Consumer Reports Finds Drug Safety Information Lacking

Drug labels and medication guides are necessary for patients, caretakers, and physicians and are meant to contain important information on drug safety, efficacy, side effects, and dosing. WebMD noted that in a recent Consumer Reports investigation, some drug labels are missing important safety warnings and some pharmacies are not providing federally mandated medication guides.

The researchers discovered that even in larger chain stores, provided <"">drug safety information is inconsistent. “Our small spot check reveals major differences among the warnings on the bottle and among the patient information material,” said Lisa Gill, prescription drug editor for Consumer Reports Health. “It’s shocking that the FDA (Food & Drug Administration) medication guide was not included in four of the five prescription bags,” she added, quoted WebMD.

“Consumers need to be ever vigilant, especially when you consider how many medication errors there are,” she pointed out. According to Consumer Reports, some 1.5 million preventable medication errors occur annually; one-third of these take place outside of hospitals.

The report follows last week’s Supreme Court ruling that consumers cannot sue generic drug makers under state law alleging of inadequate warnings. The justices said the ruling was needed because state law does not give way to federal law, which mandates identical warnings on brand and generic drugs, wrote WebMD. Some state laws call for revisions when new drug risk information is revealed but that can happen long after the brand version is released but relatively soon after the generic, noted WebMD.

The research looked at if drugstores provide federally mandated medication guides for specific drugs and reviewed information provided to consumers on labeling, warning stickers, and printed data and if that information differed by store, said WebMD. The team filled a warfarin prescription; the blood thinner is a relatively common drug. The prescription was filled at Costco, CVS, Target, Walgreens, and Walmart pharmacies. Only “Costco got it right,” Gill told WebMD. The guide is mandated for warfarin and over 130 other medications.

Target and CVS claimed the information is automatically printed but, for some reason, was not provided. “Walmart and Walgreens did not respond” to calls from Consumer Reports, Gill said. All of the pharmacies provided in-store patient materials, said Gill, but these were not what was approved by the U.S. Food and Drug Administration (FDA) for warfarin and the information also contained conflicting information on alcohol consumption, wrote WebMD. In some cases, print size was so small the information was hard to read and confusing medical jargon was also deemed problematic for patients, said WebMD. Information also varied by store. Target had four clear warnings. Walgreens had four warning stickers; CVS had three; Costco, two; and Walmart, none, said WebMD. On two follow-up visits, Walmart had three warnings on each visit.

Allen J. Vaida, PharmD, executive vice-president of the advocacy group, Institute for Safe Medication Practices, reviewed findings for WebMD and found that, ”What is most surprising is that four of the five failed to provide the mandated medication guide for something like warfarin,” quoted WebMD. “You would think they would at least have that standardized,” in each store, he added.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.