An autoinjector pen went from concept lower right) to detailed design elements to finished product for one client.
With the time and resources invested in developing and evaluating new drugs through clinical trials, the reality is much of a new treatment’s success is dependent on patients’ ability to comprehend and adhere to the instructions for use (IFU) supplied by the manufacturer and approved by the FDA. As a result, many brands rely heavily on learned intermediaries such as a physician or clinical specialist to teach patients the usage techniques and behaviors associated to drug delivery devices.
This approach, however, can result in highly variable educational experiences that rely on healthcare providers (HCPs) to retain and re-articulate information provided to them by the manufacturer. Realizing this quality and communication gap, leading drug-delivery brands have developed device-training solutions to complement the training provided by HCPs. Recently, training devices have been developed with smart technologies to detect and correct errors in real-time. Such capabilities are reshaping the way brands educate patients throughout the product lifecycle, from new product launches to the revitalization of established brands.
With the continued growth of self-injection treatments, more patients are finding themselves interfacing with drug delivery devices. As a result, FDA has seen a proportional increase in errors and adverse events related to patients self-administering. This trend is likely to continue as submissions of Biologic License Applications (BLA) outnumber those of new chemical entities. In 2010, the global biologics market was valued at an estimated $149 billion and is expected to reach $239 billion by 2015. Much of this growth can be attributed to the launch of new biologic and large-molecule drugs that are best delivered via injection or infusion. Patients benefiting from self-administered treatments often use auto-injectors, injection pens or prefilled syringes to deliver a subcutaneous dose of medication as prescribed by their physician.
Risk of error
From a pharmacologic point of view, biologic drugs are novel treatments that are reshaping how we practice medicine and treat chronic and acute conditions. With the benefits however, also come risks. In the case of self-administration there is a risk of patient injury caused by product misuse, much of which can be mitigated through educational programs. Due to the complex nature of disease management, few patients have the expertise to evaluate the therapeutic effectiveness of their treatments. As a result, many patients are limited in their ability to prevent or recover from use-related errors, many of which adversely affect the delivery of a dose. In response to this, regulators provide manufacturers guidance and processes to improve patient safety and reduce errors specific to combination products (see box). Within this realm, education and training has emerged as a cornerstone to risk management in human factor studies, post-marketing surveillance and throughout the product lifecycle.
Successful delivery of a full, prescribed dose relies on a user’s successful interaction with a device interface. Delivery steps are described in package inserts such as IFUs and medication guides. These delivery steps are device-specific and vary across manufacturers and drug brands. This can result in confusion and anxiety for patients and HCPs when onboarding to new delivery devices or treatments. During this time, outcomes are highly variable and the risk of errors is high. Errors can result from a number of factors including slips, lapses, mistakes and simply a lack of awareness of dosage administration practices. Such errors adversely affect the effectiveness of a drug and often lead to interventions and changes in a patient’s treatment plan. Usage errors that are most commonly mitigated through a training device include the following:
- Wet injection – premature removal of the device from the injection site while the medicament is still being delivered. This results in partial delivery of a dose.
- Injection site pain – excessive force on the device through the injection process. This can result in swelling and/or bruising of the injection site.
- Needle orientation – self-administered injections are often delivered perpendicular to an injection site. Deviations from this adversely affect the needle depth, deposition and uptake of a drug.
- Reconstitution – Lyophilization is used to improve the stability and access of various pharmaceutical ingredients. This requires patients to reconstitute APIs with a diluent. Failure to do so effectively results in partial delivery of the dose.
As the adoption of and acceptance of self-administered therapies grows, patients are spending less time with physicians and are playing a greater role in the delivery and management of their treatments. With the growing demand for extended-release and high-concentration formulations, patients are injecting less frequently and thus limited to the capacity of working memory to store and retrieve dose-related information prior to each administration.
As this dosing window continues to grow, long-term adherence will be affected by a patient’s access to education at multiple touch points during their treatment. The frequency and consistency of this education supports patients in their transition from naïve to autonomous usage as safely and effectively as possible. Doing so reduces the occurrence of errors early in patient’s treatments where they tend to be most severe and problematic. Such an approach is made possible by understanding the human and therapeutic factors affecting patient populations. Following are examples of these variables:
- Psychological and emotional impact of diagnosis.
- Physical impairments associated to age or therapies.
- Fear and anxiety associated with self-administration, often leading to avoidance behaviors.
- Social needs of the patient, including family and medical support systems.
- Lack of experience and education with drug delivery devices leading to onboarding challenges.
- Tactile – If a patient pushes the injection button, there is a distinct feel of a click. The FDA has issued a rule that by the time the injection is complete, you can feel and hear the click.
- Auditory – This component utilizes spoken instruction and diverse audio tones to help patients understand when a step has been completed properly.
- Visual – There is a window on device training pens where the plunger is visible to see if a patient has fully injected.
At its core, the ultimate goal of device training is to improve the patient experience and create value for HCPs and industry stakeholders. As new brands continue to launch and augment markets, brands will continue looking for strategies to differentiate themselves from competitors. In the modern era of patient-centric care, those able to provide a superior product and educational experience to patients will be competitively positioned and benefit from the loyalty established by patients and HCPs.
ABOUT THE AUTHOR
Jeff Baker is president and CEO of Noble®, an international product development company he co-founded with his wife in 1994. His vision and deep-rooted values have grown Noble into an award-winning product development company known for innovation and family-first values. Noble is located in Orlando, FL (www.gonoblerx.com).