Monitoring Efek Samping

Obat

Managing ADRs

Dr. Donald Brodie, 1965 :

The ultimate goal of the
Services of Pharmacy
must be
the SAFE USE of DRUGS
by the Public

Efek Samping Obat (ADR)

ADR : an effect which is noxious and
unintended, and which occurs at
doses used in man for prophylaxis,
diagnosis or therapy (WHO)
Adverse drug event : an injury
resulting from medical intervention
related to a drug (Bates et al,
1995b)
Medication error : an error in
ordering, transcribing, dispensing,
administering a medication

Definitions
Quality of life (Schron & Schumaker)
a multidimentional concept referring to a persons total
well-being including his or her psychological, social and
physical health status
the value assigned to duration of life as modified by the
impairments, functional status, perception and social
opportunities that are influenced by diseases, injury,
treatment or policy (Patrick & Erickson)
HEALTH OUTCOME =
HEALTH-RELATED QUALITY OF LIFE

2006 Patient-Specific Clinical

Pharmacy Services in Hospitals
Pharmacokinetic Consultation
ADR Management
Drug Protocol Management
Drug Therapy Monitoring
Medical Rounds Participation
Drug Therapy Counseling
TPN Team Participation
CPR Team Participation
Admission Drug Histories

87%
81%
77%
63%
51%
46%
45%
37%
7.5%

Bond CA, Raehl, CL. Pharmacotherapy 2008;28(1):1-13.

7 Hospital Clinical Pharmacy

Services Save Lives

Drug use evaluation

In-service education
Adverse drug reaction management
Participation on CPR team
Drug protocol management
Participation on medical rounds
Admission drug histories
Bond CA, Raehl CL. Clinical Pharmacy Services, Pharmacy Staffing,
and Hospital Mortality Rates. Pharmacotherapy 2007;27(4):481-493.

Clinical Pharmacy Services

Improve Care
Decreased
Adverse drug events
Adverse medication reactions
Medication errors

Improved
Medication adherence
Drug knowledge
Appropriate medication use

Shortened length of hospital stay

Kaboli PJ et al. Clinical Pharmacists and Inpatient Medical Care:
A Systematic Review.
Arch Intern Med. 2006;166:955-964

ESO
SETIAP EFEK OBAT YG DPT
MEMBAHAYAKAN / MERUGIKAN SI
PEMAKAI, JANIN YG DIKANDUNG
MAUPUN BAYI YG BARU LAHIR
ESO INI, YI/ EFEK SAMPING PD DOSIS
NORMAL UNT. TUJUAN PROFILAKSIS,
DIAGNOSIS MAUPUN PENGOBATAN.
PENGGUNAAN OBAT YG MENINGKAT
DOSIS MAUPUN FREK. NYA APT ADIKSI
JUGA DIMASUKKAN DLM ESO

ANGKA KEJADIAN
HAMPIR SEMUA OBAT YG EFEKTIF
DPT MENIMBULKAN ESO

PENYEBAB ESO
REAKSI AKIBAT KELAIANAN BAWAAN
ALERGI :TJD KRN MEKANISME IMUNOLOGI,
SIFAT: TDKA ADA HUB. DGN SIFAT
FARMAKOLOGI, TIMBUL PD DOSIS KECIL
ESO KRN KELAINAN GENETIK

ESO KRN KELAINAN YG DIDAPAT, EX:

ADANYAGANGGUAN HATI YG
MENGGANGU DETOKSIFIKASI OBAT,
GANGGUAN GINJAL YG MENGGANGU
ELIMINASI OBAT MISAL GENTAMISIN
BISA MENYEBABKAN TULI.

PENYEBAB ESO
KELAINAN AKIBAT BENTUK SERTA
CARA PEMBERIAN OBAT
RX YG TJD AKIBAT BPERUBAHAN
BIOAVAIALBILITAS, ATAU CARA
PEMBERIAN YG KURANG TEPAT : MISAL
EFEKA DITIF, BAHAN PELARUT,
PENGAWET YG DITAMBAHKAN SAAT
PEMBUATAN OBAT

