Product ICSR

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Product Brief - ICSR

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Product Name

HL7 Version 3 Standard: Public Health Reporting: Individual Case Safety Report (ICSR)

Standard Category

  • Health Information Exchange Standards

Integration Paradigm

  • Messaging

Type

Normative, ANSI Standard (R1) DSTU (R2)

Releases

ANSI/HL7 V3 RRCS, R1-2005, HL7 V3 RRCS, R2-2006 DSTU expired October 2008

Summary

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 reporting sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers.

Description

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 pharmacovigilence 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: Any adverse event associated with the use of a product in humans or animals, whether or not considered product related, including the following: An adverse event occurring in the course of the use of a product in professional practice; an adverse event occurring from overdose of the product whether accidental or intentional; an adverse event occurring from abuse of the product; an adverse event occurring from withdrawal of the product; and any failure of expected pharmacological action. Note these events may result in unintended harm to the patient by an act of commission or omission, rather than by the underlying disease or condition of the patient.

b) Suspected adverse reaction: A noxious and unintended response to a product for which there is a reasonable possibility that the product caused the response. In this definition, the phrase "a reasonable possibility" means that the relationship cannot be ruled out. The range of product types for which reports may be generated is set by regulatory and/or organizational administrative practice within the jurisdiction controlling the reporting between parties.

c) Suspected product problems or defects: Any problem or defect observed or detected before a product is used. This includes the use of drugs, biologics or medical devices used for treatment, or other consumer products such as cosmetics or dietary supplements. Some examples of product problems include faulty packaging or labeling, receipt of an expired therapeutic drug product, or suspected contamination based upon inappropriate or unauthorized preparations or mixtures.

d) An affected person or animal: If applicable to the report, this includes the investigative subject (patient) that experienced an adverse event.

e) Substance administrations: Includes information about how the product was given or used, or intended to be given or used by the investigative subject.

f) Medical procedures related to devices: Includes information about how a medical device was used or intended to be used by a patient or investigative subject. For example, device implant or removal procedures.

g) Supporting clinical information: Includes additional clinical detail such as relevant observations, procedures, substance administrations, supply acts or patient encounters. These observations are included if the reporter considers them relevant to the investigation, whether referring to the same point in time as the suspect event or as part of the patient's medical history.


Business Case (Intended Use, Customers)

Implementation efforts by the US Food and Drug Administration (FDA) for ICSR Release 1 to support medical device reporting revealed several limitations to the standard which required substantial changes to the ICSR Release 1 RMIMs.

Benefits

Harmonize reporting formats for FDA so that regulated industries that are required by law to submit both human drugs, biologics, vaccines and medical device adverse events and product problems can use a single standard.

Implementations/ Case Studies (Actual Users)

  • U.S. FDA
  • Center for Medical Devices and Radiological Health (Release 1)

Resources

Work Groups

Patient Safety

Education

Presentations

Relationship to/ Dependencies on, other standards

  • Common Product Model
  • Structured Product Labeling
  • CDISC Content to HL7 Message

Links to current projects in development

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