Guide For Med Ra Users V12.1

MedDRA® TERM SELECTION:
POINTS TO CONSIDER

Release 3.13
Based on MedDRA Version 12.1

ICH-Endorsed Guide for MedDRA Users

Application to Adverse Drug Reactions /Adverse Events
&
Medical and Social History & Indications

1 October 2009

© Copyright ICH Secretariat (c/o IFPMA)

Copying is permitted, with reference to source, but
material in this publication may not be used in any
documentation or electronic media which is offered
for sale, without the prior permission of the copyright
owner.

IFPMA
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P.O. Box 195
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Switzerland
Tel: +41 (22) 338 32 00
Fax: +41 (22) 338 32 99

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Table of Contents

1.0 INTRODUCTION ...................................................................................................................... 4
1.1 OBJECTIVE OF THIS DOCUMENT ................................................................................................. 4
1.2 PURPOSES OF USING MEDDRA ................................................................................................. 5
1.3 BACKGROUND ........................................................................................................................... 5
1.4 SCOPE OF THE POINTS TO CONSIDER ......................................................................................... 6
2.0 GENERAL PRINCIPLES ......................................................................................................... 6
2.1 QUALITY OF SOURCE DATA ....................................................................................................... 6
2.2 LEVEL OF TERM SELECTION ....................................................................................................... 6
2.3 USE OF “CURRENT”/”NON-CURRENT” LOWEST LEVEL TERMS (LLTS) .................................... 7
2.4 CHOICE OF TERM ....................................................................................................................... 7
2.5 DO NOT SUBTRACT OR ADD INFORMATION ................................................................................ 8
2.6 QUALITY ASSURANCE ............................................................................................................... 8
3.0 TERM SELECTION POINTS .................................................................................................. 9
3.1 DIAGNOSES AND PROVISIONAL DIAGNOSES WITH AND WITHOUT SIGNS AND SYMPTOMS ......... 9
3.2 DEATH AND OTHER PATIENT OUTCOMES ................................................................................ 11
3.3 SUICIDE AND SELF-HARM ........................................................................................................ 13
3.4 CONFLICTING/AMBIGUOUS/VAGUE INFORMATION ................................................................... 13
3.5 COMBINATION TERMS ............................................................................................................. 14
3.6 AGE VS. EVENT SPECIFICITY .................................................................................................... 15
3.7 BODY SITE VS. EVENT SPECIFICITY .......................................................................................... 16
3.8 LOCATION VS. INFECTIOUS AGENT .......................................................................................... 16
3.9 PRE-EXISTING MEDICAL CONDITIONS ...................................................................................... 17
3.10 EXPOSURE DURING PREGNANCY AND BREAST FEEDING ......................................................... 18
3.11 CONGENITAL TERMS................................................................................................................ 19
3.12 NEOPLASMS ............................................................................................................................ 19
3.13 MEDICAL/SURGICAL PROCEDURES ........................................................................................ .20
3.14 INVESTIGATIONS ..................................................................................................................... 20
3.15 MEDICATION/ADMINISTRATION ERRORS AND ACCIDENTAL EXPOSURES .................................. 22
3.16 TRANSMISSION VIA MEDICINAL PRODUCT OF INFECTIOUS AGENT ............................................ 24
3.17 OVERDOSE/TOXICITY/POISONINGS ......................................................................................... 25
3.18 DEVICE TERMS ........................................................................................................................ 25
3.19 DRUG INTERACTIONS .............................................................................................................. 26
3.20 NO ADVERSE EFFECT ............................................................................................................... 27
3.21 UNEXPECTED THERAPEUTIC EFFECT ........................................................................................ 27
3.22 MODIFICATION OF EFFECT ....................................................................................................... 27
3.23 SOCIAL CIRCUMSTANCES ........................................................................................................ 28
3.24 MEDICAL AND/OR SOCIAL HISTORY ......................................................................................... 30
3.25 INDICATION FOR PRODUCT USE................................................................................................ 30
3.26 OFF LABEL USE ........................................................................................................................ 32

4.0 Appendices: ............................................................................................................................... 34
4.1 CURRENT MEMBERS OF THE ICH POINTS TO CONSIDER WORKING GROUP: .............................. 34
4.2 PAST MEMBERS/AFFILIATIONS OF THE ICH POINTS TO CONSIDER WORKING GROUP: .............. 35

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1.0 INTRODUCTION
The Medical Dictionary for Regulatory Activities (MedDRA) 1 was designed for
the specific use of sharing regulatory information for human medical products.
However, unless users can achieve consistency in the way they assign particular
terms to particular symptoms, signs, diseases, etc., use of MedDRA terminology
will yield little improvement over the divergent practices of the past.

This MedDRA Term Selection: Points to Consider document is an ICH-endorsed
guide for MedDRA users. It is designed to be updated based on MedDRA
changes, and is a companion document to the MedDRA terminology. It was
developed and is maintained by a working group charged by the ICH steering
committee consisting of regulatory and industry representatives of the European
Union, Japan and the United States, as well as representatives from Canada, the
MedDRA Maintenance and Support Services Organization (MSSO), and
Japanese Maintenance Organization (JMO). (See appendix for members).

Specific examples contained in this document are based on MedDRA Version
12.1.

1.1 Objective of this document
The objective of this ICH Term Selection: Points to Consider document is to
promote accurate and consistent term selection. Organizations are encouraged to
document their term selection strategies, methods, and quality assurance
procedures in organization-specific coding guidelines, which should be consistent
with the Term Selection: Points to Consider document.

Consistency in term selection will promote medical accuracy when using
MedDRA to share data worldwide. This will in turn facilitate a common
understanding of data shared among academic, commercial, and regulatory
entities. The document could also be used by healthcare professionals,
researchers, and other interested parties outside of the regulated
pharmaceutical/biological industry.

At the request of users, in some cases where there is more than one option for
selecting terms, a “preferred option” is identified. The fact that a “preferred
option” is identified does not limit MedDRA users to using that option.

The document is intended to provide term selection advice either for a business
purpose or regulatory requirement. There might be examples that do not reflect
practices or requirements in all regions; this document does not intend to
communicate specific regulatory reporting requirements or address database
issues. In addition, it is expected that as experience with MedDRA increases,
there will be changes to the document.
1
MedDRA refers to all sequential and translated versions of the terminology, which are maintained by
either the Maintenance and Support Services Organization (MSSO) or the Japanese Maintenance
Organization (JMO).

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1.2 Purposes of Using MedDRA
To aggregate reported terms in medically meaningful groupings for the
purpose of reviewing and/or analyzing safety data

To facilitate identification of common data sets for evaluation of clinical and
safety information

To facilitate consistent retrieval of specific cases or medical conditions from
a database

To improve consistency in comparing and understanding “safety signals”
and aggregated clinical data

To facilitate electronic data interchange of clinical safety information

To report adverse reaction/adverse event (ADR/AE) 2 terms via individual
case safety reports

To include ADR/AEs in tables, analyses, and line listings for reports

To identify frequency of medically similar ADR/AEs

To capture and present product indications, investigations, medical history,
and social history data

1.3 Background
This Points to Consider document has been prepared to help all MedDRA
users to begin on common ground, as the terminology itself does not contain
specific guidelines for its use; it provides a framework to foster consistent
use of MedDRA for data input and retrieval. The end result allows for
medically meaningful review and analysis of clinical data.

