Child Safe Packaging Group

Chicago Speech Prompts Response

Date of page: Thu 24 Jun 1999 at 12:37pm

Stephen Wilkins??? presentation to the United States Closure Manufacturers Association, at their conference in Chicago in September 1999, caused quite a stir. The USA Plastics News magazine wrote two articles which sum up how surprised the USA packaging industry is at the UK???s ???resistance??? to Child resistant packaging for pharmaceuticals

Child Resistant Closures In The United Kingdom
For The Closure Manufacturers Association


Ladies and Gentlemen Good Morning.

Firstly let me say what an honour and a privilege it is to address you here in Chicago this morning.

As your chairman said when he introduced me I am the Secretary of the Child-Safe Packaging Group in the UK. Secretary is one of those peculiar British words you know and it can have a multitude of meanings.

Some would argue that in my case it means chief bottle washer! Or even lord high everything else. But it is true to say that over the past four and a half years I have project managed and driven every initiative that has been undertaken by the Child-Safe Packaging Group.


This group represents the greater part of the supply industry for reclosable child resistant packaging in the UK, most of them closure manufacturers. You can see on the screen that our membership is truly impressive.

I would like to start now by giving you some background into child resistant packaging in the UK, perhaps draw some distinctions between the way we have tackled the subject and way that you have done so here in the United States. I will then go on to tell you how this group was formed and its initial and continuing objectives, and then I will finish by saying what we have achieved, where we are now and what we have yet to achieve in our mission to promote child resistant packaging solutions wherever the packaged product could cause distress to a child if they, either ingest it or come into contact with it in some other way.

CR Packaging

In the UK

In the UK our decade of consumerism occurred somewhat later than yours; perhaps we did not have a Ralph Nader to drive it?

But it can be fairly said that the 1970???s saw the greater part of the UK???s consumer legislation being enacted. Amongst this plethora of regulation was the 1975 Medicines (Child Safety) regulations. Initially these regulations were applicable only to childrens Aspirin and Paracetamol. Although subsequently increased to include adult versions of these drugs, Aspirin and Paracetamol remained the only products where child resistant packaging is legally required.

Its use elsewhere arises solely as a piece of self-regulation by either the pharmaceutical industry, the Royal Pharmaceutical Society or other manufacturers or retailers.

The move to child resistant packaging gave rise to products which you will find familiar ???

Push down & turn CRC???s

Double walled squeeze & turn closures

Single walled squeeze & turn closures

Jigger cap CRC???s

And Line up the arrow systems

The regulations were drafted by a committee of physicians, pharmacists and pharmaceutical manufacturers but sad to say not one packaging designer or engineer. And it is probably for this reason that the anomaly of blister and strip packs first came into being and has continued to this day.

Keep in mind blister and strip packs were fairly rare in the UK back in the early 1970???s. However the regulations initially said, and I quote, "Blister packs should be constructed from materials with a view to making them child resistant."

Over the intervening years between the mid 70???s and late 90???s this rather woolly specification grew into the dictum, again quoting, "Blister packs may be considered to be inherently child resistant".

The ascription of inherently child resistant was first given to blister packs by the National Pharmaceutical Association in the UK and based upon work undertaken by H.M. Wiseman et al (1987) and an extrapolation of Wiseman???s work published by the Proprietary Association of Great Britain (PAGB) also in 1987. Interestingly it was the PAGB that sponsored Wiseman???s study, and, to explain, the Proprietary Association of Great Britain is the industry group representing manufacturers of over the counter medicines and preparations in the United Kingdom. It just could be that the 1987 research was self-serving for its sponsor. However I must stress ??? it just could be.

Now remember these were not peel and push or any other system requiring, for example, an element of understanding or cognisance, they were simple push through PVC and foil blister packs.

In 1995 the UK Government, in response to EU directive 92/27EEC concerning patient information, launched what it termed the Patient Pack Initiative. Part of this project included the dispensing of prescription drugs ex-factory in quantities of fixed numbers of daily doses.

