Modern pharmaceutical packaging needs to prevent children from accidentally ingesting medicines, but without becoming too difficult for the elderly to use. We review some current trends in child-resistant and senior-friendly packaging, and highlight some of the latest innovative designs to hit the market.
What is child-resistant packaging?
Child-resistant packaging (CRP) is designed to prevent young children from ingesting products that could be harmful or toxic. It is intended to be significantly difficult for children under five to open. At the same time, CRP still has to be easy for adults, particularly seniors, to use.
According to the World Health Organization, CRP is one of the best-documented successes in preventing child poisoning. Medicinal drugs are the leading cause of non-fatal poisoning in children in middle- and high-income countries.
CRP is a fast-growing area of the packaging industry. Recently, Research N Reports analysts forecast that the global CRP market would grow at a CAGR of +7.4% over the next 5 years. Although CRP is used in personal care and other industries, most of that growth is due to developments in pharmaceutical packaging.
An important point to remember about CRP is that ‘child-resistant’ does not mean ‘child-proof’. All medicines should still be stored out of children’s sight and reach, however they are packaged. CRP is intended only as the last line of defence should a child get hold of the packaging.
Testing and sourcing CRP
The official test criterion for CRP requires 200 able-bodied children aged 3.5–4. 80% of the children must be unable to open the packaging within 10 minutes. However, 90% of a panel of 50–70-year-old adults must also be able to open and reclose the packaging within a minute.
To gain approval, both the container and its closure must be tested together; the fact that one combination has passed does not necessarily mean that another one will too.
Some closures, such as those with a push-and-turn mechanism, may appear child-resistant, but they may not be. Pharma firms selecting packaging options should ask their suppliers to provide a technical file and certificate of child resistance for the specific package they are sourcing. Products sold in the UK and EH will be certified under BSEN ISO8317, while US products require the 16CFR1700.20 certificate.
In August 2017, the US Food and Drug Administration (FDA) published its guidance on labelling CRP. To help healthcare professionals and consumers identify whether or not packaging is child-resistant, the FDA recommends that CRP statements should be clearly linked to a particular package.
If information on CRP is included in prescribing information, it should go in the ‘How supplied/storage and handling’ section, where practitioners are most likely to look for packaging information. Information for patients should appear under a heading ‘How should I store [drug name]?’ and be consistent with whatever appears in the prescribing information.
Some firms, such as Boehringer Ingelheim, have questioned the FDA’s guidance. They have pointed out that since the guidance is voluntary, not all CRP packages will feature labelling, which could confuse consumers. Moreover, many prescription drugs are repackaged by pharmacists, meaning that the CRP advice may never reach the consumer at all.
At the other end of the spectrum is senior-friendly packaging, which is designed around the specific needs of older users (those aged 50–70). This sector is also set to grow, with the older population of the US alone set to increase by 88.5m from 2010 to 2050.
A key requirement of senior-friendly packaging is that it’s easy to open and reseal, since seniors often have a weaker grip or less dexterity than younger consumers, perhaps due to conditions such as arthritis.
Senior-friendly packaging also needs to communicate information about the product in a way that is easy to see, read and understand, in order to help those with visual or cognitive impairments. Some senior-friendly packages may also be visually distinctive in themselves, so users can easily find them or pick them out from other items.
Meeting both groups’ needs
In many cases, pharmaceutical packaging needs to be both child-resistant and senior-friendly. For example, capsules may be made brightly coloured to help older users see and recognise them. But that may increase their visual appeal to children. So packaging needs to meet the usability needs of seniors while also aiming to ensure that children don’t come to any harm.
This can be a difficult balance for packaging designers, since the very factors that increase child resistance can also make it more difficult for seniors to open packaging. And as populations age, there are questions on whether 70 should remain the upper limit for packaging testing.
With 23% more grandparents and grandchildren living together since 2005, and one in eight grandparents regularly caring for grandchildren, these issues are very real for a growing number of families. In 2014, three out of four cases of child drug poisoning in the US originated with a parent’s (39%) or grandparent’s medication (38%).
Some innovative types of CRP
Originally, most CRP took the form of bottles with the familiar child-resistant ‘press to turn’ closure. However, more and more prescription drugs are now dispensed in blister packs, which provide a perfect seal, prevent contact with the atmosphere or other products and can be dispensed in retail environments with no risk of contamination. In response, several packaging firms have developed innovative CRP options beyond traditional bottles.
Presto Products has introduced a child-resistant flexible pouch. It features a ‘press-to-engage’ resealable slider that is challenging for under-fives but easy for adults. This gives brand owners a CRP alternative to rigid packaging.
Locked4Kids is a recloseable, child-resistant folding carton made from tear-resistant laminated paperboard with a polyethylene terephthalate blister tray that locks in place with small hooks on either side. The tray can only be removed when both hooks are released simultaneously, which is simple for adults but impossible for young children, whose hands are too small to work the mechanism.
Another folding carton is the MedLock EZ from Colbert Packaging. Here, the blister card is held by an integrated locking mechanism that is disengaged by squeezing and holding touchpoints at one end of the paperboard shell while sliding the blister card out of the other. The blister cannot be completely removed from the carton, and is slid back into place to re-engage the lock.
Focusing on the blister pack itself, Amcor has introduced the Amcor Opening Feature (AOF), a blister lidding that requires a ‘targeted’ push-through motion rather than using traditional peel tabs. As well as being highly usable by seniors, the total packaging can be 40% smaller than traditional peel-push or peelable blister cards.
Finally, Origin Pharma Packaging has launched the SmartX tablet wallet, which is made from a single piece of folding box board and contains conventional blister packs. It has a tear band that must be removed to release the child-resistant slider, which moves to reveal the slots through which the product can be removed. Its large panels and printable spine offer good opportunities for branding, and it also has as an internal space to include the patient information leaflet.
To learn more about child-resistant packaging, come to the conference seminar for Child-resistant packaging – poison emergency, legislation, standards, successful examples at Pharmapack Europe. It will be held on 7 February 2018 from 10.00am to 10.30am.
Global Child Resistant Packaging Market - Size, Status and Forecast | Reserach N Reports | medgadget.com | 12 October 2017
Senior Friendly Packaging Market Set to Witness Steady Growth through (2016-2026) | Abhishek Budholiya | military-technologies.net | 06 October 2017
Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements | Zachary Brennan | RAPS | 10 October 2017
WHAT’S NEW IN CHILD-RESISTANT PACKAGING | Anton Steeman | Best In Packaging | 25 January 2015
4 Things to Consider for Child-Resistant Packaging | Tim Hayes | Healthcare Packaging | 22 September 2017
Locked4Kids’ Interlocking Carton Provides CR, Usage Flexibility | Jim Butschili | Healthcare Packaging | 29 June 2017
Origin Pharma Packaging: SmartX Blister Pack Wallet | Healthcare Packaging | 17 May 2017