Labeling inconsistencies common with children's OTC meds

Medication dosing directions and markings on manufacturer-provided dosing devices were inconsistent in 98.6% of the nation's top selling pediatric over-the-counter liquid medications, study findings published online first in the Journal of the American Medical Association reveal.

H. Shonna Yin, MD, MS of New York University School of Medicine and colleagues from several other U.S. sites, analyzed 200 oral liquid OTC medications in the 52 weeks prior to Oct. 30, 2009. In November 2009, the FDA issued voluntary manufacturer safety guidelines in response to numerous reports of unintentional pediatric OTC drug overdoses.

The researchers found that nearly all of the 148 OTC products in which a standardized measuring device was provided contained at least one error including: one or more superfluous measurement markings on the provided device (81.1%) or a lack of necessary markings (24.3%); inconsistencies between measurement units listed in the directions and those used on the device (89%); and the use of nonstandard units of measurement (5.5) – including units such as drams, cubic centimeters and fluid ounces.

To confuse matters worse, different products used different units of measurement. These included milliliter (n=143), teaspoon (n=155) and tablespoon (n=37). Additional data indicated that 97 products used a nonstandard abbreviation for milliliter, and 163 products did not define at least one of the abbreviations used in the directions.

“Our findings document that high levels of variability and inconsistency currently exist within medication labeling and measuring devices of OTC products,” the researchers wrote, noting that the product sample used in the study represented 99% of U.S. market share for pediatric OTC oral liquid analgesic, cough and cold, allergy and gastrointestinal products.

In fact, this is a common occurrence. Forty percent to 60% of parents make dosing errors when they administer medications to their children, according to background information provided in the study.

“Supporting consumer comprehension by providing clear, consistent and standardized information increases the likelihood that consumers can safely and effectively use OTC medications,” Yin and colleagues wrote.

They reinforced the importance of the 2009 FDA guidelines, specifically emphasizing the following three “critical areas:”

  • The adoption of standardized measurement units, abbreviations and numeric formats across all OTC liquid products.
  • The provision of a standardized measuring device with every OTC liquid medication.
  • Limiting the number of markings on dosing devices to only those that are necessary.

Elizabeth Burke-Roberts, APRN, CPNP-PC, of Norwich Pediatric Group in Norwich, Connecticut, told The Clinical Advisor that her practice has adopted a system using pre-printed tables that identify the correct doses of ibuprofen and acetaminophen to administer depending the child's weight and the product's concentration.

“I personally ask the family which product they have at home, highlight or underline their child's weight on the table and the corresponding dose,” Burke-Roberts said. She also makes sure to write a note clarifying the correct dosing intervals for each medication (administer doses at least 6 hours apart for ibuprofen and 4 hours for acetaminophen) and discusses the dangers of alternating between the two.

When it comes to OTC cough and cold preparations, Burke-Roberts said that her practice has adopted a policy to discourage use. “As a team we believe that the risk of unfortunate side effects from accidental overdose do not outweigh any perceived benefit,” she said.

Burke-Roberts tells parents that these medications will not make the cold go away any more quickly, and discusses the risk of side effects and significant financial cost. She suggests honey as a natural cough suppressant for children older than one year.

But Serena Cherry Flaherty, MSN, CPNP, of The Door Health Center in New York City, said that many OTC medications are used without ever contacting a health care provider.  Because of this, she supports making the voluntary FDA medication guidelines mandatory ­– a move that Burke-Roberts supports as well.

“When we are dealing with ill children and exhausted parents, simplicity is critical. Making things like dropper size, medication concentration and dosing abbreviations universal could dramatically reduce errors,” Burke-Roberts said.

 In the meantime, Flaherty said that providers should review dosing instructions for common OTC medications at each well child visit and every sick visit, and encourage parents to call if they are uncertain about dosing instructions.

Additionally, she suggests that clinicians make efforts to write doses consistently in milliliters, and encourage parents to use a syringe instead of a spoon when administering liquid medications.

“With OTC medication labeling inconsistencies, kids are at risk for subtherapeutic dosing and drug toxicities,” Flaherty said. “There is a great misunderstanding that simply because these medications are available for purchase without a prescription that they are safe and effective.”

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