In this article, Jon Lant, head of product development and innovation at Origin, looks at the importance of ensuring that pharmaceutical packaging addresses two essential – and sometimes competing – considerations: protecting children from accidental ingestion, and remaining accessible for elderly users.
Pharmaceutical companies have a responsibility and legal obligation to design effective packaging that both protects children from accidental ingestion and ensures ease of use for senior citizens and those with limited dexterity.
With a broad spectrum of requirements and health needs, the ageing population that so many societies are facing needs diverse and innovative packaging solutions. Not only does packaging need to be easy to use but it needs to be easy to read, all the while being child resistant.
Protecting child safety with packaging solutions
Child Resistant Packaging (CRP) is the first line of defence to safeguard children against accidental medicinal poisoning. The importance of CRP is highlighted by the fact that out of all the recorded children admitted to the hospital due to poisoning, 70 percent are due to the consumption of medicines.
CRP for pharmaceutical products is required whenever the contained product poses a potential health threat to a child. To be classified as CRP, a child aged up to 52 months should be unable to open the package without an adult present.
Examples of such products with the following ingredients include Aspirin, Acetaminophen, Elemental iron, Ibuprofen, and Naproxen. Any OTC product that, historically, required a prescription will require CRP.
There are four stringent regulatory standards that need to be met and they depend on the type of packaging being regulated:
- BS EN ISO 8317:2004 – an international standard for resealable packaging
- BS EN 14375:2003 – a European standard for non-resealable packaging of medication products
- BS EN 862:2005 – a European standard for non-resealable packaging for non-medication products
- 16 CFR 1700.20 – an American regulation that regulates both resealable and non-resealable packaging
Usually, companies within the UK are required to comply with at least the first three of these standards.
The regulations require the packaging to pass a specific test. 200 children, aged between 42-51 months, are given five minutes to attempt to open the packaging. This is done twice, once on their own and once after watching a demonstration. To pass, a failure-to-open rate of 85 percent in the first instance, and 80 percent in the second instance is required.
Ensuring ease of access for seniors
Advancements in medicine and healthcare are affording people longer life spans, but this isn’t always translated into a healthier older population. In many countries, there is a demographic shift taking place with more demand being placed on healthcare resources to manage.
WHO has predicted that by 2050, the worldwide population of over 60s will double to 2.1 billion and those living into their 80s will grow by roughly 426 million. China, India, Japan, Brazil, and the United States all have the largest number of elderly citizens worldwide.
Pharmaceuticals help the elderly manage common and, sometimes, acute ailments and diseases which make living difficult. But CRP can pose a significant challenge to how the elderly population use and benefit from medicines if they are unable to or find them difficult to open. Visual impairments can also impede a person’s ability to use a product effectively
Like CRP, to pass the test of being ‘senior-friendly’, no less than 90 percent of the test group must have no difficulty in opening the package and be able to close it within 5 minutes (if it is a resealable package).
The relevant UK regulations to comply with are the BS EN 8317:2015 and BS 8404: 2001, covering the open/close mechanism, the shape and size of the vessel and the labelling.
Innovation in child-safe and senior-friendly design
Pharma packaging must wear two hats: protect child safety and support ease of use for the adult population, including seniors. The Consumer Product Safety Commission (CPSC) has designed the testing protocol mentioned previously to ensure both criteria are met.
Common design safety mechanisms for children include two opening motions. Both require advanced dexterity to open.
1. The push and twist lid
2. Targeted pressure to pop a blister pack
Beyond these traditional measures, a new advancement requires the lid of a bottle to be moistened with water. This then allows the peel to be removed and the package easily opened.
Laminates are popular as a material used in pharma packaging, but they lack CR properties as they’re commonly made from paper-based materials. PET, however, is a material much harder for children to open or tear. Laser perforation is commonly used which requires a dextrous tearing motion easily done by elderly citizens to open.
However, the most secure packaging has two consecutive motions, like the push and twist lids. Recently, there are new designs featuring a ziplock (most children won’t have the dexterity to open this) and a flap (to disguise and deter).
Furthermore, technologies designed to distort depth perception make it difficult for children to open the package, but it has no effect on an adult’s ability to.
Digital innovation has also led to innovative new ‘smart packaging’ systems and their adoption is increasing within the sector. However, any technological advancement should not alienate the elderly population by being too complex.
An example of smart packaging is printed QR codes that link access to digital and audio instructions for dosage and administration of medications – allowing for more detail to be included without the restriction of space on the packaging and supporting those with poor eyesight.
Furthermore, intelligent remote patient monitoring technology is being integrated into packaging or medicinal devices. It is wireless and allows for the tracking of drug usage. Once a tablet is ejected from the packaging or a medical device is used, a signal is sent to a smartphone via the cloud. This can be conveniently set to occur in real-time or when it has been scheduled to do so, helping to boost compliance.
Healthcare providers can better care for their patients through digitalised scheduling and monitoring of medication administration. Often, these innovations don’t require CR regulatory approval as they are included in addition to those requirements.