". Pharmacopeial Forum, 35 (5), 1383-1387." />
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The Hidden Threat in Parenteral Drugs: Glass Particle Contamination

Yıl 2022, Cilt: 11 Sayı: 3, 1265 - 1273, 27.09.2022
https://doi.org/10.37989/gumussagbil.1003849

Öz

In parenteral applications, drugs in the form of glass ampoules are frequently used in healthcare units. While the glass ampoule form of drugs is being prepared for treatment, a large number of micro and macro sized glass particles are formed during the breakage of the neck part and spilled into the ampoule and contaminates the drug. Medicines in glass ampoule form are injected parenterally to patients. In this context, drugs contaminated with micro-sized glass particles spread throughout the body and pose a potential danger to patients. Although newborns, the elderly and patients treated in long-term intensive care units are at greater risk, it is predicted that some complications may occur in patients. For this reason, it is recommended to use filter materials at the stage of drawing the drug from the ampoule to the syringe in order to prevent glass particle contamination. In parenteral drug applications, used filter materials can reduce the risk of health problems that may develop due to glass particle contamination in patients and increase patient safety accordingly. It is important for physicians and nurses to be aware of glass particle contamination. The aim of this study is to draw attention to glass particle contamination in glass ampoule parenteral drugs.

Kaynakça

  • 1. Stoker, R. (2009). "Preventing injuries from glass ampoule shards: Advances in glass ampoule breakers". Managing Infection Control, 45-47.
  • 2. Erkoç Hut, A. ve Bayır Y. (2017). "Cam ilaç ampullerinde tehlike: kıymık şeklinde cam parçacıklar". Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6 (3), 105-110.
  • 3. Carbone-Traber, K. B. and Shanks C. A. (1986). "Glass particle contamination in single-dose ampules". Journals of Anesthesia Analgesia, 65, 1361-1363.
  • 4. Carraretto, A. R, Curi, E. F, de Almeida, C. E. and Abatti, R. E. (2011). "Glass ampoules: risks and benefits". Brazilian Journal of Anesthesiology, 61 (4), 513-521.
  • 5. Lye, S. T. and Hwang, N. C. (2003). "Glass particle contamination: is it here to stay?". Anaesthesia, 58 (1). 93-94.
  • 6. Lee, K. R, Chae, Y. J, Cho, S. E. and Chung, S. J. (2011). "A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application". Drug Development and Industrial Pharmacy, 37 (12), 1394-1401.
  • 7. Sabon, R. L, Cheng, E. Y, Stommel, K. A. and Hennen, C. R. (1989). "Glass particle contamination: influence of aspiration methods and ampule types". Anesthesiology, 70 (5), 859-562.
  • 8. Park, J. S, Oh H. R, Seo, B. H. and Bhang, J. H. (2006). "Comparison of glass particle contamination according to method of ampule cutting and needle aspiration". Journal of Korean Academy of Nursing, 36 (6), 1033-1041.
  • 9. Yorioka, K, Oie, S. and Kamiya, A. (2009). "Comparison of particulate contamination in glass and plastic ampoules of glycyrrhizin injections after ampoule cutting". Journal of Food and Drug Analysis, 17, 225-228.
  • 10. Kawasaki, Y. (2009). "Study on insoluble microparticulate contamination at ampoule opening". Journal of the Pharmaceutical Society of Japan, 129 (9), 1041-1047.
  • 11. Zabir, A. F, Choy, C. Y. and Rushdan, R. (2008). "Glass particle contamination of parenteral preparations of intravenous drugs in anaesthetic practice". Southern African Journal of Anaesthesia Analgesia, 14 (3), 17-19.
  • 12. Timmons, C. L, Liu, C. Y. and Merkle, S. (2017). "Particulate generation mechanisms during bulk filling and mitigation via new glass vial". PDA Journal of Pharmaceutical Science and Technology, 71 (5), 379-392.
  • 13. Bukofzer, S, Ayres, J, Chavez, A, Devera, M, Miller, J, Ross D, Shabushnig, J, Vargo, S, Watson, H. and Watson, R. (2015) "Industry perspective on the medical risk of visible particles in injectable drug products". PDA Journal of Pharmaceutical Science and Technology, 69, 123-139.
  • 14. Preston, S. T. and Hegadoren, K. (2004). "Glass contamination in parenterally administered medication". Journal of Advanced Nursing, 48, 266-270.
  • 15. Heiss-Harris, G. M. and Verklan, M. T. (2005). "Maximizing patient safety: filter needle use with glass ampules". The Journal of Perinatal and Neonatal Nursing, 19 (1), 74-81.
