Download - DIPENSING SITOSTATIKA - iKnow
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DIPENSING SITOSTATIKA
Drs. Muhammad Yahya., Sp.FRS, Apt
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Disampaikan Pada Acara In House Training RS PHC
Surabaya, 13-14 November 2018
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Tujuan Umum
Memahami fasilitas / kebutuhan dalam melakukan Dispensing Sediaan Steril
Memahami penggunaan APD Memahami Telaah Rekam Pemberian Obat
Sitostatika dan Parenteral Memahami penyiapan dispensing sediaan
pencampuran obat suntik sitostika Memahami tenik aseptis
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Pokok Bahasan
Pendahuluan Fasilitas pencampuran sediaan steril Alat pelindung diri (APD) Telaah RPO Penyiapan pencampuran sediaan steril
Obat, Pelarut, wadah alkes, etiket, dll Tehnik aseptik
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Definisi
Dispensing sediaan steril merupakan rangkaian perubahan bentuk obat dari kondisi semula menjadi produk baru dengan proses pelarutan atau penambahan bahan lain yang dilakukan secara aseptis oleh apoteker di sarana pelayanan kesehatan
Tehnik aseptik adalah Pelaksanaan suatu prosedur dibawah kondisi yg terkontrol utk mencegah atau meminimalkan terjadinya kontaminasi mikro organisme atau partikel kontaminan (mempertahankan sterilitas sediaan
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Ruang Lingkup Dispensing Sediaan Steril
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Ø Pencampuran Obat SuntikØ Pengemasan ulang (repackaging)
obat injeksi Ø Penyiapan Nutrisi Parenteral Ø Penanganan Sediaan Sitostatika
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Permasyalahan
Tidak Aman
Kotak Aseptis
Bangzal
R Terbuka
Dispensing Cytotoxic drugs
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Dasar Hukum
PMK No 72 Tanun 2016 tentang Standar Pelayanan Kefarmasian di
Rumah Sakit, dispensing sediaan steril harus dilakukan di Instalasi Farmasi dengan tehnik aseptik.
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Pelayanan Sdiaan Steril
Dispensing Sediaan
Steril
Unit Pelayanan
Unit Pelayanan
Unit Pelayanan
Unit Pelayanan
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Tujuan Dispensing Sediaan Sterilq Menjamin px menerima obat sesuai
dengan dosis yang dibutuhkan q Menjamin sterilitas dan stabilitas q Melindungi petugas dari paparan zat
berbahayaq Menghindari kesalahan pemberian obat
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Penangan Sitostatika Membutuhkan
q Sumber Daya Manusiaq Ruangan q Peralatan
qAlat Pelindung Diri (APD)qBiological safety cabinet (BSC)
q Tehnik aseptis Pelatihanq Distribusi / penyimpananq Penanganan limbah
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Sumber Daya Manusia
Apoteker Ø Mempunyai skill penyiapan dan pengelolaan
komponen sediaan steril termasuk prinsip teknik aseptis.
Ø Memiliki kemampuan membuat prosedur tetap Ø Meningkagtn pengetahuan dan ketrampilanTenaga Teknis KefarmasianTTK Ø Sehat jasmani & rohaniØ Tidak merencanakan kehamilan, hamil,
menyusui (penanganan sitostatika)
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Ruangan12
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Ruangan
Ruang PersiapanAdministrasi dan penyiapan alkes , obat,
pelarut-wadah (etiket, pelabelan, penghitungan dosis dan volume cairan).
Ruang cuci tangan dan ganti pakaian Ruang Antara (ante room) Ruang Steril (Clean room)
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Ruang Steril
q Jumlah partikel berukuran 0,5 mikron → tidak lebih 350.000 partikelq Jumlah jasad renik : ≤ 100 / m3
q Suhu 18 – 22°Cq Kelembaban 35 – 50%q High Efficiency Particulate Air (HEPA) Filterq Tekanan udara di dalam ruang lebih positif
dari pada tekanan udara di luar ruangan.q Pass box
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RUANG BERSIH (CLEAN ROOM)
Kondisi ruang terkontrol :suhu : 18 – 22 ° Ckelembaban : 35 – 50% tekanan udara (positif pressure, negatif pressure)suplai udara ke dalam clean room disaring dengan hepa filter
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Permukaan lantai dan dinding dibuat dari bahan yang mudah dibersihkan lapisan (epoksi/vinyl) & sudut dibuat melengkung
RUANG BERSIH (CLEAN ROOM)
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RUANG BERSIH (CLEAN ROOM)
Ruang dibersihkan dan didesinfeksi secara berkala harian mingguan bulanan
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Ada ruang antara (ante room):Kegiatan cuci tangan, memakai APD
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Alat Pelindung Diri (APD)
ü Coverall (baju pelindung)ü maskerü Kaca mata googles (untuk handling sitotatika)ü Sarung tangan poeder free untuk sitostatika rangkap2ü Sarung kakiü Penutup rambut
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Pass Box
Untuk memasukkan dan mengeluarkan obat & peralatan ke ruang bersih)
→ Interlock mencegah aliran udara antara 2 ruang
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Biohazard Safety Cabinets (BSC)
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Class I BSC
Only operator protection (no product protection).
