UK child resistance legislation needs attention, says CSPG
non-recloseable pharmaceutical packaging such as blister packs
contains a serious flaw that must be addressed, according to
Stephen Wilkins, secretary of the UK's Child Safe Packaging Group.
While the overall basis of the new legislation is sound, one problematic element is that it contains what is essentially a positive list of materials that are acceptable for use in child resistant packaging. Put simply, if a manufacturer manufactures a pack using only certified materials, it will get accreditation for its product, regardless of how it is constructed.
"In fact, different designs can have a dramatic impact on the effectiveness of child-resistant packaging," Wilkins told the TOTAL 2004 exhibition in Birmingham, UK, last week. He was responding to a question from the floor from a representative of a company specialising in the manufacture of foil-based products for packaging applications, who expressed his own discomfort at the regulation.
The new legislation is the Medicines (Child Safety) Regulations 2003, which came into effect last October and holds that child resistant packs should be accredited according to two standards - BS 8404 and ISO 8317. Both standards use panels of children to test for child resistance and panels of adults to test for openability. The legislation initially affects products containing paracetamol, aspirin and iron (24mg or over).
"I do have an objection that design is excluded [from the new legislation]," said Wilkins, who noted that the CSPG will orchestrate a lobbying process in the UK Parliament to address the flaws in this approach.
He told In-Pharmatechnologist.com that the legislation holds that materials passing Germany's standard - DIN 55 559 - will be accepted under the new UK legislation, which is due to come into full force by October 2005.
While the German standard and legislation has a lot of positive factors that should be included in the UK and European Union regulations - for example it has adopted a US-style concept which alters the pass or fail threshold of a product depending on the toxicity of the drug involved - accepting DIN 55 559 accreditation is an imperfect control, said Wilkins.
He noted that the EU is talking about drawing up new legislation that will be based on BS 8404 but also include the toxicity variable included in DIN 55 559 and current requirements in the US.
But is the drug industry doing enough to tackle the issue of child safety? Yes, noted Wilkins, but they are constrained by the fluidity of the legal requirements and the fundamental difficulty in designing a child-resistant pack - particularly for a recloseable - that is also openable by its intended user who may be old or incapacitated.
The CSPG has commissioned a number of new package designs that try to improve the design of pharmaceutical packs, and is offering the intellectual property behind them free to any organisation interested in developing them. He presented a few examples at TOTAL, including a blister that can only be opened by squeezing the pack with an adult-sized hand.
Looking at what is available to date, he pointed to the peel back and push system for blisters, which has been used for many years in the US (although blisters as a rule are not as widely used as in the EU). The Vicks Nyquil liquid caps pack is a good example of this design, he said. The peel back laminate is unburstable, two actions are required and the result is a pack that cannot be torn to destruction by a child and cannot be opened save in the two steps required.
Another recent advance is the Pill Protect system, which was launched in the UK about a year ago as a development of the 'peel and push through' system. This pack has been certified as child resistant under BS 8404.
Other recent advances from the US are based on the concept of a recloseable pack that is child resistant and contains the blister within it. These include Meadwestvaco's Surepak and Dosepak technologies, as well as the BlisterLok, a plastic blister container developed by Dragon Plastics of Pontypridd in Wales.
Wilkins said that these products are interesting but at the moment are too expensive to be widely adopted. They were originally designed for use in clinical trials, he noted.
"Clearly, it is desirable for the whole industry to have harmonised standards and to manufacture to the highest world standard. In that way products can be marketed worldwide without repackaging," he said.
The pharmaceutical industry and others have taken 'tremendous steps' over the past 12 months to produce acceptable, user-friendly openable and workable child resistant flexible packs, he added.
