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Enabling Electronic Prescribing Enabling Electronic Prescribing and Enhanced Management of and Enhanced Management of
Controlled SubstancesControlled Substances
AHRQ Annual ConferenceSeptember 8, 2008
Grant M. Carrow, Ph.D.Massachusetts Department of Public Health
Bureau for Health Care Safety and QualityDrug Control Program
Project CollaboratorsProject 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
Project TeamProject Team
Adele Audet, RPh, DPHArnold Bilansky, RPh, DPHMichael B. Blackman, MD, MBA, Berkshire Health Systems, Inc.Grant M. Carrow, PhD, DPH, Principal InvestigatorNancy Coffey, U.S. Drug Enforcement AdministrationJohn L. Eadie, MPA, DPHPeter N. Kaufman, MD, DrFirst Stephen J. Kelleher, Jr., MHA, FACHE, Project Manager MeeLee Kim, BA, Brandeis UniversityPeter Kreiner, PhD, Brandeis UniversityAnn McDonald, RN, MN, BHS & Project LiaisonLee Panas, MS, Brandeis UniversityCindy Parks Thomas, MSPH, PhD, Brandeis UniversityStan Walczyk, RPh, O’Laughlin’s Pharmacy & DPH Formulary Comm.
AgendaAgenda
Project Purpose and Method Background Project Specific Aims Protocol Preliminary Findings Expected Outcomes
Project Purpose and MethodProject 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.
Background:Background:Challenges Unique to EPCSChallenges 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.
Background:Background:Challenges (cont’d)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
Background:Background:Challenges (cont’d)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, 20082IMS Health, 20063U.S. Substance Abuse and Mental Health Services Administration, 2006
Background:Background:Challenges (cont’d)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
Background:Background:Benefits Unique to EPCSBenefits 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 Increase in adoption of e-prescribing of non-controlled (legend) medicationsnon-controlled (legend) medications
Elimination of need for two separate Elimination of need for two separate systems (i.e., e-prescribing for legend systems (i.e., e-prescribing for legend medications and paper for controlled medications and paper for controlled medications)medications)
Background:Background:Security RequirementsSecurity Requirements
DEA has identified a set of security elements that must be included in a
health IT solution for EPCS
Background:Background:Security RequirementsSecurity 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
Background:Background:Security RequirementsSecurity 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
E-prescribing Transaction E-prescribing Transaction Current (non-EPCS)Current (non-EPCS)
EPCS TransactionEPCS Transaction
Background:Background:Regulatory MilestonesRegulatory Milestones
2003: 2003: Medicare Modernization Act mandated Medicare Modernization Act mandated standards standards for e-prescribingfor e-prescribing
2005: AHIC chartered2005: AHIC chartered2005: 2005: CMS final rule on foundation standards CMS final rule on foundation standards
(Medicare Part D)(Medicare Part D)2006: 2006: IOM report on role of e-prescribing in reducing IOM report on role of e-prescribing in reducing
medication errorsmedication errors2007: All states and D.C. allow e-prescribing of non-2007: All states and D.C. allow e-prescribing of non-
controlled (legend) medicationscontrolled (legend) medications2008: 2008: CMS final rule on additional standardsCMS final rule on additional standards2008: DEA Notice of Proposed Rulemaking for EPCS2008: DEA Notice of Proposed Rulemaking for EPCS
Project Specific AimsProject 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.
Project Specific Aims (cont’d)Project Specific Aims (cont’d)
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.
