Patient safety and adverse event reporting: Creating alignment between specialty pharmacy and manufacturer

Abstract

S pharmacy has always prided itself on providing patientcentered, high-touch care that focuses on both therapy efficacy and safety. This aim is also a top priority for manufacturers, but both parties have different obligations and processes to meet their respective regulatory requirements and internal processes. Ordinarily, specialty pharmacies adhere to their state’s pharmacy laws, whereas global pharmaceutical companies are often required to abide by not only FDA’s rules and regulations but also those of international authorities.1 When specialty pharmacies partner with pharmaceutical companies, they are often obligated to follow the same guidelines as the global establishment. This is especially important for partnerships involving adverse event reporting, as a lack of standardization among manufacturers adds additional complexity and confusion to the process.