FDA Drug Info Rounds, September 2012: Medication Errors

FDA Drug Info Rounds, September 2012: Medication Errors


Captain Mary Kremzner: Since 2000 the FDA
has received more than 95,000 reports of medication errors. Preventable events that may cause
harm to a patient. Why do these errors happen and how can they be reduced. I’m Captain Mary
Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division
of Drug Information. I’m joined today by two FDA pharmacists, Commander Jaewon Hong, Lieutenant
Commander Sam Skariah, to discuss medication errors and what they FDA does to prevent them.
So Jae what are some of the main causes of medication errors? Commander Jaewon Hong: Usually there are multiple
complex factors that apply. For example it could be some combination of illegible handwriting,
packaging design that looks alike or similarities in drug names and product characteristics
such as the drug strengths, dosage forms and dosing intervals. Captain Mary Kremzner: Jae, can you give us
an example of a recent case that the FDA handled? Commander Jaewon Hong: Sure. FDA’s Division
of Medication Error Prevention in an analysis recently reviewed and analyzed 226 reports
related to the drugs Risperidone, brand name Risperdal and Ropinirole brand name Requip.
In some instances patients who took the wrong medications were hospitalized. FDA’s analysis
revealed an increase in confusion between these drugs after the generic versions for
both were introduced. Both brand and generic similarity was a prime suspect. Other possible
factors included illegible handwriting on prescriptions and similarities in the container
labels and carton packaging within the generic product lines. You can see the labels are
almost identical. Because both products started with R they could have been stocked near each
other on shelves. Lt. Commander Sam Skariah: The FDA requested
that drug manufacturers use Tall Man lettering on labels and packaging to make the names
more distinct. We also requested changes to the generic labels and cartons so that the
fonts, layout and colors are no longer similar. We advised healthcare professionals to clearly
print the drug names on written prescriptions, spell out the drug names for phone prescriptions
and to verify the purpose of the drugs with their patients. We asked pharmacists to physically
separate stocks of the drugs and confirm the drug name with prescribers if the prescription
is not legible. Captain Mary Kremzner: Sam, what does FDA
do on a regular basis to reduce the risk of medication errors? Lt. Commander Sam Skariah: Well plenty. Each
month the FDA reviews and analyzes approximately 1,400.00 reports of medication errors that
come through MedWatch which is the FDA’s adverse event reporting program. We conduct pre marketing
reviews of all proprietary drug names, labeling and packaging to minimize the potential for
confusion. Since 2004 the FDA has required bar codes on product labels for certain drugs
and biologics like blood. Bar codes help ensure the right dose of the right drug at the right
time. Last but certainly not least we educate the public. The FDA spreads messages about
medication error prevention through public health advisories, medication guides and outreach
partnerships with other organizations. Captain Mary Kremzner: It sounds like all
parts of the healthcare system from medical professionals to patients themselves play
a critical role in preventing and reporting medication errors. You can easily report any
adverse events or potential medication errors through the MedWatch web site. If you have
questions about medication errors call or email the FDA’s Division of Drug Information.

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