Alagu Subramaniam, MD, India, West Pharmaceutical Services, gives an insight how pharma companies are turning to innovative integrated drug delivery systems to make self-administration a less painful and more convenient process
For many patients, being diagnosed with a chronic condition means the beginning of a journey of lifelong care. This can be an especially difficult concept to process for patients with conditions such as rheumatoid arthritis or haemophilia, which may require regular administration of injectable medicines. While adjusting to their new normal, many patients are also seeking freedom from frequent doctors’ visits, opting instead to self-administer many critical medications at home, when possible.
In-home self-administration of injectable medicines presents an opportunity to improve the overall patient experience. It also adds an additional layer to the challenge of patient compliance with prescribed treatment regimens. To help address this challenge many pharmaceutical companies are turning to innovative integrated drug delivery systems to make self-administration a less painful and more convenient process.
When injectable delivery systems are intuitive and efficient, they stand a better chance of helping patients stick with their treatment protocol because the impact on daily routines lessens. Conversely, drug delivery systems deemed inconvenient, intimidating or complicated can negatively affect a patient’s emotional attitude and motivation to sustain adherent behavior.
Putting patients first in delivery system design
No matter what type of delivery system is selected for a particular injectable drug product, there are several elements that must be carefully considered early in the design process. First and foremost is ensuring that a patient safely receives the proper dose of a prescribed medication. In past years, if a delivery system failed or was used incorrectly, patient error was most often the culprit. Now, the industry is rethinking that stance, and the priority is engineering improved usability into the integrated drug delivery system to help enable patients to achieve better outcomes. In order to design a drug delivery system that meets the needs of both the drug and the patient, the pharma manufacturer and its packaging and delivery system partner must carefully consider the interface between the drug, container, delivery system and patient.
Understanding patient needs informs usability
Effective drug therapy requires more than simply having an effective molecule. It involves the combination of a safe, effective drug within a suitable container and/ or delivery system, as well as an understanding of patient needs as they relate to administration. Drug manufacturers should take into account four main facets of this integrated drug delivery approach that, when planned early in the development process with a packaging and delivery system partner and executed successfully, may lead to better outcomes:
- Primary Container Format – The selection of a drug’s primary container throughout its lifecycle is an important consideration for drug efficacy and stability. Vials may be necessary for initial use during the drug development stages, but a syringe or cartridge system may provide a desirable solution for the patient when the medicine reaches the market. Custom containment systems may also help to differentiate the product, and should be considered early in the development process.
- Drug/ Container Compatibility – Hand-in-hand with the type of primary container is making sure the container material can be safely and effectively paired with the injectable drug product. Is the elastomeric material compatible with the drug? What are the levels of extractables and leachables? Will a barrier film or coating be required for the elastomer? Choosing the proper container material can help prevent chemical incompatibility issues that could impact a drug’s purity, stability or efficacy.
- Container/ Delivery System Interface – Once the primary container system has been selected, efforts must be made to ensure that it works with the delivery system. If the interface between the primary container and the delivery system is not effectively understood, the performance of the combined system may suffer.
- Patient Interaction – Simply designing a drug delivery system that patients can use is no longer sufficient. Delivery systems should be designed in a way that encourages patients to want to use them. This starts from a thorough understanding of patient needs, including the fact that these needs may change during their treatment journey. Human factors analysis may be helpful here and can yield significant insight into patient behaviors, motivations and needs.
Developing smart delivery systems
Technology is a ubiquitous part of our culture, and drug delivery systems are following this trend. Far removed from a vial and syringe, today’s advanced drug delivery systems are complex pieces of technology that can incorporate innovative and intuitive features that can make it easier for patients to self-administer critical medications. Pharma companies are beginning to embrace ‘smart’ self-administration systems with electronics to deliver doses at specific intervals and connectivity that allows patients and providers to track adherence via smartphone apps.
However, this shift has created an interesting challenge: while self-administration technology grows more complex, it must easily integrate into a patient’s life. Drug delivery system manufacturers must ensure a number of qualities are present to bring value to patients. Key to this mission is creating technology that patients want to use by providing drug delivery systems that are:
- Less painful: Many drug delivery partners are developing self-administration systems that minimise discomfort. For example, using a large-volume injector can help to address the issue of discomfort during self-administration, as they can mitigate perceived pain with lower flow rates (higher flow rates are often associated with pain).
- Easy to use: Regardless of how innovative a delivery system is, it must be simple enough for anyone to use successfully. Arthritis patients, for example, may have limited dexterity, which inhibits their ability to use the delivery system. Through rounds of patient testing, manufacturers can ensure the platform is easy for patients to use.
When delivery systems are intuitive and efficient, they reduce the impact on patients’ daily lives, increasing the potential for optimum adherence which, in turn, delivers the kind of platform pharma partners need to market their drug.
Partnering for patients
Patients travel a long road with a chronic condition. Pharma and delivery systems manufacturers must begin product development with that in mind, and create systems and options that will help patients comply with their prescribed treatment regimens throughout their course of care.
To best create patient-centric systems, pharma manufacturers should seek packaging and delivery system partners that can apply proprietary technologies, manufacturing excellence and patient understanding to their drug products and the products’ delivery and administration systems. Such partnerships will help drug marketers offer successful integrated solutions, benefitting manufacturers, clinicians and patients alike, while helping to improve patient compliance and outcomes. Because after all, isn’t that the shared goal of everyone involved?