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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.
Suppose that we wish to compare the drug of interest to a class of drugs, for which nausea was reported as an adverse event 1489 times, out of 53789 total adverse events reported for drugs in the class. Thus, nausea was reported with proportion 1489 / 53789 = 0.028 for the class of drugs. The PRR in this case is 0.061 / 0.028 = 2.18.
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.
Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material), which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; or are developed by a patient safety organization for the conduct ...
Between 1998 and 2007, 33 serious adverse drug or device reactions have been reported by RADAR investigators. The toxicities involved multiple biological system and included thrombotic thrombocytopenic purpura (TTP) (ticlopidine and clopidogrel), thromboembolism (thalidomide and lenalidomide), liver failure (gemtuzumab and nevirapine), hypersensitivity (drug eluting coronary arterial stents ...
The aggregated patient data are utilised by users including the Cochrane Collaboration, the United States Preventive Services Task Force, and multiple professional societies in providing support for clinical practice guidelines. Aggregate patient data are also used in time-to-event studies of meta-analyses as the results can inform investors ...
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The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...