This document discusses the process of triaging adverse drug reaction (ADR) cases based on their seriousness and expectedness. It defines seriousness criteria such as death, life-threatening conditions, hospitalization, disability, and birth defects. It also discusses how to determine if a reported ADR is expected or unexpected based on a product's reference safety information. The key aspects of triaging covered are classifying ADR seriousness using FDA criteria, identifying verbatim or equivalent ADR terms in reference documents, considering other sections like warnings and precautions, and categorizing cases based on their combined seriousness and expectedness.

1. Triage of cases-with seriousness
and expectedness
Name – Sumit
Roll no. 2250981548

2. Triaging
Triage is the assessment, classification & prioritization of the
information received according to key regulatory, scientific
and medical criteria.
Triage
Seriousness
Relatedness
Expectedness

3. SERIOUSNESS ASSESSMENT
 Seriousness of an ADR is related to its life threatening
nature and is defined as any untoward reaction to the
medicinal product that may result in death and requires
patient hospitalization.
 Seriousness of reaction is categorized according to FDA
criteria on the basis of their life threatening nature.
1. Death.
2. Life-threatening.
3. Hospitalization (initial or prolonged).
4. Disability or Permanent Damage.
5. Congenital Anomaly/Birth Defect.
6. Medical Significant.

4. 1. Death
1. Death should be considered as seriousness criteria only if
it is reported by reporter.
2. The reporter must mention in the report that patient died
while on/after receiving treatment medication.
3. If reported event is completed suicide then it should be
categorised under death.
4. If reported event is suicide then follow up request to be
sent to confirm as attempted suicide or completed suicide.
For example: A patient experienced an ADR after the
administration of Drug A and died in an airplane accident.

5. 2. Life-threatening
1. Life-threatening refers to a reaction in which the patient
was at risk of death at the time of the reaction; It does not
refer to a reaction that hypothetically might have caused
death if more severe.
2. For example, if patient had cardiac arrest and taken to
hospital then seriousness willbe hospitalisation not life
threatening.
3. If patient was in coma or require ventilator support can be
considered as lifE threatening conditions.
4. Life threatening can be considered as seriousness if
reporter clearly mentions inreport that patient is in Life
threatening condition.

6. 3. Hospitalization:
 Hospitalisation considered as serious criteria if patient
administered to hospital (with minimum 24 hrs stay) or
caused prolongation of hospitalisation for any event.
 Example:
 Patient was admitted to emergency department due to
severe headache experienced after administration of Drug
A.
 Patient was admitted to emergency department due to
diabetic foot and was put on Drug A. On the day of
discharge, she experienced severe gastritis, vomiting and
abdominal pain. Patient was treated with Drug B ad
discharged after 2 days.

7. 4. Disability/incapacity:
 A substantial disruption of a person’s ability to conduct
normal life function.’’ (FDA definition)
 Applicable when and ADR resulted in alteration of function
or of quality of life for a particular duration •
 For example: –
 Headache lasting 24 hours
 Partial deafness in one ear

8. 5. Congenital anomaly/birth defect:
1. Congenital anomalies, also commonly referred to as birth
defects, congenital disorders, congenital malformations,
or congenital abnormalities, are conditions of prenatal
origin that are present at birth, potentially impacting an
infant's health, development and/or survival.
2. This seriousness criteria can be used only in pregnancy
reports where parent exposed to medication while mother
being pregnant and baby had birth defect
because of medication.

9. 6. Medically Important/Significant:
 Medical judgment shall be exercised to define the
seriousness of the case-based type of adverse event and
intervention required to treat the adverse event. •
 These cases will be considered as serious.
 Under EU Pharmacovigilance system, an important medical
event (IME) terms list is available based on the Medical
Dictionary for Regulatory Activities (MedDRA) Preferred
terms. The IME list is referred to define seriousness of case
based on Medically Important/Significant.
 In safety database, the IME list is integrated to assign the
seriousness automatically once the particular adverse event
is populated.

10. EXPECTEDNESS DETERMINATION
 Very important part of case processing to determine
expectedness of adverse event reported in the relevant
Reference safety information documents of the medicinal
product.
 A signs, symptoms or diagnosis reported in a case which
are present in the list (even as synonyms) of adverse
reactions in an RSI document will be classified as
‘‘Expected’’.
 A signs, symptoms or diagnosis reported in a case which
are different or present with different severity (mild,
moderate, severe) in adverse reactions list of RSI will be
classified as ‘‘Unexpected’’.

11.  RSI may be one or more of the following:
Investigator Brochure (IB)
Company’s core safety information (CCSI) within its
internal core data sheet, or
The official local data sheet (e.g., Package Insert in the
US, Summary of Product Characteristics (SPC) in the
EU).
 The terms Listed/Unlisted will be used for ADRs referred
in IB/CCSI
 The terms Labeled/Unlabeled will be used for ADRs
referred in PI/SmPC.
 The terms 'Listed/Labelled” are used during assessment for
the “Marketed products”.
 The term “Expectedness” is used during assessment for
“Developmental drugs or Investigational molecules.

12. POINTS TO CONSIDER:
 Medical judgments shall be made in regards to choice of
term and clinical evidence of the term to assess the
expectedness.
 If ‘‘verbatim’’ term of ADR reported is not present in the
RSI, synonym or medically equivalent term should be
identified and consider for expectedness.
 If ADR presented in the RSI in overdose section then same
ADR if reported with normal dose of the drug should be
considered as “Unexpected”.
 Expectedness should be determine for drug associated
medical experiences only like any adverse event happened
before the drug administrations should not be considered
for expectedness assessment.

13.  In addition to Adverse Event list of RSI document, other
sections clinical pharmacology, contraindications,
warnings, precautions should also be included for
expectedness assessment.
 Death Cases: In situations where ADR is associated with
death as outcome, the case should be considered
‘Unexpected’ until unless the RSI specify a fatal outcome
associated with ADR.
 TRIAGE Categories
Serious + Unexpected
Serious + Expected
Non-serious + Unexpected
Non-serious + Expected