DRUG DEVICES – Inhalers: Can’t Use, Won’t Use
When ranking levels of compliance in healthcare, the use of preventive inhalers for the treatment of asthma falls pretty near the bottom. The current situation sees some of the worst reported rates of patient compliance mirrored by a shockingly high number of emergency room visits due to asthma attacks – a situation you would imagine many are working to improve. In this discussion, we aim to provide some insight into the reasons behind the low levels of compliance. We focus not only on the patient, but consider what the healthcare industry could be doing to tackle the problem, including the issue of whether it will require regulatory authorityenforced legislation to move this market forward.
Compliance, also commonly referred to as adherence, describes the extent to which a person’s behavior – taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a healthcare provider.1 Compliance problems are observed in all situations in which the self-administration of treatment is required, regardless of the type of disease, disease severity, and access to health resources, with many factors contributing to compliance difficulties.2 Findings suggest that compliance of patients to a prescribed therapy for a variety of diseases is rarely more than 60%, with rates ranging from 15% to 93% depending on the condition.3,4 Studies suggest that those with conditions such as HIV or cancer tend to comply more to treatment regimens than those with pulmonary disease, diabetes, and sleep disorders.5 Poor compliance can also be associated with numerous demographic factors, including age greater than 65 years, failure to complete high school, the complexity and length of the regimen, poor physician-patient relationship, memory problems, and inability to pay for treatment.5 Patient attitude and beliefs as well as their perception of disease/treatment are known to be key in ensuring compliance.6 Patient willingness is also seen as a critical element.6
Broadly speaking, compliance can be broken down into two categories: voluntary and involuntary compliance. Voluntary compliance can be viewed as the patient’s choice as to whether they wish to follow the agreed recommendations. Poor compliance may occur because a patient actively chooses not to attempt to follow the advice of their healthcare provider. In contrast, involuntary poor compliance may occur when a patient is intending to follow recommendations but is unable to. This may occur because a patient has not fully understood the advice or is unable to follow the advice, for example, the medication required is too expensive or a drug delivery device requires a level of dexterity beyond that of the patient. Tackling voluntary and involuntary compliance raises two distinct sets of difficulties, and both must be overcome to ensure success.
Compliance should, in the main, be the choice of the patient, and the aim should be for this to remain as such. However, of vital importance is that this choice is an informed one and in this, healthcare providers, pharmaceutical companies, and device manufacturers take responsibility. A healthcare provider needs to provide sufficient training and tailor treatment where possible to the patient. Importantly, pharmaceutical companies and device manufacturers have a responsibility to ensure the correct use of devices. However, the extent to which this happens in practice remains debatable. Current regulations in healthcare provisions state that “devices must be designed and manufactured in such a way that”¦they will not compromise the clinical condition or the safety of patients”¦and are compatible with a high level of protection of health and safety”.7 This includes “reducing as far as possible the risk of user error due to the ergonomic features of the device and the environment in which the device is intended to be used”.7 In addition, there must be “consideration of the technical knowledge, experience, education and training, and, where applicable, the medical and physical conditions of intended users”.7 The persistence of low compliance suggests that a more active commitment to these responsibilities is required across all parties.
ASTHMA AS AN EXAMPLE: DETAILED USER INSIGHT
There are an estimated 300 million asthma sufferers worldwide, and its prevalence increases by 50% every decade.8 On average, more than three Americans go to the emergency room every minute due to asthma attacks. In the UK, the figure is one person every seven minutes. Asthma patients often go through periods of symptom remission and are required to take preventive medication.9 This perception of “feeling well” exacerbates low compliance and erratic use.9 Despite an estimated 90% of deaths from asthma being preventable and an estimated 75% of hospital admissions for asthma avoidable, as few as 28% of individuals in developed countries comply with the regular taking of their preventive therapies.10-12
Asthma is a debilitating disease that can be deadly; however, it is a disease that can be effectively managed with treatment. By far, the most common treatment is through the use of inhalers that have a well-documented low rate of compliance. Human Factors research is important to study how people use inhaler technology, providing insight for Human Factors Engineering, which utilizes this information in the design of devices and systems. There are many techniques for gaining usability data; one of the most effective being one-to-one in-depth interviews. Cambridge Consultants conducted a series of extensive interview programs with asthma patients to examine inhaler use and compliance.
