HEALTH CARE Health Services Administration [N04] Health Services Administration Organization and Administration [N04.452] Organization and Administration Risk Management [N04.452.871] Risk Management Risk Assessment [N04.452.871.715] Risk Assessment Risk Evaluation and Mitigation [N04.452.871.758] Risk Evaluation and Mitigation Risk Sharing, Financial [N04.452.871.800] Risk Sharing, Financial Safety Management [N04.452.871.900] Safety Management HEALTH CARE Environment and Public Health [N06] Environment and Public Health Public Health [N06.850] Public Health Epidemiologic Measurements [N06.850.505] Epidemiologic Measurements Risk Assessment [N06.850.505.715] Risk Assessment Adverse Outcome Pathways [N06.850.505.715.250] Adverse Outcome Pathways Healthcare Failure Mode and Effect Analysis [N06.850.505.715.500] Healthcare Failure Mode and Effect Analysis Risk Evaluation and Mitigation [N06.850.505.715.750] Risk Evaluation and Mitigation

Risk Evaluation and Mitigation - Preferred

Concept UI	M000625026
Scope note	Strategies required by the US Food and Drug Administration (FDA) Amendments Act of 2007 when a question exists as to whether the benefits of a drug outweigh its risks. These constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients.
Preferred term	Risk Evaluation and Mitigation

Elements to Assure Safe Use - Narrower

Concept UI	M000625027
Preferred term	Elements to Assure Safe Use
Entry term(s)	ETASU