When thinking about factors that can impact the patient experience – especially regarding self-injection with pre-filled syringes – one might think of lifestyle, scheduling for self-care, patients’ attitudes toward their diagnoses, commitment to the treatment regimens, side effects and other factors that come with a drug. What these have in common is that each of those factors lies with the patients themselves.
Probably the last things that come to mind when thinking about the patient experience are an injectable medication’s syringe and its components. Yet pharmaceutical packagers are increasingly looking to engineer easier usability and improved patient experience into pre-filled syringe systems. While the syringe has been around in one form or another for 2,000 years, historians believe, for all those centuries it has mostly been physicians and nurses using them in patient care.
Now, however, new treatment modalities and healthcare economics have enabled patients with many chronic disease diagnoses to self-administer medication at home. Patients with chronic conditions want freedom from the doctor’s office – and freedom from the costs of an office visit, too – and the healthcare system is willing to accommodate them. But these cutting-edge 21st-century care enhancements necessitate new thinking around drug delivery system usability to help patients have a trouble-free treatment regimen that is consistently effective.
Design With The Patient In Mind
Figure 1. West’s 1-3mL NovaPure® plunger, designed for higher-volume injectable drug delivery systems.Pharmaceutical manufacturers and their drug packaging partners can engineer features into syringe components that can help make it easier to stick to a care plan – by making the injection as consistent and reliable as possible. In fact, several recent blockbuster drug launches have involved specialized products developed to address unmet medical needs related to diabetes, multiple sclerosis, osteoporosis, psoriasis and schizophrenia which all have one thing in common: they were launched with patient-centric delivery methods.
Research indicates that a patient’s improved medication adherence is directly linked to favorable treatment outcomes for a variety of chronic conditions, including multiple sclerosis and diabetes. Yet patient compliance with chronic medication therapies is remarkably low – the World Health Organization estimates it at 50% internationally. Non-compliance leads to poor clinical outcomes, lost revenue for pharmaceutical companies worldwide and increased costs for many healthcare financial stakeholders, including the patients themselves.
For individuals with incurable-but-controllable chronic conditions, innovative biologic therapies offer the potential to improve their quality of life by not only reducing symptoms, but also offering new independence enabled by at-home treatment. However, as biologic therapies are often administered in higher viscosities and higher injected volumes, it creates challenges to ensure appropriate selfadministration by patients consistently and effectively, without the expert oversight of their healthcare provider. Combine this with growing regulatory scrutiny to ensure the quality and efficacy of therapeutic offerings throughout their lifecycle, and our industry finds itself in a new, increasingly patient-centric wave of drug delivery.
Technical Considerations
Drug packaging partners can help. Accurate dosing of the drug product, reliable delivery and ease of use can be significant factors in patient affinity and satisfaction. The mutual dependency between the drug product and administration systems throughout the drug product lifecycle should be established early and monitored.
Additionally, drug product quality indicators are based on uniformity, purity, integrity and stability, and can be strongly influenced by the components with which the drug may come into contact.
A drug product’s formulation is comprised of multiple raw materials, as are the components of pre-filled syringes, and it is ultimately the compatibility of these systems that will help to qualify the system for its intended use. Components of pre-fillable systems typically include pistons, syringe barrels, needles and needle shields, all of which must be compatible as a system and with the drug product.
Regulatory agencies and pharmaceutical companies have increased quality expectations in an effort to enhance patient safety, in addition to encouraging adherence. In order to meet those expectations, all components that come in contact with an injectable medication should be designed with quality and ease-of-use in mind, but must also suit the unique characteristics of the drug product itself.
How Component Design – And Materials – Can Play Into The Patient Experience
Pre-fillable syringes as a category of drug packaging can potentially lead to better patient experiences than traditional means. For example, there is some degree of variability when removing a drug product from a vial with a conventional disposable needle and syringe. With a pre-fillable syringe system, the very nature of its design eliminates the withdrawal step and delivers the drug product directly to the patient, which can result in a more accurate dose of the drug with less exposure to needles.
Figure 2. West pre-fillable syringe and cartridge component technologies.Conventional wisdom says that a better delivery system can lead to a better patient experience. Specifically, “better” means: easier to handle, with plungers that move smoothly and with the same force, consistently, every time. Additionally, they should cater to the particular diagnosis; e.g., for multiple sclerosis patients, pre-fillable syringes should be designed to accommodate patients who may struggle with dexterity issues while handling smaller items. For patients who must take larger doses at a time, it is of paramount importance to have the right size syringe – so they aren’t forced to inject themselves multiple times for a single dose.
