Should I submit patient package inserts (PPIs), medication guides (MedGuides), and patient information leaflets (PILs) in SPL?
If your package insert has a PPI, MedGuide, or PIL at the end, that information should be included in SPL. There are specific LOINC codes for the PPI and the MedGuide subsections of the Patient Counseling Information section. Each of the approved patient labeling documents should have a separate LOINC code. Patient information that is not part of the approved labeling, such as patient information produced by third parties, should not be included in SPL.
Related Questions
- For the Patient Characteristics Survey, we intend to submit data electronically for the entire facility. Do we need to register for SMS ??
- Why do I need to submit a medical form? What if I have allergies or other conditions requiring medication or field based treatment?
- Can I submit one story from a special section or feature series package in the Feature Article category?
