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Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2

DESCRIPTION

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report has two parts: Part 1: The Framework for Adverse Event Reporting, R2 has been published by ANSI as ANSI/HL7 V3 ICSRP1, R2-2012; Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2; has been approved by ANSI as ANSI/HL7 V3 ICSRP2, R2-2012.

The Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.

ALTERNATIVE NAMES

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 may also go by the following names or acronyms:

"HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: the framework for adverse event reporting, Release 2", ICSR

TARGETS

  • Healthcare Institutions (hospitals, long term care, home care, mental health)
  • Healthcare IT Vendors
  • Public Health and Regulatory Agencies

BENEFITS

  • Harmonized reporting formats that enable regulated industries that are required by law to submit human drugs, biologics, vaccines and medical device adverse events and product problems to use a single standard.

IMPLEMENTATIONS/CASE STUDIES

  • US Food and Drug Association (FDA)
  • Center for Medical Devices and Radiological Health (Release 1)

DEVELOPMENT BACKGROUND

The HL7 ICSR Release 1 specification was most particularly oriented towards reporting of reactions to regulated drugs, therapeutic biologics, vaccines, and medical devices. In addition to the products supported in release 1, the ICSR Release 2 supports a wider variety of products including: a) veterinary products, b) food and food additives, c) dietary supplements and cosmetics, and d) combination products. ICSR Release 2 provides a minimal level of backward compatibility or harmonization with ICSR Release 1, by supporting concepts and attributes introduced in the original release, including international pharmacovigilance reporting requirements described in the International Conference on Harmonisation's (ICH) E2B M2 ICSR message transmission specification.

 

The standards are oriented around the following concepts:

 

a) Adverse experiences b) Suspected adverse reaction
c) Suspected product problems or defects d) An affected person or animal
e) Substance administrations f) Medical procedures related to devices
g) Supporting clinical information  


ICSR is now in final International Standards Organization (ISO) TC-215 final ballot as an international standard.

RELATED DOCUMENTS

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2

(Download) (23.15 MB)

ADDITIONAL DETAILS

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 has been published by ANSI as ANSI/HL7 V3 ICSRP1, R2-2012.

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2; has been approved by ANSI as ANSI/HL7 V3 ICSRP2, R2-2012.

TOPIC

  • Public Health

BALLOT TYPE

  • Normative

STATUS DATE

2012-01-31

RESPONSIBLE WORK GROUP

Patient Safety

PRODUCT TYPE

  • ANSI-approved

STAKEHOLDER

  • Healthcare Institutions

FAMILY

  • V3

CURRENT STATE

  • Stable

REALM

  • Universal
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