INTERAKSI OBAT

FAKTOR PREDISPOSISI
TIMBULNYA ESO
SAAT TIMBULNYA REAKSI
ESO DAPAT TIMBUL PD AWAL
PENGOBATAN (AYOK ANAFILAKSIS KRN
PEMBERIAN PENISILIN)
SETELAH PENGOBATAN BERLANGSUNG
LAMA (RETINOPATI KRN PENGOBATAN
DGN KLOROKUIN)
TIMBUL LAMA SETELAH OBAT DIHENTIKAN
( KARSINOMA AKIBAT PEMBERIAN
DIETILSTILBESTEROL)

 UMUR
INSIDEN ESO MENINGKAT PD PENDERITA
MUDA & USIA LANJUT

KONDISI PATOFISIOLOGIS
BEBERAPA PENYAKIT YG MENYERTAI
PENDERITA BISA MEROBAH
FARMAKOKINETIK OBAT, ( HATI PRMBERIAN
BETA BLOKER PD ORANG ASMA)

JUMLAH OBAT YFG DIBERIKAN

PENGOBATAN YG TERLALU LAMA BISA
MENCETUSKAN TIMBULNYA ESO

JENIS KELAMIN
HASIL PENELITIAN : WANITA LEBIH MUDAH
MENGALAMI ESI DIBDG LAKI

 RIWAYAT ALERGI SEBELUMNYA

PENDERITA DGN RIWAYAT ALERGI SBLMNYA
LEBIH PEKA MENDAPAT RX. ESO BERBENTUK
ALERGI DAR PENDERITA NORMAL

MULTIPLE DRUGS THERAPI

MAKIN BANYAK JUMLAH OBAT YG DIBERIKAN
MAKIN > KEMUNGKINAN KENA ESO

FAKTOR RASIAL ATAU GENETIK

DIDUGA ADA PENGARUH RASIAL / GENETIK
UNTUK TIMBULNYA ESO TERTENTU

Masalah - DAMPAK
Assessment SEJARAH EFEK SAMPING, UMUR,
GENETIK
PASIEN TDK MENDAPAT INFO CUKUP TENTANG
EFEK SAMPING
IDENTITAS/PENANDA PERNAH MENGALAMI
EFEK SAMPING
EFEK SAMPING AKIBAT TIDAK MENDAPAT OBAT
YANG TEPAT
MORBIDITAS TURUN
BIAYA

Macam ADR
TYPE A, intrinsic
Bisa diprediksi, dimungkinkan
pencegahan
Ada hubungan dengan dosis
Sering terjadi (70%-80%), tdk fatal

TYPE B, idiosyncratic

Sukar diprediksi
Tdk tergantung dosis
Seringkali fatal
Memerlukan populasi besar untuk
mengetahui kejadian
Umumnya individual sekali, tdk tampak
dlm binatang

ADWE, widrawal events

Efek Samping Obat,

Kenapa perlu diMonitor ?
Merupakan dampak negatif dari
pengobatan
Kontra produktif terhadap
pengobatan rasional
Tingkat kejadian relatif kecil
Dipengaruhi faktor individual pasien
Keterbatasan prediksi dalam proses
pengembangan obat baru

The phases of drug development in the US

(Smith, 1978; Kaitlin et al.,1987; and Young et al., 1988)

PRECLINICAL TESTING
Animal
CLINICAL TESTING
PHASE I : Normal volunteers
PHASE II : selected patients
PHASE III : large sample of
selected patients

In vitro
Safety,
biological effects,
Metabolism,
Kinetics,
Drug interactions

NDA REVIEW
POSTMARKETING SURVEILLANCE
PHASE IV :
Patients given drug for therapy

ADR,
patterns of drug utilization,

FAKTOR YG BERPENGARUH TIMBULNYA

EFEK SAMPING
DRUG
DOSE
ROUTE
DURATION
PREPARATION

PATIENT
PHARMACOKINETIC VARIABLES
AGE
GENETICS
ALLERGY

INFORMATION
ABSENT OR IN ADEQUATE

PERAN FARMASIS thd EFEK SAMPING ?

