The document discusses a collaboration between several organizations including healthcare providers, technology companies, and regulators to improve the system of spontaneous adverse event reporting. They aim to demonstrate that utilizing standardized data and new technologies can enhance data quality, reduce the burden on reporters, and ultimately benefit public health monitoring. The project calls for incorporating reporting into normal clinical workflows using structured EHR data to create safety reports.

1. Different Approaches to Spontaneous Reporting: A New Business Model How a collaboration between Partners Healthcare, CRIX, Int’l., FDA, CDISC, Pfizer and others is trying to demonstrate that it’s possible to improve spontaneous reporting

2. The spontaneous reporting system remains the primary source of information regarding potential adverse events associated with pharmaceutical products. Improving the quality of the data received through this system while lowering the burden on the reporter would immediately benefit public safety. The participants in this session will represent major users of the current system who are working together to test practical applications of standards and technology to improve data quality and facilitate use of the system.

3. How Will This Session Work? We want to leave discussion time at the end, so I’m going to say what I have to say in 15 minutes The other presenters will then have 20 minutes 15 minutes limits me to broad concepts (but I can talk all day about this) So to explain things in 15 minutes I’ll start with something familiar…

4. Mp3 file Copyright Ownership Napster Cost of a digital download of the same album on Amazon: Cost of Bruce Springsteen’s Live in Dublin Album CD on Amazon: Cost of recent Nine Inch Nails Album: $14.99 $12.99 $0

7. This is just beginning to occur in safety Digitized healthcare data and new technologies provide us the chance to truly change how we do safety It’s an open question as to what the new business model will look like Here’s one idea for part of it…

8. The ASTER Project

9. W A R N I N G This is not your typical pharma project… Each organization owns their work at the end No organization is ‘working for’ another one If this succeeds, it first benefits drug and device safety as a whole, i.e., public health

10. THEN WHY DO THIS? It’s finally possible to do it (‘we have the technology…’) It will truly improve public safety by fixing a clunky system (the SRS) This is a rare opportunity in safety where means and motivation are lined up

11. The Chance of a Lifetime Digital healthcare data is increasing, technology is evolving, the public is calling for change, the government is breaking new ground If we don’t act now to try and improve the situation, then shame on us

12. What Does It Take? It takes standards, technology, changes in regulations It takes a systems approach – fix one thing, break another It takes collaboration It takes good will It takes lots of talking

13. How Big Is The Problem? Patients Providers Hospitals Regional Organizations Payers Point of Care Applications Data Collection and Storage Technologies Communications Technologies Pharmaceutical Companies FDA EMEA Other Regulators Worldwide

14. Spontaneous Reporting the problem

15. Problem to be solved: Inconvenience Constrains Reporting Reporting adverse events interrupts the routine of providing care and imposes a burden on providers – greatly decreasing the probability that events will be reported Not part of normal routine Not available at point of recognition Duplicate data entry High nuisance factor

16. Summary (references available upon request) Spontaneous reporting is built on a paper-based model and driven too much by regulations that focus us on process vs science Physicians/HCP don’t report mainly because it is such a hassle with no value back to them Digitize healthcare data Transactions costs disappear New business models appear

17. Public / Private Organization Computer-assisted Surveillance Provider / Patient Manufacturers Data collection incorporated at point of care Very light footprint for EMR Portable to other EMRs, applications Can take advantage of further developments in automated recognition Global solution 15 *RFD = Retrieve For for Data Capture – an IHE/CDISC profile EMR Regulators Structured by safety elements requirements (E2B/HL7 ICSR) Mediated through RFD, Server-side XForms

21. Demonstrate a decreased burden of reporting Demonstrate viability of directly sourcing EMR data to create a postmarketing report Demonstrate viability of using an information exchange to receive and distribute postmarketing reports Test the mapping of ICH E2B and HL7 ICSR against Partners LMR Investigate the definition of quality as it pertains to reports

22. Implications / Questions What’s the regulatory status of the reported events? What’s the regulatory status of CRIX? The current E2B fields are built on an original paper-based model of reporting All signs point to an increase in the number of events received We need to solve this at a systems level

23. Who’s Who Clinical Data Interchange Standards Consortium “ The mission of CDISC is to develop and support global, platform-independent data standards” Integrating the Healthcare Enterprise “… a multi-year initiative that creates the framework for passing vital health information seamlessly-from application to application…” Healthcare Information Management Systems Society “… is the healthcare industry's membership organization exclusively focused on providing global leadership for the optimal use of healthcare information technology (IT) and management systems for the betterment of healthcare.” Partners Healthcare / Brigham & Women’s Hospital “… an integrated health system founded by Brigham and Women's Hospital and Massachusetts General Hospital….also includes…specialty hospitals, community health centers, a physician network, other health-related entities.” CRIX International “… dedicated to providing a common infrastructure and suite of services that will accelerate and streamline the interaction between sponsors of new drug products…research institutions, academia, and health authorities…” FDA CDER / CDRH

24. A Good Idea… When we came up with the ideas described here We found that others were thinking of very similar ideas Close discussion and collaboration with Lilly (call Kraig Kinchen)

25. The ASTER Collaborators… Partners Healthcare CRIX, International FDA (CDISC)