A medicine’s product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe and effective use.
ePI is often presented in three forms:
- Information for healthcare professionals
- Information for patients
- Information on the package label
ePI, also sometimes called a drug product label, goes by different names depending on the region of the world. For example,
- USA - Prescription Drug Label or Patient Package Insert (USPI)
- Europe - Summary of Product Characteristics (SmPC) or Package Leaflet
- Japan - Package Insert (JPI)
Since these documents are often based on PDF, they are unstructured electronic paper. As a result, they are difficult to search, difficult to find, and the content does not meet patient needs (e.g., larger fonts, accessibility support, multimedia, multiple languages, always current).
It is known that current procedures based on PDF are not adequate to support electronic initiatives. To support new programs, the international community is adopting a new technology for exchanging medicinal product information between computer systems based on FHIR.
Adoption of FHIR for ePI is anticipated to stimulate the delivery of healthcare applications from innovative 3rd parties. A common standard for ePI exchange will allow the creation of aggregated cross-industry content which is a foundational element for creation of more personalized ePIs directing patients to the most relevant content; facilitating integration with other datasets such as Electronic Health Records (EHR); and data from wearable devices and diagnostics which will ultimately lead to a step-change in patient centric solutions.
- ePI document types (Information for healthcare practitioners, Information for patients, Package labels.
- Human pharmaceutical, radiopharmaceutical and biologic medicinal products (prescription and physician-administered).
- Over the counter (non-prescription) drugs
- Investigational and authorized medicinal products
- Medical devices co-packed with a biopharmaceutical product (e.g., pre-filled syringe).
Out of Scope
- Self-care products
- Natural health products
- Medical devices
- Veterinary drugs.
- ACTIVE (Status Date: 2022-08)
Approved as a HL7 Vulcan sponsored project by Vulcan Steering Committee on 2021-08-16
Approved as a BR&R sponsored project on 2022-07-12 (2022-07-12 Conference Call meeting minutes)
Approved by HL7 TSC on 2022-08-29 (2022-08-29 TSC Agenda/Minutes)
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Upcoming Events or Milestones
September 14-15, 2021
January 10-12, 2022
May 2-4, 2022
July 12, 2022
HL7 Project Scope Statement Approved by the WG
August 29, 2022
HL7 Project Scope Statement Approved by the TSC
September 17-18, 2022
September 28, 2022
October 5, 2022
November 1, 2022
November 24, 2022
December 8, 2022
IG Complete and published for balloting
December 11 - January 10
HL7 Balloting and review of ballot comments
FHIR Resources (Draft)