Fatal Flaw: Child Resistant Packaging—Well Worth the Risk
In the healthcare packaging industry, packaging design and testing for Child Resistance/Senior Friendly (CR/SF) is a niche business. Few people or organizations fully understand all the requirements needed to achieve a safe and cost-effective package for their pharmaceutical products.
There tends to be a lack of accurate information for clients to make informed decisions about their CR needs. For instance, they may go to a contract packager, a testing facility, a materials supplier, and a machine manufacturer and get differing facts from each about what is required. This leads to two major issues. First, packaging that is over engineered for CR, which results in a much higher cost of goods than necessary. And second, packaging that lacks the necessary CR to be safe and compliant. This results in putting lives in danger, and companies at financial and legal risk. It is important to realize that to design, develop, test, and manage a successful CR/SF package program comes at a modest cost, but it is considerably less than the cost of ignoring this requirement.
Child resistance packaging regulation in the United States falls under the Consumer Product Safety Commission (CPSC), specifically their Poison Prevention Packaging Act. This act was instated in 1970 to protect children from the accidental consumption of chemicals and prescription medications. At the time, pediatricians considered poisoning—from both medications and household chemicals—as the leading cause of injury and death in children under the age of five. Following the creation of this Act, the United States saw a dramatic drop in child fatalities associated with poisoning incidents. Today, the CPSC can (and does) take action—such as recalling a product or pulling it off the market—if a poisoning incident is caused due to inadequate packaging. However, CR testing it is still a choice that is in the hands of the pharmaceutical company. Therefore, some companies debate … is the risk or reward greater? After 25 years in the industry, I can tell you confidently that the potential risk is far greater than the reward or savings one might experience by not completing a CRSF protocol of their package prior to going to market.
During this time, the industry has come a long way, but I would be remiss if I didn’t admit that it is still a constant struggle to educate the market and ensure full understanding of CR testing. Every single package is different, and CR testing is in place to protect children. But what companies don’t always realize is that it is done to also protect the companies selling the product.
When it comes to specific CR testing, this can be a confusing area where it may be common to cut corners. The CPSC requires that testing for compliance be done by a CPSC accepted accredited laboratory. Each package should be tested in this format. It is not acceptable to rely on previous testing data from similar packages. If you follow their protocol and there is an issue, you will be in a much better position both legally and financially.
From a testing perspective, the CPSC follow the Federal Hazardous Substances Act (FHSA) Title 16, which will indicate an F (or failure) rating. The F rating is equal to the dosage amount required to cause harm. For example, if one (1) pill is sufficient to cause a child harm, the F rating for the product would be F1.
To maximize your chances of passing CR testing, you must start at the design level. It can’t be an afterthought, or something you address at a later date. I would go so far as to say that if you are in the healthcare industry, one of your very first considerations should be CR requirements and packaging. Package design is critical and working with a design engineer who truly understands CR is just as important.
At the end of the day, companies may save time and even money by skipping CR package testing. But I think we can all agree that a child’s safety is not worth the risk or gamble. CR testing is a minor inconvenience for the rewards it reaps … including safety, but also the financial and legal implications companies might face should something go terribly wrong. Over the years, I’ve learned a lot and still find CR testing fascinating. My recommendation to pharmaceutical companies is to find an expert consultant or company who specializes in CR/SF packaging and testing, and you will reap the rewards.