부산대학교 도서관

The occasion of an adverse event is not forever throughout appointment to the Healthcare Center. It can occur after several hours of administering the drug. Patients fail to remember all the relevant information about adverse events and are not able to report it accurately. Patients are anxious and report all their discomfort as adverse events. Adverse drug events (ADE) reported are not always serious and may be symptoms of a disease. Other incidents where a patient has not followed instructions during medication or patient has had side effects caused by concomitant medicines taken along with the study drug could be reported as adverse events. Such wrong reporting can lead the drug safety committees to incorrect conclusions which in turn lead to the suspension or withdrawal of drugs. Pharmacovigilance is observed as the regular process of knowing the secure use of pharmaceutical products and assists in reducing the risk of any harm that may come to patients. Most of Pharma Companies have to perform a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and FDA guidance. [ABSTRACT FROM AUTHOR]