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Training Session

Correctly self-administering prescription medication has proven difficult for many patient populations. According to a recent study conducted by the University of Texas Medical Branch in Galveston, 93% of patients who use an inhaler fail to follow proper technique (1), which is just one of many studies demonstrating the importance of proper training and education.

“Recent publications have confirmed that most patients with asthma do not use their inhalers properly. In addition, only 7% of users demonstrated perfect technique, while 63% failed to complete three or more steps. This is a good reason for much-needed education, both verbally and visually, to be administered by physicians and asthma educators,” says Dr Sam Pejham, Assistant Clinical Professor at the University of California, San Francisco School of Medicine. “Also, the ability for patients to demonstrate to their provider how they use their inhaler is crucial to ensure proper technique. Currently, asthma patients’ poor inhaler technique is causing them to have diminished drug delivery, which could lead to poor asthma management.”

COMMON PROBLEMS

A study conducted by the New England Journal of Medicine found patients feel their healthcare providers do not spend enough time explaining the drug requirements and importance of completing a full dose (2). Unlike healthcare professionals, patients have not been trained on the specific techniques needed to properly administer medications. For those who have limited to no experience with a drug delivery device, in-office training may be difficult to remember or fully understand. This disconnection can lead to misuse when the device is taken home, which could result in higher user errors, lower adherence and unsuccessful patient outcomes.

Additionally, patients are often new to medical terminology and therefore do not fully understand medical instructions. Memory recall is an important factor to patient onboarding and long-term adherence, but unfortunately the more information delivered by the healthcare provider, the lower the probability of the patient to recall the information, with 40-80% of the information being forgotten immediately (3).

The most common patient errors seen in respiratory device use are failure to prime, exhale and coordinate actuation with the necessary timing and force. Factors such as rate of inhalation and proper sequencing can impact a patient’s success or failure rate with a respiratory device. If a patient misinterprets and/or improperly executes the instructions provided, the risk of an unsuccessful delivery, deposition and absorption of inhaled drug increases (4). For patients who use self-injection devices, frequent mistakes include ensuring the needle is inserted at the correct angle, depth and injection site. For patients who use auto-injectors, a common error is the misinterpretation of the length of time a full injection requires during administration (1). Patients unaware of using improper technique are less likely to receive the prescribed dose – creating the possibility of discontinuation of treatment, due to the perception of the drug not working as intended.

“With increasing self-administration of medications, it is becoming critical that we recognise the best drug in the best delivery system is only effective if the dose is delivered correctly, and in accordance with the appropriate treatment regimen,” believes Graham Reynolds, Vice President of Marketing and Communications and Pharma Delivery Systems at West Pharmaceutical Services. “While manufacturers continually work to better understand user needs and design drug delivery systems for affinity, it is also imperative that our pharma partners spend the necessary time on effective training and onboarding for patients – with the aim of improving patient adherence and outcomes over the long run.”

USER STUDY

Noble conducted an in-depth analysis of secondary literature to understand causes of product misuse and to develop strategies that could be implemented to improve patient adherence and outcomes. Based on the literature review, it was found that errors and technique are significant adherence barriers for patients using drug delivery devices. Following this, a study was conducted to understand the impact of various forms of training materials and devices on patient performance.

Table 1 is a summary of common tasks associated with the use of a metered dose inhaler (MDI). Included is a preliminary risk level assessment correlating the severity, detectability and probability of errors in common usage steps.

Findings revealed that training devices helped decrease patient anxiety – a key factor resulting in avoidance behaviours that adversely affect patients’ adherence to therapy. Some of these adverse effects might include missing treatments, incorrectly administering the medication, intaking improper dosage amounts and discontinuing treatment altogether.

Patient anxiety was shown to reduce by 18% across all training methods evaluated during the study. Smart training devices with error-detecting technologies – ones that coach users through a step-by-step process on how to use the devices during the onboarding process – are preferred methods in overcoming anxiety and preventing errors. The training devices were also evaluated to determine how each affected patient confidence. Based on participants’ feedback, 82% of users would feel most confident when training with a device that detects and corrects errors. Across all configurations, training devices increased confidence by 41%, which is consistent with other device-related studies.

Figure 1 is a summary of these findings related to expected delivery outcomes and overall preferences. Users trained with smart, error-detecting technologies made the fewest errors when administering pulmonary devices, with 77% having improved outcomes. 84% of users preferred using instructions for use (IFU) with error correction devices over other platforms.

PRACTICE MAKES PERFECT

In a follow-up study, additional research identified a link between the use of drug delivery training technologies during the onboarding process and patient compliance. The research revealed that patients who practice with device trainers and self-inject on a regular basis are more compliant throughout treatment.

Additional data collected during the study found that:

• 61% of patients do not completely read the provided IFU
• 90% rated the value of their training device a seven out of 10 or higher
• 74% reported that, in hindsight, they should have used a training device more
• As age increases, the value of a training device increases
• Patients who use a trainer are less likely to discontinue treatment

While the majority of participants surveyed said they saw the value in using a device trainer, only slightly more than half (56%) had actually used one. “In the last year we have come to realise the value of optimising our training tools and methodology as a frontline strategy for improving success rates with our delivery systems, to support our customers in both their clinical studies and commercial launches,” said Chris Evans, Vice President of Research and Innovation at West Pharmaceutical Services. “For us, usability and human factors go hand in hand with effectively training patients to use our drug delivery systems. By instilling confidence with good training, you reduce fear or anxiety when someone is injecting themselves or a loved one, and help eliminate some major barriers to adherence and compliance.”

PATIENT SUPPORT

When it comes to patient adherence and brand loyalty, there is not a onesolution- fits-all approach that can be taken. Whether it is a pulmonary delivery device or an injection delivery device, it is up to the stakeholders to help provide an ecosystem of support to patients. As drug delivery markets keep evolving, patients and industry stakeholders will continue searching for value and differentiation. Most importantly, the goal of device training is to fulfill such needs and support patients in the successful management of their treatments. Based on the aforementioned research, it is clear that patient education and training devices are the future of effective drug delivery.

Going further, multisensory training technology has the potential for major impact as it stimulates the senses to enhance memory recall through audio, visual and tactile features – an added benefit beyond in-office patient training.

It is quite clear that many patients do not read their instructions, do not understand the terminology and are highly anxious when faced with selfadministration, thus making errors and demonstrating poor compliance. If devices do not improve and training is not utilised, why then should patient outcomes be expected to improve?

References
1. Bonds R, Asawa A and Ghazi A, Misuse of medical devices: A persistent problem in selfmanagement of asthma and allergic disease, November 2014. Visit: www.annallergy.org/article/S1081-1206(14)00752-2/fulltext
2. Jha S, Patient non-adherence: Perceived challenge or next big opportunity, Business Today, November 2014. Visit: www.businesstoday.intoday.in/story/pharmaceutical-companiesdigital-health-start-up-drugcompanies/1/211981.html
3. Kessels RP, Patients’ memory for medical information, May 2003. Visit: www.ncbi.nlm.nih.gov/pmc/articles/PMC539473
4. Melani AS et al, Inhaler mishandling remains common in real life and is associated with reduced disease control, March 2011. Visit: www.sciencedirect.com/science/article/pii/S0954611111000096

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Jeff Miller, Senior Business Development Manager at Noble, is responsible for servicing key biopharma clients and has served the pharma solutions industry for over 10 years. Prior to Noble, he worked at MediMedia as Director of Business Development. Jeff also spent time in Market Research/Ethnography with Verilogue. He graduated with a double major in Pharmaceutical Marketing and Management with a focus in research.
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