From the August 2005 issue

Last month we received a report about an 11-day-old infant whose parents were directed by their physician to administer TYLENOL (acetaminophen) Infants’ Drops following his circumcision. A community pharmacist directed them to a store-brand equivalent product and instructed them to give the baby one-half dropperful for each dose. The pharmacist was familiar with the product, but did not realize that the manufacturer had recently changed the measuring device supplied with the product. It previously contained a dropper with a marking for “0.4 mL” and “0.8 mL” (see Figure 1), but the new package contained an oral syringe bearing only a “1.6 mL” mark nearly halfway up the syringe (see Figure 2). Subsequently, the infant received an unknown number of four-fold overdoses (intended dose was 40 mg [0.4 mL], baby received 160 mg [1.6 mL] per dose). The physician discovered the error when parents brought the baby in for follow up. The baby was hospitalized and treated with acetylcysteine for acetaminophen toxicity, but suffered no long-term harm. While investigating this error, we learned that this product was part of a recent recall by Perrigo Company that involves several different formulations of concentrated infants’ oral drops packaged with this poorly designed oral syringe. (Click here for a link to the FDA Alert) As illustrated in the case above, they are inappropriate for measuring doses less than 1.6 mL, which pediatricians may order for children less than 2 years of age.

However, this case illustrates a few other important points that should be considered. Practitioners must be fully aware of the over-the-counter products they recommend and keep in stock. To do so, manufacturers should provide an image of the device on the outer package. Then, pharmacists can see how dosages are indicated on the device and know its limitations. Also, because devices are available in different types (e.g., oral syringe, dropper), sizes, and with different markings, patients and their caregivers must be provided with accurate dosing information for the specific product that is being used. For example, in this case, using the term “dropperful” was incorrect for the device provided, but it can also be misleading and may be misunderstood. However, if the parents were instructed to use 0.4 mL, they may have called to question how to administer the dose with the device provided. Similarly, it seems likely that the parents would have also overdosed their child with the previously available product since the maximum fill line (0.8 mL) on the dropper is not even halfway up the pipette. Finally, practitioners must ensure that patients or their caregivers understand how to measure and administer the proper dose. This may require opening the package to provide a demonstration as well as a return demonstration by the patient or caregiver. Please share this report with your staff to illustrate the importance of communicating dosing information properly.