Enhancing Pediatric Pharmaceutical Care: Development and Evaluation of a Rectal Demonstration Model for Pediatric Patients with Inflammatory Bowel Diseases.

BACKGROUND/OBJECTIVES: Inflammatory bowel disease (IBD) may require topical rectal treatment for distal colonic inflammation. Rectal foams or rectal enemas can reach deeper bowel sections but are complex to administer, especially for pediatric patients with IBD. Furthermore, it is a challenge to visualize this administration process in a structured manner. We aimed to design a rectal demonstration model to enable the visualization of rectal foam administration and to assess the clinical risk potentially associated with detectable errors. METHODS: A rectal demonstration model was developed, handling errors were defined, and their clinical risk was rated. The model was tested for rectal foam administration by 19 adolescent patients (aged 12-18 years). RESULTS: A total of 12 observable administration steps, including their clinical risk, were defined by an expert panel of physicians and pharmacists. Seven handling errors were rated with a high clinical risk, such as "Not shaking the spray can at all before administration". In demonstrations by adolescent patients, a median of three (Q25/Q75; 2/4.5; min/max 1/7) handling errors were identified. The most frequent error was releasing the pump dome too quickly after pushing down (11/19, 58%). At least one error with high clinical risk (score: 5-6) was identified in 15/19 (79%) of patients' administrations. CONCLUSIONS: The developed demonstration model facilitates the visualization of handling errors in rectal foam administration that would otherwise not be accessible in routine care. A high rate of clinically relevant handling errors was identified in adolescents. Prospectively, the model can be used to practice rectal foam administration and address patient handling errors to increase patient safety.