Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting

Size: px
Start display at page:

Download "Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting"

Transcription

1 pharmacoepidemiology and drug safety 2010; 19: Published online 11 October 2010 in Wiley Online Library (wileyonlinelibrary.com).2027 BRIEF REPORT Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting Jeffrey A. Linder 1,2 *,JenniferS.Haas 1,2,AarthiIyer 1, Michael A. Labuzetta 1, Michael Ibara 3, Michael Celeste 3, George Getty 4 and David W. Bates 1,2 1 Division of General Medicine and Primary Care, Brigham and Women s Hospital, Boston, MA, USA 2 Harvard Medical School, Boston, MA, USA 3 Worldwide Safety and Regulatory Operations, Pfizer Inc., New York, NY, USA 4 Claricode, Waltham, MA, USA SUMMARY Purpose Physicians in the United States report fewer than 1% of adverse drug events (ADEs) to the Food and Drug Administration (FDA), but frequently document ADEs within electronic health records (EHRs). We developed and implemented a generalizable, scalable EHR-based system to automatically send electronic ADE reports to the FDA in real-time. Methods Proof-of-concept study involving 26 clinicians given access to EHR-based ADE reporting functionality from December 2008 to May Measurements Number and content of ADE reports; severity of adverse reactions (clinician and computer algorithm defined); clinician survey. Results During the study period, 26 clinicians submitted 217 reports to the FDA. The clinicians defined 23% of the ADEs as serious and a computer algorithm defined 4% of the ADEs as serious. The most common drug classes were cardiovascular drugs (40%), central nervous system drugs (19%), analgesics (13%), and endocrine drugs (7%). The reports contained information, pre-filled from the EHR, about comorbid conditions (207 reports [95%] listed 1899 comorbid conditions), concurrent medications (193 reports [89%] listed 1687 concurrent medications), weight (209 reports [96%]), and laboratory data (215 reports [99%]). It took clinicians a mean of 53 seconds to complete and send the form. In the clinician survey, 21 of 23 respondents (91%) said they had submitted zero ADE reports to the FDA in the prior 12 months. Conclusions EHR-based, triggered ADE reporting is efficient and acceptable to clinicians, provides detailed clinical information, and has the potential to greatly increase the number and quality of spontaneous reports submitted to the FDA. Copyright # 2010 John Wiley & Sons, Ltd. key words adverse drug reaction reporting systems; product surveillance; post-marketing; medical record systems; computerized; ambulatory care Received 9 December 2009; Revised 28 June 2010; Accepted 5 July 2010 INTRODUCTION About a quarter of outpatients experience adverse drug events (ADEs) and 13% of these are serious. 1 ADEs also represent common reasons for emergency department visits for adults and children. 2,3 However, because of barriers to reporting, physicians report as few as 0.3% of ADEs to the Food and Drug Administration (FDA). 4,5 A low reporting rate has contributed to the widespread agreement that it takes * Correspondence to: J. A. Linder, Division of General Medicine and Primary Care, Brigham and Women s Hospital, 1620 Tremont Street, BC-3-2X Boston, MA 02120, USA. too long to identify problem drugs and quantify risks of older drugs. 6 8 Consistent with recommendations from the Institute of Medicine, 9 proactive, automated reporting imbedded within electronic health records (EHRs), which are now used by about 35% of ambulatory physicians, 10 may improve public health by facilitating the submission of ADE reports. We developed the ADE spontaneous triggered electronic reporting system (ASTER), to submit ADE reports directly from EHRs using data collected as part of routine care to the FDA in a manner that was scalable and independent of a specific EHR. We conducted an initial pilot implementation of ASTER to assess the Copyright # 2010 John Wiley & Sons, Ltd.

2 1212 j. a. linder ET AL. feasibility of sending automated, real-time spontaneous, triggered reports from an EHR to the FDA and evaluated clinicians attitudes toward the system. METHODS We designed ASTER for use with any EHR that has a coded ADE documentation event or trigger. ASTER was remotely hosted by CRIX TM International, which could serve as a central aggregator of reports from multiple sources. For this proof-of-concept study, we used the Longitudinal Medical Record (LMR), an ambulatory EHR developed by Partners Healthcare, an integrated healthcare delivery system in Eastern Massachusetts. The LMR is an internally developed, web-based, fully functional, Certification Commission for Health Information Technology-certified EHR that uses a services-oriented architecture and includes notes from primary care and subspecialty practices; coded problem lists; a health maintenance grid for documenting preventive counseling and health habits; medication prescribing; and medication allergies. 11 ASTER used a flexible technical standard for data collection known as Retrieve Form for Data Capture (RFD) from the Clinical Data Interchange Standards Consortium (CDISC) and Integrating the Healthcare Enterprise (IHE). 12 RFD allowed remote hosting at CRIX, local aggregation and presentation of data within the EHR, and direct electronic submission to the FDA using the Individual Case Safety Report (ICSR) standard. ASTER was automatically triggered in the LMR when clinicians discontinued a medication due to an adverse reaction. When triggered, the LMR stored a unique identifier for the patient, clinician, and suspect medication. This identifier the key for which was retained within the LMR was passed to the ASTER application. ASTER then retrieved medication, demographic, vital sign, medical problem, and laboratory information from the LMR to populate an ADE reporting form. The ADE reporting form was available for the clinician to review within the LMR. Before submitting the form, the clinician had to provide two additional pieces of data: (1) the outcome of the ADE and (2) the earliest date of occurrence of the ADE. The clinician-defined outcomes were derived from the FDA MedWatch form. 13 We considered two types of seriousness: clinician coded and computer algorithm defined. For clinician coding, we considered the outcomes of death, life threatening, hospitalization, disability or incapacity, congenital anomaly or birth defect, and other serious outcomes as serious ADEs. For computer algorithm defined seriousness, events were automatically coded by CRIX using the Medical Dictionary for Regulatory Activities (MedDRA). 16 The event was then compared to a predefined list of designated always serious medical events created by the FDA. The study ran from 9 December 2008 to 22 May We selected, invited, and gave access to ASTER to 26 clinicians who frequently discontinued medications due to adverse reactions. As a comparison group, we used Partners Healthcare clinicians who wrote a prescription or had had at least one patient visit in the prior year. We compared these clinicians with the ASTER participants based on age, length of LMR use, and, in the year prior to the pilot, medication prescribing, and discontinuations due to adverse reactions. We classified drugs using First Data Bank s Enhanced Therapeutic Classes. 14 The main outcome of interest was the number of ADE reports received by the FDA. Additional measures of interest included the content, detail, and quality of the ADE reports and the speed, usability, and value of ASTER as reported by clinicians in a postpilot survey. We discussed the original concepts for ASTER with the FDA, which had input on the initial design. The design team met with the FDA a month prior to going live to review the project and processes. The Institutional Review Board and Health Information Systems Group of Partners Healthcare required signed data use agreements with CRIX and the FDA and approved the study protocol. RESULTS The 26 selected pilot clinicians, compared to 2606 nonparticipating clinicians, were older (mean age in years, 52 versus 45; p < 0.001); had used the EHR longer (mean years, 6.2 versus 4.8; p < 0.01); and, in the year prior to the pilot, prescribed more medications (mean, 4404 versus 578; p < 0.001), discontinued more medications (mean, 1422 versus 154; p < 0.001) and, by design, discontinued more medications due to adverse reactions (mean, 35 versus 2; p < 0.001). During the 5-month study period, the 26 pilot clinicians discontinued 319 medications due to ADEs. Reports for some of these ADEs were not submitted through ASTER because they were submitted before the system was saving data (13); errors in transmitting the data early in the study period (21); and either the clinician closed the pop-up form before submitting data or the form timed out because of delays (68). The FDA received 217 reports. The mean time from triggering to submitting the form was 53 (standard deviation [SD], 28) seconds.