Aside from medication cost, which can be a major factor for non-compliance, two areas were identified as key to tackling compliance: first, encouraging patients to use their inhaler, and second, ensuring patients use their inhaler properly. Many patients do not regard inhalers as “medication,” and some patients regard them as optional. Whether this should be reinforced or accommodated in inhaler design is of importance. Many patients place a low priority on using their medication; when they are busy, it is the first thing to be skipped. As people pay more attention to things they value, the aim is to make patients value their inhaled medication through device design, as patients don’t stop being consumers when they are diagnosed with asthma. Designers need to make inhalers fit better into the patient’s existing lifestyle and make their first interaction a positive one.
To ensure patients are using their inhalers correctly, devices are required to be more intuitive to use and the possibility to use them incorrectly needs to be reduced. Patient understanding of their therapy varies enormously. Many patients have a poor understanding of how maintenance and rescue inhalers work and sometimes use the wrong one. Patients need to know when they have taken their dose and when their next dose is needed. The patient needs to feel in control of their medication, which can be achieved through aspects such as clear dose counters and improved user feedback. The inhaler needs to be used as a vehicle to reinforce good behaviors or routines. Many patients receive very little training and have no effective follow-up on their inhaler use.
DEVICE APPROACHES TO AID COMPLIANCE
Failure to master the use of the inhaler is regarded as a main reason for inefficacy of inhaled treatment. It is commonly reported that design can improve compliance, however, in practice, distinct examples of this are limited.13 Poor inhaler technique prevents patients receiving the full therapeutic benefit, and can often lead to more severe conditions that result in emergency room visits. Training can improve technique; however, it is mainly performed through a patient observing an inhaler-use demonstration by their healthcare provider, which is often ineffective. With this in mind, Cambridge Consultants has developed two inhaler devices with a primary focus on improving compliance.
Coordination of inhalation by the patient with device actuation is a major problem with current metered dose inhalers (MDIs). In addition, when using some devices, patients cannot easily tell when they have received their medication, leading to confusion or even overdosing. The T-Haler, a simple training device, could be a truly life-changing technology. Interactive software, linked to a wireless training inhaler, monitors how a patient uses their device and provides real-time feedback via an interactive video “game”. The THaler has been developed to provide visual, engaging, and interactive feedback to the user on the steps that were performed correctly and coach the user in the areas that need improvement. This device, based on an MDI, can be used as a standalone training device or incorporated into a prescription inhaler product, retaining the original pharmaceutical primary packaging. The device provides real-time indication of correct use and could securely report poor usage and compliance issues back to the healthcare provider. Wireless data transfer from the inhaler could be achieved via a mobile phone or computer. Compliance data can be relevant to the healthcare provider and pharmaceutical companies, as well as enable new business models, such as targeted incentive programs. The T-Haler measures the following three key factors for proper inhaler use:
1. whether the patient has shaken the inhaler prior to breathing in,
2. the force with which they breathed in, and
3. when they pressed down on the canister (the step which releases the drug).
These three variables can determine the efficacy with which drugs are delivered in a real MDI device. More than 50 healthy participants, aged 18 to 60, took part in a study conducted by Cambridge Consultants to test the efficacy of the T-Haler. Before using the training system, participants were asked to use a standard inhaler, and the average success rate of the group to use this inhaler correctly was around 20% – in line with numerous other studies carried out. The participants had no prior experience with asthma or inhalers and were given no human instruction beyond being handed the T-Haler and told to begin. The on-screen interface walked the group through the process, which takes just three minutes to complete. Without any human direction, participants went from around a 20% success rate without training to a success rate of more than 60% after only three minutes with the T-Haler device. This is more than twice the compliance rate observed in other studies with trained participants. Importantly, a week later, 55% were still correctly using the device, showing that they retained what they learned.
