Adverse Event Reporting and Electronic Health Records

Transcription

1 Adverse Event Reporting and Electronic Health Records Mitra Rocca Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration

2 Team Michael Ibara, Pfizer George Cole, AllScripts Dan Levy, Outcome Sciences/Quintiles HIMSS

3 The Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation s food supply, cosmetics, and products that emit radiation. HIMSS

4 Some Initiatives Focusing on Improving Drug Safety Sentinel OMOP MedWatch ADE Spontaneous Triggered Event Reporting HIMSS

5 MedWatch: The FDA Adverse Event Reporting Program Background: MedWatch, announced by Commissioner David Kessler Spontaneous voluntary reporting Benefits: Make it easier for providers to identify and report adverse events Increase physician understanding and awareness of drug induced diseases More widely disseminate safety information on the FDA s actions that have resulted from adverse event and product problem reporting HIMSS

6 Current Process in Adverse Event Reporting: Healthcare Provider s Perspective Challenges: Inconvenient to healthcare providers Issues: Interrupts healthcare provider s workflow The 30 second rule [C. McDonald] Requires multiple entry of data from various sources into free text and structured fields Not clear what data required/requested Not clear how or where to submit report Lack of knowledge and training HIMSS

7 ADE Spontaneous Triggered Electronic Reports David Westfall Bates, MD, M.Sc. Chief of the Division of General Internal Medicine at the Brigham and Women's Hospital; Professor of Medicine at Harvard Medical School and Professor of Health Policy and Management at the Harvard School of Public Health (Co- Director of the Program in Clinical Effectiveness) Jeffrey A. Linder, MD, MPH, FACP - PI of *ASTER Assistant Professor of Medicine, Harvard Medical School Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston MA

8 ASTER at Brigham and Women s Patient Physician Service Provider EHR * Coding Bus Rules * Regulator Ambulatory Clinics CDISC/IHE RFD * Triggered Adverse Event Reports *AE Report - EHR pt data - Physician Assessment - Coding & Bus Rule Results - Electronic Wrapper MAH

9 10:30:00 A Thursday in February, 2009 A doctor is working at an ambulatory clinic affiliated with Brigham and Women s Hospital They discontinue a patient s drug due to an adverse event

10 Screen Shots

11 Screen shots #2

12 Screen shots #3

13 Screen shots #4

14 Screen shots #7

15 10:30:00 10:31:00 The doctor goes back to seeing the patient

16 10:40:00 A MedWatch report* derived directly from the source document (EHR), validated by the doctor, is delivered to FDA *The report is MedDRA coded and has an initial serious/nonserious assessment

17 "Overall ASTER was well-accepted by the participating physicians, who felt it was unobtrusive and who saw the public health potential. The clinicians, most of whom submitted no reports in the prior year - submitted over 200 reports in 3 months." Jeffrey A. Linder, MD, MPH, FACP Brigham and Women s Hospital / Partners Healthcare PI on ASTER Study

18 Traditional Paper or separate site 36 minutes Several days or more 0 reports per physician 1 page of information ASTER At point of care 60 seconds 20 minutes (triaged) 5 reports per physician 7 pages of information

19 ASTER: Subsequent Efforts ASTER-D ASTER model for device reporting MHLW / Hamamatsu Explore ASTER model for reporting in Japan SPEAR project Cerner and MHRA duplicating ASTER in UK EHR setting

20 RFD Actors and Transactions Retrieve Form for Data Capture A Form Filler Submit Form Retrieve Form B C Form Manager Form Receiver

21 RFD Roles EHR, EDC A EHR Submit Form Form Filler Retrieve Form B C EDC 21 Form Manager Form Receiver

22 RFD Roles EHR, EDC, and FDA A EHR Submit Form Form Filler Retrieve Form B C EDC FDA 22 Form Manager Form Receiver 22

23 CDEs & Transformation CCD delivered to Form Manager Form Manager responsible for data transformations and prepopulation of MedWatch Form ICSR delivered to FDA Source:

24 Security and RFD Risk Analysis Content Profiles / Domains using RFD need to perform Some issues easily addressed with standard profiles Time clock variations use Consistent Time (CT) Secure Node use Audit Trail and Node Authentication (ATNA) EHR User use Cross Enterprise User Assertion (XUA) Audit Logging - use Audit Trail and Node Authentication (ATNA)

25 Auto-population Form Filler may supply patient content Some Content Profiles specify use of CCD Form Manager maps patient content to form fields

26 CCD Content auto-population examples for Adverse Event Reporting

27 Retrieved Form auto-populated for Adverse Eve

28 MedWatch Form

29 Q & A

30 Backup

31 Safety Reporting for EHR EHR (LMR) Adverse Event Reporting Information Flow (Brigham and Women s Hospital) Physician discontinues drug due to Adverse Event (AE) EHR System creates XML data file EHR System sends XML data file via RFD Physician completes and submits AE form XML data file is received and pre-populates AE form AE form is displayed to physician AE Form data is stored in AE repository as an AE report AE report data coded (MedDRA) Transmit message to FDA via CONNECT Create an ICSR message Set serious flag (Y/N) Receive message via CONNECT Adverse event message is displayed (MedWatch form) HIMSS

32 Safety Reporting for EHR (PrimeSuite) Adverse Event Reporting Information Flow (Greenway Medical Technologies) Physician discontinues drug due to Adverse Event (AE) EHR System creates XML data file EHR System sends XML data file via RFD Physician completes and submits AE form XML data file is received and pre-populates AE form AE form is displayed to physician AE Form data is stored in AE repository as an AE report AE report data coded (MedDRA) Transmit message to FDA via CONNECT Create an ICSR message Set serious flag (Y/N) Receive message via CONNECT Adverse event message is displayed (MedWatch form) HIMSS