REMS 1

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REMS 1 in progress.

Storyboard Text

  • 1.REMS is Risk Evaluation and Mitigation Strategy.
  • Oh ?! But how do I proceed with the treatment ?
  • Hello Mr. James, we have the right treatment and right medicines for you !
  • 3. Typical REMS elements: Medication guide /package insert communication plan ETASU
  • Hmm.... so this is where the REMS enrolment form shall come in . I get it !
  • Ex: Pharmacies,practitioners or healthcare settings that dispense the drug are specially certified
  • 1. Elements To Assure Safe Use (ETASU)
  • We shall first start "Patient Initiation" process and make you aware of what , where, how, when , whom of this medicine .
  • The REMS enrolment form told me exactly what to expect in due course of my "special" treatment!
  • After the "special" medicine infusions were administered ...
  • I am glad James! Owing to the nature of this medicine, we need to send out patient information to FDA for staying compliant !
  • FDA needs to audit if all parties (patient , doctor ,facility) were REMS trained while working towards administering medicine.
  • Example risks: serious allergic reaction, liver damage etc.
  • ..that use risk minimization strategies to ensure benefits of certain prescription drugs outweigh their risks.*
  • 2.These are required risk management plans ...
  • Mr. Jack from FDA shall tell us more about ETASU...
  • 2. These are intended to reduce a specific serious risk listed in the labeling of the drug.
  • EG: Prescribers have specific training/experience or special certifications
  • EG: Drug be dispensed only in certain healthcare settings
  • EG: Each patient using the drug be subject to monitoring
  • EG: Pharmacies, practitioners or healthcare settings that dispense the drug be specially certified
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