A Coloured Pen Needle Education System Improves Insulin Site Rotation Habits: Results of a Randomized Study

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Despite advances in insulin therapy and new strategies to educate on good injection self-care practices, many insulin users have poor injection site rotation habits and favour the same few injection sites [1‐9]. Many insulin users also use their pen needles more than once to reduce expenses or perhaps for convenience [1]. The repeated local insult with or without a dulled pen needle encourages lipohypertrophy [10, 11]. Administration of insulin in areas of lipohypertrophy can impede insulin absorption and trigger undesirable glycaemic excursions [2], which can in turn increase the need for higher doses of insulin [2], cause greater overall hypoglycaemia [12], heighten the risks of severe hypoglycaemia and all-cause mortality [13], and elevate the risk for developing heart failure with preserved fraction in type 2 diabetes [14, 15].

Although it is recommended that new insulin users be counselled on the importance of rotating their injection sites to make their injections easier, safer, and more comfortable [16], many may not recall being instructed on the importance of site rotation and using a new needle for each injection. That said, it is also possible that while supporting insulin-using patients, the importance of teaching and reinforcing proper insulin injection habits tends to be ignored with the assumption of competence in proper injection technique among experienced insulin users.

In response to the escalating incidence of lipohypertrophy [1‐9], the Canadian Forum for Injection Technique (FIT) has been proactive in increasing awareness of proper site rotation [16] in part by expanding the range of educational tools available to insulin users and their healthcare teams. FIT Canada recommends that all new users of insulin be provided with individualized education on the importance of injection site and zone rotation. FIT Canada also encourages reinforcing self-care practices of routine site and zone rotation with every insulin user at all follow-up visits.

Given that insulin users arguably see their pharmacists more frequently than they do their physicians or diabetes educators, community pharmacists are uniquely poised to partner with their insulin-using clients to help optimize their diabetes management. The primary objective of this pharmacist-facilitated study was to determine if coloured pen needles, dispensed at community pharmacies with colour-associated injection zone maps in boxes with in-built reminder sound chips, would promote injection site and zone rotation among insulin users who live with type 1 or type 2 diabetes. Recognizing that pharmacists often multitask among patient care, service delivery, and business management, the participating pharmacists were specifically instructed not to offer counselling on pen needle use beyond standard practice and to only respond to queries about study participation. This afforded the opportunity to also evaluate the effectiveness the coloured pen needles and accompanying education materials in the absence of active pharmacist intervention. Given that pharmacists do not typically have advanced training in the nuances of diabetes management, pharmacists who do not have specialized diabetes practices were specifically targeted to facilitate this study. In that vein, we also report herein the predefined analysis that sought to determine whether participation in this initiative would alter the knowledge and perspectives community pharmacists have on injection site rotation and whether their confidence and comfort related to identifying and educating insulin users on recommended injection self-care practices would improve over the course of the study. This trial is registered at ClinicalTrials.gov (Identifier: NCT03914183).

The current study demonstrated that the combination of coloured pen needles with supportive education and reminder tools (colour-associated injection zone maps and reminder sound chips built into the dispensing box) significantly improved injection site and zone rotation among insulin users. While the practice of reusing pen needles was still evident in the group assigned the coloured pen needles, there was an overall trend towards less reuse with 72% reporting at the end of the study that they only used each pen needle once. Importantly, these positive findings arose from dispensing actions initiated with no additional verbal education in community pharmacies and support the translational potential of this practical approach to enhance self-care injection practices among individuals who use insulin to manage their type 1 or type 2 diabetes.

Lipohypertrophy is the most significant complication of poor injection technique [1‐4, 6, 9, 17, 18]. While convenience, habitual behaviour, and “less pain” may partially account for why areas of lipohypertrophy are repeatedly accessed over prolonged periods, the growing prevalence of lipohypertrophy [1‐9] appears to be at least in part due to a poor understanding of why it is important to rotate injection sites [4, 7] and how to go about maximizing injection zones to optimize site rotation and minimize lipohypertrophy.

