Pre-filled Safety Syringes and the Self-administration Trend A Mutually Reinforcing Relationship

Under growing pressure resulting from staff shortages, overburdened funding, an ageing population and most recently a global pandemic, healthcare systems across the world are supporting the drive towards selfadministration of injectable medication for patients with chronic diseases. The number of people aged 60 and over worldwide – a demographic that disproportionally requires treatment for chronic conditions – is projected to nearly double from 962 million in 2017 to 2.1 billion by 2050.1 By shifting the administration of certain therapies towards the home and away from the traditional clinical setting, hospitals are exporting a lowerrisk medical procedure, helping to manage occupancy pressures within their facilities and encouraging patients to be more involved in their own medication regime. This is a particularly welcome development during this unprecedented time of demand for healthcare.

Typically administered via subcutaneous injection, a wave of biological therapies for patients with chronic conditions has entered the market since the late 1990s. These therapies often are the only ones to provide best outcomes for patients suffering from chronic conditions such as neurological, cardiovascular, and autoimmune diseases. They are particularly wellsuited to self-administration through prefilled safety syringes because they require regular injections, for which it would be impractical and not cost-effective to visit a clinic or call out a nurse each time. Patients who self-administer their treatment are not only empowered by the responsibility of managing their own drug administration but can also alleviate some of the pressure on hospitals and healthcare professionals.

Today, over two-fifths of registered nurses are now employed in non-hospital settings in the USA,2 and an estimated 7.5 billion syringes are used in the homecare environment every year.3 While this migration may be cost-effective and practical for both parties, needlestick injuries still present a significant risk within hospital settings, let alone in non-clinical sites where there is no presiding professional. In this context of growing home-administration, it is vital that equal attention be given to the safety of sharp devices and best practice injection procedures both within the confines of hospitals and outside.

While the introduction of the US Needlestick Safety and Prevention Act (NSPA) almost two decades ago has led to a 30% decline in sharps injuries, they continue to occur – averaging 1000 reported sharps injuries per day in US hospitals.4 Beyond the clinical setting, it is currently estimated that over 50% of non-hospital settings are in violation of Occupational Safety and Health Administration (OSHA) laws.5 In the EU, compliance levels for safety-engineered injection devices are at 70% across EU economies, a number which falls to 60% in the homecare environment.6

Non-compliant settings have a much higher risk of needlestick injuries occurring, leaving patients, carers and non-users at risk of potentially contracting unwanted infections. Family members and other residential non-users are particularly vulnerable to exposure for they are often unaware of the extent of the risk presented by a potentially contaminated sharp. This makes them unlikely to report needlestick injuries and get proper treatment when required – in fact, studies show that up to half of sharps injuries may go unreported.7 As the administration of drugs and its associated risks migrate into the homes of chronic patients, manufacturers must take on some of the responsibility of guarding non-professional users against the dangers of needlestick injuries.

Amidst this evolving healthcare landscape, it comes as no surprise that demand for pre-filled safety syringes has taken off in recent years. With some reports stating that 80% of needlestick injuries can be avoided by using safer needle devices,7 disposable safety-engineered delivery devices have become instrumental in the prevention of sharps injuries and recent figures confirm this growing trend. In fact, the global safety syringe market is expected to reach $1.137 billion by 2023, up from $772 million in 2018 – representing an impressive CAGR of 8.1%.9

In a context of mounting self-care, one of the main driving forces behind the growth of pre-filled safety syringes is therefore ensuring convenience and safety for the patient and/or their carer. The design of a drug delivery device determines the level of its needlestick injury prevention capabilities, with certain designs potentially making some devices less safe than others. For instance, devices with hollow-bore needles or syringes that retain an exposed needle after use carry a greater risk.10

Many of the new biological drugs are designed to treat inflammatory conditions such as rheumatoid arthritis – meaning that self-administering patients may be debilitated and yet still need to be able to securely hold and operate the injection device. Similarly, older patients are often less dextrous than their younger counterparts and could struggle with handling and administering an accurate dosage. It is therefore crucial that selfadministration devices should be as simple as possible to use, require a minimum amount of force to activate and include passive safety mechanisms to reduce additional activation steps. Pre-filled safety syringes as well as auto-injector devices fulfil both ease-of-use and safety device requirements at the same time.