The working group recognizes that this document is not able to address
every situation. Medical judgment and common sense should also be
applied.

This document is not a substitute for MedDRA training. It is considered
essential that users have knowledge of the MedDRA structure and content.
For optimal MedDRA term selection, it is suggested that the reader also
refer to the MedDRA Introductory Guide 3 , which is provided with each
MedDRA subscription.

2
For ADR/AE definitions, refer to ICH Guidelines and CIOMS publications.
3
The MedDRA Introductory Guide can be found at the following link (Note: MedDRA user ID and
password are required): http://www.meddramsso.com/translations/translationdownloads.htm (JMO
website reference in Japanese version).

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1.4 Scope of the Points to Consider
The current document addresses term selection for data entry of ADR/AEs,
medical history, social history, indications, and investigations.

2.0 GENERAL PRINCIPLES
2.1 Quality of source data
Good MedDRA term selection is best accomplished with clear initial data.
Clarification of data that are ambiguous, confusing, or unintelligible should
be obtained. If clarification cannot be obtained, refer to Section 3.4,
Conflicting/ambiguous/vague information. The quality of the information
originally reported directly impacts the quality of data output. Proper term
selection allows for systematic and consistent recording, interpretation, and
comparison of data. It also provides for easy storage, retrieval, and analysis
of the clinical information.

Example: The presence or absence of a single letter in the reported verbatim
text can make a difference in the final term selected. If “lip sore” is
reported, select “Lip sore” (PT “Lip pain”). If “lip sores” are reported,
select “Sores lip” (PT “Cheilitis”). Similarly, if “sore gums” are reported,
select “Sore gums” (PT “Gingival pain”) and if “sores gum” is reported,
select “Sores gum” (PT “Gingivitis”).

2.2 Level of term selection
Lowest level term(s) that most accurately reflects the reporter’s words should
be selected.

MedDRA users should be aware of the degree of specificity that MedDRA
terms may have and the challenges this specificity may pose for appropriate
term selection.

Below are examples that illustrate the specificity of MedDRA:

• Gender terms

MedDRA generally excludes demographic descriptors, such as gender and
age, but some terms with gender qualifiers are included when the gender
renders the concept unique.

Example: There are terms “Infertility”, “Infertility female” and “Infertility
male” in MedDRA.

It is recommended that organization-specific coding guidelines address
instances in which it is important to capture gender-specific concepts.
MedDRA users should also consider the impact of gender-specific terms
when comparing MedDRA coded data to data coded with older
terminologies which may not have had corresponding gender-specific terms.
For example, if the organization’s prior terminology had only a single term
for “breast cancer”, consider the impact of selecting gender-specific terms
for breast cancer for current data.

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• Post-operative terms

MedDRA contains some post-operative terms. The most specific terms
should be selected.

Example: If “Post-operative bleeding” is reported, “Postoperative
bleeding” (not “Bleeding”) can be selected.

• Newly added terms

A new version of MedDRA is released every six months. When using a new
version of MedDRA, additional, more specific LLTs may be available for
term selection.

2.3 Use of “Current”/”Non-current” Lowest Level Terms (LLTs)
For term selection, only current LLTs should be used. The use of non-
current terms should be restricted to the conversion of historical/legacy data.

2.4 Choice of term

2.4.1 In this document, more than one option for term selection is
sometimes proposed. This is to allow a solution to accommodate
different database configurations and historic working practices.

2.4.2 It is not considered appropriate to address deficiencies in MedDRA by
developing organization-specific solutions. If the medical concept
reported is not adequately represented in the latest version of
MedDRA, it is appropriate to submit a change request to the MSSO.
In general, the MSSO will add such terms if medical significance has
been demonstrated (MedDRA Introductory Guide, Version 12.1).

Example: The term “HCV coinfection” was added to MedDRA
following a user’s request.

2.4.3 Medical judgment should be used if an exact match cannot be found,
but the medical concept can be adequately represented by an existing
term.

Example: If “brittle hair” is reported, “Hair breakage” more
accurately reflects the medical concept than the less specific term
“Hair disorder”.

2.4.4 In situations where a specific medical concept is not represented by a
single MedDRA term, a new term should be requested from the
MSSO. While awaiting the addition of the new term, it is considered
appropriate to select one or more existing terms. A consistent
approach should be used. The impact on data retrieval, analysis, and
reporting should be carefully considered.

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Example: If “metastatic gingival cancer” were not represented in
MedDRA by a single term, it would be appropriate to select
“Gingival cancer” or “Metastatic carcinoma” or both “Gingival
cancer” and “Metastatic carcinoma.”

2.4.5 Sometimes more than one choice of term selection is provided within
the document. If only one term is selected, specificity might be lost,
whereas the selection of two terms might lead to redundant counts.
Organizations are encouraged to document their established
procedures.

2.5 Do not subtract or add information

2.5.1 Do not omit reported information
Terms should be selected for every ADR/AE reported, regardless of
perceived relationship to the drug product. No reported medical
concept should be excluded from the term selection process.

Terms should be selected for each reported indication, investigation,
medical history and social history concept, as appropriate.

If a diagnosis (medical concept) is reported with characteristic signs
and symptoms, it is preferable to select a term for the diagnosis only
(see Section 3.1 for more details and examples). As the diagnosis
encompasses the signs and symptoms, this is not considered a loss of
information.

2.5.2 Do not add information
No new medical concepts should be added. Neither a diagnosis nor a
mechanism of action should be derived or inferred from reported
signs or symptoms.

Example: If “abdominal pain, increased serum amylase, and
increased serum lipase” are reported, it is considered inappropriate
to assign a diagnosis of “pancreatitis”.

2.6 Quality Assurance
Tools such as auto-encoders can be helpful, but human intervention is
necessary to assure the end result fully reflects the original information and
makes medical sense.

To promote consistent term selection, organizations are encouraged to
document their term selection strategies, methods, and quality assurance
procedures in coding guidelines, which should be consistent with the Term
Selection: Points to Consider document.

Data clarity can be promoted through internal procedures such as careful
design of data collection forms and training of individuals involved in the

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data collection and follow-up processes, e.g., clinical investigators/monitors,
medical product sales representatives and others. For example, an
organization may wish to make investigators and monitors aware of the
issues of reporting “combination” terms (see Section 3.5).

The MedDRA terminology is multi-axial and more complex than common
terminologies previously used. Therefore, term selection should be reviewed
by a qualified individual, a person with medical background and/or training
who is also trained in the use of MedDRA.

MedDRA is a standardized terminology. It is considered essential that ad hoc
structural changes in MedDRA not occur. The assignment of terms across
SOCs is pre-determined within the terminology and should not be altered by
users. If MedDRA users believe that term(s) are inappropriately placed in
the hierarchy, they should inform the MSSO by the change request process.

Example: In a previous version of MedDRA it was found that the primary
SOC for the term “Factor VIII deficiency” was “Blood and lymphatic system
disorders”. It was corrected by making “Congenital, familial and genetic
disorders” the primary SOC and “Blood and lymphatic system disorders”
the secondary SOC.

