/publications/issue/2007/2007-05/2007-05-6518

Child-resistant Does Not Mean Childproof

Author: Michael J. Gaunt, PharmD

In 2005, media in Minneapolis, Minn, reported a tragic story about a 15-month-old child who died after ingesting the contents of a bottle that contained a compounded liquid formulation of flecainide. The child had a congenital heart defect, which required her parents to administer 3 doses of the medication each day. Because she occasionally required an extra dose to control acute episodes of tachycardia, her parents carried the medication in the child's diaper bag. At a friend's home, the mother sat the child on the floor next to the diaper bag while she ran into the kitchen to get a bottle of milk from the refrigerator. In that short amount of time, her child was able to remove the cap from the bottle and drink the medication. The child was rushed to the hospital but could not be saved.

The parents were shocked at how easily the 15-month-old child was able to remove the child-resistant cap and were surprised that they were never warned of the severe risks of this medication at any time during her treatment. They shared their story with local media after viewing a news investigation that alerted parents to how easily a group of children between the ages of 3 and 8 years old could open the various child-resistant containers from a sampling of area pharmacies. Despite the variation of bottles and vials with accompanying child-resistant caps, all appeared to meet federal standards outlined in the Poison Prevention Packaging Act (PPPA).

The PPPA was established in the early 1970s in response to the number of unintentional poisoning deaths among young children. This act gives the US Consumer Product Safety Commission the authority to require child-resistant packaging on oral prescription medications as well as many household products. A child-resistant package is defined as one that is designed to be significantly difficult for children under 5 years of age to open or obtain a harmful amount of the contents within a reasonable time and not difficult for normal adults to use properly. To be child-resistant, 85% of tested children less than 5 years old must not be able to open the package within 5 minutes (this means 15% of children can open the package quickly), and 90% of tested adults must be able to open and properly close the package within 5 minutes. Although this packaging has significantly decreased the number of unintentional poisoning deaths among children under 5 years old, poison centers across the nation received more than 1.3 million calls in 2003 about unintentional exposures. Over 40% of these calls were related to pharmaceutical ingestions by young children.

Safe Practice Recommendations

Consider the following to help protect children from accidental poisonings:

•Remind patients that all prescription and OTC medications, as well as vitamins, herbals, and household products, are potentially dangerous to children and should be kept out of their reach and sight

•Alert parents, grandparents, and caregivers that medications stored in non-child-resistant vials, pillboxes, or weekly pill planners must not be accessible to children. More than one third of all childhood ingestions involve a grandparent's medication.

•If non-child-resistant caps are requested, explain or provide a leaflet that explains the risk of accidental poisonings and what preventive steps should be taken to safeguard medications. Promote the use of child-resistant caps, especially for those who have children that live with or visit them.

•Demonstrate the proper method to open and close the child-resistant container to those who find it difficult, before resorting to non-child-resistant caps

•Periodically query patients with blanket requests for non-child-resistant closures to verify that they understand the consequences if children access these medications

•Ensure that child-resistant packaging used at your pharmacy meets current standards by requesting child-resistant packaging test data from the prescription vial manufacturer or supplier

•Do not mix vials and closures from different manufacturers because they may not function properly together

•Utilize additional resources that are available at:www.poisonprevention.org and www.cpsc.gov.

Dr. Gaunt is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/Ambulatory Care Edition.

Subscribe to Newsletter

Pharmacy Times and the Institute for Safe Medication Practices (ISMP) would like to make community pharmacy practitioners aware of a publication that is available.

The ISMP Medication Safety Alert! Community/ Ambulatory Care Edition is a monthly compilation of medication-related incidents, error-prevention recommendations, news, and editorial content designed to inform and alert community pharmacy practitioners to potentially hazardous situations that may affect patient safety. Individual subscription prices are $48 per year for 12 monthly issues. Discounts are available for organizations with multiple pharmacy sites. This newsletter is delivered electronically. For more information, contact ISMP at 215-947-7797, or send an e-mail message to community@ismp.org.