Summary of Changes to
MedDRA® TERM SELECTION:
POINTS TO CONSIDER
ICH-Endorsed Guide for MedDRA Users
Release 4.3
Based on MedDRA Version 15.0
1 April 2012
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The following is a listing of changes made between releases 4.2 and 4.3 of
MedDRA Term Selection: Points to Consider:
Throughout document
1)
2)
3)
4)
Correction of general spelling, punctuation, spacing, and format errors
Replacement of references to MedDRA Version 14.1 to Version 15.0
Update of examples based on MedDRA version changes
Links to the MSSO Web site (e.g., in Section 4.2) have been updated
3.1 – Definitive and Provisional Diagnoses with or without Signs and
Symptoms
The first sentence of the third paragraph:
The preferred option for a single or multiple provisional diagnosis(es) is to
select a term(s) for the diagnosis(es) and terms for signs and symptoms.
Was changed as follows (the word “reported” was added):
The preferred option for a single or multiple provisional diagnosis(es) is to
select a term(s) for the diagnosis(es) and terms for reported signs and
symptoms.
3.10.2 Events in the child or fetus
The examples in the table:
Example
Setting/Patient
Child/fetus with AE;
exposed in utero; mother
took product
Child/fetus with AE;
exposed in utero; father
took product
Child with AE; exposed to
product via breast milk
Reported
Pregnant woman taking drug
X had fetal tachycardia
noted on routine
examination
Baby born with cleft palate;
father had been taking
drug X at time of
conception
Mother exposed to drug X;
nursing newborn
experienced vomiting
LLT Selected
Fetal tachycardia
Drug exposure in utero
OR Drug exposure
during pregnancy
Cleft palate
Paternal drug exposure
Vomiting neonatal
Drug exposure via
breast milk (See
2
Setting/Patient
Reported
LLT Selected
Section 3.15.3,
Accidental exposures)
Were changed as follows (“Setting/Patient” rewording; minor change to
“Reported Information” in first example; revision of selected LLTs for the first two
examples):
Example
Setting/Patient
Fetus with AE; exposed in
utero; mother took product
Baby with AE; exposed in
utero; father took product
Newborn with AE; exposed
to product via breast milk
Reported
Pregnant woman taking drug
X; fetal tachycardia noted
on routine examination
Baby born with cleft palate;
father had been taking
drug X at time of
conception
Mother exposed to drug X;
nursing newborn
experienced vomiting
LLT Selected
Fetal tachycardia
Drug exposure in utero
Cleft palate
Paternal drug exposure
before pregnancy
Vomiting neonatal
Drug exposure via
breast milk (See
Section 3.15.3,
Accidental exposures)
3.15.2 Medication error reported without clinical consequences
The section header was reworded to “Medication errors and potential
medication errors reported without clinical consequences”.
A third paragraph was added to this section as follows:
In instances where the medication did not reach the patient, it is acceptable to
select LLT Drug not taken in context of intercepted medication error.
The examples in the table:
Example
Reported
Medication was given
intravenously instead of
LLT Selected
Intramuscular formulation
administered by
Comment
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Reported
intramuscularly
Medication was given
intravenously instead of
intramuscularly
without sequelae
Patient was dispensed the
wrong drug strength. The
error was detected prior to
patient administration
Pharmacist notices that the
names of two drugs are
similar and is concerned
that this may result in a
medication error
LLT Selected
other route
Intramuscular formulation
administered by
other route
No adverse effect
Comment
See Section 3.20
Intercepted drug
dispensing error
Circumstance or
information capable of
leading to medication error
LLT Drug name
confusion could be an
optional additional term
to select (for tracking
purposes). Note: this
example is a potential
medication error
Were changed as follows (Removal of the word “strength” from the “Reported”
information in the third example; addition of a fifth example):
Example
Reported
Medication was given
intravenously instead of
intramuscularly
Medication was given
intravenously instead of
intramuscularly
without sequelae
Patient was dispensed the
wrong drug. The error was
detected prior to patient
administration
Pharmacist notices that the
names of two drugs are
similar and is concerned
that this may result in a
medication error
LLT Selected
Intramuscular formulation
administered by
other route
Intramuscular formulation
administered by
other route
No adverse effect
Comment
See Section 3.20
Intercepted drug
dispensing error
Circumstance or
information capable of
leading to medication error
LLT Drug name
confusion could be an
optional additional term
to select (for tracking
purposes). Note: this
example is a potential
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Reported
LLT Selected
Drug inadvertently
administered. The error
was noticed soon
afterwards.
