Could pre-filled safety syringes facilitate the adoption of home administration for cancer patients?

Intravenous vs. subcutaneous

While subcutaneous self-administration of biologics for diseases such as diabetes, Rheumatoid Arthritis or Multiple Sclerosis is already the standard of care, oncology still has some way to go. In fact, biologics on the market for cancer treatment are commonly administered intravenously. ¹ , ² Intravenous drug delivery is more complex and time consuming as it requires administration to take place in a controlled healthcare setting under supervision of a healthcare professional – further exacerbating the pressure on healthcare budgets and resources – while the subcutaneous route is suitable for self-administration. The first subcutaneous formulations in oncology have been developed as an alternative to intravenous infusions. For example, trastuzumab for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer was introduced in 2013 and rituximab for non-Hodgkin’s lymphoma (NHL) in 2014. ¹ After this point, it became evident that subcutaneous injections were not only preferred by patients, ¹ ,^3–5 but that they also had the potential to reduce the drug administration burden on the healthcare system, making it an attractive alternative to invasive and time-consuming intravenous infusions.

Could home-administration be on the cards for cancer patients?

Subcutaneous trastuzumab and rituximab must be administered by a healthcare professional in a clinical setting. However, efforts are ongoing to assess the feasibility of trastuzumab for home-administration for cancer patients in the future. ¹ , ⁶ Such a change can improve patient quality of life and provide support to patients who live far from a hospital or who are less able to travel. Initial data for this treatment has been promising, with the safety profile of home-administration being consistent with that in a hospital setting. ¹ , ⁶ Of course, sharps injuries and infections are also a concern, ⁷ but neither hospitals nor other clinical settings are immune to this risk, so there is a need to reinforce best practices and adherence to sharps safety in both traditional healthcare and home environments alike. With appropriate training, some cancer patients may soon have the option to administer specific treatments at home.

Considerations for self-administration in oncology

Before home-administration of subcutaneous biotherapeutics can become a reality, there are numerous formulation challenges which need addressing: creating the right volume and viscosity for subcutaneous delivery, optimising injection time, and use of excipients to aid absorption. Even if a biotherapeutic has been deemed safe, home-administration carries the risk of incorrect or incomplete dosing. The integration of a fixed dosing regimen, whereby patients would receive the same dose independent of body size, could therefore be a key requirement in the development of subcutaneous administrations. ¹ Alternatively, prescriptions might designate one of a range of prefilled dosage options which broadly match the patients’ body size and precise therapeutic requirement. This would reduce the potential for dosing errors. To enable convenient self-administration, medication would also preferentially be delivered in a ready-to-use injection device.

The role of pre-filled safety syringes

This is where pre-filled drug delivery devices step in. Patient self-administration or caregiver-supported subcutaneous injection of biologics for the treatment of numerous chronic diseases in the home setting has been greatly facilitated by prefilled syringes and auto-injectors. ⁸ The importance of accurate dosing and prevention of needlestick injuries are among the factors fuelling the demand for pre-filled syringes. Alongside the growth in self-administration, the pre-filled safety syringe market has therefore expanded significantly: the global safety syringe market is expected to reach $1.137 billion by 2023, up from $772 million in 2018 – representing an impressive CAGR growth rate of 8.1%. ⁹ The device and its design are an important part of the therapy; as well as accurate dosing, ease of use, comfort, and convenience of the device could potentially influence patient adherence and so have an impact on efficacy. Selecting an appropriate device is therefore an important factor for the feasibility and success of home-administration for oncology patients.

Ensuring safe device design

In terms of the features of pre-filled safety syringes, they must be as simple as possible, integrating a minimum of components. This makes the device easy to use and less intimidating for patients and carers, while ensuring that less dextrous patients are also able to use the device. Crucially, the needle must be shielded before and after injection with the help of an automatic or passive safety mechanism; the needle is therefore immediately covered as soon as the injection procedure is complete, reducing the potential for inadvertent needlestick injuries. Finally, it is important that the syringe plunger at the rear of the device is secure and cannot be easily removed, as this can lead to drug leakage and wastage; this could mean the full dose is not administered but could also lead to tampering or re-use of a device that is single-use only.

If subcutaneous formulations in oncology are approved for home administration, then – in theory at least – this may open the door to self-administration for some cancer patients. Equipped with pre-filled safety drug delivery devices, these patients may in the future be able to benefit from the independence that comes with self-administration, while reducing their risk of needlestick injuries and dosage errors. Moving from intravenous to subcutaneous dosing can also help to alleviate some of the pressure on healthcare resources and finances.