Once drugs are available to the public, The U.S. Food and Drug Administration (FDA) has a tool that tracks potential side effects. Unfortunately, the tool is voluntary and not used as often as may be necessary.
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While drugs are studied using test groups, sometimes side effects remain unseen until a drug is prescribed to a much larger group of people. Yet even after this occurs, many times, the adverse effects are not reported to the FDA.
A 2016 study found that 51% of health care professionals had not filed an adverse event in the previous five years.
Adverse events include any unanticipated experience or side effect associated with the use of a drug. It could occur from an overdose, abuse, withdrawal or from lack of expected effectiveness.
Why aren’t healthcare providers reporting adverse side effects?
One reason is time. Many doctors are busy and don’t have the time for additional reporting.
Another large reason is uncertainty over which drug caused the adverse side effect. Many patients are on more than one type of drug, and it can be difficult to determine which drug caused the side effect, or if it were the interaction of multiple drugs.
Sometimes, physicians choose to report the issues directly to the drug manufacturer instead of the FDA.
How does the FDA use the adverse reports?
The FDA uses the reports to look for new safety concerns, manufacturer’s compliance in reporting regulations, and responding to information requests.
The reports are evaluated to monitor the safety of products.
Drugs have been removed from the market due to adverse reporting to the FDA. Between 1969 and 2002, over 75 drugs were removed due in part to the adverse event reports.
It is also used to issue additional warnings.
While the reporting serves an essential function, there are a lot of potential issues. Anyone can submit a report and yet, due to unknowns and lack of time, many adverse effects go unreported.
How often have you reported adverse effects to the FDA? What has your reporting experience been?
Let us know your thoughts below!
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