Analysis of reconstitution process, stability, stability of intravenous antibiotics in hospitalised patients in a private hospital

  • Kiki Amelia Bhakti Pertiwi College of Pharmacy Palembang, Indonesia
Keywords: antibiotics, reconstitution, stabilitas, sterility


Introduction: reconstitution of sterile preparations is a series of changes in the drug from its original condition to a new product by dissolving or adding other ingredients carried out aseptically by the pharmacy.

Aim: determine the suitability of the reconstitution technique, the suitability of stability (solvent type and solvent volume), and the suitability of the sterility of the reconstitution product.

Methods: data collection obtained by observation is carried out with the help of a checklist that is adapted to hospital standard operating procedures (SOPs), Inject-able Drug Guide, guidelines for mixing inject-able drugs, and preparations. 48 processes of reconstitution of intravenous antibiotics were carried out in hospitals that could be observed as samples.

Results: conformity to the preparation stage were 99%, the mixing stage was 73%, the labelling was 100%, and the labelling was 90%. In evaluating the stability of the solvent type category, the suitability of 100%. In the volume category of the solvent used, 90% were suitable, and 10% were unsuitable for the antibiotic’s cefotaxime 1 gram, vancomycin 1 gram, and sulbactam + ampicillin Na 1 gram. From the sterility test results, the reconstitution of ceftriaxone intravenous antibiotic preparations showed that the bacterial preparations were free of microorganisms (sterile).

Conclusion: the personnel performing the reconstitution are nurses trained in intravenous antibiotic recovery. One of the factors that caused the reconstitution process not to be under the hospital's KSB was the lack of training and supervision from the hospital management. SPO recovery is not installed in an intravenous drug mixing room.


Download data is not yet available.

Author Biography

Kiki Amelia, Bhakti Pertiwi College of Pharmacy Palembang, Indonesia

Pharmacy Study Program


Abbas, M. N., Iqbal, W. and Khan, S. (2022) ‘Sterile Products’, in Essentials of Industrial Pharmacy. Springer, pp. 177–201.

Ahmed, S. F. et al. (2022) ‘Green approaches in synthesising nanomaterials for environmental nanobioremediation: Technological advancements, applications, benefits and challenges’, Environmental Research, 204, p. 111967. doi: 10.1016/j.envres.2021.111967.

Akakuru, O. U., Iqbal, Z. M. and Wu, A. (2020) ‘TiO2 nanoparticles: properties and applications’, TiO2 Nanoparticles: Applications in Nanobiotechnology and Nanomedicine, pp. 1–66.

Beaney, A. M. et al. (2020) ‘Council of Europe Resolution CM/Res(2016)2: a major contribution to patient safety from reconstituted injectable medicines?’, European Journal of Hospital Pharmacy, 27(4), pp. 216–221. doi: 10.1136/ejhpharm-2018-001723.

Cousins, D. H., Otero, M. J. and Schmitt, É. (2021) ‘Time to review how injectable medicines are prepared and administered in European hospitals’, Farmacia Hospitalaria, 45(4), pp. 204–209. doi:

Dixon, J. et al. (2021) ‘Antibiotics, rational drug use and the architecture of global health in Zimbabwe’, Social Science & Medicine, 272, p. 113594. doi: 10.1016/j.socscimed.2020.113594.

Fawaz, S. (2021) ‘Optimising antibiotic therapy for inpatient and outpatient settings’. Kingston University.

Firesbhat, A. et al. (2021) ‘Bacterial profile of high-touch surfaces, leftover drugs and antiseptics together with their antimicrobial susceptibility patterns at University of Gondar Comprehensive Specialized Hospital, Northwest Ethiopia’, BMC Microbiology, 21(1), p. 309. doi: 10.1186/s12866-021-02378-w.

Ghert, M. et al. (2022) ‘Comparison of Prophylactic Intravenous Antibiotic Regimens After Endoprosthetic Reconstruction for Lower Extremity Bone Tumors’, JAMA Oncology, 8(3), p. 345. doi: 10.1001/jamaoncol.2021.6628.

Jeličić, M.-L. et al. (2021) ‘Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools’, Pharmaceutics, 13(3), p. 400. doi: 10.3390/pharmaceutics13030400.

Kiggundu, R. et al. (2022) ‘Point Prevalence Survey of Antibiotic Use across 13 Hospitals in Uganda’, Antibiotics, 11(2), p. 199. doi: 10.3390/antibiotics11020199.

