Enabling Electronic Prescribing and Enhanced Management of Controlled Substances

1. Enabling Electronic Prescribing and Enhanced Management of Controlled Substances AHRQ Annual Conference September 8, 2008 Grant M. Carrow, Ph.D. Massachusetts Department of Public Health Bureau for Health Care Safety and Quality Drug Control Program

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

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.

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

5. Project Purpose and Method • Encourage the expansion, adoption and diffusion of e-prescribing, a key component of health 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.

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.

7. Background:Challenges (cont’d) • 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. Source: Alliance of States with Prescription Monitoring Programs, 1999

8. Background:Challenges (cont’d) • Controlled substances prescriptions estimated to comprise 326M prescriptions1 (ca. 8.8%) of total 3,700M U.S. prescriptions2 • Prevalence of non-medical use of prescription psychotherapeutics in U.S. estimated at 7M current users3 • Incidence of non-medical use of prescription psychotherapeutics in U.S. estimated at 2.2M new users3 1U.S. Drug Enforcement Administration, 2008 2IMS Health, 2006 3U.S. Substance Abuse and Mental Health Services Administration, 2006

9. Background:Challenges (cont’d) 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

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)

11. Background:Security Requirements DEA has identified a set of security elements that must be included in a health IT solution for EPCS

12. Background:Security Requirements

13. Background:Security Requirements

14. E-prescribing Transaction Current (non-EPCS)

15. EPCS Transaction

16. Background:Regulatory Milestones 2003: Medicare Modernization Act mandated standards for e-prescribing 2005: AHIC chartered 2005: CMS final rule on foundation standards (Medicare Part D) 2006: 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

17. Project Specific Aims

18. Project Specific Aims (cont’d)

19. Protocol:Study Site Berkshire Health Systems Catchment Area • BHS is primary provider in Berkshire County, MA (contained “laboratory”) • Community Pain Management Project • Leadership in EHR adoption • >300 physicians, dentists, nurse practitioners, physician assistants • Service to medically underserved populations

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

21. Protocol:Phase I (cont’d) 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

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

23. Protocol:Phase II (cont’d) • 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

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

25. Protocol:Phase III (cont’d) • 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

26. Protocol:Phase IV (months 28 - 36) • Complete Evaluation • Prepare Reports • Submit Final Reports to AHRQ and DEA • Dissemination of Findings

27. Protocol:Independent Security Analysis • 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

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

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 1Mass. Code Regs., 105 CMR 721.000

30. Preliminary Findings:Potential Regulatory Barriers (cont’d) • Do state laws allow EPCS (cont’d)? • FL law requires written prescription for Schedule II drugs1 • TX law prohibits e-prescribing of Schedule II prescriptions and requires manual signature2,3 • Time needed to change state laws and regulations may be significant 1Fla. Statutes, Chapter 893 2Tex. Health & Safety Code, Chapter 481 3Tex. Admin. Code, Title 22, §291.34

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

32. Preliminary Findings:Other Potential Challenges (cont’d) • 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)

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

34. Expected Outcomes (cont’d) • 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 • Increases access to needed pharmaceuticals, particularly by those with chronic medical conditions • Reduced non-medical use and abuse of controlled substances

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

36. QUESTIONS?