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ICH ICSR Implementation Guide 12 April 2013
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but another one, repeatable Sections G should be completed with the
information about the prescribed drug (including the fact that it was not
administered), as well as the information on the dispensed drug as the
‘suspect’ drug. The medication error should be captured with the
appropriate MedDRA LLT code in Section E.i Reaction(s) /Event(s).
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.13
Value Allowed 1 =Suspect
2 =Concomitant
3 =Interacting
4 =Drug Not Administered
Business Rule(s)
Each ICSR must contain at least one ‘Suspect’, ‘Interacting’ or ‘Drug Not
Administered’.
Suspect medications are those health products taken by the patient and suspected by
the reporter to have contributed to the adverse reaction described in Section E.
Concomitant medications are only those health products taken by the patient at the
time the reaction is observed other relevant medication history should be recorded
in Section D.8.
G.k.2 Drug Identification
Medicinal product names or active ingredient names should be provided in G.k.2.2 as they were
reported by the primary source. To standardise the identification of medicinal products, the ICH
M5 IG should be used. When available, the most precise structured information should be
provided when identifying medicinal products and redundant information does not have to be
repeated. For example, if a MPID is provided in G.k.2.1.1, there is no need to provide a PhPID
in G.k.2.1.2.Likewise, if a PhPID is provided, there is no need to provide information for
Substance.
In case of investigational drugs, provide as much information as known in G.k.2.2 and
G.k.2.3.r.1 even if only an abstract code might be known.
If more than one substance name is specified for a drug product, each of them should be
included in this section by repeating the item G.k.2.3 as necessary.
The product name used by the reporter should always be provided.
ICH ICSR Implementation Guide 12 April 2013
-117-
but another one, repeatable Sections G should be completed with the
information about the prescribed drug (including the fact that it was not
administered), as well as the information on the dispensed drug as the
‘suspect’ drug. The medication error should be captured with the
appropriate MedDRA LLT code in Section E.i Reaction(s) /Event(s).
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.13
Value Allowed 1 =Suspect
2 =Concomitant
3 =Interacting
4 =Drug Not Administered
Business Rule(s)
Each ICSR must contain at least one ‘Suspect’, ‘Interacting’ or ‘Drug Not
Administered’.
Suspect medications are those health products taken by the patient and suspected by
the reporter to have contributed to the adverse reaction described in Section E.
Concomitant medications are only those health products taken by the patient at the
time the reaction is observed other relevant medication history should be recorded
in Section D.8.
G.k.2 Drug Identification
Medicinal product names or active ingredient names should be provided in G.k.2.2 as they were
reported by the primary source. To standardise the identification of medicinal products, the ICH
M5 IG should be used. When available, the most precise structured information should be
provided when identifying medicinal products and redundant information does not have to be
repeated. For example, if a MPID is provided in G.k.2.1.1, there is no need to provide a PhPID
in G.k.2.1.2.Likewise, if a PhPID is provided, there is no need to provide information for
Substance.
In case of investigational drugs, provide as much information as known in G.k.2.2 and
G.k.2.3.r.1 even if only an abstract code might be known.
If more than one substance name is specified for a drug product, each of them should be
included in this section by repeating the item G.k.2.3 as necessary.
The product name used by the reporter should always be provided.