FDA issues final guidance for liquid OTC drug products with dispensing devices

The FDA recently released its final guidance to firms that manufacture, market or distribute over-the-counter liquid drug products packaged with measuring devices. On the same day, makers of over-the-counter single-ingredient liquid pediatric acetaminophen medicines announced they will voluntarily change the formulation and offer a single dosage of liquid acetaminophen.

According to the FDA, the guidance was issued because of concerns about the potential for accidental drug overdoses that can occur from the use of dosage delivery devices with markings that are confusing, unclear or inconsistent with the labeled dosage directions.

“Accidental medication overdose in young children is an increasingly common but preventable public health problem,” Karen Weiss, MD, program director for the FDA’s Safe Use Initiative in the Center for Drug Evaluation and Research, said in a press release.

The same day that the FDA issued this guidance, the makers of OTC liquid pediatric acetaminophen announced they would convert these pediatric products to just one concentration, according to a press release from the Consumer Healthcare Products Association. The current children’s strength of liquid acetaminophen (160 mg/5 mL) will become the only liquid concentration available for all children aged younger than 12 years, and sale of the current concentrated infant drops will cease.

The key recommendations for manufacturers in the FDA guidance include:

• Dosage delivery devices should be included for all oral OTC liquid drug products.
• Devices should be marked with calibrated units of liquid that are the same as the units of liquid measure specified in the directions for the product, and there should not be any unnecessary markings.
• Manufacturers should ensure that dosage delivery devices are used only with the products they are packaged with.
• Liquid measure markings on dosage delivery devices should be clearly visible and not obscured when the liquid product is added to the device.

Edward Bell

These announcements by the FDA and the Consumer Healthcare Products Association are welcome, and are steps in the right direction. Problems with dosage form confusion, dosing, and dose measurement by caregivers have long been known for pediatric OTC liquid products, such as acetaminophen. Significant medication adverse effects have resulted from these problems. Changing liquid acetaminophen pediatric products to one concentration only will hopefully reduce confusion over dosage form differences, and dosing and administration errors. While this product change transitions over this year, parents and caregivers are likely to continue to be confused about dosing and dose measurement, especially as current home supplies of liquid infants' and children's acetaminophen products remain and are used. Pediatric clinicians can help by discussing this with families - do more than say, "Give him some acetaminophen." Discuss differences in acetaminophen product dosage forms, specify a mg and volume dose, and emphasize appropriate dose volume measurement. This discussion should only take a few minutes. Don't assume that parents know what dose and product to use - several studies have shown that they often do not.

-Edward Bell, PharmD, BCPS
Infectious Diseases in Children Editorial Board member

Jose Romero

Since the recommended restrictions for the use of salicylates in children issued in the early 1980s, acetaminophen has become the most widely used antipyretic and analgesic in the United States and worldwide. Acetaminophen is present singly or in combination in more than 200 OTC medications. Although acetaminophen use is associated with a very low incidence of toxic effects, concern regarding accidental acetaminophen toxicity exists due to its widespread use and increasing frequency. Factors contributing to unintentional acetaminophen toxicity in children include the use of inappropriate measuring devices or incorrect preparations for age of the child, erroneous dosing as a result of failure to read or understand dosing instructions, co-administration with other OTC medications containing acetaminophen and concomitant use with other potentially hepatotoxic medications.

Currently available acetaminophen liquid formulations for use in infants include 80 mg per 0.8 mL and 80 mg per 1.0 mL strengths, as well as a 160 mg per 5 mL preparation for use in children aged 2 to 11 years. Manufacturers will no longer produce the concentrated formulations. Availability of a single liquid acetaminophen concentration of 160 mg per 5 mL for use in children younger than 12-years will aid reducing the risk of overdoses that result from errors in dosing due to product variations in drug concentration. The packaging of syringes for dosing of medication in infants will also help reduce the number of inadvertent overdoses. The use of dosing cups will remain a problem as documented by studies showing that caregivers tend to overfill these dosing devices, which could lead to excessive administration of medication over time. As indicated in the recently published clinical report by the American Academy of Pediatrics Section on Clinical Pharmacology and Therapeutics, Committee on Drugs on fever and antipyretic use, it is essential that physicians and health care providers provide caregivers with education and recommendations concerning the appropriate use of analgesics and antipyretics in children as the cornerstone in preventing inadvertent overdoses of these medications.

-Jose R. Romero, MD
Infectious Diseases in Children Editorial Board member

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