Monitoring Efek Samping Obat 12.pdf
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Transcript of Monitoring Efek Samping Obat 12.pdf
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Monitoring Efek Samping Obat
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Managing ADRs
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Dr. Donald Brodie, 1965 :
“ The ultimate goal of the
Services of Pharmacy
must be
the SAFE USE of DRUGS
by the Public “
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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
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Definitions
• Quality of life (Schron & Schumaker)
a multidimentional concept referring to a person’s 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
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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
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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
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ANGKA KEJADIAN
• HAMPIR SEMUA OBAT YG EFEKTIF DPT MENIMBULKAN ESO
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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.
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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
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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)
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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”
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• 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
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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
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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
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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
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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
NDA REVIEW
POSTMARKETING SURVEILLANCE PHASE IV :
Patients given drug for therapy
In vitro
Safety, biological effects,
Metabolism, Kinetics,
Drug interactions
ADR, patterns of drug utilization,
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FAKTOR YG BERPENGARUH TIMBULNYA EFEK SAMPING
DRUG DOSE ROUTE DURATION PREPARATION
PATIENT PHARMACOKINETIC VARIABLES AGE GENETICS ALLERGY
INFORMATION ABSENT OR IN ADEQUATE
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PERAN FARMASIS thd EFEK SAMPING ?
• MEMAHAMI ADR DGN INFO TERKINI
• MENGENALI ADR
• INTERVENSI
– STOP/TETAP OBAT
– KONSELING
– PENANDA
• EFEKTIF MELAPORKAN KEJADIAN
• SISTEM MESO
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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
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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.
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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
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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
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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
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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
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Alamat pelaporan
2004
183
RS 74.7%
2003
70
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Safe use of prescription medication
• Avoid agents - either food, 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