DISPENSING
What it is ?
• Aseptik dispensing is one of the pharmaceutical service
that handle the preparation and supply of the steril
preparations for the hospital
MENTERIKESEHATA
N REPUBLIK
INDONESIA
TENTANG
Standard MMU.5
Medications are prepared and dispensed in a and
safe clean environment.
1. Medications are prepared and dispensed in clean and safe areas with
appropriate equipment and supplies.
2. Medications preparation and dispensing adhere to law, regulation, and
professional standards of practice.
3. Staff preparing sterile products are trained in aseptic techniques
Standar pelayanan Farmasi RS PMK 58 tahun 2014
(2) Persyaratan ruangan steril dan nonsteril harus
memenuhi kriteria Cara Pembuatan Obat yang Baik
(CPOB) untuk:
(a) Ventilasi ruangan;
(b) Suhu;
(c) Kelembaban;
(d) Intensitas cahaya.
(3) Pemasangan instalasi harus sesuru kriteria CPOB
untuk:
(a) Pipa saluran udara;
(b) Lampu;
(c) kabel dan peralatan listrik.
Kelas A: Zona untuk kegiatan yang berisiko tinggi, rnisal zona pengisian,
wadah tutup karet, arnpul dan vial terbuka, penyarnbungan secara aseptis.
Urnurnnya kondisi ini dicapai dengan rnernasang unit aliran udara laminar
(laminar air flout; di ternpat kerja. Sistern udara laminar hendaklah
rnengalirkan udara dengan kecepatan rnerata berkisar 0,36 - 0,54 rn/ detik
(nilai acuan) pada posisi kerja dalarn ruang bersih terbuka.
Keadaan laminar yang selalu terjaga hendaklah dibuktikan dan divalidasi.
Aliran udara searah berkecepatan lebih rendah dapat digunakan pada isolator
tertutup dan kotak bersarung tangan.
Kelas B: Untuk pernbuatan dan pengisian secara aseptis, Kelas 1n1 adalah
lingkungan latar belakang untuk zona Kelas A.
Kelas C dan D: Area bersih untuk rnelakukan tahap proses pernbuatan yang
rnengandung risiko lebih rendah.
CLEAN ROOM
Tujuan:
Menjaga agar kontaminasi partikel dan mikroorganisme
terjadi seminimal mungkin
JUMLAH
PARTIKEL
• Penetapan jumlah
maksimum partikel
berukuran lebih dari 0,5 µm
yang dapat diterima
• Ruangan Pencampuran/
Oplos harus sesuai standar
ISO Class-7
SUPLAI UDARA
CLEANROOM
HEPA FILTER HEPA FILTER HEPA FILTER
Ruang Ruang
Persiapan Gowning
Ruang
Oplos
DENAH CLEANROOM
Alur Petugas
Alur Barang/Obat
TEKANAN NON
CLEANROOM
SITOSTATIK
A +20 Pa
• Perbedaan
tekanan antar
ruangan :
10 s/d 15 Pascal
• Untuk cleanroom
non-sitostatika, +10 Pa +30
tekanan ruangan Pa
semakin kedalam
maka semakin
positif
TEKANANCLEANROOMSITOSTATIK
A
─ 20 Pa • Untuk cleanroom
SITOSTATIKA,
tekanan ruangan
semakin kedalam
maka semakin
NEGATIF
─ 10 Pa ─ 30 Pa
TEMPERATU DAN KELEMBABA
R N
CLEANROOM
TEMPERATUR
ruangan dijaga pada
suhu 22 oC s/d 23 oC
(atau lebih rendah)
KELEMBABAN
ruangan dijaga pada
50 – 60%
Bakteri : 0,2 – 2 µm
Hanya 0,03%
partikel
berukuran
> 0,3 µm yang
Aerosol : 1 – 10 µm bisa lewat
3. LAMINAR AIR FLOW (LAF)
CABINET
LAMINARAIR FLOW (LAF) CABINET
Laminar Air Flow Cabinet tipe horizontal
untuk pencampuran obat suntik yang
tidak berbahaya bagi petugas
Petugas
- Mulai dari
Bersihkan/ Bersihkan lantai dalam ke arah
Lakukan
menggunakan pintu keluar
pembersihan di pungut sampah
mop yang telah
pagi hari dan yang - Gerakan
dibasahi air
siang/sore hari berserakan searah dan
bersih
overlapping
PEMBERSIHAN LAF/BSC
Swab LAF/BSC setiap :
1. Sebelum memulai pekerjaan
2. Setelah selesai dan/atau akan menutup
LAF/BSC
Integrity Test
:
Tekanan Kelembaban Smoke Test
PAO/
Aeroso
l
Photometer
Mesin
APD lengkap, Perlengkapan Produk:
LAF/BSC Teknik aseptik
dikenakan pencampuran
disiapkan: yang benar Sediaan
dengan baik aseptik jadi steril
dihidupkan &
dan benar disiapkan
desinfeksi
Potensi ?
