# Presentation: 198809

## Patient Safety Initiatives

- Kelly Cronin
- Director, Patient Safety and Outcomes Research
- Office of Policy and Planning
- Office of the Commissioner
- FDA

## Overview

- Review strategic planning effort
- Update on ongoing initiatives
- Vision of future
- Challenges

## Strategic Planning: 5 Key Areas

- Strong FDA
- Risk management
- Focus on pre-approval activities
- Better informed consumers
- Patient and consumer safety
- Focus on post-approval activities
- Counter-terrorism

## Strategic Goal and Objectives for Patient Safety 

- Improve patient and consumer safety by reducing risks of FDA-regulated products
- Enhance ability to quickly identify risks associated with FDA-regulated products
- Increase capacity to accurately analyze risks associated with FDA-regulated products
- Take appropriate actions to communicate risks and correct problems associated with FDA-regulated products

## 4 Agency Wide Working Groups 

- Improving safety reporting systems across centers
- Using external data sources to improve risk assessment
- Improving risk communication to consumers and health care professionals
- Developing new approaches to control and prevent risks

## Adverse Event Reporting Systems

- Suspected Adverse Drug Reaction Rule proposed in March
- Proposes new standards to improve the quality and usefulness of patient safety data submitted by industry
- Would reduce industry’s reporting burden by using the same definitions and one common set of procedures worldwide

## Adverse Event Reporting Systems

- MedSun has 80 health care facilities enrolled to report device related adverse events
- 100 sites to be added in the next year
- Identifying potential partners that collect medical errors and adverse event data to access additional reports

## External Data Sources to Assess Risks

- Created an inventory of all in-house healthcare databases
- IMS, Premier, Advanced PCS, etc.
- Measure exposure and adverse events
- Identifying new databases that would supplement ability to analyze risks
- Planning to monitor higher risk products approved under PDUFA III

## Marconi Project

- A public-private collaboration to facilitate the development of standards for electronic communication of health care information
- FDA will receive reports on possible drug adverse events generated automatically from provider's electronic medical records
- Launch planned for June

## External Data Sources to Assess Risks

- Next steps include expanding the data collection with providers participating in the Marconi project
- Develop strategy for automatic data collection and analysis
- For a real-time assessment of product risks from a representative sample of electronic medical records
- Must be compliant with HIPAA

## Risk Communication

- Recently completed inventory of all types of risk communications across centers
- Plan to evaluate the effectiveness of existing communication strategies
- Identifying new strategies to address weaknesses with current processes and dissemination vehicles
- Exploring new policy to communicate potential risks to health care professionals after signal detection

## Risk Communication

- DailyMed initiative with NLM
- Provide health care information systems with up to date product labeling information in computer readable format
- Support multiple functions including prescribing decision applications use at the point of care
- Other proposed initiatives include:
- A dedicated web site for patient safety information
- Electronic distribution of patient safety news

## Risk Prevention and Control

- Bar coding rule proposed in March
- Would require bar codes on prescription drugs, over-the-counter drugs packaged for hospital use, vaccines, blood and blood components.
- Allow for unique identification of products through scanning bar codes that reflects the National Drug Code number
- Expected to facilitate uptake of scanners in hospitals and prevent errors related to medication administration, i.e.,
- Wrong drug
- Wrong dose
- Wrong time to administer a drug

## Risk Prevention and Control

- Identifying actions to correct safety problems and prevent adverse events
- i.e., Risk-based recalls
- Release of concept papers on risk management programs and pharmacovigilance plans

## Partnerships 

- CDC
- Data collection through existing surveys and surveillance systems
- AHRQ
- Establishing ways to facilitate data collection and share expertise
- VA
- Working with PBM database and exploring several new projects

## Partnerships 

- Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- Communicate product related risks through JCAHO dissemination vehicles
- Share information related to root causes of medical errors, i.e., transfusion errors

## Vision for Patient Safety

- Spontaneous reporting systems are valuable but do not reveal the true safety profile for marketed medical products
- FDA needs to develop capability for automatic collection of safety data from health care providers information systems
- The flow of information across information systems will depend on partnerships with health care providers and interoperability standards
- Healthcare databases will significantly improve the agency’s ability to identify and analyze product related risks

## Vision for Patient Safety

- More rapid detection of adverse events and medical errors and proactive management will significantly reduce risks associated with FDA-regulated products
- Informed health care professionals and patients will be empowered to prevent adverse events and reduce morbidity and mortality, human suffering, and health care costs

## Challenges

- Budget constraints
- Reliance on partnerships
- New initiatives are IT intensive
- HHS directing IT consolidation
- FDA has less control over IT resources
- Limited resources make it difficult to recruit and keep talent
- Have legacy IT systems and need to transition to new systems without interrupting our programs