[Pharmaceutical services in expanded access, compassionate use, and post-trial access: the perspective of clinical...

This study sought to understand the flows of pharmaceutical services and the contributions of pharmacists in expanded access programs, compassionate use, and the post-trial access of medications, from the perspective of healthcare professionals experienced in clinical research. A organizacional case study was conducted at an oncology hospital in Rio de Janeiro, followed by the administration of a questionnaire to pharmacists from different regions of Brazil. The study was grounded in Denzin's theoretical framework of interpretive interactionism. Data were analyzed using an explanatory construction technique and interpreted via thematic content analysis. In total, three thematic axes emerged: the operationalization of pharmaceutical services; the clinical responsibilities of the pharmacist; and continuous quality improvement. A total of ten professionals participated in the organizational case study phase, and 12 responded to the questionnaire. The results indicated convergent needs, underscoring the importance of optimizing logistical and operational activities, drug therapy monitoring, continuing education, pharmacovigilance, information dissemination, and healthcare quality. These findings have the potential to inform future guidelines to enhance program processes, address regulatory gaps, and provide better support for healthcare.