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Aggregate reporting, also known as periodic reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports.
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
The problem began in 2012, when the process for making tetrazole, a chemical intermediate in the production of various angiotensin II inhibitor medications for hypertension (popularly known by their common drug name suffix "sartan") was changed by generic drug manufacturers in favor of several cheaper and more efficient processes.
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports.
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of conditions. These medications are “slated to make a big clinical impact."
The reports are created by the Best Buy Drugs team and an independent academic group, Research on Adverse Drug Events and Reports (RADAR), devoted to detecting drug safety issues. [6] The project also reports on drugs prescribed off-label to highlight common off-label uses, evaluates the clinical evidence and safety information for those uses ...
Prescriptions for hydroxychloroquine increased 80-fold between March 2019 and March 2020, according to the Centers for Disease Control and Prevention.. The drug is used safely to tamp down over ...
Among others, ISMP maintains and disseminates a list of "do not crush" medications, [3] as well as clinical best practices. [4] The ISMP's Medication Safety Self-Assessment tool has been used in surveys of medication safety in hospitals in the United States and elsewhere. [5] [6] [7] [8]