Graham Reynolds, VP and GM, Global Biologics, West Pharmaceutical Services, in this article emphasises that pharma companies and drug delivery system manufacturers must work together to develop a delivery system that meets the needs of both the drug and the patient
Across India and around the world, increasing healthcare costs are driving care for many conditions out of the doctor’s office and into the home environment. In particular, treatments for many chronic conditions such as diabetes, multiple sclerosis, rheumatoid arthritis and haemophilia often require patients or caregivers to deliver regular injections of medication themselves. As new home therapies are developed, it is important that drug delivery systems evolve to ensure that injectable medications can be easily, safely and effectively delivered in the home environment.
Considerations for pharma manufacturers
Pharma manufacturers must fully understand and incorporate the needs of end users when bringing a self-injected therapy to market. How these medications will be delivered by patients and caregivers at home necessitates careful thought to optimise therapeutic outcomes. Delivery system design is becoming a more essential aspect of drug delivery and, as such, requires consideration in the early stages of drug development.
Auto-injectors have quickly become popular choices by drug manufacturers for delivering many therapies for chronic conditions. They are convenient and easy-to-use and can eliminate the need for patients to measure dosages and help prevent the risk of needlestick injuries. However, as sophisticated new therapies reach the market – for example, high-viscosity injectable biologics and biosimilars – administration challenges have arisen. To address these challenges, pharma companies and drug delivery system manufacturers must work together to develop a delivery system that meets the needs of both the drug and the patient. There are several areas that should be considered at the start of this collaboration.
The World Health Organization (WHO) reports that adherence rates for patients with chronic conditions are only approximately 50 per cent in developed countries. This number is much lower in developing countries. It is critical that the healthcare industry find ways to improve patients’ ability and desire to maintain an appropriate self-care treatment regimen.
Administering injectable drugs in the home can be an intimidating task for patients and caregivers. Some patients either don’t want to inject themselves with medications or their conditions make it difficult to do so. However, with many chronic conditions on the rise — and a corresponding increase in self-injectable therapies — it is becoming more important to design self-administration systems that patients not only can use, but want to use, to aid compliance.
The user experience is an extremely important element when designing a drug delivery system. An easy-to-use self-administration system can be key to creating the routines that aid in compliance with care plans. While many products do this reasonably well, a truly successful combination product must also consider the needs of the end user at a variety of stages during the patient journey. For a diabetes patient, for instance, they may transition through a variety of injection systems, from a syringe, to an auto-injector, and ultimately to a wearable pump.
When creating a delivery system, pharmaceutical companies and their drug delivery system partners must consider patient needs in conjunction with functionality along all stages of the patient journey. Manufacturers stand a better chance of satisfying the needs of the intended user throughout the course of treatment if they bring the relationship between the delivery system design and the patient interface into the center of the development process.
Human factors research, testing and analysis can facilitate a deeper view of the emotional needs and desires of the intended user, and provide perspective on features and visual cues. It can help manufacturers understand the nuances between where a device is used (e.g., a patient’s home) and who is using it (e.g., a patient or caregiver). This research can yield valuable insight into users’ preferences and emotional requirements. Those findings can then translate into feature sets and design elements of the drug delivery system.
Compatibility of delivery system components
Equally important to patient centricity and human factors is a consideration of how the various components of a drug delivery system function together. Advanced delivery systems that effectively manage the interrelationship of a drug, its primary container and its administration system can help ensure a delivery system functions accurately, effectively and reliably.
Compatibility is of utmost 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 can help enable effective drug containment and delivery. Polymers offer particular benefits that are gaining increased attention from manufacturers seeking solutions to growing drug delivery challenges, including: break resistance, dimensional precision, consistent gliding forces, reduced extractables and leachables, and minimised risk of drug-container 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.
While an integrated drug delivery system is being developed, it is essential for pharma and drug delivery companies to consider patient onboarding – how the patient will learn to use the self-injection system. New patients with self-injectors often make errors in administration. One reason for this is many patients do not thoroughly read the required steps outlined in a self-injection system’s Instructions for Use document prior to beginning drug treatment. This can potentially lead to administration errors and may impact a patient’s compliance with a prescribed therapy.
Patient-friendly delivery systems must go hand-in-hand with comprehensive education around self-injection to improve the patient experience. Multi-sensory, human factors-based educational and training programmes for drug delivery systems can be helpful to improve patient experience by reducing anxiety and the risk for administration errors.
While there are numerous auto-injector devices on the market, pharma companies need forward-thinking drug delivery system partners that anticipate and address the needs of end users and the requirements of new sophisticated therapies for chronic conditions. The overall patient experience can be improved by careful consideration of patient-centric device design, human factors, the integration between a delivery system and its components, and effective training and onboarding. Advanced self-administration systems that incorporate these essential elements can help improve the overall value and effectiveness of drug delivery systems, and may drive down healthcare costs by helping keeping patients on their medication plans and avoid health problems associated with non-compliance.