study of the use and effect of medicine in large number of people
Pharmacoepidemiology
it can be defined as the study of the therapeutic effect(s), risk and use of drugs, usually in large populations, using epidemiological methods and/or reasoning
Pharmacoepidemiology
study of the relationships between diseases or any other biological phenomenon and various factors which can influence their frequency, distribution and evolution
Pharmacoepidemiology
PHARMACOEPIDEMIOLOGY
study of the relationships between diseases or any other biological phenomenon and various factors which can influence their ____, ____ and ____ (DEF)
frequency, distribution, evolution
PHARMACOEPIDEMIOLOGY: BRIDGING BETWEEN PHARMACOLOGY AND EPIDEMIOLOGY:
Application of the principles of epidemiology to drug effect and drug use
Pharmacoepidemiology
PHARMACOEPIDEMIOLOGY: BRIDGING BETWEEN PHARMACOLOGY AND EPIDEMIOLOGY:
Better assessment of ____ balance for the use of any particular drug in any particular patient
risk/benefit
CLINICAL PHARMACOLOGY vs PHARMACOEPIDEMIOLOGY
Drug effect in individual patient
Clinical Pharmacology
CLINICAL PHARMACOLOGY vs PHARMACOEPIDEMIOLOGY
drug usage pattern and appropriateness of drug use in groups
Clinical Pharmacology
CLINICAL PHARMACOLOGY vs PHARMACOEPIDEMIOLOGY
relation between drug exposure and health outcomes in defined population
Pharmacoepidemiology
KEY DEFINITIONS
a noxious and unintended response to a medicine that occurs at normal therapeutic doses used in humans for prophylaxis, diagnosis, or therapy of disease, or for the medication of physiologic function
Adverse Reactions
KEY DEFINITIONS
the word "effect" is used interchangeably with "____"
reaction
KEY DEFINITIONS
the word "effect" is used interchangeably with "reaction"
Adverse Reactions
KEY DEFINITIONS
Patient injury caused by a medicine taken in therapeutic dose
Adverse Effect
Types of Adverse Effects
A, B, C, D, E, F (6)
Augmented
Bizarre
Chronic or continuous or long term
Delayed
End of use
Failure of efficacy
Types of Adverse Effects
Dose-related
Augmented
Types of Adverse Effects
Non dose-related
Bizarre
Types of Adverse Effects
Dose-related and time related
Chronic or continuous or long term
Types of Adverse Effects
time related/lag time
Delayed
Types of Adverse Effects
withdrawal
End of Use
Types of Adverse Effects
unexpected failure of therapy/no response
Failure of efficacy
Types of Adverse Effects
Exaggerated pharmacological response
Augmented
Types of Adverse Effects
E.g.
Pharmacodynamic (eg. bronchospasm from beta-blockers)
Idiosyncratic reactions (eg. aplastic anemia with chloramphenicol)
Bizarre
Types of Adverse Effects
Osteoporosis with oral steroids
Chronic or continuous or long term
Types of Adverse Effects
Paracetamol can cause hepatotoxicity
Chronic or continuous or long term
Types of Adverse Effects
Teratogenic effects with anticonvulsants or lisinopril
Delayed
Types of Adverse Effects
Withdrawal syndrome with benzodiazepines
End of use
Types of Adverse Effects
Resistance to antimicrobials
Failure of efficacy
Types of Adverse Effects
Decrease of clearance in dialysis
Failure of efficacy
KEY DEFINITIONS
any unintended effect of a pharmaceutical product occurring at normal therapeutic doses and is related to its pharmacological properties
Side Effect
KEY DEFINITIONS
such effects may be well-known and even expected and require little or no change in patient management
Side Effect
KEY DEFINITIONS
any untoward medical occurrence that occurs at any dose and results in death, requires hospital admission or prolonged hospital stay, results in persistent or significant disability, or is life threatening
Serious Adverse Effect
KEY DEFINITIONS
Serious Adverse Effect:
eg. ____, originally made to cure hypertension now for erectile dysfunction
Sildenafil
KEY DEFINITION
the probability that a particular medicine is responsible for an isolated effect or ADR
Causality
KEY DEFINITION
reported information on a possible causal relationship between an adverse event and a medicine, the relationship being previously unknown or incompletely documented
Signal
KEY DEFINITION
usually more than one signal report is required to generate a signal, depending on the seriousness of the event and the quality of the information
Signal
KEY DEFINITION
example is Domperidone
Signal
KEY DEFINITION
when drugs have unique benefit and risk can be manage