Packaging and labeling accounts for nearly 33 percent of all medication errors.

FDA publishes new safety guidelines to prevent medication errors

The Institute of Medicine's 2006 report "Preventing Medication Errors" found that packaging and labeling were the cause of 33 percent of all medication errors. In response to this significant problem, the Food and Drug Administration recently released the first of three consecutive industry guidelines to fight labeling and packaging errors for prescription and nonprescription drugs, along with biologic products monitored by the Center for Drug Evaluation and Research, according to Packaging Digest.

This first guideline, "Safety Considerations for Product Design to Minimize Medication Errors," focuses on eliminating hazards that could cause medication mistakes, while the second "focuses on minimizing risks associated with the design of drug product container labels and carton labeling, and the third focuses on minimizing risks when developing and selecting proposed proprietary names."

Accurate medication labeling can save lives.
Accurate medication labeling can save lives.

How dangerous are medication errors?
Before the IOM's 2006 report, the agency released "To Err Is Human: Building a Safer Health System" in 1999. This particular report found that anywhere from 44,000 to 98,000 patients die in hospitals across the country due to preventable medication errors. Even when using conservative estimates, the report states, medical errors are one of the leading causes of death in the U.S.

Some of the highest rates for medication errors occur in high-risk environments, such as emergency rooms or on the operating theaters table. However, common issues arise when medical professionals administer the wrong medication for their patients, leading to adverse side effects and even death. Thus, medication errors remain one of the most frequent types of mistakes occurring in the health care industry.

While the loss of life or health problems associated with medication errors is a dire problem, the financial burden is significant as well. Errors may lead to additional care costs, lowered productivity, permanent disability and losses in household income. These mistakes also lead to financial losses for health care systems. Hospitals or patient care clinics face lawsuits, patient dissatisfaction, federal fines and more.

Through the IOM's report, researchers concluded that this medication error epidemic is not solely due to recklessness or oversight on the part of the doctors or nurses. The vast amount of medical mistakes occur in difficult or extensive working conditions where people are more prone to make errors. Meanwhile, other mistakes occur when dealing with faulty processes or systems that do not support health care professionals. A hospital, for example, may have ordered certain drugs that can be deadly if not diluted. If the drug supplier does not indicate as much clearly on the label, nurses could prescribe these medications, leading to patient illness, injury or death.

"Legibility is key to lowering the risk of medication errors."

What are the FDA's recommendations to minimize medication errors?
The explicit purpose of the FDA's report is to create and monitor a set of regulations for drug packaging, labeling and deign to boost patient safety. Meanwhile, the FDA also advises pharmaceutical organizations to analyze their drug names to change any that look or sound similar to existing drugs. This latter request should lower the chance of health care professionals accidently administering or prescribing the wrong medication based on name or packaging similarity.

Legibility is key to lowering the risk of medication errors, the report finds, especially when a container's closure, such as  cap, stopper or seal, serves as the label. According to the report, manufacturers should "Avoid container closures that provide poor visual contrast between the container closure material and label information, such as foil, clear labels on glass/plastic syringes, or information etched on the syringe itself, or materials that have no affixed label but deboss or emboss the information directly on the container closure, such as a low-density polyethylene vial."

A key area highlighted in the report is that manufacturers should conduct proactive risk assessments regarding the product's end-users and environment. Manufacturers can achieve this through failure mode and effects analysis and simulated use testing. Essentially, in the early design and production of a pharmaceutical, enterprises must identify any medical packaging or labeling errors to avoid future problems.

This will save manufacturers from undergoing costly recalls or redesigns, while also supporting patient safety and lowering medication risk on the part of health care professionals. If everyone, from manufacturers to the patients, are confident in the accuracy of the medication and labeling, the industry as a whole can focus on treating patients, not worry about dangerous medical errors.

At Stranco, we understand the necessity of patient safety and accurate medication labeling. If you are a pharmaceutical or medical device manufacturer, you want to invest in durable thermal transfer labels that won't smudge, fade or become illegible throughout your supply chain process. Contact us today to learn more about our custom labeling options.

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