Validation of human factors for 3 mg sumatriptan autoinjector in migraine patients
Migraine headaches are extremely painful, debilitating, and can lead to severe impairment and reduced cognitive function. It has been found that a person’s reaction time, reasoning, attention, working memory, and visual–spatial processing capacity decreases in migraine attack as compared to those not experiencing migraine attack.
Migraine pain relief was reported by more than 50% of patients who received low dose (3 mg) of sumatriptan. Currently, there is no two-step autoinjector of low-dose sumatriptan available for acute migraine. To fulfill this need, a fully assembled, single dose, 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. A study was conducted to determine if DFN-11 autoinjector can be used correctly and safely by migraine patients.
In the conducted study, a human factors validation study was conducted with 45 migraine patients (30 oral-only medications users; 15 injectable sumatriptan users) who performed one unaided simulation 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 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 reported no difficulty administering the injection and no concerns about using the autoinjector during a severe migraine onset.
After the study was completed, results showed that 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 there was injection experienced, unexperienced trained or self-trained.