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.