3.0 TERM SELECTION POINTS
3.1 Diagnoses and provisional diagnoses with or without signs and
symptoms

The table below provides options for term selection regarding diagnoses and
provisional diagnoses, with or without signs/symptoms reported. Examples of
certain points are listed below the table.

A provisional diagnosis may be described by, “suspicion of”, “probable”,
“presumed”, “likely”, “rule out”, “questionable”, “differential”, etc.

Note that the preferred option for a single or multiple provisional diagnosis(es)
is to select a term(s) for the diagnosis(es) as well as terms for signs and
symptoms. The alternate approach is to select terms for only the signs and
symptoms; this is because the diagnosis(es) – being provisional – is subject to
change while the signs and symptoms are not.

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SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS
Single diagnosis without Single provisional diagnosis without
signs/symptoms signs/symptoms
Diagnosis (only possible option) Provisional diagnosis (only possible
option)
Single diagnosis with Single provisional diagnosis with
• Preferred: Single diagnosis only • Preferred: Single provisional
• Alternate: Diagnosis and diagnosis and signs/symptoms
signs/symptoms • Alternate: Signs/symptoms only
(as provisional diagnosis may
Note: Always include change)
signs/symptoms not associated with
diagnosis Note: Always include
signs/symptoms not associated with
Example 1 diagnosis

Example 2

MULTIPLE DIAGNOSES
DEFINITIVE DIAGNOSES PROVISIONAL DIAGNOSES
Multiple diagnoses without Multiple provisional diagnoses without
• Multiple diagnoses (only possible • Multiple provisional diagnoses
option) (only possible option)

Multiple diagnoses with Multiple provisional diagnoses with
• Preferred: Multiple diagnoses • Preferred: Multiple provisional
only diagnoses and signs/symptoms
• Alternate: Diagnoses and • Alternate: Signs/symptoms only
signs/symptoms (as provisional diagnoses may
change)
Note: Always include
signs/symptoms not associated with Note: Always include
diagnoses signs/symptoms not associated with
diagnoses
Example 3
Example 4

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Example 1:

If “anaphylactic reaction” is reported with “rash, dyspnea,
hypotension, and laryngospasm”, selecting “Anaphylactic reaction”
alone is preferred.

Alternatively, “Anaphylactic reaction”, “Rash”, “Dyspnea”,
“Hypotension”, and “Laryngospasm” can be selected.

If “myocardial infarction” is reported with “chest pain, dyspnea,
diaphoresis, ECG changes, and jaundice”, it would be appropriate to
select terms for both “Myocardial infarction” and “Jaundice.” Note
that jaundice is not typically associated with myocardial infarction.

Example 2:

If “possible myocardial infarction with chest pain, dyspnea,
diaphoresis” is reported, selecting “Myocardial infarction”, “Chest
pain”, “Dyspnea”, and “Diaphoresis” is preferred.

Alternatively, “Chest pain”, “Dyspnea”, and “Diaphoresis” can be
selected.

Example 3:

If multiple diagnoses that include “pulmonary embolism, myocardial
infarction, and congestive heart failure” are reported along with
“chest pain, cyanosis, shortness of breath, and blood pressure
decreased”, selecting “Pulmonary embolism”, “Myocardial
infarction”, and “Congestive heart failure” is preferred.

Alternatively, “Pulmonary embolism”, “Myocardial infarction”,
“Congestive heart failure”, “Chest pain”, Cyanosis”, “Shortness of
breath”, and “Blood pressure decreased” can be selected.

Example 4:

If a differential diagnosis that includes “pulmonary embolism,
myocardial infarction, and congestive heart failure” is reported
along with “chest pain, cyanosis, shortness of breath, and blood
pressure decreased”, selecting “Pulmonary embolism”, “Myocardial
infarction”, “Congestive heart failure”, “Chest pain”, Cyanosis”,
“Shortness of breath”, and “Blood pressure decreased” is preferred.

Alternatively, “Chest pain”, Cyanosis”, “Shortness of breath”, and
“Blood pressure decreased” can be selected.

3.2 Death and Other Patient Outcomes
Death is an outcome and is not usually considered to be an ADR/AE. In
general, when an ADR/AE is reported along with a patient outcome, a

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term for the ADR/AE should be selected and the outcome should be
captured in the appropriate field. However, some death terms in
MedDRA provide additional clinical information and should be
considered for term selection as described in the following examples:

3.2.1 Death
3.2.1.1 If there are ADRs/AEs reported along with death, select
terms for the ADRs/AEs. The fatal outcome can be
otherwise captured in the appropriate data field.

Example: If “death due to myocardial infarction” is reported,
“Myocardial infarction” can be selected and death should be
captured as the outcome.

Example: If “constipation, ruptured bowel, peritonitis,
sepsis, and patient died” are reported, “Constipation”,
“Perforated bowel”, “Peritonitis”, and “Sepsis” can be
selected, and death should be captured as the outcome.

3.2.1.2 If the only information reported is death, then the most
specific death term available should be selected.
Circumstances of death should not be inferred, but captured
only if stated by the reporter.

Example: If a reporter states only that “a patient was found
dead”, “Found dead” can be selected.

Example: If a reporter states that “a patient dies during
childbirth”, “Maternal death during childbirth” can be
selected.

Example: If the autopsy report states, “the cause of death
was natural”, “Death from natural causes” can be selected.

3.2.1.3 If the particular death term adds important clinical
information to the case, it can be selected.

Example: If “patient experienced a rash and had sudden
cardiac death” is reported, “Rash” and “Sudden cardiac
death” can be selected.

3.2.2 Other Patient Outcomes
Consequences of an event such as hospitalization and disability are not
generally considered to be ADR/AEs.

Example: If “hospitalisation due to congestive heart failure” is
reported, “Congestive heart failure” can be selected and hospitalisation
should be captured as the consequence of the event.

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3.2.2.1. If the only information reported is the outcome term, then the
most specific term available should be selected.

Example: If a reporter states only that “a patient was hospitalised”,
“Hospitalisation” can be selected.

3.3 Suicide and Self-harm

Accurate and consistent term selection for reports of suicide attempts,
completed suicides and self-harm is necessary for appropriate data retrieval.
Where the motive for the injury is unclear, attempts should be made to gain
more specific information.

3.3.1 It is not acceptable to assume that an overdose is a suicide attempt.
Only the appropriate term that describes the overdose can be selected.

3.3.2 Similarly, for reports of self-injury that do not mention suicide/suicide
attempt, only the appropriate self-injury term should be selected.

Example: If “self slashing” or “cut her own wrists” is reported, select
“Self inflicted laceration” which is linked to PT “Intentional self-
injury.”

Example: If “cut wrists in a suicide attempt” is reported, select
“Suicide attempt.” “Laceration of arm” can also be selected.

3.3.3 If a suicide attempt is successful, it is acceptable to select the term that
reflects the outcome instead of the attempt only.

Example: If “suicide attempt resulted in death” is reported, select
“Completed suicide” and capture death as a fatal outcome.

3.4 Conflicting/ambiguous/vague information

When conflicting, ambiguous, or vague information is provided, it can be
difficult to select a term that will lead to appropriate data retrieval. In such
circumstances, attempts should be made to obtain more specific information.
(See Section 2.1, General Principles: Quality of source data). If
clarification attempts have failed, the examples below might be helpful:

3.4.1 Conflicting information

Example: If only “hyperkalemia with a serum potassium of 1.6
mEq/L” is reported, “Serum potassium abnormal” can be selected
because this single term conveys both medical concepts.

