Pengkajian,‭‭‭‭Rekomendasi

dan Pelaporan Adverse Drug

Reaction di Rumah Sakit
Dr. WIDYATI, MClin Pharm, Apt
Farmasis Klinik RSAL dr Ramelan
Manajemen ESO
AKTIF (mencari
PASIF
ADR saat
(menunggu
PTO/Pharm
laporan dr, wat)
Care)

Data Data
collection collection

ADR Analysis ADR Analysis

Rekomendasi Rekomendas

Pelaporan Pelaporan
 ADE vs ADR

ADE‭as‭“any‭untoward‭
medical occurrence that may
present during treatment
with a pharmaceutical
product but which does not
necessarily have a causal
relationship with this
treatment”.

ADR‭as‭“a‭response‭to‭a‭
drug which is noxious and
unintended and which
occurs at doses normally
used in man for prophylaxis,
diagnosis, or therapy of
disease or for the modi
cation of physiologic
function.”‭(WHO‭2005)
 SERIOUS ADVERSE DRUG REACTION

A serious adverse event or reaction is any

untoward medical occurrence that at any dose:
• results in death
• requires inpatient hospitalisation or
prolongation of existing hospitalisation
• results in persistent or significant
disability/incapacity
• is life-threatening
 Potential ADR
• Clinically significant ADR yang perlu dilaporkan
• Jangan melaporkan semua ADR dari DI
Checker, ESO yg tertera pd Lit 3rd
• Clinically significant= insiden besar, tingkat
keparahan tinggi.
 Pengkajian ADR
Match each drugs-ADR listed in 3rd literature

Untuk mempersempit dugaan obat pemicu

Assessing the timing between administration of the drug and development of the
reaction is important.

Sesuaikan dengan waktu paruh

Identify patterns in ADR symptoms

Do the symptoms t the normal pharmacology Have case reports been published on this
or allergy pro le of the drug? reaction?
 CAUSALITY ASSESSMENT
• Several algorithms and probability scales have
been developed to assist with causality
determination. Among those published are
the Jones algorithm, the Yale algo- rithm, the
Karch algorithm, the Begaud algorithm, and a
quantitative approach algorithm (Srinivasan
2011)
• Naranjo ADR Probability Scale (Naranjo 1981).
• Liverpool ADR causality assessment tool
 DIPS
Questions Yes No Not
known or
NA
1. Are there previous credible reports of this +1 -1 0
interaction in humans?
2. Is the observed interaction consistent with the +1 -1 0
known interactive properties of precipitant
drug?
3. Is the observed interaction consistent with the +1 -1 0
known interactive properties of object drug?
4. Is the event consistent with the known or +1 -1 0
reasonable time course of the interaction (onset
and/or offset)?
5. Did the interaction remit upon dechallenge of +1 -2 0
the precipitant drug with no change in the object
drug? (if no dechallenge, use Unknown or NA
and skip Question 6)
6. Did the interaction reappear when the -2 +1 0
precipitant drug was readministered in the
 DIPS continued ......
7. Are there reasonable alternative causes for -1 +1 0
the event?a
8. Was the object drug detected in the blood or +1 0 0
other fluids in concentrations consistent with the
proposed interaction?
9. Was the drug interaction confirmed by any +1 0 0
objective evidence consistent with the effects on
the object drug (other than drug concentrations
from question 8)?
10. Was the interaction greater when the +1 -1 0
precipitant drug dose was increased or less
when the precipitant drug dose was decreased?
 Scoring

• Highly Probable: >8

• Probable: 5–8
• Possible: 2–4
• Doubtful: <2
 REKOMENDASI

Stop Terapi Tambah Obat Ganti Suspected

Suspected lain utk atasi Drugs dg obat
Drugs ADR lain

Stop terapi SD Ganti SD &

Rechallenge bila
& tambah obat tambah obat
etis
lain untuk ADR lain untuk ADR
 PELAPORAN
INTERNAL RS
 Dilaporkan ke KFT
 Meningkatkan kewaspadaan PPA thd ADR
 Sangat berharga bagi pencegahan ADR di RS
NASIONAL
 Dilaporkan ke BPOM (online or written dg Form
Kuning)
 Sangat berharga bagi pencegahan ADR secara
nasional
 KESIMPULAN
• Establishing a pharmacovigilance and ADR
surveillance and reporting program is helpful
for ADR detection, evaluation, reporting, and
prevention.
• Pharmacists are ideal professionals to assist in
development of such programs.
 Thank you
To know of something that is
harmful to another person, who
does not know, and not telling, is
unethical
Not reporting a serious unknown
reaction is unethical