Components of the syringe as well as the containment system must support drug efficacy and quality as well. Drug manufacturers should seek packaging partners that employ Quality by Design (QbD) processes in the design and manufacturing of packaging components. QbD promotes understanding of the product and manufacturing process starting with product development.
When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes. This leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a manufacturer can continually monitor and improve its manufacturing process to help assure consistent product quality.
Having a plunger created with QbD processes also enables consistent breakloose and glide force, which makes it more reliable, stable and constant in its performance whether the syringe was filled yesterday or six months ago.
The pre-fillable syringe component with the maximum drug product contact area is the syringe barrel, which can have a major influence on drug product quality. The compatibility of the drug product with the barrel’s contact surface is critical to the drug product quality, while the breakloose and glide forces are key to the administration. Pre-fillable syringe barrels are manufactured from either glass or a polymer. While glass works well in many cases, it is not always compatible with today’s sophisticated therapies. Drug makers are exploring safe, effective alternatives, such as cyclic olefin polymers (COPs), especially for sensitive and complex drugs such as biologics and biosimilars.
While the technical concepts of breakloose and glide force may seem like subtle details only engineers and physicians could appreciate, patients will notice them, too, in the dosing experience - especially with more and more patients treating themselves at home. Living with a chronic condition can be challenging; when the medication experience differs from day to day or the injection isn’t finished because the parts of the syringe aren’t moving right, it may lead to fear from patients they aren’t administering their medication correctly, skipped doses, or quitting the therapy altogether.
Considerations For Drug And Biologic Manufacturers
Drugs, understandably, are the primary focus of research and development for pharmaceutical and biopharmaceutical companies. But with increased regulatory focus on quality in drug packaging and delivery systems, pharmaceutical manufacturers are considering the importance of drug containment and delivery systems earlier and earlier in the drug development process. Forward-thinking companies build in time for early collaboration with packaging and delivery system partners during the lengthy development process.
This better positions the injectable drug to serve the needs of both the manufacturer and the patient.
Pharmaceutical and biotechnology companies need a strategic packaging partner that knows their patients to help ensure patient centricity in the technology responsible for delivering their medications. That not only includes the consistency of experience as outlined above, but the administration system also has to be convenient and easy to use – or patients likely won’t accept the therapy.
Waste is another important consideration for drug makers and packaging partners. Because some drug products are in short supply and can be very costly to produce, manufacturers are increasingly seeking new innovations to minimize waste. Pre-fillable syringes, with their premeasured dosage, have the potential to reduce dosing errors and increase patient compliance while potentially saving manufacturers money. Unlike single- or multi-dose vials that may require drug product overfill by as much as 30 percent to ensure adequate withdrawal, a pre-fillable syringe can virtually eliminate the need for excess overfill, thus conserving expensive drug product. This is important where manufacturing and product costs are high and bulk manufacturing capacity is limited.
Lastly, modern molecules require packaging that keeps drugs stable for longer periods in storage and transit. It’s important to select packaging components that can help ensure drug compatibility and stability throughout the supply chain.
These are among the many reasons why it is important to work with an established, experienced drug packaging partner that has invested in QbD processes and patient-centric solutions to support their customers. To help ensure that a product has the best chance to be well-received on the market - and doesn’t suffer from inconsistent performance from dose to dose - pharmaceutical manufacturers need to make sure their packaging partners are locked in to patient needs related to self-injection. In the end, it will give patients their best chance of complying with their medication plans – and enjoying the full benefits of the treatments their physicians prescribe.
When devices are intuitive and efficient, they reduce the impact on daily routines, increasing the potential for adherence. Conversely, delivery and administration systems deemed inconvenient can negatively affect a patient’s emotional attitude and motivation to sustain adherent behavior. Discreetness of the device is also important. It enables use without calling undue attention or creating feelings of stigmatization. This shift from a product-centric focus to a patient-centric focus helps manufacturers address the barriers to adherence, benefitting both patients and the companies providing their needed treatments.
References
- http://www.who.int/chp/knowledge/publications/adherence_Section1.pdf