Protocol:Protocol:Study SiteStudy 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
Protocol: Protocol: Phase I Phase I (months 1 – 6)(months 1 – 6)
Obtain DEA waiver to allow e-prescribing of Obtain DEA waiver to allow e-prescribing of Schedule II-V drugs at Berkshire Health SystemsSchedule II-V drugs at Berkshire Health Systems
Introduce project to Berkshire medical communityIntroduce project to Berkshire medical community
Recruit providers to participate in projectRecruit providers to participate in project
Develop authentication process for use by providersDevelop authentication process for use by providers
Conduct provider and pharmacy interviews/surveysConduct provider and pharmacy interviews/surveys
Protocol:Protocol:Phase I (cont’d)Phase I (cont’d)
Providers will use e-prescribing technology utilizing Providers will use e-prescribing technology utilizing DrFirst’s Rcopia softwareDrFirst’s Rcopia software
Group IGroup I (current DrFirst users) will be split into 2 (current DrFirst users) will be split into 2 sub-groups: sub-groups:
50% to use EPCS (including digital 50% to use EPCS (including digital signature)signature)
50% to use standard prescribing process50% to use standard prescribing process
Group IIGroup II (new users of e-prescribing) will be split (new users of e-prescribing) will be split into 2 sub-groups: into 2 sub-groups:
50% to use EPCS (including digital 50% to use EPCS (including digital signature)signature)
50% to use standard prescribing process50% to use standard prescribing process
Protocol:Protocol:Phase II (Phase II (months 7 – 12)months 7 – 12)
Group I (control) will use standard prescribing Group I (control) will use standard prescribing process for Schedule II-V drugsprocess for Schedule II-V drugs
Group I (test) will begin using e-prescribing for Group I (test) will begin using e-prescribing for Schedule II-V drugsSchedule II-V drugs
Group II baseline data collection beginsGroup II baseline data collection begins
Assess prescription pick-up complianceAssess prescription pick-up compliance
Protocol:Protocol:Phase II (cont’d)Phase II (cont’d)
Develop and test interfacing between DrFirst and the Develop and test interfacing between DrFirst and the Massachusetts Prescription Monitoring Program Massachusetts Prescription Monitoring Program (PMP)(PMP)
Review PMP data to assess potential diversion Review PMP data to assess potential diversion issuesissues
Evaluate outcomes for:Evaluate outcomes for: improvement in patient careimprovement in patient care reductions in adverse drug events (ADEs) reductions in adverse drug events (ADEs) decrease in non-medical use of controlled decrease in non-medical use of controlled
substances.substances.
Conduct provider and pharmacy surveysConduct provider and pharmacy surveys
Protocol:Protocol:Phase III Phase III (months 13 – 27)(months 13 – 27)
Group I (test and control) continue to use e- Group I (test and control) continue to use e- prescribing and standard prescribing process prescribing and standard prescribing process respectively, for Schedule II-V drugsrespectively, for Schedule II-V drugs
Group II (control) will use standard prescribing Group II (control) will use standard prescribing process for Schedule II-V drugsprocess for Schedule II-V drugs
Group II (test) will begin using EPCSGroup II (test) will begin using EPCS
Data collection on Groups I and II continueData collection on Groups I and II continue
Protocol:Protocol:Phase III (cont’d)Phase III (cont’d)
Continue review of PMP data to assess potential Continue review of PMP data to assess potential diversion issuesdiversion issues
Continue to assess prescription pick-up complianceContinue to assess prescription pick-up compliance
Continue to evaluate outcomes for improvement in Continue to evaluate outcomes for improvement in patient carepatient care reductions in adverse drug events (ADEs)reductions in adverse drug events (ADEs) decrease in non-medical use of controlled decrease in non-medical use of controlled
substancessubstances
Conduct provider and pharmacy interviews/surveysConduct provider and pharmacy interviews/surveys
Evaluation of resultsEvaluation of results
Protocol:Protocol:Phase IV Phase IV (months 28 - 36)(months 28 - 36)
Complete EvaluationComplete Evaluation
Prepare ReportsPrepare Reports
Submit Final Reports to AHRQ and DEASubmit Final Reports to AHRQ and DEA
Dissemination of FindingsDissemination of Findings
Protocol:Protocol:Independent Security AnalysisIndependent 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
Protocol:Protocol:EvaluationEvaluation
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
Preliminary Findings:Potential State Regulatory Barriers
Do state laws allow EPCS?Do state laws allow EPCS? CA, MA, NY: laws allow for EPCS pending CA, MA, NY: laws allow for EPCS pending
DEA regulationsDEA regulations e.g., MA regulations set minimum security e.g., MA regulations set minimum security
standards and adopt DEA regulations by standards and adopt DEA regulations by referencereference11
1Mass. Code Regs., 105 CMR 721.000
Preliminary Findings:Potential Regulatory Barriers (cont’d)
Do state laws allow EPCS (cont’d)?Do state laws allow EPCS (cont’d)? FL law requires written prescription for FL law requires written prescription for
Schedule II drugsSchedule II drugs11
TX law prohibits e-prescribing of TX law prohibits e-prescribing of Schedule II prescriptions and requires Schedule II prescriptions and requires manual signaturemanual signature2,32,3
Time needed to change state laws and Time needed to change state laws and regulations may be significantregulations may be significant
1Fla. Statutes, Chapter 8932Tex. Health & Safety Code, Chapter 4813Tex. Admin. Code, Title 22, §291.34
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
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)
Expected OutcomesExpected 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
Expected Outcomes (cont’d)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
ContactsContacts
Grant M. Carrow, Ph.D.Grant M. Carrow, Ph.D.Principal InvestigatorPrincipal [email protected]@state.ma.us
Stephen J. Kelleher, Jr., MHA, FACHEProject [email protected]
QUESTIONS?QUESTIONS?
