ULFA FIKRIA PUTRI, 051615153029 (2018) STABILITAS MIKROBIOLOGI SEDIAAN MEROPENEM SETELAH DIREKONSTITUSI (Studi di Ruang Neonatal Intensive Care Unit (NICU) SMF Ilmu Kesehatan Anak Rumah Sakit Umum Haji Surabaya). Thesis thesis, Universitas Airlangga.

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Abstract

Background: Injection meropenem is circulating in Indonesia, available in vials in the form of sterile lyophilized powder with a strength of 0.5 g and 1.0 g, with a relatively expensive price, has not been available special packaging for children until now. The inefficient use of meropenem for pediatric patients in hospitals appears to be of large amounts of meropenem in disuse or discarded because its stability has declined after reconstitution. Ideally dispensing of the product is done centrally in hospital pharmacy installations to ensure product stability. However, in some hospitals in Indonesia, the dispensing of sterile products is performed by nurses in the patient's room due to lack of adequate trained personnel and facilities, so the risk of contamination is higher than the preparation of sterile products in a special room equipped with laminar air flow (LAF). Objective: Aimed to analyze the microbiological stability of parenteral meropenem on repeated use. Method: This study is clinical randomized controlled trial. Data were collected between April and June 2018. Samples were meropenem powder in vials that have been reconstituted with 0.9% NaCl solution by nurses in NICU Haji General Hospital Surabaya. The reconstitution of meropenem was done by 5 nurses and each of them replicated 3 times, so that overall 15 samples were obtained. Samples were stored for 0, 6, 18, and 24 hours in the refrigerator (2-8 °C). Microbiological stability test was seen from antibacterial activity, by measuring the diameter of inhibition zone of bacterial growth using papper disk diffusion method. Furthermore, a statistical analysis with paired t test was done to find out the significance of diameter of inhibition zone of bacterial growth from the first hour to the next hours. Result: The result of paired t test, sig. (2-tailed) which is the probability value (p value) gives result = 0,000. The p value <0.05 (95% confidence). Meaning: There is a significant difference between the test sample at the 0th hour with the 6th hour, the 6th hour with the 18th hour, and the 18th hour with the 24th hour. In this study also conducted regression test, and obtained a standard curve equation y = 9,149-0,173 (x1) +0,817 (x2). From the standard curve can be obtained maximum data limit meropenem storage after reconstitution against the SOP implementation score. Conclusion: Based on this study, it can be concluded that there were a decrease in the stability of microbiology of parenteral meropenem after reconstituted with NaCl 0.9% by several nurses in the NICU, Department of Pediatrics General Hospital Haji Surabaya after 6 hours storage in the refrigerator. Therefore, treatment with recurrent meropenem injections should not be used.

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