Doms № 1 -2022

Doms № 1 -2022 (64-72 p)

Practical recommendations for storage of medication of insulin medications
Vlasenko I. O., Davtyan L. L.

Abstract

Biological thermolabile medications, such as insulin, are sensitive to the effects of temperature, light, etc. Improper storage can cause insulin medications to break down, affecting its ability to be effective in control the level of glucose in the patient’s blood. Therefore, storage of insulin medications is an important aspect in ensuring its effectiveness and safety. Determining the importance of insulin storage scientists are conducting research on the risk of insulin freezing in household refrigerators. It was found that insulins were very often stored outside the recommended range (from +2oС to +8oС). Insulin that was subjected to freezing does not have full activity and its use melting leads to suboptimal glycemic control. This is especially important for young patients with diabetes mellitus (DM), who are more sensitive to changes in insulin activity and for insulin pumps users. Proper storage at home will help avoid unwanted episodes for patients with diabetes. Based on the analysis of international standards, recommendation, the latest scientific studies and instructions for the use of insulin medications detailed recommendations for the storage of insulins for patients with diabetes were developed. Attention is drawn to the high risk of exposure to temperature during storage and to prevention of these risks. Recommendations are developed from the point of view of practical application. Tips for storing insulin while traveling Separately formulated. The recommendations are designed to provide medical and pharmaceutical care for patients with diabetes and for training in diabetes self-management schools.

Keywords: storage, insulin, diabetes, recommendations.

