Child Safe Packaging Group

Packaging For??The Third Age Presented As Part Of Retail Pack98

Date of page: Wed 14 Oct 1998 at 12:51pm

Paper presented at Retailpack 98,

Wednesday 14th October 1998,

as part of Packaging for the 3rd Age -

Stephen Wilkins, The Child-Safe Packaging Group.

A number of special problems become apparent when pharmaceuticals or other potentially hazardous products are packaged. Here in the UK the regulations concerning child resistant packaging originated in 1975 as the "Medicines (Child Safety Regulations)". And after really very little changes during the intervening twenty three years have now emerged as BS EN 28317, the English language version of ISO 8317.

Here in the UK we are obliged to use child resistant packaging only for aspirin and paracetamol although, needless to say, CRC???s are used for many other products.

In addition, although unit dose packaging, namely blister and strip packs, are not tested for child resistance if their use is the packaging of pharmaceuticals, they are subject to testing for other potentially hazardous unit and dose products. This blister pack testing standard is BS EN 862.

Here is a definition of child resistant packaging, it is: " packaging that is designed and constructed to be difficult for young children to open within a reasonable time and that is not difficult for adults to use properly."

Both of the two standards to which I have referred, namely BS EN 28317 and BS EN 862, assess child resistance based upon a sequential test of a panel of children. Because of the complex nature of children???s abilities, child resistant effectiveness is panel tested; thus far the only method of testing that has been accepted by elements of the industry and the International Standards Organisation.

Now both standards set out an adult test to check if the criterion..... is not difficult for adults to use properly, can be complied with.

Sequential test is a test procedure in which individual results are plotted on control charts as they are obtained, and the test stopped as soon as the plot exceeds the prescribed limits.

Both standards set out an adult test, the criterion is that at least 90% of the panel of adults should be able to open the packaging by following the written instructions.

However two disquieting points arise, the first is that in the case of BS EN 862 the adult test is optional and in the case of BS EN 28317 a test for elderly adults is also optional.

The panel composition for the adult test is "The 100 adults, of whom 70 should be female, should be between 18 years and 60 years inclusive and have no obvious physical or mental handicap likely to effect the results of the test and all should be able to read the language used in or on the packaging concerned in the test."

The selection of the panel for the elderly adult test which is totally optional across both standards is as follows; "Select 100 elderly adults of whom 70 are female and are between 60 years and 75 years of age inclusive and have no obvious physical or mental handicap likely to affect the results of the test."

And so the inescapable conclusion has to be that there is very little in the way of design criteria or performance subject to test which will serve to render packaging for pharmaceuticals or potentially hazardous products openable by those people in the third age.

Standards of testing are totally optional and the packaging manufacturer or specifier may be forgiven for avoiding an unnecessary and troublesome cost, namely creating packaging that will pass a barely existent test.

And yet it is the openability or the lack of openability by members of the third age that impact most directly upon the very effectiveness of child resistant packaging.

Members of the third age as a group are the greatest users of pharmaceuticals and they also exhibit the greatest anxiety levels as to the possible consequences of being prevented from gaining access to their medicines.

Now it may be that only a very limited number of drugs are so critical for the well being of the patient that a delay in their ingestion could prove harmful or even uncomfortable. But "Try telling this to the user".

It is for this reason that where a member of the third age cannot, or fears that they cannot, gain access to their drugs they will be tempted to decant them into a convenient container within easy reach. Like a cream jug for example.!

And it is in just such circumstances that a visiting grandchild on a mission of exploration will discover the product and is at greatest danger of potential ingestion.

This is not a fanciful scenario, it has happened and it does happen.

I would suggest therefore that compliance with optional elderly and the optional adult tests, is at least as important as compliance with the mandatory child test when designing or producing child resistant packaging.

But perhaps this whole scenario gives the packaging industry un-looked for opportunities to develop new drug delivery systems specifically for the third age and I have long espoused the slogan "Design for the young and exclude the old but design for the old and include the young."

My organisation, The Child-Safe Packaging Group, last year sponsored a design competition at Manchester Metropolitan University and a number of interesting and workable ideas emerged.

Some of you here may well have seen these concepts because they received substantial coverage in the trade press. However, without apology, here are two of them again.

The first is a blister pack that, to become accessible, needs a light squeezing with an adult hand. An infirm or an elderly hand will do. The only thing that will not work is a child???s hand, because it is too small.

Or secondly here is a complete electronic drugs delivery system designed for the elderly. It is inoperable except at its pre-programmed dispensing time, when it not only dispenses the medication but alerts the user. It is a product designed specifically for those people who are elderly. But because it is inoperative for the vast majority of the time statistically it is child resistant.

These are merely concepts but they demonstrate a route that our industry could go in addressing a potentially serious problem.

There are as many as 30,000 child ingestions each year according to the DTI, our own research suggests 45,000. It is clear that child resistant packaging is necessary but we must never lose sight of the packs openability - if we do, we risk alienating a large segment of our users.

Stephen Wilkins


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