Sistem Pelaporan

Keamanan Obat
 WHY ?

Clinical trial data insufficient to

evaluate drug risk.
CLINICAL TRIAL LIMITATION
1. The limited number of patients participating.
2. The relatively short duration of clinical trials.
3. The characteristics of the participants do not always correspond to
the characteristics of the population in which it will later be used.

Eur J Clin Pharmacol (2008) 64:743–752

 POST MARKETING STUDIES
• study rare ADRs,
• ADRs with a long latency
• ADRs in specific population
• penyalahgunaan obat (drug abuse),
• penggunaan yang salah (misuse),
• keracunan obat, kegagalan
• terapi (therapeutic failure)
• kesalahan dalam pengobatan (medication errors).

Eur J Clin Pharmacol (2008) 64:743–752

FARMAKOVIGILANS (KEAMANAN OBAT) PANDUAN DETEKSI DAN PELAPORAN EFEK SAMPING OBAT UNTUK TENAGA KESEHATAN
area aktivitas farmakovigilan
• Regulator
• Akademik
• Industri

Eur J Clin Pharmacol (2008) 64:743–752

 METODE
FARMAKOVIGILANS / POST MARKETING STUDIES
• Descriptive studies
• Analytical studies

• passive and active surveillance systems

https://www.who.int/hiv/pub/10.pdf
Eur J Clin Pharmacol (2008) 64:743–752
 Descriptive studies - generate hypotheses and attempt to
describe the occurrence of events related to drug toxicity and efficacy.

• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Reporting
• Cohort Event Monitoring

Eur J Clin Pharmacol (2008) 64:743–752

 A practical handbook on the pharmacovigilance of antimalarial medicines

Passive or active pharmacovigilance

1. Passive pharmacovigilance
• Passive surveillance means that no active measures are taken to look for adverse effects
other than the encouragement of health professionals and others to report safety concerns.
Reporting is entirely dependent A practical handbook on the pharmacovigilance of
antimalarial medicines 11 on the initiative and motivation of the potential reporters. This is
the most common form of pharmacovigilance. It is commonly referred to as “spontaneous”
or “voluntary” reporting. In some countries this form of reporting is mandatory.
2. Active pharmacovigilance
• Active (or proactive) safety surveillance means that active measures are taken to detect
adverse events. This is managed by active follow-up after treatment and the events may be
detected by asking patients directly or screening patient records. It is best done
prospectively. Active pharmacovigilance is sometimes very descriptively referred to as, “hot
pursuit”. The most comprehensive method is cohort event monitoring (CEM). Examples of
this are the Intensive Medicines Monitoring Programme (IMMP) in New Zealand and
Prescription Event Monitoring (PEM) in England. Other methods used include the use of
registers, record linkage and screening of laboratory results in medical laboratories.
Analytical studies - hypotheses and seek to determine associations or
causal connections between observed effects and particular drugs, and to
measure the size of these effects.
• Case control studies
• Cohort studies Randomized
• Clinical Trials
• Meta-analysis

Eur J Clin Pharmacol (2008) 64:743–752

Spontaneous Reporting System (SRS)
• A system to monitor the safety of all medicines on the market
• Voluntary submission of ICSRs (Individual Case Study Report) by
health professionals, pharmaceutical manufacturers and patients to
the national pharmacovigilance centre
• The primary method of collecting post_x0002_marketing information
on the safety of drugs.
• The main function of SRS is the early detection of signals of new, rare
and serious ADRs.
Requires two initial steps:

A reporter
• 1. suspects that an undesirable medical event may have been caused
by exposure to a medicine
• 2. reports the suspicion to the national pharmacovigilance centre

• If in doubt, report !
Intensified ADR Reporting
• To enhance ADR reporting of specific medicines in early post‐
marketing phase
• Extension of Spontaneous Reporting Programme

• Medicines under evaluation | European Medicines Agency

https://www.ema.europa.eu/en/medicines/medicines-under-
evaluation
Targeted
spontaneous
reporting

• Intensified
ADR
Reporting
within a
defined
cohort
Drug Saf (2015) 38:395–408
Cohort Event Monitoring (CEM)
• To gather more information on the safety profile of a new chemical
entity in early post‐marketing phase
• Observational cohort study design
• Patients enrolled into cohort and actively followed‐up during treatment
to record all adverse events (not just suspected ADRs)
CEM ....
• Characterise known reactions
• Detect signals of unrecognised reactions
• Identify interactions with other medicines and TCAMs
• Detect inefficacy of medicine
• Assess safety in pregnancy & lactation
• Identify risk factors for ADRs
https://repository.unej.ac.id/bitstream/handle/123456789/19885/Unlock-gdlhub-gdl-rhiyanagum-3849-1-rhiyanaa_1.pdf?sequence=1&isAllowed=y