Knowledge of Intravenous Preparation among Health Professionals and Assessment of the Sterile Product Label Information Coverage
Keywords:
intravenous medication preparations, individual knowledge, package brochures
Abstract
Individual knowledge of intravenous medicine (IVM) preparation is essential in patient safety. Comprehensive information on IV product preparation is indispensable within healthcare settings. Brochures constitute a primary resource for understanding the preparation of injectable medications. This research aims to investigate individual knowledge of IVM preparations and to assess the completeness of the information provided in package brochures regarding the IVM preparation processes. This research employed a cross-sectional design to investigate the subject matter. Questionnaires were utilized to identify the characteristics and individual knowledge of healthcare professionals involved in dispensing intravenous medicine (IVM). A cohort of 80 health professionals participated in the study. A checklist form was employed to evaluate the completeness of the information provided in 148 package brochures regarding IVM preparation. Subsequently, the data within the brochures were compared to the Regulation outlined by the Indonesian National Food and Drug Authority. The findings indicated that 79 respondents (98.75%) comprehended the reconstitution process, with 46 respondents (57.5%) undergoing aseptic dispensing training. Among the respondents, 48 (60%) primarily relied on brochures as their main information source, while 49 (61.25%) reported encountering details primarily concerning dose and solubility products. Among the 148 assessed brochures, storage methods were included in 146 (99%) brochures, reconstitution methods in 54 (36%) brochures, drug incompatibility in 28 (19%), stability of drugs in 12 (8%), and only 10 (7%) brochures provided a list of excipients. Enhancing individual knowledge regarding IVM preparation is crucial, necessitating support through comprehensive training initiatives. A significant proportion of medical personnel rely on brochures for information during IVM preparations, yet not all brochures comply with mandatory government regulations. These findings underscore the necessity for manufacturers to ensure completeness in brochure content. The comprehensive inclusion of information within brochures is vital in preventing discrepancies and increasing the safety standards associated with administering intravenous preparations to patients.
References
Ahmad Iqbal; Ali Sheraz Muhammad; Ahmed Sofia. (2016). Stability of drugs and drug products. In Medical services journal, Canada (First). Higher Education Commission – Pakistan Disclaimer
Al Bardaweel, S., & Dashash, M. (2018). E-learning or educational leaflet: Does it make a difference in oral health promotion? A clustered randomized trial. BMC Oral Health, 18(1), 1–8. https://doi.org/10.1186/s12903-018-0540-4
Azni, M., Rahmawati, F., & Wiedyaningsih, C. (2021). Pengetahuan Perawat Mengenai Faktor Risiko Sediaan Intravena yang Berkaitan dengan Kejadian Flebitis. Jurnal Sains Farmasi & Klinis, 8(2), 174. https://doi.org/10.25077/jsfk.8.2.174-181.2021
Benlabed, M., Perez, M., Gaudy, R., Genay, S., Lannoy, D., Barthélémy, C., Odou, P., Lebuffe, G., & Décaudin, B. (2019). Clinical implications of intravenous drug incompatibilities in critically ill patients. In Anaesthesia Critical Care and Pain Medicine (Vol. 38, Issue 2, pp. 173–180). Elsevier Masson SAS. https://doi.org/10.1016/j.accpm.2018.04.003
da Silva Castro, M., Camerini, F. G., de Mendonça Henrique, D., Marins, A. L. C., & Fassarella, C. S. (2021). Analysis of drug incompatibilities in a cardiac intensive unit: a cross-sectional study. Enfermeria Global, 20(2), 95–108. https://doi.org/10.6018/eglobal.438931
Dwijayanti, S., Irawati, S., & Setiawan, E. (2016). Profile of Intravenous Admixture Compatibility in The Intensive Care Unit (ICU) Patients. Indonesian Journal of Clinical Pharmacy, 5(2), 84–97. https://doi.org/10.15416/ijcp.2016.5.2.84
Fernandez-Pena, A., Katsumiti, A., De Basagoiti, A., Castaño, M., Ros, G., Sautua, S., De Miguel, M., & Campino, A. (2021). Drug compatibility in neonatal intensive care units: gaps in knowledge and discordances. European Journal of Pediatrics, 180(7), 2305–2313. https://doi.org/10.1007/s00431-021-04028-9
Frankenfeld, C., Mittal, S., Melendez, Y., Mendez-Vigo, L., Lamp, K. C., Keller, K. N., & Bertolami, S. R. (2018). Daptomycin: A comparison of two intravenous formulations. Drug Design, Development and Therapy, 12, 1953–1958. https://doi.org/10.2147/DDDT.S167010
Gaetani, M., Frndova, H., Seto, W., & Parshuram, C. (2017). Concurrent intravenous drug administration to critically ill children: Evaluation of frequency and compatibility. Journal of Critical Care, 41, 198–203. https://doi.org/10.1016/j.jcrc.2017.05.027
Gahart, B. L., & Nazareno, A. R. (2014). Intravenous Medications (Deborah L. Vogel (ed.); THIRTIETH). Deborah L. Vogel.
