Labeling and packaging issues are the leading cause of medication errors.
If you’ve ever thought that the instructions and warnings that come with your medications and medical devices required a medical degree to understand, you aren’t alone.
In fact, an Institute of Medicine study found that labeling and packaging issues (particularly confusing instructions) were the leading cause of medication errors (33%) and deaths from medication errors (30%). Medical devices trend the same way. The FDA’s Center for Devices and Radiological Health reports that one-third of the roughly 100,000 medical device event reports they receive each year are attributed to use error.
Part of the problem is that there is a lack of consistency across labeling. While manufacturers are required to include important warnings and dosage information in their packaging, the format and symbols can vary between products. And, if a physician can’t find information on a label quickly, or if a patient can’t understand how to use their medical device or drug at home, it can result in serious complications.
Only 15% of Pharmaceutical Drugs Follow FDA Standards
The FDA realizes the medical industry is suffering from weak labeling regulations, but fixing the problem has proven to be a decade-long process.
Currently, there is no standard for medical device labeling or instructions. While manufacturers are required to include certain information in those materials, there is no format for them to follow, nor is there a set of common terminology to use.
In 2006, the FDA addressed this problem with pharmaceutical drugs. The Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, or the Physician Labeling Rule, established standards for everything from what information should be highlighted, to what size font should be used and what should be bolded.
Though the standards have existed for more than 10 years, only 15% of pharmaceutical drugs follow the labeling rule.
Confusing Labeling Can Result in Drug Overdosing
Every 21 seconds, someone in the U.S. calls the Poison Control Center because of a medication error.
In 2006, drug officials stated that the U.S. spent $4 to $4.8 billion on medical errors that could be prevented if drug manufacturers improved the information they provided to doctors.
But this isn’t just a financial problem; it’s a public health issue.
A 2017 study reported that every 21 seconds, someone in the U.S. calls the Poison Control Center because of a medication error. Medication misuse, they found, has increased 100% since 2000.
Henry Spiller, one of the study’s authors and the director of the Central Ohio Poison Center, emphasized the role that drug manufacturers and pharmacists play in reducing medication errors.
“There is room for improvement in product packaging and labeling,” he said in a statement. “Dosing instructions could be made clearer, especially for patients and caregivers with limited literacy or numeracy.”
Labeling confusion recently resulted in a number of patients overdosing on the antibiotic Zerbaxa. The FDA warned that Zerbaxa’s vial and carton listed the strength of each ingredient, rather than the strength of the dose. This caused some patients to receive 50% stronger doses than they should have.
Hernia Mesh Manufacturers Accused of “Extreme Underreporting”
Medical device manufacturers are just as guilty of providing weak labeling and instructions.
- 67% of hernia mesh labels did not provide information on the device composition.
- 69% of hernia mesh instructions did not provide information on the device mechanics.
- 89% of hernia mesh instructions did not provide information on the device thickness.
“There is an extreme underreporting and lack of consistency of clinically important mesh properties,” concluded researchers. More standardized information and terminology, they claimed, would improve physician decision making during hernia repair.
The complete lack of information available to physicians is astounding given how common hernia mesh injuries are. Thousands of lawsuits that have been filed against manufacturers alleging that the mesh migrated and stretched in their bodies, causing internal injuries and ultimately requiring revision surgery.
In 2011, C.R. Bard offered to pay $184 million to settle 2,600 lawsuits for its Composix Kugel Mesh. And Ethicon—whose Physiomesh was recalled in July of 2016 for its high complications risk—faces its first trial in January 2018.
Medical Device Manufacturers Fight Labeling Database for Patients
As part of their effort to reduce confusion and medical device use error, the FDA is piloting an electronic database for medical device labeling. Because medical devices are typically used for years, patients often discard or misplace the original packaging and instructions, and may not know if the manufacturer has issued new warnings.
Since 2007, the FDA has required medical device manufacturers to submit their device registration information electronically, but not the labeling. Currently, there is no easy way for patients to find the original labeling and instructions for their medical devices.
Astoundingly, manufacturers claimed that a database for medical device instructions would actually negatively affect patient safety.
But not everyone is eager to improve communication with patients. AdvaMed, the trade association for medical device manufacturers, went so far as to claim that a database for medical device instructions would actually negatively affect patient safety.
“An online medical device repository would pose numerous problems, including risk to patient safety due to the number of medical devices and the frequency of which patient labeling may be updated,” AdvaMed claimed.
Their reasons? Because if people go online, they may not pick up the phone to call customer service.
“An online repository for all medical devices may divert users from human interaction with Customer Service personnel trained in the operation and maintenance of their devices,” they stated.
It’s an extremely weak attempt to fight regulations which will enable patients to easily find vital safety information.
This isn’t the first time that manufacturers have resisted recommendations to improve patient safety, nor will it be the last. If you or a loved one were injured by a medical device or medication, contact us for a free, no-obligation legal review.