Closing the Knowledge Gap of Black Box Warnings: A Novel Approach for Enhanced Awareness and Prevention Among Health Professionals for Patient Safety

Abstract

The knowledge and awareness of health professionals and patients surrounding black box warnings are still gaping. Our target is finding solutions to prevent potential side effects and severe interactions. Black box warnings are the strongest drug safety warnings issued by regulatory authorities, highlighting the potential risks associated with specific medications. However, there is often limited understanding and awareness of these warnings among both healthcare providers and patients, which can lead to inadequate risk management and patient safety. Therefore, closing knowledge gaps and proposing strategies for improving awareness and reducing adverse events related to medications with black box warnings is crucial. As we witness an unprecedented surge in drug discoveries, especially biological drugs for immunological disorders and cancer therapy, growing dramatically and receiving approvals by the FDA, the landscape of healthcare is rapidly evolving. With the remarkable advancements in immunotherapy, particularly the proliferation of monoclonal antibody drugs, we are witnessing a paradigm shift in the treatment of various conditions. However, this surge in drug approvals has brought forth a crucial concern - the increasing prevalence of Black Box Warnings associated with many of these drugs. A Black Box Warning, recognized as the most critical indication of potential serious side effects by the FDA, is typically issued post-marketing. This revelation highlights a significant gap in our understanding, particularly in terms of knowledge and adherence to these warnings by healthcare professionals, including physicians and pharmacists. We suggest the black box warning must have a barcode or logo on the outer pack of the drug if it has a black box warning, as this will give an alert for serious side effects or interactions for patient safety and provide an alert for physicians, patients, and pharmacists. Also, we suggest the warning black box drugs must be registered as notes in prescriptions and medical records at hospitals and in pharmacist and patient files, as this enhances health outcomes and avoids serious side effects for patient safety.