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

2. Overview Review strategic planning effort Review strategic planning effort Update on ongoing initiatives Update on ongoing initiatives Vision of future Vision of future Challenges Challenges

3. Strategic Planning: 5 Key Areas Strong FDA Strong FDA Risk management Risk management Focus on pre-approval activitiesFocus on pre-approval activities Better informed consumers Better informed consumers Patient and consumer safety Patient and consumer safety Focus on post-approval activitiesFocus on post-approval activities Counter-terrorism Counter-terrorism

4. Strategic Goal and Objectives for Patient Safety Improve patient and consumer safety by reducing risks of FDA- regulated products Improve patient and consumer safety by reducing risks of FDA- regulated products Enhance ability to quickly identify risks associated with FDA-regulated productsEnhance ability to quickly identify risks associated with FDA-regulated products Increase capacity to accurately analyze risks associated with FDA-regulated productsIncrease capacity to accurately analyze risks associated with FDA-regulated products Take appropriate actions to communicate risks and correct problems associated with FDA- regulated productsTake appropriate actions to communicate risks and correct problems associated with FDA- regulated products

5. 4 Agency Wide Working Groups 1) Improving safety reporting systems across centers 2) Using external data sources to improve risk assessment 3) Improving risk communication to consumers and health care professionals 4) Developing new approaches to control and prevent risks

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

7. Adverse Event Reporting Systems MedSun has 80 health care facilities enrolled to report device related adverse events MedSun has 80 health care facilities enrolled to report device related adverse events 100 sites to be added in the next year100 sites to be added in the next year Identifying potential partners that collect medical errors and adverse event data to access additional reports Identifying potential partners that collect medical errors and adverse event data to access additional reports

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

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

10. External Data Sources to Assess Risks Next steps include expanding the data collection with providers participating in the Marconi project Next steps include expanding the data collection with providers participating in the Marconi project Develop strategy for automatic data collection and analysis Develop strategy for automatic data collection and analysis For a real-time assessment of product risks from a representative sample of electronic medical recordsFor a real-time assessment of product risks from a representative sample of electronic medical records Must be compliant with HIPAAMust be compliant with HIPAA

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

12. Risk Communication DailyMed initiative with NLM DailyMed initiative with NLM Provide health care information systems with up to date product labeling information in computer readable formatProvide 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 careSupport multiple functions including prescribing decision applications use at the point of care Other proposed initiatives include: Other proposed initiatives include: A dedicated web site for patient safety informationA dedicated web site for patient safety information Electronic distribution of patient safety newsElectronic distribution of patient safety news

13. Risk Prevention and Control Bar coding rule proposed in March 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.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 numberAllow 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.,Expected to facilitate uptake of scanners in hospitals and prevent errors related to medication administration, i.e., Wrong drug Wrong drug Wrong dose Wrong dose Wrong time to administer a drug Wrong time to administer a drug

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

15. Partnerships CDC CDC Data collection through existing surveys and surveillance systemsData collection through existing surveys and surveillance systems AHRQ AHRQ Establishing ways to facilitate data collection and share expertiseEstablishing ways to facilitate data collection and share expertise VA VA Working with PBM database and exploring several new projectsWorking with PBM database and exploring several new projects

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

17. Vision for Patient Safety Spontaneous reporting systems are valuable but do not reveal the true safety profile for marketed medical products 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 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 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 Healthcare databases will significantly improve the agency’s ability to identify and analyze product related risks

18. 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 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 Informed health care professionals and patients will be empowered to prevent adverse events and reduce morbidity and mortality, human suffering, and health care costs

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