1. -1- Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. ER/LA Opioid Analgesic REMS Program Companies (RPC) Update to the MedBiquitous Working Group February 12, 2013

2. -2- Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. RPC Update to the MedBiquitous Working Group To fulfill the FDA REMS reporting requirements, a uniform standard for reporting CE participant data was required. Early in the REMS development process, CE Accreditors proposed a modified MedBiquitous MEMS specification as a means of compiling data from multiple Providers and Accreditation Systems into one data set.  Background:  Flow of Data: Providers report REMS CE data to Accreditors, who have been requested to compile the data & provide aggregate CE participant data to a third-party database to be aggregated & included by RPC in the periodic FDA Assessment Reports required by the ER/LA Opioid Analgesic REMS  RPC has provided support for the development of the MEMS 2.0 standard & has been one of the invited participants in the MedBiq Working Group  MEMS Specs & REMS-specific CE Dataset:  MedBiq Working Group confirmed final draft of the MEMS specs on Jan 28  REMS-specific dataset needed to compile FDA reports was defined & mapped to MEMS specs  On Feb 6, RPC sent inquiry to the Accreditors who have been participating in the MedBiq Working Group officially requesting their assistance collecting/reporting the REMS-specific CE dataset  Once Accreditor responses are received and path forward finalized, RPC plans telecon with national Provider orgs to familiarize them w/ REMS dataset (RPC will coordinate w/ Accreditors & other MedBiq Working Group members & welcomes their participation in the call)  MedBiquitous creates an ER/LA Opioid Analgesic REMS-specific implementation guide to assist CE Providers in incorporating these specs into their systems  Third Party CE Data Aggregator:  Role is to collect aggregated CE participant data for reporting to FDA  Details to be finalized once Accreditors’ responses to request for assistance in data collection have been received Flow of CE Participant Data CE Provider AccreditorAccreditor CE Data Aggregator RPCRPC FDA Assessment Report

3. -3- Copyright © 2013 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. REMS-specific CE Dataset 1.Start and End Date of Report 2.Accreditor Identifier 3.Program Name/Identification 4.Accredited Provider Name 5.Joint Accreditation 6.An indicator of whether program is RPC-supported 7.An indicator of full compliance to REMS 8.An indicator that an activity is related to REMS 9.Blueprint elements addressed by Instruction (optional for courses addressing some Blueprint elements) 10.Blueprint sections addressed by Assessment (optional for courses addressing some Blueprint sections) 11.Number of prescribers who have taken the above REMS-compliant training including all Blueprint elements and passed the knowledge assessment covering all sections of the Blueprint  Total Active (prescribed at least one ER/LA Opioid Analgesic in the past 12 months)  Breakdown of Total Active by Profession  Breakdown of Total Active by Practice Type (optional for Providers) The REMS-specific CE Dataset developed by the MedBiquitous Working Group and designed to permit CE data aggregation and reporting to FDA is provided below for reference.