Tracey Sainsbury, group product manager at Owen Mumford, details the numerous elements of the injection experience that must be considered to make it effective.
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Patient safety
Safety is of paramount importance during clinical care procedures, particularly as the world recovers from the COVID-19 pandemic and the result of increasingly overstretched services. Protecting both healthcare professionals (HCPs) and patients during procedures helps to improve clinical experiences and ensure patients recover faster, while also helping to avoid the financial and psychological implications of injuries from both parties. Of particular note for HCPs is needlestick injuries (NSIs), with two million being logged across the globe each year.
There is legislation in place to mitigate this risk, including the EU Directive on Sharps Safety which requires the use of safety devices as opposed to standard needles, but the global prevalence of NSIs shows that there is still work to be done to promote safety. For patients living with diabetes, the most prevalent long-term condition, recent data that shows that being in a hospital environment increases the risk of harm, most commonly in the form of increased risk of hypoglycaemia.
A nervous patient, incorrect procedure from lack of training and human error can all increase the risk of harm for HCP and patient. The type of device used, either active or passive, can also affect the experience. Passive devices use an automatic safety mechanism which shields the needle after use. Active devices require the user to manually cover the needle once the medication has been administered.
There are pros and cons to each device, but the EU directive does not mention a preference for either. At Owen Mumford, we make active and passive devices for a variety of clinical scenarios. To understand more about the real-world differences between the two, we commissioned a clinical evaluation in 2020 to survey the opinions of HCPs, patients and caregivers using both these devices when administering insulin injections.
In the context of patient safety, a passive device has obvious benefits. A hidden needle means virtually no risk of needlestick injury before, during and after administration. However, its design can raise issues around control and visibility of the injection, and accurate dosage.
Take a nervous patient, for example. The hidden needle can put them at ease but can also trigger a response when the device makes contact with the skin – particularly if they are prone to flinching. This may prematurely activate the safety mechanism and either render the device unusable or give an inaccurate dose of medication if the needle penetrates the skin. Incorrect dosage can cause serious issues whether it be administration of a growth hormone, fertility, or osteoporosis treatment. For diabetes patients, the potential consequences can cause serious issues if they have not received the correct amount of insulin, including diabetic ketoacidosis. Our clinical evaluation found that only 43% of respondents agreed that they were in control of the safety activation feature on the passive safety pen needle, contrasted with 96% of respondents agreeing they were in control using the active device.
With an active device, the exposed needle can trigger a nervous patient, but it can also give the HCP (or the patient themselves if they are self-administering) more control of the injection experience. 98% of respondents in our clinical evaluation agreed they were in control of the dose delivery using the active safety pen needle, with 59% of respondents agreeing they were in control using the passive device.
Seeing the needle before administration means both parties have visibility of exactly where and when the needle will make contact with the skin. This also provides confidence in dose delivery, as seen in results from the clinical evaluation. 96% of respondents agreed they were confident they were able to deliver the full dose of medication with no leakage using the active safety pen needle, whereas only 41% agreed they were confident with the passive device. Further highlighting the issue of inaccurate dose delivery was a recent study by independent research company MindMetre. After contacting all NHS Trusts across England and Wales under the Freedom of Information Act, the company found that 36.4% of respondents said they had experienced insulin pooling, and 25% experienced incorrect dosage of insulin evidenced by an on-premises adverse event by the patient.
Training is a complicated issue because it is difficult to ensure consistency across so many institutions and that training is refreshed to account for new staff members. Lack of training can result in improper procedure, increasing the likelihood of risks like NSI or inaccurate dosage. Moreover, a negative injection experience can have harmful psychological effects on both the HCP and patient, not to mention the financial implications of extended bed stays, time off, and administration involved in addressing adverse events.
Overstretched and understaffed institutions require devices that are easy to use, intuitive, and mitigate risk. They also want to feel confident in the safety and usability of the devices their patients are using when self-administering. This goes beyond protecting from NSI and into ensuring the device they use is going to give the right dose amount each time, particularly when patients are off-premises and urgent care is not so easily found should an adverse event arise. In our clinical evaluation, 98% of respondents agreed that it was easy to educate their patient on the use of the active safety pen needle.
Choosing the right device for the right scenario must factor key elements including protection, confidence, and usability, but, crucially, must consider these for both HCPs and patients during the entire injection experience. A passive device helps to reduce the risk of needlestick injury, but at the potential expense of dose delivery confidence. Similarly, an active device can provide more control and confidence, but an exposed needle can increase the risk of NSI before administration – though there is no risk of viral infection since the needle has not made contact with skin beforehand.
Each patient will require different needs based on their experience, and as with all clinical scenarios, the right choice is the one that promotes the safety and wellbeing of all parties involved and ensures that the procedure can be completed with certainty. Although certainly not failproof, analysing and addressing these factors is essential to a positive injection experience.
