ICHEndorsed Guide for MedDRA UsersWord格式.docx
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ICHEndorsed Guide for MedDRA UsersWord格式.docx
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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):
Soresgum(PTNoninfectivegingivitis)
3.3.2Ifself-injuryisreported
Comment
Selfslashing
Selfinflictedlaceration
LLTSelfinflictedlacerationislinkedtoPTIntentional
self-injury
Cutherownwrists
Cutwristsinasuicideattempt
Suicideattempt
Inaddition,LLTSelfinflictedlacerationcanbeselected
Tookanoverdoseinanattempttocommitsuicide
Intentionaloverdose
Ifoverdoseisreportedinthecontextofsuicideorasuicideattempt,themorespecificLLTIntentionaloverdosecanbeselected(seealsoSection3.18)
Waschangedasfollows(notethatSelfinflictedlacerationhasbeenmovedfromtheCommentcolumntotheLLTSelectedcolumnforthesecondexample):
.
3.10.1Eventsinthemother
Therewereseveralchangesmadetothissectionofthedocumenttoprovideexamplesoftermselectionandtoidentifyapreferredoptionforexposureswithoutclinicalconsequences.
Thewordingandexamplesinthissectionwerereplacedwiththefollowing:
3.10.1.1.Pregnantpatientexposedtomedicationwithclinicalconsequences
Ifapregnancyexposureisreportedwithclinicalconsequences,selecttermsforboththepregnancyexposureandtheclinicalconsequences.
PregnantpatientreceivingdrugXexperiencedapruriticrash
Maternalexposureduringpregnancy
Pruriticrash
3.10.1.2Pregnantpatientexposedtomedicationwithoutclinicalconsequences
Ifapregnancyexposurereportspecificallystatesthattherewerenoclinicalconsequences,thepreferredoptionistoselectonlyatermforthepregnancyexposure.Alternatively,atermforthepregnancyexposureandtheadditionalLLTNoadverseeffectcanbeselected(seeSection3.21).
PreferredOption
PatientreceiveddrugXwhilepregnant(noadverseeffect)
Maternalexposureduringpregnancy
Noadverseeffect
3.15–MedicationErrors,AccidentalExposuresandOccupationalExposures
Therewereseveralchangesmadetothissectionofthedocumenttoprovideexamplesoftermselectionandtoidentifyapreferredoptionformedicationerrorsandpotentialmedicationerrorswithoutclinicalconsequences.
First,thesectionname:
3.15–MedicationErrors/AdministrationErrors,AccidentalExposuresandOccupationalExposures
Waschangedasfollows:
Second,thesectionname:
3.15.1Medication/administrationerrors
3.15.1Medicationerrors
3.15.1.1Medicationerrorsreportedwithclinicalconsequences
Patientwasadministeredwrongdrugandexperiencedhypotension
Wrongdrugadministered
Hypotension
Becauseofsimilarsoundingdrugnames,thepatienttookthewrongdrugandexperiencedarash
Drugnameconfusion
Rash
Insulinwasgivenusingthewrongsyringeresultingintheadministrationofanoverdose.Thepatientdevelopedhypoglycaemia.
Wrongdeviceused
Accidentaloverdose
Hypoglycaemia
Ifanoverdoseisreportedinthecontextofamedicationerror,themorespecifictermLLTAccidentaloverdosecanbeselected(seealsoSection3.18)
Waschangedasfollows(notethechangesandtheadditionofacommenttothesecondexample):
Becauseofsimilarsoundingdrugnames,thewrongdrugwasdispensed;
asaresult,thepatienttookthewrongdrugandexperiencedarash
Wrongdrugdispensed
Itisimportanttoselecttermsforallmedicationerrorconcepts,i.e.,donotsubtractinformation
3.15.1.2Medicationerrorsandpotentialmedicationerrorsreportedwithoutclinicalconsequences
ThewordingandExampletablesinthissection:
MedicationerrorswithoutclinicalconsequencesarenotARs/AEs.However,itisimportanttorecordtheoccurrenceorpotentialoccurrenceofamedicationerror.Selectatermthatisclosesttothedescriptionofmedicationerrorreported.
Also,ifspecificallyreportedthatnoadverseeffecthasoccurred,itisacceptabletoselectLLTNoadverseeffect.
Ininstanceswherethemedicationdidnotreachthepatient,itisacceptabletoselectLLTDrugnottakenincontextofinterceptedmedicationerror.
Medicationwasgivenintravenouslyinsteadofintramuscularly
Intramuscularformulationadministeredby
otherroute
Medicationwasgivenintravenouslyinsteadofintramuscularly
withoutsequelae
SeeSection3.21
Thepharmacistselectedthewrongdrugstrengthbuttheerrorwasdetectedpriortodispensingtothepatient
Interceptedwrongdrugstrengthselected
LLTInterceptedwrongdrugstrengthselectedlinkstoPTIntercepteddrugdispensingerror
Pharmacistnoticesthatthenamesoftwodrugsaresimilarandisconcernedthatthismayresultinamedicationerror
Circumstanceorinformationcapableofleadingtomedicationerror
Note:
thisexampleisapotentialmedicationerrorandLLTDrugnameconfusionprovidesadditionalinformationaboutthenatureofthepotentialmedicationerror
Druginadvertentlyadministered.Theerrorwasnoticedsoonafterwards.
Drugadministrationerror
Werechangedasfollows(notethatapreferredoption–toselectonlyatermforthemedicationerror–isnowidentifiedandexamplesofinterceptedmedicationerrorshavebeendeleted):
Ifamedicationerrorreportspecificallystatesthattherewerenoclinicalconsequences,thepreferredoptionistoselectonlyatermforthemedicationerror.Alternatively,atermforthemedicationerrorandtheadditionalLLTNoadverseeffectcanbeselected(seeSection3.21).
Medicationwasgivenintravenouslyinsteadofintramuscularlywithoutsequelae
3.15.1.3Medicationmonitoringerrors
Theconceptdescriptionformedicationmonitoringerror:
ForthepurposesoftermselectionandanalysisofMedDRA-codeddata,amedicationmonitoringerrorisanerrorthatoccursintheprocessofmonitoringtheeffectofthemedicationthroughclinicalassessmentand/orlaboratorydata.Itcanalsorefertoerrorsinfollowinginstructionsorinformationpertinenttothesafeuseofthemedication.
Waschangedasfollows(notetheadditionoftheword“monitoring”inthesecondsentence.ThisconceptdescriptionhasalsobeenupdatedintheMedDRAIntroductoryGuideandtheWeb-BasedBrowser):
ForthepurposesoftermselectionandanalysisofMedDRA-codeddata,amedicationmonitoringerrorisanerrorthatoccursinth
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