Pharmacists would no longer count out tablets or capsules, but manufacturers would pack ready for dispensing. As well as constraining the physicians authority to dispense in the exact number that he or she considered proper, this directive acted consciously or unconsciously to promote the use of blister packs, the majority of which, because they were manufactured solely from PVC and alu foil were essentially a less good non-child resistant product, and enjoyed a cost advantage over child resistant closures and reclosable containers.

It was then that the founder members of this group decided they had better do something.

It was not just a case of loss of market share; it was more than that. When you work for twenty years designing, manufacturing, perfecting, improving and re-engineering a product, it gets somewhat disheartening when a competitor system can take away market share, not because it is better, not because it is as good but cheaper, but purely because it has for years enjoyed an incorrect ascription, in this case inherent child resistance ascribed to blister packs.

Our group was fairly quick off the mark. We commissioned a batch of standard PVC and foil blisters filled with placebos and we subjected them to child panel testing; commonly used here in the United States. We used the US protocol because simply we did not have one in the UK.

As some of you will know child panel testing uses the stepped approach where a pack can fail after a relatively short number of trials but needs to go the whole course to succeed. And you will see on the screen how quickly the UK blisters failed. I have to say that if we were launching this sort of product here in the United States we would have looked pretty grim indeed.

However these results were good news for us, we had always believed that blister packs were not child resistant here at last was proof.

We ???shouted the message from the housetops???. But I know that you will not be surprised here today when I tell you that the Department of Health in the UK and many from the official information disseminating secretariats of the UK pharmaceutical industry were less than impressed. In fact you might argue that they were considerably underwhelmed.

The two secretariats to which I refer where the Association of the British Pharmaceutical Industry; the ABPI which deals the prescribed pharmaceuticals, and the Proprietary Association of Great Britain (PAGB) which I have already mentioned, which deals with over the counter medicines.

These two organisations have been established for many years, keep in mind they do represent our most successful, and one of our senior manufacturing industries in the UK. And they responded to our organisation???s announcements by saying that we were "Self serving, self centred and almost Luddite??" in trying to promote old technology to the detriment of everybody not least the user.

You will laugh when I set out the dicta that were fired at us. You will laugh because they would have been exceptionally amusing ??? if indeed we were not speaking about so serious a topic. Here are a few modest examples;
"Using child panels to test for child resistance creates a learning effect and teaches children how to open CRC???s." We countered this one on the basis that panel testing was undertaken by children aged 42 to 51 months when they were on the down curve of the ingestion danger sector. We knew from our research, backed up by research undertaken by the Department of Trade and Industry that ingestions peak at 36 months.

But in the UK we have now only one authorised test house, Burford Research Laboratories, based in Berkshire, near to London, and through the last ten years since mid 1980 all child panel testing had been undertaken within that area, surely were there any learning effect it would have shown itself up in that area of Berkshire near to London. But of course no local peaks or outliers of ingestion have been observed.
The next comment was that using child resistant packaging induced an element of apathy or over security in parents. One of our opponents waxed lyrical on this and conjured up images of children playing with medicine bottles handed out to them by indulgent parents in the belief that the children were quite safe because the medicines were packed using a child resistant closure.

The Department of Health in the UK was resentfully silent and declined to get involved in the issue. This has been true with both administrations, Conservative and Labour.

Our organisation???s major impediment was that we were perceived to be a self centred industry organisation and so to dispel that charge, which incidentally was not true; but if it was so what! We decided to sponsor a child resistant blister pack. As a result of our tremendous publicity effort in 1995 and early 1996 my telephone rang one February day.

It was Dr James Robertson, a paediatrician from Arrowe Park Hospital, Merseyside. Arrowe Park is a General Hospital serving a population of some 400,000, and James Robertson was a staff grade paediatrician, pretty senior but just below consultant.

He said to me "Look I am calling you because I am fed up with treating child ingestions and I have designed a child resistant closure. Let me come and show it to you and you can tell me what you think."

