# Presentation: 586401

## 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**

## 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**

## 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.**

## Agenda

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

## 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****.**

## 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.**

## 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

## Background:Challenges (cont’d)

**Controlled substances prescriptions estimated to comprise 326M prescriptions****1**** (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**** **

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

**Notes:**
Psychotherapeutics = pain relievers, tranquilizers, stimulants, sedatives

## 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****  **

## 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)**

## Background:Security Requirements

**DEA has identified a set of security elements that must be included in a health IT solution for EPCS**

## 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
 |

## 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
 |

## E-prescribing Transaction Current (non-EPCS)

## EPCS Transaction

## 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**

## 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. |

## 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: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**

## 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**

## 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**

## 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**

## 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**

## 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**

## 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**

## Protocol:Phase IV (months 28 - 36)

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

## 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 **

## 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**

## 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 reference****1**

- 1Mass. Code Regs., 105 CMR 721.000

## Preliminary Findings:Potential Regulatory Barriers (cont’d)

**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**

- 1Fla. Statutes, Chapter 893
- 2Tex. Health & Safety Code, Chapter 481
- 3Tex. 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 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)

**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**

## 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**

## QUESTIONS?