Pharmaceutical and Medical Packaging News
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Originally Published October 1999
REGULATORY FOCUS
Policy for Clinical Trial Packaging Takes Shape
CPSC allows latitude on some aspects of clinical trial packaging.
After more than a year of controversy, industry and regulators appear closer to an agreement on the issue of child-resistant packaging for clinical trial drugs.
Both regulators from the Consumer Product Safety Commission (CPSC) and industry representatives left an August 18 meeting optimistic that there can be a way to make child resistant the drug packages that clinical trial subjects take into their homes without overburdening industry.
"There has been a lot of education taking place on both sides," says Frank Tiano, vice president and general manager of PCI Clinical Services (Philadelphia) and a member of the Clinical Interest Group that industry has formed.
Last year, CPSC announced that regulations requiring child-resistant packaging for prescription drugs also apply to clinical trial drugs brought into the home. Many in industry had been unaware of the policy and therefore were not in compliance with it.
The extent of clinical trial drug–related poisonings is not known, but the potential for problems is the same as with other toxic drugs in the home, says Laura Noble, CPSC's compliance officer. When drug poisonings are reported to poison control centers, there is no mention of whether the drug was from a clinical trial, so there are no data beyond anecdotal evidence on the subject, she says. As a result, while the issue cannot be characterized as an epidemic, it cannot be dismissed either.
Industry was concerned that subjecting clinical trial drug packages to the same child-resistant/senior-friendly tests that marketed drug packages are subjected to might escalate clinical trial costs and stifle innovation.
On May 18, both sides met to try to devise a solution.
Subsequent to that meeting, on June 21, Noble issued a letter offering options not normally available under the Poison Prevention Packaging Act for clinical trial drug packages.
First, clinical trial packages would not have to undergo child-resistant/senior-friendly testing; they would only need to carry a child-resistant feature described in ASTM D 3475. That document lists general descriptions (e.g., peel and push) and does not specify specific materials or designs.
"There may be technical problems" in developing such packages, Tiano says, "but are they insurmountable? I don't think so."
If using a child-resistant feature described in ASTM D 3475 was not feasible, the letter stated, child resistance could be addressed with an outer container that meets the standards of 16 CFR 1700.15.
Noble also noted that child-resistant packaging is not required if the amount of active ingredient brought home is not toxic enough to cause injury or illness to a small child, but data demonstrating this condition must be kept on file with the sponsor company.
The letter stated that the options would apply to Phase II and Phase III trials, but the agency is reevaluating whether to include Phase IV.
Industry asked for another meeting to clarify the letter, and that was the purpose of the August 18 session.
One issue that came up at the session was a request from industry that the policy include provisions from existing law that allow child-resistant packaging not to be used if a physician dispenses the drug directly or if the patient gives his or her informed consent when requesting non-child-resistant packaging.
CPSC agreed to those provisions, but an appropriate way to implement them still must be devised.
"If a physician does a blanket waiver to direct the whole trial not to be child resistant, we need to make sure the physician is aware of what that entails, especially the liability," Noble says. "And for the patient, it has to be a meaningful choice. If it's a blanket waiver buried in the study that says you can only be in the trial if you agree not to have child-resistant packaging, that's not meaningful. The choice is best addressed on a patient-by-patient basis."
A system seems to be coming into place, but several issues remain unresolved, like how to offer child-resistant and non-child-resistant options without compromising the blindness and integrity of the study. Industry interest groups are to discuss ways to accomplish these seemingly contradictory tasks and report back to CPSC.
"We don't promote any particular packaging type," Noble says. "We will let the interest groups come tell us what packages fit their needs."
Another issue is when to start enforcing the policy, and what to do about trials that begin before the enforcement but continue during it. The industry interest groups will write a letter to CPSC requesting that those trials be exempted and suggesting a timeline, and those applications will be considered by the agency, Noble says.
Once these issues are resolved, CPSC would like to put together a fact sheet explaining the policy, Noble says.
