The document discusses the assessment of adverse drug reactions (ADRs), focusing on definitions, severity, seriousness, and preventability. It includes various classification systems such as Karch and Lasagna for severity and the Naranjo algorithm for determining ADR probability. Additionally, it emphasizes the significant percentage of preventable ADRs and references key literature on the topic.

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