ADR Flashcards
The science and activities relating to the detection,
assessment, understanding and prevention of adverse effects
and other medicine-related problems
Pharmacovigilance
Pharmacovigilance is aka
Post marketing surveillance
Monitor drugs already available in the marke
Post marketing surveillance
Show how the genetic makeup of an individual or population
affects drug response
Pharmacogenetic
Pharmacogenetic Show how the _______________ of an individual or population
affects drug response
genetic makeup
Show how the _______________ of an individual or population
affects drug response
Pharmacogenetic
analysis of genetic determinants of drug efficacy
and toxicity
Pharmacogenomics
Genome wide analysis of genetic determinants of drug efficacy
and toxicity
Pharmacogenomics
Study of the utilization and effects of drugs in large numbers of people
Pharmacoepidemiology
Adverse drug effects / reaction A noxious and unintended reaction which occurs
at _____________ doses in man for prophylaxis,
diagnosis, and therapy of disease
Therapeutic doses
A noxious and unintended reaction which occurs
at therapeutic doses in man for prophylaxis,
diagnosis, and therapy of disease
Adverse drug effects / reaction
Any adverse effect / injury associated with use of drugs in humans whether or not
considered to be drug-related
Adverse drug event
Any preventable event that may lead to
inappropriate drug use or patient harm
Medication error
Special care necessary for
safe and effective use of the
drug
Precautions
Strong advice; statement of
danger
Warning
A drug, procedure, or
surgery should not be used
because it may be harmful to a person
Contraindications
What are the risk factor for ADR
Age
Concurrent Medicines
Sex
Comorbidities
Duration of Therapy
Narrow Therapeutic Index
Ethnicities and
Genetics
Factors ( problems) for Concurrent Medicines
Drug adherence
Drug interaction
Problem for Age ADR
Pediatrics
Geriatrics
Problems : Sex ADR
Females are pront to QT prolonged elongation with anti- arrhythmic drugs
Problems: Comorbidities ADR
Liver- primary metabolism
Kidney - excretion
primary metabolism
Liver
Main site for excretion
Kidney
Problems: Duration of therapy ADR
Increase toxicity
TYPE C ADR (continuous)
Problems: Narrow Therapeutic index ADR
Increase toxicity
Problems: Erhnicity and genetics ADR
Asian: fast acetylators
Western : slow acetylators
FastEast
SloWest
Asian: fast acetylators
Western : slow acetylators
TITE meaning in therapeutic index
The bigger the better, and safer
Therapeutic index formula
TI= TD50/ ED50
< 37 weeks AOG
Premature
37-42 weeks AOG
Term
> 42 weeks AOG
Post-term
0-30 days
Neonate
0-1 year
Infant
1-3 years
Toddler
3-5 years
Pre-schooler
6-12 years
School age/ late childhood
13-17 years
Adolescent at
Severity of reaction
Mild
Modertae
Severe
Lethal
Bothersome but requires no
change in therapy
Mild
Change in therap
Moderate
Life-threatening, cause
significant disability
Severe
Directly or indirectly causes
death
Lethal
Occurence of drug interaction
Established
probable
Suspected
Possible
Unlikely
Well-proven clinically
Established
Not proven clinically Very likely
Probable
Some data,
Might
Suspected
Limited data,
Could
Possible
No evidence
Doubtful
Unlikey
Types of AdDR
Type A, B, C, D, E, F
Type A
Augmented
type B
BIzarre
Type C
Continuous
Type D
Delayed
Type E
End of use
Type F
Failure of therapy
Extension effects
* Side effects
Type A: Augmented
Idiosyncratic
Type B Bizarre
Type B
Hypersensitivity
* Type I -
* Type II -
* Type III –
* Type IV –
Type I - Anaphylactic
* Type II - Cytotoxic
* Type III – Immune complex
* Type IV – Delayed / cell-mediated
Tolerance and tachyphylaxis
* Dependence
* Addiction
* Habituation
Type C continuous
Carcinogenicity
* Teratogenicity
Type D delayed
Type A: Augmented : __- related to MOA
Extension
Type A: Augmented is it Pharmacologically
predictable
Yes
Type A: Augmented is it Dose-Dependent
Yes
Type A: Augmented INCIDENCE
More common
Type A: Augmented: DETECTION
Early un clinical development
Type A: Augmented: MORTALITY
Type III- Low
Type A: Augmented MANAGEMENT
Dose reduction
Type A: Augmented unintended or
secondary effects; not-so related
Sode effects
Type B: Bizarre
due to genetics
Idiosyncratic
Type B: Bizarre
MANAGEMENT
Change the drug/ discontinue
Type B: Bizarre
Mortality
High
Type B: Bizarre
DETECTION
Post Licensing
Phase 1-4
Type B: Bizarre
Incidence
Uncommon
Type B: Bizarre
DOSE DEPENDENT
No
Type B: Bizarre PHARMACOLOGICALLY ACTIVE
No
Type B: Bizarre
exaggerated
response by the immune system
Hypersensitivity
Type A: Extension effect: exmaple of drugs
Sulfonylureas
CNS Depressant
Antidepressants
Anticoagulant
Antihypertensive
Furosemide
Nitroglycerin
Cytotoxic drugs
nSaids
Atropine
Steroids
Antihistamine
Sulfonylureas are for
Hypoglycemia
Sulfonylure causes the dx
Whipples triad
Nitroglycerin effects
Flushing
Throbbing headache
Moa of nitroglycerin ointment
Vasodilation
Dose dependent CNS depressant effects
Tranquilizing →
Sedating → Hypnotic
→Anesthesia →
Respiratory depression
→Coma → Death
Moa of Cytotoxin drugs
Kill
Cytotoxin drugs
Alopecia
* Nausea and vomiting
* Myelosuppression
Suppresion of bones
Myelosuppression