Presenting Authors: Jahmal Williams, PharmD, RPh, and Claire Groce, PharmD, Ernest Mario School of Pharmacy, Piscataway, NJ
Co-Authors: Madison Henry, PharmD, RPh, Kyle Taylor, PharmD, RPh, Nik Mohan, PharmD, Joseph Barone, PharmD, FCCP, and Michael Toscani, PharmD, Ernest Mario School of Pharmacy, Piscataway, NJ; Paul Weber, MD, RPh, MBA, Ernest Mario School of Pharmacy and Rutgers Robert Wood Johnson Medical School, Piscataway, NJ
BACKGROUND: Expanded access programs (EAPs) provide a pathway for patients with serious or life-threatening conditions to obtain investigational treatments outside of clinical trials, when no satisfactory or comparable treatment options exist, or they do not qualify for a clinical trial. Use is limited by a number of challenges, including poor access to information, document burden, and lack of response from drug sponsors regarding the ability to supply drug.1 This study aims to gauge the baseline knowledge gaps and barriers that may deter oncology/hematology pharmacists from enrolling patients into an EAP.
OBJECTIVES: To assess the knowledge of US academic and community oncology/hematology pharmacists regarding EAPs and identify barriers to patient access through these programs.
METHODS: Dissemination of a Rutgers electronic Institutional Review Board–approved protocol #Pro2024000713 voluntary Qualtrics survey through the Hematology/Oncology Pharmacy Association’s email list. The research survey was sent only to US members who practice clinical oncology/hematology pharmacy in academic and/or community settings. Students, residents, fellows, technicians, and pharmaceutical industry members were excluded from the study. The survey was disseminated in June 2024 and was open until the end of July 2024.
RESULTS: After reviewing 38 survey responses, our findings suggest pharmacists working in an academic setting were more aware of EAPs than those working in a community setting. A total of 69% of participants requested use of a drug through an EAP. However, most (63%) participants were slightly knowledgeable or not knowledgeable at all when it comes to finding access to investigational drugs for patients via EAPs. The information sources varied among pharmacists, with the most common being the pharmaceutical manufacturer (59%). The top barriers included time to enroll patients (66%), documentation burden (59%), and lack of familiarity with EAP processes (56%).
CONCLUSIONS: Pharmacists, as part of the interprofessional care team, play a critical role in decision-making during a patient’s treatment journey. EAPs are an option for patients who have limited or no treatment options remaining. This study identifies key knowledge gaps and barriers to treatment access via EAPs. These results provide an opportunity to close knowledge gaps and barriers related to EAPs by providing continuing education credits to pharmacists in the academic and community settings. Informing oncology/hematology pharmacists in academic and community centers regarding EAPs allows the opportunity to educate and offer alternative treatment options to patients, providing hope to patients and families. Further research will be needed to assess the unmet educational needs and the potential benefits of increased education on patient care and outcomes.
- Fu S, Muquith M, Williams EF, et al. Barriers to implementing expanded access programs in oncology: a multidisciplinary perspective. J Clin Oncol. 2023;41(16 suppl):e18632.