Potensi Bahaya Obat
Sitostatika
Hemminki K, Kyyronen P, Lindbohm ML. Spontaneous
• Hemminki K. (1985) abortions and malformations in the offspring of
nurses exposed to anaesthetic gases, cytostatic
drugs, and other potential hazards in hospitals, based
on registered information of outcome.
Penanganan obat J.Epidemiol.Community Health 1985 Jun;39(2):141-147
Nurses working in selected departments of general
sitostatika hospitals in Finland were collected from a central register
on health personnel in Finland. Using the Hospital
diasosiasikan Discharge Register and the Register of Congenital
dengan kelainan Malformations, case nurses were selected who had had a
spontaneous abortion (N = 217) or a malformed child (N =
yang
(malformasi)
muncul pada 46) between the years 1973 and 1979. Controls consisted
of three nurses who had had a normal birth; the control
janin nurses were matched for age and hospital of employment.
Information on exposure in the first trimester of pregnancy
was sought through the head nurses of the hospitals. No
significant increase in risk of spontaneous abortion or of
malformation was observed after exposure to anaesthetic
gases (odds ratio for spontaneous abortion 1.2), sterilising
gases and soaps, or x-rays. Handling of cytostatic
drugs did not affect the frequency of spontaneous
abortion but was associated with malformations in the
offspring. The odds ratio, based on eight cases, was 4.7
(p = 0.02) when the logistic model was adopted. The
results suggest that the exposures investigated, other than
cytostatic drugs, do not cause a strong reproductive risk.
Further studies are needed, particularly on cytostatic
drugs.
Potensi Bahaya Obat Sitostatika
Valanis B, Vollmer W, Labuhn K, Glass A.
Occupational exposure to antineoplastic agents and
self-reported infertility among nurses and
pharmacists. J.Occup.Environ.Med. 1997
Jun;39(6):574-580.
Although infertility has been identified as an effect of
chemotherapy for some cancer patients, the association of
infertility with occupational exposure has not been
investigated. This case-control study investigated the
relationship of infertility with occupational handling of
chemotherapy drugs by nurses and pharmacy personnel.
Data were gathered by questionnaire from 4659 staff at
facilities participating in the National Surgical Adjuvant
Valanis B. (1997) Breast and Bowel Project collaborative clinical trials
network of the National Cancer Institute. The 405 subjects
reporting infertility were each matched by sex and age
with three control subjects and compared for history of
chemotherapeutic drug handling. Results for the total
sample and for women showed a significantly elevated
Infertilitas (kemandulan) odds ratio (OR = 1.5; CI = 1.1 to 2.0) for self-reported
yang diasosiasikan infertility associated
chemotherapeutic withprior
drugs occupational handling
to onset of of For
infertility.
men, the odds ratio was similar but not statistically
dengan penanganan significant. This worker population, with a mean age of 37,
obat sitostatika is in the prime of reproductive life. Prevention of
chemotherapy side effects by use of available protection
is preferable to risking infertility
Potensi Bahaya Sitostatik
Obat
Labuhn K, Valanis B, Schoeny R, Loveday K, et al.
Nurses' and pharmacists' exposure to antineoplastic
a Labuhn K. (1998)
drugs: findings from industrial hygiene scans and urine
mutagenicity tests. Cancer Nurs. 1998 Apr;21(2):79-89.
