KAJIAN INKOMPATIBILITAS SEDIAAN INTRAVENA PASIEN DI INTENSIVE CARE UNIT (ICU)
Erna Prasetya Ningrum, Dr. apt. Fita Rahmawati,Sp.FRS; apt. Marlyn Dian Laksitorini; Prof. Dr.rer.nat.apt. Endang Lukitaningsih,M.Si.
2025 | Disertasi | S3 Ilmu Farmasi
Pemberian obat secara intravena banyak digunakan di ruang
ICU. Namun risiko terjadinya inkompatibilitas
dapat terjadi akibat kurangnya pengetahuan tenaga kesehatan. Inkompatibilitas pada sediaan intravena merupakan reaksi kimia fisika yang tidak diinginkan
akibat pencampuran dua atau lebih sediaan obat. Penelitian ini bertujuan
menganalisa pengetahuan tenaga medis tentang penyiapan sediaan IV dan menilai
kelengkapan informasi brosur sediaan intravena, mengidentifikasi
inkompatribilitas fisika sediaan intravena, mengetahui perbedaan
inkompatibilitas kimia berbagai sediaan fenitoin dan mengetahui cara penanganan
inkompatibilitas sediaan IV di ICU.
Metode penelitian terdiri dari empat tahap, tahap
pertama menggunakan cross sectional, kuesioner
digunakan untuk mengevaluasi pengetahuan tenaga medis yang menggunakan sediaan
IV pada 80 responden tenaga kesehatan. Untuk melakukan evaluasi kelengkapan informasi brosur, sejumlah 148 sampel
brosur sediaan intravena di evaluasi berdasarkan Peraturan Badan Pengawas Obat
dan Makanan Indonesia No 24 tahun 2017. Tahap kedua diawali dengan pengambilan
data secara prospektif menggunakan rekam medis pasien yang sesuai dengan
kriteria penelitian sebanyak 100 sampel, kemudian obat yang diberikan secara IV
dilakukan evaluasi inkompatibilitas menggunakan referensi. Campuran obat yang tidak ada direferensi standar Lexicomp dan Handbook on injectable drug 19th edition ASHP’S Guide to IV Compatibility and Stability di uji inkompatibilitas fisik meliputi
ukuran partikel, kekeruhan dan viskositas. Tahap ke tiga, dilakukan uji
inkompatibilitas fisika kimia sediaan intravena fenitoin dalam pelarut normal salin dari berbagai pabrik yaitu dengan pengujian
stabilitas sediaan, bobot molekul dan gugus fungsi
sebanyak tiga kali replikasi. Tahap empat penelitian melakukan survei
dengan pengisian kuesioner oleh tenaga medis di rumah sakit terkait pengatasan
inkompatibilitas sediaan intravena.
Hasil penelitian tahap satu responden yang memahami proses rekonstitusi sejumlah
79
(98,75%), telah menjalani pelatihan aseptik sejumlah 46 (57,5%) dan yang
mengandalkan brosur sebagai informasi utama 49 (61,25%). Informasi brosur yang
menyantumkan penyimpanan sejumlah
148 (99%), cara rekonstitusi 54 (36%),
inkompatibilitas obat 28 (19%), stabilitas obat 12 (8%), dan daftar eksipien sejumlah 10 (7%). Pada
tahap dua seratus campuran sediaan IV di ICU diketahui sebanyak 68% kompatibel
(K), 19% inkompatibel (I) dan 13% no
information (NI). Hasil uji inkompatibilitas fisik dari 9 campuran sediaan
IV yang tidak ada di referensi menunjukkan adanya peningkatan pH,
perubahan ukuran partikel, perubahan kekeruhan, dan perubahan viskositas. Hasil
uji tahap tiga menunjukkan ketidakstabilan
yang berbeda-beda pada sediaan fenitoin sampel A, B, dan C pada konsentrasi 7
ppm. Uji Fisik pH tidak ada kenaikan lebih dari 1 unit dari waktu 0, 3, dan 6 jam ke tiga sampel
dan terjadi peningkatan kekeruhan hal ini sesuai
dengan pengujian organoleptis ukuran partikel dengan terbentuknya kristal
jarum. Pengujian bobot molekul antara fenitoin murni dan endapan sediaan
didapat hasil yang sama yaitu 252 m/z. Tahap empat melibatkan 14 responden
tenaga kesehatan di ruang ICU diketahui sejumlah 13 (92.9 %) responden
menjumpai kejadian inkompatibilitas pada 7 jenis obat, dan sejumlah 5 (29.4%) responden
menjumpai problem inkompatibilitas pada sefoperazon. Tujuh (53,8%)
responden menyatakan inkompatibilitas yang sering muncul berupa perubahan warna
pada sediaan sefoperazon dan seftriakson, dan sebanyak 6 (46,2%) perawat
mengatasi inkompatibilitas dengan mengganti sediaan baru. Pencantuman informasi
yang komprehensif dalam brosur sangat penting untuk mencegah inkompatibilitas
dan meningkatkan standar keselamatan yang terkait dengan pemberian sediaan
intravena kepada pasien.
