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U.S. Department of Health and Human Services

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Communicating Drug Safety Messages: Transcript

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We’re at the U.S. Food and Drug Administration with the Division of Drug Information pharmacists. Today they are discussing how pharmacists play a vital role assisting FDA with communicating drug safety messages. This is FDA Drug Info Rounds, a program by pharmacists for pharmacists.

Pharmacists have consistently partnered with FDA on drug safety. Since pharmacists have direct contact with patients, they are one of our main reporters of adverse events to the MedWatch program. They also report product problems, errors in use and also therapeutic failures or inequivalence.

In addition, they play a key role in discussing FDA’s drug safety messages to patients. 

That’s right. Working at the FDA augments my skills as a community pharmacist. The other day while counseling a patient using a Medication Guide, I was able to discuss the potential risk and how to use the medication safely.

The combination of accessibility and a good patient-pharmacist relationship can result in improved medication use and the gathering of useful reports when patients experience adverse events from their medications.

In the past, our communication efforts were largely restricted to the labeling of FDA-regulated products. Now, the Internet, social media and emerging technologies allow FDA to be more transparent and to communicate with pharmacists, healthcare professionals and patients in real time.

When pharmacists report adverse events on behalf of their patients, they help FDA identify new risks and sometimes this information alerts FDA to an increase in the magnitude of a known risk.

Just last week I was speaking to a pharmacist who called FDA to report an adverse event based on new safety information contained in an FDA_Drug_Info “tweet.” The pharmacist was thrilled to be ahead of the patient in receiving timely drug safety information and was grateful that she was able to educate her patient about this important safety issue.

As technologies and social media have expanded, so has their value to communicating important safety information to healthcare professionals. Currently, FDA’s Office of Communications utilizes several channels or tools to communicate safety information to the public including:

  • Division of Drug Information Listserv
  • Drug Safety Communications 
  • FDA_Drug_Info Twitter
  • Drug Safety Audio Podcasts for Healthcare Professionals
  • Drug Information Widget
  • And, of course, our FDA Drug Info Rounds web videos

One of FDA’s essential roles is to ensure its various audiences get the information they need to make informed choices. Ultimately, the decision to act on a drug warning is made by the patient, after considering the information received, his or her knowledge and values, and often in consultation with their pharmacist. However, before an informed decision can be made, the patient needs to first receive and understand this information.

Pharmacists have a very unique opportunity to play an important role by engaging patients and educating them about Medication Guides and other materials that provide risk/benefit information, by informing patients of the latest safety information for the medications they are taking, by ensuring patients understand what it means for them to be compliant with their treatment and enabling them to achieve this, and by encouraging patients to discuss any adverse events they experience when taking medications.

FDA relies on voluntary reporting of adverse events by pharmacists, other healthcare professionals, and patients. This vital information is used to maintain safety surveillance of medications.

One report may be the critical point that prompts a change in use or design of a product, improves its safety profile, and leads to increased patient safety. And to make it easy, anyone may submit a report online, by mail, or by calling FDA.

As pharmacists, it’s essential for us to stay informed of the latest drug safety information so we can discuss it with patients and other healthcare professionals. Luckily, FDA’s new social media tools make it even easier for us to do this.

To receive information on using social media look for the “stay informed” section of the CDER homepage www.fda.gov/cder

Thanks for joining the FDA pharmacists at their Drug Info Rounds. This is our FDA program of pharmacists helping pharmacists educate consumers, so they can make better medication choices.