Data from 83 nurses and pharmacists handling
antineoplastic drugs and 35 nurse/pharmacist controls who
participated in a national study of antineoplastic drug- Penanganan obat
handling risks were examined to investigate antineoplastic
drug exposure. Measures of external exposure included self-
sitostatika tanpa
completion drug logs and industrial hygiene scans APD (kontak
conducted in clinical settings. Internal exposure was
measured by urine mutagenicity tests on end-of-week 24- dengan kulit)
hour urine specimens. To control for potential confounders,
the staff was asked to complete food and hobby diaries and
hasilberhubungan
tes mutagenisitas
to avoid identified mutagenic substances for 1 week before dengan
yang positif
collection of 24- hour urine samples. On the scans of the
drug handlers, 13% showed one or more spots of drug
contamination on gloved and ungloved hands, gowns, or
shoes. Of 15%
samples, the 24-hour urine
were mutagenic for Salmonella
typhimurium: Rates did not differ significantly for drug
handlers and controls. Among nurses who both prepared
and administered antineoplastics, those with positive
mutagenicity tests handled more doses of the drugs, used
less skin protection, and had more skin contact with the
drugs than those with negative tests. Nurses who only
administered the drugs and had positive mutagenicity tests
handled fewer doses of drugs than those with negative
tests, but they also reported less use of protection and
more skin contact. For both groups of nurses, skin contact
with antineoplastics was associated with positive
mutagenicity test results (p < 0.01).
PotPotensi Bahaya Obat Sitostatika
Cancer incidence and adverse pregnancy outcome in
registered nurses potentially exposed to antineoplastic
drugs : Pamela A Ratner, 1 John J Spinelli,2 Kris Beking,3
Maria Lorenzi,2 Yat Chow,4 Kay Teschke,5 Nhu D Le,2
Richard P Gallagher,2 and Helen Dimich-Ward3
Methods
Female RNs registered with a professional regulatory body
for at least one year between 1974 and 2000 formed the
cohort (n = 56,213). The identifier file was linked to
Canadian cancer registries. An RN offspring cohort from
1986 was created by linkages with the BC Birth and Health
Status Registries. Exposure was assessed by work history
in oncology or cancer agencies (method 1) and by Pamela Ratner (2009)
estimating weighted duration of exposure developed from a
survey of pharmacists and nursing unit administrators of all
provincial hospitals and treatment centers and the work
history of the nurses (method 2). Relative risks (RR) were
calculated using Poisson regression for cancer incidence
and odds ratios
Peningkatan resiko
(OR) were calculated for congenital anomaly, stillbirth, low terkena kanker
birth weight, and prematurity incidence, with 95% confidence
intervals. payudara dan kanker
Conclusions
Female RNs having had potential exposure to antineoplastic
drugs were not found to have an excess risk of leukemia,
rektal pada petugas
stillbirth, or congenital anomalies in their offspring, with the terpapar obat
exception of congenital anomalies of the eye, based on only
three cases; however, elevated risks of breast and rectal sitostatika
cancer were observed.
The Question is ?
• How to avoid that potential efect the preparation of
chemoterapi accured ????
Negative Alat-alat
Pressure Steril
DESINFEKSI
ALAT PELINDUNG (APD)
DIRI
Perlindungan terhadap petugas
(dari bahan berbahaya, misalnya
obatBaju
1. terusan (jumpsuit)
sitostatika):
berbahan non-serat
2. Gown pelapis
3. Masker N95
4. Sarung tangan 2 lapis
5. Kacamata google
Jaminan Mutu ( Quality Assurance)
Tujuan Pharmacy lntravena Admixture Services (PIVAS)
: Safe Handling Cytotoxic
12
10
0
Personnel
• Program kesehatan karyawan
Medical cek up, pemeriksaan laboratorium (6
rutin bulan sekali) :
- darah lengkap
- Fungsi hati (SGPT & SGOT)
- Fungsi ginjal (elektrolit dan urea)
- Albert Einstein
Pelayanan kemoterapi di Rsud Tarakan
25
20
10
0
AGUSTUS SEPTEMBER OKTOBER NOVEMBER DESEMBER
PELAYANAN KEMOTERAPI TAHUN 2016 JUMLAH
PASIEN
50
45
40
35
30
PELAYANAN KEMOTERAPI TAHUN 2016
25 JUMLAH PASIEN
20
15
10
0
I I T IL EI NI LI S R R R R
UAR UAR ARE PR M JU JU STU BE OBE BE BE
A M M M
JA
N BR M U E T VE SE
FE AG EPT OK DE
S NO
PELAYANAN KEMOTERAPI TAHUN 2017 JUMLAH
PASIEN
60
50
40
20
10
0
I I T IL EI NI LI S R R R R
UAR UAR ARE PR M JU JU STU BE OBE BE BE
N R M A U EM T EM EM
JA FEB AG EPT OK OV DES
S N