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Manufacture Packaging

Packaging for All

For the elderly, the gradual and persistent loss of dexterity, vision and hearing can contribute to the ability to read, handle and open pharmaceutical packaging, which in turn can affect medical adherence. For example, an elderly patient may fail to correctly prime an inhaler because of their poor grip strength or inability to read or understand instructions. They may be unable to muster the strength to open a blister pack. Moreover, fear or embarrassment of not being able to perform such tasks may prevent patients asking for help – even from those they are close to, further driving noncompliance.

But let’s forget age for a moment: counterintuitive design is a limiting factor for us all.

Designers and manufacturers may feel that they must make their packaging as unique as possible to set it apart from competitor products, but it is essential that it doesn’t create false affordances. Manufacturers should never assume that a patient will know how to use a particular piece of packaging. Elderly patients with dementia may even struggle with well-known packaging options. A friend of mine always used to say that if you design for the old you include the young, but if you design for the young, you exclude the old. I strongly believe that designers need to fully understand the challenges of sensory impairment and dexterity loss, which prevent older patients from being able to open packaging correctly. I have come across older patients who rely on tools to open packaging that is supposed to be opened by hand. Fingertip friction reduces significantly as we age. If you try dabbing your fingers in flour and trying to pick something up, the difficulty of that short-lived experience will inform you of an everyday reality faced by many older adult patients.

Senior-friendly standards

There is a lot that pharma companies can do to help matters. For instance, there are myriad charities with expertise in catering to the elderly and their specific needs. The Royal National Institute of Blind People undoubtedly has a much greater appreciation for the struggles of the partially-sighted and blind than the average person working in pharma. By forming connections with these types of organizations, a deeper understanding can be formed about the specific needs of the consumer.

The opportunity to create new packaging offers up other advantages for pharma companies. Counterfeit and illicit drugs are most likely to be used by adults aged over 50 in the US, a demographic that also receives 71 percent of outpatient prescriptions. As raw materials will invariably be used to create new packs, the opportunity to incorporate covert anti-counterfeiting devices or taggers also arises, increasing the protection provided to all patients who use a particular pharmaceutical product and shielding the older population who typically have lower rates of medical literacy or knowledge from the harms of fake drugs.

On both national and international levels, there are also groups dedicated to ensuring the quality of packaging – and they have a great deal of advice to offer pharma companies. The International Organization for Standardization (ISO), for example, is a global network made up of 164 member countries. The organization is a world leader in providing clear guidance for products, services and systems, but adherence to its specifications is completely voluntary. One of the aims of the organization, however, is to maintain the quality of packaging made available to the public.

Pediatric and geriatric patients present different but equally difficult challenges for the pharma industry. To ensure the safety of children, packaging should not be easy to open, but it should simultaneously be accessible to older adult patients who are more likely to struggle with packaging openability than younger patient groups. Currently, there is no regulation available for adult openability, but ISO’s child-resistance standards are often used as a measure of packaging suitability for the older patient population. The guidelines that can be used to test the ease of accessibility for older adults are:

  • ISO 17480: specifies accessible design for packaging with a focus on ease of opening

  • ISO 8317: specifies performance requirements and test methods for reclosable packages designated as resistant to opening by children

  • ISO 28862: performance requirements and methods of test for non-reclosable packaging that has been designated child-resistant and which is intended to contain non-pharmaceutical products

  • ISO 13127: specifies test methods for mechanical testing of reclosable child-resistant packaging

Prior to any child-resistance test being conducted, all packaging must be tested to ensure that it closes correctly. Foil that fails to stick to a blister pack’s train, for instance, would fail such testing.

For packaging to be considered child-resistant and senior-friendly, it has to pass tests in one of three ISO standards (ISO 8317, ISO 28862 or ISO 13127). The tests are made up of both a child and adult test. Eighty percent of children (aged between 42 and 51 months) should fail to open a pack within five minutes – including after being given an appropriate demonstration of how to do so. The adult test requires 90 percent of adults aged between 50 and 70 to open a pack and re-close it successfully within the same period of time.

Though these tests accurately determine the child-resistance of a pack, the broad inclusion criteria for adult volunteers means that the older patient demographic is poorly represented. ISO 17480, however, stipulates that only adults aged 65 to 80 years can participate in such testing, which enables packaging to be tested in patient groups that more accurately reflect this particular patient population. The needs of a patient with arthritis are not the same as a healthy patient. In short, taking into consideration the natural variability between older adults can only help improve the quality of future packaging.

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About the Author
Stephen Wilkins

Stephen Wilkins is Director of Davies Development and Testing Limited, and Chief Executive of the Child-Safe Packaging Group.

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