A STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL OF PUNE

 

Naranjo’s algorithm scale for causality assessment of ADR:

 

Question

Yes

No

Don’t know

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 event reappear when the drug was re-administered?

+2

-1

0

5.

Are there alternative causes (other than drug) that could on their own have caused the reaction?

-1

+2

0

6.

Did the reaction re-appear when a placebo was given?

-1

+1

0

7.

Was the drug detected in blood (or other fluids) in concentration 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

Table-5


Naranjo’s Causality Assessment score.


My score (%)


Definite


>9


5 (11.11%)


Probable


5-8


23 (51.11%)


Possible


1-4


17 (37.77%)


Doubtful


0


0

Table-6


Hartwig’s severity assessment scale


Mild reactions which were self limiting and able to resolve over time without treatment and did not contribute to prolongation of length of stay.


 

Moderate ADR’s were defined as those that required therapeutic intervention and hospitalization prolonged by 1 day but resolved in <24hrs or change in drug therapy or specific treatment to prevent a further outcome


Severe ADR’s were those that were life threatening, producing disability and those that prolonged hospital stay or led to hospitalization, required intensive medical care or led to the death of the patient.

Table-7


My score


Mild


21(46.66%)


Moderate


20 (44.44%)


Severe


4 (8.88%)

Table-8

Outcome:



Recovered


38 (84.44%)


Continuing


3 (6.66%)


Recovering


4 (8.88%)


Unknown


0


Fatal


0

Table-9

Suspected drugs with ADR


Sr.No.


Suspected drug


No. of ADR


Description of an ADR


1

 


Vancomycin


5


Rash and itching (5)


2.


Ceftriazone


3


Urticaria

Rash and itching (2)


3.


Ranitidine


3


Palpitation

Rash and itching (2)


4.


Povidone Iodine


3


Severe burning in vagina

Rash and itching (1)

Vomiting


5.


Diclofenac


3


Rash and itching (1)

Breathlessness

Giddiness


6.


Ferric Carboxymaltose


2


Rash and itching (2)

 


7.


Piperacillin+Tazobactum


2


Rash and itching (2)

 


8.


Polymixin-B


2


Dizziness

Rash and itching (1)


9.


Amiodarone


2


Phlebitis

Rash and itching (1)


10.


Tramadol


2


Rash and itching (1)

Restlessness,


11.


Amphotericin B


1


Rash and itching (1)

 


12.


Cefotaxim


2


Urticaria

Rash and itching (1)


13.


Cefixime


1


Rash and itching (1)


14.


Orofer FCM

MVI

(Multivitamin)


2


Tingling sensation at injection site

Rash and itching (1)


15.


Colistimethate Sodium


1


Numbness over face and upper lips, breathing difficulty

 


16.


Ciprofloxacin


2


Rash and itching (1)

Swelling of lips

 


17.


Hydrocortisone


1


Rash and itching (1)


18.


Drotaverine


1


Rash and itching (1)

 


19.


Omeprazole


1


Reddish discoloration on injection site, rash and itching (1)

 


20.


Levofloxacin


2


Tachycardia, Tachypnoea(1)

Breathlessness (1)


21.


Antithymocyte immunoglobulins


1


Rash and itching (1)


22.


Terlipressin acetate


1


Skin necrosis


23


Ondansetron


2


Rash and itching (1)

Rash and no itching (1)

Table 10

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