1. PHIConnect CDC Center of Excellence in Public Health Informatics E S P – V A E R S Michael Klompas MD, MPH, FRCPC CDC Center of Excellence in Public Health Informatics Harvard Medical School & Harvard Pilgrim Health Care, Boston, MA CDC Public Health Informatics Network Conference August 27, 2008 Electronic medical record Support for Public Health Vaccine Adverse Event Reporting System

2. PHIConnect CDC Center of Excellence in Public Health Informatics CDC Center of Excellence in Public Health Informatics (Boston) Harvard Medical School / Harvard Pilgrim Health Care Department of Ambulatory Care and Prevention Children’s Hospital Informatics Program Massachusetts Department of Public Health Harvard Vanguard Medical Associates (for Atrius Health) Brigham and Women’s Hospital Channing Laboratory

3. PHIConnect CDC Center of Excellence in Public Health Informatics The importance of vaccine surveillance Vaccine use is prolific Over 200 million vaccines administered annually in the US alone >95% of school children vaccinated against ≥8 diseases New vaccines continually introduced Accurate detection of vaccine adverse events is essential Adverse events problematic since “hurting the healthy” Guides policy makers in deciding who to vaccinate and when Helps assure the safety of national vaccine programs Vaccine safety data from clinical trials incomplete Controlled populations, small relative to eventual target pop’n Limited power to detect rare, idiosyncratic adverse effects

4. PHIConnect CDC Center of Excellence in Public Health Informatics Two vaccine surveillance systems Large, rigorous, multi- center epi studies in defined populations Seek statistically significant increases in pre-defined adverse events e.g. CDC’s Vaccine Safety Datalink ACTIVEPASSIVE Spontaneous reporting of possible adverse events after vaccines Clinicians, drug companies, patients can report any possible adverse event e.g. CDC/FDA’s Vaccine Adverse Event Reporting System

5. PHIConnect CDC Center of Excellence in Public Health Informatics

7. Vaccine Adverse Event Reporting System (VAERS) Strengths: Detects new, unusual, or rare vaccine adverse events May detect increases in known adverse events Weaknesses: Under-reporting  clinicians may not link patient’s illness to recent vaccine  may not be aware of the existence of VAERS  may be put off by the labour required to report Statistical relevance of reports unclear  Denominators and comparators not apparent

8. PHIConnect CDC Center of Excellence in Public Health Informatics Our objectives Improve vaccine safety surveillance by combining the completeness of active surveillance with the sensitivity to rare events and clinical input of passive surveillance Improve efficiency & usability by integrating surveillance into the electronic medical record workflow ACTIVE SURVEILLANCE PASSIVE SURVEILLANCE Computer-assisted clinician-directed surveillance

9. PHIConnect CDC Center of Excellence in Public Health Informatics Leverage the ESP platform ESP: Electronic med record Support for Public Health Software and architecture to automate detection and reporting of notifiable diseases  Surveys codified electronic medical record data for patients with notifiable conditions  Generates and sends secure electronic case reports to the state health department Currently reports TB, acute hepatitis A/B/C, gonorrhea, chlamydia, and PID Over 2000 cases reported to date PI: Richard Platt MMWR 2008;57:372-375 Advances Disease Surveillance 2007;3:3

10. PHIConnect CDC Center of Excellence in Public Health Informatics Atrius Health ~27 multispecialty ambulatory practices in MA EpicCare EMR ~600,000 patients 750 clinicians An ESP server resides in the central data processing center Analyzes data from all 27 sites ESP Operational in Atrius Health January 2007 to present © Google Maps Boston, MA

11. PHIConnect CDC Center of Excellence in Public Health Informatics Practice EMR’sESP Server D P H Health Department HL7 electronic case reports of notifiable conditions ESP: Automated detection and reporting of notifiable conditions diagnoses lab results meds demographics vital signs

12. PHIConnect CDC Center of Excellence in Public Health Informatics Adding vaccine safety surveillance to ESP Create a new ESP module to: Detect possible adverse events after vaccination Prompt the responsible clinician  Seek clinician endorsement and invite annotation Submit pre-populated electronic reports to VAERS of clinician endorsed adverse effects ESP-VAERS module funded by AHRQ PI: Ross Lazarus

13. PHIConnect CDC Center of Excellence in Public Health Informatics How it works ESP prospectively follows each patient for 30 days following vaccination If the patient has an encounter within 30 days of vaccination, ESP assesses the record for new ICD9 codes, lab results, or allergies that might indicate an adverse event from vaccination Query patient’s prior record – if suspected event is old then discard If a possible new event is found, a message is sent to the clinician’s secure in basket describing the event and inviting comment If clinician concurs, submit an HL7 report to VAERS