Hani, C., Vonbach, P., Fonzo-Christe, C., Russmann, S., Cannizzaro, V., & Niedrig, D. F. (2019). Evaluation of incompatible coadministration of continuous intravenous infusions in a pediatric/neonatal intensive care unit. Journal of Pediatric Pharmacology and Therapeutics, 24(6), 479–488. https://doi.org/10.5863/1551-6776-24.6.479
Hecq, J.-D., Krämer, I., & Vigneron, J. (2019). European Databases on Stability and Compatibility of Injectable Medicinal Products in Europe. Pharmaceutical Technology in Hospital Pharmacy, 4(3–4), 113–117. https://doi.org/10.1515/pthp-2019-0012
Henkel, E., Vella, R., Behan, K., Austin, D., Kruger, P., & Fenning, A. (2020). The effect of concentration, reconstitution solution and pH on the stability of a remifentanil hydrochloride and propofol admixture for simultaneous co-infusion. BMC Anesthesiology, 20(1), 1–12. https://doi.org/10.1186/s12871-020-01194-5
Kemenkes. (2016). PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA NO 72 TAHUN 2016 TENTANG STANDAR PELAYANAN KEFARMASIAN DI RUMAH SAKIT. 1–63. file:///Users/andreataquez/Downloads/guia-plan-de-mejora-institucional.pdf%0Ahttp://salud.tabasco.gob.mx/content/revista%0Ahttp://www.revistaalad.com/pdfs/Guias_ALAD_11_Nov_2013.pdf%0Ahttp://dx.doi.org/10.15446/revfacmed.v66n3.60060.%0Ahttp://www.cenetec.
Kumar, A., Singh, P., & Nanda, A. (2020). Hot stage microscopy and its applications in pharmaceutical characterization. Applied Microscopy, 50(1). https://doi.org/10.1186/s42649-020-00032-9
La Pietra, L., Calligaris, L., Molendini, L., Quattrin, R., & Brusaferro, S. (2005). Medical errors and clinical risk management: state of the art. Acta Otorhinolaryngologica Italica : Organo Ufficiale Della Società Italiana Di Otorinolaringologia e Chirurgia Cervico-Facciale, 25(6), 339–346.
Maison, O. (2019). Drug incompatibilities in intravenous therapy: evaluation and proposition of preventive tools in intensive care and hematology units. European Journal of Clinical Pharmacology, 75, 179–187.
Malfará, M., Pernassi, M., Aragon, D., & Carlotti, A. (2018). Impact of the clinical pharmacist interventions on prevention of pharmacotherapy related problems in the paediatric intensive care unit. International Journal of Clinical Pharmacy, 40(3), 513–519. https://doi.org/10.1007/s11096-018-0632-x
Malik, A., & Chusni, M. (2018). Pengantar Statistika Pendidikan (Pertama). Deepublish.
