Originally Published PMPN
January 2004
Letters
Blister Use Hampered by ProtocolDear Editor:
I am writing in response to the letter from John Bitner published in the December 2003 issue of Pharmaceutical & Medical Packaging News. I take issue with Bitner’s comments that “Blister use is not deterred by [CPSC’s child-resistant test] protocol” and with his insinuation that the Healthcare Compliance Packaging Council (HCPC) is merely trying to “increase revenue” for its members by petitioning the U.S. Consumer Product Safety Commission (CPSC).
First of all, the HCPC’s sole motivation for filing the petition is to remove an unnecessary barrier to greater use of unit-dose packaging in the United States. This barrier is CPSC’s subjective pass/fail criteria that applies only to unit-dose formats. It has often been cited as the primary reason why so few prescription drugs in the United States are distributed by manufacturers in unit-dose formats, despite the fact that these formats are routinely used throughout the rest of the world for the exact same products.
Numerous packaging professionals have told the HCPC over the years that unit-dose formats are rarely used in the United States because manufacturers fear that CPSC might remove product from the market if the manufacturer fails to comply with protocol provisions that, to them, are confusing, vague, and subjective.
Packaging experts from a wide variety of pharmaceutical companies reiterated these concerns as recently as October 13, 2003, during a conference on packaging, storage, and distribution held in Washington, DC. One packaging executive spoke for many during the conference when he said, “The worst words I have ever heard are ‘marketing wants it in a blister.’ “
In addition, as many of your readers likely know, pharmaceutical manufacturers have no child-resistant packaging responsibilities when they distribute product in bulk containers. This is due to legal requirements that the child-resistant feature(s) be on “immediate” packaging (i.e., the package that comes into direct contact with the product and is intended to go into a consumer’s home). Since pharmaceuticals shipped in bulk containers must be repackaged in the pharmacy, child-resistant requirements fall on pharmacy personnel. But the manufacturer inherits child-resistance responsibility and compliance with vague CPSC requirements if drug product does not require pharmacy repackaging.
The HCPC posits that greater use of unit-dose formats as manufacturers’ original packaging offers a host of benefits, some of which were pointed out by Pfizer in comments filed with CPSC last summer. Specifically, Pfizer wrote that unit-dose formats
offer: 1) increased patient compliance with pharmaceutical regimens; 2) decreased opportunities for medication errors and cross-contamination; 3) better product stability; and 4) counterfeit deterrence. Indeed, the deadly consequences of pharmacy repackaging errors and counterfeit drugs to people of all ages have been page-one news throughout the country in recent months.
And, when it comes to protecting small children, many of the physicians, poison control center operators, and other health officials who wrote to CPSC last summer lauded the child-resistance benefits of unit-dose formats, even though they took issue with our proposed change to the protocol. The director of Maryland’s Poison Control Center, for example, wrote, “Blister packaging works! I advocate [use of] blister packaging for any pharmaceutical product that can cause serious personal injury or serious illness to a child.”
But a number of these comments also noted, as Bitner pointed out in his letter, that some drugs can kill or seriously injure a small child if he or she ingests even one dosage unit. In response to these concerns, the HCPC sent correspondence to CPSC on October 27, 2003, in which we asked the commission to consider requirements that F1 blisters (i.e., the package fails if children gain access to even a single dosage unit during protocol review) be used with drugs that are especially lethal to small children. We also offered to work with CPSC if the commission determines that a numerical pass/fail standard should be more stringent than the one we originally requested.
Simply stated, it has never been HCPC’s intent to put small children at risk by making it somehow “easier” for unit-dose formats to pass protocol. Instead, our efforts seek to encourage, not require, the replacement of bulk containers that have no required child-resistant feature whatsoever and must be repackaged in the pharmacy with unit-dose formats as manufacturers’ original packaging.
In closing, I also take exception to Bitner’s comments regarding use of small children during protocol testing and to his claim that “The protocol has earned the right to stand as is.”
While Bitner contends that “The best preventive measure for our children may well be their participation in protocol testing,” the HCPC counters that poison prevention is best accomplished by limiting the abilities of small children to access toxic amounts of any product. Adults must be constantly reminded, therefore, to keep harmful substances out of reach of small children. Child-resistant features that require proper resecuring every time the package is used should be avoided whenever possible. The HCPC also maintains that children can be hurt during protocol testing, and there is the possibility that kids might act out protocol scenarios under unsupervised conditions. In short, the HCPC asserts that small children should only be subjected to protocol testing when absolutely necessary, and they should certainly not be used to test packages that have already passed protocol.
Moreover, even though child-resistant packaging does help prevent accidental poisonings, Bitner’s claim that the protocol should not be altered is questionable. According to the American Association of Poison Control Centers, for instance, more than a half-million children (543,764) under the age of six suffered poison exposures involving pharmaceutical products in the United States during 2002 alone. The number of childhood fatalities due to ingestion of all harmful household substances has more than doubled over the past 20 years (climbing from 10 deaths in 1983 to 23 deaths in 2002). These data by themselves contradict Bitner’s assertions and suggest that changes to the U.S. view of what constitutes “child-resistant” packaging are very much in order.
Peter Mayberry
Executive Director
The Healthcare Compliance
Packaging Council
The editors welcome other opinions on CPSC’s child-resistant packaging testing protocol and on HCPC’s proposed revision.
Please send letters to editor Daphne Allen via fax at 310/445-4269 or via e-mail at daphne.allen@cancom.com.
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