A Model for Monitoring Spontaneously Reported Medication Errors Using the Adjuvanted Recombinant Zoster Vaccine as an Example

Table 2

Example of table with reported medication errors by MedDRA® HLT and PT for the category medication without harm.

MedDRA® HLT	MedDRA® PT	Period^a	Total^b
Accidental exposure to product	Accidental exposure to product	20	201
Complications associated with device NEC	Injury associated with device	1	9
Device physical property and chemical issues	Needle issue	0	13
	Syringe issue	0	27
Medication errors, product use errors and issues NEC	Circumstance or information capable of leading to medication error	2	2
	Medication error	0	2
	Product use in unapproved indication	0	1
	Product use issue	0	1
	Vaccination error	0	296
	Wrong technique in device usage process	0	3
	Wrong technique in product usage process	8	43
Occupational exposures	Occupational exposure to product	11	40
Overdoses NEC	Overdose	2	15
Pathways and sources of exposure	Exposure via eye contact	4	35
	Exposure via skin contact	31	215
Product administration errors and issues	Accidental overdose	0	9
	Accidental underdose	54	308
	Contraindicated product administered	1	1
	Expired product administered	18	21
	Extra dose administered	83	338
	Inappropriate schedule of product administration	376	2016
	Incomplete course of vaccination	1290	4025
	Incorrect dose administered	199	1951
	Incorrect route of product administration	49	675
	Product administered at inappropriate site	8	49
	Product administered to patient of inappropriate age	41	218
	Product administration error	5	17
	Wrong product administered	10	68
Product confusion errors and issues	Product label confusion	0	4
	Product name confusion	0	1
	Product packaging confusion	0	4
Product dispensing errors and issues	Product dispensing error	2	14
Product label issues	Product label issue	1	2
Product monitoring errors and issues	Labelled drug-disease interaction medication error	1	1
Product packaging issues	Product packaging issue	0	6
Product preparation errors and issues	Product preparation error	37	737
	Product preparation issue	161	1283
Product prescribing errors and issues	Contraindicated product prescribed	1	1
	Product prescribing error	18	76
Product storage errors and issues in the product use system	Product storage error	65	680
Therapeutic procedures NEC	Interchange of vaccine products	0	1
Underdoses NEC	Underdose	5	39
Grand total^c		2189	10504

HLT, high-level term; MedDRA®, medical dictionary for regulatory activities; NEC, not elsewhere classified; PT, preferred term. ^aData for a chosen period. ^bData from entry of the first case in the database until date of database freezing. ^cTotal number of distinct cases; may not correspond to the sum per event reported in the table as different MedDRA® PTs may be reported in the same case.