor shopping; indiscriminate prescribing; and illegal sales of prescriptions and pharmaceuticals.

Note: Source: Alliance of States with Prescription Monitoring Programs, 1999.

Slide 8

Background: Challenges (continued)

• Controlled substances prescriptions estimated to comprise 326M prescriptions¹ (ca. 8.8%) of total 3,700M U.S. prescriptions.²
• Prevalence of non-medical use of prescription psychotherapeutics in U.S. estimated at 7M current users.³
• Incidence of non-medical use of prescription psychotherapeutics in U.S. estimated at 2.2M new users.³

Note:
¹ U.S. Drug Enforcement Administration, 2008.
² IMS Health, 2006.
³ U.S. Substance Abuse and Mental Health Services Administration, 2006.

Slide 9

Background: Challenges (continued)

The lack of approved standards has contributed to a delay in realizing the full patient safety, clinical benefits, and risk reductions that are known to result from e-prescribing, including:

• Better medication management and coordination of care
• Better decision support
• Clinician workflow improvement
• Prevention of medication errors

Slide 10

Background: Benefits Unique to EPCS

In addition, there are potential benefits unique to EPCS:

• Reductions in non-medical use and abuse of federally controlled pharmaceuticals.
• Increase in adoption of e-prescribing of non-controlled (legend) medications.
  • Elimination of need for two separate systems (i.e., e-prescribing for legend medications and paper for controlled medications).

Slide 11

Background: Security Requirements

The Drug Enforcement Agency (DEA) has identified a set of security elements that must be included in a health IT solution for EPCS.

Slide 12

Background: Security Requirements

Authentication: Positively identifying the signer and establishing who is sending and receiving data.

Non-repudiation: That parties to an activity cannot reasonably deny having participated in the activity.

Record Integrity: Data and signature have not been altered after signature.

Slide 13

Background: Security Requirements

Legal Sufficiency: Litigation strength for prosecution, i.e., the ability to be proven beyond a reasonable doubt.

Signature Verification: Ascertainment that an identified signer intended to endorse a writing.

Confidentiality: Only authorized persons have access to the data.

Slide 14

E-prescribing Transaction Current (non-EPCS)

The diagram depicts the e-prescribing transaction for non-EPCS.

• Patient
• Prescriber
• E-Prescribing System (DrFirst, etc.)
• E-Prescribing Network (eRx Network, SureScripts-RxHub, etc.)
• Pharmacy Benefit Manager (PBM)
• or
• Patient
• Pharmacy
• Pharmacy Management System (PDX, QS/1, Walgreens, etc.)
• E-Prescribing Network or PBM
• PBM

Slide 15

EPCS Transaction

The diagram depicts the EPCS transaction.

• Patient.
• Prescriber.
  • Prescriber credentialing & authorization process.
• E-Prescribing System (DrFirst, etc.)
  • Security Token.
• E-Prescribing Network (eRx Network, SureScripts-RxHub, etc.)
  • Digital Signature & Archiving.
• PBM and DEA Database.

OR

• Patient.
• Pharmacy.
  • Digital Signature & Archiving.
• Pharmacy Management System (PDX, QS/1, Walgreens, etc.)
• E-Prescribing Network or PBM.
• PBM and DEA Database.

Slide 16

Background: Regulatory Milestones

2003: Medicare Modernization Act mandated standards for e-prescribing.
2005: American Health Information Community (AHIC) chartered.br /> 2005: Centers for Medicare & Medicaid Services (CMS) final rule on foundation standards (Medicare Part D).
2006: Institute of Medicine (IOM) report on role of e-prescribing in reducing medication errors.
2007: All states and D.C. allow e-prescribing of non-controlled (legend) medications.
2008: CMS final rule on additional standards.
2008: DEA Notice of Proposed Rulemaking for EPCS.

Slide 17

Project Specific Aims

• Aim 1: Develop, implement and verify a system of safe and secure electronic transmission of prescriptions for federally controlled substances in an ambulatory care setting.
• Aim 2: Develop and test the interfacing of the e-prescribing system developed in Aim 1 with the Massachusetts Prescription Monitoring Program.

Slide 18

Project Specific Aims (continued)

• Aim 3: Conduct systems process and outcomes evaluations of improvements to patient care, risk reductions, patient and clinician benefits, patient safety, information privacy, confidentiality.
• Aim 4: Develop and implement a plan for dissemination of findings for Aims 1, 2 and 3.

Slide 19

Protocol: Study Site

Berkshire Health Systems (BHS) Catchment Area.

• BHS is primary provider in Berkshire County, MA (contained "laboratory").
• Community Pain Management Project.
• Leadership in electronic health record (EHR) adoption.
• >300 physicians, dentists, nurse practitioners, physician assistants.
• Service to medically underserved populations.

Slide 20

Protocol: Phase I (months 1 - 6)

• Obtain DEA waiver to allow e-prescribing of Schedule II-V drugs at Berkshire Health Systems.
• Introduce project to Berkshire medical community.
• Recruit providers to participate in project.
• Develop authentication process for use by providers.
• Conduct provider and pharmacy interviews/surveys.

Slide 21

Protocol: Phase I (continued)

Providers will use e-prescribing technology utilizing DrFirst's Rcopia software.

