What Pharmacists Should Report to FDA MedWatch


Pharmacists should take advantage of the FDA's adverse drug event reporting system to promote patient safety.

Pharmacists should take advantage of the FDA’s adverse drug event reporting system in order to promote patient safety.

There are several reasons why medications that make it to the market are not risk-free, even when they are used as indicated. For example, the clinical drug reviews that precede FDA approvals often have limitations, such as the study cohort being too small to observe any rare but yet-to-be-seen side effects of a medication on certain populations.

In a session at the 2015 American Society of Health-System Pharmacists (ASHP) Midyear meeting, panelists explained the importance of reporting all adverse drug events in order to address any potential risks as quickly as possible.

Shannon Thor, PharmD, of the FDA’s Office of Health and Constituent Affairs discussed how the agency’s MedWatch Program acts as both a means to submit adverse drug event reports and a vehicle to receive drug warnings.

So, what should pharmacists report to MedWatch? According to Dr. Thor, a reportable situation is any event that:

  • Is fatal
  • Is life-threatening
  • Is permanently disabling
  • Requires or prolongs hospitalization
  • Causes a birth defect
  • Requires intervention to prevent permanent impairment or damage

Dr. Thor also explained that pharmacists should report products that have even the potential to cause harm. Examples of issues include illegible handwriting or abbreviations; labels and packaging that appropriate detailing of strength/dose or have unclear placement of information; and look-alike or sound-alike drugs that could cause miscommunication of orders/nomenclature.

Natasha Nicol, PharmD, FASHP, director of global patient safety affairs at Cardinal Health, explained to Pharmacy Times at ASHP Midyear that pharmacists should be more proactive when it comes to medication risks.

“It’s a common mistake we make in health care, that we’re extremely reactive. We wait for something to happen, then we respond to it,” she explained. “We often focus on the harmful event itself and not what led up to it.”

Not properly analyzing the causal factors for the adverse event could mean that future harmful events will occur for the same reason.

Panelists concluded their session by reminding attendees that increasing awareness about the important of reporting adverse drug events across all care settings is a vital strategy in mitigating future risks.

“Even one report can make a difference,” Dr. Thor concluded.

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