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The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
A kardex (plural kardexes) is a genericised trademark for a medication administration record. [2] The term is common in Ireland and the United Kingdom.In the Philippines, the term is used to refer the old census charts of the charge nurse usually used during endorsement, in which index cards are used, but has been gradually been replaced by modern health data systems and pre-printed charts and ...
In 2020, clinical settings enrolled in the REMS program asked the FDA to make their reviews of REMS compliance public so that they can more easily view the records and adjust to feedback. [8] Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse. [ 9 ]
The American Medical Association (AMA) Physician Professional Data (formerly known as the AMA Physician Masterfile) includes current and historical data on all physicians, including AMA members and nonmembers, and graduates of foreign medical schools who reside in the United States and who have met the educational and credentialing requirements necessary for recognition as physicians. [1]
Prescription drug monitoring programs, or PDMPs, are an example of one initiative proposed to alleviate effects of the opioid crisis. [1] The programs are designed to restrict prescription drug abuse by limiting a patient's ability to obtain similar prescriptions from multiple providers (i.e. “doctor shopping”) and reducing diversion of controlled substances.
Medication therapy management, generally called medicine use review in the United Kingdom, is a service provided typically by pharmacists, medical affairs, and RWE scientists that aims to improve outcomes by helping people to better understand their health conditions and the medications used to manage them. [1]
The National Council Licensure Examination (NCLEX) is a nationwide examination for the licensing of nurses in the United States, Canada, and Australia since 1982, 2015, and 2020, respectively. [2] [3] There are two types: the NCLEX-RN and the NCLEX-PN. After graduating from a school of nursing, one takes the NCLEX exam to receive a nursing license.
Trifluridine/tipiracil (FTD–TPI), sold under the brand name Lonsurf, is a fixed-dose combination medication that is used as a third- or fourth-line treatment of metastatic colorectal cancer or gastric cancer, after chemotherapy and targeted therapeutics have failed.