Sadly it was not workable, never mind commercially acceptable. But I said to James "design for us a child resistant blister." Thinking that he would go away. But a week later he was back again?? "I???ve done it."

What he had produced was a blister which allowed access only in a predetermined order, it thus produced a cogniscent barrier to opening, and within the terms of the United States protocol, was probably child resistant whilst at the same time presented no problems of opening, even those who were elderly or handicapped.

And let me now set out a definition of child resistance, it is;

Packaging that is difficult for children to open within a reasonable period but represents no difficulty for adults to use properly.

Let me immediately distinguish between child resistant packaging and child proof packaging; nothing is child proof and child resistant packaging never claims to be proof against opening by children.

The measure of testing is tightly defined, for example the child resistant reclosable pack must undergo panel testing by children and adults, and at least 85% of the children must be unable to open the pack within five minutes and at least 80% must fail to open the container within five minutes following a non-verbal demonstration. For adults at least 90% must be able to open and properly close the containers.

The above has been abstracted from ISO 8317 (1993).

Until 1997 there was no UK standard for non-reclosables, there is one now, BS EN 862 or ISO 97 862, from which the pharmaceutical industry has excluded itself, and there within 862 the timings are three minutes prior to demonstration and three minutes after demonstration. In all a less rigorous test, and a level playing field.

By backing James Robertson???s invention, even though it looked Heath Robinson at the time to say the very least, the Child-Safe Packaging Group was able to turn its critics very much on their heads. You will see on the screen various bits of press comment. But all of a sudden we were not a self-centred industry group, but a caring watchdog, you will forgive of course the British tabloideeze!!!

In May 1997 we had a change of Government in the UK, Tony Blair???s administration came in in a blaze of glory and with a mandate to do pretty much as it pleased.

One of the first things to get axed at the Department of Health was the Patient Pack Initiative. Whatever your political viewpoint this deserved to go anyway, it was a piece of garbage can decision making, in other words "we do not need to make a decision but lets make one anyway.."

By this stage the pharmaceutical industry though was committed to patient packs it had made a large capital investment, and early last year, 1998, it announced that it was going to proceed with unit dose dispensing.

Now the Child-Safe Packaging Group???s objectives, as I have said had always been to create a level playing field of testing for child resistance across all forms of packaging for pharmaceuticals and other potentially hazardous products be they reclosable or non-reclosable. And we were nearing a breakthrough.

Firstly the non-reclosables that we had sponsored had been picked up by SmithKline Beecham, and discussions with them and other members of ???big pharma??? indicated that the UK and European industry was conscious of the lack of child resistance of existing blisters and keen to improve its non-reclosable packaging.

We had involved SmithKline Beecham because when the Child-Safe Packaging Group first sponsored the design of James Robertson???s child resistant blister, we formed the view that we could not just issue a couple of press releases saying how good this design was and that we were sponsoring its patent application. We had to go all the way and act almost as though we were launching our own new product, in direct competition if you will, with our existing products.

Frequent and substantial lobbying is still failing to move the UK???s Department of Health.

I???ve stood on many platforms at numerous of events, The Institute of Packaging, PIRA and Retailpack in London together with provincial platforms throughout the UK.

We have achieved breakthroughs. The first one came about in the form of BS EN 862 or ISO 97 862 as I have already mentioned, the standard, the main points of which you will see on the screen, dealing with child panel testing for the effectiveness of blister packs. But blister packs from which the pharmaceutical industry had excluded itself.

The next breakthrough came in the form of a Department of Trade and industry, the DTI, initiative. That department, under the new labour administration sought to limit the incidents of packaging related accidents, which it put at 67,000 in the last year of record.

As a matter of fact the number was considerably higher because again pharmaceuticals were excluded. In fact almost 100,000 hospital admissions occur in the UK through accidents related to packaging. More than a third of those involving medicines.

The total figure for ingestions of medicines by children is, based upon research by our organisation, around 45,000.