The increase in scrutiny on medical administration from health authorities further to medication error scandals in the US and Europe11 is another driver for growth of the pre-filled device market. Biological drugs often have low-volume, specific dosage requirements, which explains the preference for pre-filled syringes as delivery devices for these types of drugs. Pre-filled syringes not only reduce the potential for inadvertent needlestick injuries and exposure to contamination that can occur while drawing medication from vials, but also help ensure that the correct drug is accurately delivered, significantly reducing the risk of medical errors. Pre-filled devices and syringes also have time-saving

potential, helping overburdened healthcare staff accurately deliver medication more rapidly, speeding up clinical pathways and procedures.

Similarly, safety syringes as well as other needle-safe devices help protect hospital and non-hospital healthcare workers against infection through sharps. The risk of unsafe injections as a result of contamination with blood-borne viruses is a concern in the spread of HIV, hepatitis B, and particularly hepatitis C among healthcare workers. For instance, although modern treatments that eliminate the hepatitis C virus mean that infection through sharps no longer ruins healthcare workers’ careers, expensive and disruptive treatment periods are still required. Introducing safety devices is a proven strategy to remove unnecessary risk from the healthcare professional’s working environment, including home visits.

Further driving this growth in demand for pre-filled safety syringes is the large number of original biologics continuing to come out of patent protection and the associated emergence of biosimilars. This host of new drugs entering an increasingly competitive market is reducing cost to patients, boosting the use of biosimilars and encouraging home-based selfadministration. Between 2018 and 2020 alone, seventeen original biologics have reached their patent expiration date in Europe, opening the market to biosimilar competitors.

The demand for safety-engineered devices and pre-filled syringes is growing around the world in parallel to the rise of self-administration. Pre-filled safety syringes are not only safer than those without needle protection but also more convenient and well-adapted to the self-administration trend. In particular, retracting and needle shielding mechanisms used in pre-filled safety syringes and autoinjectors allow both ease-of-use and safety device requirements to be met all at once, while also potentially reducing the risk of dosage errors. Allowing older, debilitated and less dextrous patients to securely hold and operate them, these safety-engineered devices contribute to providing patients with the independence that comes with self-administration, while reducing the risks associated with unsupervised selfcare.

REFERENCES

1. UN, Department of Economic and Social Affairs, World Population Ageing, 2017 2. Montana State University, Proportion of Registered Nurses Employed in Hospitals Falls Below 60% in 2013, May 2014 3. Gold K (2011). “Analysis: The impact of needle, syringe, and lancet disposal in the community”. Journal of Diabetes Science and Technology. 5 (4): 848–50. 4. OSHA, http://www.osha.gov/SLTC/etools/ hospital/hazards/sharps/sharps.html 5. Medical Devices: Evidence and Research, Vol 10, Clinical, economic, and humanistic burden of needlestick injuries in healthcare workers, 2 May 2017 6. European Biosafety Network, Sharps Safety Survey 2016 7. Centres for Disease Control and Prevention, Stop Sticks Campaign, February 26, 2019: https://www.cdc.gov/nora/councils/hcsa/ stopsticks/sharpsinjuries.html 8. World Health Organization, Needlestick Safety and Prevention, Independent Study 9. Market Data Forecast, Safety Syringes Market by Technology, Oct 2018 10. World Health Organization, Needlestick Safety and Prevention, Independent Study 11. e.g. Nursing Times, College warns short staffing is key factor in medication errors, February 2018: https://www.nursingtimes.net/news/ reviews-and-reports/college-warns-shortstaffing-is-key-factor-in-medication-errors23-02-2018/

George I’ons

George is currently Head of Product Strategy and Insights at Owen Mumford, having worked for the former OEM and now Pharmaceutical Services division of the organisation since 2006. His current focus is on deciphering the rapidly changing pharmaceutical and biotech sectors in relation to their needs for combination products. In his previous roles in business development, he worked closely alongside R&D to develop devices for a variety of global pharmaceutical and diagnostic clients. Prior to Owen Mumford, George worked for Abbott in EMEA marketing roles in Germany, focusing on their diabetes business.