SPL REMS Requirement Terminology

Preferred Label : SPL REMS Requirement Terminology;

NCIt synonyms : Structured Product Labeling REMS Requirement Terminology;

NCIt definition : Terminology used in the framework of REMS SPL data to represent the clinical or administrative activities that a REMS program may require participants to perform.;

NCI Metathesaurus CUI : CL508979;

Details

Origin ID

C128491;

UMLS CUI

C4288179;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
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- FDA Structured Product Labeling Terminology [NCIt concept]
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- Adhere to REMS Patient Safe Use Conditions [NCIt concept]
- Assess Patient Condition, Health Status, or Adverse Event [NCIt concept]
- Be Able To Perform a Clinical Activity [NCIt concept]
- Complete Healthcare Knowledge Assessment [NCIt concept]
- Complete Patient Form [NCIt concept]
- Complete Patient Questionnaire [NCIt concept]
- Cooperate with REMS Audits [NCIt concept]
- Designate a Healthcare Setting Representative [NCIt concept]
- Dispense Limited Days Supply [NCIt concept]
- Dispense Limited Quantity [NCIt concept]
- Distribute Only to Certified Healthcare Provider or Setting [NCIt concept]
- Do Not Dispense Outside of Specified Facility [NCIt concept]
- Do Not Dispense Refills [NCIt concept]
- Do Not Distribute, Transfer, Loan, or Sell Product [NCIt concept]
- Do Not Prescribe Refills [NCIt concept]
- Enroll Patient in the REMS [NCIt concept]
- Enroll in the REMS [NCIt concept]
- Establish Processes and Procedures to Notify [NCIt concept]
- Establish Processes and Procedures to Provide [NCIt concept]
- Establish Processes and Procedures to Verify REMS Safe Use Conditions [NCIt concept]
- Get Lab Test or Monitoring [NCIt concept]
- Have Necessary Healthcare Personnel or Equipment [NCIt concept]
- Inform Prescriber [NCIt concept]
- Maintain Healthcare Records [NCIt concept]
- Notify of Safe Use Conditions [NCIt concept]
- Obtain REMS Dispensing Authorization [NCIt concept]
- Patient Must have a Specified Item or Intervention [NCIt concept]
- Prescribe Limited Days Supply [NCIt concept]
- Prescribe Limited Quantity [NCIt concept]
- Provide Patient with Materials [NCIt concept]
- Provide Safe Use Conditions [NCIt concept]
- REMS Counsel Patient [NCIt concept]
- REMS Participate in Training Session [NCIt concept]
- Receive Counseling [NCIt concept]
- Report Adverse Events [NCIt concept]
- Report Treatment Discontinuation or Transfer of Care [NCIt concept]
- Return Unused Product [NCIt concept]
- Review Healthcare Training or Educational Materials [NCIt concept]
- Review Prescribing Information [NCIt concept]
- Risk Evaluation and Mitigation Strategies Requirement [NCIt concept]
- Train Staff about Medication Use Process [NCIt concept]
- Use REMS Prescription Ordering Form [NCIt concept]
- Verify Safe Use Conditions [NCIt concept]

Keyword's position in hierarchy(ies) :

You can consult :

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