3 The mean time between the ADE and report submission was 10 days (SD, 10). The most common suspect drug class was cardiovascular therapy agents (Table 1). The most common specific suspect drugs were lisinopril (n ¼ 34), simvastatin (n ¼ 10), nortriptyline (n ¼ 7), tramadol (n ¼ 6), and alendronate (n ¼ 5). Clinicians coded 168 (77%) of outcomes as non-serious and the majority of the remainder as other. The automatic algorithm coded 4% of reactions as serious. Reports contained information about demographics, comorbid conditions, concurrent medications, vital signs, and labs (Table 2). The mean number of comorbid conditions listed, on reports that had at least one comorbid condition, was 9 (SD, 6). The mean number of concurrent medications listed, on reports that had at least one concurrent medication, was 8 (SD, 5). The most commonly listed concurrent medications were lisinopril (n ¼ 26), aspirin (n ¼ 26), simvastatin ehr-based ade reporting 1213 Table 2. Example content of electronic adverse drug event reports (N ¼ 217) Characteristic Value Patient age, mean (SD) 58 (15) Women, N (%) 159 (73) Reports with any comorbid condition, N (%) 207 (95) Total number of comorbid conditions, N 1899 Report with any concurrent medication, N (%) 193 (89) Total number of concurrent medications, N 1687 Weight, N (%) 209 (96) Height, N (%) 177 (82) Reports with any laboratory data, N (%) 215 (99) Specific laboratory results, N (%) White blood cell count 211 (98) Creatinine 205 (95) Alkaline phosphatase 205 (95) Total bilirubin 185 (86) ALT 201 (94) Most common comorbid conditions were musculoskeletal problems (n ¼ 297), surgical procedures and tests (n ¼ 168), cardiovascular disease (n ¼ 159), lung disease (n ¼ 152), and cancer (n ¼ 111). Table 1. Suspect drug characteristics and outcomes (N ¼ 217) Characteristic N (%) Drug class Cardiovascular therapy agents 86 (40) Central nervous system agents 41 (19) Analgesic, anti-inflammatory or antipyretic 28 (13) Endocrine 14 (7) Anti-infective agents 13 (6) Chemical dependency, agents to treat 9 (4) Other classes 26 (12) Clinician-assigned outcomes No serious outcome 168 (77) Other serious outcome 36 (17) Inpatient hospitalization y 7 (3) Disability or incapacity z 4 (2) Life-threatening x 2 (1) Congenital anomaly or birth defect 0 (0) Death 0 (0) Automatically coded outcomes Serious reactions 8 (4) Non-serious reactions yy 158 (72) Not coded zz 53 (24) Most common other outcomes were musculoskeletal and connective tissue disorders (n ¼ 7), respiratory, thoracic, and mediastinal disorders (n ¼ 6), and psychiatric disorders (n ¼ 5). y Inpatient hospitalization outcome reactions were flu-like syndrome, seizure, heart block, rectal bleeding, myalgias, mental status change, and druginduced lupus (n ¼ 1 for all outcomes). z Disabling/incapacitating outcome reactions were flu-like syndrome, breathing difficulties, lung nodules, and rash (n ¼ 1); hepatotoxicity (n ¼ 1); insomnia (n ¼ 1); and chronic edema (n ¼ 1). x Life-threatening outcomes were bradycardia (n ¼ 1) and gastrointestinal intolerance (n ¼ 1). Serious reactions were angioedema (n ¼ 4), hyperkalemia (n ¼ 2), and myositis (n ¼ 2). yy Most common non-serious reactions were respiratory, thoracic, and mediastinal disorders (n ¼ 27); gastrointestinal disorders (n ¼ 26); psychiatric disorders (n ¼ 21); and nervous system disorders (n ¼ 20). zz Most common non-coded reactions were gastrointestinal disorders (n ¼ 30), nervous system disorders (n ¼ 5), and hepatobiliary disorders (n ¼ 4). (n ¼ 25), atorvastatin (n ¼ 15), and atenolol (n ¼ 12). Over 95% of reports had weight and laboratory data. After the pilot period, 23 of the 26 participants responded to the survey. Of the 23 respondents, 21 (91%) reported they had submitted no MedWatch forms in the prior year and two (9%) reported submitting three or more. Overall, 18 (78%) said they would like to view aggregate national data from the FDA about similar events. Importantly, 21 (91%) felt that ASTER would improve the care of their patients and 22 (96%) said that ASTER would improve their ability to accurately report drug risks. Among the freetext comments provided, 17 respondents (74%) stated that ASTER was either fast or easy to use and eight (35%) mentioned loading failures or ASTER taking time away from clinical care. DISCUSSION In this proof-of-concept study, clinicians who generally reported submitting no ADE reports in the prior year submitted 217 reports to the FDA in 5 months using an EHR-based, triggered, spontaneous reporting system. Despite initial technical challenges, the system met many of the requirements for a successful ADE reporting system: ease-of-use, acceptability to clinicians, and generation of reports containing a wide variety of data types. 15 Potential advantages of EHRbased, spontaneous triggered ADE reporting include secondary use of data collected as part of clinical care; integrating ADE reporting into clinicians workflow; the promptness and speed with which ADEs are reported; the ability to know the denominator of drug