Drug administration error
Comment
medication error
3.15.3 Accidental exposures
For this example table:
Example
Reported
Nurse splashed injectable drug in her
own eye resulting in excessive tearing
Child accidentally took grandmother’s
pills and experienced projectile vomiting
LLT Selected
Inadvertent exposure to drug
Excess tears
Accidental drug intake by child
Vomiting projectile
An additional example was added as follows:
Example
Reported
Nurse splashed injectable drug in her
own eye resulting in excessive tearing
Child accidentally took grandmother’s
pills and experienced projectile vomiting
Father applying topical steroid to his
arms accidentally exposed his child to
the drug by carrying her
LLT Selected
Inadvertent exposure to drug
Excess tears
Accidental drug intake by child
Vomiting projectile
Exposure via skin contact
3.25 – Indication for Product Use
A new sub-section was added as Section 3.25.2; all subsequent sub-sections
were renumbered as a result. No sub-sections were deleted from Section 3.25.
The added sub-section is as follows:
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3.25.2 Indications with genetic markers or abnormalities
For indications that describe a genetic marker or abnormality associated with a
medical condition, select a term for both the medical condition and the genetic
marker or abnormality.
Example
Reported
Non small cell lung cancer with K-ras
mutation
LLT Selected
Non-small cell lung cancer
K-ras gene mutation
3.26.1 Off label use when reported as an indication
The second paragraph:
If a medical condition is reported as an indication along with “off label use”, the
preferred option is to select a term for the medical condition for the “indications”
field. Alternatively, select terms for the medical condition /indication and LLT Off
label use. Select LLT Off label use alone only if it is the only information
available.
Was changed as follows (wording of “or other appropriate LLTs linked to PT Off
label use” was added):
If a medical condition is reported as an indication along with “off label use”, the
preferred option is to select a term for the medical condition for the “indications”
field. Alternatively, select terms for the medical condition/indication and LLT Off
label use or other appropriate LLTs linked to PT Off label use. Select LLT Off
label use alone only if it is the only information available.
For the second example table:
Example
Reported
Off label use
LLT Selected
Off label use
A new example was added:
Example
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Reported
Off label use
LLT Selected
Off label use
Off label use in paediatric patients
Drug use in unapproved population
3.26.2 Off label use when reported with an AR/AE
The first paragraph:
If an AR/AE occurs as a result of off label use, the preferred option is to select a
term for the AR/AE; alternatively, select LLT Off label use and a term for the
AR/AE.
Was changed as follows (note the change of preferred option):
If an AR/AE occurs as a result of off label use, the preferred option is to select
LLT Off label use, or other appropriate LLTs linked to PT Off label use, and a
term for the AR/AE; alternatively, select a term for the AR/AE.
Additionally, the example table in this section:
Example
Reported
Patient was administered a
drug off label for pulmonary
hypertension and suffered
a stroke
LLT Selected
Preferred Option
Stroke

Stroke
Off label use
Was changed as follows (note the change of preferred option):
Example
Reported
Patient was administered a
drug off label for pulmonary
hypertension and suffered
a stroke
LLT Selected
Stroke
Stroke
Intentional use for
unlabeled indication
Preferred Option

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3.27.3 Product quality issue vs. medication error
For the example table:
Example
Reported
Pharmacist dispensing Drug
A inadvertently attached a
product label for Drug B
The drug store clerk noted
that the wrong product
label was attached to some
bottles in a shipment
of mouthwash
LLT Selected
Wrong label placed
on medication
during dispensing
Product label
on wrong product
Comment
Medication error
Product quality issue
A new example was added:
Example
Reported
Pharmacist dispensing Drug
A inadvertently attached a
product label for Drug B
The drug store clerk noted
that the wrong product
label was attached to some
bottles in a shipment
of mouthwash
The mother administered
insufficient amount of
prescribed antibiotic
because the lines on the
dropper were hard to read
LLT Selected
Wrong label placed
on medication
during dispensing
Comment
Medication error
Product label
on wrong product
Product quality issue
Product dropper calibration
unreadable
Insufficient dosage
Product quality issue
and medication error
4.3.1 Current members of the ICH Points to Consider Working Group
Carmen Kreft-Jais’s name was replaced by Maria Luisa Casini’s for the
Commission of the European Communities membership.
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Judy Harrison’s name was added for the MedDRA MSSO membership.
Izuma Oba’s name was replaced by Nogusa Takahara’s for the Ministry of
Health, Labour and Welfare membership.
Go Yamamoto’s name was added for the Ministry of Health, Labour and Welfare
membership.
4.3.2 Former members of the ICH Points to Consider Working Group
Carmen Kreft-Jais’s name was added for the Commission of the European
Communities membership.
Izuma Oba’s name was added for the Ministry of Health, Labour and Welfare
membership.
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