WEBCAST WRAP UP

In June 2008, PMP News held the second installment in its exclusive Webcast series, Reducing Risk through Packaging, titled “Developing Child-Resistant, Senior-Friendly Compliance Packaging.”

To address some of the technical questions posed during the event, the speakers will be addressing them in this and upcoming columns. If you think of another question, please feel free to submit it to PMP News Editor Daphne Allen at daphne.allen@cancom.com.

To listen to the Webcast, please visit www.devicelink.com/pmpn/compliance.

To what extent is child-resistant packaging required for Clinical Phase II and III clinical trials?

Answered by Daryl J. Madeira, Director of Marketing, Alcan Pharmaceutical Packaging, Contract Packaging, and by PMP News Phase II and III clinical trials need to use child-resistant compliance packaging if products are meant to be used in the household. In 2000, the Consumer Product Safety Commission (CPSC) wrote to PMP News to clarify its position on the packaging of clinical products taken into the home:

“Clinical trial drugs with sufficient toxicity to cause serious injury or illness to a young child (‘toxic’) must be packaged with a child-resistant feature. This can be achieved in one of two ways. The units can be made with any of the features described in ASTM D-3475, provided that the packaging has at least one recognized child-resistant feature.

“To further clarify this option, its purpose is to alleviate the need to conduct tests on the packaging of each different drug that is to be used in clinical trials. Thus, we would generally expect manufacturers who avail themselves of the option to procure packaging from firms who can demonstrate that the package designs to be used with clinical trial drugs have been tested and meet the requirements for child-resistance. The clinical trial package itself, however, would not require testing.”

PMP News checked in with CPSC to confirm that this position is current. It is, and CPSC added that clinical trial packages for any phase must be child resistant if those packages are dispensed by a physician for use in the household.

CPSC offers a guide to child-resistant packaging, listed by manufacturer and type of child resistance per ASTM classifications. The guide can be found at www.cpsc.gov/businfo/pppaguid/crpindex.html.

Child-resistant compliance packaging is also appealing to clinical trial managers because some package designs can help generate outcomes data through improved participant adherence.

Is it imperative to be on board with your child-resistant package at the clinical stage in order for the package to be selected for commercial use?

Answered by Paul Glintenkamp, Director of Pharmaceutical Packaging, Packaging Insights & Carton Service Inc.

It is not imperative. However, it makes it much more difficult to transition to the child-resistant package postlaunch owing to timing, additional package development, testing involved, and additional costs needed to make the transition. The branding of the product is also influenced by the package appearance, so marketing managers are often leery of making product changes too soon after launch that could affect patient perspective.