Advances in Pharmacological and Pharmaceutical Sciences

Research Article

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

Table 1

General principles of the algorithm used to categorize medication errors for a dose of product X (MedDRA® version 23.1).


Category	Algorithm

Potential errors	If one of the reported MedDRA® PTs is “Circumstance or information capable of leading to medication error,” the case is categorized as potential error for the dose of product X
Intercepted medication errors	If one of the reported MedDRA® PTs contains the word “intercepted” and the MedDRA® PT “Circumstance or information capable of leading to medication error” was not reported after a dose of product X, the case is categorized as intercepted medication error for the dose of product X
Medication errors without harm	If there is no potential error or intercepted medication error and all MedDRA® PTs reported belong to the SMQ “medication error,” the case is categorized as medication error without harm for the dose of product X
Medication errors with harm	If there is no potential error or intercepted medication error, at least one valid event belonging to the SMQ “medication error” and at least one event not belonging to the SMQ “medication error,” the case is categorized as medication error with harm for the dose of product X
Medication errors with harm	The following MedDRA® PTs are not considered valid events to be used for the definition of medication error with harm: the MedDRA® PTs belonging to the primary SOC “product issues,” the HLGT “off-label uses and intentional product misuses/uses issues,” the HLTs “adverse effect absent,” “exposure associated with pregnancy, delivery and lactation,” “normal newborn status” and “normal pregnancy, labor and delivery” or the PT “breastfeeding”
Conflicting category	For a dose of product X, if one of the reported MedDRA® PTs contains the word “intercepted” and the PT “circumstance or information capable of leading to medication error,” the case is categorized under conflicting category and should be corrected

HLGT, high-level group term; HLT, high-level term; MedDRA®, medical dictionary for regulatory activities; PT, preferred term; SMQ, standardized MedDRA® query; SOC, system organ class.