Do You Really Know About Drug Side Effects?

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.

We can help your practice stay on top of the latest healthcare news, rules, regulations and trends.  Subscribe to stay current and up to date on important matters that will impact your practice.  (To subscribe to our blog ).

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!

In our next blog post, we will keep you informed of related issues.  To get this important information delivered directly to your mail box, 

Do you need help staying current and compliant with the latest laws, rules and regulations?  We can help. To contact us about your new government rules and regulations, your practice’s risk assessment, or about your other legal needs:  CLICK HERE.

Related Posts


Recent Posts

Red Flags in Physician Contracts
December 6, 2022
Estate Planning Terms to Know
December 1, 2022
Are You Providing Patients with their Records Quickly Enough?
November 29, 2022
Happy Thanksgiving from Rickard & Associates!
November 24, 2022
Protect Your Practice Against Telemedicine Fraud
November 22, 2022


Enter your email to subscribe now and receive your FREE HIPAA Risk Assessment book!

An essential tool for all healthcare providers, Easy Guide to HIPAA Risk Assessments breaks down the requirements of HIPAA so you can successfully complete your required risk assessment.


Get it now for FREE (an $8.99 value!)

One more step! Please check your email to confirm your subscription and receive your FREE book!