MANUFACTURING |
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Child resistant packaging:
How the next generation
will save lives and produce
added value
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Child resistant (CR) packaging was a product of the 1970s – that consumerist decade where, for the first time, people began to question the supremacy of major organisations and to look seriously at child poisoning in the home due to accidental ingestion of medicines and other products that were potentially harmful.
After development in the United States of America, CR packaging was introduced into the UK market in 1974 and its use enshrined in legislation by the Medicines (Child Safety) Regulations 1975. Those regulations have been continually updated and their latest manifestation is the Medicines (Child Safety) Regulations 2003, which became fully effective in October 2005. The regulations cover products containing aspirin, paracetamol and iron, which of course are the principal active ingredients in the vast majority of painkillers, minor remedies and over-the-counter multivitamins. The distribution of prescription drugs in the UK is covered by practice direction from the Royal Pharmaceutical Society of Great Britain. This direction, embodied in the Society’s annual publication Medicines, Ethics & Practice, a guide for pharmacists, calls for the use of child resistant packaging in all but the least common and most tightly controlled circumstances.
How is child resistance achieved?
Early researchers discovered that children below the age of five generally were unable to undertake two actions simultaneously. From this research emerged the “push down & turn” and “squeeze & turn” child resistant closures. Particularly though, the push down & turn product invoked the ergonomic concept of the false affordance. Everything we see gives us an affordance, in other words an indication as to how it might work; as we go through life our ability to recognise these signs or affordances increases with experience, but at five years of age a child only knows that caps can be unscrewed or pulled off, never pushed down. It is simply beyond their comprehension.
It was also discovered that a child under five could not follow a simple algorithm; step one and then step two, and thus the “line up the arrows” product emerged and, in the United States of America where flexible packs, for example strip and blister, were subject to CR legislation. The “peel back and push through” system are now common in both the United States and the European Union.
To achieve the certification as child resistant, packs are tested to various British, European and International standards. The current standards throughout the European Union are BS EN ISO 8317:2004 for reclosable products, BS EN 14375 for non-reclosable medicine packs and BS EN 862 for non-reclosable packs for all products other than medicines. The standards employ a broadly similar type testing procedure, which consists of a child test and an adult test. The child test utilises a panel of up to 200 children, though Bayesian sequential testing is used where packs can pass or fail with as few as thirty children or five children respectively. The child test involves two five minute periods on either side of a silent demonstration and for the product to pass 80% of the sample must fail to open the pack after the demonstration. The adult test involves a panel of 100 adults aged 50 to 70 and 90% of the panel, after familiarisation, must be able to open the pack, extract one unit and reclose it within one minute, or in the case of a non-reclosable extract one unit within one minute.
Undoubtedly the system has been shown to work and over the last thirty years child ingestions have reduced substantially and child fatalities from accidental poisoning have become an absolute rarity. From time to time dissenting voices are raised and the raison d’etre of CR packaging is questioned. Occasionally these take the form of silly comments, for example “children can open them but adults can’t” or more reasonable complaints of potential over packaging or “a problem in search of a solution”.
CR packaging though has become a way of life throughout the European Union and the question that now emerges is: how do we maximise upon this now accepted superior form of packaging?
Giving added value
There are a number of factors that still trouble the pharmaceutical packaging industry, and apply to some other consumer products in varying degrees. These factors are compliance, openability and anti-counterfeiting. Openability or the want thereof can be regarded as an ongoing area of concern, not only for the pharmaceutical packaging industry but also for pack design generally. The classic examples, vacuum packed bacon and inexpensive biscuits, are most obvious but medicines, which defy attempts to allow access, are potentially dangerous on two counts. Firstly the obvious for chronic invalids; but of equal importance the probability of adults, particularly elderly ones who fear they will not be able to access their medicines, decanting those medicines into non-child resistant containers.
Lack of compliance is a major problem for the pharmaceutical industry and numerous statistics are bandied around, suggesting that the cost throughout the European Union of non-compliance runs into billions of Euros. There are a number of reasons for non-compliance, the most common being simple forgetfulness closely followed by diminution of symptoms. In many cases, particularly during treatment by antibiotics, this lack of compliance exacerbates the condition under treatment by selecting for antibiotic resistant bacteria. Symptoms return and the patient simply does not recover.