Biosafety level 1,2,3 Inflow away from operator. HEPA filtered exhaust to
environment. Current trend: Switch to
Class II
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Class II BSC: Basics
Both operator and product protection Biosafety level 1, 2, 3 Inflow away from operator HEPA filtered exhaust to environment HEPA filtered laminar downflow Volatile Toxic Chemical in cell culture:
biological & chemical -> need ducting Class II BSC: Basics
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Class II Type A1 , A2 BSC Airflow
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Class II Type A1 vs A2: Negative Pressure Isolated Plenum
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Class II B1 - B2 BSC Airflow
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Class II BSC: Ducting
Class II BSC with no duct can’t be used if toxic chemicals are used - Chemical vapor buildup in lab is dangerous
Class II,Type A2 with optional thimble duct: - Suitable for non-toxic chemicals - Not suitable for volatile (vaporizing) chemical - Re-circulation of hazardous chemical vapor is bad
Class II Type B2 with built-in hard ducting: - Suitable for volatile (vaporizing) chemical
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Class II BSC: Ducting
Thimble ducting: have holes for room air - Building exhaust fluctuations affect cabinet airflow
Hard ducting: no holes; difficult >> fluctuations - Building exhaust must precisely match cabinet
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Class III BSC
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Cytotoxic Safety Cabinet Cytotoxic drug (ex: cancer drug)
is very hazardous for the technician who change the filter, and it can not be neutralized by formalin or hydrogen peroxide
The first exhaust filter, located under the work tray, can be sealed and removed when the cabinet is still running, so the negative pressure protects the technician. This filter prevents particle spread inside cabinet, unlike if Class II type B2 is used
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Cytotoxic Safety Cabinet Cytotoxic drug (ex: cancer drug)
is very hazardous for the technician who change the filter, and it can not be neutralized by formalin or hydrogen peroxide
The first exhaust filter, located under the work tray, can be sealed and removed when the cabinet is still running, so the negative pressure protects the technician. This filter prevents particle spread inside cabinet, unlike if Class II type B2 is used
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Laminar Flow Cabinets
Definition of laminar / unidirectional flow: Air flow straight, parallel pass in enclosed space
Principle of laminar flow cabinet: Sterilize air though filter and blow it across work surface as a particle-free laminar air stream
Typical laminar air flow velocity: 0.3 - 0.5m/s
Purpose of a laminar flow cabinet: Product protection only (does not protect operator) Laminar Flow Cabinets
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LAF Laminar Flow Cabinet (Clean Bench): - Product protection (no personnel protection) - Not for biohazard agents or chemical fumes
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Horizontal vs. Vertical
Advantage of Vertical Laminar Flow Cabinet:
- No blocking caused by large object - Not blowing air straight to operator’s face 8hrs/day
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Horizontal vs. Vertical
Advantage of Horizontal Laminar Flow Cabinet:
- Easier to put sensitive object near HEPA filter
- Not blowing dust on straight to sensitive object
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Dispensing Sitostatika vs Nonsitostatika
Sitostatika NonsitostikaTekanan Aliran udara
Tekanan Negatif Tekanan Positip
Alat BSC LAFGoogle Ya tidakSarung Tangan Double
(nonpowder)Singgle (Nonpoeder
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HANLING SITOSTATIKA
Drs. Muhammad Yahya., Sp.FRS, Apt
37
Disampaikan Pada Acara In House Training RS PHC
Surabaya, 13-14 November 2018
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Paparan Sitostatika
Karsinogenik Dapat menyebabkan kanker.
Mutagenik Dapat menyebabkan mutasi genetik.
Teratogenik Dapat membahayakan janin.
