How patient focused drug delivery is affecting medical devices
Graham Reynolds, West Pharmaceutical Services, explains how patient-centric drug delivery is having a marked effect on device manufacture.
The biopharmaceutical industry is experiencing a rapid shift toward greater patient engagement. The voice of the patient is beginning to permeate every facet of the industry – from drug discovery to clinical trials, to regulatory approval and beyond.
This increased focus on patient centricity is spurring significant advances in injectable drug administration. Biopharmaceutical manufacturers are working to engineer better patient experiences into their treatments by focusing on an injectable drug’s delivery system earlier in the drug development process and working with delivery system manufacturers to create administration systems that are easy and convenient for patients to use.
The rise of self-administration
Increasing healthcare costs are driving care for many conditions out of the doctor’s office and into the home. In particular, treatments for many chronic conditions such as diabetes, multiple sclerosis and rheumatoid arthritis often require patients or caregivers to deliver regular injections of medication themselves. It is, therefore, important that drug delivery systems evolve to ensure that injectable medications can be easily, safely and effectively delivered in the home environment.
To create easy-to-use self-administration systems that aid in compliance with care plans biopharmaceutical companies and their drug delivery system partners must consider user needs along all stages of the patient journey. For an arthritis patient, for instance, they may transition through a variety of injection systems, from a syringe to an auto-injector to a wearable injector. Manufacturers stand a better chance of satisfying the needs of the patient throughout the course of treatment if they put the patient experience at the center of delivery system development.
Human factors research and analysis can be greatly beneficial in this process. This systematic, data-driven approach can facilitate a deeper view of patients’ needs, desires and behaviors. This research can yield valuable insight into patients’ preferences and emotional requirements, which can be translated into the design of the drug delivery system.
Drug/component compatibility
Equally important to understanding how a patient will use a delivery system is a consideration of how the components of a drug delivery system function together. Delivery systems that effectively manage the interrelationship of a drug, its primary container and its administration system can help ensure that it functions effectively, accurately and reliably.
Compatibility is a top concern for all injectable drugs and particularly with biologics. Many modern biologic formulations may be sensitive to silicone oil – used as a lubricant in glass syringes – or tungsten and therefore, may require alternative packaging. Cyclic olefin polymers can be attractive alternatives that help enable effective drug containment and delivery as they offer benefits including break resistance, consistent gliding forces, reduced extractables and leachables, and minimized risk of drug/container/component incompatibility due to the impact of silicone oil and tungsten on drug stability and protein aggregation. Additionally, polymer-based syringes can provide dimensional precision and strength, which can be significant factors when combining a syringe with a spring-based auto injector.
Connected health
With the rise of self-administration, it is increasingly important for patients to be fully engaged and invested in their treatment regimens. However, as patients take administration into their own hands, there is greater potential for adherence levels to drop, particularly when they are asymptomatic.
Connected health shows great promise for improving the patient experience and help better adherence. One way to achieve this is by integrating the self-administration process with technologies patients use in their everyday lives: smart devices. West’s collaboration with HealthPrize Technologies is an example of how this challenge is being addressed. The collaboration allows patients to use electronically-connected drug delivery systems to track in real-time when they take their medication and uses gamification to reward patients for compliance. The platform is accessed through a mobile app or web portal and can also gather information such as dosage and device history use for trends and analytics.
By tapping into the ubiquitous nature of smart devices, self-administration can be a personalized experience that more easily dovetails into a patient’s lifestyle.
Conclusion
The shift toward patient centricity is a step toward improving the patient experience and health outcomes. Yet it requires a novel approach to drug delivery that considers the relationship between the patient, the drug and the delivery system at all stages. Biopharmaceutical companies who partner early on with drug delivery partners to design innovative systems with the patient in mind stand the best chance of providing demonstrable benefit for patients.