Developing a patient and healthcare provider pragmatic guide approach to standardize adverse event management with targeted therapy.

PURPOSE: A growing number of solid tumors harbor actionable molecular alterations, treated with targeted therapies. These have unique adverse event (AE) profiles, leading to challenges in providing consistent, specific care. We describe the use of a structured framework to develop patient and healthcare provider guides for AE management.

METHODS: A five-step process was used to develop guides and electronic medical record (EMR) scripts. AE data was collected from clinical trials, product monographs, and real-world studies, then analyzed to extract relevant information, supplemented by expert input. Extracted data was built into a prepare, monitor, manage, and reassess (PMMR) framework, which was adapted into healthcare provider/patient guides, and scripts. Guides and scripts were implemented for preliminary use, with ongoing revisions through audit and feedback.

RESULTS: Guides and scripts were developed using the PMMR framework for specific targeted drugs, focused initially on non-small cell lung cancer patients. Patients/caregivers were prepared prior to treatment with education on potential AEs, including timing, severity, likelihood, and prophylactic strategies. Common and severe AEs were monitored at specific frequencies, based on knowledge of each AE. AEs were managed based on the degree of impact to patient/caregiver quality-of-life, or concern to the healthcare team. Mitigation strategies were divided into non-pharmacologic and pharmacologic approaches. Reassessment frequency was based on AE severity and degree of impact to patient, caregiver, and/or healthcare team.

CONCLUSIONS: The PMMR framework and guides provide a flexible yet structured starting point for AE management, adaptable to different clinical settings and the ever-growing list of cancer drugs.