14. PHIConnect CDC Center of Excellence in Public Health Informatics 11,993 ICD9’s unlikely to be vaccine related e.g. periodic health exam, broken bones, med refills 78 ICD’s already associated with adverse events e.g. seizure, Guillain-Barré, intussusception 1,473 ICD9’s possible novel adverse events e.g. myocarditis, lymphadenopathy, laryngitis Triaging 13,544 ICD9 codes  query clinician, report automatically if no response  query clinician, report if clinician agrees  automatically discard

15. PHIConnect CDC Center of Excellence in Public Health Informatics Day 0 – influenza vaccine administered Day 9 – patient has routine lab work – creatinine 2.3 1.Assess patient’s past encounters  last creatinine 2.2 2.Stop Example ESP-VAERS Logic

16. PHIConnect CDC Center of Excellence in Public Health Informatics Day 0 – measles vaccine administered Day 6 – patient diagnosed with meningitis 1.Assess patient’s past encounters  no ICD9 for meningitis in the past year 2.Send message to patient’s clinician “could this be related to recent vaccine?” 3.Clinician agrees it is possible, adds comments 4.Send HL7 report to VAERS Example ESP-VAERS Logic

17. PHIConnect CDC Center of Excellence in Public Health Informatics Dear Dr. JONES Your patient BOB WIGGINS may have suffered an adverse effect from a recent vaccine. BOB WIGGINS was diagnosed with MENINGITIS on AUGUST 12, 7 days after receiving MEASLES VACCINE. If you think the MENINGITIS might have been due to the vaccine, we can automatically submit an electronic report to CDC / FDA’s Vaccine Adverse Event Reporting System on your behalf. Please provide any additional clinical details on this event that you think might be helpful to CDC and FDA vaccine safety investigators: SUBMITDECLINE

18. PHIConnect CDC Center of Excellence in Public Health Informatics Messages to VAERS HL7 version 2.3.1 Conveyed using PHIN-MS Report includes Patient name, gender, date of birth, contact Reporting clinician name and contact Vaccine name, lot number, date of administration Adverse event, date, value Clinician comments

19. PHIConnect CDC Center of Excellence in Public Health Informatics Preliminary Data – Validation In Progress Atrius Health (Jan 1-Dec 31, 2007) 600,000 patients 45 vaccines 392,205 doses given to 175,889 individuals 3,621 possible reactions  pre-defined ICD’s and lab abnormalities  protocol for idiosyncratic reactions yet to be implemented

20. PHIConnect CDC Center of Excellence in Public Health Informatics Distribution of 3,621 events

21. PHIConnect CDC Center of Excellence in Public Health Informatics Comparative event rates VaccineNEvent rate Measles-mumps-rubella-varicella6,1452.1% Measles-mumps-rubella6,1741.7% Diptheria-tetanus-acellular pertussis-H.flu1,2832.1% Diptheria-tetanus-acellular pertussis14,0321.3% Influenza90,3760.8% Pneumococcus (adult polysaccharide)6,6152.0% Varicella zoster (chicken pox)23,1981.2% Herpes zoster (shingles)4,9731.1%

22. PHIConnect CDC Center of Excellence in Public Health Informatics Current Status and Future Steps ESP-VAERS module still being actively programmed and tested Messaging protocol has been established and successfully tested Performance of ESP-VAERS to be tested against usual spontaneous reporting in cluster randomized trial amongst different practices in Atrius Health Outcomes: number and accuracy of reports

23. PHIConnect CDC Center of Excellence in Public Health Informatics ESP Team Harvard Medical School / Harvard Pilgrim Health Care Department of Ambulatory Care and Prevention Richard Platt MD, MSc  Ross Lazarus MBBS, MPH, MMed Julie Dunn MPH  Michael Calderwood MD Ken Kleinman ScD  Yury Vilk PhD Kimberly Lane MPH  Michael Klompas MD, MPH Harvard Vanguard Medical Associates (Atrius Health) Francis X. Campion MD Benjamin Kruskal MD, PhD Massachusetts Department of Public Health Alfred DeMaria MD  Bill Dumas RN Gillian Haney MPH  Daniel Church MPH James Daniel MPH  Dawn Heisey MPH Channing Laboratory of Brigham and Women’s Hospital Xuanlin Hou MSc Collaborators Wanted! mklompas@partners.org http://esphealth.org