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Mekanisme Paparan Sitastatika Inhalasi → Terhirup pada saat rekostitusi Absorpsi → Masuk dalam kulit jika
tertumpah Ingesti → Kemungkinan masuk jika tertelan
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Ø Personil Administrasi (Penyiapan )Ø Personil Pencampuran
Personil Dispensing Sitostika
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Persiapan Handling Sitostatika
Telaah RPO Kemo
Entry Data
Penyiapan obat, alkes, pelarut, wadah dan etiket
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Telaah RPO Kemo
Kelengkapan Administrasi Kelengkapan pengisisan RPO kemo Indikasi ü Sesuai dg Protokol ü Sesuai dg Restriksi Penggunaan (Fornas)
Dosisü Tailor dose ü Sesuai dg Restriksi Peresepan maksimal (Fornas)
Kelarutan & Stabilitas
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Kelengkapan Administrasi
KTP/KSK Surat Jaminan Protokol terapi Hasil PA (Biopsi) / Pemeriksaan spesifik
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Indikasi sesaui dg protokol Obat Sitostaika bisa di tagihkan terpisah ke BPJS Agar bisa ditagihkan harus memenuhi persyaratan (Verifikasi BPJS)
Ø Obat sitostika hanya untuk penyakit Kanker Ø Indikasi ditunjang dg hasil PA (Biopsi) Pemerisaan
spesifik Ø Indikasi memenuhi Restriksi penggunaan
Indikasi 44
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Personil Administrasi (Penyiapan) Mengkaji RPO sitostatika Menghitung dosis, kelarutan Mengentri data Menyiapkan alkes dan bahan obat, pelarut
dan wadah, etiket Memasukkan alkes, bahan obat, etikat ke
dalam pass box Mengecek (identifikasi, jumlah dan
kesesuaian) Sebelum, selama dan sesudah pengerjaan
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Perhitungan dan Persamaan … (1)
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A. Body Surface Area BSA = Tinggi (cm) x BB
(kg)
3600
B. Creatinine Clearance (CrCl) Cockcroft and Gault,
CrCl female = [140-Umur(th)] x BB(kg) x 0.85 72 x
Scr CrCl ~ GFR
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Perhitungan Dosis dan Persamaan A. Body Surface Area (Mosteller) BSA = Tinggi (cm) x BB
(kg)
3600
B. Body Mass Index BMI = BB (Kg) Tinggi (m2)
BMI ≥ 30 obese
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C. Creatinine Clearance (CrCl) Cockcroft-Gault Jika Px tidak
Obese CrCl = {(140 – age) BW}/ 72xScr
untuk wanita dikalikan 0,85
q Salazar-Corcoran Jika Px Obese Corcoran
Wt dlm kg ; Ht dlm m
(Bauer LA., 2008)
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Jelliffe jika px tidak diketahui BB/tinggi nya CrCl = (98 - 0.8[umur – 20]) x 0.9 Scr Scr sebaiknya ≥ 0.6 mg/dL. If < 0.6 mg/dL gunakan 0.6 mg/dL
D. Menghitung dosis cARBOplatin Calvert Formula
Dosis cARBOplatin = AUC x [CrCl + 25].5
Di SMF Obgin Disepakati AUC = 5 Ca Endometrium Ca Ov Yg menggunakan (Gemci-
cARBO ; DOCE-cARBO) AUC = 6 Ca Cervix, Ca Ov
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Penyesuaian Dosis Taxane50
PACLItaxel
DOCEtaxel
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Penyesuaian Dosis CISplatinGFR DOSIS CISplatin (mg/m2)
> 60 100 %
50 – 59 75 %
40– 49 50 %
< 40 Ganti CARBOplatin
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Penyesuaian Dosis CARBOplatin
52 GFR DOSIS CARBOplatin
> 60mg CARBOplatin = AUC
(GFR+25)
41 – 59mg CARBOplatin = LPT x
250
16 – 40mg CARBOplatin = LPT x
200
< 16 Jangan diberikanCARBOplatin :Jika GFR > 60 Dosis CARBOplatin ditentukan dg Calvert formulaJika GFR < 60 Dosis CARBOplatin ditentukan dg membandingkan Callvert dg LPT Hasil dipilih yang kecil
Calvert
LPT
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Ca Ov post TAH BSOPacli Carbo IV
Ny SKM01.03.64126540xx
Merpati73 160 1.80
Paclitaxel22.03.1
8
315,2 mg
1
1
Dr HDI
NaCl 0,9 %, 500 ml
IV
DGDP/GD2JPP : 95/101
34 th Scr 0,76
Mereview dan Mengisi RPO Kemo
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D5 %, 250 ml
Dr HDI
I
1IV
Carboplatin
22.03.18
735,1mg
Disi oleh dr/perawat
Disi oleh Farmasi
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Perhitungan Dosis
Dari Protokol Dosis Paclitaxel : 175 mg/m2 Dosis Carboplatin : (GFR + 25)*AUC
AUC-6 Dari Aplikasi masukkan
TB = 160 kg ; BB = 73 kg ; SCr = 0,76 Didapat :