Krämer, I., Thiesen, J. and Astier, A. (2020) ‘Formulation and Administration of Biological Medicinal Products”’, Pharmaceutical Research, 37(8), p. 159. doi: 10.1007/s11095-020-02859-z.

Kuitunen, S. et al. (2021) ‘Systemic Causes of In-Hospital Intravenous Medication Errors: A Systematic Review’, Journal of Patient Safety, 17(8), pp. e1660–e1668. doi: 10.1097/PTS.0000000000000632.

Landersdorfer, C. B. and Nation, R. L. (2021) ‘Key Challenges in Providing Effective Antibiotic Therapy for Critically Ill Patients with Bacterial Sepsis and Septic Shock’, Clinical Pharmacology & Therapeutics, 109(4), pp. 892–904. doi: 10.1002/cpt.2203.

Leeuwerik, A. F. et al. (2023) ‘A new approach to drug intravenous compatibility research: the case of obstetric parenteral drugs’, European Journal of Hospital Pharmacy, p. ejhpharm-2022-003577. doi: 10.1136/ejhpharm-2022-003577.

Li, Y. et al. (2020) ‘One step synthesis of positively charged gold nanoclusters as effective antimicrobial nanoagents against multidrug-resistant bacteria and biofilms’, Journal of Colloid and Interface Science, 569, pp. 235–243. doi: 10.1016/j.jcis.2020.02.084.

Mambula, G. et al. (2023) ‘Practices and challenges related to antibiotic use in paediatric treatment in hospitals and health centres in Niger and Uganda: a mixed methods study’, Antimicrobial Resistance & Infection Control, 12(1), p. 67. doi: 10.1186/s13756-023-01271-7.

Marufu, T. C. et al. (2022) ‘Nursing interventions to reduce medication errors in paediatrics and neonates: Systematic review and meta-analysis’, Journal of Pediatric Nursing, 62, pp. e139–e147. doi: 10.1016/j.pedn.2021.08.024.

Marzal-Alfaro, Mb. et al. (2020) ‘Risks and medication errors analysis to evaluate the impact of a chemotherapy compounding workflow management system on cancer patients’ safety’, Health Informatics Journal, 26(3), pp. 1995–2010. doi: 10.1177/1460458219895434.

Menga, M. K. and Hartaty, H. (2023) ‘Nurse Determinants of the Incidence of Nosocomial Infections in Hospitals’, Jurnal Ilmiah Kesehatan Sandi Husada, 12(2), pp. 353–360. doi: 10.35816/jiskh.v12i2.1089.

Rodriguez-Merchan, E. C. and Ribbans, W. J. (2022) ‘The role of vancomycin-soaking of the graft in anterior cruciate ligament reconstruction’, Journal of ISAKOS, 7(2), pp. 94–98. doi: 10.1016/j.jisako.2021.12.006.

Smith, J. and Larmené-Beld, K. (2023) ‘Containers’, in Practical Pharmaceutics: An International Guideline for the Preparation, Care and Use of Medicinal Products. Springer, pp. 169–206.

Suprapto et al. (2024) ‘Building Nurse Competency Strategy at Public Health Center in Indonesia: A Descriptive Qualitative Approach’, The Malaysian Journal of Nursing, 15(03), pp. 62–70. doi: 10.31674/mjn.2024.v15i03.008.

Telles, J. P. et al. (2021) ‘Ceftriaxone and methicillin-susceptible staphylococcus aureus : a perspective from pharmacokinetics/pharmacodynamics studies’, Expert Opinion on Drug Metabolism & Toxicology, 17(9), pp. 1039–1048. doi: 10.1080/17425255.2021.1951221.

Tuncay, S. et al. (2021) ‘Detection of drug medication errors of nursing students in pediatric patients through a hospital simulation’, Ege Üniversitesi Hemşirelik Fakültesi Dergisi, 37(2), pp. 121–129. doi: 10.53490/egehemsire.873143.

How to Cite
Amelia, K. (2024). Analysis of reconstitution process, stability, stability of intravenous antibiotics in hospitalised patients in a private hospital. Jurnal Ilmiah Kesehatan Sandi Husada, 13(1), 92-101.

Most read articles by the same author(s)

Obs.: This plugin requires at least one statistics/report plugin to be enabled. If your statistics plugins provide more than one metric then please also select a main metric on the admin's site settings page and/or on the journal manager's settings pages.