Marsilio, N. R., Da Silva, D., & Bueno, D. (2016). Drug incompatibilities in the adult intensive care unit of a university hospital. Revista Brasileira de Terapia Intensiva, 28(2), 147–153. https://doi.org/10.5935/0103-507X.20160029
National Food and Drug Authority. (2017). PERATURAN KEPALA BADAN PENGAWAS OBAT DAN MAKANAN REPUBLIK INDONESIA NOMOR 24 TAHUN 2017 TENTANG KRITERIA DAN TATA LAKSANA REGISTRASI OBAT. Bpom Ri, 1–261.
National Food and Drug Authority. (2022a). Peraturan Badan Pengawas Obat dan Makanan No. 14 Tahun 2022 tentang Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamann, Khasiat, Mutu, dan Label. Bpom, 1–16.
National Food and Drug Authority. (2022b). Peraturan Badan Pengawas Obat Dan Makanan Nomor 23 Tahun 2022 Tentang Standar Dan/Atau Persyaratan Mutu Obat Dan Bahan Obat. Bpom Ri, 11, 1–16.
Neininger, M. P., Buchholz, P., Frontini, R., Kiess, W., Siekmeyer, W., Bertsche, A., Siekmeyer, M., & Bertsche, T. (2019). Incompatible intravenous drug combinations and respective physician and nurse knowledge: A study in routine paediatric intensive care. European Journal of Hospital Pharmacy , 26(4), 214–217. https://doi.org/10.1136/ejhpharm-2017-001248
NHS. (2019). Policy for the Safe Management and Administration of Intravenous Medicines. April, 1–42.
Nilsson, N., Storesund, I., Tho, I., & Nezvalova-Henriksen, K. (2022). Co-administration of drugs with parenteral nutrition in the neonatal intensive care unit—physical compatibility between three components. European Journal of Pediatrics, 181(7), 2685–2693. https://doi.org/10.1007/s00431-022-04466-z
Oyebode, F. (2013). Clinical errors and medical negligence. Medical Principles and Practice, 22(4), 323–333. https://doi.org/10.1159/000346296
Pangestika, R. W. (2022). Hubungan Usia, Pendidikan, dan Lama Bekerja dengan Pengetahuan Tenaga Kesehatan tentang Inkompatibilitas Sediaan Intravena. Media Farmasi, 18(1), 36. https://doi.org/10.32382/mf.v18i1.2693
PERMENKES. (2014). STANDAR PELAYANAN KEFARMASIAN DI APOTEK. PMK NO 35. https://eje.bioscientifica.com/view/journals/eje/171/6/727.xml
Royal Hospital For Women. (2011). ADMINISTRATION OF INTRAVENOUS MEDICATION BY NURSING STAFF (Issue July). https://doi.org/10.1002/14651858.CD001000.pub3.Couser
S. Sriram, Aishwarya, S., Kumar, A. A., Moithu, A., & Sebastian, A. (2018). Intravenous drug incompatibility in intensive care units - A comprehensive review. Innovations in Pharmaceuticals and Pharmacotherapy, 6(3), 55–60. www.innpharmacotherapy.com
Sabins, D., Diep, T., McCartan, P., Patel, S., & Zhao, F. (2019). Stability and Compatibility of Diphenhydramine Hydrochloride in Intravenous Admixtures: A New Look at an Old Drug. Hospital Pharmacy, 54(5), 330–334. https://doi.org/10.1177/0018578718802586
Sohrevardi, S. M., Jarahzadeh, M. H., Mirzaei, E., Mirjalili, M., Tafti, A. D., & Heydari1, B. (2017). Medication errors in patients with enteral feeding tubes in the intensive care unit. In Journal of Research in Pharmacy Practice (Vol. 6, Issue 2). https://doi.org/10.4103/jrpp.jrpp_17_9
