FDA and ISMP Work to Prevent Medication Errors
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What is the Food and Drug Administration (FDA) doing to help protect consumers from medication errors?
FDA’s Center for Drug Evaluation and Research (CDER) has formalized a long standing relationship with the Institute for Safe Medication Practices (ISMP) a non-profit organization based in Horsham, Pa.
What's wrong with this picture? The strength looks different for one of these medications, even though all mean the same thing—5 mg. The problem is that one of them uses an unnecessary zero after the decimal point. Sometimes prescriptions are written this way and the decimal point can be missed, leading to a tenfold overdose (50 mg instead of 5 mg). This is one example of a potential preventable medication error. Get this hi-res artwork on Flickr.
ISMP‘s mission, says founder and president Michael R. Cohen, is to educate the health care community and consumers. Medication errors are preventable mistakes that can happen in labeling, packaging, prescribing, dispensing, and communications when the medication is ordered. Causes include:
- Incomplete patient information, with the health care professional not knowing about allergies and other medications the patient is using
- Miscommunication between physicians, pharmacists and other health care professionals. For example, drug orders can be communicated incorrectly because of poor handwriting
- Name confusion from drug names that look or sound alike
- Confusing drug labeling
- Identical or similar packaging for different doses
- Drug abbreviations that can be misinterpreted
As a part of its ongoing effort to fight these and other risks, CDER has entered into an agreement with ISMP to develop collaborative efforts to reduce preventable harm from medicines, and to more effectively reach consumers with information on how to use medicines safely.
Sharing Error Reports
FDA and ISMP each have well-established online pathways for the reporting of medication errors. Cohen says that ISMP hears from “front line practitioners” —like pharmacists, nurses and physicians—via its national Medication Errors Reporting Program. ISMP also has a medication error reporting program for consumers.
ISMP shares these reports with MedWatch, FDA’s safety information and adverse event reporting system, which covers bad experiences with medical procedures and products that include drugs, devices, supplements and cosmetics.
Carol Holquist, director of FDA’s Division of Medication Error Prevention and Analysis, says that ISMP’s sharing of the detailed information from its national reporting system helps the agency get to the root cause of medication errors.
“We're trying to fix problems before someone gets hurt” says Holquist.
For example, FDA was getting reports last year of dosing confusion involving a new, less concentrated form of acetaminophen for infants. ISMP contacted the agency about reports it had also received, and this information helped form a more complete picture of the number of events.
FDA later issued a Drug Safety Communication advising consumers how to avoid confusion and dosing errors.
Expanding FDA’s Reach
The collaboration is also designed to provide more informational and educational materials for both consumers and health care professionals. And the relationship will broaden FDA’s ability to reach out to these groups when there are issues with product safety and effectiveness.
If there is a problem that arises from the way a medication is given to patients, , ISMP helps get the word out, Holquist says. For example, FDA learned that single-use insulin pens were being reused in hospitals. Even though the needles were being replaced, there was a risk of infection, she says. In situations like that, ISMP is able to reach specific audiences through their newsletters.
ISMP also has two web sites:
- www.ConsumerMedSafety.org: This site is designed to help consumers get involved in preventing medication errors. The extensive information here includes interactive features. For example, typing in the name of a medication will bring up information about side-effects, duplicative treatments and drug interactions. A free safety alert service, about medications patients or their family members are taking, also is available.
- www.ismp.org: This site is designed more for health care professionals, with information that includes medication safety tools and resources, as well as educational and professional webinars and training programs.
Both ISMP web sites have lists of potential medication safety issues, such as the drugs most likely to be involved in harmful errors, medications with look-alike or sound-alike names, and error-prone abbreviations.
ISMP publishes four newsletters that are distributed electronically to consumers, industry and health care professionals and frequently presents educational programs. One of the newsletters, called "Safe Medicine", shows consumers how to become active partners with their health care professionals in preventing medication errors.
Cynthia Fitzpatrick, project manager in FDA’s Safe Use Initiative, says the partnership is already benefiting FDA by further extending its reach into all aspects of health care, including consumers and professionals. “It is so helpful for FDA to be able to access the front-line health care professionals so we can provide them with the most up-to-date information they can use for the care of their patients.”
“And the partnership gives consumers more resources to help them protect themselves and their families from medication errors,” she adds.
This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.
March 29, 2012