References

  1. International diabetes federation Diabetes Atlas – 9th edition. http://www. diabetesatlas.org Accessed February 15, 2021.
  2. Маньковский Г.Б. Диагностика нарушений углеводного обмена у больных с ишемической болезнью сердца. Медичні перспективи. 2018;18(2):46-52.
  3. Кондрацька І.М. Реімбурсація препаратів інсуліну: аналіз даних реєстру 2018. http://health-ua.com/article/40479- rembursatcya-preparatv-nsulnu-analz-danih-restru Accessed February 20, 2021.
  4. WHO Model List of Essential Medicines. https://www.who.int/ selection_medicines/list/en/]. Accessed February 15, 2021.
  5. Storing Insulin. https://www.iddt.org/about/living-with- diabetes/storing-insulin). Accessed February 15, 2021.
  6. Arpit B, Varun G, Prashant T, et al. Last mile delivery of cold chain medicines – challenges and recommendations. Indian J Pharm Biol Res. 2018;6(1):34–41.
  7. Chandler C, Gryniewicz C.M., Pringle T., Cunningham F. Insulin temperature and stability under simulated transit
  8. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products. WHO Technical Report Series, No.961, Annex 9; 2011. http://apps.who.int/medicinedocs/documents/ s18683en/s18683en.pdf Accessed February 15, 2021.
  9. Nitschke E, Heinemann L, Cartner A, et al. What Do Health- care Professionals and People With Diabetes Know About Insulin Transport and Storage? A Multinational Survey. Journal of Diabetes Science and Technology 2021;00(0):1-4.
  10. Heinemann L, Braune K, Carter A, et al. Insulin Storage: A Critical Reappraisal. Journal of Diabetes Science and Technology. 2021;15(1):147-159.
  11. EADSG Guidelines: Insulin Storage and Optimisation of Injection Technique in Diabetes Management. Bahendeka S, Kaushik R, Babu Swai A. et al. Diabetes Ther 2019;10:341-366.
  12. Державний реєстр лікарських засобів. http://www.drlz. com.ua Accessed March 02, 2021.
  13. European Medicines Agency (EMA). https://www.ema.europa.eu Accessed March 02, 2021.
  14. European Commission. Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use. Official Journal of the European Union.Commission guideline 2013. C. 343/01- 343/14. https://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:001 4:EN:PDF Accessed March 02, 2021.
  15. Food and Drug Administration’ https://www.fda.gov/consumers/free-publications-women/insulin. Accessed March 02, 2021.
  16. Mahony P. What happens to insulin after it is dispensed? Material of 15 National Rural Health Conference 24-27 march, 2019 Tasmania.
  17. Майоров А.Ю. Мельникова О.Г. Национальные рекомендаии для медицинских работников по технике инъекций при лечении сахарного диабета. Москва, 2012,43с.
  18. Braune K, Kraemer LA, Weinstein J, et al, Storage Conditions of Insulin in Domestic Refrigerators and When Carried by Patients: Often Outside Recommended Temperature Range. Diabetes Technology & Therapeutics. 2019;21(5):238-244.
  19. Minuto N., Tambroni B., Vannati M., et al. Diabetic ketoacidosis caused by exposure of insulin to low temperature. Diabetes Technology and Therapeutics. 2010;12(9):745-746.
  20. Mirghani HO, Alatawi EF, Albelwi NM, et al. The site of insulin storage inside domestic refrigerators is associated with ketoacidosis and hypoglycemic episodes among patient with diabetes mellitus, in Tabuk City, The Kingdom of Saudi Arabia. AMJ 2019;12(12):350–355.
  21. Vlieland ND, Gardarsdottir H, Bouvy ML, et al. The majority of patients do not store their biologic diseasemodifying antirheumatic drugs within the recommended temperature range. Rheumatology. 2016;55:704–709.
  22. de Jong M, Pierik M, Peters A, et al: Exploring conditions for redistribution of anti-tumor necrosis factors to reduce spillage: A study on the quality of anti-tumor necrosis factor home storage. J Gastroenterol Hepatol. 2018;33:426-430.
  23. Ostman J., Andersson D. Diabetes mellitus in the book: Drugs Swedish pharmaceutical company, 1993.474p.
  24. Khurana G, Gupta V. Effect on Insulin upon Storage in Extreme Climatic Conditions (Temperature and Pressure) and Their Preventive Measures. J Soc Health Diab. 2019;7:6–10.
  25. Grajower MM, Fraser CG, Holcombe JH, et al. How long should insulin be used once a vial is started? Diabetes Care. 2003;26(9):2665-2666.
  26. Rathod M., Saravolatz L., Pohlod D., et al. Evaluation of the sterility and stability of insulin from multidose vials used for prolonged periods. Infect Control. 1985;6:491-494.
  27. Kongmalai T, Preechasuk L, Junnu S, et al. The Effect of Temperature on the Stability of In-Use Insulin Pens DOI Exp Clin Endocrinol Diabetes. Published online: 2019-10-21.
  28. Kaufmann B, Boulle P, Berthou F, et al. Heat-stability study of various insulin types in tropical temperature conditions: New insights towards improving diabetes care. PLoS ONE. 2021;16(2):e0245372.
  29. Gregory R, Edwards S, Yateman NA. Demonstration of insulin transformation products in insulin vials by high-performance liquid chromatography. Diabetes Care. 1991;14 (1):42-48.
  30. Besser R. Type 1 Diabetes in Children, Adolescents and Young Adults: How to Become an Expert on Your Own Diabetes. CLASS PUBLISHING. Bridgwater, United Kingdom. 2009,400p.
  31. Arya S. C. Insulin storage in clay pot. Annals of Saudi Medi- cine. 2000;20:491-492.
  32. Guidelines for insulin storage and handling. http://patientinfo. org.au/Resources/Guidelines%20for%20insulin%20stor- age%20and%20handling.pdf Accessed February 12, 2021.
  33. Insulin storage and syringe safety. American Diabetes Association http://www.diabetes.org/living-with-diabetes/ treatment-and-care/medication/insulin/insulin-storage-and- syringe-safety.html Accessed February 12, 2021.
  34. Bahendeka S, Kaushik R, Babu Swai A, et al. EADSG Guidelines: Insulin Storage and Optimisation of Injection Technique in Diabetes Management. Diabetes Therapy. 2019;10(2):341-366.
  35. Insulin Recommended Safe Practice Guidelines California Hospital Association Medication Safety Committee. https:// www.calhospital.org/sites/main/files/file-attachments/tk_in- sulin_guidelines_rev_9-21-17_final.pdf ]. Accessed February 12, 2021.
  36. Krämer L, Vlasenko I, Zayani A. Storage of insulin – IDF Europe awareness paper. https://idf.org/our-network/regions- members/europe/publications-and-resources/70-storage-of- insulin-idf-europe-awareness-paper.html Accessed February 12, 2021.
  37. Kalra S., Kalra B. Storage of insulin in rural areas. Journal of Academy of Medicinal Science. 2012;2(2):86-89.
  38. Practice Guidance on the Care of People with Diabetes. Royal Pharmaceutical Society of Great Britain Diabetes. Task Force:2004,74p. http://studyres.com/doc/8005614/practice- guidance-on-the-care-of-people-with-diabetes Accessed January 20, 2021.
  39. Власенко ІО, Давтян ЛЛ, Фармаевтична допомога хворим на цукровий діабет щодо зберігання препаратів інсуліну. Фармацевтичний журнал. 2019;5:21-34.
  40. Travelling and diabetes. https://idf.org/our-network/regions- members/europe/publications-and-resources/76-travelling- and-diabetes.html Accessed January 15, 2021.
  41. Traveling with insulin: How to keep it cool. https://www. sweettrip.org/traveling-with-insulin/#INSULIN-STORAGE- RULES: Accessed January 29, 2021.
  42. How to keep insulin cold while traveling: All you need to know! URL: https://www.dreambigtravelfarblog.com/blog/ how-to-keep-insulin-cold-while-traveling Accessed January 30, 2021.

 

 

Received: 04.12.2021

Revised: 10.01.2022

Accepted: 10.01.2022