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FDA issues guidance to reduce drug-related errors

| May 3, 2016 | Medical Malpractice |

The Food and Drug Administration has issued two final guidance documents that could reduce the number of medication-related deaths in Oklahoma and across the U.S. The documents are part of the agency’s efforts to satisfy a 2007 law which called for a reduction in unclear medication labels, look-alike and sound-alike brand names and problematic label and packaging designs.

According to the Institute of Medicine, approximately 7,000 people die from medication-related causes each year in the U.S., and studies show that drugs with similar names are a top contributor to the problem. To address the issue, the first FDA guidance recommends that new drug submissions include specific information to help the agency identify brand name problems. This information would include the drug’s proposed proprietary name, pronunciation, pharmacology category, label design and dispensing method.

The FDA’s second guidance outlines ways that medication applicants can improve a drug’s user interface and container closure system. For example, all medications should feature label designs that make critical user information easy to locate and read. The agency also suggests that applicants consider the different environments in which their product may be used, such as hospitals, pharmacies and homes, when designing drug labels. It also says that pharmacists should counsel patients on potentially harmful drug interactions each time a medication is filled.

Taking medication that has been wrongly prescribed can lead to a worsened medical condition and other harm. This could rise to the level of medical malpractice, and an attorney can determine the party or parties that should be held financially responsible.

Source: Pharmacy Times, “FDA Issues Guidance to Reduce Medication Errors,” Allison Gilchrist, April 25, 2016

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