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The National Safety and Quality Health Service Standards (NSQHS Standards) are Australia's principal health care standards, and apply to all health services including inpatient, outpatient, and community care. [5] There are 8 standards: Clinical governance; Partnering with consumers; Preventing and controlling infections; Medication safety
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch
Data exclusivity is a regulatory measure limiting the use of clinical trial data and provides conductor of the trial temporary exclusive rights to the data. [6] Many suggest that extending exclusivity periods can have consequences in delivering medication, especially generic brands, to developing countries.
The Patient Safety Reporting System (PSRS) is a program modeled upon the Aviation Safety Reporting System and developed by the Department of Veterans Affairs (VA) and the National Aeronautics and Space Administration (NASA) to monitor patient safety through voluntary, confidential reports. [79]
The Institute for Safe Medication Practices (ISMP) is an American 501(c)(3) organization focusing on the prevention of medication errors and promoting safe medication practices. [1] It is affiliated with ECRI .
“The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children,” the U.S. Consumer Product Safety Commission said. Nearly 4.2 ...
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 ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...