Prescribing Information – PI
Prescribing Information – PI Prescribing Information – PI, known also as a Package Insert or Product Labeling, is an obligatory medicine description for prescription drugs in USA. For OTC drugs…
Glossary Group: drug safety
Boxed Warning
Boxed warning In USA drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the…
Adequate Provision
Adequate Provision An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug’s risk information…
Adherence
Adherence Adherence is a measure of patient compliance or obedience to the prescription of the medicine (or usage of medical device) in self-administration. Ie. 100% adherence is when patient took…
Adverse Event Report (AER)
Adverse Event Report (AER) AER is a report of a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that is suspected to be associated with the…
Adverse Event
Adverse Event An adverse event is any undesirable experience associated with the use of a medical product in a patient.