Case JS, a 3-year-old child weighing 16 kg, was recently hospitalized for acute appendicitis. Upon discharge, the physician instructed JS’s mother to purchase OTC acetaminophen and to administer 7.5 mL (1.5 teaspoonfuls) 4 times per day for post-appendectomy pain. What can the hospital pharmacist add to the instructions?
Answer
An estimated 12% of children younger than 11 years of age take acetaminophen in any given week.1 This OTC antipyretic/ analgesic is first-line therapy for pain and fever in children at a dose of 10 to 15 mg/ kg every 4 to 6 hours as needed (maximum: 5 doses per 24- hour period).2,3 Commercially available acetaminophen has historically been supplied in 2 formulations: 1) concentrated acetaminophen 80 mg/0.8 mL, and 2) acetaminophen elixir 160 mg/5 mL.1,3
Without specific instructions, JS’s mother might inadvertently administer a significantly higher dose than intended. If she purchased the 80 mg/0.8 mL rather than the 160 mg/5 mL concentration and gave 1.5 teaspoonfuls, she would administer her child a 3-fold overdose by giving 750 mg rather than the intended 240 mg dose.
Acetaminophen-associated medication errors are commonly reported to result from improper administration of concentrated acetaminophen drops instead of less concentrated acetaminophen elixirs, in addition to confusion with units of measure (ie, teaspoonfuls vs dropperfuls).4-7
A pharmaceutical industry–wide initiative began in mid-2011 in response to a 2009 FDA Advisory Committee recommendation for standardization of acetaminophen concentrations for children less than 12 years of age.1,8-11 Commercially available acetaminophen products will be converted to 1 standardized concentration: 160 mg/5 mL. Additionally, age-appropriate, accurate administration devices with a standardized unit of measure (mL) will be included with all medication packages. These changes are specifically aimed at improving patient safety by decreasing acetaminophen- associated medication errors.
While the transition to 1 standardized strength will ultimately lead to improved patient safety, during the period of transition both formulations continue to be on pharmacy shelves and in homes. Pharmacists are uniquely positioned to safely shepherd this change and to provide appropriate education to providers and caregivers alike. By maintaining awareness of the concentrations of products, appropriate administration devices, and effective provider/caregiver education, pharmacists play an important role in promoting safe medication practices for children and reducing pediatric medication errors.
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