Table 6.

Characteristics of the 43 “drug ineffective” reports determined to be “useful”^a

Recorded information	Observation	N	%
The suspect product of “drug ineffective” was specified from narrative field	Yes	43	100.0
	No	0	0.0
Suspect product’s type from narrative field	Brand	19	44.2
	Generic	22	51.2
	Unknown	2	4.7
Most frequently identified products (top 3)	Fentanyl	4	9.3
	Alprazolam	3	7.0
	Adalimumab	2	4.7
Medication switching was reported	Yes	19	44.2
	No	24	55.8
A beneficial response to the product’s active ingredient prior to suspect product exposure	Yes	20	46.5
	No	8	18.6
	Not reported/unknown	15	34.9
Suspect product was continued	Yes	9	20.9
	No	16	37.2
	Not reported/unknown	18	41.9
Suspect product’s batch or lot number was reported	Yes	17	39.5
	No	26	60.5
Product application type	NDA	13	30.2
	BLA	3	7.0
	ANDA	16	37.2
	Missing	11	25.6
PT(s) other than DI reported	Yes	36	83.7
	No	7	16.3
Concurrently reported PTs (top 3)	Product quality issue	10	23.3
	Product substitution issue	8	18.6
	Feeling abnormal	5	11.6

ANDA abbreviated new drug application, BLA biologics license application, DI drug ineffective, NDA new drug application, PTs preferred terms

^aA “useful” report meets criterion 1 and 2 plus one or more of the other four criteria listed in Table 1