4 1214 j. a. linder ET AL. prescriptions from which ADEs emerge; and increasing reports from clinicians rather than manufacturers, who presently submit over 80% of reports. 16 Potential disadvantages of EHR-based, spontaneous triggered ADE reporting include many of the biases inherent to spontaneous reports reporting bias, availability bias, channeling, and the Weber effect (the tendency of newly approved drugs to generate more ADE reports); 17 the potential volume of reports; the complexity of the data received; data incompatibility; 18 and the frequent submission of well-known, non-serious ADEs. 19 Finally, any reporting system must protect the privacy of patients and clinicians, who may be concerned about medical liability. 20 ASTER complements many other ongoing and emerging pharmacovigilance efforts such as the FDA Sentinel Initiative or the European Adverse Drug Reaction Project; 21,22 prospective and retrospective observational studies; 23,24 population-based outcome studies; 25 patient monitoring studies; 26 automated ADE detection techniques; 27 and independent reporting systems. 28,29 Compared to other methods of ADE identification, an EHR-based, spontaneous, triggered reporting system has several advantages. Clinicians, as opposed to researchers, identify and define potential ADEs ASTER is not dependent on pre-identified safety questions, has the potential to identify unexpected associations, 34,35 and takes advantage of the existing spontaneous reporting system. 19 ASTER could also be used to report vaccine-related or device-related adverse events to the FDA. 36 This study has limitations. First, by design, the clinicians we selected and who agreed to participate were different from the broader population of clinicians at Partners Healthcare. In addition, given that it is academically affiliated, our results may not generalize to broader community practice. Third, technical problems, now resolved, in conducting the pilot limited clinician satisfaction with ASTER. Finally, as a proof-of-concept study, the number of clinicians and reports was small. To address these limitations, we plan to continually monitor and quickly correct technical problems, expand participation to a larger, more representative set of clinicians, and expand participation beyond a single health system and EHR. During the project, we kept FDA staff apprised of our work and we have presented pilot results to the FDA. As we expand the number of clinicians with access to ASTER, we hope to continue working with the FDA to ensure that EHRbased, spontaneous triggered ADE reports provide high quality information. To that end, we may refine the ADE identification method, ensure the appropriate KEY POINTS EHR-based, triggered ADE reporting is efficient and acceptable to clinicians, and provides detailed clinical information. EHR-based, triggered ADE reporting has the potential to greatly increase the number and quality of submitted spontaneous reports. data elements are included, and, if the volume of reports becomes too large, limit submissions to only serious events. The true public health value of a system such as ASTER, will emerge when thousands of clinicians are submitting reports. We designed and implemented ASTER in a scalable way: a central aggregator allows collection of reports from multiple EHRs or electronic systems and can pre-process reports before sending them to the FDA. Such a system could also be bidirectional the FDA could request additional or follow-up information about specific ADEs and could serve as part of a national distributed health data network with functions other than ADE reporting. 37 Like any pharmacovigilance system, EHRbased, spontaneous triggered reporting should help identify new ADEs and accurately define the risks associated with drugs. 8,26 CONFLICT OF INTEREST Dr Ibara and Mr Celeste are employees of Pfizer and were involved in the planning, implementation, data collection, data analysis, manuscript drafting, and the decision to submit the manuscript for publication. Dr Linder had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. ACKNOWLEDGEMENTS This study was supported by a grant from Pfizer. REFERENCES 1. Gandhi TK, Weingart SN, Borus J, et al. Adverse drug events in ambulatory care. N Engl J Med 2003; 348(16): Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006; 296(15): Cohen AL, Budnitz DS, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. J Pediatr 2008; 152(3):

5 ehr-based ade reporting Health, Education, and Human Services Division. Adverse Drug Events: The Magnitude of the Health Risk Is Uncertain Because of Limited Incidence Data (Report GAO/HEHS-00-21), US General Accounting Office, Washington, DC, January Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of underreporting of adverse drug reactions: a systematic review. Drug Saf 2009; 32(1): Bates DW. Drugs and adverse drug reactions: how worried should we be? JAMA 1998; 279(15): Strom BL. How the US drug safety system should be changed. JAMA 2006; 295(17): Avorn J, Schneewiess S. Managing drug-risk information what to do with all those new numbers. N Engl J Med 2009; 361(7): Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public, National Academy of Sciences, Washington, DC, Hing E, Hsiao CJ. Electronic medical record use by officebased physicians and their practices: United States, National health statistics reports; no 23, National Center for Health Statistics, Hyattsville, MD, Certification Commission for Healthcare Information Technology. Partners HealthCare System Longitudinal Medical Record (LMR) Available at: [8 December 2009]. 12. Integrating the Healthcare Enterprise. Technical Framework Supplement Retrieve Form for Data Capture. Available at: Technical_Framework/upload/IHE_ITI_TF_Supplement_RFD_TI_ pdf [December 2009]. 13. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Available at: htm [December 2009]. 14. First Data Bank. Enhanced Therapeutic Classification System. Available at: [December 2009]. 15. Wu JH, Shen WS, Lin LM, Greenes RA, Bates DW. Testing the technology acceptance model for evaluating healthcare professionals intention to use an adverse event reporting system. Int J Qual Health Care 2008; 20(2): Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, Arch Intern Med 2007; 167(16): Stephenson WP, Hauben M. Data mining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf 2007; 16(4): Glass LM. Data incompatibility of adverse event reports electronically submitted to the AERS database. Pharmacoepidemiol Drug Saf 2008; 17(2): Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, : the importance of reporting suspected reactions. Arch Intern Med 2005; 165(12): Lee LM, Gostin LO. Ethical collection, storage, and use of public health data: a proposal for a national privacy protection. JAMA 2009; 302(1): Platt R, Wilson M, Chan KA, Benner JS, Marchibroda J, McClellan M. The new Sentinel Network improving the evidence of medicalproduct safety. N Engl J Med 2009; 361(7): Trifiro G, Pariente A, Coloma PM, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 2009; 18: Psaty BM, Vandenbroucke JP. Opportunities for enhancing the FDA guidance on pharmacovigilance. JAMA 2008; 300(8): Bennett CL, Nebeker JR, Yarnold PR, et al. Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Arch Intern Med 2007; 167(10): Booth CM, Mackillop WJ. Translating new medical therapies into societal benefit: the role of population-based outcome studies. JAMA 2008; 300(18): Harmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008; 64(8): Wang X, Hripcsak G, Markatou M, Friedman C. Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study. J Am Med Inform Assoc 2009; 16(3): Zafar A, Hickner J, Pace W, Tierney W. An adverse drug event and medication error reporting system for ambulatory care (MEADERS). AMIA Annu Symp Proc. 2008: Miller MR, Clark JS, Lehmann CU. Computer based medication error reporting: insights and implications. Qual Saf Health Care 2006; 15(3): Bates DW, Evans RS, Murff H, Stetson PD, Pizziferri L, Hripcsak G. Detecting adverse events using information technology. J Am Med Inform Assoc 2003; 10(2): Honigman B, Light P, Pulling RM, Bates DW. A computerized method for identifying incidents associated with adverse drug events in outpatients. Int J Med Inform 2001; 61(1): Brown JS, Kulldorff M, Petronis KR, et al. Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations. Pharmacoepidemiol Drug Saf 2009; 18(3): Brown JS, Kulldorff M, Chan KA, et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf 2007; 16(12): Platt R, Madre L, Reynolds R, Tilson H. Active drug safety surveillance: a tool to improve public health. Pharmacoepidemiol Drug Saf 2008; 17(12): Poluzzi E, Raschi E, Moretti U, De Ponti F. Drug-induced torsades de pointes: data mining of the public version of the FDA adverse event reporting system (AERS). Pharmacoepidemiol Drug Saf 2009; 18(6): Hinrichsen VL, Kruskal B, O Brien MA, Lieu TA, Platt R. Using electronic medical records to enhance detection and reporting of vaccine adverse events. J Am Med Inform Assoc 2007; 14(6): Maro JC, Platt R, Holmes JH, et al. Design of a national distributed health data network. Ann Intern Med 2009; 151(5):

