Thianti Sylviningrum

Menjelaskan definisi farmakoepidemiologi

Menjelaskan tujuan farmakoepidemiologi
Menjelaskan proses current drug approval
Menjelaskan jenis rancangan dalam
farmakoepidemiologi
Menjelaskan prinsip pelaksanaan
farmakoepidemiologi
Menjelaskan pertimbangan isu bioetik
dalam farmakoepidemiologi
 The study of the use of and the
effects of the drugs in large numbers
of people
Comparison : pharmacology,clinical
pharmacology,and epidemiology
Clinical pharmacology :
pharmacokinetics and
pharmacodynamics
 adverse reaction of drug :
a. Type A reaction
b. Type B reacion
c. Epidemiology : study of distribution
and determinants of diseases in
population
 improve the rational use of drugs
(efficacy, safety,cost-effectiveness, and
drug utilization)
to bring together the various
specialties of medicine, epidemiology,
biostatistics, health services research,
and the social sciences to evaluate the
effectiveness of existing and new
prescription drugs in relation to their
risks and costs
 to study how medications are
used by physicians and patients
to develop methods to optimize
prescription drug use
 Preclinical animal testing
Phase I : not more than 30
volunteers
Phase II : normally no fewer than
100200 individuals with target
disease
Phase III : hundred to thousand of
people
Phase IV : post-marketing surveillance
 Random error
Bias
Confounding variables
 Case report : Simply reports of a single
patients
Case series : as a collection of patients
with a single exposure whose clinical
outcomes are evaluated and described
Case control studies : a study that
compares cases with a disease to
controls without the disease, looking
for differences in prior exposures
 Cohort studies : a study that identifies
an exposed group and a comparison
group and follows them over time,
looking for differences in their outcomes
Randomized clinical trials : key feature
of this design is the random allocation
of patients to receive the treatment of
interest, thereby making the study
groups as comparable as possible
 Minimize the risks for subjects
Informed consent
Privacy vs confidentiality