Child resistant packaging: a success that still requires EU Harmonisation

Stephen Wilkins

Wilkins and Wilkins Company Ltd

In its World Report on Child Injury Prevention, published in 2008 The World Health Organization (WHO) said. “Child resistant packaging is one of the best-documented successes in preventing the unintentional poisoning of children.”1 Data were cited for a number of affluent nations, in England and Wales for example, according to the WHO, unintentional poisoning deaths amongst children under 10 years of age, fell from 151 per 100,000 in 1968 to 23 per 100,000 in 2000.2 In the same report the WHO said that medicinal drugs were the leading cause of non fatal poisoning in children in middle and high income countries and in the USA: “Prescription medicines were more commonly implicated than over the counter drugs.”3

For manufacturers of child resistant (CR) packaging in the UK this is good news, but it is disturbing that very many prescription drugs here still do not enjoy the protection of child resistant packaging. It is worth investigating how this situation has come about. In the early 1970s when the child resistant pack first appeared in this country its statutory use was confined to products containing aspirin and paracetamol, the active ingredient in just about every over- the-counter medicine, its use for prescription medicines was covered by practice direction of the Royal Pharmaceutical Society of Great Britain (RPSGB). In practice this meant that generally prescription medicines were dispensed in CR packs.4

However RPSGB made some exceptions in its practice direction, principal amongst these was the exclusion of unit dose packed products, for example medicines packed in blister packs. In the early 1970s when this direction was first formulated blister packs or original pack dispensing (OPD) packs were uncommon but the converse is true today and now more than 50% of prescription drugs are dispensed in easy open blister packs and represent a real danger of child poisoning.

 

“…medicinal drugs were the leading cause of non fatal poisoning in children in middle and high income countries and in the USA.”

 

This is bad enough, but progress has been made towards developing inexpensive and effective child resistant blister packs, and there is a European standard (EN 14375) against which to test them.

It is true that, for blister packs, there is disagreement as to the definition of an opening. How many units need to be extracted before the pack is considered to be open? In the United States every medicine is accorded a ‘toxicity value’ so for some, a pack is considered open when one unit is extracted, whilst for others up to nine tablets need to be accessed before the pack is regarded as open.

Here in the EU we don’t have a common regulation for medicine packaging as we do for non-medicinal chemicals ( EC 1272/2008).5 Therefore, whilst the standard setters have defined an opening for blister packs in EN14375(6) as ‘more than eight units’ the industry has developed products that exceed that standard terming them F8, F7, F6 etc. down to F0.6

As a packaging system for medicines and a range of other products the blister pack is excellent, it incorporates a perfect seal preventing contact either with the atmosphere or other products and permits dispensing with no risk of contamination at the retail level. Thus far though, big pharma in the EU has only toyed with CR blisters and EU manufactured prescription drugs for the US market are often dispensed in containers with traditional CR closures.

Clearly the UK design industry needs to tackle the problem of creating a truly effective CR blister pack in which the pharmaceutical industry can have confidence, both for its child resistance and its ease of opening by adults.

Meanwhile and for the foreseeable future we have the trusted bottle and CR closure, this true success story is manufactured throughout the EU, it is inexpensive and very effective. Referred to as reclosable child resistant packaging CR containers comply with an international standard (ISO8317: 2003) and this tests their resistance to child opening and their ease of opening by adults. Children, 80% of a panel aged 42-51 months, must be unable to open the pack in ten minutes, even after a demonstration, and 90% of a panel of 50-70 year old adults have to open and properly re close the pack in one minute.6

 

“Clearly the UK design industry needs to tackle the problem of creating a truly effective CR blister pack in which the pharmaceutical industry can have confidence…”

 

Ill informed individuals have from time to time quipped that CR packs are so difficult for the elderly to open that grandparents have to ask grandchildren to open their medicines for them. This is simply untrue.

Recently Global Closure Systems a member of the Child-Safe Packaging Group, the trade association for EU CR pack manufacturers commissioned a case study. This subjected its closure to an adult open ability test far more stringent than required by ISO 8317. A panel of 100 adults aged 60-80 was assembled, 25 of them suffered from serious mental or physical handicaps. They were all asked to open and reclose, in one minute, a CR pack being a push and turn CRC and glass bottle. And, amazingly they all did. Quickest time to open and close was 2 seconds, slowest 58 seconds and the mean 8 seconds.

On reflection the reason for this performance became obvious. Even though CR closures incorporate a built-in impediment to opening by children, to adults they incorporate basic rules of ergonomy. Obvious how and easy to do.

So, the packaging industry, the plastics industry have the products, there are standards to which we can adhere or which can be exceeded and CR packs are recognized lifesavers. In these circumstances it is inconceivable that their use is not mandatory for all medicines.

References:

1. World Report On Child Injury Prevention ed.Margie Peden et al. World Health Organization 2008

2. Child resistant packaging saves lives. US Consumer Product Safety Commission (CPSC Document No. 5019)

3. Burt A et al. Nonfatal, unintentional medication exposures among young children: United States, 2001-2003. Morbidity and Mortality Weekly Report 2006, 55:1-5.

4. Paediatric Toxicology. Bates et al. Macmillan Reference 1997.

5. Regulation EC 1272/2008 Classification labeling and packaging of substances and mixtures.

6. ISO 8317 &amp, EN 14375 both 2003. BSI London.

7. CPSC requires child-resistant packaging for common household products containing hydrocarbons, including some baby oils. US Consumer Products Safety Commission.

About the author:

Stephen Wilkins is a Chartered Scientist and a Fellow of both the Institute of Materials Minerals and Mining and 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, in 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 is a director of Davies Development and Testing Limited, a laboratory, accredited by UKAS, to undertake testing of child resistant packaging under various European and International standards. He also acts for clients in the UK in other disciplines, where he delivers marketing communications consultancy and parliamentary liaison. Stephen Wilkins will be speaking at the upcoming Pharma Packaging and Labelling Compliance Conference.

Why is child resistant packaging not mandatory for all medicines?