The second device, the Starhaler, developed by Cambridge Consultants in collaboration with Sun Pharma Advanced Research Company Ltd, is an ergonomic inhaler designed to ensure efficient delivery of a drug to the lungs and increase the likelihood of the patient receiving their required dose. The Starhaler is an easy-to-use device for pediatric, geriatric, and adult patients and ensures a uniform dose delivery independent of patient effort. The device is equipped with a breath-activated mechanism, with only inhalation triggering the drug release. There is tactile feedback when the cap is opened and an immediate audible sound when inhaling, indicating the dose pocket is pierced and drug delivery has started. While inhaling, a whistle-like sound confirms the dose is delivered. Lactose taste provides additional confirmation on the dose delivery. Dose indexing occurs when cap is closed only after a successful inhalation, making a fail-safe dose counter. There is no dose waste if the dose is not inhaled by the patient. The airway of the inhaler has a unique design that efficiently de-agglomerates the formulation providing highly effective delivery to the lungs. It has been demonstrated that a half dose given by the Starhaler is as effective as full dose given by an alternative inhaler due to the efficient delivery system in place.12
MOVING FORWARD: EDUCATION, REGULATION & CREATION
It is fundamental for patients to receive sufficient education and training to understand the importance of their inhaler medication as well as understand how their inhaler should be used. There is a clear disconnect between the impact of poor inhaler use and patients’ understanding of this impact. According to Asthma UK, people who do not have a written personal asthma action plan are four times more likely to have an asthma attack requiring emergency hospital treatment.14 Healthcare providers and the industry need to work to lessen this gap.
The current regulatory situation for approving inhalers could be seen to be unsupportive of improving compliance. For example, an inhaler that is comparable to existing inhalers at peak flow but performs better at lower flow rates would need to undergo a more rigorous approval process compared with an inferior device, because of the absence of equivalence. This extended approval process for superior devices is seen by many as a barrier to progress. Regulatory authorities need to recognize the need for new technology that is more effective and respond to this by facilitating the approval of superior devices. Alternatively, the regulatory authorities are in a position to force change. They could, for example, ban the use of inhalers that cannot demonstrate good compliance from 2020. This would allow sufficient time for development while forcing the industry to improve devices, leading to increased compliance.
The need for superior devices compared with those currently dominating the market is clear. Superiority could, for example, be achieved by a breath-activated MDI or an inhaler that provides a patient-tailored reminder system or direct feedback to the healthcare provider or ideally a device that incorporates these three features. Research suggests that internet-based patient adherence interventions may be particularly effective , and web-enabled monitoring technologies will enable healthcare providers to actively engage patients in managing their health.5 A new inhaler needs to ensure effective drug delivery with minimal opportunities for incorrect use. For device designers and manufacturers to develop such a device they require assurance from pharmaceutical companies that these progressive devices will be welcomed. In turn, pharmaceutical companies need assurance that a new device not only provides a competitive advantage over existing products but has a feasible route for gaining regulatory approval and reimbursement. The reimbursement of these, inevitably higher priced devices, can be a challenge. The reimbursement authorities need to be encouraged to reimburse devices based on overall cost of treatment if these, more innovative, devices are to be widely accepted. Reliable measures of compliance would certainly aid this.
It is, however, difficult to accurately measure compliance, and current methods are considered inaccurate and of limited use. If compliance could be accurately demonstrated, the benefit of one inhaler over another would become apparent. An inhaler that maximises the likelihood of a dose being taken correctly, records only those doses that are taken correctly, and remotely logs this compliance data, could provide pharmaceutical companies with the necessary evidence to demonstrate the advantage of their product over that of a competitor. Furthermore, accurate compliance data could be used to illustrate improved compliance results in better health outcomes and the financial benefits of this in the long-term. This would increase the likelihood of buy-in from reimbursement authorities, payers, and individual users and subsequently increase sales.
IDEALISTIC VISION FOR 2020
Sufficient data to demonstrate true compliance and associations between this, long-term health outcomes, and financial benefits, are enabling a step-change in the inhaler market. A change that occurs without the introduction of regulatory legislation, and is instead driven by the current missed market opportunities. Any change will require co-operation from all responsible parties, but the benefits are likely to be large and they may just help us all breathe a little easier.
