ICHEndorsed Guide for MedDRA Users.docx

1、ICHEndorsed Guide for MedDRA UsersSummary of Changes toMedDRA TERM SELECTION: POINTS TO CONSIDERICH-Endorsed Guide for MedDRA UsersRelease 4.9Based on MedDRA Version 18.0 1 March 2015The following is a listing of changes made between releases4.8 and 4.9 of the MedDRA Term Selection: Points to Consid

2、erdocument:Throughout document1) Correction of general spelling, punctuation, spacing, and format errors2) Replacement of references to MedDRA Version 17.1 to Version 18.03) Update of examples based on MedDRA version changes2.4 Always Select a Lowest Level TermThe Example table:ExampleReportedLLT Se

3、lectedLip soreLip sore (PT Lip pain)Lip soresSores lip (PT Cheilitis)Sore gumsSore gums (PT Gingival pain)Sores gumSores gum (PT Gingival inflammation)Was changed as follows (note the change of PT Gingival inflammationto PT Noninfective gingivitis, related to MedDRA version changes):ExampleReportedL

4、LT SelectedLip soreLip sore (PT Lip pain)Lip soresSores lip (PT Cheilitis)Sore gumsSore gums (PT Gingival pain)Sores gumSores gum (PT Noninfective gingivitis)3.3.2If self-injury is reportedThe Example table:ExampleReportedLLT SelectedCommentSelf slashingSelf inflicted lacerationLLT Self inflicted la

5、ceration is linked to PT Intentional self-injuryCut her own wristsCut wrists in a suicide attemptSuicide attemptIn addition, LLT Self inflicted laceration can be selectedTook an overdose in an attempt to commit suicideIntentional overdoseSuicide attemptIf overdose is reported in the context of suici

6、de or a suicide attempt, the more specific LLT Intentional overdose can be selected (see also Section 3.18)Was changed as follows (note that Self inflicted laceration has been moved from the Comment column to the LLT Selected column for the second example):ExampleReportedLLT SelectedCommentSelf slas

7、hingSelf inflicted lacerationLLT Self inflicted laceration is linked to PT Intentional self-injuryCut her own wristsCut wrists in a suicide attemptSelf inflicted lacerationSuicide attempt. Took an overdose in an attempt to commit suicideIntentional overdoseSuicide attemptIf overdose is reported in t

8、he context of suicide or a suicide attempt, the more specific LLT Intentional overdose can be selected (see also Section 3.18)3.10.1 Events in the mother There were several changes made to this section of the document to provide examples of term selection and to identify a preferred option for expos

9、ures without clinical consequences. The wording and examples in this section were replaced with the following:3.10.1 Events in the mother 3.10.1.1. Pregnant patient exposed to medication with clinical consequences If a pregnancy exposure is reported with clinical consequences, select terms for both

10、the pregnancy exposure and the clinical consequences.ExampleReportedLLT SelectedPregnant patient receiving drug X experienced a pruritic rashMaternal exposure during pregnancy Pruritic rash3.10.1.2 Pregnant patient exposed to medication without clinical consequencesIf a pregnancy exposure report spe

11、cifically states that there were no clinical consequences, the preferredoption is to select only a term for the pregnancy exposure. Alternatively, a term for the pregnancy exposure and the additional LLT No adverse effect can be selected (see Section 3.21).ExampleReportedLLT SelectedPreferred Option

12、Patient received drug X while pregnant (no adverse effect)Maternal exposure during pregnancyMaternal exposure during pregnancyNo adverse effect3.15 Medication Errors, Accidental Exposures and Occupational Exposures There were several changes made to this section of the document to provide examples o

13、f term selection and to identify a preferred option for medication errors and potential medication errors without clinical consequences. First, the section name: 3.15 Medication Errors/Administration Errors, Accidental Exposures and Occupational Exposures Was changed as follows:3.15 Medication Error

14、s, Accidental Exposures and Occupational Exposures Second, the section name: 3.15.1 Medication/administration errors Was changed as follows:3.15.1 Medication errors 3.15.1.1 Medication errors reported with clinical consequences The Example table:ExampleReportedLLT SelectedCommentPatient was administ

