Skip to main content

Good Pharmacovigilance Practices (GPPs)

BayBiotech.NET
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

Comments

Post a Comment

Popular posts from this blog

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more