Consumer Reports Health Investigation Finds Drug Label Warning Inconsistency

A recent investigation that our Hartford County pharmacy error injury attorneys have been following found evidence that drug labels are often missing the important safety warnings necessary to prevent medication error and that many pharmacies neglect to include the proper medication guides that are required by the U.S. Food and Drug Administration (FDA).

The investigation was performed by Consumer Reports Heath, by filling warfarin prescriptions at five different New York drugstores. Warfarin is a blood thinner used for stroke prevention that is one of the most frequently prescribed drugs in the country.

The results found that four out of the five pharmacies neglected to provide the FDA-approved medication instructions that are required for specific drugs, warfarin included. Although the pharmacies reportedly provided their own medication materials, they were different from the warfarin drug information approved by the FDA, in that the warnings about the usage of alcohol were different. Warfarin can reportedly cause life-threatening internal bleeding if used incorrectly, and is the second in line for drugs that cause emergency room visits in hospitals across the country, due to medication error.

Another goal in the investigation was to see how certain drug labels, consumer drug information sheets, and medication warning stickers differed in each pharmacy. Although a certain degree of variation was expected, as various drugstore chains use different software to print labels and drug instructions, the findings raised significant concern.

The study found that critical drug warnings were not on some drug labels, and the medication information sheets caused confusion as they were difficult to read due to small print, and filled with confusing medical jargon. The authors of the study found that consumers are taking dangerous drugs without the proper warnings, which could lead to personal injury or harm.

Lisa Gill, the Consumer Reports Heath’s prescription drug editor, stated that currently there is no national standard for drug warnings, like the “Nutrition Facts” on food packages, or the “Drug Facts” on medication purchased over-the-counter. While the FDA requires certain details on the drug labels like the name and dosage instructions for the patient, the FDA does not monitor the actual details on the drug labels—which are left to each state’s board of pharmacy. And every pharmacist is responsible for whether or not the medication bottle has warnings, which leads to omissions and dangerous drug inconsistencies, according to the investigation.

Contact our medication error injury attorneys at Lebowitz and Mzhen, LLC today, in Anne Arundel County, Baltimore County, Frederick County and Charles County and other counties throughout Maryland, for a free consultation about your rights.

Consumer Reports Health: Key Drug Warnings Falling Through the Cracks, PR Newswire, June 28, 2011

Related Web Resources:

Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services

Institute for Safe Medication Practices, (ISMP)

Institute of Medicine (IOM)

U.S. Food and Drug Administration: Medication Error Reports

Related Blog Posts:

FDA Tips for Administering OTC Medication to Children—to Reduce Medication Error Injury, Pharmacy Error Injury Lawyer Blog, June 6, 2011
A Pharmacy’s Guide to Medication Therapy Management, Pharmacy Error Injury Lawyer Blog, January 6, 2011
FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury, Pharmacy Error Injury Lawyer Blog, May 9, 2011
Study Finds Small Doses of Drugs From Syringes Could Cause Medication Error in Children, Pharmacy Error Injury Lawyer Blog, February 4, 2011

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