3.4.2 Ambiguous information

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Example: If “GU pain” is reported, “GU” could refer to either
“genito-urinary” or “gastric ulcer”. However, since pain was
reported, “Pain” can be selected.

It may be advisable to seek clarification for some terms as the final
result of term selection may be very different.

Example: COLD may refer to the common cold (PT
“Nasopharyngitis”) or Chronic Obstructive Lung Disease.
.
3.4.3 Vague information

Example: If the only information reported is “patient experienced
every listed adverse event”, and attempts to obtain more specific
information are unsuccessful, “Unevaluable event” can be selected.

3.5 Combination terms

A combination term in MedDRA is a single medical concept combined with
an additional medical term to provide important information on
pathophysiology or etiology. A combination term represents an
internationally recognized distinct and robust medical concept, e.g. PT
Diabetic retinopathy, PT Hypertensive cardiomegaly, and PT Eosinophilic
pneumonia.

When combination terms are reported, medical judgment should be applied
and the following points should be considered:

3.5.1 If one of the terms is a diagnosis and the other is a characteristic sign
and/or symptom, the diagnosis term can be selected (See Section 3.1).

Example: If “Chest pain due to myocardial infarction” is reported,
“Myocardial infarction” can be selected.

3.5.2 If one term is more specific than the other, then the most specific term
should be selected.

Example: If “hepatic function disorder (acute hepatitis)” is reported,
“Hepatitis acute” can be selected.

Example: If “arrhythmia due to atrial fibrillation” is reported, “Atrial
fibrillation” can be selected.

3.5.3 If a term exists that describes the combination, it should be used.

Example: If “retinopathy due to diabetes” is reported, “Diabetic
retinopathy” can be selected.

Example: If “rash with itching” is reported, “Itchy rash” can be
selected.

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3.5.4 If splitting provides more clinical information, it is considered
appropriate to select more than one term.

Example: If “diarrhea and vomiting” is reported, “Diarrhea” and
“Vomiting” can be selected.

Example: If “DIC due to sepsis” is reported, “DIC” and “Sepsis” can
be selected.

Example: If “wrist fracture due to fall” is reported, “Wrist fracture”
and “Fall” can be selected.

However, be aware that splitting may occasionally result in loss of
information unless one is attentive to the particular terms selected and
especially where they lie in the MedDRA hierarchy.

Example: If “Hematoma due to an animal bite” is reported, “Animal
bite” and “Traumatic hematoma” can be selected. Note that
“Traumatic hematoma” is more appropriate than “Hematoma” based
on the linkage in the MedDRA hierarchy (HLT Non-site specific
injuries NEC and HLT Haemorrhages NEC for “Traumatic
hematoma”; HLT Haemorrhages NEC for “Hematoma”).

3.5.5 If the reported term is a combination of an event and a pre-existing
condition that has not changed (see Section 3.9) and the combination term
does not exist in MedDRA, it is considered sufficient to select a term for the
event.

Example: If “shortness of breath due to cancer” is reported in a
patient with cancer, “Shortness of breath” can be selected

3.6 Age vs. Event Specificity

3.6.1 Some MedDRA terms describe the age group and the event. If
available, the term with the specific age group and event should be
selected.

Example: If “jaundice in a newborn” is reported, “Neonatal jaundice”
can be selected.

3.6.2 If a term is not available to capture both concepts, the preferred option
is to select the term for the event and capture the age group in a
demographic field.

Example: If “oral candidiasis in a neonate” is reported, then it is
preferable to select “Oral candidiasis”, and the neonatal status can be
captured in a demographic field.

15

Alternatively, it is acceptable to select terms for both age and event.

Example: If “oral candidiasis in a neonate” is reported, “Oral
candidiasis” and “Neonatal candida infection” can be selected.

3.7 Body site vs. Event specificity

3.7.1 Some MedDRA terms describe both the body site location and the
event. If available, the term with both the specific body site and the
event should be selected.

Example: If “skin rash on face” is reported, “Rash on face” can be
selected.

3.7.2 Not all MedDRA terms describe body sites. If the suitable MedDRA
term with the specific site description is not available, in general, the
relevant medical event should have priority.

Example: If “skin rash on chest” is reported, “Skin rash” can be
selected.

There will however be occasions when medical judgment is required
and the body site description should have priority.

Example: If “cyanosis at injection site” is reported, “Injection site
reaction” can be selected instead of “Cyanosis” as cyanosis implies a
generalized disorder.

3.7.3 If a term contains multiple body sites, and all link to the same PT, the
relevant medical event should have priority.

Example: If “skin rash on face and neck” is reported, “Skin rash”
can be selected.

3.8 Location vs. Infectious agent

3.8.1 Some MedDRA terms have both the location and the specific
organism/infection. If available, the term with both the specific
location and the organism should be selected.

Example: If “pneumococcal pneumonia” is reported,
“Pneumococcal pneumonia” can be selected.

3.8.2 Not all infection terms in MedDRA describe location. If the suitable
MedDRA term with the organism description is not available, the
preferred option would be to select the infective agent. It is also
considered acceptable to select the infection site term alone or to select
terms for both concepts.

16

Example: If “respiratory chlamydial infection” is reported, it is
preferable to select “Chlamydial infection”.

Example: If “respiratory chlamydial infection” is reported,
“Respiratory infection” can be selected.

Example: If “respiratory chlamydial infection” is reported,
“Chlamydial infection” and “Respiratory infection” can be selected.

3.9 Pre-existing medical conditions
Pre-existing medical conditions that have not changed should generally be
classified as medical and/or social history (See Section 3.24). Pre-existing
medical conditions that have changed can be classified as ADR/AEs.

3.9.1 It is important to capture the concept that a pre-existing condition was
modified, such as aggravated, exacerbated, worsened, intermittent,
recurrent, progressive, or improved. If a pre-existing medical
condition is modified, the specific MedDRA term should be selected,
provided that it exists.

Example: If “exacerbation of myasthenia gravis” is reported,
“Myasthenia gravis aggravated” can be selected.

3.9.2 In the absence of such a term, the following options are considered
appropriate:

3.9.2.1 A term for the condition should be selected and the
modification should be captured in a consistent, documented
way. The non-specific modifier term alone should not be
selected.

Example: If “halitosis worsened” is reported, “Halitosis” can
be selected.

3.9.2.2 A term for the condition and an additional term to describe the
modification of the condition should be selected, e.g.,
“Condition aggravated”, “Disease progression.”

Example: If “progression of Addison’s disease” is reported,
“Addison’s disease” and “Disease progression” can be
selected.

Example: If “aggravation of jaundice” is reported, “Jaundice”
and “Condition aggravated” can be selected.

3.9.3 If the reported term is a combination of an event and a pre-existing
condition that has not changed and the combination term does not exist
in MedDRA, it is considered sufficient to select a term for the event.

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Example: If “shortness of breath due to cancer” is reported in a
patient with cancer, “Shortness of breath” can be selected.

