In 1970, Richard Nixon signed into law the Poison Prevention Packaging Act (PPPA). The act was written in response to a growing number of child poisonings from unintentional ingestion of drugs and other products. The Act was successful, but a lot has changed in the last 47 years.
Back in 1970, as today, the dominant containers for pharmaceuticals in the U.S. were the bottle and vial. As the law was being written and child resistance (CR) being defined, two drastically different containers had to be regulated – the bottle, with hundreds of years of consumer experience, and the blister, having only come into the U.S. market in 1960, driven by a need for a specific dosing regimen required by a new drug for birth control.
Back then, Congress addressed this different package in protocol testing but that doesn’t tell the whole story. In a controlled environment, CR caps provide designed protection but in practice, caps are not properly resealed and access to a large number of doses is too easily realized. Perhaps we should revisit the section of the protocol that brought us to the current situation.
PPPA 1700.20 (a) Test Protocol (2) Child Test (ii)
A test failure shall be any child who opens the special packaging or gains access to its contents. In the case of unit packaging, however, a test failure shall be any child who opens or gains access to the number of individual units which constitute the amount that may produce serious personal injury or serious illness, or a child who opens or gains access to more than 8 individual units, whichever number is lower, during the full 10 minutes of testing. … The determination of the amount of a substance that may produce serious personal injury or serious illness shall be based on a 25-pound (11.4 kg) child. Manufacturers or packagers intending to use unit packaging for a substance requiring special packaging are requested to submit such toxicological data to the Commission’s Office of Compliance.1
Defining the toxicity of drugs so we can determine what is safe, with limited access makes sense. If we consider that a cap failure provides access to the entire container, regardless of toxicity, then this arbitrary designation of eight units or an amount that may produce serious injury should be applied equally to bottles but, it is not. This special circumstance applies only to unit dose packaging and resulted in unintended consequences for many years following the release of the act. No basic blister or lidding material would prevent access, especially under the test protocol, where demonstrations are given to children on opening the container.
The industry responded by building a better mouse trap. Today there are dozens of well-designed blister packs that meet F-1, the highest CR rating. Why shoot for F-1 instead of just passing the eight unit hurdle? Because of the toxicity question. To allow greater access means a manufacturer has to define the toxicity of their product to a 25-pound child, and not surprisingly this is not an attractive option. If you presented this same hurdle to CR cap closures we probably would see quite a different cap today. There is ample evidence to support that blister packages, even without CR features, are inherently safer than bottles simply because they do not allow access to the entire contents of the container with one opening motion, no one needs to properly reclose them after each use and a child needs to repeatedly push out doses in order to access a harmful dose. In test protocol, with conditions defined by PPPA 47 years ago, the cap wins and we have our current situation.
Since the act, however, the in-home use of potentially harmful pharmaceuticals has risen dramatically and child exposure has increased. But, evidence cited by the Centers for Disease Control & Prevention is clear that the switch to unit dose assisted in reducing the emergency room visit rate for children.2
The premise for the 1970 PPPA was excellent and should be protected: to keep children safe from pharmaceuticals and harmful products in the home. The testing protocol ignores the realities of the use environment. Bottles closures not properly sealed are no safer than if the medicine was placed in a bowl. The PPPA needs to be revisited with an eye toward the 47 years of experience gained and the realities of practical in home use of CR closures. A modernization of the act will increase safety for our children.