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Paul Sullivan is Associate Director, Business Development at Noble International Inc., a developer of patient-centric advanced drug delivery system trainers including autoinjector, prefilled syringe, wearable and respiratory devices to help improve patient experiences and outcomes.
Realistic, multisensory training devices can contribute to a drug’s reception in the eyes of both patients and healthcare practitioners, writes Paul Sullivan.
Innovation is vital for survival in the pharma industry. Although huge amounts of time, money and creativity are conventionally spent on the clinical development and commercialization of new drugs, success in the modern marketplace sometimes requires a wider perspective. For example, even the most effective drug won’t find success if patients simply aren’t comfortable using it. This is especially true for any drug that requires the patient to use prefilled syringes and autoinjectors, pulmonary delivery systems or on-body devices. If a patient is unfamiliar with a device or feels anxious or apprehensive when prescribed a drug that requires these kinds of delivery methods, there’s a risk they’ll misuse their device-and possibly fail to obtain the proper dose. As a result, it’s important to adopt a more “patient-centric” approach that trains them properly and ensures they feel confident when taking their medication.
An evaluation of conventional training methods utilized with self-administered drug delivery devices includes the following approaches for educating patients: a series of tutorial sessions conducted by a nurse or specialist in the doctor’s office; the expectation that patients will read and understand the Instructions for Use (IFU) packaged with the device; and having patients watch an instructional video. While these methods have been helpful to patients, there is a need to further improve the training experience to be more realistic to ultimately help achieve greater adherence.
One promising method involves offering patients realistic training devices that replicate the appearance, feel and operation of prefilled syringes, autoinjectors, pulmonary delivery systems and on-body devices-some of which can even provide real-time feedback to the patient on whether that device is being used properly. Such realistic trainers can be a positive tactic for pharmaceutical companies-one that could put a brand far ahead of its competitors.
While self-administration enables patients to take an active role in their own care and offers the convenience of avoiding regular visits to the hospital or healthcare practitioner’s office, realistic trainers represent the next step forward in elevating the standard of care. And just as the vast array of devices involved in self-administration (autoinjectors, prefilled syringes, nebulizers, metered-dose inhalers, dry-powder inhalers, soft-mist inhalers, on-body injectors, etc.) are available in a variety of forms and sizes, so can trainers be manufactured with features fitting into all these form factors-allowing an interactive experience to complement healthcare provider instruction and patient education materials.
There are multiple benefits for pharmaceutical companies to launch with a training device included as part of their patient support materials. Studies have suggested the use of trainers can help patients overcome anxiety, which in turn can help improve onboarding. Additional studies have shown current training methods, such as healthcare provider in-office training and IFUs, may not be sufficient for patients to recall correct device usage. Pharmaceutical companies incorporating training materials may experience higher brand loyalty from HCPs, as patients who are adherent may have a higher likelihood of improved outcomes.
Research has highlighted the potential of training devices to alleviate the anxiety that can accompany self-administration. For example, a 2015 study conducted by Noble focused on patients who had been instructed to use prefilled syringes. It found that 64 percent of these patients reported having a training device to practice with at home would help decrease their anxiety. A separate study, published by Elsevier Science Ireland, found that anxiety regarding injections could lead to decreased compliance.
Additionally, studies have indicated the IFUs that accompany self-administration devices may not show any significant effect in ensuring compliance. For example, the 2015 Noble study also determined that utilizing IFUs as the sole guide to their devices-without any additional forms of training-would result in an increase in patient anxiety. A separate Noble study determined that 61 percent of patients fail to completely read the IFU.
Of course, even among those patients who do manage to keep up with their dosing regimens, it’s vital to ensure they are using their devices properly-because failing to do so can limit their effectiveness. A pair of studies from Rice University, reported in COPD News Today, concluded that-due to device misuse-patients who use metered-dose inhalers may be limiting their medication’s efficacy by delivering only half the medication they require.
In addition to these factors, the availability of trainers can significantly enhance the detailing process. When a pharma sales representative brings a training device to a healthcare practitioner’s office and demonstrates the specific features of the device as well as discussing how these features can benefit patients, it distinguishes that product from others on the market for the same indication. Since healthcare practitioners are keenly aware of the challenges of adherence, having these features explained and shown to them may convince them that this drug is the right one to prescribe-especially if their patients have expressed unease with self-administration. As a result, healthcare practitioners may be more likely to remember the drug and appreciate the appeal of the trainer. With competition bound to increase as more self-administered drugs enter the marketplace, this can allow a pharmaceutical company to not only make a positive impression on practitioners and patients, but also raise its profile among its peers.
It is for reasons like these that including training devices as part of a comprehensive approach to commercial launch can be a win-win. Patients may benefit after using a realistic trainer because they are less anxious when administering the prescribed therapeutic and are more likely to do so correctly; healthcare practitioners may benefit due to improved outcomes among their patients; and pharma companies may benefit from having their drug associated with a positive experience for patients.
A variety of mechanical and smart features available for self-injection, pulmonary and on-body trainers further increase the benefits and appeal for patients. For example, trainers can be built to replicate the size, shape, color and feel of prescribed therapeutic devices down to the smallest detail. Prefilled syringe trainers and autoinjector trainers can also simulate plunger speed and resistance, as well as replicate the sensation and force of a needle. Noble has developed agitator needle simulation tips mirroring the phases of needle insertion into the skin experienced by patients using prescription autoinjectors and prefilled syringes. This provides the patients with a hyper-realistic simulation of the sensation of the actual needle.
Pulmonary trainers can not only simulate the actuation of the real device, but also monitor proper usage by utilizing mechanical features such as calibrated whistles that sound as long as the patient is inhaling at the proper rate. Similarly, on-body trainers simulate the look and feel of the prescribed therapeutic devices as they adhere to the skin.
Meanwhile, “smart” features incorporated into trainers are designed to monitor the steps of their use and provide users with real-time feedback. Smart trainers incorporate sensors with advanced capabilities-including audio guidance cues, error detection/correction reminder messages and wireless data collection during use-which can be configured to work in tandem with smartphones and tablets.
Collectively, these multisensory features have exhibited potential value in reducing levels of patient anxiety compared to traditional training or no training at all. According to the 2015 Noble study, 89 percent of self-injection device users reported having a better understanding of a real injection when given the opportunity to practice with a simulated syringe. The same study also showed 69 percent of users reported that they feel it is very important to have a training device that looks and feels similar to a real needle.
Furthermore, these features are all device-agnostic, meaning they can be easily incorporated into a wide variety of form factors depending on a pharmaceutical manufacturer’s specific needs. Because a range of preconfigured components can be incorporated into various types of trainers, this expands the selection of patient-centric features that can enhance the realistic experience for patients.
Given the evidence supporting the use of realistic trainers, some of the top pharma companies have realized the value of incorporating them into the commercialization and marketing strategy of their new drugs intended for self-administration.
It is ideal to start development of a trainer as early in the process as possible-preferably in parallel with combination product development. This gives an ample opportunity to collaborate on a variety of conceptual, technical and logistical requirements regarding trainer design, development, manufacturing and launch. For example, a pharmaceutical company can determine the precise specifications of the trainer, along with the specific mechanical and smart features they would like it to incorporate. The company can also address any technical and manufacturing challenges associated with meeting these specifications and implementing these features. Finally, the company can help shape the development of a global launch strategy for when the combination product is ready to go to market.
With a pharma company’s success ultimately tied to the reception of each new drug, the availability of a realistic, multisensory training device could contribute significantly to a drug’s reception in the eyes of both patients and healthcare practitioners.
Paul Sullivan is Associate Director, Business Development at Noble International Inc.