1 Drug adverse reaction and drug- induced disease Department of Pharmacology Shantou University Medical College Yan-Qiong Zhou 2 Drug adverse reaction reaction common/normal application dosage harmful and unexpected reaction 3 Drug adverse reaction Side effect ( ) toxic effect ( ) Residual effect ( ) dependence ( ) Idiosyncratic reaction/ Idiosyncrasy ( ) allergic reaction/hypersensitive reaction ( / ) Carcinogenesis, teratogenesis, mutagenesis ( ) ( not including Overdose; drug abuse; error treatment ) 4 Drug-induced disease drug-induced functional or structural damage of the body ; clinical course Essence: result/sequel of the Drug adverse reaction 5 Classify adverse reactiondrug dosage adverse reactionpeculiarity WHO;World Health Organization 6 adverse reactiondrug dosage concerned with dosage (A-type reaction) A dosage indifference (B-type reaction) B 7 A B 8 adverse reactionpeculiarity side effect( ) toxic effect( ) residual effect( ) dependence( ) idiosyncratic reaction( ) allergic reaction( ) carcinogenesis( ) teratogenesis( ) mutagenesis( ) 9 adverse reaction classified by WHO side effect ( ) adverse event ( ) adverse reaction ( ) unexpected adverse reaction ( ) signal( ) 10 Aetiology of drug adverse reaction and drug-induced disease congenital abnormality of patient reaction Acquired abnormity drug factor drug interactions Indirect reaction 11 Congenital abnormality of patient reaction allergic / hypersensitive reaction autoimmune response genetic factor pharmacokinetics abnormality pharmacodynamics abnormality idiosyncrasy Inborn sensitivity age; cyesis/pregnancy 12 Acquired abnormality Hepar affection kidney affection drug receptor abnormity 13 Drug factor Overdosage alter of bioavailability incorrect administration route withdrawal symptom spatial isomerism 14 Indirect reaction fetal anomaly thalidomide 3rd Generation effective diaethylstilbestrol carcinoma of vagina else Antihistamine drug traffic accident 15 Mainstay of drug adverse reaction 1.Reported or not 2.adverse event time series 3.adverse reaction amelioration 4.Rechallenge irritation dischallenge 16 5.Questionable factor 6.Happen or not with the dummy 7.Detect or not from the blood or other body fluid 8. dosage irritation 9. identical reaction or not before 10. confirm or not Mainstay of drug adverse reaction 17 Degree of probability definite ( ) probable( ) possible( ) conditional( ) doubtful( ) 18 Standard of definite 1. reasonable chronologicaol order 2. confirmed from body fluid or tela 3. consistent with characteristic of reaction 4. amelioration by discontinue medication or irritation 5. no explanation 19 Therapeutic principle to deal with drug-induced disease adopt treatment perscription discontinue medication doubt drug allergy inform patient symptomatic treatment serious Specific antagon withdrawal relieve 20 Monitoring of drug adverse reaction Effectiveness of drug monitoring Representative clozapine temafloxacin drug monitoring latest / exceptional adverse reaction drug-induced disease 21 Means of drug monitoring cohort study case control study submit a voluntary report 22 Cohort study common/effective pharmacoepidemiology: retrospective study prospective study retrospective study: definite factor prospective study: follow-up visit Cohort study cannot discover exceptional adverse reaction 23 Case control study Suspect adverse effect discover Diethylstilbestrol adenocarcinoma vagina thalidomide phocomelia infant event No application application compare rare event daughter 24 Submit a voluntary report Earlier signal Delayed adverse reaction Discover Drug interactions 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39