Adverse Event Reporting and Electronic Health Records

Adverse Event Reporting and Electronic Health Records 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 Team Michael Ibara, Pfizer George

More information

Medication error is the most common

Medication error is the most common Medication Reconciliation Transfer of medication information across settings keeping it free from error. By Jane H. Barnsteiner, PhD, RN, FAAN Medication error is the most common type of error affecting

More information

CDISC and Clinical Research Standards in the LHS

CDISC and Clinical Research Standards in the LHS CDISC and Clinical Research Standards in the LHS Learning Health System in Europe 24 September 2015, Brussels Rebecca D. Kush, PhD, President and CEO, CDISC CDISC 2015 1 CDISC Healthcare Link Goal: Optimize

More information

Methodology for Safety Surveillance of Adverse Events Following Vaccination During Pregnancy

Methodology for Safety Surveillance of Adverse Events Following Vaccination During Pregnancy Methodology for Safety Surveillance of Adverse Events Following Vaccination During Pregnancy C. Jouquelet-Royer September 2012 Fondation Merieux NAME OF PRESENTATION 1 Presentation Outline Background Company

More information

Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER

Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER LT Andrew Fine, Pharm.D., BCPS Safety Evaluator Division of Pharmacovigilance Office of Pharmacovigilance and Epidemiology

More information

SALUS: Enabling the Secondary Use of EHRs for Post Market Safety Studies

SALUS: Enabling the Secondary Use of EHRs for Post Market Safety Studies SALUS: Enabling the Secondary Use of EHRs for Post Market Safety Studies May 2015 A. Anil SINACI, Deputy Project Coordinator SALUS: Scalable, Standard based Interoperability Framework for Sustainable Proactive

More information

An adverse drug event (ADE) is

An adverse drug event (ADE) is Practice reports Monitoring adverse drug reactions P R A C t i c e R e P O R T S Monitoring adverse drug reactions across a nationwide health care system using information technology Thomas Emmendorfer,

More information

Public Health and the Learning Health Care System Lessons from Two Distributed Networks for Public Health

Public Health and the Learning Health Care System Lessons from Two Distributed Networks for Public Health Public Health and the Learning Health Care System Lessons from Two Distributed Networks for Public Health Jeffrey Brown, PhD Assistant Professor Department of Population Medicine Harvard Medical School

More information

The Electronic Medical Record (EMR)

The Electronic Medical Record (EMR) Journal of Applied Medical Sciences, vol. 2, no. 2, 2013, 79-85 ISSN: 2241-2328 (print version), 2241-2336 (online) Scienpress Ltd, 2013 The Electronic Medical Record (EMR) PeterChris Okpala 1 Abstract

More information

EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1

EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1 EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1 October 4, 2005 Guideline on Risk Management Systems for Medicinal Products for Human Use DRAFT London, 6 September 2005. This guideline will be included as chapter

More information

Electronic Medical Record Customization and the Impact Upon Chart Completion Rates

Electronic Medical Record Customization and the Impact Upon Chart Completion Rates 338 May 2010 Family Medicine Improving Workflow Electronic Medical Record Customization and the Impact Upon Chart Completion Rates Kevin J. Bennett, PhD; Christian Steen, MD Objective: The study s objctive

More information

Conflict of Interest Disclosure

Conflict of Interest Disclosure Leveraging Clinical Decision Support for Optimal Medication Management Anne M Bobb, BS Pharm., Director Quality Informatics Children s Memorial Hospital, Chicago IL, February 20, 2012 DISCLAIMER: The views

More information

Beyond the EMR: Disease Registries 3/5/2010

Beyond the EMR: Disease Registries 3/5/2010 Beyond the EMR: Disease Registries Better Health Greater Cleveland Learning Collaborative March 5, 2010 Anil Jain, MD, FACP Senior IT Executive, Information Technology, Cleveland Clinic Managing Director,

More information

FDA's Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products. Progress and Direction

FDA's Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products. Progress and Direction FDA's Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products Progress and Direction Richard Platt Harvard Pilgrim Health Care Institute Harvard Medical School for the Mini-Sentinel Investigators

More information

Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices: United States, 2001 2013

Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices: United States, 2001 2013 Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices: United States, 2001 2013 Chun-Ju Hsiao, Ph.D., and Esther Hing, M.P.H. Key findings In 2013, 78% of office-based

More information

Overview of FDA s active surveillance programs and epidemiologic studies for vaccines

Overview of FDA s active surveillance programs and epidemiologic studies for vaccines Overview of FDA s active surveillance programs and epidemiologic studies for vaccines David Martin, M.D., M.P.H. Director, Division of Epidemiology Center for Biologics Evaluation and Research Application

More information

Clinical Environment:

Clinical Environment: Medicos Consultants Structured Product Labeling (SPL) in the Clinical Environment: Electronic Health Records (EHR) & Digital Medical References (DMR) September 21, 2010 All Rights Reserved. 2010 No part

More information

Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

Guidance on adverse drug reactions

Guidance on adverse drug reactions Guidance on adverse drug reactions Classification of adverse drug reactions Adverse drug reactions are frequently classified as type A and type B reactions. An extended version of this classification system

More information

A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting

A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting Merrick Zwarenstein, MBBCh, MSc Senior Scientist Institute for Clinically Evaluative Science 2075 Bayview Avenue

More information

Using Electronic Medical Records to Enhance Detection and Reporting of Vaccine Adverse Events

Using Electronic Medical Records to Enhance Detection and Reporting of Vaccine Adverse Events Journal of the American Medical Informatics Association Volume 14 Number 6 Nov / Dec 2007 731 Application of Information Technology Using Electronic Medical Records to Enhance Detection and Reporting of

More information

HIMSS Electronic Health Record Definitional Model Version 1.0

HIMSS Electronic Health Record Definitional Model Version 1.0 HIMSS Electronic Health Record Definitional Model Version 1.0 Prepared by HIMSS Electronic Health Record Committee Thomas Handler, MD. Research Director, Gartner Rick Holtmeier, President, Berdy Systems

More information

2008 Wisconsin Ambulatory Health Information Technology Survey

2008 Wisconsin Ambulatory Health Information Technology Survey 2008 Wisconsin Ambulatory Health Information Technology Survey March 31, 2009 State of Wisconsin Governor s ehealth Care Quality and Patient Safety Board Department of Health Services P-00831 (03/09) -

More information

AAP Meaningful Use: Certified EHR Technology Criteria

AAP Meaningful Use: Certified EHR Technology Criteria AAP Meaningful Use: Certified EHR Technology Criteria On July 13, 2010, the US Centers for Medicare and Medicaid Services (CMS) released a Final Rule establishing the criteria with which eligible pediatricians,

More information

How Electronic Health Records Might Change Birth Defects Surveillance (and what to do about it!)

