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PHARMACOVIGILANCE
What is
Pharmacovigilance?
PHARMACOVIGILANCE
Pharmacovigilance
a aco g a ce ((PV)) iss dedefined
ed as tthee science
sc e ce
and activities relating to the detection,
assessment, understanding and prevention of
adverse
d effects
ff or any other
h d drug-related
l d
problem

Ilmu atau aktivitas yang terkait dengan penelusuran,


penilaian,, tindakan untuk mengatasi,
p g ,p
pemahaman dan
pencegahan ROTD (ROTD= Reaksi Obat yang Tidak Diinginkan)
serta Drug Related Problem (DRP=permasalahan lain yang
berhubungang dengang obat). )
Tujuan dari Pharmacovigilance (WHO, 2002):
1 improve patient care and safety in relation to the
1.
use of medicines and all medical and paramedical
interventions,
2. improve public health and safety in relation to the
use of medicines
3 contribute to the assessment of benefit
3. benefit, harm
harm,
effectiveness and risk of medicines
4. encouraging their safe, rational and more effective
(i l di cost-effective)
(including t ff ti ) use
1. Meningkatkan pelayanan dan keselamatan pasien
2. Meningkatkan kesehatan dan keselamatan masyarakat, terutama
yang berhubungan dengan penggunaan obat
3. Memberikan kontribusi terhadap analisis keuntungan, bahaya,
risiko dan efektivitas penggunaan obat
4. Meningkatkan penggunaan obat yang aman, rasional dan lebih
efektif ditinjau dari sisi biaya (cost-effectiveness)
WHO established its Programme for International Drug
Monitoringg in response
p to the thalidomide disaster detected
in 1961
In 2002, more than 65 countries have their own
pharmacovigilance centres.
centres
Membership of the WHO Programme for International Drug
Monitoringg is co-ordinated byy the WHO Collaboratingg Centre
for International Drug Monitoring, known as the Uppsala
Monitoring Centre (UMC).
At the
th end d off 2010
2010, 134 countries
t i were partt off th
the WHO PV
Programme.
EVIDENCE-BASED MEDICINE
Evidence-based Medicine (EBM)
Pengobatan Berdasarkan Bukti Terkini
EBM menuntut kemampuan seorang farmasis dalam
menggabungkan
b k bukti
b kti terkini
t ki i dari
d i suatu
t pengobatan
b t
dengan kemampuan klinisnya dalam praktek kefarmasian.

Penerapan EBM akan menurunkan kejadian ROTD dan


mencegah terjadinya medication error.

Informasi bahwa suatu obat itu aman dan efektif


berdasarkan bukti diperoleh dari studi
farmakoepidemiologi.
p g
Literatur medis dalam EBM dapat dikelompokkan menjadi:

Primary medical literature provides new information to the


field of medicine and consists of descriptive, observational,
and interventional studies. All of these study designs are used
to provide new information about the use or effect of a
particular drugg in a specific
p p p
population.
p These studies are then
published in pharmacy and medical journals.
Hundreds of medical journals are published every week.
Th
These jjournals
l ffallll iinto
t either
ith generall or specialty
i lt categories.
t i
General medical journals publish information on topics of
interest to general practitioners, whereas specialty medical
journals publish in specific areas of medical practice (e.g.,
dermatology, cardiology). To remain current in the field of
practice, practitioners typically subscribe to a few medical
journals within their scope of practice.
J
Journals
l
American Journal of Epidemiology American Journal of Public Health
Biometrics Annals off Epidemiology
p gy

Drug Safety Epidemiology


Emerging Infectious Diseases Epidemiology and Infection
Epidemiologic Reviews Journal of Clinical Epidemiology
Journal of Epidemiology and Community Pharmacoepidemiology and Drug Safety
Health
Viral and Health Statistics Weekly Epidemiological Record
World Health Statistics Quarterly Society for Clinical Trials
Secondary medical literature consists of indexing systems. It
is impractical to search one by one through the thousands of
editions of medical journals to find clinical information
information. The
secondary systems allow practitioners to search through the
vast array of medical journals to find information about a
particular
i l subject.
bj SSearch
h terms are entered d iinto a d
database,
b
and the database then reveals when and where information
has been published on the topic of interest. Some databases
provide access to complete article(s), and others provide
information only on where to locate the article(s). The most
commonly used indexing system is the Medline database
database,
which was created in 1966 and indexes more than 1600
medical journals.
Tertiary medical literature consists of literature reviews,
which can be in the form of textbooks, reference books, or
review articles in medical journals. Before a review is written,
a literature search is conducted using the secondary systems
to identify all of the articles published on a particular subject.
The information is then collated and presented in a manner
that is easily used by practitioners
practitioners. Tertiary resources are
quick, efficient resources that are used to answer questions
about the most common clinical problems.