Farmakovigilans

Ni Made Amelia Ratnata Dewi,

M.Farm.Klin., Apt
 Farmakovigilans
PHARMACOVIGILANCE
(WHO),2002

Pharmakon =
Obat/substansi
obat Ilmu dan aktivitas yang
berhubungan dengan
mendeteksi, menelusuri,
memahami dan mencegah
kejadian/efek yang tidak
diinginkan atau masalah yang
terkait dengan obat
Vigilia =
Monitoring
 TUJUAN
• Meningkatkan keamanan dan kesehatan
masyarakat terhadap risiko akibat
penggunaan obat
• Memberikan informasi terkait keamanan
produk kepada pasien, tenaga kesehatan
dan masyarakat
 Adverse Drug Reactions

Adverse Drugs Event

• Kejadian yang tidak diinginkan terjadi saat penggunaan suatu
produk tetapi tidak memiliki kaitan langsung dengan
pengobatan
• Contohnya : penggunaan obat yang tidak benar

Adverse Drugs Reaction

• Respon yang terjadi akibat penggunaan obat yang mana reaksi
tersebut tidak diinginkan dan merugikan dan terjadi pada
dosis normal baik untuk profilaksis, diagnosis, atau terapi
• Terjadi pada pemberian obat yang sesudah sesuai dengan
indikasi dan dosis normal
Relationship between ME,
ADE and ADR
 Medication Error
• Medication error can be defined as ‘a failure in
the treatment process that leads to, or has the
potential to lead to, harm to the patient’[
 Klasifikasi ADR
Type of Features Examples Management
Reaction
Augmented • Common • Dry mouth with • Reduce dose or
(Dose Related) • Related to the TCA, withhold drug
pharmacologic • respiratory • Consider effects
action of the drug depression with of concomitant
• Predictable opioids, therapy
• Low mortality • bleeding with
warfarin,
• digoxin toxicity
Bizzare • Uncommon • Immunologic • Withhold and
(Non Dose • Not related to the reactions: avoid in future
Related) pharmacologic anaphylaxis to
action of the drug penicillin
• Unpredictable
• High mortality
 Classifications of ADR
Type of Reaction Features Examples Management
Chronic • Uncommon • Hypothalamic- • Reduce dose
(Dose Related and • Related to the pituitary-adrenal axis or
Time Related) cumulative dose suppression by • withhold;wit
corticosteroids, hdrawal may
• osteonecrosis of the have to be
jaw with Prolonged
bisphosphonates
Delayed • Uncommon • Carcinogenesis Often
(Time Related) • Usually dose • Teratogenesis intractable
related
• Occurs or
becomes
apparent
• sometime after
use of the drug
 Classifications of ADR
Type of Reaction Features Examples Management
End of Use • Uncommon • Withdrawal • Reintroduce
(Withdrawal) • Occurs soon syndrome with drug and
after withdrawal opiates withdraw
of the drug • benzodiazepines slowly
(e.g., insomnia,
anxiety)
Failure • Common Resistance to • Increase
(Unexpected Failure • Dose related antimicrobial agents dosage
of Theraphy) • Often caused by • Consider
drug interactions effects of
concomitant
therapy
• clinical response to the administration of a
drug combination that is different from the
anticipated effects of the two drugs when
given alone
 Food and drugs Interaction
• milk decreases the absorption of antibiotics
such as tetracycline or ciprofloxacin
• Food interfere with captopril absorption
Herb medicines –drugs interaction
• ginkgo biloba may increase the effect of
anticoagulants
• calcium supplements may reduce the
absorption of thyroid supplements
• beta-agonist (salbutamol) berikatan dengan
reseptor adrenergic receptors relaksasi otot
pernafasan. Beta blocker (propanolol)
menghambat reseptor beta agonist.
Kombinasi kedua obat dapat menurunkan
efektivitas kedua obat tersebut (antagonis)
• Aspirin (antiplatelet) dan heparin mencegah
pembekuan darahpemakaian bersama
resiko bleeding (additive)
• Kombinasi penggunaan antihipertensi, untuk
menurunkan tekanan darah (sinergi)
 Assesment of suspect ADRs
Several methods for assigning ADR causality
probability have been developed e.g :
• World Health Organization – Uppsala
Monitoring Centre (WHO-UMC)
• Naranjo Scale (Dipakai Oleh BPOM)
• The Liverpool adverse drug reaction causality
tool.
Form Pelaporan Efek
Samping Obat
BPOM
1. Informasi Pasien

