A dangerous pitfall of OTC meds

By Naveed Saleh, MD, MS
Published July 15, 2021

Key Takeaways

Prescribing and managing prescription drugs for patients is one of the most important roles a physician plays—but what happens when over-the-counter (OTC) medications are added into the mix? Unless a patient faithfully informs their physician of OTC agents taken and in what dosage, such medication history may never be apparent, and the physician is unable to advise patients on these drugs.

Like any medication, OTC drugs can cause adverse reactions, may not mix well with prescriptions, may actually worsen certain medical conditions, or have the potential for misuse.   

Consequently, it’s highly important that patients read the labels of these drugs and follow instructions exactly.

To ensure that OTC drug labels clearly communicate safety and usage information to a lay audience, the government mandates that OTC packaging be designed with a Drug Facts Label (DFLs). Although initial tests of these labels have proven that modern labels are the best iteration to be designed to date, they still leave much to be desired, according to a recent study published in Pharmacy. 

Let’s take a closer look at DFLs and their limitations.

What’s on the label

All OTC medications sold in the United States display detailed usage and safety information. According to the FDA, this information includes the following:

  • Active ingredients and amounts per unit

  • Uses including symptoms or diseases the product treats

  • Warnings about when not to use the product, adverse effects, when to seek medical attention, concerns if pregnant/breastfeeding, and guidance on keeping out of reach of children

  • Inactive ingredients such as color or flavoring

  • Product action or categories (eg, antihistamine, antacid)

  • Directions on administration

  • Other information such as storage

The label also includes the expiration date, lot/batch code, name/address of the manufacturer, net quantity, and what to do in case of overdose.

Issues with DFLs

The authors of the aforementioned review noted various limitations with respect to current OTC labeling.

Health literacy. This term refers to how well a patient processes treatment-related information when making healthcare decisions. Along with other factors, OTC labels may not cater to those with lower health literacy. 

“[T]he DFL is a static, text-based medium written in English, which means that it is inherently limited in its ability to serve the needs of limited literacy, visually impaired, and/or non-English speaking populations. These populations are thus vulnerable to poor comprehension and heeding of the DFL,” the review authors wrote.

Age. The authors highlighted older age as a contributing factor to the inefficacy of OTC labels. Although older adults are more engaged with their OTC purchase and studies show that they are no more likely to overdose on NSAIDs and acetaminophen, as a group, older adults exhibit lower levels of health literacy vs younger ones. 

The authors noted that “while age may heighten the level of personal relevance or involvement with OTC drug purchases, there are issues inherent to aging (eg, decreased cognitive function, reduced vision) that may hinder effective interaction with OTC drug labeling.”

Preconceived notions. Consumer beliefs can contribute to OTC misuse. For instance, many consumers believe that OTC medications are safe at any dosage, and take them at their own discretion without heed for the packaging (which is often discarded).

The researchers wrote that “even if consumers attend to and understand the information provided in the DFL, their existing beliefs and attitudes may lead them to behave discordantly or to ignore the package labeling altogether. Such misconceptions and apathy toward OTC instructions suggest a broader need to educate consumers about OTC products in a way that goes beyond what the DFL can be expected to accomplish on its own.” 

What can be done?

The authors suggested various ways in which OTC labeling and the consumption of these drugs can be improved.

  • Labeling could be printed in a larger font for elderly individuals.

  • Pharmacists could be available at the point of purchase to advise patients on OTC medication use.

  • Warnings could be more explicit. For instance, with regard to acetaminophen, packaging could stress the medication's impact on the liver.

  • Icons could provide visual information for those with lower health literacy.

As a physician, it may be a good idea to make a point of discussing OTC drug use—especially with certain patient populations, including those with diabetes, blood-clotting disorders, dementia, respiratory disease, and liver disease. It is also important to evaluate OTC drug use in the context of polypharmacy among older adults.

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