Final answer:
A pharmacovigilance system is required for dispensing drugs from the inpatient pharmacy, ensuring ongoing safety and effectiveness post-approval. The FDA regulates this process, which can have both protective effects and unintended consequences such as delayed treatment access.
Step-by-step explanation:
There must be a pharmacovigilance system for all drugs dispensed from the inpatient pharmacy. This system involves the continuous monitoring of medications to ensure long-term safety and efficacy in specific patient populations. It includes post-approval drug surveillance to handle any adverse effects or other drug-related issues that may arise as more patients use the medication.
The Food and Drug Administration (FDA) plays a crucial role in the regulation of medicines, requiring rigorous testing and approval processes through New Drug Applications (NDAs) for new pharmaceuticals. Furthermore, pharmacists, who must have a doctorate in pharmacy and be state-licensed, are responsible for dispensing prescription drugs and advising on their correct use. The winners in this system are those protected from unsafe drugs; however, the losers tend to be the more anonymous individuals who may suffer from delayed access to new treatments due to the lengthy and stringent regulatory process.