• Group I (current DrFirst users) will be split into 2 sub-groups:
  • 50% to use EPCS (including digital signature).
  • 50% to use standard prescribing process.
• Group II (new users of e-prescribing) will be split into 2 sub-groups:
  • 50% to use EPCS (including digital signature).
  • 50% to use standard prescribing process.

Slide 22

Protocol: Phase II (months 7-12)

• Group I (control) will use standard prescribing process for Schedule II-V drugs.
• Group I (test) will begin using e-prescribing for Schedule II-V drugs.
• Group II baseline data collection begins.
• Assess prescription pick-up compliance.

Slide 23

Protocol: Phase II (continued)

• Develop and test interfacing between DrFirst and the Massachusetts Prescription Monitoring Program (PMP).
• Review PMP data to assess potential diversion issues.
• Evaluate outcomes for:
  • Improvement in patient care.
  • Reductions in adverse drug events (ADEs).
  • Decrease in non-medical use of controlled substances.
• Conduct provider and pharmacy surveys.

Slide 24

Protocol: Phase III (months 13-27)

• Group I (test and control) continue to use e- prescribing and standard prescribing process respectively, for Schedule II-V drugs.
• Group II (control) will use standard prescribing process for Schedule II-V drugs.
• Group II (test) will begin using EPCS.
• Data collection on Groups I and II continue.

Slide 25

Protocol: Phase III (continued)

• Continue review of PMP data to assess potential diversion issues.
• Continue to assess prescription pick-up compliance.
• Continue to evaluate outcomes for improvement in:
  • Patient care.
  • Reductions in adverse drug events (ADEs).
  • Decrease in non-medical use of controlled substances.
• Conduct provider and pharmacy interviews/surveys.
• Evaluation of results.

Slide 26

Protocol: Phase IV (months 28-36)

• Complete Evaluation.
• Prepare Reports.
• Submit Final Reports to AHRQ and DEA.
• Dissemination of Findings.

Slide 27

Protocol: Independent Security Analysis

• National Institute of Standards and Technology (NIST) Trained/Certified.
• Review the design of the project.
• Test the security of the pilot system once it is operational.
  • Pre-deployment Risk Analysis.
  • Periodic (6 month) assessments throughout the project.
• Report on essential DEA security components for EPCS.
• Available to assess/report on major security breaches.

Slide 28

Protocol: Evaluation

Conduct process and outcome evaluations of:

• Improvements to Patient Care.
• Reduction of Risk.
  • Medication Errors.
  • Diversion.
  • Abuse.
• Patient and Clinician Benefits.
• Patient Safety.
• Information Privacy and Confidentiality.

Slide 29

Preliminary Findings: Potential State Regulatory Barriers

• Do state laws allow EPCS?
  • CA, MA, NY: laws allow for EPCS pending DEA regulations.
    • e.g., MA regulations set minimum security standards and adopt DEA regulations by reference¹

Note:
¹ Mass. Code Regs., 105 CMR 721.000

Slide 30

Preliminary Findings: Potential State Regulatory Barriers (continued)

• Do state laws allow EPCS (cont'd)?
  • FL law requires written prescription for Schedule II drugs.¹
  • TX law prohibits e-prescribing of Schedule II prescriptions and requires manual signature.², ³
• Time needed to change state laws and regulations may be significant.

Note:
¹ Fla. Statutes, Chapter 893
² Tex. Health & Safety Code, Chapter 481
³ Tex. Admin. Code, Title 22, §291.34

Slide 31

Preliminary Findings: Other Potential Challenges

• State laws and regulations can change.
• State controlled substances laws can be more restrictive than federal law.
• Many States place responsibility for security and validity of prescriptions on prescribers and pharmacies, both of which are regulated/licensed at state and federal levels.
• Transaction system providers (e.g., eRx software, transmission network and switches, pharmacy software) are not separately regulated/licensed.

Slide 32

Preliminary Findings: Other Potential Challenges (continued)

• States may be unprepared to conduct in-person identity proofing (e.g., regulations, infrastructure, costs).
• Acceptance of controlled substance e-prescriptions for reimbursement by third-party payors (currently automatically rejected by Medicaid).

Slide 33

Expected Outcomes

• Facilitate and expedite adoption and expand diffusion of electronic prescribing through:
  • Field testing security standards prior to finalization and implementation of DEA proposed regulations governing EPCS.
  • Identifying unexpected barriers and outcomes prior to implementation.

Slide 34

Expected Outcomes (continued)

• Earlier adoption and expanded diffusion of e-prescribing is expected to result in benefits such as:
  • Improved medication management by ambulatory care clinicians at the point-of-care.
  • Increased access to needed pharmaceuticals, particularly by those with chronic medical conditions.
  • Reduced non-medical use and abuse of controlled substances.

Slide 35

Contacts

• Grant M. Carrow, Ph.D.
  Principal Investigator
  Grant.Carrow@state.ma.us
• Stephen J. Kelleher, Jr., MHA, FACHE
  Project Manager
  Steve.Kelleher@state.ma.us

Slide 36

Questions?

Current as of January 2009

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Internet Citation:

Enabling Electronic Prescribing and Enhanced Management of Controlled Substances. Slide Presentation from the AHRQ 2008 Annual Conference (Text Version). January 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualmtg08/090808slides/Carrow.htm

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