Intravenous
drug administration is widely used in the ICU. However, the risk of
incompatibility can occur due to a lack of knowledge of health workers.
Incompatibility in intravenous preparations is an undesirable chemical-physical reaction due to the mixing of two
or more drug preparations. This study aims to analyze the knowledge of medical
personnel about the preparation of IV preparations and assess the completeness
of information in intravenous preparation brochures, identify the physical
incompatibility of intravenous preparations, determine the differences in
chemical incompatibility of various phenytoin preparations, and determine how
to handle IV preparation incompatibility in the ICU.
The
research method consists of four stages, the first stage uses cross-sectional,
questionnaires were used to evaluate
the knowledge of medical personnel using IV preparations in 80 health worker respondents. To evaluate the completeness of brochure information, a total of 148 samples
of intravenous preparation brochures were evaluated based on the Regulation of the Indonesian Food and Drug Supervisory Agency
No. 24 of 2017. The second stage
began with prospective data collection using patient medical records
that met the research criteria as many as 100 samples, then the drugs given IV
were evaluated for incompatibility using references. Drug mixtures that
were not in the Lexicomp
standard reference and the Handbook
on Injectable Drugs 19th edition ASHP'S Guide to IV Compatibility and Stability
were tested for physical incompatibility including particle size,
turbidity, and viscosity. In the third
stage, a physical chemical incompatibility test was carried out on intravenous phenytoin preparations in normal saline solvents
from various factories, namely by testing the stability of the preparation,
molecular weight, and functional groups of as many as three replications. The
fourth stage of the research involved surveying by distributing a questionnaire
to medical personnel in the hospital regarding the management of
incompatibility in intravenous preparations.
The
results of the first phase
of the study showed that respondents who understood the reconstitution process were 79 (98.75%), had undergone aseptic
training 46 (57.5%),
and those who relied on brochures as the
main information were 49 (61.25%).
Brochure information that
included storage was 148 (99%), reconstitution methods 54 (36%), drug
incompatibility 28 (19%), drug stability 12 (8%), and a list of excipients 10
(7%). In the second phase of one hundred IV preparation mixtures in the ICU,
68% were known to be compatible (K), 19% incompatible (I), and 13% no information (NI). The results
of the physical incompatibility test
of 9 IV preparation mixtures that were not in the reference showed an increase
in pH, changes in particle
size, changes in turbidity, and changes in viscosity. The results of the third phase test showed different instability in
phenytoin preparations samples A, B, and C at a concentration of 7 ppm. Physical
pH test showed
no increase of more than 1 unit from 0, 3, and 6 hours to the three samples and there was an
increase in turbidity, this was in accordance with the organoleptic testing of
particle size with the formation of needle crystals. Molecular weight testing
between pure phenytoin and the precipitated preparation obtained the same
results, namely 252 m / z. The fourth
stage involved 14 respondents of health workers
in the ICU room, it was found that 13 (92.9%)
respondents encountered incompatibility events in 7 types of drugs,
and 5 (29.4%) respondents encountered incompatibility problems in cefoperazone.
Seven (53.8%) respondents stated
that incompatibility that often occurs
is in the form of color changes in cefoperazone and ceftriaxone
preparations, and 6 (46.2%) nurses overcome incompatibility by replacing new preparations. The inclusion of comprehensive information in the brochure is very important to
prevent incompatibility and improve safety standards associated with
administering intravenous preparations to patients.
Kata Kunci : sediaan intravena, inkompatibilitas fisika, fenitoin, inkompatibilitas kimia, pengetahuan perawat
