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Pharmaceutical Manufacturing and Packing Sourcer

Leading the Way

Poisoning is the fifth leading cause of unintentional death for children and adolescents in the EU (1), and according to the World Health Organization (WHO), medications available at home are associated with the greatest risk of death to children (in high income countries) (2).

One of the best ways to keep children safe from medication poisoning is to keep drugs out of sight, out of reach and out of their hands altogether. But what about when a child does get hold of a medication? Child-resistant (CR) medication packaging is one of the bestdocumented successes in preventing the unintentional poisoning of children (3) – helping to stop them gaining access to medications even after they have got hold of a package.

Global Trends

Regulations for CR packaging differ around the world, but the responsibility to consider it for medication goes beyond simply meeting regulations – driven by the desire to protect children, best practices should also be borne in mind when deciding whether to implement CR more broadly. If a medication’s toxicity warrants the use of CR packaging in one region, then drug manufacturers should consider integrating it in other locations as well – even if a formal regulation has yet to be put in place. Some current CR packaging regulations and trends include:

United States
The US is one of only a few countries in the world that requires the use of CR packaging for pharmaceutical products. US regulations were initiated by the Poison Prevention Packaging Act of 1970. This law was passed in response to growing concern over the accidental poisoning of children by toxic household chemicals.

European Union
The EU has CR testing standards that are similar to the US regulations, but certification is generally not required by law. Each individual member state has the right to determine product requirements in their respective country. The two commonly followed standards in the EU are:
  • ISO 8317: Child-resistant packaging – Requirements and testing procedures for reclosable packages
  • EN 14375: Child-resistant, non-reclosable packaging for pharmaceutical products. Requirements and testing
China
The China Pharmaceutical Packaging Association has issued a report arguing for CR legislation. The government has indicated that it plans to institute CR requirements in the future.

India
The Indian Minister of Health has announced a national programme to control chronic diseases within the country. The programme will focus on, among other things, the prevention of exposure to risk factors such as child poisoning.

Taking Responsibility

Not only are regulatory authorities in various regions pushing for greater consideration of child resistance, but individual organisations are beginning to implement more broadly. Research demonstrates that CR packaging saves lives, and many manufacturers are choosing not to wait until mandates are in place to transition.

Generally, drug manufacturers or packaging fillers bear the potential legal responsibility of ensuring that a medication is packaged safely. If a package has not been appropriately tested, risks may include:
  • Increased likelihood of accidental child poisoning/fatality
  • Regulatory enforcement/recall
  • Reputational damage
  • Associated potential public and civil liabilities
Understanding the Issues

To reduce these risks, there are things drug manufacturers should require of packaging suppliers. Specifically, they should ask about testing protocol, such as:
  • Product specification – describes the product and identifies features that would not be considered a ‘significant change’ affecting compliance if modified, as all significant changes should be re-tested
  • Certification tests – a study of a sufficient number of samples identical to the in-market product in terms of material attributes (for example, graphics or instructions)
  • Production testing plan – ensures that products produced post-certification continue to comply; this may include recurring testing and/or process management techniques
  • Remedial action plan – steps to be taken in case of a test or compliance failure
  • Recordkeeping – records of each compliance certificate and documentation of the above elements of the reasonable testing plan
Because CR regulations do not specify under which circumstances CR packaging must be tested or re-tested, drug manufacturers should also have a firm understanding of how suppliers determine a protocol ‘pass’.

In addition to testing protocol, drug manufacturers should also enquire about their supplier’s approach to delivering consumer-friendly packaging. There is a common misconception that every test ‘pass’ yields a package that is child-safe and easy to use. However, some packaging suppliers are less diligent about testing and making minor modifications to design that could impact the consumer experience.

Product Engagement

A recent international packaging satisfaction study, Packaging Matters, commissioned by MeadWestvaco (MWV), found that the packaging usage experience is very important to consumers’ overall engagement with a product.

In fact, consumers’ feelings towards a package, both positive and negative, influence whether or not they choose to repurchase (a key factor for over-the-counter drugs) and whether or not they are adherent to their medication regimen (particularly important for prescription products). Specifically, the study found:
  • 41% of respondents said they have purchased a product again because they were pleased with the experience of using, transporting and storing the packaging
  • 36% of respondents have switched brands because of a negative experience while using new packaging
Further, a separate quantitative consumer preference study, conducted by MWV in 2014, showed that even adults without children living in the home recognised the importance of, and appreciated, CR packaging. Ease of use was the most important packaging attribute among this group; however, they also wanted child-resistance features and did not feel they should have to give up one for the other.

Packaging Preferences

In order to achieve both child safety and a positive consumer experience, insights should be gathered and applied to packaging design, as well as the development of any accompanying communications or instructions. For example, there are two ways to approach CR packaging – you can either require strength and force to access medication, or use cognitive abilities, such as sequential motions like pushing then pulling.

Another consumer preference study conducted by MWV found that when using the latter approach, there is sometimes a learning curve or educational element that is needed, but the overall opening experience is improved. Ultimately, the study affirmed that consumers preferred cognitive-based approaches, and package designs were modified based on these findings.

Developing Design

An example of a CR package that was designed based on consumer insights is the HiMark CR Nasal Pump. The pump was developed in response to regulations in the US requiring CR packaging for over-the-counter and prescription drug products containing more than a designated amount of a specific drug called imidazoline. The affected products included commonly used eye drops and nasal sprays, which can cause serious adverse reactions in children when accidentally ingested.

During the development of the nasal pump, three concepts were tested with consumers, and the preferred design was refined based on their feedback. Specific features that were incorporated as a result included:
  • Use of a simple range of motion to open the pump, without requiring extreme precision, making the package truly senior-friendly
  • Audible indication, so the product locks and seals tightly without any wiggling
  • Integration of the child-resistance feature into the pump versus the over cap; this ensures the highest level of protection for children by preventing access to the medication, even if the over cap is left off or lost
These design modifications yielded a package to meet the needs of both children and seniors, taking dexterity and cognitive skills into account.

Final Thoughts

It is important to remember that when consumers have a good experience with their medication package, it can help create a more positive overall healthcare experience, including the possibility of better adherence to medication regimens. When choosing a packaging supplier, drug manufacturers should consider the benefi ts of using CR packaging that not only minimises risk, but is also based on consumer insights.

References
1. The European Child Safety Alliance, The Child Safety Report Card Europe 2012. Visit: www.childsafetyeurope.org/publications/info/child-safetyreport- cards-europe-summary-2012.pdf
2. WHO, European Report on Injury Prevention 2008. Visit: www.euro.who. int/__data/assets/pdf_file/0003/83757/ E92049.pdf
3. WHO, World Report On Child Injury Prevention, Margie Peden et al (ed), 2008

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Hung Le is Vice President of Innovation Engagement for MWV’s Home, Health and Beauty group. An engineer by training, he leverages a deep understanding of the development and commercialisation of consumer packaging. The Innovation Engagement group includes project managers, designers and open innovation resources, and collaborates with the company’s technical, operating, marketing and commercial teams to ensure rapid speed to market for innovative packaging solutions. Hung has previously served as Vice President of Global Design for MWV, as well as Senior Director of Innovation and Product Line Management for MWV Healthcare.
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