Child-resistant packaging: the next step towards safety

24 January 2018



Richard Quelch, head of marketing at Origin Pharma Packaging, discusses child-resistant packaging and how to prevent incidences of medical poisoning.


As physicians become more reliant on prescribing medications to treat illness, instead of advocating preventive measures, the risks associated with accidental medication poisoning are increasing. In the UK, approximately 50% of the population take prescription medicine, with the figure reaching more than 60% in the US. These figures provide an insight into the volume of medicines in circulation and, with this, the potential risk to children. In the US, poison centres treat 60,000–70,000 children each year for accidental ingestion.

Advancements in packaging technology, including soluble packs and films, undoubtedly show progression, but it is questionable if a parallel effort is being made to create child-resistant packaging, which ensures that medicinal products are safe for every environment. Mercola found that pain medications are the most frequent cause of fatalities from accidental medication poisonings in children – but household products still produce an alarming number of ingestion cases. In medical terms, the category of substances with the largest number of deaths across all ages – including the intentional use of opioids in teens – are medications containing acetaminophen, sedatives, sleeping medications, stimulants and cardiovascular drugs. For household products, the most common issue lies with soluble-packed alkaline detergents.

There is an abundance of creative solutions available to the industry, and the accessibility of online information enables manufacturers to also appraise themselves with consumer and regulatory concerns – and safety is no exception. However, there may be a lack of understanding about what constitutes child-resistant packaging, and a readiness to await regulatory changes before introducing protective measures.

One question Origin Pharma Packaging hears is whether the effectiveness of conventional child-resistant packaging is appropriate enough. Some companies will feel strongly that it is, but one could query whether the combined impact of freedom of information, intelligence of today’s children and the tragic increase in cases of diminished responsibility is being effectively measured.

Non-medicinal packaging

Origin’s experience spans more than 50 years and has revolved around medicinal packaging and drug delivery devices; however, there is perhaps a sharper increase in casualties from non-medical products.

The advancement of soluble packaging is an example of a welcomed and convenient technological development, but Origin believes that it has been delivered with an apparent disregard for potential harm to children; for example, soluble dishwasher tablets contain aggressive and corrosive alkaline salts. The ingestion of these products is becoming a common occurrence but, apart from warnings printed on the box, there is no physical barrier in place to protect children. It is important to acknowledge that these often-colourful capsules are attractive to young children. One should consider the number of homes in which these are accessible to children and how many people have actually read the product information.

Unlike medicines, there are virtually no defined regulations to control the packaging of household products; guidance notes on the packs emphasise environmental impact, but fall short on promoting child safety values. If this situation continues, little is likely to change on a commercial scale to develop packaging that reduces risks. Without apportioning the burden unfairly, should the industry and parents really wait for regulations to be imposed? Regulation supports good practice and will no doubt adopt changes one day; in the meantime, Origin wonders if society’s moral and ethical obligations are being fairly considered.

Child resistant is not child-proof

Terminology for child safety is an important issue to consider because packaging is rarely ever child-proof. The balance between child resistance and senior accessibility restricts how far the industry can safeguard children – and the senior-friendly challenge is an interminable debate. Accommodating protection and accessibility aspects in packaging designs for pharmaceutical products is a significant challenge, as is regulating such a conflicting scope.

In many ways, the senior accessibility aspect is less definable than child resistance. In child-safe testing, there are prescribed parameters for the abilities of children aged between 3.5 years to just over four years old. On the other hand, the scope of abilities for an adult test panel of 50 to 70-year-olds presents a hugely different picture.

The loss of dexterity and, in some cases, coordination is often diminished in a person’s later years. The key principles required in achieving effective child resistance are, by definition, the same principles needed to aid the elderly. As the UK’s ageing population is also increasing, and advances in medicine are allowing people to retain their independence for longer, questions could be raised as to whether 70 is still a relevant top-end age for the testing protocol.

