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Supporting Material (SM)

Supporting Material is a broad term encompassing both regulated Additional Risk Minimization Measures (aRMM) and non-regulated Health Education Material (HEM), intended to complement the ePI.

Types of Supporting Material​

Additional Risk Minimization Measures (aRMM)​

  • Regulated content from authorities
  • Mandatory for certain high-risk medications
  • Additional safety information beyond ePI
  • Examples: Patient alert cards, prescriber checklists

Health Education Material (HEM)​

  • Non-regulated content from trusted sources
  • General health education
  • Disease management guides
  • Medication adherence tools
  • Examples: Videos, infographics, interactive content

FHIR Representation​

Supporting Material metadata is stored using the Additional Support Material Profile:

  • Based on DocumentReference resource
  • Contains source information
  • Includes language metadata
  • Links to standard terminologies

Matchmaking​

The Supporting Material Matchmaking process:

  1. Takes ePI, IPS, and PV as input
  2. Returns relevant SM matching:
    • Patient conditions
    • Medication terms
    • Language preferences
    • Health literacy level

Management​

Managed through:

Integration with Focusing​

Lenses can:

  • Add hyperlinks to relevant SM
  • Embed SM content (images, videos)
  • Suggest SM based on patient context