The Poison Prevention Packaging Act turns 50 next year.  What have we learned?

The Poison Prevention Packaging Act turns 50 next year. What have we learned?

The Poison Prevention Packaging Act turns 50 next year in 2020.

For those not familiar here is a synopsis from www.CPSC.gov

Enacted in 1970, the PPPA, requires a number of household substances to be packaged in child-resistant packaging. The packaging required by the PPPA 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. For the sake of the elderly and handicapped who might have difficulty opening such containers, the Act provides that a regulated product available for purchase on store shelves may be packaged in one non-complying size provided it carries a warning that it is not recommended for use in households with children, and provided that the product is also supplied in complying popular size packages. Regulated prescription drugs may be dispensed in non-child-resistant packaging upon the specific request of the prescribing doctor or the patient. Since the regulation has been in effect, there have been remarkable declines in reported deaths from ingestions by children of toxic household products including medications.

Full details can be found under: www.ecfr.gov Title 16 CFR parts 1700 through 1702

It’s hard to imagine all the good the PPPA has done. The countless lives saved or at least adverse events prevented. At a time when packaging was purely about storage, get the product from point A to point B,  this legislation aimed to do more. Make it functional, protect the innocent from their own actions when those who should be protecting them do not.

There are a lot of good ideas in the Act and the results over the decades are a testament to those who worked for its enactment and signing into law by President Richard Nixon. While there have been modifications along the way there are opportunities for improvement that could ensure the law continues to do good and even reaches beyond the intent of the original Act. I’ll highlight two here.

Maybe the most glaring omission from the Act is the fact that it ignores real use scenarios for packages. What happens in the home? Now, the Child Resistant testing protocol does consider real use in a sense because it requires the demonstration of opening methods to children to see whether witnessing the action is enough to enable them to gain access. I’ve never cared for this demonstration but I understand it. Kids will see their parents accessing their medications and could conceivably learn how to open a container. OK, reasonable but along the way we are teaching hundreds and thousands of kids about opening containers in these testing protocols. I’m not sure about the risk reward balance in that scenario.

So, we’ve considered the  unintentional in-home demonstration in the testing protocol but have ignored the fact that containers are all too often not properly resealed. This means that CR closure or not,  kids have access to a complete container because the Act does not consider poor practices by the user.

So why point this out? Well, other safety devices do account for poor practices by the user. Your car has seatbelt warning alarms in case you forget to buckle up, your car can brake itself in case you are too busy texting to notice the stopped vehicle in front of you ( I can’t wait for autonomous vehicles) , your car can keep itself in the proper lane IF YOU ARE TOO BUSY TEXTING to see me motioning wildly for you to stay in your lane ! (I really can’t wait for autonomous vehicles)   With this in mind maybe your pharmaceutical container should warn you if it is not properly sealed. Not only would this be safer for children but it would be safer for the drugs since it would protect them from moisture and oxygen and prevent product degradation but that is a different story.

Thanks to the PPPA and its distinction between bottles and blisters there is a class of packaging , the F-1 blister pack, that acts like automatic brakes in this scenario. No action required by the user. No forgetting to reclose the container and every dose protected for that matter.

The second point I want to mention is the Senior Friendly testing protocol. The intention behind this makes absolute sense. CR features cannot be so complex or ingenious as to prevent adults from gaining access to the package (in theory, see the Peel-Push blister found harboring most cold medicines with scissors near by). So, part A makes sense but . . . . the protocol specifically excludes any seniors with obvious impairments (physical or other) from testing. What ??? It excludes the very people from the testing protocol who are likely to have the most problems gaining access to a CR container. This to me makes no sense and I know of some packaging companies that agree. One specific package comes to mind that was designed to hold a drug to treat Rheumatoid Arthritis. Imagine this package with your run of the mill F-1 CR feature. It is a non-starter. This drug company obviously had the sense to include their target patient in their own design testing. Thank goodness.

You could argue that these examples go beyond the intent of the Act which is of course child safety but I believe the PPPA needs to be modernized based on what we’ve learned.  CPSC has periodically added additional chemicals and drugs to the list of products covered why not address the real in-home use of containers. The Act as it stands is a wonderful piece of legislation that still serves the people well today but it can be better and I hope we can work to improve it as we close in on the 50th anniversary of its’ adoption.

What do you think?

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