MEMAHAMI ADR DGN INFO TERKINI
MENGENALI ADR
INTERVENSI
STOP/TETAP OBAT
KONSELING
PENANDA

EFEKTIF MELAPORKAN KEJADIAN

SISTEM MESO

FLOWCHART OF ASSESSMENT
AND MANAGEMENT OF AN ADR
DETECTION
OF POSSIBLE ADR

PUBLISHED LITERATURE REVIEW

PATIENT-SPECIFIC DATA

COMPARE PX REACTION TO
DESCRIPTION IN THE LITERATURE
CONTINUE DRUG

EVALUATE SEVERITY
DECHALLENGE
EVALUATE PATIENT

RECHALLENGE

QUESTION
9.1.1

Naranjo
algorithm

YES

NO

DO
NOT
KNOW
0

Are there previous conclusive reports on

+1
0
this reaction?
9.1.2
Did the adverse event appear after the
+2
-1
0
suspected drug was administered?
9.1.3
Did the adverse reaction improve when the
+1
0
0
drug was discontinued or specific
antagonist was administered?
09.1.4 Did the adverse reaction reappear when the +2
-1
0
drug was readministered?
9.1.5
Are there alternative causes (other than the -1
+2
0
drug) that could on their own have caused
the reaction?
9.1.6
Did the reaction reappear when a placebo
-1
+1
0
was given?
9.1.7
Was the drug detected in the blood (or
+1
0
0
other fluids) in concentration known to be
toxic?
9.1.8
Was the reaction more severe when the
+1
0
0
dose was increase, or less severe when the
dose was decreased?
9.1.9
Did the patient have a similar reaction to
+1
0
0
the same or similar drugs in any previous
exposure?
9.1.10 Was the adverse event confirmed by any
+1
0
0
objective evidence?
TOTAL SCORE
SCORE : Adverse event possible : 1-4; probable= 5-8; definite = 9 or more
Maximum possible score = 13

Pendekatan PELAPORAN
MESO
Voluntery,
baik untuk penemuan ESO baru
Lebih menjanjikan dari pendekatan lain

Cohort study
Kerjasama tim (dokter, farmasis, perawat)
Frekuensi Eso selama rawat

Mandatory
Keharusan bedasar aspek legal
Data tinggi, validitas diragukan

Record linkage
Catatan medik, bervariasi ESO terliput
Data terlalu bervariasi

Pelaporan MESO RAWAT JALAN RS

Bethesda

KELOMPOK FARMAKOLOGI
N = 29 kasus (Juni - Des 2004)
7% 3%
0%

52%
38%

0%

Antiinfeksi
Otot Skelet & Sendi
Sal. Napas
SSP
Kardiovaskuler
Sal. Cerna
Hormon

MANIFESTASI ESO
N=29 kasus (Juni-Des 2004)
3%

7%

Kulit
Saluran Cerna

10%

39%

Saluran Napas
Sistem saraf

10%

Kardiovaskuler
Mata

3%

Extremitas
28%

What is the role of pharmacist in PTC

Managing adverse drug reactions (ADRs)
- the pharmacist must address the issue of adverse
drug reactions on a regular basis since hospital
admissions resulting from adverse drug reactions
accounts for 3-7% of patients. These do not
include errors of administration, which would only
increase the total incidence of morbidity and
mortality.

Managing ADRs
Pharmacists should facilitate :
- analysis of each reported ADR
- identify the drug and patient at high risk for being
involved in ADRs
- develop policies and procedures for ADR monitoring
and reporting program
- use ADR program for educational purposes
- develop, maintain and evaluate ADR records within
the organization
- report serious ADR to Ministry, FDA or manufacturer

Manfaat pelaporan
Perubahan Kebijakan NasionaL
(Kasus penarikan obat ppa-FDA)
Perubahan Kebijakan Lokal ( rumah
sakit)
Praktisi waspada dalam farmakoterapi
Mencegah timbulnya efek samping
berulang
Informasi munculnya efek samping
yang baru dan membahayakan

Manfaat klinik
Informasi penting dalam
pengambilan keputusan : Rasio
manfaat terhadap resiko
Informasi terkini untuk pendekatan
kondisi pasien terhadap respon obat
Mencegah kejadian kembali pada
kasus serupa
Menurunkan morbiditas dan
mortalitas

Kerjasama
Keamanan masyarakat dalam aspek
obat adalah tanggung profesi
kesehatan
Perlu sistem kerjasama dengan
masyarakat luas dan PIHAK TERKAIT
(Pemerintah)
Terbuka untuk komunikasi nasional
maupun internasional

Alamat pelaporan

2004
183
2003
70

RS
74.7%

Safe use of
prescription
Avoid agents - either
food,
medication
alcohol, other drugs - that
may decrease effectiveness or
increase side effects.
Recognize side effects and
know what to do if they occur.
Understand indications and
expectations for the
prescribed agents
Periodically review
medications
Get prescription refilled in
advance