1. World Heath Organisation. Setting the scene: Defining adherence. World Health Organization: 2003.
2. World Health Organisation. Setting the scene: How does poor adherence affect policy-markers and health managers? World Health Organisation: 2003.
3. Norman G. It takes more than Wireless to Unbind Healthcare. Presentation at Healthcare Unbound 2007 conference.
4. Balkrishnan R. The importance of medication adherence in improving chronic-disease related outcomes. Med Care. 2005;43:517-520.
5. Herriman E, Cerretani J. Patient non-adherence – pervasiveness, drivers, and interventions. IC Sciences. 2007;2(4):1-6.
6. Van Ganse E, et al. Factors affecting adherence to asthma treatment: patient and physician perspectives. Primary Care Respir J. 2003;12(2):46-51.
7. European Medical Device Directive 93/42/EEC.
8. The Global Burden of Asthma. Chest. 2006;130(1 suppl):45-125.
9. Mangan JM, et al. Enhancing patient adherence to asthma therapy. http://www.uptodate.com/contents/enhancing-patient-adherence-toasthma-therapy/ Printed 2011.
10. Asthma UK – Homepage at http://www.asthma.org.uk. May 2012.
11. World Heath Organization. Adherence to long-term therapies: evidence for action. World Health Organization: 2003.
12. Bardapurkar S, et al. Efficacy And Safety Evaluation Of A Dry Powder Inhaler Containing Salmeterol Xinafoate 25 Mcg/Fluticasone Propionate 250 Mcg In Subjects With Asthma: A Randomized, Open Label, Comparative, Active Controlled, Parallel Groups, And Multi-Centric Study. – ISPUB. at http://www.ispub.com/journal/the-internet-journal-of-asthmaallergy-and-immunology/volume-7-number-2/efficacy-and-safetyevaluation-of-a-dry-powder-inhaler-containing-salmeterolxinafoate-25-mcg-fluticasone-propionate-250-mcg-in-subjectswith-asthma-a-randomized-open-label-comparative-activecontroll-1.html.
13. Nasal and pulmonary drug delivery market. Device can enhance compliance. January 2011.
14. Asthma UK – Facts for journalists. http://www.asthma.org.uk/news-centre/facts-for-journalists/. June 2012.
Dr. Kate Farmer is a Senior Healthcare Consultant leading the strategic work in this area at Cambridge Consultants. With over 15 years of experience across medical devices and pharmaceuticals, Dr. Farmer specializes in the technical and commercial assessment of products and technologies, market analysis, market strategy, licensing, and acquisitions. She earned her PhD in Molecular Biology from the University of Sheffield and her MBA from Nottingham University Business School. Dr. Farmer can be reached at email@example.com and is happy to receive correspondence.
Kate Farrell is a Senior Engineer within the Medical Technology division of Cambridge Consultants. She specializes in and has led the design and development of drug delivery devices, being cited in subsequent patents from some of these developments. She earned her MEng in Product Design Engineering from the University of Glasgow and Glasgow School of Art, which gives her a wide interest and user focused approach to device development. Ms. Farrell has written and presented to industry peers on methods of improving the Metered Dose Inhaler technique for users.
Andy Pidgeon leads the Industrial Design and Human Factors team at Cambridge Consultants in the UK. He has been developing new products in the consumer and medical markets for over 25 years and is a vocal proponent of user centric design. Over the past few years, he has conducted hundreds of interviews across the US, Europe, and Japan, with patients and healthcare professionals as a part of new device development programs. Mr. Pidgeon has managed the design and development of novel inhalation and parenteral drug delivery systems and has been cited as the inventor on a number of patents. He lectured in Industrial Design at Oxford Brookes University and has been published across a range of journals on design, usability, and compliance.
Dr. Anna Rickard is a Healthcare Analyst at Cambridge Consultants. She works across a broad range of medical device and pharmaceutical projects providing expertise in areas such as the evaluation of candidate medical technologies, user and expert insight interview programs, and market and company assessments. Dr. Rickard earned her PhD in Nutritional Epidemiology from the University of Cambridge.
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