Child Resistant, Senior Friendly: Is Your Blister Packaging Serving All Needs?

Pharmaceutical products are typically formulated for medicinal purposes. In the wrong hands — especially those of children — certain prescription and over-the-counter (OTC) medications and dietary supplements meant for healing could be harmful.

Therefore, protective packaging is imperative. The United States took action several decades ago by passing the Poison Prevention Packaging Act (PPPA) into law in 1972. Under this legislation, child-resistant packaging must be “designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly.”¹

The PPPA definition may sound vague, but the stringent testing and requirements behind it shed light on the law’s specificity.

The Fundamentals of Child Resistant Packaging

Panel testing is essential in deeming packaging as child-resistant. In simple terms, packaging is tested for openability by a panel of children under 5 years of age. To pass, 80% of the children must not be able to access the pharmaceutical product in amounts that could cause accidental poisoning.

Ideally, the children wouldn’t be able to open the packaging altogether but, realistically, it could happen. This is where failure values (or, F values) come into play.

Failure values correlate to the number of individual doses of the pharmaceutical product that would be toxic to a 25-pound child. An F1 value means 1 dose contains dangerous toxicity levels, an F3 value means 3 doses could imperil a child, and so on.

If a child can access the dosage defined by the F value in under 10 minutes, the packaging fails the child-resistance standard.² In the United States, there is a “greater than 8” default for packaging that doesn’t carry an F value of 7 or below. In this scenario, packaging failure occurs if a child accesses nine doses of the pharmaceutical product.²

All things considered, logic seems to dictate that using the strongest materials available aligns with constructing child-resistant packaging. However, strong materials could limit proper use by normal adults — another part of the PPPA mandate.

Don’t Ignore Senior-Friendliness

Of adult users, the senior population is particularly impacted by pharmaceutical packaging that is difficult to open. Solutions that bridge the gap between child-resistance and senior-friendliness rely on sophisticated opening structures rather than the brute strength of materials.

Panel testing is also required to determine whether child-resistant packaging meets senior-friendly requirements. If 90% of testing participants (ages 50-70) can open and reclose packaging within a given time period, the construction is deemed both child-resistant and senior-friendly.2

Packaging Innovations in Child Resistant Blister Packaging

One such sophisticated child-resistant blister packaging innovation that also incorporates senior-friendliness is Amcor’s PushSmart™ lidding. Micro-perforated and labeled “Release Zones” enable push-through access and easy capsule release for seniors, but block release using any other push motion:

Lidding materials play an important role in advancing peel-push and tear-open blister packaging solutions that keep children safe and seniors proactive in adhering to medication dosing protocols. So does the relationship with your pharma packaging partner.

Find out how Amcor is leaning into child-resistant packaging and other advanced solutions in our guide, Exploring Pharmaceutical Blister Packaging Opening Features. Click the button below to download your copy.

SOURCES
¹Drug Plastics, A Guide To Child-Resistant Packaging | Drug Plastics & Glass, July 16, 2021
²Packaging 360, Child-Resistant Packaging in Pharmaceuticals [white paper], June 2020