药品不良反应预警信号的处置在药品安全性监管中的应用(1)[1]

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1、药品不良反应预警信号的处置在药品安全性监管中的应用(1)[1]ApplicationofdrugaggregationsignalprocessingindrugsafetysupervisionGuangdongadversedrugreactionmonitoringcenterTwoyearsnine,NovembercontentDefinitionanddiscoverymethodsofadversedrugreactionssignalConcentrateddrugsafetywarningsignalExtraction,evalu

2、ationanddisposalofwarningsignalsfordrugsafetyIntroductionofnetworkplatformforadversedrugreactions(ADR)inGuangdongProvinceOurprovinceisresponsiblefordrugsafetywarningsignaldisposalindrugsafetyCasesofapplicationinfullsupervisionDefinitionanddiscoverymethodofadversedrugreactionsig

3、nalAdversedrugreactionsignalUnknownorincompletedrugsandadverseeventsRelevantinformation.AccordingtotheseverityoftheeventandtheinformationQualityusuallyrequiresmultiplereportstoproduceasignal.Agroupofhypothetical,rational,safedrugsusedinhumanbeingsData,usuallyclinical,pharmacolo

4、gical,pathological,orprevalentPathologicalnature.Signalsconsistofhypothesesanddataandarguments.Thethreephasesofasignal(1)adversereactionslatency,discoveryofdoubt,signalphase(2)Dataaccelerationaccumulation,signalenhancementperiodWeaksignalsdevelopintostrongquestions(orsignals).s

5、tayAttheendofthisphase,abasicestimateofthedatawillappear,i.e.,forthedrugRegulatorymeasures(manualcorrection,theindicationsofdruguserestrictionsOrthepublicationofarticlesrelatingtomedicaljournals.InstantcurveThesteeppartofthemiddleisimportantforpharmacovigilance.(3)evaluationper

6、iod,thatis,adversereactionsareconfirmed,explainedanddeterminedItcanalsobecalledsignaltestorfollow-upAttheendofthesecondphase,theknowledgeoftheADRisfarfromcompleteEndpoints,rates,mechanisms,andriskfactorsareoftennotClear.Theadverseeffectsarelegallyrecognized,butremaintobeseenSci

7、entificproof.Thisisthethirdissue.ItcostsoneSetasidefundsforalongerperiodofobservationandin-depthanalysisCarryoutexperimentalstudies,ifpossible,andsoon.Signaldiscoveryfactor1.clinicaleventsorsyndromeshaveoneormoreofthefollowingcharacteristics:Background(NATURAL)incidenceisverylo

8、w;Havingcharacteristicorabnormalsignsorsymptoms;Occurr