SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S Definitions, Severity assessment, Seriousness assessment Naranjo algorithm, Preventability assessment By Ms. B. Mary Vishali Department of Pharmacology

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
SEVERITY AND SERIOUSNESS
ASSESSMENT OF ADR’S
A Seminar as a part of curricular requirement
for I year M. Pharm II semester
Presented by
Ms. B. Mary Vishali
(Reg. No. 20L81S0104)
Department of Pharmacology
Under the guidance/Mentorship of
Dr. Pradeep Kumar., PhD
Assistant Professor
Department of Pharmacology.

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
• Definitions
• Severity assessment
• Seriousness assessment
• Naranjo algorithm
• Preventability assessment
• References
CONTENTS:

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
• Adverse Drug Reaction: According to WHO Adverse drug reaction is
defined as ”A response to a drug which is noxious and unintended,
and which occurs at doses normally used in man for the prophylaxis,
diagnosis, or therapy of disease, or for the modifications of
physiological function.”
• Adverse Event: Adverse event is defined as ” Any medical
occurrence temporally associated with the use of a medicinal product,
but not necessarily causally related.”
• Severity: It describes the extent to which the ADRs influence the
everyday life of a patients.
• Seriousness: It is 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.
DEFINITIONS:

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
1.Karch and Lasagna classify severity into minor, moderate, severe and
lethal.
• Mild(Minor)
• Moderate
• Severe
• lethal
2.Hartwig et al categorized ADRs into seven levels as per their
severity.
• Level 1 & 2 fall under mild category, level 3 & 4 under moderate and
level 5, 6 & 7 fall under severe category.
Severity Assessment:

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
• Seriousness of reaction is categorized according to FDA criteria on
the basis of their life threatening nature.
• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability or Permanent Damage
• Congenital Anomaly/Birth Defect
• Required Intervention to Prevent Permanent Impairment or Damage
(Devices)
• Naranjo Algorithm: It is used to determine adverse drug reaction
probability.
Seriousness Assessment:

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
Questions: Yes No Don’t
know
Score
1. Are there previous conclusive reports on
this reaction?
+1 0 0
2. Did the adverse event appear after the
suspected drug was administered?
+2 -1 0
3. Did the adverse reaction improve when
the drug was discontinued or a specific
antagonist was administered?
+1 0 0
4. Did the adverse reaction reappear when
the drug was re-administered
+2 -1 0
NARANJO ALGORITHM:

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9
5. Are there alternative causes(other than the
drug)that could on their own have caused the
reaction?
-1 +2 0
6. Did the reaction reappear when a placebo
was given?
-1 +1 0
7. Was the drug detected in the blood(or other
fluids)in concentrations known to be toxic?
+1 0 0
8. Was the reaction more severe when the
dose was increased or less severe when the
dose was decreased?
+1 0 0
9. Did the patient have a similar reaction to the
same or similar drugs in any previous
exposure?
+1 0 0
10. Was the adverse event confirmed by any
objective evidence?
+1 0 0

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
• According to WHO factsheet, it is estimated that at least 60% of
ADRs are preventable. In some countries ADR-related costs, such as
hospitalization, surgery and lost productivity, exceed the cost of the
medications.
• Historically, studies have shown that between 20% and 80% of ADEs
and ADRs are preventable with the majority of latter studies showing
around 60- 70% preventability.
• Preventability of ADRs is assessed by using Schumock and Thornton
scale.
Preventability Assessment:

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
1. Parthasarathy G, Hansen k Nyfort, Nahata CM; A textbook of
Clinical Pharmacy Practice; pp 89-97
2. Schumock GT and Thornton JP. Focusing on the Preventability of
Adverse Drug Reactions. Hosp. Pharm. 1992;27:538.
3. Uppsala Monitoring Centre. Hospital based pharmacovigilance: a
clinical pharmacist’s perspective. Uppsala reports. 2002;20:10–11.
REFERENCES :

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13