How Electronic Health Records Might Change Birth Defects Surveillance (and what to do about it!) How Electronic Health Records Might Change Birth Defects Surveillance (and what to do about it!) Seth Foldy, MD MPH FAAFP Senior Advisor Public Health Informatics and Technology Program Office Office of

More information

STRENGTHENING OUR NATIONAL SYSTEM FOR MEDICAL DEVICE POSTMARKET SURVEILLANCE

STRENGTHENING OUR NATIONAL SYSTEM FOR MEDICAL DEVICE POSTMARKET SURVEILLANCE STRENGTHENING OUR NATIONAL SYSTEM FOR MEDICAL DEVICE POSTMARKET SURVEILLANCE UPDATE AND NEXT STEPS CENTER FOR DEVICES AND RADIOLOGICAL HEALTH U.S. FOOD AND DRUG ADMINISTRATION APRIL 2013 BACKGROUND In

More information

PRACTICE BRIEF. Preventing Medication Errors in Home Care. Home Care Patients Are Vulnerable to Medication Errors

PRACTICE BRIEF. Preventing Medication Errors in Home Care. Home Care Patients Are Vulnerable to Medication Errors PRACTICE BRIEF FALL 2002 Preventing Medication Errors in Home Care This practice brief highlights the results of two home health care studies on medication errors. The first study determined how often

More information

800 17th Street, NW Suite 1100, Washington, DC 20006

800 17th Street, NW Suite 1100, Washington, DC 20006 800 17th Street, NW Suite 1100, Washington, DC 20006 September 3, 2015 Mr. Andrew Slavitt Acting Administrator, Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H.

More information

Presented by. Terri Gonzalez Director of Practice Improvement North Carolina Medical Society

Presented by. Terri Gonzalez Director of Practice Improvement North Carolina Medical Society Presented by Terri Gonzalez Director of Practice Improvement North Carolina Medical Society Meaningful Use is using certified EHR technology to: Improve quality, safety, efficiency, and reduce errors Engage

More information

HL7 and Meaningful Use

HL7 and Meaningful Use HL7 and Meaningful Use Grant M. Wood HL7 Ambassador HIMSS14 2012 Health Level Seven International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International.

More information

Stage 1 vs. Stage 2 Comparison Table for Eligible Hospitals and CAHs Last Updated: August, 2012

Stage 1 vs. Stage 2 Comparison Table for Eligible Hospitals and CAHs Last Updated: August, 2012 CORE OBJECTIVES (16 total) Stage 1 vs. Stage 2 Comparison Table for Eligible Hospitals and CAHs Last Updated: August, 2012 Stage 1 Objective Use CPOE for medication orders directly entered by any licensed

More information

Dr. Peters has declared no conflicts of interest related to the content of his presentation.

Dr. Peters has declared no conflicts of interest related to the content of his presentation. Dr. Peters has declared no conflicts of interest related to the content of his presentation. Steve G. Peters MD NAMDRC 2013 No financial conflicts No off-label usages If specific vendors are named, will

More information

Stage 1 Meaningful Use for Specialists. NYC REACH Primary Care Information Project NYC Department of Health & Mental Hygiene

Stage 1 Meaningful Use for Specialists. NYC REACH Primary Care Information Project NYC Department of Health & Mental Hygiene Stage 1 Meaningful Use for Specialists NYC REACH Primary Care Information Project NYC Department of Health & Mental Hygiene 1 Today s Agenda Meaningful Use Overview Meaningful Use Measures Resources Primary

More information

EMR Benefits and Benefit Realization Methods of Stage 6 and 7 Hospitals Hospitals with advanced EMRs report numerous benefits.

EMR Benefits and Benefit Realization Methods of Stage 6 and 7 Hospitals Hospitals with advanced EMRs report numerous benefits. EMR Benefits and Benefit Realization Methods of Stage 6 and 7 Hospitals Hospitals with advanced EMRs report numerous benefits February, 2012 2 Table of Contents 3 Introduction... 4 An Important Question...

More information

HEAL NY Phase 5 Health IT RGA Section 7.1: HEAL NY Phase 5 Health IT Candidate Use Cases Interoperable EHR Use Case for Medicaid

HEAL NY Phase 5 Health IT RGA Section 7.1: HEAL NY Phase 5 Health IT Candidate Use Cases Interoperable EHR Use Case for Medicaid HEAL NY Phase 5 Health IT RGA Section 7.1: HEAL NY Phase 5 Health IT Candidate Use Cases Interoperable EHR Use Case for Medicaid Interoperable Electronic Health Records (EHRs) Use Case for Medicaid (Medication

More information

NCQA PCMH 2011 Standards, Elements and Factors Documentation Guideline/Data Sources

NCQA PCMH 2011 Standards, Elements and Factors Documentation Guideline/Data Sources NCQA PCMH 2011 Standards, Elements and Factors Documentation Guideline/Data Sources Key: DP = Documented Process N/D = Report numerator and denominator creating percent of use RPT = Report of data or information

More information

Better patient care and better practice management

Better patient care and better practice management www.hitecla.org INTRODUCTION BENEFITS CHALLENGES WHY NOW? INCENTIVES FOR PROVIDERS HOW WE HELP SUMMARY Better patient care and better practice management Using Electronic Health Records in a meaningful

More information

Adverse Events in Clinical Trials: Definitions and Documentation

Adverse Events in Clinical Trials: Definitions and Documentation Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators Adverse Events in Clinical Trials: Definitions

More information

Medicine Safety Glossary

Medicine Safety Glossary The following definitions are provided as a resource to supplement the information provided in the Medicine Safety Education section of the Pfizer.com Web site; they are not intended as a comprehensive

More information

GAO ADVERSE EVENTS. Surveillance Systems for Adverse Events and Medical Errors. Testimony

GAO ADVERSE EVENTS. Surveillance Systems for Adverse Events and Medical Errors. Testimony GAO For Release on Delivery Expected at 10:30 a.m. Wednesday, February 9, 2000 United States General Accounting Office Testimony Before the Subcommittees on Health and Environment, and Oversight and Investigations,

More information

Stage 1 measures. The EP/eligible hospital has enabled this functionality

Stage 1 measures. The EP/eligible hospital has enabled this functionality EMR Name/Model Ingenix CareTracker - version 7 EMR Vendor Ingenix CareTracker Stage 1 objectives Use CPOE Use of CPOE for orders (any type) directly entered by authorizing provider (for example, MD, DO,

More information

C A LIFORNIA HEALTHCARE FOUNDATION. s n a p s h o t The State of Health Information Technology in California

C A LIFORNIA HEALTHCARE FOUNDATION. s n a p s h o t The State of Health Information Technology in California C A LIFORNIA HEALTHCARE FOUNDATION s n a p s h o t The State of Health Information Technology in California 2011 Introduction The use of health information technology (HIT), defined as the software used

More information

THE ROLE OF CLINICAL DECISION SUPPORT AND ANALYTICS IN IMPROVING LONG-TERM CARE OUTCOMES

THE ROLE OF CLINICAL DECISION SUPPORT AND ANALYTICS IN IMPROVING LONG-TERM CARE OUTCOMES THE ROLE OF CLINICAL DECISION SUPPORT AND ANALYTICS IN IMPROVING LONG-TERM CARE OUTCOMES Long-term and post-acute care (LTPAC) organizations face unique challenges for remaining compliant and delivering