2. Informasi Efek Samping

3. Informasi Obat
Data Pasien

Skala Naranjo
 Bagaimana cara melaporkan?

Email : pv-
center@pom.go.ig
e-MESO
(http://e-meso.pom.go.id
Monitoring of patients who are at high
risk experiencing ADRs
• Polypharmacy
• Extremes of ages (Neonatal, pediatric and
geriatric)
• Presence of concurrent disease states (e.g
Impaired renal and Hepar function)
• Severity of illness
• History of allergy or previous ADR
• Pharmacodynamic/pharmacokinetic changes
 Monitoring of patients who are
receiving medications known to have a
high potential for causing ADRs
• Anticoagulants (e.g Heparin dan Warfarin)
• Antimicrobials (e.g penicilins, cephalosporins,
sulfa, and aminoglycosides)
• Antineoplastic
• Cardiac Agents (Antyarrythmics, digoxin, diuretic
and hypertensive)
• Central Nervous System (CNS) Agents e.g
Anticonvulsant and sedative
• Diagnostic agent (e.g contrast media)
 Monitoring
• Observasi : Gejala Klinis, Hasil Lab, Tanda-
tanda vital
• Analisis : Bandingkan dengan nilai normal
(Hasil lab), Gejala Klinis sebelumnya
• Action : Tulis Rekomendasi, hubungi klinis bila
obat harus dihentikan
 TINDAK LANJUT BPOM

1. Perubahan informasi produk (termasuk tetapi tidak

terbatas pada perubahan indikasi, posologi dan
pembatasan dosis)
2. Pembatasan penggunaan
3. Pembekuan izin edar
4. Pembatalan izin edar
5. Penarikan produk dari peredaran
 PHARMACOVIGILANCE
DI INDUSTRI FARMASI

Pemantauan dan pelaporan mengenai:

1. Aspek keamanan obat dalam rangka deteksi,
penilaian, pemahaman dan pencegahan efek
samping atau masalah lain terkait dengan
penggunaan
2. Perubahan profil manfaat-risiko obat
3. Aspek mutu yang berpengaruh terhadap
keamanan obat
 CONT…
Macam pelaporan di industri farmasi:
a. Pelaporan spontan (spontaneous reporting)
b. Pelaporan berkala pasca pemasaran (periodic
safety update report)
c. Pelaporan studi keamanan pasca pemasaran
d. Pelaporan publikasi/literatur ilmiah
Post Marketing Surveillance

Ni Made Amelia Ratnata Dewi

• No fixed duration/Patient population
• Starts immediately after marketing
• Report all ADRs
• Help to detect
• Rare ADRs
• Drug interaction
• Also new uses for drugs[sometimes called
Phase V]
 Metode Surveilans
• Controlled clinical trials,
• Spontaneous or voluntary recording
• Cohort studies
• Case control studies
 Laporan Spontan
• A communication from an individual (e.g:
health care professional, consumer) to a
company or regulatory authority .
• This describes a suspected adverse event(S)
• But the actual incidence of adverse drug
reaction can not be determined through
spontaneous reporting.
• Levomethorpan isomer dari dextromethor
pan
• Turunan opioid  5x lebih kuat dari morfin
• Tidak pernah dipasarkan di Amerika
THANK YOU