Dosis Paclitaxel : 315,2 mg Dosis Carboplatin 871,2 mg
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Perhitungan Dosis dg Apilkasi
Entry data :Tinggi Badan, Berat Badan, Umur, Serum kreatinin
IMT < 30 : Nonobese≥ 30 : Obese
GFR IMT < 30 : Lihat GFR NonbeseIMT ≥ 30 : Lihat GFR obese
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Kadar, Pelarut dan Stabilitas Sitostatika
BC Cancer Agency Cancer Drug Manual Chemotherapy preparation & stability chart Drugs A to K Drugs L to Z
Gaharts 2018, Intravenous Medication
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Volume yang diambil
Paclitaxel 315,2 mg (300 + 15,2) mg Dari 300 mg/50 ml diambil (1 vial = 50 ml) Dari 30 mg/5 ml diambil 15,2/30 x5 ml = 2,53ml
Carboplatin 871,2 mg (450 + 421,2) mg Dari 450 mg/45 ml diambil (1 vail = 45 ml Dari 450 mg/45 ml diambil 421,2/450x 45
ml = 42,12 ml
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Dari RPO Preparation and Stabilitity Cahrtq Paclitaxel 315,2 mg dilarututkan dlm 500 ml NaCl 0,9 % 315 mg/500 mL = 0,63 mg/ml dalam rentang (0,3-1,2) Stabilitas stl di oplos, 24 jam pd suhu kamar
q Carboplatin 871,2 mg dilarutkan dlm 250 ml D5 % 871,2 mg/250 ml =3,48 mg/ml dalam rentang (0,3-10)
Stabilitas stl di oplos , 24 jam pd suhu kamar, 48 jam pd suhu 2-8 oC
Kelarutan dan Stabilitas59
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Etiket mencantumkan :1. Identitas pasien (nama,no.reg/tgl lahir,
ruangan)2. Nama obat dan cairan infus yang dicampur3. Dosis obat dan volume cairan infus4. Tanggal pencampuran5. Waktu kadaluwarsa (Beyond Use Dated)6. Volume akhir 7. Kecepatan pemberian/drip
Etiket 60
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Ca Ov post TAH BSOPacli Carbo IV
Ny SKM01.03.64126540xx
Merpati73 160 1.80
Paclitaxel
Fonkopac
22.03.18
Minta infuset dan wadah bebas PVC/DEHP
315,2 mg
52,5
1
1
Dr HDI
NaCl 0,9 %, 500 ml
rr nnt
Pk. 13.00 25.03.18 500 ml
M. Yahya Apt
IV
23.03.18
DGDP/GD2JPP : 95/101
34 th Scr 0,76
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Dosis di setujui 871,2 mg (AUC = 6)
D5 %, 250 ml
rr nnt
Pk. 13.00 24.03.18337,1 Dr Handi M. Yahya Apt
I
1IV
Carboplatin
Carboplatin22.03.18
735,1mg
87,1
Disi oleh dr/perawat
Disi oleh Farmasi
23.03.18
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Pemberian Etiket
Etiket mencantumkan :1. Identitas pasien (nama,no.reg/tgl lahir,
ruangan)2. Nama obat dan cairan infus yang
dicampur3. Dosis obat dan volume cairan
infus4. Tanggal pencampuran5. Waktu kadaluwarsa (Beyond Use
Dated)6. Volume akhir 7. Kecepatan pemberian/drip
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Personil Pencampuran Sediaan Sitostatika
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Personil Pencampran Sediaan Sitostatika Memakai APD
Mamakai baju dalam Cuci tangan Memakai baju luar (steril) Tutup kepala Memakai Masker Memakai Sarung Tangan
Menylakan Alat BSC Tehnik Aseptis dispensing
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TEHNIK ASEPTIS DSIPENSING
Drs. Muhammad Yahya, Apt. Sp.FRS
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Atehnik septis Diapensing
Pelaksanaan suatu prosedur dibawah kondisi yg terkontrol
utk mencegah atau meminimalkan terjadinya kontaminasi mikro organisme atau partikel kontaminan
(mempertahankan sterilitas sediaan).
Pelatihan
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Ditjen Binfar & Alkes, Depkes RI, 2009, Pedoman Dasar Dispensing Sediaan Steril
Ditjen Binfar & Alkes, Depkes RI, 2009, Pedoman Pencampuran Obat Suntik dan Penanganan Sediaan Sitostatika.
Gaharts 2018, Intravenous Medication Pharmacy Practice for
Technicians.Preparing Sterile Intravenous Product.
USP, 797, Sterile compounding of pharmaceutics
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Ditjen Binfar & Alkes, Depkes RI, 2009, Pedoman Dasar Dispensing Sediaan Steril
Ditjen Binfar & Alkes, Depkes RI, 2009, Pedoman Pencampuran Obat Suntik dan Penanganan Sediaan Sitostatika.
Gaharts 2018, Intravenous Medication Pharmacy Practice for
Technicians.Preparing Sterile Intravenous Product.
USP, 797, Sterile compounding of pharmaceutics
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