15、ered wrong drug and experienced hypotensionWrong drug administeredHypotensionBecause of similar sounding drug names, the patient took the wrong drug and experienced a rashDrug name confusionWrong drug administeredRashInsulin was given using the wrong syringe resulting in the administration of an ove

16、rdose. The patient developed hypoglycaemia.Wrong device usedAccidental overdoseHypoglycaemiaIf an overdose is reported in the context of a medication error, the more specific term LLT Accidental overdose can be selected (see also Section 3.18)Was changed as follows (note the changes and the addition

17、 of a comment to the second example):ExampleReportedLLT SelectedCommentPatient was administered wrong drug and experienced hypotensionWrong drug administeredHypotensionBecause of similar sounding drug names, the wrong drug was dispensed; as a result, the patient took the wrong drug and experienced a

18、 rashDrug name confusionWrong drug dispensedWrong drug administeredRashIt is important to select terms for all medication error concepts, i.e., do not subtract informationInsulin was given using the wrong syringe resulting in the administration of an overdose. The patient developed hypoglycaemia.Wro

19、ng device usedAccidental overdoseHypoglycaemiaIf an overdose is reported in the context of a medication error, the more specific term LLT Accidental overdose can be selected (see also Section 3.18)3.15.1.2 Medication errors and potential medication errors reported withoutclinical consequences The wo

20、rding and Example tables in this section:Medication errors without clinical consequences are not ARs/AEs. However, it is important to record the occurrence or potential occurrence of a medication error. Select a term that is closest to the description of medication error reported.Also, if specifical

21、ly reported that no adverse effect has occurred, it is acceptable to select LLT No adverse effect.In instances where the medication did not reach the patient, it is acceptable to select LLT Drug not taken in context of intercepted medication error.ExampleReportedLLT SelectedCommentMedication was giv

22、en intravenously instead of intramuscularlyIntramuscular formulation administered by other routeMedication was given intravenously instead of intramuscularly without sequelaeIntramuscular formulation administered by other routeNo adverse effectSee Section 3.21The pharmacist selected the wrong drug s

23、trength but the error was detected prior to dispensing to the patientIntercepted wrong drug strength selected LLT Intercepted wrong drug strength selected links to PT Intercepted drug dispensing errorPharmacist notices that the names of two drugs are similar and is concerned that this may result in

24、a medication errorDrug name confusionCircumstance or information capable of leading to medication error Note: this example is a potential medication error and LLT Drug name confusion provides additional information about the nature of the potential medication errorDrug inadvertently administered. Th

25、e error was noticed soon afterwards.Drug administration errorWere changed as follows (note that a preferred option to select only a term for the medication error is now identified and examples of intercepted medication errors have been deleted): Medication errors without clinical consequences are no

26、t ARs/AEs. However, it is important to record the occurrence or potential occurrence of a medication error. Select a term that is closest to the description of medication error reported.If a medication error report specifically states that there were no clinical consequences, the preferredoption is

27、to select only a term for the medication error. Alternatively, a term for the medication error and the additional LLT No adverse effect can be selected (see Section 3.21).ExampleReportedLLT SelectedPreferred OptionMedication was given intravenously instead of intramuscularly without sequelaeIntramus

28、cular formulation administered by other routeIntramuscular formulation administered by other routeNo adverse effectExampleReportedLLT SelectedCommentPharmacist notices that the names of two drugs are similar and is concerned that this may result in a medication errorDrug name confusionCircumstance o

29、r information capable of leading to medication error Note: this example is a potential medication error and LLT Drug name confusion provides additional information about the nature of the potential medication errorDrug inadvertently administered. The error was noticed soon afterwards.Drug administra

30、tion error3.15.1.3 Medication monitoring errors The concept description for medication monitoring error: For the purposes of term selection and analysis of MedDRA-coded data, a medication monitoring error is an error that occurs in the process of monitoring the effect of the medication through clini

31、cal assessment and/or laboratory data. It can also refer to errors in following instructions or information pertinent to the safe use of the medication.Was changed as follows (note the addition of the word “monitoring” in the second sentence. This concept description has also been updated in the MedDRA Introductory Guide and the Web-Based Browser):For the purposes of term selection and analysis of MedDRA-coded data, a medication monitoring error is an error that occurs in th