Poison Prevention Packaging Act Continues to Save Children’s Lives

THE YEAR MARKS THE 50TH ANNIVERSARY of a monumental piece of public health legislation and pharmacy practice laws: the Poison Prevention Packaging Act (PPPA) of 1970.¹

Then-President Richard M. Nixon signed the PPPA into law on December 30, 1970. This statute and the regulations adopted to put it into effect² required use of child-resistant containers for hazardous materials, household chemicals, and OTC and prescription drugs. This piece of legislation has proved highly effective in reducing the incidence of poisonings in children. Although not much has changed over the past 50 years regarding this safety measure, it is a good time for a refresher on exactly what the PPPA means for pharmacy practice.

The entirety of the PPPA is beyond the scope of this article. The expectation for pharmacy practice is that orally administered prescription medications must be dispensed in containers with child-resistant packaging, with rare exceptions.

One key point: Either the patient or the prescriber may request a standard-closure container. There is no legal requirement for documentation of such requests. However, it is in pharmacists’ best interest to have proof in case an issue arises. If a professional liability action ensues as a result of a child ingesting medication from a container lacking a safety cap, a pharmacist should have evidence that a standard closure container requested. It is important to note that patients may sign a blanket waiver requesting that all that their medications be dispensed in nonsafety containers, but a prescriber cannot make such a request. A physician or other practitioner authorized to prescribe must make each request for a nonsafety container individually.

It is key to understand the difference between childproof and child-resistant. The idea behind child-resistant packaging is to delay a child’s access to the contents of the container. These closures are child-resistant, not childproof, as they often are erroneously designated. This is not intended as a way to keep children out of contact with dangerous substances forever but, rather, to buy time to intervene before a child succeeds in opening a package. Anyone who has worked with children knows that the time to investigate their activities is when they are quiet, which can indicate that they are doing something they should not.

For a cap to be deemed child-resistant, it must meet 3 criteria. First, the closure is given to 200 children without a demonstration of how it works. The children have 5 minutes to try to open it. For this group, 85% must be unable to gain access. Next, children who were unsuccessful in opening the container are given a demonstration and an additional 5 minutes with the cap; 80% must be unable to gain access. Last, the closure is given to 100 adults who have 5 minutes to open the closure after reading instructions on how to do so, and 90% of participants must successfully open the bottle. This last standard leads to the situation in which up to 10% of adults cannot open these closures. Pharmacists frequently hear about this challenge from their patients.

Prescription drugs exempt from child-resistant packaging requirements include sublingual dosage forms of nitroglycerin, as well as chewable and sublingual forms of isosorbide dinitrate in strengths of 10 mg or less, because the patient may need unfettered access to the medications. Conjugated estrogen tablets when dispensed in mnemonic packages containing no more than 32 mg of the drug and hormone replacement therapy products that rely solely on the activity of 1 or more estrogen or progestogen substances are exempt, as are numerous others.

The point about having heart medications dispensed in containers with standard, non—child-resistant closures was emphasized by a Reader’s Digest article in the late 1970s. A man found his elderly father, who had had a heart condition and had been prescribed nitroglycerin for angina, deceased in the garden with a brick in his hand. Next to him was his battered medication container with a child-resistant closure. The older man apparently had been using the brick to open the container because he could not remove the cap while in the throes of a heart attack.³

The PPPA not only provides patients an extra level of security by keeping children out of danger but also gives pharmacists the opportunity to discuss proper storage of medications. By understanding and upholding this law, pharmacists will continue to help protect children from a potential hazard.

Payton L. Noble is a PharmD candidate at the University of Kentucky College of Pharmacy in Lexington.Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy.

REFERENCES

• Poison Prevention Packaging Act, 15 USC §1471-1475 (1970). govinfo.gov/content/pkg/CFR-2019-title16-vol2/xml/CFR-2019-title16-vol2-part1700.xml. Accessed April 10, 2020.
• Poison Prevention Packaging Act. 16 CFR §1700-1704 (2012). govinfo.gov/app/details/CFR-2012-title16-vol2/CFR-2012-title16-vol2-part1700. Accessed April 10, 2020.
• CPSC reminds public of exemption to child-resistant packaging regulations. News release. US Consumer Product Safety Commission. August 25, 1976. Accessed April 9, 2020. https://cpsc.gov/Newsroom/News-Releases/1976/CPSC-Reminds-Public-Of-Exemption-To-Child-Resistant-Packaging-Regulations