Wednesday, July 23, 2014
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FDA and ISMP working together help consumers prevent errors

To reach as many consumers as possible, FDA's Center for Drug Evaluation and Research (CDER) has formally strengthened its relationship with ISMP so the two agencies can work together to provide consumers with information on how to use medicines safely.

FDA and ISMP working together help consumers prevent errors

by Michael R. Cohen, R.Ph.

The U.S. Food and Drug Administration (FDA) and the organization I work for, the nonprofit Institute for Safe Medication Practices (ISMP), have long shared a common goal of helping consumers prevent medication errors. Now, to reach as many consumers as possible, FDA’s Center for Drug Evaluation and Research (CDER) has formally strengthened its relationship with ISMP so the two agencies can work together to provide consumers with information on how to use medicines safely.

Reviewing information from reported errors and timely posting of crucial information on both agencies’ Web sites are just two of the ways that ISMP and FDA are working together towards this goal. For example, late in 2011, both FDA and ISMP received reports of dosing confusion involving a new, less concentrated form of acetaminophen for infants. A more complete picture of the problem was possible by combining the reports submitted to both agencies. Then, ISMP and FDA both issued advisories with tips to help consumers avoid confusion and dosing errors. Click here to link to ISMP’s advisory on this topic, or click here to watch an FDA podcast about infant acetaminophen safety.

More recently, a similar situation developed when ISMP and FDA were alerted to a tragedy involving a little boy who swallowed a drug patch containing fentanyl, a powerful narcotic that’s applied to the skin. The little boy found the patch while visiting his great grandmother, who was staying at a nursing home. The patch was somehow left in reach of the child when the person applying a fresh patch failed to properly discard the used one. The used patch contained enough drug to be lethal after the boy swallowed it. Both FDA and ISMP alerted health professionals and the public through widely disseminated national safety alerts.  

Also, this Web site—ISMP’s ConsumerMedSafety.org—offers a new, dedication section for FDA consumer alerts, videos, and special communications related to drug safety. Click here to go to this section, where you will find a wide assortment of important FDA consumer advisories and videos ranging from accidental testosterone exposure in women and children, to mercury poisoning from skin products. Or watch a video on how to teach kids about using medications safely. This video, and others, are also provided in Spanish.

Check this Web site frequently to stay informed about important FDA and ISMP safety alerts. Be sure to visit the site often.


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Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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