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The Art of Compliance

Matt Coe at One World Design & Manufacturing Group explains how reusable self-injection training devices are the smart money approach to building patient confidence and compliance

For years Syms clothing retail chain has touted that “an educated consumer is our best customer”. In the same way, an educated patient is the best patient – the patient voted most likely to succeed and experience better health outcomes as a result of their improved adherence.

The issue of patient non-compliance is not a new one; pharmaceutical companies have been struggling with this mounting problem for a long time. The economic cost of noncompliance is well into the billions each year, with $100 billion being the figure most often thrown around. However, emerging statistics suggest that the impact of non-adherence could be as high as $300 billion in resulting healthcare costs (1).

Understandably, the need for educating and training patients is felt most in the therapeutic areas where treatment calls for selfinjection. Rheumatoid arthritis, multiple sclerosis (MS), diabetes, as well as hormone replacement therapies and emergency drugs (such as those needed for migraine and anaphylactic shock), are just some of the conditions that require patients to perform injections. Anxiety is common in patients new to the experience and can often result in poor adherence. This cause and effect is even seen in therapeutic areas where one would expect patients to be highly motivated to adhere to their treatment. Despite patient awareness of the potentially debilitating nature of MS, long-term adherence to therapy is known to be poor (2).

Studies have shown that anxiety over self-injection can be a strong predictor of discontinued treatment in patients. For patients being treated for MS, the drop off in adherence can occur as early as six months (2).

THE PROBLEM WITH NON-COMPLIANCE

We all know the ramifications of non-compliance: reduced drug efficacy, poor health outcomes, as well as increased healthcare costs brought about by relapses, additional hospital time, and a variety of other factors. The emergence of auto-injectors, prefilled syringes and pre-filled injection pens is testament to the industry’s desire to help patients become more comfortable with the self-injection process. In fact, pharmaceutical companies invest a tremendous amount of time and money in research and development addressing the human factors related to injections, studying factors such as the amount of force required to administer the injection. For patients suffering from arthritis, the inability to actuate a pen or syringe can be a deal breaker with regards to treatment. Other ergonomic factors are also considered when designing and engineering these devices: orientation – which side of the pen is up or down, are patients overwhelmed or intimidated by the appearance of the device, and is it too complicated to understand? And so it goes – feedback from focus groups, revision after revision, until finally a design is agreed on.

PATIENT TRAINING

While these more sophisticated injection devices may be better suited to the needs of the user, the bottom line is that they still require patient training. Most current training sessions involve costly one-time use solutions. A training auto-injector, for example, is typically identical to the actual auto-injector minus the medication. Because these training devices are manufactured on the same production line that is used for producing the real auto-injectors or pens, pharma companies incur all the same costs associated with the stringent manufacturing of regulatory devices – which results in the price of the trainer costing the same amount as the actual device.

Although the practice of using actual pens with placebo allows patients to train with the device they will ultimately be using, the economics can be staggering. As an example, a training injector that costs $10 may be used only once by one patient and then must be discarded. Depending on how much practice an individual patient requires, that number can add up very quickly. Not surprisingly, the high cost involved with the single-use training device may restrict the ability of the patient to receive the full practice time they really need to feel comfortable with the injection process.

Given that pharmaceutical companies devote so many years of research and budget addressing the human factors of their injection devices, it is easy to conclude that patient comfort with the device and understanding of the process is imperative to the brand.

IMPROVED LOGISTICS

Pharma brands are now beginning to recognise the cost-saving and logistical benefits of training patients using reusable devices. One example is an injection pen from a leading manufacturer of an RA medication. Treatment requires selfinjection and is used in adults to reduce the signs and symptoms of moderate to severe RA. The marketing team was interested in replicating, not only the look and feel of the newly released injection pen, but also replicating the injection noise and dosing indicator of the device.

Recreating the sound that the injection device makes when it is actuated is an important part of easing the patient’s anxiety. Patients can become alarmed or confused by the noise, and reactively remove the device too soon. Mimicking the sound with the trainer helps patients understand that the noise is a normal part of the injection process, which, in turn, helps them relax so that they do not rush. As was the case with the RA medication, patients needed to wait until the dosing indicator lets them know the injection was fully completed and it was time to remove the device from contact.

Today’s drug manufacturers understand the value of patient comfort with treatment. They recognise that this comfort correlates to adherence, persistence and brand loyalty. The reusable training device helps patients gain this comfort, which makes the reusable device an even smarter choice as an educational tool, because it builds on the brand’s investment in research and development.

COST BENEFITS

Reusable training auto-injectors, training pens and syringes help manufacturers realise significant cost improvements. As an example, a reusable auto-injector that costs $3 can be used 100 times in training, and in most cases, many times more. Compare that to a $10 one-time disposable solution that costs $1,000 for the same 100 practice injections. Naturally, the figures that support training with reusable devices grow exponentially as larger quantities are factored in. A pharma manufacturer ordering 50,000 reusable training devices in one year would need to order five million single-use pens to get the equivalent value. Using our hypothetical $10 cost per piece, the manufacturer would therefore need to spend $50 million for training devices, which realistically would never happen.

For drug companies already struggling with issues of patient noncompliance, the dramatic cost of single-use training devices can force companies to limit the amount of training that can be offered. This, in turn, may contribute to further non-compliance on the part of patients, who are either confused about the injection process, or not yet comfortable with the experience.

Other factors that weigh in, quite literally, when considering reusable solutions are the obvious ‘green’ advantages. Environmentally, the reusable solution significantly reduces the amount of plastic being produced and discarded. (Consider, for example, the two ounces of plastic required for one reusable device versus 12.5 pounds of plastic for 100 single-use pieces)

THE RIGHT SUPPLIER

Choosing the right supplier to produce a reusable device is very important. The cGMP supplier who currently manufactures a brand’s auto-injector is often not the best choice for a reusable trainer. Because their entire operation is typically set up to design and manufacture devices regulated by the FDA, they tend to add unnecessary time and cost into a non-regulated trainer project. On the other hand, a low cost manufacture, unfamiliar with the special needs of pharma clients can find it difficult to meet the quality standards these clients are accustomed to. The ideal supplier lies somewhere in the middle – a manufacturer with a proven track record producing regulated medical devices with a separate product development division dedicated to producing non-regulated devices.

Today’s economy demands that drug manufacturers and medical device companies find more creative solutions for cost-effective patient training. For some innovative companies, the rewards of finding these innovative solutions are already being realised.

References

  1. Pharmaexec.com, Adherence Through Education, accessed 20 September 2010, http://pharmexec.findpharma.com/ pharmexec/Marketing/Adherence-Through- Education/ArticleStandard/Article/detail/682860
  2. Biomedcentral.com, Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, singlearm, multicentre, Phase IIIb study, accessed 24 September, 2010, http://www.biomedcentral.com/1471-2377/10/28www.samedanltd.com

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Matt Coe is the COO of One World Design & Manufacturing Group, based in Warren, New Jersey, US. He received his BFA in Industrial Design from the Rochester Institute of Technology (RIT), and in 1989 he joined PharmaDesign as an industrial designer. He was later appointed VP of Industrial Design and partner in the firm. With over 20 years of industrial design experience, Matt is the creative force behind several award-winning projects. In 2006, with his partner Fred Pether, he created One World DMG to develop patient compliance. Matt’s work has also been recognised by the Industrial Design Society of America, as well as the American Society on Aging.
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