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Pharmacovigilance is a branch that involves the identification and evaluation of safety signals generated by the usage of a medical product.
Safety Signal: is a concern raised when excess of adverse events are observed compared
to what would be expected with a product's use. Signals can arise from collection of post marketing data, preclinical data and events associated with other products in the same pharmacologic class.
Even a single well-documented case report can be viewed as a signal, particularly if the report describes an event that is extremely rare in the absence of drug use.
Signals indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event.
After a signal is identified, it should be further assessed to determine whether it represents
a potential safety risk and whether other action should be taken.
Good Pharmacovigilance Practice is based on acquiring complete data from
spontaneous adverse event reports, also known as case reports.
In order to understand and interpret the adverse events, good and well documented reports are emphasized following Good Reporting Practice guidelines:
Good Reporting Practices
A good and well documented Case reports of adverse events submitted to the sponsor and FDA, as well as reports from the medical literature or clinical studies, may generate signals of adverse effects of drugs.
A good quality report is critical for appropriate evaluation of the adverse events caused by the usage of the product.
FDA recommends that reasonable attempts be made to obtain complete information for case assessment during initial contacts and subsequent follow-up, especially for serious events.
Sponsors may use trained and well informed health care practitioners to query reporters.
Computer-assisted interview technology, targeted questionnaires, or other methods developed to target specific events can help focus the line of questioning.
When the report is from a consumer, it is often important to obtain permission to
contact the health care practitioner familiar with the patient’s adverse event to obtain further
medical information and to retrieve relevant medical records, as needed.
It is further recommended that the most aggressive follow-up efforts be directed towards serious
adverse event reports, especially of adverse events not known to occur with the drug.
To find out more about FDA’s guidelines on Good Pharmacovigilance Practices follow the link as under:
http://www.fda.gov/cder/guidance/6359OCC.htm
Pharmacovigilance is a branch that involves the identification and evaluation of safety signals generated by the usage of a medical product.
Safety Signal: is a concern raised when excess of adverse events are observed compared
to what would be expected with a product's use. Signals can arise from collection of post marketing data, preclinical data and events associated with other products in the same pharmacologic class.
Even a single well-documented case report can be viewed as a signal, particularly if the report describes an event that is extremely rare in the absence of drug use.
Signals indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event.
After a signal is identified, it should be further assessed to determine whether it represents
a potential safety risk and whether other action should be taken.
Good Pharmacovigilance Practice is based on acquiring complete data from
spontaneous adverse event reports, also known as case reports.
In order to understand and interpret the adverse events, good and well documented reports are emphasized following Good Reporting Practice guidelines:
Good Reporting Practices
A good and well documented Case reports of adverse events submitted to the sponsor and FDA, as well as reports from the medical literature or clinical studies, may generate signals of adverse effects of drugs.
A good quality report is critical for appropriate evaluation of the adverse events caused by the usage of the product.
FDA recommends that reasonable attempts be made to obtain complete information for case assessment during initial contacts and subsequent follow-up, especially for serious events.
Sponsors may use trained and well informed health care practitioners to query reporters.
Computer-assisted interview technology, targeted questionnaires, or other methods developed to target specific events can help focus the line of questioning.
When the report is from a consumer, it is often important to obtain permission to
contact the health care practitioner familiar with the patient’s adverse event to obtain further
medical information and to retrieve relevant medical records, as needed.
It is further recommended that the most aggressive follow-up efforts be directed towards serious
adverse event reports, especially of adverse events not known to occur with the drug.
To find out more about FDA’s guidelines on Good Pharmacovigilance Practices follow the link as under:
http://www.fda.gov/cder/guidance/6359OCC.htm
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