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

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.

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…

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

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…

The ASTER Project

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

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

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

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

How Big Is The Problem?

Patients

Providers

Hospitals

Regional Organizations

PayersPoint of Care Applications

Data Collection and Storage Technologies

Communications Technologies

Pharmaceutical Companies

FDA

EMEA

Other Regulators Worldwide

Spontaneous Reportingthe problem

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

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

Public / PrivateOrganization

Computer-assisted Surveillance

EMR

Provider / Patient

Manufacturers

Regulators

• 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• Structured by safety elements requirements (E2B/HL7 ICSR)

• Mediated through RFD, Server-side XForms

15*RFD = Retrieve For for Data Capture – an IHE/CDISC profile

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

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

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

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)

The ASTER Collaborators…

Partners Healthcare

CRIX, International

FDA

(CDISC)