3,852
Views
1
CrossRef citations to date
0
Altmetric
Original Research

Risk of dosing errors in ART treatment: user experience of single- vs multi-use follitropin alfa pens

, , , , &
Pages 643-654 | Received 12 Nov 2020, Accepted 10 Dec 2020, Published online: 27 Dec 2020

References

  • Papanikolaou EG, Kolibianakis E, Devroey P. Emerging drugs in assisted reproduction. Expert Opin Emerg Drugs. 2005;10(2):425–440.
  • Rettenbacher M, Andersen AN, Garcia-Velasco JA, et al. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015;30(5):504–513.
  • Ferrando M, Coroleu B, Rodríguez-Tabernero L, et al. The continuum of ovarian response leading to BIRTH, a real world study of ART in Spain. Fertil Res Pract. 2020;6:13.
  • Allahbadia GN. The ideal stimulation protocol: is there one? J Obstet Gynaecol India. 2015;65(6):357–361.
  • Howles CM, Saunders H, Alam V, et al. Predictive factors and a corresponding treatment algorithm for controlled ovarian stimulation in patients treated with recombinant human follicle stimulating hormone (follitropin alfa) during assisted reproduction technology (ART) procedures. An analysis of 1378 patients. Curr Med Res Opin. 2006;22(5):907–918.
  • Weiss N. Gonadotrophin products: empowering patients to choose the product that meets their needs. Reprod Biomed Online. 2007;15(1):31–37.
  • Schertz JC, Saunders H, Hecker C, et al. The redesigned follitropin alfa pen injector: results of the patient and nurse human factors usability testing. Expert Opin Drug Deliv. 2011;8(9):1111–1120.
  • Steinke DT, Zarroug OH, Mathur R, et al. Qualitative risk assessment of follicle stimulating hormone injectable products. Expert Opin Drug Deliv. 2020;17(11):1647–1654.
  • Domar AD, Rooney K, Hacker MR, et al. Burden of care is the primary reason why insured women terminate in vitro fertilization treatment. Fertil Steril. 2018;109(6):1121–1126.
  • Lunenfeld B. Historical perspectives in gonadotrophin therapy. Hum Reprod Update. 2004;10(6):453–467.
  • de Mora F, Fauser B. Biosimilars to recombinant human FSH medicines: comparable efficacy and safety to the original biologic. Reprod Biomed Online. 2017;35(1):81–86.
  • US Department of Health and Human Services Food and Drug Administration (FDA). Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. Silver Spring, MD: FDA; 2009. cited 2020 Oct 19. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims
  • Rubin RR, Peyrot M. Quality of life, treatment satisfaction, and treatment preference associated with use of a pen device delivering a premixed 70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart) versus alternative treatment strategies. Diabetes Care. 2004;27(10):2495–2497.
  • Asakura T, Jensen KH. Comparison of intuitiveness, ease of use, and preference in two insulin pens. J Diabetes Sci Technol. 2009;3(2):312–319.
  • Gameiro S, Boivin J, Peronace L, et al. Why do patients discontinue fertility treatment? A systematic review of reasons and predictors of discontinuation in fertility treatment. Hum Reprod Update. 2012;18(6):652–669.
  • Longobardi S, Seidler A, Martins J, et al. An evaluation of the use and handling errors of currently available recombinant human follicle-stimulating hormone pen injectors by women with infertility and fertility nurses. Expert Opin Drug Deliv. 2019;16(9):1003–1014.
  • Imthurn B, McVeigh E, Stiller R, et al. Evaluation of the use and handling of three different pen systems considered for in vitro fertilization treatment. Expert Opin Drug Deliv. 2014;11(12):1859–1864.
  • Mahony MC, Patterson P, Hayward B, et al. Human factors engineering and design validation for the redesigned follitropin alfa pen injection device. Expert Opin Drug Deliv. 2015;12(5):715–725.
  • Foxon G, Mitchell P, Turner N, et al. Bemfola(R) fixed dose pens potentially reduce drug wastage and associated costs of infertility treatment. Hum Fertil (Camb). 2018;21(4):275–280.
  • Strowitzki T, Kuczynski W, Mueller A, et al. Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART). Reprod Biol Endocrinol. 2016;14:1.
  • Strowitzki T, Kuczynski W, Mueller A, et al. Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to main study. Reprod Biol Endocrinol. 2016;14(1):31.
  • International Electrotechnical Commission (IEC). IEC 62366-1. Medical devices - Part 1: Application of usability engineering to medical devices. Geneva: International Electrotechnical Commission; 2015.
  • Weinhold T, Del Zotto M, Rochat J, et al. Improving the safety of disposable auto-injection devices: a systematic review of use errors. AAPS Open. 2018;4(1):7.
  • Mahony M, Dwyer A, Barkume R, et al. US human factors engineering evaluation of an updated follitropin alfa pen injector (GONAL-f®) RFF Redi-ject®) and instructions for use. Expert Opin Drug Deliv. 2018;15(1):5–15.
  • Rombauts L. Is there a recommended maximum starting dose of FSH in IVF? J Assist Reprod Genet. 2007;24(8):343–349.
  • Popovic-Todorovic B, Loft A, Bredkjaeer HE, et al. A prospective randomized clinical trial comparing an individual dose of recombinant FSH based on predictive factors versus a ‘standard’ dose of 150 IU/day in ‘standard’ patients undergoing IVF/ICSI treatment. Hum Reprod. 2003;18(11):2275–2282.
  • Association for the Advancement of Medical Instrumentation (AAMI). Human factors design process for medical devices. Report No.: ANSI/AAMI HE 74:2001. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2001.
  • Faulkner L. Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003;35(3):379–383.