3.10 Exposures During Pregnancy and Breast Feeding

MedDRA contains various terms that address exposures to medical products
(drug and nondrug) during pregnancy and breast feeding. To select the most
appropriate term(s) to capture the information, first determine if the
subject/patient who experienced the event(s) was the mother or the
child/fetus.

3.10.1 Events in the Mother

3.10.1.1 Patient became pregnant while receiving medication

Pregnancy is not normally considered an adverse event, but
organizations may wish to capture this information in their databases.

If the occurrence of pregnancy is reported but no adverse event has
occurred, it is appropriate to select both “Pregnancy” and “No
adverse effect” (see Section 3.20).

If the occurrence of pregnancy is reported but there is no pregnancy
outcome and it is not known yet whether any adverse event occurred,
select “Pregnancy” only.

3.10.1.2 Pregnant patient experienced adverse event(s) while receiving
medication.

Appropriate term(s) for the adverse event and “Drug exposure during
pregnancy” can be selected. “Pregnancy” can also be selected for the
medical history and/or concomitant medical condition.

3.10.2 Events in the child or fetus

It is helpful to first determine if the child or fetus was exposed or
potentially exposed to the medical product from the mother or the
father.

3.10.2.1 Child or fetus experienced adverse event(s) and was exposed to the
drug in utero; mother received the product. (Note that the patient is
the child or fetus).

Appropriate term(s) should be selected for the adverse event(s). In
addition, “Drug exposure in utero” or “Maternal drug exposure” can
also be selected.

3.10.2.2 Child or fetus experienced adverse event(s) and was exposed to the
drug in utero; father received the product. (Note that the patient is the
child or fetus).

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Appropriate term(s) should be selected for the adverse event(s). In
addition, “Paternal drug exposure” can also be selected.

3.10.2.3 Child experienced an adverse event and was exposed to the drug from
breast milk.

Appropriate term(s) should be selected for the adverse event(s). (Note
that the patient is the child). In addition, “Drug exposure via breast
milk” can also be selected.

3.11 Congenital terms
The definition of “congenital” for MedDRA is “any condition present at
birth, whether genetically inherited or occurring in utero” (MedDRA
Introductory Guide, Version 12.1).

3.11.1 Terms from the SOC Congenital, familial and genetic disorders
should be used when the condition is described as congenital by the
reporter or when medical judgment establishes that the condition was
present in the child at the time of birth.

Example: If either “congenital heart disease” or “child born with
heart disease” is reported, “Heart disease congenital” can be
selected.

3.11.2 If the condition is not specified as congenital and not stated to be
present at birth, the non-specific term should be selected or in its
absence, the acquired term should be selected.

Example: If “night blindness” is reported, the term “Night
blindness” can be selected which links to the PT “Night blindness”.

Example: If “cholangiectasis” is reported, the term “Cholangiectasis
acquired” can be selected.

3.12 Neoplasms
Given the wide variety of neoplasm types, it is not possible to provide
specific guidance applicable to all situations. However, MedDRA users
should be aware that the MedDRA Introductory Guide has rules and
conventions for the way certain neoplasm and related terms are used in
MedDRA. For example, in MedDRA:

• The words “cancer” and “carcinoma” are used synonymously.
(Appendix B, MedDRA Concept Descriptions, of MedDRA
Introductory Guide, Version 12.1).
• The word “tumo(u)r” is considered neoplastic.
• The words “lump” and “mass” are not considered neoplastic.

These points should be kept in mind for term selection.

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Clarification from the reporter should be sought if the type of neoplasia
described is not clear. When selecting terms for neoplastic conditions,
medical experts should be consulted for difficult or unusual neoplasms.

3.12.1 Malignancy should not be inferred but captured only if stated
specifically by the reporter. Reported events of “tumor” should not
be assigned a “cancer” or “carcinoma” term unless it is clear that a
malignancy is present.

Example: If “Tumour growing on skin” is reported, “Skin tumour”
can be selected.

Example: If “Cancer growing on tongue” is reported, “Malignant
tongue cancer” can be selected.

3.13 Medical/Surgical Procedures
The use of the SOC Surgical and medical procedures is generally not
appropriate for ADR/AEs. The terms in the SOC Surgical and medical
procedures are not multi-axial in MedDRA. Users should be aware of the
impact that use of these terms will have on data retrieval, data analysis, and
reporting. When selecting terms for procedures, the following points might
be helpful:

3.13.1 If the procedure represents the only information provided, a term
should be selected for the procedure.

Example: If “patient had gallbladder surgery” is the only
information reported, “Gallbladder operation” can be selected.

Example: If “patient had tonsillectomy in childhood” is reported,
“Tonsillectomy” can be selected.

3.13.2 If a procedure is reported in combination with a diagnosis, it is
preferable to select a term for the procedure in addition to a term for
the diagnosis, since information concerning a procedure may indicate
severity of the condition. Alternatively, it is considered sufficient to
select a term for the diagnosis alone.

Example: If “liver transplantation due to liver injury” is reported, it
is preferable to select both “Liver injury” and “Liver
transplantation”. Alternatively, “Liver injury” alone can be
selected.

3.14 Investigations
SOC Investigations includes test names without qualifiers and test names
with qualifiers (e.g., increased, decreased, abnormal, normal).
Corresponding medical conditions, such as “hyper” and “hypo” terms, are
represented in other “disorder” SOCs. By design, the terms in SOC
Investigations are not multi-axial. Therefore, for data retrieval, SOC

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Investigations should always be considered, in addition to the specific
“disorder” SOC(s).

3.14.1 Investigation terms without qualifiers
Terms in SOC Investigations without qualifiers can be used to
capture test names such as in the E2B field B.3.1c.

Example: If “bilirubin” test is performed, then “Bilirubin” can be
selected.

Example: If “cardiac output” is measured, then “Cardiac output”
can be selected.

Example: If “blood glucose increased” is reported, and the user
wishes to capture laboratory results, the term “Blood glucose” can
be selected for the test name and the free text “increased” can be
entered in the result field. It is not appropriate to put “Blood glucose
increased” as a test name.

3.14.2 The results of investigations might represent ADR/AEs. When
selecting terms for results of investigations, the following points
might be helpful:

3.14.2.1Medical conditions vs. laboratory results.

Example: If “hypoglycemia” is reported, “Hypoglycemia” can
be selected.

(Note: “Hypoglycemia” links to SOC Metabolism and nutrition
disorders.)

Example: If “decreased glucose” is reported, “Glucose
decreased” can be selected.

(Note: “Glucose decreased” links to SOC Investigations.)

3.14.2.2 Unambiguous laboratory results

Example: If a value is reported that is clearly below the
reference range, e.g., glucose 40 mg/dL, “Glucose low” can be
selected.

3.14.2.3 Ambiguous laboratory results

Example: If “his glucose was 40” is reported without units,
and additional clarification cannot be obtained, “Glucose
abnormal” can be selected.

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3.14.3 It is not considered necessary to select terms for each diagnostic
result that is consistent with the clinical diagnosis provided by the
reporter. (See Section 3.1.)

Example: If “elevated potassium, K 7.0 mmol/L and hyperkalemia”
are reported, “Hyperkalemia” can be selected. An additional term
for elevated potassium (e.g., “Potassium increased”) is not
necessary.

