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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.
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]
Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some countries consumers) to identify and report any adverse events to their national pharmacovigilance center, health authority (such as the European Medicines Agency or FDA), or to the drug manufacturer ...
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Community Health Accreditation Program(CHAP) DNV GL Healthcare; Foundation for the Accreditation of Cellular Therapy (FACT) [4] Global Healthcare Accreditation (GHA) [5] Healthcare Facilities Accreditation Program (HFAP) Healthcare Quality Association on Accreditation (HQAA) Institute for Medical Quality (IMQ) Joint Commission (TJC)
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
A patient safety organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors.Common functions of patient safety organizations are data collection, analysis, reporting, education, funding, and advocacy.
In the US, where a system of quasi-private healthcare is in place, a formulary is a list of prescription drugs available to enrollees, and a tiered formulary provides financial incentives for patients to select lower-cost drugs. For example, under a 3-tier formulary, the first tier typically includes generic drugs with the lowest cost sharing ...