Support H.R. 6259 – Protecting Our Kids’ Medicine Act of 2016

Unintentional medication overdoses pose a significant threat to the health of children. I urge pediatricians to ask their Congressional representatives to vote “Yes” on H.R. 6259. The bill would require manufacturers to provide liquid medication dosing devices that are more in conjunction with the recommendations of the American Academy of Pediatrics and the PROTECT Initiative.

Numerous studies document the risks and harm of unintentional overdoses. In 2009, The American Journal of Preventative Medicine published a study entitled “Medication Overdoses Leading to Emergency Department Visits Among Children” that estimated over 70,000 emergency visits were due to medication overdoses each year. The study found that medication error and misuse accounted for 14.3% of the visits, while 82.2% of the visits were due to medication overdoses from unsupervised ingestions. 81.3% of the visits included in the study involved children age 5 and under, and over-the-counter medications were implicated in 33.9% of visits. The study concluded that medication overdoses among children, in particular unsupervised ingestions, represent a substantial burden to the emergency department and to the safety of children.

Furthermore, a 2016 study published in Pediatrics entitled “Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment” found that 84.4% of parents made at least 1 dosing error (defined >20% deviation of the dose), and 68% of these errors resulted in overdosing.  Additionally, 21% of parents made at least one large dosing error (defined as >2 times the dose). The study also found that the use of teaspoon-only labels resulted in a greater number of errors than milliliter-only labels, and that cups were associated with greater number of errors than syringes, especially for larger doses.

In light of the need for new efforts to prevent pediatric medication overdoses, the CDC convened healthcare professional societies, public health agencies, poison control centers, patient/consumer advocates, and OTC medication manufacturers to work together towards preventing unintentional medication overdoses in children. This developed into a medication safety program entitled the PROTECT (Preventing Overdoses and Treatment Errors in Children Taskforce) Initiative. The PROTECT Initiative works to redefine dosing measurements for medications, medication packaging, and patient education to reduce medication errors.

In conjunction with the PROTECT initiative, the American Academy of Pediatrics released a policy statement in March 2015 with recommendations to prevent unintentional medication overdoses. Firstly, the AAP recommends that all oral liquid medications be dosed exclusively in the metric-dosing system with milliliters, only abbreviated as “mL”, as to avoid errors associated with common kitchen spoons. It recommends eliminating labeling, instructions, and dosing devices that contain units other than metric units. In addition, dosing devices should not have extraneous measure markings, and dosing devices should not be significantly larger than the dose described in the labeled dosage to avoid errors. Furthermore, the policy statement states that syringes, optimally designed to partner with flow restrictors, are the preferred dosing device for administering oral liquid medications. For pediatricians, the AAP recommends reviewing milliliter-based dosing and incorporating advance counseling strategies, such as drawings and teach-back methods to educate patients and families on proper medication dosing.

In 2011 the FDA published Guidance for Industry which outlined recommendations to the pharmaceutical industry regarding dosage delivery devices for over-the-counter liquid medications. The Guidance recommends that dosage delivery devices should be included for all liquid oral OTC drug products, delivery devices should be marked with units that correspond to any accompanying instructions, and delivery devices should not have extraneous measure markings, and standard abbreviations should be used. However, the FDA guidance does not standardize labels to milliliter-only labeling, therefore allowing for the more inaccurate teaspoon labeling. In addition, the guidance does not address any flow restrictors to prevent unsupervised ingestions. Furthermore, FDA guidance recommendations are non-binding, and therefore it does not establish legally enforceable responsibilities for manufacturers.

H.R. 6259 would amend the Federal Food, Drug, and Cosmetic Act to ensure that liquid over-the-counter medications are packaged with appropriate dosage delivery devices and, in the case of such medications labeled for pediatric use, appropriate flow restrictors. Pediatricians should ask their representatives to support the bill.  In addition, I urge pediatricians to incorporate advance counseling strategies, such as drawings and teach-back methods to educate patients and families on proper medication dosing. Additional information for families can be found at https://www.healthychildren.org/English/safety-prevention/at-home/medication-safety/Pages/The-Healthy-Children-Show-Giving-Liquid-Medicine-Safely.aspx, an educational site for parents sponsored by the AAP. As the PROTECT Initiative demonstrates, we need cooperative efforts to prevent medication overdoses in children.

Stephanie Nguyen, MD

 

  1. “FDA Guidance for Industry [PDF – 14 Pages].” Accessed October 24, 2016. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992.pdf.
  2. “The Healthy Children Show: Giving Liquid Medicine Safely …” Accessed October 24, 2016. https://www.healthychildren.org/English/safety-prevention/at-home/medication-safety/Pages/The-Healthy-Children-Show-Giving-Liquid-Medicine-Safely.aspx.
  3. “H.R.6259 – Protecting Our Kids’ Medicine Act of 2016.” Congress.gov. Accessed October 24, 2016. https://www.congress.gov/bill/114th-congress/house-bill/6259?resultIndex=88.
  4. “Metric Units and the Preferred Dosing of Orally Administered Liquid Medications.” Pediatrics 135, no. 4 (2015): 784-87. doi:10.1542/peds.2015-0072.
  5. “The PROTECT Initiative: Advancing Children’s Medication …” Accessed October 24, 2016. http://www.cdc.gov/medicationsafety/protect/protect_Initiative.html.
  6. Schillie, Sarah F., Nadine Shehab, Karen E. Thomas, and Daniel S. Budnitz. “Medication Overdoses Leading to Emergency Department Visits Among Children.” American Journal of Preventive Medicine 37, no. 3 (2009): 181-87. doi:10.1016/j.amepre.2009.05.018.
  7. Yin, H. S., R. M. Parker, L. M. Sanders, B. P. Dreyer, A. L. Mendelsohn, S. Bailey, D. A. Patel, J. J. Jimenez, K.-Y. A. Kim, K. Jacobson, L. Hedlund, M. C. J. Smith, L. Maness Harris, T. Mcfadden, and M. S. Wolf. “Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment.” Pediatrics 138, no. 4 (2016). doi:10.1542/peds.2016-0357.
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