It's probably impossible to make it through pharmacy school without hearing about the Poison Packaging and Prevention Act (PPPA) of 1970; it is a staple of the MPJE and landmark legislation that impacts not only pharmacies but a range of industries.
We also hear a lot about the long list of products that are exempt from PPPA and can either be dispensed in an easy cap (like nitroglycerin) or dispensed without further packaging (like birth control).
Unfortunately, in all of this though, we never really are taught what child resistant packaging means, so in case you haven't guessed it yet that is the subject of today's post.
Why is it important?
Because too often we assume it means a 'child can't get into it,' or 'it's safe in the home.'
Certainly PPPA has made medicines (and other household items, like cleaning agents) safer in the home and reduced childhood poisoning, but unfortunately every year there are still more than 60,000 visits to the ER for poisoning. While some of these might be attributable to parents not sealing the bottle or moving the medicine to a package that is not child-resistant, many of these children are poisoned from approved child resistant packaging.
The point is, the packaging is designed to supplement, not replace, safe practices for storing medications around children.
Medicine vials and everything else that falls under the PPPA are regulated by the Consumer Product Safety Commission. The requirements for child resistant packaging are found in the Code of Federal Regulations, Part 1700:
"(1) Child-resistant effectiveness of not less than 85 percent without a demonstration and not less than 80 percent after a demonstration of the proper means of opening such special packaging. In the case of unit packaging, child-resistant effectiveness of not less than 80 percent."
And in the section on how manufacturers are required to test their packaging we get more details. Here are some highlights:
1. Ages of the children:
30% are 42-44 months old
40% 45-48 months old
30% are 49-51 months old
2. Number of children tested: 50 in the first panel; if further testing is required, additional groups of children are tested, up to a total of 200 children.
3. Time frame:
Step 1: In the first 5 minutes, the kids are given the package to try to open themselves.
Step 2: If they aren't able to open it after 5 minutes, the demonstrator says "Watch me open my package," demonstrates how to open the package, and hands it back to the child. They are then given another 5 minutes (for a total of 10 minutes) to try to open the package.
This table from the eCFR shows the pass and fail rates. It also shows the rates that require further testing (i.e. getting another panel of 50 kids together to test them):
I like to think about these numbers in the opposite way than the way the legislation was written: 20% of children tested (40/200) could open the package within 10 minutes and it would still be approved for use.
Why is that? Because you also have to balance child-resistance with the ability for adults, including those with arthritis and other conditions, to be able to open the vial. In fact, testing the packaging for the ability of senior adults to open it is also a requirement of the PPPA. It is specified clearly in the packaging standards:
"(2) Ease of adult opening—(i) Senior-adult test. Except for products specified in paragraph (b)(2)(ii) of this section, special packaging shall have a senior adult use effectiveness (SAUE) of not less than 90% for the senior-adult panel test of §1700.20(a)(3)."
Thankfully, the Up and Away campaign is working to educate both parents and children on household medication safety. There is plenty of info on their website and even a coloring book for kids. When we teach pharmacy students how to counsel patients on proper medicine storage, we focus on temperature and humidity, but should also be focusing on medication safety in the home, so Up and Away is a great website to introduce students to on rotation or even in labs.
Keywords: PPPA, Poison Packaging and Prevention Act, child resistant
