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Migraine pain relief is reported by more than 50% of patients who receive low dose (3 mg) of sumatriptan.
In this original
article, DFN-11 autoinjector (3 mg sumatriptan autoinjector) and IFU were
eminently implemented by all study participants without use errors. There were
no differences observed between the trained and self-trained conditions. All
injection-naïve users and injection-experienced users were able to accomplish
injection procedure in safe and effective manner in accordance with training.
Migraine pain
relief is reported by more than 50% of patients who receive low dose (3 mg) of
sumatriptan. Currently, there is no two-step autoinjector of low-dose
sumatriptan available on the market for acute migraine treatment. To fulfill
this need, a fully assembled, singledose, subcutaneous autoinjector
(sumatriptan 3 mg; product-code DFN-11) was developed. The device allows for
injection with a simple two-step, push-to-inject process and provides feedback
of the injection activation, progress, and completion. To determine if DFN-11
autoinjector can be used correctly and safely by migraine patients.
A human factors
validation study was conducted with 45 migraine patients (30 oral-only
medications users; 15 injectable sumatriptan users) who performed one unaided
simulated injection. Two days’ prior, half the oral participants were briefly
trained. All others were only given the device to inspect and written
instructions to review. No injections were performed during the initial
session. All participants received written instructions at the injection
session.
All participants
(45/45; 100%) performed the injection without any errors. Objective measures
included device removal from packaging, cap removal, expiration date check,
inspection of fluid in window, identification of allowable injection site,
proper device positioning, dose confirmation, and device disposal. All
participants (45/45; 100%) reported no difficulty administering the injection
and no concerns about using the autoinjector during a severe migraine onset.
The results
showed that the DFN-11 autoinjector can be used with safe handling without
patterns of confusion, failures, high-risk errors, wet injections, or patient
safety risks. The DFN-11 autoinjector was validated to be used correctly and
safely by migraine patients, whether they were injection experienced,
unexperienced, trained, or self-trained.
Medical Devices: Evidence and Research
Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients
Elimor Brand-Schieber et al.
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