Stroppel, L., Schultz-Fademrecht, T., Cebulla, M., Blech, M., Marhöfer, R. J., Selzer, P. M., & Garidel, P. (2023). Antimicrobial Preservatives for Protein and Peptide Formulations: An Overview. Pharmaceutics, 15(2), 1–53. https://doi.org/10.3390/pharmaceutics15020563
Tomczak, S., Gostyńska, A., Nadolna, M., Reisner, K., Orlando, M., Jelińska, A., & Stawny, M. (2021). Stability and compatibility aspects of drugs: The case of selected cephalosporins. Antibiotics, 10(5), 1–16. https://doi.org/10.3390/antibiotics10050549
Villiers, M. M. De. (2017). Compatibility and Stability of Drug Products and Preparations. January 2009, 672–702. https://www.researchgate.net/publication/318380441%0ACompatibility
WHO. (1996). Annex 5: Guidelines for Stability Testing of Pharmaceutical Products Containing Well Established Drug Substances in Conventional Dosage Forms. World Health Organization Technical Report Series, 863, 65–80. https://www.paho.org/hq/dmdocuments/2008/6_Annex_5_report_34.pdf
Al Bardaweel, S., & Dashash, M. (2018). E-learning or educational leaflet: Does it make a difference in oral health promotion? A clustered randomized trial. BMC Oral Health, 18(1), 1–8. https://doi.org/10.1186/s12903-018-0540-4
Azni, M., Rahmawati, F., & Wiedyaningsih, C. (2021). Pengetahuan Perawat Mengenai Faktor Risiko Sediaan Intravena yang Berkaitan dengan Kejadian Flebitis. Jurnal Sains Farmasi & Klinis, 8(2), 174. https://doi.org/10.25077/jsfk.8.2.174-181.2021
Benlabed, M., Perez, M., Gaudy, R., Genay, S., Lannoy, D., Barthélémy, C., Odou, P., Lebuffe, G., & Décaudin, B. (2019). Clinical implications of intravenous drug incompatibilities in critically ill patients. In Anaesthesia Critical Care and Pain Medicine (Vol. 38, Issue 2, pp. 173–180). Elsevier Masson SAS. https://doi.org/10.1016/j.accpm.2018.04.003
da Silva Castro, M., Camerini, F. G., de Mendonça Henrique, D., Marins, A. L. C., & Fassarella, C. S. (2021). Analysis of drug incompatibilities in a cardiac intensive unit: a cross-sectional study. Enfermeria Global, 20(2), 95–108. https://doi.org/10.6018/eglobal.438931
Dwijayanti, S., Irawati, S., & Setiawan, E. (2016). Profile of Intravenous Admixture Compatibility in The Intensive Care Unit (ICU) Patients. Indonesian Journal of Clinical Pharmacy, 5(2), 84–97. https://doi.org/10.15416/ijcp.2016.5.2.84
Fernandez-Pena, A., Katsumiti, A., De Basagoiti, A., Castaño, M., Ros, G., Sautua, S., De Miguel, M., & Campino, A. (2021). Drug compatibility in neonatal intensive care units: gaps in knowledge and discordances. European Journal of Pediatrics, 180(7), 2305–2313. https://doi.org/10.1007/s00431-021-04028-9
Frankenfeld, C., Mittal, S., Melendez, Y., Mendez-Vigo, L., Lamp, K. C., Keller, K. N., & Bertolami, S. R. (2018). Daptomycin: A comparison of two intravenous formulations. Drug Design, Development and Therapy, 12, 1953–1958. https://doi.org/10.2147/DDDT.S167010
Gaetani, M., Frndova, H., Seto, W., & Parshuram, C. (2017). Concurrent intravenous drug administration to critically ill children: Evaluation of frequency and compatibility. Journal of Critical Care, 41, 198–203. https://doi.org/10.1016/j.jcrc.2017.05.027
Gahart, B. L., & Nazareno, A. R. (2014). Intravenous Medications (Deborah L. Vogel (ed.); THIRTIETH). Deborah L. Vogel.