3.14.4 It is considered necessary to select terms for each diagnostic result
that is not consistent with the clinical diagnosis provided by the
reporter.

Example: If “alopecia, rash, and elevated potassium 7.0 mmol/L”
are reported as adverse events, then “Alopecia”, “Rash”, and
“Potassium increased” can be selected.

3.14.5 Non-specific investigation terms should only be used when more
specific result terms are not available.

Example: If “abnormal liver function tests” is reported,
“Abnormal liver function tests” can be selected.

Example: If “increased alkaline phosphatase, increased SGPT,
increased SGOT, and elevated LDH” is reported, four individual
terms should be selected. A single term such as “Liver function
tests abnormal” should not be selected.

3.15 Medication/administration errors and accidental exposures
There are specific medication error terms in MedDRA. Information may be
reported describing medication errors with or without clinical
consequences.

3.15.1 If a medication error results in clinical consequences, term(s) for the
medication error and the clinical consequences should be selected.

Example: If “hives due to medication error” is reported, “Hives”
and “Medication error” can be selected.

Example: A patient was administered the wrong drug and
experienced hypotension. The term “Hypotension” and “Wrong
drug administered” can be selected

Explanations of the interpretations and uses of certain medication error terms
(e.g., “dispensing error”) are found in The MedDRA Introductory Guide
(Appendix B, MedDRA Concept Descriptions).

3.15.2 Medication errors in the absence of clinical consequences are not
ADR/AEs; however, it is important to capture the occurrence or the

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potential occurrence of a medication error. The term closest to the
type of medication error should be selected.

Example: If “medication was given intravenously instead of
intramuscularly” is reported, “Intramuscular formulation
administered by other route” can be selected.

Example: A patient was dispensed the wrong drug strength. The
error was detected prior to patient administration. The term
“Intercepted drug dispensing error” can be selected.

Additionally, information may be received describing the potential
for a medication error.

Example: A pharmacist notices that the names of two drugs are
similar and is concerned that this may result in a medication error.
The term “Drug name confusion” can be selected.

Example: A patient reports that tablets of a different strength are
the same color and shape and this may result in a medication error.
The term “Circumstance or information capable of leading to
medication error” can be selected.

3.15.3 The same principle applies to accidental exposures.

Example: If “nurse splashed an injectable drug in her own eye” is
reported, “Inadvertent exposure to drug” can be selected.

Example: If “child exposed to maternal drug during breast feeding”
is reported, “Drug exposure via breast milk” can be selected.

3.15.4 It is considered acceptable to select the additional term “No adverse
effect”, if specifically so reported. (See Section 3.20)

Example: If “medication was given intravenously instead of
intramuscularly without sequelae” is reported, “Intramuscular
formulation administered by other route” and “No adverse effect”
can be selected.

3.15.5 If the product label clearly states that co-administration with
specified drugs, specified food or administration to patients with
specified disease states have known effects, the appropriate term for
“Labelled drug-drug interaction medication error”, “Labelled
drug-food interaction medication error”, “Labelled drug-disease
interaction medication error” or” Documented hypersensitivity to
administered drug” can be selected.

Example: If "patient became pregnant whilst taking an antifungal
drug and an oral contraceptive" is reported, and this interaction is

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clearly stated in the product data sheet, "Labelled drug-drug
interaction medication error" can be selected.

Example: If "patient drank grapefruit juice whilst taking a calcium
channel blocker" is reported and the calcium channel blocker is
labelled for grapefruit juice interaction, "Labelled drug-food
interaction medication error" can be selected.

Example: If “a patient with renal failure is prescribed a drug for
which renal failure is contraindicated” is reported, “Labelled drug-
disease interaction medication error” can be selected.

Example: If a patient is administered a sulfonamide-based drug
when it was clearly noted in his medical file that he had a sulfa
allergy, “Documented hypersensitivity to administered drug” may
be selected

3.15.6 It is not considered appropriate to infer that a medication error has
occurred unless specific information is provided. (See Section 2.5.2)

Example: If “antibiotic was prescribed for a week and the patient
stopped treatment after 2 days because of bitter taste” is reported,
“Prescribed dosing duration not completed” and “Taste bitter” can
be selected.

Example: If “antibiotic was prescribed and the patient stopped
treatment after 2 days because of bitter taste” is reported, only
“Taste bitter” can be selected as it is not appropriate to assume the
medication was prescribed for a longer period.

3.15.7 It is not considered appropriate to infer an extra dose, overdose or
underdose if that is not explicitly reported. (See Section 3.17.1).

Example: If “incorrect dosing by patient” or “Inadvertent dose
administered” is the only information reported, “Wrong dose
administered” can be selected. It is not considered appropriate to
select “Extra dose administered” or “Overdose” on the basis of this
information only.

Example: If “patient took only half the prescribed dose,” is
reported, then “Underdose” can be selected.

3.16 Transmission via medicinal product of infectious agent

If a report of transmission of infectious agent via medicinal product is
received, it is considered appropriate to select a term for the transmission.
In addition, if the infectious agent is specified, it is considered appropriate
to select the specific infectious agent as a second term.

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Example: If “suspected transmission of Hepatitis C via a blood product” is
reported, “Suspected transmission of an infectious agent via a medicinal
product” and “Hepatitis C” can be selected.

Example: If “confirmed transmission of Hepatitis C via a blood product” is
reported, “Transmission of an infectious agent via a medicinal product”
and “Hepatitis C” can be selected.

In some instances, the reporter may not have clearly stated that transmission
of infection had occurred via a medical product. Medical judgment should
be used as transmission may be implied by data within a single case. The
term “Suspected transmission of an infectious agent via a medicinal
product” may be selected.

Alternatively, “Suspected transmission of an infectious agent via a
medicinal product” may be selected for the E2B field reserved for the
sender’s diagnosis (B.5.3, “Sender’s diagnosis/syndrome and/or
reclassification of reaction/event”).

3.17 Overdose/Toxicity/Poisonings

3.17.1 Overdose, toxicity, and poisoning terms exist within MedDRA.
Overdose terms are grouped under the HLT Overdoses. Toxicity and
poisoning terms are grouped under the HLT Poisoning and toxicity
(for more information please refer to the MedDRA Introductory
Guide, Version 12.1). If overdose, toxicity, or poisoning is explicitly
reported, the appropriate term should be selected.

Example: If “overdose of pills” is reported, “Overdose” can be
selected.

Example: If “A child was accidentally poisoned when she ingested a
cleaning product” is reported, “Accidental poisoning” can be
selected.

3.17.2 Terms for the clinical consequences reported in association with an
overdose should be selected.

Example: If “stomach upset from study drug overdose” is reported,
“Stomach upset” and “Overdose” can be selected.

3.17.3 If an overdose is reported and it was specifically stated that there were
no clinical consequences, it is considered acceptable to select
“Overdose” and the additional term “No adverse effect”. (See Section
3.20).

3.18 Device terms

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3.18.1 Device information may be reported with or without clinical
consequences. If a device term in the absence of clinical
consequences is reported, the appropriate term should be selected

Example: If "medical device breakage" is reported, "Device
breakage" can be selected.

Example: If “my patch is leaking on my arm” is reported, “Leaking
patch” can be selected

3.18.2 Some MedDRA terms capture both the device event and the clinical
consequence; if available, the term with both the event and
consequences should be selected.