More information

Core Set of Objectives and Measures Must Meet All 15 Measures Stage 1 Objectives Stage 1 Measures Reporting Method

Core Set of Objectives and Measures Must Meet All 15 Measures Stage 1 Objectives Stage 1 Measures Reporting Method Core Set of Objectives and Measures Must Meet All 15 Measures Stage 1 Objectives Stage 1 Measures Reporting Method Use Computerized Provider Order Entry (CPOE) for medication orders directly entered by

More information

Mona Osman MD, MPH, MBA

Mona Osman MD, MPH, MBA Mona Osman MD, MPH, MBA Objectives To define an Electronic Medical Record (EMR) To demonstrate the benefits of EMR To introduce the Lebanese Society of Family Medicine- EMR Reality Check The healthcare

More information

Meaningful Use. Medicare and Medicaid EHR Incentive Programs

Meaningful Use. Medicare and Medicaid EHR Incentive Programs Meaningful Use Medicare and Medicaid Table of Contents What is Meaningful Use?... 1 Table 1: Patient Benefits... 2 What is an EP?... 4 How are Registration and Attestation Being Handled?... 5 What are

More information

TOWARD A FRAMEWORK FOR DATA QUALITY IN ELECTRONIC HEALTH RECORD

TOWARD A FRAMEWORK FOR DATA QUALITY IN ELECTRONIC HEALTH RECORD TOWARD A FRAMEWORK FOR DATA QUALITY IN ELECTRONIC HEALTH RECORD Omar Almutiry, Gary Wills and Richard Crowder School of Electronics and Computer Science, University of Southampton, Southampton, UK. {osa1a11,gbw,rmc}@ecs.soton.ac.uk

More information

Use and Integration of Freely Available U.S. Public Use Files to Answer Pharmacoeconomic Questions: Deciphering the Alphabet Soup

Use and Integration of Freely Available U.S. Public Use Files to Answer Pharmacoeconomic Questions: Deciphering the Alphabet Soup Use and Integration of Freely Available U.S. Public Use Files to Answer Pharmacoeconomic Questions: Deciphering the Alphabet Soup Prepared by Ovation Research Group for the National Library of Medicine

More information

Overview of Today s Presentation. Minnesota Model for Adopting Interoperable Electronic Health Records

Overview of Today s Presentation. Minnesota Model for Adopting Interoperable Electronic Health Records Update on Meaningful Use Review of Proposed Definition Presented to National HIT Policy Committee on June 16, 2009 Overview of Today s Presentation Meaningful Use vs. Effective Use In the Context of the

More information

Meaningful Use Qualification Plan

Meaningful Use Qualification Plan Meaningful Use Qualification Plan Overview Certified EHR technology used in a meaningful way is one piece of a broader Health Information Technology infrastructure intended to reform the health care system

More information

PROTOCOL FOR THE PILOT STUDY OF HEALTH LEVEL 7 MESSAGE-EXCHANGE BETWEEN IMMUNIZATION INFORMATION SYSTEMS AND MINI-SENTINEL/PRISM DATA PARTNERS

PROTOCOL FOR THE PILOT STUDY OF HEALTH LEVEL 7 MESSAGE-EXCHANGE BETWEEN IMMUNIZATION INFORMATION SYSTEMS AND MINI-SENTINEL/PRISM DATA PARTNERS PROTOCOL FOR THE PILOT STUDY OF HEALTH LEVEL 7 MESSAGE-EXCHANGE BETWEEN IMMUNIZATION INFORMATION SYSTEMS AND MINI-SENTINEL/PRISM DATA PARTNERS Prepared by: Therese Hoyle, BSHE 1, Carolyn Jevit, MBA 2,

More information

Opportunities and challenges for public health surveillance: a new world of interoperability with electronic health records

Opportunities and challenges for public health surveillance: a new world of interoperability with electronic health records Opportunities and challenges for public health surveillance: a new world of interoperability with electronic health records James Daniel, MPH The Office of the National Coordinator for Health IT CMS Rule

More information

American Society of Addiction Medicine

American Society of Addiction Medicine American Society of Addiction Medicine Public Policy Statement on Core Benefit for Primary Care and Specialty Treatment and Prevention of Alcohol, Nicotine and Other Drug PREFACE Statement of the Problem:

More information

OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP

OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP OBSERVATIONAL Opportunities for Signal Detection in an Active Surveillance System Andrew Bate Pfizer, Senior Director, Analytics Team Lead Epidemiology OMOP January 2011 Symposium Contents Background Signal

More information

Risk Management Plan (RMP) Guidance (Draft)

Risk Management Plan (RMP) Guidance (Draft) Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Pharmaceuticals and Medical Devices Agency Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour

More information

Any, Certified, and Basic: Quantifying Physician EHR Adoption through 2014

Any, Certified, and Basic: Quantifying Physician EHR Adoption through 2014 ONC Data Brief No. 28 September 2015 Any, Certified, and Basic: Quantifying Physician EHR Adoption through 2014 Dawn Heisey-Grove, MPH; Vaishali Patel, PhD MPH Physician adoption of electronic health record

More information

IL-HITREC P.O. Box 755 Sycamore, IL 60178 Phone 815-753-1136 Fax 815-753-2460 email info@ilhitrec.org www.ilhitrec.org

IL-HITREC P.O. Box 755 Sycamore, IL 60178 Phone 815-753-1136 Fax 815-753-2460 email info@ilhitrec.org www.ilhitrec.org IL-HITREC P.O. Box 755 Sycamore, IL 60178 Phone 815-753-1136 Fax 815-753-2460 email info@ilhitrec.org www.ilhitrec.org INTRODUCTION BENEFITS CHALLENGES WHY NOW? HOW WE HELP SUMMARY Better patient care

More information

Meaningful Use - The Basics

Meaningful Use - The Basics Meaningful Use - The Basics Presented by PaperFree Florida 1 Topics Meaningful Use Stage 1 Meaningful Use Barriers: Observations from the field Help and Questions 2 What is Meaningful Use Meaningful Use

More information

Learning Objectives. Introduction to Reconciling Medication Information. Background. Elements of Performance NPSG.03.06.01

Learning Objectives. Introduction to Reconciling Medication Information. Background. Elements of Performance NPSG.03.06.01 Pharmacy Evaluation of Medication Reconciliation Initiated in the Emergency Department Manuel A. Calvin, Pharm.D. PGY1 Pharmacy Resident Saint Francis Hospital, Tulsa, OK OSHP Annual Meeting Residency

More information

Clinical Trials and Safety Surveillance of Drugs in Development

Clinical Trials and Safety Surveillance of Drugs in Development Clinical Trials and Safety Surveillance of Drugs in Development Hoda Eid, M.Sc., Ph.D. Manager, ADR Unit Office of Clinical Trials Therapeutic Products Directorate hoda_eid@hc-sc.gc.ca Overview Clinical

More information

Application Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research

Application Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research Application Guide 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research A Competitive Grants Program Supported by Pfizer www.aspireresearch.org Table of Contents THE ASPIRE

