ICHEndorsed Guide for MedDRA Users.docx
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ICHEndorsedGuideforMedDRAUsers
SummaryofChangesto
MedDRA®TERMSELECTION:
POINTSTOCONSIDER
ICH-EndorsedGuideforMedDRAUsers
Release4.9
BasedonMedDRAVersion18.0
1March2015
Thefollowingisalistingofchangesmadebetweenreleases4.8and4.9oftheMedDRATermSelection:
PointstoConsiderdocument:
Throughoutdocument
1）Correctionofgeneralspelling,punctuation,spacing,andformaterrors
2）ReplacementofreferencestoMedDRAVersion17.1toVersion18.0
3）UpdateofexamplesbasedonMedDRAversionchanges
2.4–AlwaysSelectaLowestLevelTerm
TheExampletable:
Example
Reported
LLTSelected
Lipsore
Lipsore（PTLippain）
Lipsores
Soreslip（PTCheilitis）
Soregums
Soregums（PTGingivalpain）
Soresgum
Soresgum（PTGingivalinflammation）
Waschangedasfollows（notethechangeofPTGingivalinflammationtoPTNoninfectivegingivitis,relatedtoMedDRAversionchanges）:
Example
Reported
LLTSelected
Lipsore
Lipsore（PTLippain）
Lipsores
Soreslip（PTCheilitis）
Soregums
Soregums（PTGingivalpain）
Soresgum
Soresgum（PTNoninfectivegingivitis）
3.3.2Ifself-injuryisreported
TheExampletable:
Example
Reported
LLTSelected
Comment
Selfslashing
Selfinflictedlaceration
LLTSelfinflictedlacerationislinkedtoPTIntentional
self-injury
Cutherownwrists
Cutwristsinasuicideattempt
Suicideattempt
Inaddition,LLTSelfinflictedlacerationcanbeselected
Tookanoverdoseinanattempttocommitsuicide
Intentionaloverdose
Suicideattempt
Ifoverdoseisreportedinthecontextofsuicideorasuicideattempt,themorespecificLLTIntentionaloverdosecanbeselected（seealsoSection3.18）
Waschangedasfollows（notethatSelfinflictedlacerationhasbeenmovedfromtheCommentcolumntotheLLTSelectedcolumnforthesecondexample）:
Example
Reported
LLTSelected
Comment
Selfslashing
Selfinflictedlaceration
LLTSelfinflictedlacerationislinkedtoPTIntentional
self-injury
Cutherownwrists
Cutwristsinasuicideattempt
Selfinflictedlaceration
Suicideattempt
.
Tookanoverdoseinanattempttocommitsuicide
Intentionaloverdose
Suicideattempt
Ifoverdoseisreportedinthecontextofsuicideorasuicideattempt,themorespecificLLTIntentionaloverdosecanbeselected（seealsoSection3.18）
3.10.1Eventsinthemother
Therewereseveralchangesmadetothissectionofthedocumenttoprovideexamplesoftermselectionandtoidentifyapreferredoptionforexposureswithoutclinicalconsequences.
Thewordingandexamplesinthissectionwerereplacedwiththefollowing:
3.10.1Eventsinthemother
3.10.1.1.Pregnantpatientexposedtomedicationwithclinicalconsequences
Ifapregnancyexposureisreportedwithclinicalconsequences,selecttermsforboththepregnancyexposureandtheclinicalconsequences.
Example
Reported
LLTSelected
PregnantpatientreceivingdrugXexperiencedapruriticrash
Maternalexposureduringpregnancy
Pruriticrash
3.10.1.2Pregnantpatientexposedtomedicationwithoutclinicalconsequences
Ifapregnancyexposurereportspecificallystatesthattherewerenoclinicalconsequences,thepreferredoptionistoselectonlyatermforthepregnancyexposure.Alternatively,atermforthepregnancyexposureandtheadditionalLLTNoadverseeffectcanbeselected（seeSection3.21）.
Example
Reported
LLTSelected
PreferredOption
PatientreceiveddrugXwhilepregnant（noadverseeffect）
Maternalexposureduringpregnancy
Maternalexposureduringpregnancy
Noadverseeffect
3.15–MedicationErrors,AccidentalExposuresandOccupationalExposures
Therewereseveralchangesmadetothissectionofthedocumenttoprovideexamplesoftermselectionandtoidentifyapreferredoptionformedicationerrorsandpotentialmedicationerrorswithoutclinicalconsequences.
First,thesectionname:
3.15–MedicationErrors/AdministrationErrors,AccidentalExposuresandOccupationalExposures
Waschangedasfollows:
3.15–MedicationErrors,AccidentalExposuresandOccupationalExposures
Second,thesectionname:
3.15.1Medication/administrationerrors
Waschangedasfollows:
3.15.1Medicationerrors
3.15.1.1Medicationerrorsreportedwithclinicalconsequences
TheExampletable:
Example
Reported
LLTSelected
Comment
Patientwasadministeredwrongdrugandexperiencedhypotension
Wrongdrugadministered
Hypotension
Becauseofsimilarsoundingdrugnames,thepatienttookthewrongdrugandexperiencedarash
Drugnameconfusion
Wrongdrugadministered
Rash
Insulinwasgivenusingthewrongsyringeresultingintheadministrationofanoverdose.Thepatientdevelopedhypoglycaemia.