Example: If “patient with a vascular implant developed an infection
of the implant " is reported, "Vascular implant infection" can be
selected.

3.18.3 If the appropriate MedDRA term is not available to capture the
device and associated clinical consequences, then both concepts
should be captured by selecting the appropriate term(s) for the
device and clinical consequence.

Example: If "ventricular tachycardia due to malfunction of device"
is reported, "Device malfunction" and "Ventricular tachycardia"
can be selected.

3.19 Drug interactions
This term includes drug/drug 4 , drug/food, drug/device, and drug/alcohol
interactions. With respect to interactions, MedDRA does not include
specific product names.

3.19.1 When the reporter specifically states that an interaction occurred, an
appropriate interaction term should be selected in addition to term(s)
for any medical event(s) described.

Example: If “torsade de pointes with suspected drug interaction” is
reported, “Torsade de pointes” and “Drug interaction” can be
selected.

Example: If “patient drank grapefruit juice which interacted with
lipid lowering drug causing muscle pain” is reported, “Food
interaction” and “Muscle pain” can be selected.

3.19.2 If two products are used together and the reporter does not
specifically state there is an interaction but does report a medical
event, only an event term should be selected.

4
In this document, the term “drug” includes biological products

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Example: If “patient was started on an anti-seizure medication and a
heart medication and developed syncope” is reported, “Syncope”
can be selected.

Example: If “patient was already on an anti-seizure medication and
was started on a heart medication and anti-seizure medication levels
increased” is reported, “Anticonvulsant drug level increased” can be
selected.

Labeled drug interactions may constitute medication errors. (See Section 3.15.5)

3.20 No adverse effect
Some organizations might wish to use this term to maintain records for
administrative purposes, e.g., for pregnancy registries, overdoses, and
medication errors.

The term “No adverse effect” could be used when it is specifically reported
that no ADR/AE occurred, despite exposure to a product (See Section
3.15.4 and 3.17.3).

Terms describing normal states and outcomes exist in MedDRA, such as
“Normal baby”, “Normal electrocardiogram”, and “Sinus rhythm”, which
can be used as needed.

3.21 Unexpected therapeutic effect
Some organizations might wish to use the term “Unexpected therapeutic
effect” although such effects are not usually considered ADR/AEs. Reports
occasionally describe a beneficial effect of a drug aside from the use for
which it had been given.

Example: If “a bald patient was pleased that he grew hair while using a
product” is reported, the term “Hair growth increased” can be selected. In
addition, “Unexpected therapeutic effect” can be selected.

3.22 Modification of effect
Modifications of effect are not always considered ADR/AEs; however, it is
important to capture this information, and in certain situations, lack of
effect is a reportable event. MedDRA contains many terms that describe
modifications of effect. The closest term(s) available to capture the reported
medical concept(s) should be selected, unless this information is captured
by other means.

3.22.1 It is considered appropriate to use lack of effect terms when the
reporter specifically states that the drug was ineffective (or did not
work, or similar wording) or that the expected effect was not obtained.
The preferred option is to select only the lack of efficacy term, even if
the consequences are reported.

27

Example: If “patient took drug and her headache didn’t go away,
drug ineffective” is reported, selecting only “Drug ineffective” is
preferred.

Example: If “antibiotic didn’t work” is reported, “Lack of drug
effect” can be selected.

3.22.2 Some organizations may also wish to select the event resulting from
the lack of effect. The term(s) describing the consequence(s) of lack
of effect may be selected for one or more database field(s), for
example, adverse event, medical history or drug indication).

Example: If “patient took drug, her headache didn’t go away, drug is
ineffective” is reported, “Drug ineffective” can be selected.
“Headache” can also be selected.

3.22.3 It is not considered appropriate to infer lack of effect.

Example: If “AIDS patient taking anti-HIV drug died” is reported,
“Lack of drug effect” should not be assumed. A term for death
should be selected, as described in Section 3.2 of this document.

3.22.4 Increased, Decreased, and Prolonged effects
It is considered appropriate to use this group of terms when the
reporter specifically identifies a modification of effect.

Example: If “patient had increased effect from drug A” is reported,
“Increased drug effect” can be selected.

Example: If “patient had decreased effect from drug A” is reported,
“Drug effect decreased” can be selected.

Example: If “patient had prolonged effect from drug A” is reported,
“Drug effect prolonged” can be selected.

3.23 Social circumstances
The terms in this SOC describe social factors and might be suitable for
social and medical history data term selection. Use of the SOC Social
circumstances is generally not considered appropriate for ADR/AEs.
However, some terms currently contained within this SOC are the only
option for capturing certain ADR/AEs.

Example: If “patient’s ability to drive was impaired” is reported,
“Impaired driving ability” can be selected.

The terms in SOC Social circumstances are not multi-axial in MedDRA.
This SOC contains terms that are similar to terms in the disorder SOCs;
however, terms in SOC Social circumstances generally refer to a person,
rather than a condition. Users should be aware of the impact that use of

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these terms will have on data retrieval, data analysis, and reporting. The
following example is illustrative:

SOC Social circumstances “Disorder” SOC
Alcoholic Alcoholism
Drug abuser Drug abuse
Tobacco user Nicotine dependence
Glue sniffer Glue sniffing

Note that abuse terms not associated with drugs/substances appear in SOC
Social circumstances regardless of whether they refer to the person or the
condition. The following example is illustrative.

SOC Social circumstances
LLT PT
Child abuse Child abuse
Child abuser Child abuse
Elder abuse Elder abuse
Elder abuser Elder abuse

3.23.1 Illegal acts and concepts of crime or abuse (excluding
drug/substance related abuse terms)

All illegal acts of crime or abuse (excluding drug and/or other
substance related abuse terms) link to the SOC Social circumstances.

Example: If “physical assault” is reported the selected term
“Physical assault” links to the SOC Social circumstances

3.23.1.1 Perpetrator
LLT terms representing the perpetrator are directly related to
the corresponding PT term describing the unlawful act/crime
committed

Example: If the reported patient history indicates that the
patient is a known sexual offender, “Sexual offender” can be
selected which links to the PT “Sexual abuse”.

(Note: The LLT “Sexual offender” links to the SOC Social
circumstances.)

3.23.1.2 Victim
PT terms representing the victims of unlawful acts are
preceded by “Victim of”. Associated unqualified terms
representing the victim are represented at the LLT level.

Example: If it was reported that the patient was a childhood
sexual assault victim, “Childhood sexual assault victim” can
be selected, which links to the PT “Victim of sexual abuse”.

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(Note: The LLT “Childhood sexual assault victim” links to the
SOC Social circumstances.)

3.24 Medical and/or social history
The examples below illustrate how MedDRA can be used to capture
medical and/or social history.

Example: If “history of gastrointestinal bleed and hysterectomy” is
reported, “Gastrointestinal bleed” and “Hysterectomy” can be selected.

Example: If “patient is a cigarette smoker with coronary artery disease”
is reported, “Cigarette smoker” and “Coronary artery disease” can be
selected.

3.25 Indication for product use
These principles can be applied to product indications collected either pre-
market or post-market. Specific regulatory requirements are not addressed
in this document.