More information

4. Understanding Clinical Data and Workflow Understanding Surveillance Data Exchange Processes Guide and Worksheet

4. Understanding Clinical Data and Workflow Understanding Surveillance Data Exchange Processes Guide and Worksheet To properly prepare for implementing the pilot of your surveillance program and its subsequent rollout, you must understand the surveillance data exchange processes. These processes can vary depending

More information

GUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION

GUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION GUIDELINES GUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION Preamble The purpose of this document is to provide guidance for the pharmacist

More information

Data Standards, Data Cleaning and Data Discipline. Insight November 24, 2008

Data Standards, Data Cleaning and Data Discipline. Insight November 24, 2008 Data Standards, Data Cleaning and Data Discipline Designing the Next Generation of EMRs Insight November 24, 2008 InfoClin Inc 2006. All Rights Reserved. Agenda Why is data quality important? Why data

More information

Streamline Your Radiology Workflow. With Radiology Information Systems (RIS) and EHR

Streamline Your Radiology Workflow. With Radiology Information Systems (RIS) and EHR Streamline Your Radiology Workflow With Radiology Information Systems (RIS) and EHR 2 Practicing medicine effectively requires transferring large amounts of information quickly, accurately, and securely.

More information

Clinical Decision Support

Clinical Decision Support Goals and Objectives Clinical Decision Support What Is It? Where Is It? Where Is It Going? Name the different types of clinical decision support Recall the Five Rights of clinical decision support Identify

More information

Continuity of Care Record (CCR) The Concept Paper of the CCR

Continuity of Care Record (CCR) The Concept Paper of the CCR Continuity of Care Record (CCR) The Concept Paper of the CCR Version 2.1b Note: Development of the CCR is an ongoing process. Thus, the following information, in particular that related to the CCR s content,

More information

ABSTRACT INTRODUCTION PATIENT PROFILES SESUG 2012. Paper PH-07

ABSTRACT INTRODUCTION PATIENT PROFILES SESUG 2012. Paper PH-07 Paper PH-07 Developing a Complete Picture of Patient Safety in Clinical Trials Richard C. Zink, JMP Life Sciences, SAS Institute, Cary, NC, United States Russell D. Wolfinger, JMP Life Sciences, SAS Institute,

More information

University of Maryland Upper Chesapeake Health: Increased Value Under a Fixed Hospital Budget

University of Maryland Upper Chesapeake Health: Increased Value Under a Fixed Hospital Budget THE RICHARD MERKIN INITIATIVE ON PAYMENT REFORM AND CLINICAL LEADERSHIP University of Maryland Upper Chesapeake Health: Increased Value Under a Fixed Hospital Budget May 4, 2015 l The Brookings Institution

More information

MedDRA in pharmacovigilance industry perspective

MedDRA in pharmacovigilance industry perspective MedDRA in pharmacovigilance industry SFDA ICH MedDRA Workshop, Beijing, 13 14 May 2011 Christina Winter, MD, FFPM Medical director GlaxoSmithKline R&D / ICH MedDRA Management Board 2011 ICH International

More information

Adverse drug events are frequently identified in the

Adverse drug events are frequently identified in the ETHICS, PUBLIC POLICY, AND MEDICAL ECONOMICS Computerized Physician Order Entry with Clinical Decision Support in Long-Term Care Facilities: Costs and Benefits to Stakeholders Sujha Subramanian, PhD, Sonja

More information

Andrew C. Bledsoe, MBA, CHPA, PCMH CCE Executive Director. Northeast KY Regional Health Information Organization. www.nekyrhio.org

Andrew C. Bledsoe, MBA, CHPA, PCMH CCE Executive Director. Northeast KY Regional Health Information Organization. www.nekyrhio.org Andrew C. Bledsoe, MBA, CHPA, PCMH CCE Executive Director Northeast KY Regional Health Information Organization www.nekyrhio.org NCQA Program Setup Standards Six Standards Outline Program Elements Six

More information

Marriott Wardman Park Hotel, Washington, D.C. 20008. Tuesday, April 28, 2009

Marriott Wardman Park Hotel, Washington, D.C. 20008. Tuesday, April 28, 2009 The National Committee on Vital and Heath Statistics (NCVHS) Executive Subcommittee special hearing on meaningful use as proposed in the American Reinvestment and Recovery Act 2009 Panel 2: Meaningful

More information

Office ID Location: City State Date / / PRIMARY CARE SURVEY

Office ID Location: City State Date / / PRIMARY CARE SURVEY A. Organizational Characteristics PRIMARY CARE SURVEY We want to learn more about the general features of your office. A1. What health-related services does your office provide (check all that apply)?

More information

The CDISC Healthcare Link Initiative

The CDISC Healthcare Link Initiative Value Proposition The CDISC Healthcare Link Initiative Spontaneous Triggered Adverse Drug Event Reporting (ASTER) In 2008, a pilot project was launched between CDISC, CRIX, Pfizer, Brigham and Women s

More information

Health Home Performance Enhancement through Novel Reuse of Syndromic Surveillance Data

Health Home Performance Enhancement through Novel Reuse of Syndromic Surveillance Data Health Home Performance Enhancement through Novel Reuse of Syndromic Surveillance Data Category: Fast Track Solutions Contact: Tim Robyn Chief Information Officer Office of Administration Information Technology

More information

Table of Contents EXECUTIVE SUMMARY... 1

Table of Contents EXECUTIVE SUMMARY... 1 Table of Contents EXECUTIVE SUMMARY... 1 I. SENTINEL SYSTEM VISION... 3 A. Active surveillance via a distributed system... 3 B. Sentinel will expand FDA s current safety surveillance capabilities... 3

More information

OPTIMIZING THE USE OF YOUR ELECTRONIC HEALTH RECORD. A collaborative training offered by Highmark and the Pittsburgh Regional Health Initiative

OPTIMIZING THE USE OF YOUR ELECTRONIC HEALTH RECORD. A collaborative training offered by Highmark and the Pittsburgh Regional Health Initiative OPTIMIZING THE USE OF YOUR ELECTRONIC HEALTH RECORD A collaborative training offered by Highmark and the Pittsburgh Regional Health Initiative Introductions Disclosures Successful completion of training

More information

Demonstrating Meaningful Use Stage 1 Requirements for Eligible Providers Using Certified EMR Technology

Demonstrating Meaningful Use Stage 1 Requirements for Eligible Providers Using Certified EMR Technology Demonstrating Meaningful Use Stage 1 Requirements for Eligible Providers Using Certified EMR Technology The chart below lists the measures (and specialty exclusions) that eligible providers must demonstrate

More information

US Perspectives on Clinical Decision Support

US Perspectives on Clinical Decision Support US Perspectives on Clinical Decision Support Blackford Middleton, MD, MPH, MSc, FACP, FACMI, FHIMSS Corporate Director, Clinical Informatics Research & Development Chairman, Center for Information Technology

More information

MedDRA in clinical trials industry perspective

MedDRA in clinical trials industry perspective MedDRA in clinical trials industry SFDA ICH MedDRA Workshop, Beijing, 13 14 May 2011 Christina Winter, MD, FFPM Medical director GlaxoSmithKline R&D / ICH MedDRA Management Board 2011 ICH International