Hani, C., Vonbach, P., Fonzo-Christe, C., Russmann, S., Cannizzaro, V., & Niedrig, D. F. (2019). Evaluation of incompatible coadministration of continuous intravenous infusions in a pediatric/neonatal intensive care unit. Journal of Pediatric Pharmacology and Therapeutics, 24(6), 479–488. https://doi.org/10.5863/1551-6776-24.6.479
Hecq, J.-D., Krämer, I., & Vigneron, J. (2019). European Databases on Stability and Compatibility of Injectable Medicinal Products in Europe. Pharmaceutical Technology in Hospital Pharmacy, 4(3–4), 113–117. https://doi.org/10.1515/pthp-2019-0012
Henkel, E., Vella, R., Behan, K., Austin, D., Kruger, P., & Fenning, A. (2020). The effect of concentration, reconstitution solution and pH on the stability of a remifentanil hydrochloride and propofol admixture for simultaneous co-infusion. BMC Anesthesiology, 20(1), 1–12. https://doi.org/10.1186/s12871-020-01194-5
Kemenkes. (2016). PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA NO 72 TAHUN 2016 TENTANG STANDAR PELAYANAN KEFARMASIAN DI RUMAH SAKIT. 1–63. file:///Users/andreataquez/Downloads/guia-plan-de-mejora-institucional.pdf%0Ahttp://salud.tabasco.gob.mx/content/revista%0Ahttp://www.revistaalad.com/pdfs/Guias_ALAD_11_Nov_2013.pdf%0Ahttp://dx.doi.org/10.15446/revfacmed.v66n3.60060.%0Ahttp://www.cenetec.
Kumar, A., Singh, P., & Nanda, A. (2020). Hot stage microscopy and its applications in pharmaceutical characterization. Applied Microscopy, 50(1). https://doi.org/10.1186/s42649-020-00032-9
La Pietra, L., Calligaris, L., Molendini, L., Quattrin, R., & Brusaferro, S. (2005). Medical errors and clinical risk management: state of the art. Acta Otorhinolaryngologica Italica : Organo Ufficiale Della Società Italiana Di Otorinolaringologia e Chirurgia Cervico-Facciale, 25(6), 339–346.
Maison, O. (2019). Drug incompatibilities in intravenous therapy: evaluation and proposition of preventive tools in intensive care and hematology units. European Journal of Clinical Pharmacology, 75, 179–187.
Malfará, M., Pernassi, M., Aragon, D., & Carlotti, A. (2018). Impact of the clinical pharmacist interventions on prevention of pharmacotherapy related problems in the paediatric intensive care unit. International Journal of Clinical Pharmacy, 40(3), 513–519. https://doi.org/10.1007/s11096-018-0632-x
Malik, A., & Chusni, M. (2018). Pengantar Statistika Pendidikan (Pertama). Deepublish.
Marsilio, N. R., Da Silva, D., & Bueno, D. (2016). Drug incompatibilities in the adult intensive care unit of a university hospital. Revista Brasileira de Terapia Intensiva, 28(2), 147–153. https://doi.org/10.5935/0103-507X.20160029
National Food and Drug Authority. (2017). PERATURAN KEPALA BADAN PENGAWAS OBAT DAN MAKANAN REPUBLIK INDONESIA NOMOR 24 TAHUN 2017 TENTANG KRITERIA DAN TATA LAKSANA REGISTRASI OBAT. Bpom Ri, 1–261.
National Food and Drug Authority. (2022a). Peraturan Badan Pengawas Obat dan Makanan No. 14 Tahun 2022 tentang Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamann, Khasiat, Mutu, dan Label. Bpom, 1–16.
National Food and Drug Authority. (2022b). Peraturan Badan Pengawas Obat Dan Makanan Nomor 23 Tahun 2022 Tentang Standar Dan/Atau Persyaratan Mutu Obat Dan Bahan Obat. Bpom Ri, 11, 1–16.
Neininger, M. P., Buchholz, P., Frontini, R., Kiess, W., Siekmeyer, W., Bertsche, A., Siekmeyer, M., & Bertsche, T. (2019). Incompatible intravenous drug combinations and respective physician and nurse knowledge: A study in routine paediatric intensive care. European Journal of Hospital Pharmacy , 26(4), 214–217. https://doi.org/10.1136/ejhpharm-2017-001248
NHS. (2019). Policy for the Safe Management and Administration of Intravenous Medicines. April, 1–42.
