Naranjo Algorithm

The total score calculated from this table defines the category as:

Possibly (total score 1-4)

Probably (Total Score 5-8)
Definitely (total score>9)

S.No Question Yes No Dont Score

Know obtained
1 Are there previous conclusive reports on this reaction? +1 0 0

2 Did the adverse event appear after the suspected drug +2 -1 0

was administered?
3 Did the adverse reaction improve when the drug was +1 0 0
discontinued or a specific antagonist was administered?
4 Did the adverse reaction reappear when the drug was re- +2 -1 0
administered?
5 Are there alternative causes (other than the drug) that -1 +2 0
could solely have caused the reaction?
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 a +1 0 0

concentration known to be toxic?
8 Was the reaction more severe when the dose was +1 0 0
increased or less severe when the dose was decreased?
9 Did the patient have a similar reaction to the same or +1 0 0
similar drugs on previous exposure?
10 Was the adverse event confirmed by objective evidence? +1 0 0

Total score: _______________________

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 Modified Hartwig and Siegel ADR severity assessment scale

Mild

Level 1: The ADR requires no change in treatment with the suspected drug.
OR
Level 2: The ADR requires that the suspected drug be withheld, discontinued, or otherwise
changed. No antidote or other treatment is required, and there is no increase in length of stay.

Moderate
Level 3: The ADR requires that the suspected drug be withheld, disco otherwise changed, and/or
on antidote or other treatment is required. There is no increase in length of stay.
OR
Level 4 (a): Any level 3 ADR that increases length of stay by at least one day.
OR
Level 4 (b): The ADR is the reason for admission.

Severe

Level 5: Any ADR that requires intensive medical care.

OR
Level 6: The ADR causes permanent harm to the patient.
OR
Level 7: The ADR either directly or indirectly leads to the death of the patient.

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 Predictability and Preventability assessment

The predictability and preventability helps in developing further guidelines to prevent and predict
an ADR.

A. Predictability assessment:

Criteria for determining predictability of an ADR

Patients who have had the drug on previous occasion (s)

If the drug was previously well tolerated at the same dose and route of administration, the
ADR is not predictable.

If there was a history of allergy or previous reactions to the drug, the ADR is predictable.

Patients who have never had the drug previously

Incidence of the ADR reported in Product Information or other literature determines its
predictability.

Incidence Rate Incidence Description Predictability

>1/10 Very common Predictable
> 1/100 and <1/10 Common Predictable
> 1/1000 and <1/100 Uncommon Not predictable
> 1/10,000 and <1/1000 Rare Not predictable
< 1/10,000 Very rare Not predictable

B. Preventability assessment

Modified Shumock and Thornton scale

Section A
Answering yes to one or more of the following implies that an ADR is definitely
preventable.

1. Was there a history of allergy or previous reactions to the drug?

2. Was the drug involved inappropriate for the patients clinical condition?
3. Was the dose, route, or frequency of administration inappropriate for the patients age?
4. Was a toxic serum drug concentration or laboratory monitoring test) documented?

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 5. Was there a known treatment for the adverse drug reaction?

If answers are all negative to the above, then proceed to section B.

Section B

Answering yes to one or more of the following implies that an ADR is PROBABLY
preventable
1. Was required therapeutic drug monitoring or other necessary laboratory tests not performed?
2. Was a drug interaction involved in the ADR?
3. Was poor compliance involved in the ADR?
4. Were preventative measures not prescribed or administered to the patient?
If answers are all negative to the above, then proceed to section B.

Section C

Answering yes to one or more of the following implies that an ADR is not preventable.

Not preventable