the role of the fda dmepa and opportunities to share ... pamer, bspharm, msc program lead,...
TRANSCRIPT
9th Annual Meeting of PSOsApril 26 - 27, 2017
The Role of the FDA DMEPA and Opportunities to Share Medication Error InformationJo Wyeth, PharmDPostmarket Surveillance Program Lead Division of Medication Errors Prevention and Analysis (DMEPA)
Carol Pamer, BSPharm, MScProgram Lead, Regulatory Science Staff (RSS)FDA CDER Office of Surveillance and Epidemiology
FDA Organization
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Medication errors in the news….
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Objectives
Increase awareness of the public health burden and costs associated with medication errors Understand the role of the Division of
Medication Error Prevention and Analysis (DMEPA) in preventing medication errors Describe the value of sharing medication
error data and ways to share that information with FDA
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Public Health Burden and Costs of Medication Errors
Outpatient and inpatient preventable medication errors have an estimated annual cost of nearly $21 billion* In 2016, we received nearly 100,000
suspected medication error cases associated with CDER-regulated products
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*Network for Excellence in Health Innovation. Dec 2011 [cited 9Feb2017]. Available from: http://www.nehi.net/bendthecurve/sup/documents/Medication_Errors_%20Brief.pdf
DMEPA Mission
To increase the safe use of drug products by minimizing use error that is related to
the naming, labeling, packaging, or design of drug products.
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Role of DMEPA - Premarket (pre-approval) Review Activities
Review and approve proposed proprietary names
Review product labeling and design – includes packaging, container labels, carton
labeling, Prescribing Information, Instructions for Use, Medication Guide
Review and incorporate human factors study information
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Role of DMEPA - Postmarket(post-approval) Activities
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Medication Errors and Product Life Cycle
9https://www.fda.gov/forpatients/approvals/drugs/
Potential Regulatory Actions to Address Medication Errors
Revise labels, labeling, and packaging Redesign products Change proprietary name Communicate safety information Issue guidance and regulations, develop
standards Risk Evaluation and Mitigation Strategy
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Case Example 1 Inability to scan barcodes
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Case Example 2 Look alike containers
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Case Example 3Product name confusion
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Case Example 4Drug Safety Communication
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Reporting Medication Errors to DMEPA
We rely on the public – healthcare providers, consumers and patients – to voluntarily report medication errors to FDA– Directly to FDA through Medwatch– Manufacturer reports– Collaborative partnerships
Focus on medication error reports that can be addressed through regulatory action
Other ways to share medication error information
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Sharing Medication Error Information with FDA
Carol Pamer, BSPharm, MScProgram Lead, Regulatory Science Staff (RSS)FDA CDER Office of Surveillance and Epidemiology
FDA Technology Transfer Arrangements
FDA has a formalized process for collaborative research and technology transfer
Types of agreements: 1. Research Collaboration Agreement2. Material Transfer Agreement3. Confidential Disclosure Agreement (also known as a Non-Disclosure
Agreement)4. Cooperative Research and Development Agreement (CRADA)5. Memorandum of Understanding (MOU)
Purpose is intended to be mutually beneficial, often exploratory in nature
These types of arrangements generally do not provide funding but commit FDA research teams and other necessary human resources.
Source: FDA Office of Translational Sciences http://inside.fda.gov:9003/CDER/OfficeofTranslationalSciences/CDERTechnologyTransfer/default.htm
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Potential FDA Research Funding
Extramural Research Funded Through the Broad Agency Announcement (BAA)
– FDA funds extramural research in regulatory science using various contract mechanisms and grants
– Purpose is to address broad Agency challenges within FDA's scientific priority areas
– Applications through FedBizOpps (www.fbo.gov): • Solicitation Number: FDABAA-16-00122
Source: FDA Regulatory Science Extramural Research and Development Projects https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm227223.htm
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FDA Scientific Priority Areas
1. Modernize Toxicology to Enhance Product Safety 2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to
Improve Product Development and Patient Outcomes 3. Support New Approaches to Improve Product Manufacturing and Quality 4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies 5. Harness Diverse Data through Information Sciences to Improve Health
Outcomes 6. Implement a New Prevention-Focused Food Safety System to Protect Public
Health 7. Facilitate Development of Medical Countermeasures to Protect Against Threats
to U.S. and Global Health and Security 8. Strengthening Social and Behavioral Science at FDA by Enhancing Audience
Understanding 9. Strengthening the Global Product Safety Net
Source: FDA Regulatory Science Extramural Research and Development Projects https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm227223.htm
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FDA Seeks Input from and Collaboration with Stakeholders
Making the healthcare system safer benefits everyone.
FDA wants to collaborate with you to achieve this goal. Sharing real world medication error information with
FDA is an effective way to collaborate. We recognize the sensitivities around privacy and
liability issues. There are legally vetted arrangements that enable
your organization to collaborate with FDA and share medication error information.
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Summary
Medication errors have a significant public health burden Sharing medication error information with
FDA facilitates our ability to prevent errors There are multiple ways to report and share
medication error information with FDA Contact Jo Wyeth for more information
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Questions
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