The FDA Takes on Pharmacy Errors and Medication Errors by Changing Drug Packaging

The U.S. Food and Drug Administration (FDA) is taking on medication errors by changing drug packaging and labeling. Medication errors are a massive problem in the healthcare systems of the United States. The Institute of Medicine reports that as many as 98,000 Americans die each year because of medical errors, and up to 7,000 of these deaths are attributed to adverse drug events (ADEs) from medication errors with at least 1.5 preventable ADEs occurring in the U.S. each year.

What is a medication error?

The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) defines a medication error as:

“any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.”

Drug names often lead to confusion for patients and pharmacists

Is it acetaZOLAMIDE or acetoHEXAMIDE? Benadryl or benazepril? ClomiPHENE or clomiPRAMINE? Micronase or Microzide? The Institute for Safe Medication Practices (ISMP) publishes a list of often confused drug names, and the similarities between drug names is mind boggling. There is even a name for the problem. It’s called the “look alike/sound alike” drug name (LASA). The Institute of Medicine, now the Health and Medicine Division of the National Academies of Science, Engineering and Medicine reports that 33% of medication errors and 30% of deaths from medication errors were a result of confusion around medication labeling and packaging.

The FDA ‘s Center for Drug Evaluation and Research is working with the pharmaceutical industry’s efforts to make medication packaging and labeling more user-friendly while improving patient safety and preventing medication errors. It all starts with the FDA’s Division of Medication Error Prevention and Analysis (DMEPA), which is responsible for the premarket preview  of proposed medication names, label designs, labeling and packaging to help prevent medication errors. DMEPA staff members last review medication error reports which are submitted to MedWatch, they evaluate causality and analyze the data to provide solutions to reduce the risk of medication errors.

In an article in American Pharmacist’s Association, Michael R. Cohen, RPh, MS, ScD(hon), DPS(hon), FASHP, president at the ISMP said, “Some companies will have a highly stylized label with their logo more prominent than the name of the drug, with colors, stripes, and all kinds of designs. It sometimes throws people off because they tend to see that more than the name of the drug and the strength.”

DMEPA is working to counteract those problems with drug labeling by making sure that the most important information is on the front of the product, that there is enough white space between the text so that it can be easily read. DMEPA also ensures that the images or logos do not overlap information about product strength, and they encourage the use of standard abbreviations.

The American Pharmacist’s Association story also mentions how pharmacists have a role to play in reporting safety issues involving the naming, labeling and packaging of drugs.

In 2016, the FDA launched a Drug Safety Labeling Changes Database, which is managed by CDER and made it available to the public in downloadable and searchable formats. The intention is to provide access to safety data to promote patient health.

Consumers who encounter problems with confusing drug names, unclear drug labeling or packaging can report it to the FDA’s MedWatch database and feel confident that what they report is being acted upon to improve drug labeling.

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