  • 16. American Society of Health-System Pharmacists. (2014). "ASHP guidelines on compounding sterile preparations". American Journal of Health-System Pharmacy, 71, 145-166.
  • 17. Langille, S. E. (2013). "Particulate matter in injectable drug products". PDA Journal of Pharmaceutical Science and Technology, 67 (3), 186-200.
  • 18. Jack, T, Boehne, M, Brent, B. E, Hoy, L, Köditz, H, Wessel, A. and Sasse, M. (2012). "In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial". Intensive Care Medicine, 38, 1008–1016.
  • 19. Joo, G. E, Sohng, K. Y. and Park, M. Y. (2016). "The effect of different methods of intravenous injection on glass particle contamination from ampules". SpringerPlus, 5 (15), 1-8.
  • 20. Painchart, L, Odoui, P. and Bussiéres J. F. (2018). "Particulate contamination associated with the manipulation of drug in glass ampules: A literature rewiev". Annales Pharmaceutiques Françeises, 76 (1), 3-15.Infusion Nurses Society. (2016). "Infusion therapy standards of practice". Journal of Infusion Nursing, 39 (1), 70.
  • 21. Infusion Nurses Society. (2016). "Infusion therapy standarts of practice". Journal of Infusion Nursing, 39 (1), 70.
  • 22. Erkoc Hut, A. and Yazici, Z. A. (2021). "Glass particle contamination threat in nursing practice: A pilot study". Journal of Advanced Nursing, 77 (7), 3189-3191.
  • 23. European Pharmacopoeia. (2008) 7th ed., Chapter 3. 2. 1. Glass containers for pharmaceutical use. European Pharmacopoeia Commission, 363-367. Erişim Adresi: http://www.biomed.co.th/english/dow0nloads/EP7-3.2.1-Glass%20containers-for-pharmaceutical-use.pdf (Erişim Tarihi: 28.09.2021).
  • 24. Süzen, B. ve Akça Ay, F. (2012). İlaç uygulamaları. F. Akça Ay. (Ed.). Sağlık Uygulamalarında Temel Kavramlar ve Beceriler (418-505). İstanbul: Nobel Tıp Kitapevleri.
  • 25. Doyle, G.R. and McCutcheon, J.A. "Clinical procedures for safer patient care". Victoria, BC: BC Campus, 2015. Erişim Adresi: https://opentextbc.ca/clinicalskills/ (Erişim Tarihi: 28.09.2021).
  • 26. Madsen, R.E, Cherris, R.T, Shabushnig, J.G. and Hunt, D.G. (2009). "Visible particulates in injections-a history and a proposal to revise USP general chapter injections <1>". Pharmacopeial Forum, 35 (5), 1383-1387.
  • 27. Puntis, J. W, Wilkins, K. M, Ball, P. A, Rushton, D.I. and Booth, I. W. (1992). "Hazards of parenteral treatment: Do particles count?". Archives of Disease Childhood, 6, 1475-1477.
  • 28. Jack, T, Brent, B. E, Boehne, M, Müller, M, Sewald, K, Braun, A, Wessel, A. and Sasse, M. (2010). "Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit". İntensive Care Medicine, 36, 707-711.
  • 29. Turco, S. J. and Davis, N. M. (1971). "Detrimental effects of particulate matter on the pulmonary circulation". Journal of America Medical Association, 217, 81-82.
  • 30. Hafez, M. A. and Al-Dars, A. M. (2012) "Glass foreign bodies inside the knee joint following intra-articular injection". American Journal of Case Reports, 13, 238-240.
  • 31. Yorioka, K, Oie, S, Oomaki, M, Imamura, A. and Kamiya, A. (2006). "Particulate and microbial contamination in in-use admixed intravenous infusions". Biological Pharmaceutical Bulletin, 29, 2321-2323.
  • 32. Hasta ve Çalışan Güvenliği Yönetmeliği. Resmi Gazete 06/04/2011, 27897.
  • 33. Çetinkaya Uslusoy, E, Taşçı Duran, E. ve Korkmaz, M. (2016). "Güvenli enjeksiyon uygulamaları". Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 3 (2), 50-57.
  • 34. Hemşirelik Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik. Resmi Gazete 19/04/2011, 27910.
  • 35. Aslan, M. (2016). "Membran Teknolojileri". Ankara: T.C Çevre ve Şehircilik Bakanlığı, TUÇEV.
  • 36. United States Pharmacopeia. Chapter 797 Pharmaceutical Compounding: Sterile Preparations, (2008). Erişim Adresi: https://www.pbm.va.gov/linksotherresources/docs/USP797PharmaceuticalCompoundingSterileCompounding.pdf (Erişim Tarihi: 28.09.2021).
  • 37. Hemingway, C. J, Malhotra, S, Almeida, M, Azadian, B. and Yentis, S. M. (2007). "The effect of alcohol swabs and filter straws on reducing contamination of glass ampoules used for neuroaxial injections". Anaesthasia, 62, 286-288.
  • 38. Villa G, Chelazzi C, Giua R, Tofani L, Zagli G, Boninsegni P, Pinelli F, De Gaudio A. R. and Romagnoli S. (2018). "In-line filtration reduces postoperative venous peripheral phlebitis associated with cannulation: A randomized clinical trial". Anesthesia and Analgesia, 127 (6), 1367-1374.

Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu

Yıl 2022, Cilt: 11 Sayı: 3, 1265 - 1273, 27.09.2022
https://doi.org/10.37989/gumussagbil.1003849

Öz

Sağlık hizmeti verilen birimlerde parenteral ilaç uygulamalarında cam ampul formu ilaçlar sıklıkla kullanılmaktadır. Tedavi sırasında bu form ilaçlar hazırlanırken ampulun boyun kısmından kırılması sonucunda çok sayıda mikro ve makro boyutlarda cam partikül oluşmaktadır. Bu parçacıkların ampul içerisine dökülmesi ile ilacın kontaminasyonu gerçekleşmektedir. Kontamine olan bu ilaçlar parenteral yollarla hastalara enjekte edildiğinde tüm vücuda yayılarak hastalar için potansiyel bir tehlike oluşturmaktadır. Yenidoğanlar, yaşlılar ve uzun süreli yoğun bakım ünitelerinde tedavi gören hastalar daha çok risk altında olmakla birlikte hastalarda bazı komplikasyonların ortaya çıkabileceği de öngörülmektedir. Bu nedenle cam partikül kontaminasyonunun önlenmesi için ilacın ampulden enjektöre çekilmesi aşamasında filtre materyallerinin kullanımı önerilmektedir. Parenteral ilaç uygulamalarında filtre materyallerinin kullanımı ile güvenli ilaç uygulaması sağlanır. Hastalarda cam partikül kontaminasyonuna bağlı gelişebilecek sağlık sorunlarını yaşama riski azaltılır ve hasta güvenliği arttırılır. Hekim ve hemşirelerin cam partikül kontaminasyonu yönünden farkındalıkları önemlidir. Bu çalışmanın amacı cam ampul formu parenteral ilaçlarda gerçekleşen cam partikül kontaminasyonuna dikkat çekmektir.