So what have we achieved in the Child-Safe Packaging Group in the four years since we set up in 1995. Well no organisation can create so many column centimetres in the trade and professional press and not make something of a name for itself.

Initially we were perceived as merely a self centered pressure group. Then something of a ???caring watchdog???. But now we have become a marketing organisation to promote the concept of child resistance in packaging for products potentially hazardous to children.

But the term hazardous is sometimes open to debate, so our objective is to "promote the specification, consideration and success of child resistant packaging for all products where ingestion or other contact could prove seriously distressing to a child."

We have, since formation, been recruiting new members but most recently we have been joined a by HSD, a toolmaker in South Wales which has designed three brand new child resistant closures. One is produced specifically for narrow bore tubes, it takes CRC technology into new market areas.

Whilst moving into new market segments can I mention one of our founder members Dragon Plastics whose DropaloK, an award winner in 1996, moved child resistant packaging solutions into the aromatherapy industry. But then, by market demand, back into pharmaceuticals where a major ???big pharma??? organisation in UK has requested prototypes for trials.

Sonoco Capseals, a multinational and UK market leader, liner manufacturer has also joined us.

And finally PAGO, the blister pack manufacturer that picked up James Robertson???s idea from SmithKline Beecham, has joined the Child-Safe Packaging Group because, PAGO like us, believes in the future of child resistant packaging for all products not intended for children.

We have debated with packaging specifiers from some of the major UK supermarket groups, and those groups are increasingly specifying CRC???s for toiletries and household products. Examples are mouthwashes, which can have a high alcoholic content, and bleach, which although only 5% sodium hyperchlorite, will still cause a child who ingests it serious distress.

Bleach, as an example, is one that I will always remember. On being challenged by a member of the chemicals lobby in the UK; who asserted that bleach was ???Quite harmless???, I was able to respond with authority from the publication Paediatric Toxicology ??? a professional journal, but sadly I did not then have with me a bottle of bleach that I could ask my chemical???s friend to drink just to demonstrate how harmless it really was.

And so as I address you now I can say that in the UK and, by inference, throughout the European Union, we, as an industry, as a small segment of the total pharmaceutical, toiletries and household products industries, have been successful in advancing the cause of child resistance in packaging for products that could cause children severe distress if ingested.

But our greatest success has come about through pointing the way for our customer, not just ???big pharma???, but the major supermarket groups in the UK, to choose suitable child resistant packaging solutions. And by demonstrating that competitive advantage can be achieved through the use of such products.

And so to come to the conclusion. The anomaly of wrongly ascribed child resistance that had existed in the UK for twenty years, from 1975 to 1995, was tackled that year by the Child-Safe Packaging Group which effectively took on the Department of Health and a large proportion of ???big pharma??? in the UK.

Whilst nobody has changed the law nobody has admitted that an incorrect ascription had been accorded to non-reclosables, we nonetheless have made real progress because we have taken child resistant packaging OUT OF THE MEDICINE CUPBOARD AND INTO THE MARKET.

And if I can leave you with one thought as a result of this perhaps overlong series of remarks, it is that ???when you have a product that is good, that is truly good, and that is better than its competitors, then even if you are a ???David taking on Goliath??? you will win.

And we in the UK are succeeding because government departments and industry organisations will not, for long, countenance incorrect ascriptions to products like child resistance to blister packs.

And whilstever we are prepared to pick up our products, to run with those products, to improve those products and to take them into new market areas, then our traditional market area, ???big pharma??? in the UK, will not allow itself to be far behind.

It will not specify packaging less good for its high value merchandise than the supermarkets use for their own brand toiletries and household products.

And so our objectives are being achieved and are being shown to be achievable because the Child-Safe Packaging Group is showing the way to competitive advantage through use of superior packaging and it is broadening its own member base to promote the concept of CR packaging. We are widening our market share and we are delivering competitive advantage to our customers. And in that was I believe we are overcoming more than twenty years of bureaucratic incorrect ascription.

Stephen Wilkins

Thursday, June 24, 1999
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