Subcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineurs

Abstract

BackgroundSeveral sumatriptan subcutaneous autoinjector devices for acute treatment of migraine patients are available, each device differs with respect to design and features. Determining device preference and ease of use is important because patients experiencing a migraine attack are often functionally impaired.ObjectiveThe objective of this human factors study was to compare migraine patients’ device use performance and preferences for three sumatriptan subcutaneous autoinjectors: a disposable two-step device (Zembrace® SymTouch®), a disposable three-step device (Sumavel® DosePro®), and a multistep reloadable device (Imitrex® STATdose®), using simulated injections.MethodsEach study subject performed two unaided simulated injections with each of three different drug delivery devices, which were presented in counterbalanced order. The participants were then asked to rate the three devices on various subjective measures. The primary end point was overall device preference using a visual analog scale.ResultsA total of 54 subjects participated and each subject performed two simulated injections with each of the three devices. Most subjects preferred the two-step device (88.9%) to the three-step (13.0%) and the reloadable (1.9%). The two-step device had higher mean overall preference ratings (F (2, 159)=56.6, P<0.01) and higher ratings for ease of use, intuitiveness, convenience, portability, and control. The two-step device had a first injection full-dose delivery success rate of 44.4%, higher than both the reloadable (24.1%) and the three-step (3.7%) devices. The number of errors with the two-step device (n=3) was ~90% lower than the three-step (n=49) and reloadable (n=44) devices.ConclusionIn this human factors study, 54 migraineurs used simulated injections to compare three sumatriptan subcutaneous delivery devices. Zembrace SymTouch, a two-step device, was most preferred compared with Sumavel DosePro and Imitrex STATdose. It also ranked highest for ease of use and various other measures. In this study, migraine patients preferred the autoinjector that they rated as simpler and more intuitive.

Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies

“… 10 , 11 Specifically, for patients with migraine, there are multiple delivery devices available for the subcutaneous formulation of sumatriptan for the acute treatment of migraine. Andre et al 12 conducted a study to compare migraine patients’ device preferences of two simulated injections using three different sumatriptan subcuautoinjectors. This human factor study determined that patients preferred the autoinjector device that they rated as the easiest and most intuitive to use.…”

Improving the safety of disposable auto-injection devices: a systematic review of use errors

“…Subcategory References Device orientation a) device held upside-down (Lange et al, 2015;Sicherer et al, 2000;Robinson et al, 2014;Matfin et al, 2015;Salter et al, 2014;Umasunthar et al, 2015;Mehr et al, 2007;Arga et al, 2011;Topal et al, 2013;Schmid et al, 2013;Hudry et al, 2017;Domańska et al, 2017;Guerlain et al, 2010b;Saleh-Langenberg et al, 2017;Hanna et al, 2016;Andre et al, 2017) b) device held at the wrong angle (Phillips et al, 2011) Preparation a) incorrect needle attachment (Stauder et al, 2014;Fujioka et al, 2015;Phillips et al, 2011;Lange et al, 2014;Schertz et al, 2011;Pfützner et al, 2012;Pfützner et al, 2010) b) incorrect priming (flow and air bubble checking/removal) (Stauder et al, 2014;Fujioka et al, 2015;Jeannerot et al, 2016;Lange et al, 2014;Schertz et al, 2011) c) incorrect device selection (Fujioka et al, 2015;Raffa et al, 2017) d) failure to check device integrity (Hudry et al, 2017;Schiff et al, 2016;Schertz et al, 2011;Saunders et al, 2012) e) failure to check product validity (Sicherer et al, 2000;Schmid et al, 2013;Hudry et al, 2017;Schiff et al, 2016) f) tampering with the device (Andre et al, 2017) Protective/safety cap a) inco...…”

“…The "device orientation" category refers to errors related to not holding a device in the correct way. The great majority of errors in this category concern holding a device upside down (Lange et al, 2015;Sicherer et al, 2000;Robinson et al, 2014;Matfin et al, 2015;Salter et al, 2014;Umasunthar et al, 2015;Mehr et al, 2007;Arga et al, 2011;Topal et al, 2013;Saleh-Langenberg et al, 2017;Hanna et al, 2016;Schmid et al, 2013;Hudry et al, 2017;Domańska et al, 2017;Guerlain et al, 2010b;Andre et al, 2017). In conjunction with the "wrong angle" subcategory, one study reported that users did not place the device perpendicular to the thigh for the injection or did not withdraw the device straight out after the injection (Phillips et al, 2011).…”

“…Furthermore, two publications reported that users failed to check the liquid (Hudry et al, 2017;Schiff et al, 2016). The last subcategory ("tampering with device") refers to a publication that stated that users could not activate an injection because they had tampered with the device during its preparation (Andre et al, 2017).…”

“…Removal of the protective/safety cap prior to an injection concerned cases in which users did not remove the cap at all, and cases in which the users did not remove the cap as recommended. For the first case ("cap not removed"), users were not aware that they had to do this, or they simply forgot to do so (Fujioka et al, 2015;Sicherer et al, 2000;Robinson et al, 2014;Matfin et al, 2015;Salter et al, 2014;Brown et al, 2013;Guerlain et al, 2010a;Umasunthar et al, 2015;Mehr et al, 2007;Arga et al, 2011;Topal et al, 2013;Hanna et al, 2016;Schmid et al, 2013;Rohrer et al, 2013;Hudry et al, 2017;Lange et al, 2014;Schertz et al, 2011;Guerlain et al, 2010b;Andre et al, 2017). In the second case ("incorrect cap removal"), users either did not hold the device correctly during cap removal (Phillips et al, 2011;Brown et al, 2013), or used the wrong hand (Saleh-Langenberg et al, 2017).…”