Drug adverse reaction and drug-induced disease

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Drug adverse reaction and drug-induced disease

• Department of Pharmacology
• Shantou University Medical College
• Yan-Qiong Zhou

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Drug adverse reaction

• common/normal application dosage?harmful and
  unexpected reaction

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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)

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Drug-induced disease

• drug-induced functional or structural damage of
  the body clinical course
• Essence result/sequel of the Drug adverse
  reaction

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Classify

• adverse reactiondrug dosage
• adverse reactionpeculiarity
• WHOWorld Health Organization

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adverse reactiondrug dosage

• concerned with dosage (A-type reaction)??????????
  ????????,???????A????
• dosage indifference (B-type reaction)????????????
  ???,??B??????

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A??B??????????
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adverse reactionpeculiarity

• side effect(???)
• toxic effect(????)
• residual effect(????)
• dependence(???)
• idiosyncratic reaction(?????)
• allergic reaction(????)
• carcinogenesis(????)
• teratogenesis(????)
• mutagenesis(?????)

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adverse reaction classified by WHO

• side effect (???)
• adverse event (????)
• adverse reaction (????)
• unexpected adverse reaction (??????)
• signal(??)

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Aetiology of drug adverse reaction and
drug-induced disease

• congenital abnormality of patient
  reaction?????????
• Acquired abnormity?????
• drug factor????
• drug interactions ??????
• Indirect reaction????

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Congenital abnormality of patient reaction

• allergic/hypersensitive reaction
• ??? ?? ?? ? autoimmune response
• genetic factor
• pharmacokinetics abnormality?pharmacodynamics
  abnormality?idiosyncrasy?
• Inborn sensitivity
• age cyesis/pregnancy

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Acquired abnormality

• Hepar affection
• kidney affection
• drug receptor abnormity

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Drug factor

• Overdosage?alter of bioavailability?incorrect
  administration route
• withdrawal symptom
• spatial isomerism

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Indirect reaction

• fetal anomaly
• thalidomide
• 3rd Generation effective
• diaethylstilbestrol? carcinoma of vagina
• else
• Antihistamine drug ? traffic accident

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Mainstay of drug adverse reaction

• 1.Reported or not
• 2.adverse event time
  series
• 3.adverse reaction
  amelioration
• 4.Rechallenge irritation

dischallenge
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Mainstay of drug adverse reaction

• 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

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Degree of probability

• definite (??)
• probable(???)
• possible(??)
• conditional(???)
• doubtful(???)

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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

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Therapeutic principle

• to deal with drug-induced disease
• adopt treatment perscription

doubt
discontinue medication
withdrawal
relieve
symptomatic treatment
Specific antagon
serious
drug allergy
inform patient
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Monitoring of drug adverse reaction

• Effectiveness of drug monitoring
• Representative (clozapinetemafloxacin)

latest / exceptional adverse reaction
drug-induced disease
drug monitoring
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Means of drug monitoring

• cohort study
• case control study
• submit a voluntary report

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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

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Case control study
event

• Suspect adverse effect
• discover
• Diethylstilbestrol
  adenocarcinoma vagina
• thalidomide phocomelia infant

application
compare
No application
rare event
daughter
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Submit a voluntary report

• Earlier signal
• Delayed adverse
  reaction

Discover
Drug interactions
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