HEALTH & SAF E T Y
personalised, as is increasingly the case with biologics.7
Effective training Training is an essential step in implementing safety products, and it must be maintained to ensure consistency. Simply adopting safety devices does not guarantee a reduction in NSI rates. It was discovered in one study that ‘safety-engineered devices do not provide complete protection and are only effective if used and disposed of correctly. Injuries which occur despite the use of an SED may be due to the failure of activation.’8 Another noted the importance of providing healthcare professionals with education in needlestick injuries, their prevention, and the current management guidelines.9
Returning to the active versus passive debate, the trial data showed that respondents felt they needed more training with a passive device, even though the safety feature does not require manual intervention. This was also the case for caregivers administering the injections, as 82% of respondents (HCPs) agreed that they did not have to provide caregivers with a lot of training on the product for them to use it correctly, compared with just 24% for the passive safety pen needle.
The safety issue
Both active and passive safety pen needles fulfil legal requirements for the mandatory use of safety devices. However, when assessing the feedback of HCP users on the safety factor, the passive safety pen needle scored higher than the active device. 92% of respondents using the passive safety pen needle agreed that they felt it adequately protected them from a needlestick injury compared with 78% of active device users. It is important to note that these scores may also be influenced by psychological factors, such as the needle’s visibility in the active device. Furthermore, in relation to overall performance in the clinical evaluation’s particular therapeutic context, 86% of the HCPs taking part in the clinical trial agreed that using the active safety pen needle offers the right balance of safety and
control of the dose delivery, whereas only 47% felt the same when using the passive safety pen needle.
Conclusions
Based on the results of the clinical evaluation and other market research, a simple differentiation between active and passive safety devices is not sufficient since safety is not the only issue at stake. In the specific clinical context of the trial discussed in this article, significantly more of those surveyed felt overall satisfied with the active safety pen needle compared with the passive safety pen needle, as the whole injection experience with an active device was deemed superior for patients and HCPs alike. However, this is not to say that active products may always be the most appropriate choice. HCPs should aim to have an optimal balance of all factors for their specific needs and clinical priorities, which are influenced by morbidity, severity, overall patient health, dexterity impairment, mental health, and so on. Human factors such as ease of use, simplicity of operation, dosage accuracy, and cost must be objectively evaluated for each clinical area. The trial highlights the importance of assessing the interplay between the many aspects of the patient and HCP experience to make the right decision.
CSJ
References 1 EU Council Directive 2010/32/EU 2 Allied Market Research, Safety Needles Market Outlook – 2026, Aug 2019
3
D.Kruger,
S.LaRue,
P.Estepa, Recognition of and steps to mitigate anxiety and fear of pain in injectable diabetes treatment, Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 16 January 2015 Volume 2015:8 Pages 49-56
4 Owen Mumford, Project Tarvos, US, Data on file, 2020 5 Project Saturn A (2017) Online study commissioned with an independent market research agency. Data on file
6 Source:
https://trenddiabetes.online/ JANUARY 2022
WWW.CLINICALSERVICESJOURNAL.COM l 81
Maria Kapoula is an accomplished product manager with extensive expe- rience in developing, managing, and mar- keting new product launch strategies for global companies and holds a degree in mechanical engineering. At Owen Mumford, Maria is responsible for managing new launches and strategy for the company’s drug delivery accessory products. Maria joined the Owen Mumford in 2020, bringing her expertise to drug delivery devices and supporting development of the company’s sustainability agenda.
7 C.A.J.Michielsens,
M.E.van Muijen,
L.Verhoef,
J.M.P.A.van den Reek, E.M.G.J de Jong, Dose Tapering of Biologics in Patients with Psoriasis: A Scoping Review, Drugs, Vol 81, pp 349–366, 16 Jan 2021; E.Kotisalmi, A.Hakulinen, M.Mäkelä,
S.Toppila-Salmi, P.Kauppi, A comparison of biologicals in the treatment of adults with severe asthma – real life experiences, Asthma Research and Practice, 13 May 2020, Vol 6, Article No.2
8 M.Dulon,
J.Stranzinger, D.Wendeler,
A.Nienhaus, Causes of Needlestick and Sharps Injuries When Using Devices with and without Safety Features, International Journal of Environmental Research and Public Health, 20 Nov 2020
9
K.C.King,
R.Strony, Needlestick, StatPearls Publishing, 20 Jan 2021
About the author
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