Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis

Richard F Pollock,1 Yujun Qian,2 Tami Wisniewski,3 Lisa Seitz,4 Anne-Marie Kappelgaard2 1Ossian Health Economics and Communications GmbH, Basel, Switzerland; 2Novo Nordisk AS, Bagsværd, Denmark; 3Novo Nordisk Inc, Princeton, NJ, USA; 4Novo Nordisk Pharma GmbH, Mainz, Germany Background: Tr...

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Auteurs principaux:	Pollock RF, Qian Y, Wisniewski T, Seitz L, Kappelgaard AM
Format:	article
Langue:	EN
Publié:	Dove Medical Press 2013
Sujets:	Medical technology R855-855.5
Accès en ligne:	https://doaj.org/article/4eecb0afab0d4b5ebc5a216b47c0bbb4
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spelling	oai:doaj.org-article:4eecb0afab0d4b5ebc5a216b47c0bbb42021-12-02T00:27:34ZProduct wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis1179-1470https://doaj.org/article/4eecb0afab0d4b5ebc5a216b47c0bbb42013-08-01T00:00:00Zhttp://www.dovepress.com/product-wastage-from-modern-human-growth-hormone-administration-device-a13875https://doaj.org/toc/1179-1470Richard F Pollock,1 Yujun Qian,2 Tami Wisniewski,3 Lisa Seitz,4 Anne-Marie Kappelgaard2 1Ossian Health Economics and Communications GmbH, Basel, Switzerland; 2Novo Nordisk AS, Bagsværd, Denmark; 3Novo Nordisk Inc, Princeton, NJ, USA; 4Novo Nordisk Pharma GmbH, Mainz, Germany Background: Treatment of growth hormone disorders typically involves daily injections of human growth hormone (GH) over many years, incurring substantial costs. We assessed the extent of undesired GH loss due to leakage in the course of pen preparation prior to injection, and differences between the prescribed dose, based on patient weight, and the actual delivered dose based on pen dosing increments in five GH administration devices. Methods: Norditropin® prefilled FlexPro®, NordiFlex®, NordiLet®, and durable NordiPen®/SimpleXx® 5 mg pens (Novo Nordisk A/S, Bagsværd, Denmark) and durable Omnitrope® Pen-5 devices (Sandoz, Holzkirchen, Germany) were tested (n = 40 for each device type). Product wastage was measured in accordance with validated protocols in an ISO (International Organization for Standardization) 11608-1 and Good Manufacturing Practice compliant laboratory. The average mass of wasted GH from each device type was measured in simulations of dripping with the needle attached prior to injection and while setting a dose. Statistical significance (P < 0.05) was confirmed by Student's t-test, and a model was constructed to estimate mean annual GH wastage per patient in cohorts of pediatric patients with GH disorders. Results: Mean GH mass wasted with the needle on prior to injection was 0.0 µg with Norditropin pens, relative to 98 µg with Omnitrope Pen-5. During dose dialing, 0.0–2.3 µg of GH was lost with Norditropin pens versus 0.8 µg with Omnitrope Pen-5. All Norditropin and Omnitrope device comparisons were statistically significant. Modeling GH wastage in a US cohort showed 5.5 mg of annual GH wastage per patient with FlexPro versus 43.6 mg with Omnitrope, corresponding to 7–8 additional pens per patient annually. Conclusion: Overall, Norditropin pens resulted in significantly less wastage than the Omnitrope Pen-5. The study suggests that GH devices of the same nominal volume exhibit differences that may affect the frequency of GH prescription refills required to remain adherent to therapy. Keywords: human growth hormone, administration, dosage, injections, subcutaneous, computer modelsPollock RFQian YWisniewski TSeitz LKappelgaard AMDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2013, Iss default, Pp 107-114 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Pollock RF Qian Y Wisniewski T Seitz L Kappelgaard AM Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
description	Richard F Pollock,1 Yujun Qian,2 Tami Wisniewski,3 Lisa Seitz,4 Anne-Marie Kappelgaard2 1Ossian Health Economics and Communications GmbH, Basel, Switzerland; 2Novo Nordisk AS, Bagsværd, Denmark; 3Novo Nordisk Inc, Princeton, NJ, USA; 4Novo Nordisk Pharma GmbH, Mainz, Germany Background: Treatment of growth hormone disorders typically involves daily injections of human growth hormone (GH) over many years, incurring substantial costs. We assessed the extent of undesired GH loss due to leakage in the course of pen preparation prior to injection, and differences between the prescribed dose, based on patient weight, and the actual delivered dose based on pen dosing increments in five GH administration devices. Methods: Norditropin® prefilled FlexPro®, NordiFlex®, NordiLet®, and durable NordiPen®/SimpleXx® 5 mg pens (Novo Nordisk A/S, Bagsværd, Denmark) and durable Omnitrope® Pen-5 devices (Sandoz, Holzkirchen, Germany) were tested (n = 40 for each device type). Product wastage was measured in accordance with validated protocols in an ISO (International Organization for Standardization) 11608-1 and Good Manufacturing Practice compliant laboratory. The average mass of wasted GH from each device type was measured in simulations of dripping with the needle attached prior to injection and while setting a dose. Statistical significance (P < 0.05) was confirmed by Student's t-test, and a model was constructed to estimate mean annual GH wastage per patient in cohorts of pediatric patients with GH disorders. Results: Mean GH mass wasted with the needle on prior to injection was 0.0 µg with Norditropin pens, relative to 98 µg with Omnitrope Pen-5. During dose dialing, 0.0–2.3 µg of GH was lost with Norditropin pens versus 0.8 µg with Omnitrope Pen-5. All Norditropin and Omnitrope device comparisons were statistically significant. Modeling GH wastage in a US cohort showed 5.5 mg of annual GH wastage per patient with FlexPro versus 43.6 mg with Omnitrope, corresponding to 7–8 additional pens per patient annually. Conclusion: Overall, Norditropin pens resulted in significantly less wastage than the Omnitrope Pen-5. The study suggests that GH devices of the same nominal volume exhibit differences that may affect the frequency of GH prescription refills required to remain adherent to therapy. Keywords: human growth hormone, administration, dosage, injections, subcutaneous, computer models
format	article
author	Pollock RF Qian Y Wisniewski T Seitz L Kappelgaard AM
author_facet	Pollock RF Qian Y Wisniewski T Seitz L Kappelgaard AM
author_sort	Pollock RF
title	Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
title_short	Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
title_full	Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
title_fullStr	Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
title_full_unstemmed	Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
title_sort	product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/4eecb0afab0d4b5ebc5a216b47c0bbb4
work_keys_str_mv	AT pollockrf productwastagefrommodernhumangrowthhormoneadministrationdevicesalaboratoryandcomputersimulationanalysis AT qiany productwastagefrommodernhumangrowthhormoneadministrationdevicesalaboratoryandcomputersimulationanalysis AT wisniewskit productwastagefrommodernhumangrowthhormoneadministrationdevicesalaboratoryandcomputersimulationanalysis AT seitzl productwastagefrommodernhumangrowthhormoneadministrationdevicesalaboratoryandcomputersimulationanalysis AT kappelgaardam productwastagefrommodernhumangrowthhormoneadministrationdevicesalaboratoryandcomputersimulationanalysis
_version_	1718403736794038272

Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis

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