Despite significant attempts to raise awareness among diabetes care providers about the importance and impact of incorporating site rotation education into diabetes-focussed visits [16, 19], uptake has been inconsistent. Indeed, patient load and the need to address more pressing clinical concerns may also limit the opportunities to review site rotation practices. Notably, insulin users who do not have regular access to diabetes care providers would likely not have had their injection practices and sites assessed or participated in discussions about the significance of site rotation.

Insulin users do, however, routinely visit their pharmacies to collect prescriptions and injection-related supplies. The pharmacists who participated in this study were explicitly instructed to not provide counselling on pen needle use beyond standard practice. It is therefore notable that despite the lack of additional explanation, none of the participants randomized to the intervention (mCPN) group indicated any issues with using the coloured pen needles suggesting therefore that the participants encountered few, if any, challenges transitioning from their usual pen needles to the intervention (mCPN) needles. Furthermore, most of these participants expressed satisfaction with the utility of the intervention (mCPN) needles and over two-thirds believed that the coloured intervention (mCPN) needles together with the accompanying education and reminder tools helped improve their injection site rotation practices.

Approximately three-quarters of the pharmacists in Canada work in community pharmacies [20, 21] where they often serve as the first point of engagement that patients have with the healthcare system [22]. Most individuals with diabetes may not think twice about regularly visiting their community pharmacy to obtain products and services beyond prescription medications but many likely do not intuitively perceive their community pharmacists as a support source for their diabetes care. Notably, two systematic reports and meta-analyses have suggested that diabetes circles of care that include pharmacists with active intervention roles are associated with better glycaemic control, improved risk factor modification (e.g. lower blood pressure, favourable lipid changes, and weight loss), better medication adherence, and improved patient-reported quality of life [23, 24].

Pharmacists are not traditionally educated on the importance of injection site rotation with injectable therapy and this likely accounted, at least in part, for the variable knowledge documented in the pre-study initiation questionnaire administered as well as the wide range in comfort and confidence in providing injection site rotation counselling. A key finding was that the participating pharmacists believed their involvement in this study not only enhanced their knowledge of the downstream effects of lipohypertrophy but also elevated their comfort in providing counselling on pen needle tip selection and the importance of routinely rotating injection sites. Taken together with the available literature, these data highlight the opportunity to expand the scope of diabetes-care services community pharmacists can offer to their local communities. Community pharmacists are highly accessible, and because of the already established familiarity, insulin users may be more inclined to cooperate with their community pharmacists to work towards improving injection practices and, in so doing, lower the risk of lipohypertrophy. A potential ripple effect of this personalized approach may be less frequent and shorter consultations with time-constrained family physicians and diabetes educators, thereby reducing imposition on healthcare costs [25].

This study has several strengths. First, it included patients with both type 1 and type 2 diabetes. Second, the pharmacists were based in pharmacies located in suburban areas and metropolitan cities of seven Canadian provinces, thus providing geographical diversity. Third, the study followed a randomized controlled design. Fourth, the questionnaire format allowed the authors to capture insights on patient and pharmacist attitudes and beliefs about injection site rotation, as well as the clinical and educational impact, and patients’ and pharmacists’ perspectives of the utility of the coloured pen needles. There are also limitations that should be noted. First, given the patient cohort size of 203, the patient data may not necessarily be generalizable to the entire Canadian population or globally. Second, this was a short 30-day-long study and whether the improved injection site rotation habits would have eventually translated into definitive reductions in lipohypertrophy is unknown. Third, there may have been some participating bias since the study pharmacists actively chose to contribute to the study. Fourth, it is likely that despite the randomized design, it was the most motivated patients who signed up. It is therefore probable that the increased understanding of proper injection site habits detected in the control group stemmed from acquisition of knowledge from sources outside of the study (e.g. other members of the Circle of care, literature search, etc.). Fifth, we cannot discount the possibility that the open-label design may have influenced the outcomes to some degree.

The growing armamentarium of antihyperglycaemic agents with benefits beyond glycaemic control has of late been at the forefront of diabetes management. However, it is a given that for many people living with diabetes, insulin therapy will likely become a reality as their condition progresses. Accordingly, novel approaches like that described herein, which promote consistent and proper injection technique to ensure complete delivery of every dose of insulin, and can be reinforced by community pharmacists, are useful tools that should not be relegated to the background of diabetes care.