Gunn & Richards, Inc.
We recently received a call from pharmacist who was concerned about the vials her pharmacy was using. She felt the vial was not child-resistant because her 7-year-old son was able to open it. As we explained to her, child-resistant does not mean child-proof. This point was driven home again when last week, MSNBC had a report raising alarm that a group of Kindergartners were able to open child-resistant bottles. Both of these illustrate that there is much confusion over the concept of child-resistance.
What is Child-Resistant?
The Poison Prevention Packaging Act (PPPA) of 1970 authorizes the Consumer Product Safety Commission (CPSC) to issue requirements that certain household substances including prescriptions be sold in child-resistant packaging. In July 1995, the Commission amended its requirements under the PPPA to change the way packaging is tested with adults and children.
The CPSC testing requires 50 to 200 children between the ages of 42 and 51 months be given bottles and told to open them. After five minutes, the children are given a demonstration on how to open the bottle, told they can use their teeth and are given five more minutes to try. To pass the test, 85 percent of the children must not be able to open the closures before the demonstration, and 80 percent of the children must not be able to open them after the demonstration.
This means that a package can be child-resistant even with up to 20 percent of the children ages 3 ½ to 4 years of age able to open it. Once a child is over age four, the percent able to open it increases rapidly. It should not be surprising to know that most Kindergartners can open child-resistant packaging.
Child-Resistant but not Adult-Resistant
Why don’t manufacturers just make packages harder to open so children simply can’t open them? Unfortunately, there is a fine line between a package a child cannot open yet a senior still can. For this reason the CPSC also recommends testing products with senior adults. For the test, 100 adults ages 50 to 70-years-old are given five minutes to open and properly re-close a child-resistant package, and then given one additional minute to repeat with an identical package. For the product to pass, 90 percent of the adults must be able to open the package and properly re-secure it.
Today’s packaging manufacturers struggle to find a balance between a package a child cannot open and one that grandma can.
No Kids? Still a Danger
Despite the availability of child-resistant caps, there are people who request non-child-resistant caps on their prescriptions. Many prefer the ease of use of these caps and assume that if they don’t have children in their home, it is safe to skip using the child-resistant version but is that true?
A study conducted by the American Association of Poison Control Centers found that 23 percent of the oral prescription drugs that were ingested by children under five belonged to someone who did not live with the child, and 17 percent belonged to a grandparent or great-grandparent. This reminds us that even in homes where no children live, there is a chance of poisoning.
More than the Cap
There is also a debate about the use of colored prescription vials in green, red, or blue instead of the traditional amber. Some pharmacies want to use a different colored vials to help distinguish themselves from competitors however many feel this is not a safe choice. Traditionally, prescription vials have been amber because it most effectively protects the medication from degradation by UV light (a USP requirement) while still seeing its contents but also because amber vials have come to signify medication. Some believe that use of colored vials makes the package more appealing to children and can increase their curiosity of its contents.
Tips for Pharmacists
There is no arguing that the use of child-resistant packaging has reduced the number of child poisonings. However, we must realize that a child-resistant closure is the last line of defense. Here are some tips that pharmacists can do to help:
• Even the best child-resistant closure is of no use if it is not properly used. Ensure customers know how to properly secure their vials after opening.
• Educate customers that child-resistant does not mean child-proof. Medications should be stored in a secured location outside a child’s reach.
• Remind parents to be sure any purses that contain medication are kept out of the reach of children at all times.
• Encourage parents to discuss medication safety with their children.
• For customers that request non-child-resistant closures, verify they fully understand their decision.
Based in Lenexa, Kansas, Gunn & Richards has been selling prescription packaging supplies directly to America’s pharmacies for over 25 years.