Table 2.

New adverse drug reactions algorithm for infants in neonatal intensive care units (similar to Table 3 of Du et al. 47)

Adverse drug reactions, assessment criteria	Yes	No	Not applicable/unknown
(1) Was the timing of AE consistent with an ADR to the suspected drug?	6	−7	0
(2) Is the AE a well-documented ADR to the suspected drug?	0	−6	0
(3) Are there published resports on this AE that are related to the suspected drug in newborns?	4	−4	0
(4) Was the AE likely to be a change (excerbation, recurence, complication or new manifestation) in a pre-existing clinical condition?	−3	7	0
(5) Are there any alternative aetiological candidates other than the pre-existing condition (e.g. concomitant drugs) that are a common cause of the AE?	−3	2	0
(6) Was an alternative aetiological candidate confirmed by any objective evidence?	−3	3	0
(7) Did the AE improve after the suspected drug was discontinued?	4	−1	0
(8) Was the AE less severe when the dose was reduced?	4	−2	0
(9) Did the AE improve after a specific antagonist was administered?	3	−1	0
(10) Did the AE significantly diminish or disappear while the patient was still taking the suspected drug?	−2	1	0
(11) Did the AE reappear/worsen when the suspected drug was reintroduced?	9	−1	0
(12) Was the suspected drug detected in blood or other fluids in concentrations known to be toxic?	4	−2	0
(13) Is there unequivocal evidence that the amount of the suspected drug received was an overdose for this patient?	4	−4	0
If total score ≥14 → definite
If 7 ≤ total score ≤ 13 → probable
If 3 ≤ total score ≤ 6 → possible	Tocal score = _______
If total score ≤2 → unlikely	Category = ___________

Abbreviations are as follows: ADR, adverse drug reaction; AE, adverse event.