Nilsson, N., Storesund, I., Tho, I., & Nezvalova-Henriksen, K. (2022). Co-administration of drugs with parenteral nutrition in the neonatal intensive care unit—physical compatibility between three components. European Journal of Pediatrics, 181(7), 2685–2693. https://doi.org/10.1007/s00431-022-04466-z
Oyebode, F. (2013). Clinical errors and medical negligence. Medical Principles and Practice, 22(4), 323–333. https://doi.org/10.1159/000346296
Pangestika, R. W. (2022). Hubungan Usia, Pendidikan, dan Lama Bekerja dengan Pengetahuan Tenaga Kesehatan tentang Inkompatibilitas Sediaan Intravena. Media Farmasi, 18(1), 36. https://doi.org/10.32382/mf.v18i1.2693
PERMENKES. (2014). STANDAR PELAYANAN KEFARMASIAN DI APOTEK. PMK NO 35. https://eje.bioscientifica.com/view/journals/eje/171/6/727.xml
Royal Hospital For Women. (2011). ADMINISTRATION OF INTRAVENOUS MEDICATION BY NURSING STAFF (Issue July). https://doi.org/10.1002/14651858.CD001000.pub3.Couser
S. Sriram, Aishwarya, S., Kumar, A. A., Moithu, A., & Sebastian, A. (2018). Intravenous drug incompatibility in intensive care units - A comprehensive review. Innovations in Pharmaceuticals and Pharmacotherapy, 6(3), 55–60. www.innpharmacotherapy.com
Sabins, D., Diep, T., McCartan, P., Patel, S., & Zhao, F. (2019). Stability and Compatibility of Diphenhydramine Hydrochloride in Intravenous Admixtures: A New Look at an Old Drug. Hospital Pharmacy, 54(5), 330–334. https://doi.org/10.1177/0018578718802586
Sohrevardi, S. M., Jarahzadeh, M. H., Mirzaei, E., Mirjalili, M., Tafti, A. D., & Heydari1, B. (2017). Medication errors in patients with enteral feeding tubes in the intensive care unit. In Journal of Research in Pharmacy Practice (Vol. 6, Issue 2). https://doi.org/10.4103/jrpp.jrpp_17_9
Stroppel, L., Schultz-Fademrecht, T., Cebulla, M., Blech, M., Marhöfer, R. J., Selzer, P. M., & Garidel, P. (2023). Antimicrobial Preservatives for Protein and Peptide Formulations: An Overview. Pharmaceutics, 15(2), 1–53. https://doi.org/10.3390/pharmaceutics15020563
Tomczak, S., Gostyńska, A., Nadolna, M., Reisner, K., Orlando, M., Jelińska, A., & Stawny, M. (2021). Stability and compatibility aspects of drugs: The case of selected cephalosporins. Antibiotics, 10(5), 1–16. https://doi.org/10.3390/antibiotics10050549
Villiers, M. M. De. (2017). Compatibility and Stability of Drug Products and Preparations. January 2009, 672–702. https://www.researchgate.net/publication/318380441%0ACompatibility
WHO. (1996). Annex 5: Guidelines for Stability Testing of Pharmaceutical Products Containing Well Established Drug Substances in Conventional Dosage Forms. World Health Organization Technical Report Series, 863, 65–80. https://www.paho.org/hq/dmdocuments/2008/6_Annex_5_report_34.pdf
Published
2024-10-23
How to Cite
Erna Prasetya Ningrum, Fita Rahmawati, Marlyn Dian Laksitorini, & Endang Lukitaningsih. (2024). Knowledge of Intravenous Preparation among Health Professionals and Assessment of the Sterile Product Label Information Coverage. Indonesian Journal of Pharmacy. https://doi.org/10.22146/ijp.11198
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Research Article