Kaynakça

  • 1. Stoker, R. (2009). "Preventing injuries from glass ampoule shards: Advances in glass ampoule breakers". Managing Infection Control, 45-47.
  • 2. Erkoç Hut, A. ve Bayır Y. (2017). "Cam ilaç ampullerinde tehlike: kıymık şeklinde cam parçacıklar". Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6 (3), 105-110.
  • 3. Carbone-Traber, K. B. and Shanks C. A. (1986). "Glass particle contamination in single-dose ampules". Journals of Anesthesia Analgesia, 65, 1361-1363.
  • 4. Carraretto, A. R, Curi, E. F, de Almeida, C. E. and Abatti, R. E. (2011). "Glass ampoules: risks and benefits". Brazilian Journal of Anesthesiology, 61 (4), 513-521.
  • 5. Lye, S. T. and Hwang, N. C. (2003). "Glass particle contamination: is it here to stay?". Anaesthesia, 58 (1). 93-94.
  • 6. Lee, K. R, Chae, Y. J, Cho, S. E. and Chung, S. J. (2011). "A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application". Drug Development and Industrial Pharmacy, 37 (12), 1394-1401.
  • 7. Sabon, R. L, Cheng, E. Y, Stommel, K. A. and Hennen, C. R. (1989). "Glass particle contamination: influence of aspiration methods and ampule types". Anesthesiology, 70 (5), 859-562.
  • 8. Park, J. S, Oh H. R, Seo, B. H. and Bhang, J. H. (2006). "Comparison of glass particle contamination according to method of ampule cutting and needle aspiration". Journal of Korean Academy of Nursing, 36 (6), 1033-1041.
  • 9. Yorioka, K, Oie, S. and Kamiya, A. (2009). "Comparison of particulate contamination in glass and plastic ampoules of glycyrrhizin injections after ampoule cutting". Journal of Food and Drug Analysis, 17, 225-228.
  • 10. Kawasaki, Y. (2009). "Study on insoluble microparticulate contamination at ampoule opening". Journal of the Pharmaceutical Society of Japan, 129 (9), 1041-1047.
  • 11. Zabir, A. F, Choy, C. Y. and Rushdan, R. (2008). "Glass particle contamination of parenteral preparations of intravenous drugs in anaesthetic practice". Southern African Journal of Anaesthesia Analgesia, 14 (3), 17-19.
  • 12. Timmons, C. L, Liu, C. Y. and Merkle, S. (2017). "Particulate generation mechanisms during bulk filling and mitigation via new glass vial". PDA Journal of Pharmaceutical Science and Technology, 71 (5), 379-392.
  • 13. Bukofzer, S, Ayres, J, Chavez, A, Devera, M, Miller, J, Ross D, Shabushnig, J, Vargo, S, Watson, H. and Watson, R. (2015) "Industry perspective on the medical risk of visible particles in injectable drug products". PDA Journal of Pharmaceutical Science and Technology, 69, 123-139.
  • 14. Preston, S. T. and Hegadoren, K. (2004). "Glass contamination in parenterally administered medication". Journal of Advanced Nursing, 48, 266-270.
  • 15. Heiss-Harris, G. M. and Verklan, M. T. (2005). "Maximizing patient safety: filter needle use with glass ampules". The Journal of Perinatal and Neonatal Nursing, 19 (1), 74-81.
  • 16. American Society of Health-System Pharmacists. (2014). "ASHP guidelines on compounding sterile preparations". American Journal of Health-System Pharmacy, 71, 145-166.
  • 17. Langille, S. E. (2013). "Particulate matter in injectable drug products". PDA Journal of Pharmaceutical Science and Technology, 67 (3), 186-200.
  • 18. Jack, T, Boehne, M, Brent, B. E, Hoy, L, Köditz, H, Wessel, A. and Sasse, M. (2012). "In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial". Intensive Care Medicine, 38, 1008–1016.
  • 19. Joo, G. E, Sohng, K. Y. and Park, M. Y. (2016). "The effect of different methods of intravenous injection on glass particle contamination from ampules". SpringerPlus, 5 (15), 1-8.
  • 20. Painchart, L, Odoui, P. and Bussiéres J. F. (2018). "Particulate contamination associated with the manipulation of drug in glass ampules: A literature rewiev". Annales Pharmaceutiques Françeises, 76 (1), 3-15.Infusion Nurses Society. (2016). "Infusion therapy standards of practice". Journal of Infusion Nursing, 39 (1), 70.
  • 21. Infusion Nurses Society. (2016). "Infusion therapy standarts of practice". Journal of Infusion Nursing, 39 (1), 70.
  • 22. Erkoc Hut, A. and Yazici, Z. A. (2021). "Glass particle contamination threat in nursing practice: A pilot study". Journal of Advanced Nursing, 77 (7), 3189-3191.
  • 23. European Pharmacopoeia. (2008) 7th ed., Chapter 3. 2. 1. Glass containers for pharmaceutical use. European Pharmacopoeia Commission, 363-367. Erişim Adresi: http://www.biomed.co.th/english/dow0nloads/EP7-3.2.1-Glass%20containers-for-pharmaceutical-use.pdf (Erişim Tarihi: 28.09.2021).
  • 24. Süzen, B. ve Akça Ay, F. (2012). İlaç uygulamaları. F. Akça Ay. (Ed.). Sağlık Uygulamalarında Temel Kavramlar ve Beceriler (418-505). İstanbul: Nobel Tıp Kitapevleri.
  • 25. Doyle, G.R. and McCutcheon, J.A. "Clinical procedures for safer patient care". Victoria, BC: BC Campus, 2015. Erişim Adresi: https://opentextbc.ca/clinicalskills/ (Erişim Tarihi: 28.09.2021).
  • 26. Madsen, R.E, Cherris, R.T, Shabushnig, J.G. and Hunt, D.G. (2009). "Visible particulates in injections-a history and a proposal to revise USP general chapter injections <1>". Pharmacopeial Forum, 35 (5), 1383-1387.
  • 27. Puntis, J. W, Wilkins, K. M, Ball, P. A, Rushton, D.I. and Booth, I. W. (1992). "Hazards of parenteral treatment: Do particles count?". Archives of Disease Childhood, 6, 1475-1477.
  • 28. Jack, T, Brent, B. E, Boehne, M, Müller, M, Sewald, K, Braun, A, Wessel, A. and Sasse, M. (2010). "Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit". İntensive Care Medicine, 36, 707-711.
  • 29. Turco, S. J. and Davis, N. M. (1971). "Detrimental effects of particulate matter on the pulmonary circulation". Journal of America Medical Association, 217, 81-82.
  • 30. Hafez, M. A. and Al-Dars, A. M. (2012) "Glass foreign bodies inside the knee joint following intra-articular injection". American Journal of Case Reports, 13, 238-240.
  • 31. Yorioka, K, Oie, S, Oomaki, M, Imamura, A. and Kamiya, A. (2006). "Particulate and microbial contamination in in-use admixed intravenous infusions". Biological Pharmaceutical Bulletin, 29, 2321-2323.
  • 32. Hasta ve Çalışan Güvenliği Yönetmeliği. Resmi Gazete 06/04/2011, 27897.
  • 33. Çetinkaya Uslusoy, E, Taşçı Duran, E. ve Korkmaz, M. (2016). "Güvenli enjeksiyon uygulamaları". Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 3 (2), 50-57.
  • 34. Hemşirelik Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik. Resmi Gazete 19/04/2011, 27910.
  • 35. Aslan, M. (2016). "Membran Teknolojileri". Ankara: T.C Çevre ve Şehircilik Bakanlığı, TUÇEV.
  • 36. United States Pharmacopeia. Chapter 797 Pharmaceutical Compounding: Sterile Preparations, (2008). Erişim Adresi: https://www.pbm.va.gov/linksotherresources/docs/USP797PharmaceuticalCompoundingSterileCompounding.pdf (Erişim Tarihi: 28.09.2021).
  • 37. Hemingway, C. J, Malhotra, S, Almeida, M, Azadian, B. and Yentis, S. M. (2007). "The effect of alcohol swabs and filter straws on reducing contamination of glass ampoules used for neuroaxial injections". Anaesthasia, 62, 286-288.
  • 38. Villa G, Chelazzi C, Giua R, Tofani L, Zagli G, Boninsegni P, Pinelli F, De Gaudio A. R. and Romagnoli S. (2018). "In-line filtration reduces postoperative venous peripheral phlebitis associated with cannulation: A randomized clinical trial". Anesthesia and Analgesia, 127 (6), 1367-1374.
Toplam 38 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Sağlık Kurumları Yönetimi
Bölüm Derlemeler
Yazarlar

