Journal of Obesity and Metabolism
Open Access

Subcutaneous semaglutide, delivered by a single-dose pen-injector at a maintenance dose of 2.4mg once weekly, is approved in the USA for weight management in people with a body mass index (BMI) of 30 kg/m2 or higher, or with a BMI of 27 kg/m2 or higher and a minimum of one obesity-related co-morbidity. The semaglutide single-dose peninjector could be a shield-activated auto-injector. Auto-injectors were at the start developed for emergency use however are used for chronic conditions for many years and for glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment for type 2 diabetes disease (T2D) since 2014. Shield activation entails the discharge of the injection by pushing the pen-injector against the patient’s skin, as hostile activation via a
button [1].

Description

As a step within the development of the semaglutide peninjector, a summational (human factors validation) usability test and safety analysis of the semaglutide pen-injector within the context of T2D management was conducted in the United States and reported previously. Four teams were tested (n =15 per group): patients with T2D with/without pen-injector expertise, non-pharmacist aid professionals (HCPs), and pharmacists. As a non-interventional summative usability study, it failed to entail medical treatment. Four tasks were assessed: (a) pen-injector carton retrieval, (b) initial simulated injection, (c) peninjector retrieval, and (d) second simulated injection. The health care providers completed solely the primary task as a result of it absolutely was the sole task that a pharmacist would conduct, whereas the opposite three teams completed all four tasks. The participants rated the ease of each task on an integer scale, upon which 1 = difficult and 7 = easy.

The aim of this post hoc analysis was to examine the usability of the semaglutide pen-injector in the subgroup of participants with T2D who met the requirements for weight management. Additionally, we have a tendency to needed to look at variations in ease-of-use ratings between pen-injector–naïve and pen-injector–experienced patients during this subgroup [2]. Of the four tasks originally studied, only the tasks representing the two simulated injections were relevant for weight management and were evaluated during this analysis. The two product-retrieval (differentiation) tasks weren’t enclosed in this post hoc analysis participants enclosed patients with a BMI of 27 kg/m2 or higher (i.e. the edge for weight management within the presence of 1 or a lot of co-morbid conditions, like T2D) and every one non-pharmacist HCPs; pharmacists failed to perform simulated injections.

This post hoc analysis examined the usability of the semaglutide single-dose pen-injector by patients appropriate for treatment with semaglutide for weight management and non-pharmacist HCPs. No serious use error was created by a member of any cluster. The nonserious errors were all made on the primary injection and none of those had the potential to cause harm [3]. Ease-of-use ratings were usually at the high end of the 1-7 scale for all 3 groups for the primary injection, and all participants whose rating was below 7 on the primary injection increased their rating on the second injection, with a mean ease-of-use rating of 6.9 in all teams. All pen-injector–experienced patients had used traditional, push-button–activated pen-injectors however not shield-activated pen-injectors (as used for semaglutide). It is so attainable that, in some cases, reliance on existing information may need hampered the immediate understanding of the working principle of the novel pen-injector. Similarly, some HCPs may need been unfamiliar with shield-activated pen-injectors. However, ease-ofuse ratings failed to dissent considerably between teams on the primary injection [4]. The shortage of significant use errors and high ease-ofuse scores were achieved with none face-to-face training. We have a tendency to infer from this outcome that the semaglutide pen-injector doesn’t compromise patient safety and is simple to use. However, it’s still necessary that HCPs counsel their patients to browse the IFU completely to avoid use errors.

The main limitation of this study is that it was a retrospective post hoc analysis. The results recommend that use errors are rare measure rare the semaglutide single-dose pen-injector once patients meet the study’s criteria for requiring weight management [5]. A prospective study is required to check this hypothesis. Alternative limitations of this study relate to the simulated nature of the injections, which could not specifically replicate the entire expertise of use within the meant surroundings. When injections are performed into an injection pad, it’s not known whether or not patients would have performed otherwise if that they had felt the needle or old discomfort thanks to the drug product.

Conclusion

The expertise in our experimental setting may additionally dissent from that within the natural setting in alternative ways; as an example, being observed while performing a task might create performance anxiety. This analysis only includes adults aged 18 years or older, which implies that the results of this analysis cannot be extrapolated to adolescents or to senior populations specifically. Additionally, usability is also completely different in people with psychological feature impairment.

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