Child resistance should, according to the International Organization for Standardization (ISO) 8404 for non-reclosable packages, be considered the last line of defence – not the first. Whatever packaging is developed to meet needs of children and seniors, it should be remembered that child resistant is not child-proof; therefore, the practice of keeping medicines out of sight – and reach – of children should be mandatory.

There is no doubt that papers on child psychology exist that substantiate this issue, but the fact is that, for all the industry’s experience, it still tends to underestimate the innocent, inquisitive nature of children. A campaign launched by the Netherlands Food and Consumer Product Safety Authority (NVWA), entitled ‘Children See Things Differently’, gave a simplistic view of how things appear to young children and created thought-provoking questions about what considerations should be made when incorporating safety into packaging; the bright colours that are used for retail marketing and shelf impact actually entice young children.

Storing harmful substances

The storage of medicines and other harmful substances requires a responsible approach. Child resistance is the last line of defence, but surely the most effective way to ensure that children do not access harmful products is to stop them seeing household or medical products in the first place?

Misusing opioid substitutes has been the greatest cause of pharmacy-dispensed child medicine ingestions that have led to fatalities in the UK. It is important to recognise that these tragic instances have rarely proved to be the result of non-compliant packaging. A report from Alder Hey Children's NHS Foundation Trust in Liverpool found that out of 30 methadone ingestion cases 22 involved reclosable screw cap bottles, and two of these were found to be original and child resistant. This evidence sadly proves that compliant packaging cannot be expected to provide necessary protections if medicine is transferred to non-child-resistant packaging.

Police investigations have proved that these breaches tend to be the outcome of diminished responsibility on behalf of an adult. One simple measure that could be enforced, in Origin’s opinion, is to educate patients who use medication that these products must be stored in the container they were supplied in.

Regulations and testing

Origin has effective and well-recognised regulations for the safe containment of medicines. The necessity of a common test protocol has long been considered essential for these products; reclosable packaging to the British, European and International Standards (BS EN ISO) 8317 and its US equivalent, 16 Code of Federal Regulations (CFR) 1700.20 are still effective, and the 2015 version of the ISO standard has cleared up some areas of confusion.

To gain approval, the complete pack must be tested – container and closure. While many pharmaceutical containers are produced with child-resistant closures, it cannot be assumed that one pack combination will pass testing because another previously has.

In the UK, testing is carried out at United Kingdom Accreditation Service-approved test centres in accordance with test protocol. Marginal differences apply between the European and US procedures, but, in Origin’s opinion, there is no meaningful difference between the two, except the resecuring aspect of the US 16 CFR 1700.20 test.

Some test centres provide an expedited pre-application test service that provides a smaller test panel for a lower cost, which Origin can advise on. Test conditions are regulated by a protocol and the results are helpful for ascertaining whether there are any fundamental issues in a pack’s design. If there appear to be no issues, full protocol testing can be scheduled quickly. A further benefit from preliminary testing is that Origin is able to ‘weight’ the test panel to include more or less of a certain age bracket, in order to create robust test conditions.

The official test protocol requires 200 able-bodied children between 3.5 years to just over four years old, and can be carried out either with the full group or via sequential testing. For the adult test, a panel of 100 is required, comprising individuals aged 50–70 years.

Compliance

With its vast experience in child-safe packaging, Origin knows that there are an increasing number of packs in circulation that cannot be considered to be child resistant; as expected, a number of these are imported. Research suggests that caps with push-and-turn mechanisms are often presumed to be child resistant; however, this is not a wise assumption.

Origin suggests that it should be common practice to ask a supplier for a technical file and certificate of child resistance for packaging. While there may be no such thing as a ‘child-resistant cap’, companies are advised to request a certificate of testing that specifies child resistance for the container and cap.

If a product is sold in the UK and EU, a BS EN ISO 8317 certificate is the correct document to have. For the US, businesses will need the 16 CFR 1700.20 certificate to comply with stateside regulations.

The company ensures that children are kept away from dangerous products.
Origin creates packaging that protects children, while being accessible for older users.


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