How Pre-Filled Polymer Syringes Help Advance Parenteral Injections in Demanding Hospital Settings

Intravenous (IV) drugs have long played an important role in hospital treatments. Injecting a drug directly into the bloodstream of a patient is the fastest way to bring a medication into action, and the 100% bioavailability allows a constant plasma concentration. Therefore, it is no surprise that more than 80% of hospitalized patients are put on some form of IV therapy (1). IV drugs are used in a variety of acute care situations, and particularly in challenging environments such as intensive care units, operating rooms, emergencies in and out of hospitals, as well as for special applications like contrast media.

Several global trends in patient care, technology, and primary pharmaceutical packaging are shaping the future of IV drugs. An aging global population with greater access to hospital treatments, especially in emerging markets, will further increase the global demand for IV drugs.

Today, new technology is emerging and changing the way in which IV drugs are administered in hospitals. For example, the use of syringe pumps is becoming more widespread, enabling new administration processes like target-controlled infusion in operating rooms. Furthermore, syringe pumps are getting smarter and have become able to recognize drugs and syringes automatically by use of smart labels. This will increase the traceability of drugs along the hospital supply chain and reduce medication errors, which is a serious problem for hospitals around the world. The WHO estimates that medication errors cost $42 billion (USD) annually (2). The reduction of medication errors is therefore a key goal for the healthcare system. New trends in primary pharmaceutical packaging, such as ready-to-use containers and especially pre-filled syringes (PFSs) play an important role in minimizing medication errors by eliminating the step of manually filling a drug from a container into a disposable syringe. This article will take a closer look at what a PFS is, and how it can help to overcome many challenges of drug administration in hospitals.

The advantages of PFSs for IV drugs

The conventional way of administering IV medications in hospitals requires two different devices:

• a container (e.g., a bottle, ampoule, or vial) that safely stores the drug
• a disposable syringe for injecting the drug

With a PFS, however, both features are combined in one packaging container.

Using a PFS has several advantages for patients, healthcare professionals (HCPs), and hospitals. First, PFSs reduce the necessary steps of preparing a drug, saving labor as well as critical time while in urgent situations such as cardiac arrests or during intubations when a fast-action drug is required.

Another advantage is increased patient safety. Since the drug is already filled in the syringes with the right dosage, critical and often even life-threatening medication errors are reduced. Moreover, PFSs decrease the risk of microbial contamination, which can lead to severe bloodstream infections in patients. In a study by Moreira et al. (2015), medication errors were simulated in the highly stressful scenario of pediatric emergency situations. The simulation revealed that PFSs significantly reduced critical dosing errors by emergency physician and nurse teams from 20% with the conventional method to 0% with PFS (3).

These aspects result in lower costs for hospitals and healthcare systems, which can further reduce drug waste of unused disposable syringes, medication overfill, or costly medication errors. The Isala hospital in the Netherlands investigated the cost saving potential of PFSs and determined that the hospital could save up to 1.15 million Euro per 100,000 injections. Under the realistic scenario of replacing 50% of its injections with PFSs, the hospital could save 4.9 million Euro per year (4).

The importance of polymer containers

In contrast to disposable syringes, which are typically produced using polypropylene (PP) or other common plastic materials, PFSs are made out of high-tech materials, such as borosilicate glass (FIOLAX®) or Cyclic Olefin Copolymer (COC). While borosilicate glass is a well-established material and the golden standard for primary packaging solutions in many therapeutic areas such as vaccines, COC is a highly suitable alternative for IV drugs and in hospital settings.

The material is chemically inert, has excellent barrier properties against oxygen and water vapor, and a low extractables and leachables profile. These properties ensure that the drug stays stable over an extended period of time, enabling a long drug shelf life. Furthermore, a survey by SCHOTT that involved 660 doctors and nurses from six EU countries and the US revealed that 76% of HCPs prefer COC PFS to glass PFS in hospitals.

SCHOTT’s PFSs made of COC, the so-called SCHOTT TOPPAC® syringes, have additional advantages including being break-resistant, lightweight, and having a glass-like transparency, which allows for easy visual inspection. They are also available in a broad portfolio ranging from 1 ml to 50 ml and covering all syringe sizes typically used in hospitals (5).

SCHOTT TOPPAC® infuse: Solving the challenges of IV drugs

A member of SCHOTT’s Polymer Design Platform, SCHOTT TOPPAC® infuse syringes, are available as a complete PFS system including the plunger and plunger rod. They were designed with the patient in mind and specifically for the challenging environments of IV drugs. Made out of high-quality polymer, the syringes offer excellent barrier properties along with low extractables and leachables to allow a drug shelf life up to three years.

The syringes can be easily sterilized with most common methods, such as gamma and x-ray radiation, ethylene oxide, or steam, allowing a tailored sterilization process to the drug. As ready-to-use (RTU) packaging, SCHOTT TOPPAC® infuse syringes are delivered in an industry-standard tub suitable for high-speed filling lines. Additionally, an improved nest design allows for easier de-nesting of the syringes.

The PFSs ensure consistent break-loose and gliding forces, which, together with the ergonomic design of the syringe, allow an easy and fast injection of the drug by the HCP. According to a SCHOTT survey, 70 % of HCPs say that pre-filled syringes like SCHOTT TOPPAC® infuse are easier to use in comparison to other administration methods.

Another aspect that plays an important role when it comes to the administration is ensuring device compatibility. In clinical settings, SCHOTT TOPPAC® infuse syringes are compatible with syringe pumps and needleless connectors (NCs). Thanks to the properties including a consistent break-loose and gliding force, no stick and slip effect, as well as tight and consistent geometrical tolerances, the syringes can generate a high pump accuracy and reliability.

Another important aspect is the seamless integration of PFSs with various NCs, which connect the syringe with the end of vascular catheters and were developed to prevent needle stick injuries of HCPs. According to SCHOTT’s survey, 80% of HCPs experience reoccurring issues with leakage and cracking while using syringes together with needleless connectors. Subsequently, SCHOTT TOPPAC® infuse features an improved Luer-Lock Adapter (LLA), preventing leakage and cracking of parts of the syringe or the connector.

Internal tests at SCHOTT showed that the improved LLA of the new syringe reduced cracking by 86% and leakage by 94% compared to a standard LLA.

Outlook

The use of RTU containers and PFSs in clinical settings will significantly increase over the next few years as they are a fast and easy-to-use solution, which saves costs and increases patient safety.

To meet future requirements and bring IV administration to the next level, additional features can be added to PFSs like SCHOTT TOPPAC® infuse syringes. These include, for example, tamper-evident solutions to get a clear visual indication of the first opening, or the possibility of complementing the syringes with solutions such as RFID chips, barcodes or smart labels.

This makes SCHOTT TOPPAC® infuse ideally suited in the demanding surrounding of IV drugs, setting new standards in acute care in and outside of hospitals.

References

1. C. Vizcarra et al., J. Infus. Nurs. 37 (2), 121-124 (2014).

2. World Health Organization, “The third WHO Global Patient Safety Challenge: Medication Without Harm” https://www.who.int/patientsafety/medication-safety/en. Accessed 15 August 2020.

3. ME Moreira, et al., Ann. Emerg. Med. 66 (2), 97-106 (2015).

4. KHM Larmene-Beld, et al., Clin. Ther. 41 (6), 1139-1150 (2019).

5. Healthcare Professional Study [internal report]. St. Gallen, Switzerland: SCHOTT AG; 2019.