Farmakoepidemiologi 1 OK

FARMAKOEPIDEMIOLOGI
Risk Estimates
Prih Sarnianto
Konsep Dasar
• Farmakoepidemiologi:
The study of the use and effects
of drugs in large numbers of
people [Strom, 2005].
>> Konten mengambil farmakologi klinis

>> Metode mengambil epidemiologi
Drug adverse effects…
Yang khas farmakoepidemiologi…
• Farmakoepidemiologi = Epidemiologi obat
Exposure Outcome
Drug exposure dapat:

► bersifat akut atau kronis
► menyebabkan efek segera atau tunda
► berasal dari beragam variasi sumber [dosis,

timing, formulasi, farmakokinetik]
dan
► drug exposure itu disengaja, karena obat
diberikan secara sengaja
Realm of pharmacoepidemiology…
• Fase pengembangan obat
► PC = Pre-Clinical Studies [menggunakan hewan uji]

► 1 = Dose escalation in healthy patients [safety, metabolism]
► 2 = Dose ranging, first time in patients with condition
[efficacy, short-term safety] >>> CAN it works?
► 3 = Pivotal trials for registration [indikasi utama, dosis, efficacy]
► 4 = Post-marketing >>> the realm of pharmacoepid
[long-term safety, rare adverse events, effectiveness] >>> DOES it works?
Why conduct a pharmaepidemiologic study?
• Describing patterns of prescribing or

medication use >>> drug utilization evaluations [DUEs]
• Quantifying the risks and benefits of drugs
>>> adverse drug reaction surveillance
► Discover unknown effects
► Increase precision of estimate
► In populations not studied [e.g. elderly, children, pregnant women]
► Compared to other drugs
• Economic implications of drug used
>>> Analisis farmakoekonomi
Why not stop after clinical trials?
• Too short to detect long-term side effects

• Too small to detect rare side effects
• Conducted in selected populations
• Few outcomes assessed
• Not all indications assessed
• Drug interactions are unknown
>>> Efficacy tidak sama dengan effectiveness
► Efficacy >> melalui uji klinis, terkontrol
► Effectiveness >> di populasi, kondisi riil
The epidemiologic side of pharmacoepid…
• Epidemiology is
► Process by which public health problems are
detected, investigated, and analyzed
>>> Risk estimates
► Based on large populations, not patients nor
their caregivers
>>> Potential bias and confounding are major
issues to be considered
► Scientific basis of public health
• Objective of epidemiology
► To determine the rates of disease [drug
intervention outcome or drug effects] by person,
place, time
>>> Absolute risk [incidence, prevalence]
► To identify the risk factors for the disease [drug
intervention outcome or drug effects]
>>> Relative risk, RR [or odds ratio, OR]
► To develop approaches for disease [adverse effects]
prevention
>>> Attributable risk [AR] / fraction [AF]
• Some definitions
► Adverse drug event
>>> A harmful and unintended event occurring
during drug therapy
► Adverse drug reaction
>>> A harmful and unintended event
considered related to drug therapy
► Side effect
>>> An effect other than the intended one
>>> belum tentu buruk, misal Aspirin, thalidomode
► Rate
>>> Rapidity of an occurrence of an event in
a population
► Ratio
>>> Frequency of one item compared to
another
► Proportion
>>> Frequency of one item compared to
the sum of the items
► Risk [<1]
>>> the chance that a person without the
disease will develop the disease in a
defined period >>> incidence? Incidence density?
► Hazard
>>> similar to risk but can be exceedingly high
>>> number of events in the target population by the
exposure period [very high in time of calamity]
► Odds
>>> if 67% of all hypertension is obese, the
odds are 67 : 33 = 2 dibanding 1
► To determine the rates of disease [drug

intervention outcome or drug effects] by person,
place, time
>>> Absolute risk [incidence, prevalence]
• Incidence = number of new cases of a disease occurring

in a specified time period divided by the number of
individuals at risk of developing the disease during the
same time
>>> most relevant clinically
• Prevalence = total number of affected individuals in a

population at a specified time period divided by the
number of individuals in the population at the time
► To identify the risk factors for the disease

[drug intervention outcome or drug effects]
>>> Relative risk [RR] or odds ratio [OR]
• RR = ratio of incidence of disease in exposed

individuals to the incidence of disease in non-
exposed individuals (from a cohort/prospective
study)
>>> RR >1, there is a positive association
>>> RR <1, there is a negative association
• OR = ratio of the odds that cases were exposed to
the odds that the controls were exposed [from a
case control/retrospective study] – is an estimate
of the RR
>>> Interpretation may be the same as RR
► To develop approaches for disease prevention

>>> Attributable risk [AR] / fraction [AF]
• AR = the amount of disease incidence that can be

attributed to a specific exposure
>>> Difference in incidence of disease between
exposed and non-exposed individuals
>>> Incidence in non-exposed = background risk
>>> Amount of risk that can be prevented
• AF = the proportion of disease incidence that can
be attributed to a specific exposure [among those
who were exposed]
>>> AR divided by incidence in the exposed x 100%
Attributable Risk
Excess
Risk
100
Risk among risk

AR =
80
factor positives
60
40
Risk among risk
20 factor negatives
0
+ -
Risk Factor
Attributable Fraction
Risk among Risk among

risk factor risk factor
positives negatives
AF = X 100%
Risk among
risk factor
positives
Major Epidemiology Study Designs
• Case Control [retrospective]
• Cohort [prospective]
• Cross sectional (one point in time)

Referensi
• Strom, B.L. [2005]. What is Pharmacoepidemiology? dalam
Pharmacoepidemiology, 4th Edition [B.L. Strom, Editor], John Willey &
Sons, Chicester, 3–14.

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FARMAKOEPIDEMIOLOGI

>> Konten mengambil farmakologi klinis

• Farmakoepidemiologi = Epidemiologi obat

Drug exposure dapat:

► menyebabkan efek segera atau tunda

► berasal dari beragam variasi sumber [dosis,

• Fase pengembangan obat

► PC = Pre-Clinical Studies [menggunakan hewan uji]

• Describing patterns of prescribing or

• Too short to detect long-term side effects

► To determine the rates of disease [drug

• Incidence = number of new cases of a disease occurring

• Prevalence = total number of affected individuals in a

► To identify the risk factors for the disease

• RR = ratio of incidence of disease in exposed

► To develop approaches for disease prevention

• AR = the amount of disease incidence that can be

Risk among risk

Risk among Risk among

• Case Control [retrospective]

• Cross sectional (one point in time)

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