# Presentation: 606578

## Pharmacovigilance and the Electronic Health Record

**Current Work**

## Pharmacovigilance and Digital Healthcare

- The pharmaceutical industry is committed to improving public safety
- At Pfizer as in the industry patient health is a top priority and we are dedicated to ensuring our medications are as safe and effective as possible
- Safety research and assessment continues throughout the life of a drug, for as long as it is being prescribed to patients
- For safety, as for the rest of medicine - technology is an enabler
- It allows all the participants in healthcare to interact directly
- It provides the possibility of new ways to achieve results
- What is true in medical practice is true in safety
- Proper application of technology requires a deep understanding of the domain
- Understanding concepts and roles precedes understanding where best to leverage technology
- It may be that organizational change is required before value can be obtained from technology

## Understanding Pharmacovigilance and Digital Healthcare – efforts at Pfizer

- Current work focuses on exploring how the EHR and digital healthcare impacts pharmacovigilance practice
- Work is still exploratory
- Goal is to gain broad understanding of the field and real world experience by working in a few targeted areas
- For a system as complex as safety in healthcare, it is vital to test our assumptions early and often
- Proof of concept studies needed to understand the challenges and opportunities in each setting
- Four current areas of investigation:
- Regional Organizations (e.g. RHIOs)
- Aggregated EHR data
- CDISC RFD project
- National Health Information Network (NHIN)

## Regional Organizations

- Tremendous learning opportunity
- The rapidly evolving regional healthcare environment differs from the traditional setting to collect safety information – this allows us to learn and understand
- Participate directly with regional health organizations as they design and implement their solutions
- ‘Executive on loan’
- Learn their challenges and concerns
- Help them understand pharmaceutical perspective as they face practical challenges
- Early Experience
- The definition of “safety” varies depending on the sector
- Healthcare providers and payers often have little information on how to interact with pharmacovigilance to benefit regional networks
- Pharmacovigilance practices and goals can be more closely integrated with regional health networks

## Aggregated EHR Data

- Aggregating data from the EHR
- As the EHR becomes more common, a significant amount of digital patient data will be available
- More organizations are now able to aggregate large amounts of digital patient data and make it available
- Leasing EHR data sets for safety investigations
- What value does data have for safety (signaling, epi, etc.)
- What is the best use of the data
- What is missing from typical EHR data
- Engaged in broad discussions with groups to understand what data is available now and what data will be available in the future
- Early Experience
- Value of the data
- Quantity of data
- New opportunities for EHR

## CDISC RFD

- Many opportunities exist at the interface between clinical practice and clinical research/regulatory reporting
- CDISC ‘Retreive Form for Data’ (RFD)
- A ‘profile’ which allows a clinical data collection form to be ‘surfaced’ from within an EHR making it transparent to the user
- RFD Pharmacovigilance Use Case
- Demonstrate how an adverse event form can be ‘surfaced’ inside an EHR and prepopulated with patient data to make it simple for the physician to report an adverse event
- The physician recognizes an AE, interacts with EHR; completes additional information on the electronic form and sends the form on to MAH, Regulators

## RFD Early Experiences

- Great impact is possible here as a result of existing technology, standards and novel thinking
- Standards are as important to progress as technology
- In this areas, theory should give way to modeling the practical problems involved with collecting data from the EHR
- Possible impacts
- Increase in the *quality*, timeliness and number of spontaneous reports
- Better and more rapid assessment of reports
- Solution can be applied globally
- Direct impact on public health
- There is great potential for Biosurveillance and Pharmacovigilance to address common issues

## Current Work – NHIN

- ‘Slipstream’ (Accenture) Consortium
- Full-time participant with other companies
- Created a pharmacovigilance use case
- Examining possible proof of concept projects to illustrate the use case design
- This offers an opportunity to learn what other companies see as the opportunities and challenges in this area, and to ensure pharmaceutical company participation in designing a national healthcare information system
- Early experience
- Biosurveillance and pharmacovigilance closely share goals and can closely share solutions
- Safety concerns are global, care is provided locally – it is necessary to fully understand the interaction of these in order to implement improvements

## Pharmacovigilance and digital healthcare - Direction

- Several factors are converging to allow new ways of thinking about pharmacovigilance
- Adoption of standards for exchanging safety information
- Maturing technologies
- Progress on digital patient data (e.g., EHR, PMR)
- Public interest
- To obtain a successful application of technology to safety we need to better understand the domain
- Standards
- Experimentation
- Concepts and Roles
- Definitions and shared terminologies
- We need a deliberate approach to the collection, use and reporting of safety information – for single events and aggregate data

## Concepts

- Value of data
- A wealth of information can create a poverty of attention
- Providing more information does not automatically create more value
- Medical judgment is required in safety
- “Data are not just waiting to be gathered, collected or recorded.  Data are created.”
- Paul Taylor From Patient Data to Medical Knowledge
-     Blackwell Publishing 2006 p. 12
- The goal is not to replace judgment but to provide decision-support
- Improving patient safety is a global enterprise
- Data is gathered and reported from persons throughout the world
- The most effective HIT applications will be designed for global use

## Concepts (continued)

- Beware the silver bullet
- In medicine, expert systems proved least effective where they had been thought to be most needed – in diagnosis.  But they have been very effective in helping support physician decisions
- Safety can learn from history and improve the adoption of HIT - thereby increasing its value and the value to patients
- An ontology for safety
- Specification of concepts and relationships that can exist in safety
- Work in this area is vital to the best use of technology and should be encouraged
- Organizational change as prelude to technological change
- “A [system] design...suitable to a world in which the scarce factor is information may be exactly the wrong one for a world in which the scarce factor is attention” (H.Simon)

**Thank You**