Wrongdeviceused
Accidentaloverdose
Hypoglycaemia
Ifanoverdoseisreportedinthecontextofamedicationerror,themorespecifictermLLTAccidentaloverdosecanbeselected（seealsoSection3.18）
Waschangedasfollows（notethechangesandtheadditionofacommenttothesecondexample）:
Example
Reported
LLTSelected
Comment
Patientwasadministeredwrongdrugandexperiencedhypotension
Wrongdrugadministered
Hypotension
Becauseofsimilarsoundingdrugnames,thewrongdrugwasdispensed;asaresult,thepatienttookthewrongdrugandexperiencedarash
Drugnameconfusion
Wrongdrugdispensed
Wrongdrugadministered
Rash
Itisimportanttoselecttermsforallmedicationerrorconcepts,i.e.,donotsubtractinformation
Insulinwasgivenusingthewrongsyringeresultingintheadministrationofanoverdose.Thepatientdevelopedhypoglycaemia.
Wrongdeviceused
Accidentaloverdose
Hypoglycaemia
Ifanoverdoseisreportedinthecontextofamedicationerror,themorespecifictermLLTAccidentaloverdosecanbeselected（seealsoSection3.18）
3.15.1.2Medicationerrorsandpotentialmedicationerrorsreportedwithoutclinicalconsequences
ThewordingandExampletablesinthissection:
MedicationerrorswithoutclinicalconsequencesarenotARs/AEs.However,itisimportanttorecordtheoccurrenceorpotentialoccurrenceofamedicationerror.Selectatermthatisclosesttothedescriptionofmedicationerrorreported.
Also,ifspecificallyreportedthatnoadverseeffecthasoccurred,itisacceptabletoselectLLTNoadverseeffect.
Ininstanceswherethemedicationdidnotreachthepatient,itisacceptabletoselectLLTDrugnottakenincontextofinterceptedmedicationerror.
Example
Reported
LLTSelected
Comment
Medicationwasgivenintravenouslyinsteadofintramuscularly
Intramuscularformulationadministeredby
otherroute
Medicationwasgivenintravenouslyinsteadofintramuscularly
withoutsequelae
Intramuscularformulationadministeredby
otherroute
Noadverseeffect
SeeSection3.21
Thepharmacistselectedthewrongdrugstrengthbuttheerrorwasdetectedpriortodispensingtothepatient
Interceptedwrongdrugstrengthselected
LLTInterceptedwrongdrugstrengthselectedlinkstoPTIntercepteddrugdispensingerror
Pharmacistnoticesthatthenamesoftwodrugsaresimilarandisconcernedthatthismayresultinamedicationerror
Drugnameconfusion
Circumstanceorinformationcapableofleadingtomedicationerror
Note:
thisexampleisapotentialmedicationerrorandLLTDrugnameconfusionprovidesadditionalinformationaboutthenatureofthepotentialmedicationerror
Druginadvertentlyadministered.Theerrorwasnoticedsoonafterwards.
Drugadministrationerror
Werechangedasfollows（notethatapreferredoption–toselectonlyatermforthemedicationerror–isnowidentifiedandexamplesofinterceptedmedicationerrorshavebeendeleted）:
MedicationerrorswithoutclinicalconsequencesarenotARs/AEs.However,itisimportanttorecordtheoccurrenceorpotentialoccurrenceofamedicationerror.Selectatermthatisclosesttothedescriptionofmedicationerrorreported.
Ifamedicationerrorreportspecificallystatesthattherewerenoclinicalconsequences,thepreferredoptionistoselectonlyatermforthemedicationerror.Alternatively,atermforthemedicationerrorandtheadditionalLLTNoadverseeffectcanbeselected（seeSection3.21）.
Example
Reported
LLTSelected
PreferredOption
Medicationwasgivenintravenouslyinsteadofintramuscularlywithoutsequelae
Intramuscularformulationadministeredby
otherroute
Intramuscularformulationadministeredby
otherroute
Noadverseeffect
Example
Reported
LLTSelected
Comment
Pharmacistnoticesthatthenamesoftwodrugsaresimilarandisconcernedthatthismayresultinamedicationerror
Drugnameconfusion
Circumstanceorinformationcapableofleadingtomedicationerror
Note:
thisexampleisapotentialmedicationerrorandLLTDrugnameconfusionprovidesadditionalinformationaboutthenatureofthepotentialmedicationerror
Druginadvertentlyadministered.Theerrorwasnoticedsoonafterwards.
Drugadministrationerror
3.15.1.3Medicationmonitoringerrors
Theconceptdescriptionformedicationmonitoringerror:
ForthepurposesoftermselectionandanalysisofMedDRA-codeddata,amedicationmonitoringerrorisanerrorthatoccursintheprocessofmonitoringtheeffectofthemedicationthroughclinicalassessmentand/orlaboratorydata.Itcanalsorefertoerrorsinfollowinginstructionsorinformationpertinenttothesafeuseofthemedication.
Waschangedasfollows（notetheadditionoftheword“monitoring”inthesecondsentence.ThisconceptdescriptionhasalsobeenupdatedintheMedDRAIntroductoryGuideandtheWeb-BasedBrowser）:
ForthepurposesoftermselectionandanalysisofMedDRA-codeddata,amedicationmonitoringerrorisanerrorthatoccursinth
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