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Transcript
Definition: it is the study of the interactions
that occur between a living organism and
chemicals that affect normal or abnormal
biochemical function.
pharmacodynamics
pharmacokinetics


unwanted effects caused by normal
therapeutic doses.
any noxious or unintended reaction
to a drug that is administered in
standard doses by the proper route
for the purpose of prophylaxis,
diagnosis, or treatment.



Standard dose
Proper route
Circumstances such as misuse,
noncompliance, abuse and
drug quality are excluded


Type A
Type B




Large proportion
dose-related and mild
consequence of the drug’s
pharmacological effect
predictable
Words for video clip
CDC : Center for Disease Control
emergency department: 急诊
adverse events
clinical
placebo
respiratory
Ingredient
Questions:
1. What is the CDC warning about?
2. What is the basis for the warning from CDC?
3. What are the suggestion from CDC ?




not predictable
not dose-related and severe,
a genetic or immunological basis
Low frequency

Allergic reactions: An immunologically
mediated reaction, characterised by
specificity, transferability by antibodies or
lymphocytes, and recurrence on re-exposure

type C --continuous reactions due to
long-term drug use
analgesic nephropathy: injury to the
kidney caused by analgesic medications
such as aspirin and paracetamol
kidney function—adequate blood flow--prostaglandins
Type D: delayed reaction
these reactions refer to carcinogenic and
teratogenic effects. These reactions are
delayed and are very rare since extensive
mutagenicity and carcinogenicity studies have
been conducted before drug is licensed.
Type E: end-of-use reactions (withdrawal
reactions)
Abnormal physical or psychological
features that follow the abrupt
discontinuation of a drug. Eg. Sudden
cessation of the use of an antidepressant can
deepen the feel of depression significantly



Large population being exposed to drugs
3% of acute hospital admissions are resulted
from type A reaction
ADRs complicate 10-20% of all admissions



patient factors
Prescriber factors
Drug factors

Gene polymorphism and ADR
CYP2D6 (common enzyme in drug
metabolism)
弱代谢型 (poor metabolizer, PM)
中间代谢型(intermediate Metabolizer,IM)
强代谢型(extensive metabolizer, EM)
超快代谢型(Ultra rapid metabolizer)


ADR monitoring/
PVG
Clinical trials in new
drug R&D

Pharmacovigilance (PV) is defined as the
science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
drug-related problem (overdose, abuse,
misuse, unqualified products, acute and
chronic intoxication report, interactions
between drug and food)

1.
2.
3.
Questions for reviewing
Try to summarize the characteristics of type
A and type B reactions.
Please paraphrase other types adverse
reactions.
Please discuss briefly about the significance
of ADR monitoring.