Safety improvement in biologic therapy for patients with moderate to severe plaque psoriasis: a pilot project and quantitative analysis

Abstract

Biologic Response Modifier (BRM) medications are indicated for moderate to severe psoriasis and demonstrate high efficacy for disease reduction. Although BRM medications are considered the most effective therapy in the treatment of moderate to severe plaque psoriasis, their side effect profile can be severe. Using BRMs may increase the risk of infections, demyelinating disease, and malignancy (Reich, Burden, Eaton, & Hawkins, 2012). With such established risks, baseline assessments and monitoring have been recommended. However, no standardized guidelines exist for the monitoring of BRM medications (Hanson, Gannon, Khamo, Sodhi, Orr, & Stubbings, 2013). Therefore, the objective of this scholarly project was to implement a BRM monitoring protocol into the Electronic Medical Record (EMR) of a Montana dermatology clinic to improve provider monitoring compliance and therefore improve psoriasis patient outcomes, safety, and education. Monitoring criteria were developed based on recommendations from the University of Illinois Medical Center Clinical Care Guidelines and the American Academy of Dermatologists Biologic Monitoring guidelines. A BRM Electronic Medical Record (EMR) template was then created to utilize such guidelines to improve clinical compliance and patient safety. Seven main criteria were measured for completion including laboratory studies, physical assessment, patient education, follow up, psoriasis severity scale, immunizations, and vital signs. Side effects experienced and patient comorbidities were also recorded. Completion rates of the protocol were analyzed using before and after comparisons, the paired t-test, and McNemar's test. Before the intervention was implemented, 54% of charts had completion of all seven categories and after the intervention 98% of charts were completed, illustrating a 44% improvement in provider compliance and monitoring. The paired t-test illustrated an average difference of 0.43 with a standard error of .029. The McNemar's test established a positive association between implementation of the BRM protocol and improvement in provider compliance. 40% of patients experienced co-morbidities associated with psoriasis and 25% of patients experienced side effects related to BRM therapy. These project findings demonstrated the efficacy of a BRM monitoring template for improving provider-monitoring compliance and improving patient safety through early identification of comorbidities and side effects.