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Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis.
Med Devices (Auckl) 2013; 6:107-14MD

Abstract

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.

Authors+Show Affiliations

Ossian Health Economics and Communications GmbH, Basel, Switzerland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23946672

Citation

Pollock, Richard F., et al. "Product Wastage From Modern Human Growth Hormone Administration Devices: a Laboratory and Computer Simulation Analysis." Medical Devices (Auckland, N.Z.), vol. 6, 2013, pp. 107-14.
Pollock RF, Qian Y, Wisniewski T, et al. Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis. Med Devices (Auckl). 2013;6:107-14.
Pollock, R. F., Qian, Y., Wisniewski, T., Seitz, L., & Kappelgaard, A. M. (2013). Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis. Medical Devices (Auckland, N.Z.), 6, pp. 107-14. doi:10.2147/MDER.S45909.
Pollock RF, et al. Product Wastage From Modern Human Growth Hormone Administration Devices: a Laboratory and Computer Simulation Analysis. Med Devices (Auckl). 2013;6:107-14. PubMed PMID: 23946672.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis. AU - Pollock,Richard F, AU - Qian,Yujun, AU - Wisniewski,Tami, AU - Seitz,Lisa, AU - Kappelgaard,Anne-Marie, Y1 - 2013/08/01/ PY - 2013/8/16/entrez PY - 2013/8/16/pubmed PY - 2013/8/16/medline KW - administration KW - computer models KW - dosage KW - human growth hormone KW - injections KW - subcutaneous SP - 107 EP - 14 JF - Medical devices (Auckland, N.Z.) JO - Med Devices (Auckl) VL - 6 N2 - 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. SN - 1179-1470 UR - https://www.unboundmedicine.com/medline/citation/23946672/Product_wastage_from_modern_human_growth_hormone_administration_devices:_a_laboratory_and_computer_simulation_analysis_ L2 - https://dx.doi.org/10.2147/MDER.S45909 DB - PRIME DP - Unbound Medicine ER -