3. post market, pharmacovigilance, ebm

7/25/2019 3. POST MARKET, Pharmacovigilance, EBM

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PHARMACOVIGILANCE


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What is

Pharmacovigilance?


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Pharmacovi ilance PV is defined as the science

and activities relating to the detection,assessment, understanding and prevention ofadverse effects or any other drug-related

problem

Ilmu atau aktivitas yang terkait denganpenelusuran,penilaian, tindakan untuk mengatasi, pemahaman dan

pencegahan ROTD (ROTD= Reaksi Obat yang Tidak Diinginkan)serta Drug Related Problem (DRP=permasalahan lain yangberhubun an den an obat .


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Tujuan dari Pharmacovigilance (WHO, 2002):

.use of medicines and all medical and paramedicalinterventions,

2. improve public health and safety in relation to theuse of medicines

. , ,effectiveness and risk of medicines

4. encouraging their safe, rational and more effectivenc u ng cos -e ec ve use

1. Meningkatkan pelayanan dan keselamatan pasien

2. Meningkatkan kesehatan dan keselamatan masyarakat, terutamayang berhubungan dengan penggunaan obat

3. Memberikan kontribusi terhadap analisis keuntungan, bahaya,

4. Meningkatkan penggunaan obat yang aman, rasional dan lebihefektif ditinjau dari sisi biaya (cost-effectiveness)


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EVIDENCE-BASED MEDICINE


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Evidence-based Medicine(EBM)

EBM menuntut kemampuan seorang farmasis dalammengga ung an u er n ar sua u pengo a andengan kemampuan klinisnya dalam praktek kefarmasian.

Penerapan EBM akan menurunkan kejadian ROTD danmencegah terjadinya medication error.

Informasi bahwa suatu obat itu aman dan efektifberdasarkan bukti diperoleh dari studifarmakoe idemiolo i.


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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

articular dru in a s ecific o ulation. These studies are then

published in pharmacy and medical journals.

Hundreds of medical journals are published every week.ese ourna s a n o e er genera or spec a y ca egor es.

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

journals within their scope of practice.


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ourna s

American Journal of Epidemiology American Journal of Public Health

Biometrics Annals o E idemiolo

Drug Safety Epidemiology

Epidemiologic Reviews Journal of Clinical Epidemiology

Journal of Epidemiology and Community Pharmacoepidemiology and Drug Safety

Viral and Health Statistics Weekly Epidemiological Record

World Health Statistics Quarterly Society for Clinical Trials


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Secondary medical literature consists of indexing systems. It

is impractical to search one by one through the thousands of

.

secondary systems allow practitioners to search through thevast array of medical journals to find information about a

part cu ar su ect. earc terms are entere nto a ata ase,

and the database then reveals when and where information

has been published on the topic of interest. Some databasesprovide access to complete article(s), and others provide

information only on where to locate the article(s). The most

,

which was created in 1966 and indexes more than 1600

medical journals.


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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 usin the secondar s stems

to identify all of the articles published on a particular subject.The information is then collated and presented in a manner

.

quick, efficient resources that are used to answer questions

about the most common clinical problems.

3. post market, pharmacovigilance, ebm

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