Historically, indication data have not been collected in a complete or
consistent way, nor has a controlled terminology been widely used for the
entry of these data. Consideration should be given to the importance of
accurate data collection, the use of auto-encoders and the impact on data
retrieval.

Reported indications can include: medical conditions, prophylaxis of such
conditions, diagnostic tests, replacement therapies, procedures such as
anesthesia induction and terms such as “anti-hypertension”. Because of the
nature of such data, terms from almost any SOC, including SOC
Investigations, may be selected for an indication.

It might be unclear in the reporting of indication data whether a medical
condition or a desired outcome is being reported.

Example: If the indication reported is “weight loss”, “Weight loss” can be
selected, as it is unknown if the reporter is expressing that the drug was
taken to induce weight loss (overweight patient) or to treat weight loss
(underweight patient).

Example: If the indication reported is “immunosuppression”,
“Immunosuppression” can be selected, as it is unknown if the reporter is
expressing that the drug was taken to induce immunosuppression or to treat
the condition of immunosuppression.

3.25.1 Medical Conditions
3.25.1.1 Where the indication is a medical condition, a term that
expresses the medical condition should be selected.

Example: If the reported indication is “hypertension”,
“Hypertension” can be selected.

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Example: If the reported indication is “anti-hypertensive”,
“Hypertension” can be selected.

Example: If the reported indication is “chemotherapy for
breast cancer”, “Breast cancer” can be selected.

Example: If “medication for gastrointestinal problem” is
reported as an indication, “Gastrointestinal disorder” can be
selected.

3.25.1.2 If the only information reported is a type of therapy, then the
most specific term available should be selected.

Example: If a reporter states only that “a patient had received
chemotherapy”, “Chemotherapy” can be selected.

3.25.2 Prevention and Prophylaxis
3.25.2.1 When the concept of prevention or prophylaxis is expressed,
the specific MedDRA term should be selected, provided that it
exists. The terms prevention and prophylaxis can be used
interchangeably.

Example: If “arrhythmia prophylaxis” is reported,
“Arrhythmia prophylaxis” can be selected.

Example: If “prevention of migraine” is reported, “Migraine
prophylaxis” can be selected.

3.25.2.2 In the absence of a specific prophylaxis term, the following
options are considered appropriate:

The preferred option is to select the closest terms for both
concepts.

Example: If “prevention of hepatotoxicity” is reported, it is
preferable to select both “Prevention” and “Hepatotoxicity”.

Or a term for the condition can be selected.

Example: If “prevention of hepatotoxicity” is reported,
“Hepatotoxicity” can be selected.

Or the closest prophylaxis or prevention term can be selected.

Example: If “prevention of hepatotoxicity” is reported,
“Prevention” can be selected.

3.25.3 Diagnostic Testing

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If the product is being used to perform a diagnostic test, a term for
the test should be selected.

Example: If “contrast agent for angiogram” is reported,
“Angiogram” can be selected.

Example: If “contrast agent for coronary angiogram” is reported,
“Coronary angiogram” can be selected.

3.25.4 Procedures
If the product is being used to perform a procedure, a term for the
procedure should be selected.

Example: If “induction of anesthesia” is reported, “Induction of
anesthesia” can be selected.

3.25.5 Supplementation and Replacement Therapies
Supplement and replacement therapies can be found in SOC
Surgical and medical procedures. (See Section 3.13)

If the product indication specifies or describes supplementation or
replacement, the closest term should be selected.

Example: If “testosterone replacement therapy” is reported,
“Androgen replacement therapy” can be selected.

Example: If “thyroid replacement therapy” is reported, “Thyroid
hormone replacement therapy” can be selected.

Example: If “prenatal vitamin” is reported, “Vitamin
supplementation” can be selected.

3.25.6 Indication not reported
If the indication is not known and no clarification is available, then
the term “Drug use for unknown indication” can be selected.

Example: If “aspirin was taken for an unknown indication” is
reported, “Drug use for unknown indication” can be selected.

3.26 Off label use

Use of a product for an indication for which it is not labeled is
referred to as “off label use.”

3.26.1 Indications for use

If a medical condition is reported as an indication and “off label
use” is also reported, the condition can be selected for the indication
field. “Off label use” should only be selected if that is the only

32

information available. Alternatively, both the indication and “Off
label use” can be selected.

Example: If the reported indication is “hypertension and this is an
off label use”, “Hypertension” can be selected, or “Hypertension”
and “Off label use” can be selected.

Example: If the reported indication is “off label use”, “Off label
use” can be selected.

3.26.2 ADR/AEs

If ADR/AEs are a consequence of use of a product for an indication
for which it is not labeled, terms for the ADR/AEs should be
selected. Alternatively, terms for both the ADR/AEs and “Off label
use” can be selected.

Example: If “a patient was administered a drug off label for
pulmonary hypertension and the patient suffered a stroke,”
“Stroke” can be selected. Alternatively, both “Stroke” and “Off
label use” can be selected.

33

4 Appendices:
4.1 Current members of the ICH Points to Consider working group:

Co-Rapporteurs:
John (Jake) Kelsey
Christina Winter

Japan:
Ministry of Health, Labour and Welfare:
Wakako Horiki
Yoshihiko Sano
Japan Pharmaceutical Manufacturers Association
Yo Tanaka
Japanese Maintenance Organization
Reiji Tezuka
Yasuo Sakurai
Osamu Handa

European Union:
Commission of the European Communities
Morell David
Carmen Kreft-Jais
European Federation of Pharmaceutical Industries Associations
Hilary Vass
Christina Winter

Canada:
Health Canada
Alison Langevin
Michelle Séguin

United States:
US Food and Drug Administration
John (Jake) Kelsey
Toni Piazza-Hepp
Pharmaceutical Research and Manufacturers of America
Susan M. Lorenski
JoAnn Medbery
MedDRA MSSO
Patricia Mozzicato

34

4.2 Past members/affiliations of the ICH Points to Consider working group:

Japan:
Ministry of Health, Labour and Welfare
Tamaki Fushimi
Kazuhiro Kemmotsu
Tatsuo Kishi
Chie Kojima
Emiko Kondo
Kemji Kuramochi
Tetsuya Kusakabe
Kaori Nomura
Kenichi Tamiya
Takashi Yasukawa
Manabu Yamamoto
Nobuhiro Yamamoto
Japan Pharmaceutical Manufacturers Association
Takayoshi Ichikawa
Akemi Ishikawa
Satoru Mori
Yasuo Sakurai
Kunikazu Yokoi
Japanese Maintenance Organization
Yuki Tada
Akemi Ishikawa

Canada:
Health Canada
Lynn Macdonald
Heather Morrison
Heather Sutcliffe
Bill Wilson

European Union:
Commission of the European Communities
Dolores Montero
European Federation of Pharmaceutical Industries Associations
Barry Hammond – past Rapporteur
Reinhard Fescharek – past Rapporteur

United States:
US Food and Drug Administration
Miles Braun
Brad Leissa
Andrea Feight
Pharmaceutical Research and Manufacturers of America
David Goldsmith
Sidney Kahn
Margaret M. Westland – past Rapporteur

35

MedDRA MSSO:
JoAnn Medbery

36

Guide For Med Ra Users V12.1

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