The recent FDA Guidance, Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products,¹ highlights growing concern about safe administration of over-the-counter (OTC) liquid medications for children.  As inventor of the first dedicated oral syringe in 1975, Baxa Corporation has a long-standing interest in oral delivery best practices.  As an organization, we view the FDA Guidance as a wake-up call for the industry to re-think the way OTC drug delivery systems for oral solutions are created and packaged for the end user.

The majority of OTC children’s medications today come pre-packaged with a dosing cup, despite growing evidence of its fallibility.  For example, a February 2010 study of more than 300 parents published in the Archives of Pediatric & Adolescent Medicine found that 79% of parents made mistakes when using a dosing cup.  Almost all of these mistakes involved administering too much medicine.

One solution is to make oral syringes readily available in OTC medications.  Leading hospitals use oral syringes to safely administer liquid medication to babies and pediatrics because of their dosage accuracy and efficiency in administration.  Both the Institute for Safe Medication Practices (ISMP) and The Joint Commission support this best practice.

Another possible solution is for drug manufacturers to include custom, pre-packaged oral syringes with dosage instructions based on a child’s weight, not age.

There is no price on safety, yet by continuing to use dosing cups, drug manufacturers are avoiding safety because of price.  It is time that the pharmaceutical and device manufacturing industries take new steps toward modifying OTC liquid drug delivery and work together to find a solution that benefits who matters most, the patient.

Marian Robinson is a vice president at Baxa Corporation, based in Englewood, Colorado. She can be reached at [email protected]. For more information about Baxa and its line of oral syringes visit: www.baxa.com/exactamed.

1    U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products. May 2011.