Nida Nur Söğüt 0000-0002-7174-9049

Arzu Erkoç Hut 0000-0001-9077-1973

Yayımlanma Tarihi 27 Eylül 2022
Yayımlandığı Sayı Yıl 2022 Cilt: 11 Sayı: 3

Kaynak Göster

APA Söğüt, N. N., & Erkoç Hut, A. (2022). Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 11(3), 1265-1273. https://doi.org/10.37989/gumussagbil.1003849
AMA Söğüt NN, Erkoç Hut A. Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu. Gümüşhane Sağlık Bilimleri Dergisi. Eylül 2022;11(3):1265-1273. doi:10.37989/gumussagbil.1003849
Chicago Söğüt, Nida Nur, ve Arzu Erkoç Hut. “Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu”. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi 11, sy. 3 (Eylül 2022): 1265-73. https://doi.org/10.37989/gumussagbil.1003849.
EndNote Söğüt NN, Erkoç Hut A (01 Eylül 2022) Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi 11 3 1265–1273.
IEEE N. N. Söğüt ve A. Erkoç Hut, “Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu”, Gümüşhane Sağlık Bilimleri Dergisi, c. 11, sy. 3, ss. 1265–1273, 2022, doi: 10.37989/gumussagbil.1003849.
ISNAD Söğüt, Nida Nur - Erkoç Hut, Arzu. “Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu”. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi 11/3 (Eylül 2022), 1265-1273. https://doi.org/10.37989/gumussagbil.1003849.
JAMA Söğüt NN, Erkoç Hut A. Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu. Gümüşhane Sağlık Bilimleri Dergisi. 2022;11:1265–1273.
MLA Söğüt, Nida Nur ve Arzu Erkoç Hut. “Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu”. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, c. 11, sy. 3, 2022, ss. 1265-73, doi:10.37989/gumussagbil.1003849.
Vancouver Söğüt NN, Erkoç Hut A. Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu. Gümüşhane Sağlık Bilimleri Dergisi. 2022;11(3):1265-73.