Hazard Alert!

From the June 5, 2008 issue

Acetaminophen concentrated drops in 1-pint pour bottle. Brookstone Pharmaceuticals has begun marketing a pint-size container (473 mL) of acetaminophen concentrated drops (80 mg/0.8 mL) called PEDIAPHEN (see photo in the PDF version of the newsletter). In advertisements, the company suggests that hospitals can help protect the environment by purchasing their new large-volume, “green” container of acetaminophen. Print advertisements also compare Pediaphen to Tylenol brand acetaminophen concentrated drops (in 15 mL bottles), noting that Pediaphen’s larger container saves time dispensing the drug and costs less than thirty-two small-volume Tylenol containers. But saving time, money, and the environment may come with a hefty price tag in terms of serious medication errors. Such a large container invites confusion between the concentrated drops (80 mg/0.8 mL, or 100 mg/mL) and children’s acetaminophen liquid or elixir (160 mg/5 mL, or 32 mg/mL). Smaller containers of the concentrated drops from Tylenol and other companies are dispensed in a dropper bottle to promote correct dosing using dropperfuls. The screw cap on the Pediaphen container suggests that the dose should be poured into a medicine cup, similar to children’s acetaminophen liquid or elixir. Safety takes a giant step backwards if organizations purchase and dispense products in large bulk containers. Limited quantities and affordances (e.g., small dropper bottle, cusps around the bottle opening to prevent pouring the medication into a cup) are important safety features because they cue practitioners that small-volume dosing is required. We fully support healthcare’s efforts to “go green,” but not at the cost of public safety. Another issue is that “Pediaphen” may lead to name confusion with other children’s products that begin with “Pedia...” In 1989, when McNeil launched PEDIAPROFEN, an ibuprofen suspension, mix-ups began to occur with PEDIAPRED, a liquid prednisolone product. For that reason, Pediaprofen was renamed CHILDREN’S MOTRIN. We have alerted the manufacturer and FDA about our concerns with the pint-size Pediaphen product.