More information

Coding with MedDRA. MedDRA and the MSSO

Coding with MedDRA. MedDRA and the MSSO Coding with MedDRA MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) MedDRA and the MSSO International support and development of

More information

Stage 1 vs. Stage 2 Comparison Table for Eligible Professionals Last Updated: August, 2012

Stage 1 vs. Stage 2 Comparison Table for Eligible Professionals Last Updated: August, 2012 Stage 1 vs. Stage 2 Comparison Table for Eligible Professionals Last Updated: August, 2012 CORE OBJECTIVES (17 total) Stage 1 Objective Stage 1 Measure Stage 2 Objective Stage 2 Measure Use CPOE for medication

More information

IMEDS-Evaluation for Conducting Post-Market Safety Studies

IMEDS-Evaluation for Conducting Post-Market Safety Studies IMEDS-Evaluation for Conducting Post-Market Safety Studies Susan Gruber Troy McCall, Greg Daniel *, Nicole Spear Reagan-Udall Foundation for the FDA * Brookings Institution Big DiP USA, Boston, Massachusetts,

More information

Mandating of Electronic Prescriptions for Medicare Patients

Mandating of Electronic Prescriptions for Medicare Patients Page 1 of 14 Mandating of Electronic Prescriptions for Medicare Patients Michelle Kaye, RN, BSN, MSN Student Drexel University Citation: Kaye, M. (June, 2008). Mandating of Electronic Prescriptions for

More information

By Natalia Wilson, MD, MPH

By Natalia Wilson, MD, MPH White Paper The value of unique device identification across healthcare By Natalia Wilson, MD, MPH Executive summary The Unique Device Identification (UDI) System Proposed Rule was published by the U.S.

More information

Achieving meaningful use of healthcare information technology

Achieving meaningful use of healthcare information technology IBM Software Information Management Achieving meaningful use of healthcare information technology A patient registry is key to adoption of EHR 2 Achieving meaningful use of healthcare information technology

More information

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2): Make copies of the blank SAE report form as needed. Retain originals with confirmation of all information faxed to DMID Pharmacovigilance Group Clinical Research Operations and Management Support (CROMS

More information

Inpatient EHR. Solution Snapshot. The right choice for your patients, your practitioners, and your bottom line SOLUTIONS DESIGNED TO FIT

Inpatient EHR. Solution Snapshot. The right choice for your patients, your practitioners, and your bottom line SOLUTIONS DESIGNED TO FIT Inpatient EHR The right choice for your patients, your practitioners, and your bottom line SOLUTIONS DESIGNED TO FIT Our customers do more than save lives. They re helping their communities to thrive.

More information

Unintended Consequences of Drug-Drug Interaction Alerts The Partners Experience

Unintended Consequences of Drug-Drug Interaction Alerts The Partners Experience Unintended Consequences of Drug-Drug Interaction Alerts The Partners Experience October 13-14, 2009 Eileen Yoshida, RPh, MBA Partners HealthCare Agenda Background Clinical Information Systems Clinical

More information

Guide To Meaningful Use

Guide To Meaningful Use Guide To Meaningful Use Volume 1 Collecting the Data Contents INTRODUCTION... 3 CORE SET... 4 1. DEMOGRAPHICS... 5 2. VITAL SIGNS... 6 3. PROBLEM LIST... 8 4. MAINTAIN ACTIVE MEDICATIONS LIST... 9 5. MEDICATION

More information

Martin C. Were, MD, MS. Regenstrief Institute, Inc. Indiana University School of Medicine BHI Lecture Series May 13, 2008

Martin C. Were, MD, MS. Regenstrief Institute, Inc. Indiana University School of Medicine BHI Lecture Series May 13, 2008 Using an Informatics Tool to Improve Implementation of Recommendations by Consultants Martin C. Were, MD, MS. Regenstrief Institute, Inc. Indiana University School of Medicine BHI Lecture Series May 13,

More information

Stage 1 vs. Stage 2 Comparison for Eligible Professionals

Stage 1 vs. Stage 2 Comparison for Eligible Professionals Stage 1 vs. Comparison for Eligible Professionals CORE OBJECTIVES (17 Total) Stage 1 Objective Stage 1 Measure Objective Measure Use CPOE for Medication orders directly entered by any licensed healthcare

More information

Institute for Safe Medication Practices

Institute for Safe Medication Practices Institute for Safe Medication Practices 1800 Byberry Road, Suite 810 Huntingdon Valley, PA 19006 FOR MORE INFORMATION, CONTACT : Michael A. Donio, MPA Marketing & Consumer Affairs 215-947-7797 Mdonio@ismp.org

More information

Incentives to Accelerate EHR Adoption

Incentives to Accelerate EHR Adoption Incentives to Accelerate EHR Adoption The passage of the American Recovery and Reinvestment Act (ARRA) of 2009 provides incentives for eligible professionals (EPs) to adopt and use electronic health records

More information

Use of MedDRA in CTCAE and in the Biopharmaceutical Industry

Use of MedDRA in CTCAE and in the Biopharmaceutical Industry Use of MedDRA in CTCAE and in the Biopharmaceutical Industry Ann Setser, BSN, MEd MedDRA MSSO MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations

More information

DRAFT. Medical School Health IT Curriculum Topics. Matthew Swedlund, John Beasley, Erkin Otles, Eneida Mendonca

DRAFT. Medical School Health IT Curriculum Topics. Matthew Swedlund, John Beasley, Erkin Otles, Eneida Mendonca Medical School Health IT Curriculum Topics DRAFT Matthew Swedlund, John Beasley, Erkin Otles, Eneida Mendonca PC3. Use information technology to optimize patient care. 1. Attributes relating to appropriate

More information

Improving drug prescription in elderly diabetic patients. FRANCESC FORMIGA Hospital Universitari de Bellvitge

Improving drug prescription in elderly diabetic patients. FRANCESC FORMIGA Hospital Universitari de Bellvitge Improving drug prescription in elderly diabetic patients FRANCESC FORMIGA Hospital Universitari de Bellvitge High prevalence, but also increases the incidence. The older the patients, the higher the percentages

More information

Virtual Mentor Ethics Journal of the American Medical Association June 2006, Volume 8, Number 6: 381-386.

Virtual Mentor Ethics Journal of the American Medical Association June 2006, Volume 8, Number 6: 381-386. Virtual Mentor Ethics Journal of the American Medical Association June 2006, Volume 8, Number 6: 381-386. Medical Education E-prescribing by Jorge G. Ruiz, MD, and Brian Hagenlocker, MD Both the federal

More information

Acute Hepatitis C Surveillance using Electronic Health Record Data

Acute Hepatitis C Surveillance using Electronic Health Record Data Acute Hepatitis C Surveillance using Electronic Health Record Data Hepatitis C National Summit Centers for Disease Control and Prevention June 18, 2014 Michael Klompas MD, MPH, FRCPC, FIDSA CDC Center

More information