english.prescrire.org > Annual Prescrire Awards > The Prescrire Awards for 2010 > The 2010 Prescrire Awards: chosen in all independence by Prescrire's Editorial staff > Prescrire's annual review of drug packaging in 2010 > FDA: inaccurate dosing devices

The Prescrire Awards for 2010

The 2010 Prescrire Awards: chosen in all independence by Prescrire's Editorial staff

Prescrire's annual review of drug packaging in 2010
FDA: inaccurate dosing devices

In 2009, the US Food and Drug Administration (FDA) examined the dosing devices for 200 oral multidose OTC products intended for pain, cough, allergy and some gastrointestinal disorders in children under 12 years of age (1). The results, published in 2010, are worthy of note.

In line with Prescrire’s findings
Only three-quarters of the products examined by the FDA included a dosing device. Four out of five devices were dosage cups, 13.5% were droppers, and only 2.7% were oral syringes, which are more precise than dosage cups and droppers (1).

At least one inconsistency was found between the instructions for use and the graduations on the dosing device for nearly all of the products examined. At least one necessary graduation was missing in nearly one-quarter of cases, while about 8 in 10 devices bore unnecessary graduations. Eleven devices bore atypical units of measurement such as cm3, and 2 different graduated scales were found on half of the dosing devices (1).

In November 2009, the FDA issued a guidance for manufacturers on the design of dosing devices for OTC oral medicines (2). It included the following recommendations: all such products should be sold with a dosing device; the instructions for use should be compatible with the graduations; the highest standards for packaging should become the norm (for example, the capacity of dosing devices should be limited to the maximum recommended dose); and user tests should be conducted.

The FDA’s example should be followed in Europe.

©Prescrire 1 June 2011

"2010 drug packaging review: identifying problems to prevent errors" Prescrire Int 2011; 20 (117): 162-165. (pdf, free)

References:
1- Yin SH et al. “Evaluation of consistency in dosing directions and measuring devices for pediatric nonprescription liquid medications” JAMA 2010; 304 (23): 2595-2602.
2- Food and Drug Administration “Draft guidance for industry. Dosage delivery devices for OTC liquid drug products” November 2009: 13 pages.