Defeating anti-counterfeiting is a similarly important task for the pharmaceutical packaging industry. The trade in counterfeit medicines is reported to be as lucrative as the equally illegal trade in prohibited drugs and clearly this trade is extremely attractive to those involved in organised crime. The pharmaceutical packaging industry has developed numerous anti-counterfeiting devices, some based around RFID (Radio Frequency Identification Devices) some around holograms and some around multidimensional barcodes, which enable track and trace to be achieved, not just of the packaging but of contents as well, thus overcoming the criticism often levelled at anti-counterfeit packaging that it, “only protects the cardboard”.
How can child resistant packaging help achieve anti-counterfeiting, compliance and other measures?
On its own child resistant packaging is just that, child resistant. But because the vast majority of child resistant packaging systems require either a midline intervention, for example blister packs with a non-burst label over the foil, or a two or more stage manufacturing process, for example push down & turn child resistant closures, the manufacturing or packaging process is already configured to allow for the insertion of RFID tags, security papers, layered security inks or other track and trace mechanisms for anti-counterfeit systems.
The incorporation of aids to compliance is a similar task. Midline applied labels facilitate the inclusion of variable compliance regimes on blister packs, and revolving ratchets on CRCs can easily be incorporated to aid compliance. More complex compliance aids including recording systems and audio reminders may be incorporated into multi piece CRCs and blister pack wallets, particularly novel child resistant packaging systems. These are blister packs, which are integrally attached to child resistant retail packs and can of course be manufactured with built-in compliance aids.
What of the standards and regulations, together of course with regulatory impact?
The early part of this decade saw the introduction of two new standards and a new statutory instrument in the United Kingdom with similar legislation in other EU countries. By 2008 we can expect a new raft of regulations covering child resistant packaging requirements for potentially hazardous non-medicine products, and at around the same time we can expect new or revised standards for CR packs. Already BSI and other members of the Comite Europeen de Normalisation (CEN) are formulating a standard for the mechanical testing of child resistant packaging and a new BSI committee and several CEN committees have been established to formulate standards for ease of opening for packaging, not only pharmaceutical but for all consumer products.
An introduction of standardised mechanical testing will not, in this author’s opinion, reduce the need for or the incidence of panel testing using panels of children and adults. There has long been a belief that it was unethical to test panels of children lest they be taught, during testing, how child resistant packaging is opened. Again in the opinion of this author, this belief is unfounded. During testing children do not learn how CR packaging is opened; in addition the standards contain strict constraints on forms of words to be used to members of the child panels and strict exhortations not to open such packaging in the future. Furthermore, no ingestions have been observed amongst children who have been tested and the age range of panel children is a clear six months older than the maximum danger age for ingestions.
The next raft of standard will, in all probability, incorporate a more onerous adult test for torque dependent closures; this will ensure that push down & turn torque dependent closures remain child resistant for second and subsequent use. It will be achieved by subjecting closures that have been opened and reclosed by the adult sample to further testing by children. In summation, child resistant packaging remains highly standardised, highly regulated and well able to continue to provide new and real value to its customers and users.
Stephen Wilkins
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Stephen Wilkins was educated at Blackrock College, Dublin and The University of Durham Business School where he obtained a Masters Degree in Business Administration. He is a Chartered Scientist and an elected member of the Institute of Packaging and a Fellow of the Royal Society of Arts.
He was appointed Chief Executive of the Child-Safe Packaging Group upon its formation in 1995 and has driven its activities since then. The Child-Safe Packaging Group has been responsible for the design and development of numerous new child resistant packaging designs, both flexible and rigid packs. Stephen Wilkins advises manufacturers on the development of CR packaging, on the need for that packaging and in more general terms he advises clients on strategic marketing issues, usually associated with packaging and its semiotics.
In addition he acts for a number of other clients in the UK, undertaking marketing communications consultancy and parliamentary liaison.
