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Safety data on non-clinician-led services have shown a low complication rate
Intravitreal pharmacotherapy has emerged as the most effective means of delivering drugs for retinal diseases. From a mere few thousand injections delivered worldwide in the early part of this century, it has now become one of the most commonly performed procedures in ophthalmology.
However, with an aging population in the western world requiring treatment for wet age-related macular degeneration, and with diabetes mellitus and its associated diabetic maculopathy projected to rise in the coming years, delivery of intravitreal injections remains a challenge. In a publicly funded health service, as with the UK’s National Health Service, resource constraints do not permit clinicians to deliver the injections themselves, as this would lead to a shortfall in clinical and surgical activity.
An approach that has been widely accepted and implemented across the UK is to allow nurses and other allied healthcare professionals (AHP), including optometrists and orthoptists, to deliver anti-vascular endothelial growth factor (VEGF). In fact, the UK is now at the forefront of adopting the nurse injector as a model for service delivery.
Initiated in 2009, the safety of this service1 has been amply demonstrated in many studies wordwide.2 However, the role of nurses and other AHPs has not yet been extended to the delivery of steroid implants for patients with macular edema due to diabetic maculopathy, retinal vein occlusion and uveitis.
Barriers to nurse-led steroid injections
Despite the demonstrated safety, there is still some apprehension about nurse-led delivery of steroid implants, one reason purportedly being the bulkier injection system used: the dexamethasone (Ozurdex, Allergan) implant delivery system uses a larger needle (19 gauge) than the fine-bore needle (30 gauge) used for anti-VEGF injections. This could potentially lead to a higher rate of complications.
There may also be concerns about a lack of demand. The number of steroid implants being injected is a small fraction of the number of anti-VEGF injections given – 1:15 in our unit. However, this ratio, while small, is significant in terms of logistics in service delivery and has been steadily increasing.
Historically, clinicians have been averse to the idea of sharing their work with AHPs. In ophthalmology, it was seen as a novelty when nurses started injecting anti-VEGF drugs, although ophthalmic nurses had been doing minor invasive procedures such as meibomian cyst excision or subtenon injections of anesthesia for cataract surgery3 from the early part of this century.
In addition, AHP and nurses have been delivering complex invasive screening and diagnostic services in gastrointestinal medicine, urology, respiratory, and hematology since the late 1980s. Randomized studies have shown comparable success and complication rates between clinicians and nurses.4
Our impetus for encouraging nurses to deliver a dexamethasone implant service arose from the protracted waiting time for patients after the clinical decision was made. This sometimes exceeded 30 days.
Audit analysis of the delay revealed two reasons for this: firstly, dexamethasone injections were delivered in the operating theatre by doctors, and secondly, the injections were being scheduled as the last procedure on the theatre list, meaning they were prone to cancellation if an emergency operation was added.
We restructured our setup by moving the dexamethasone injection service from the theatre to the cleanroom setting alongside the anti-VEGF service. This was considered the only way to reduce the waiting time for injecting the implant and sustaining the service in the long term.
Two senior nurses, experienced in intravitreal injection, were selected to undergo training for injecting the dexamethasone implant. After initially practicing using porcine eyes in a wet lab, they were then trained on patients by a retina specialist. They were certified to undertake the procedures after undergoing competency assessment by a second independent physician.
The first significant outcome of this nurse-led service was a halving of the waiting time for patients, from 30 to 15 days. In addition, the safety of the service delivered was audited after the nurses had given 1,000 injections and there were no visually significant complications such as endophthalmitis, iatrogenic cataract, vitreous hemorrhage, or retinal detachment. There was only one case of incomplete penetration of the implant5 but this resolved following conservative treatment with no sequelae.
We believe the following may be some of the reasons for our low complication rate:
Published safety data about nurse-led injection services have been encouraging, with a very low, acceptable level of complications in a clinical care environment.1,2 A patient satisfaction questionnaire conducted 3 months after introducing this service showed overwhelming patient satisfaction, with most expressing a desire for the continuation of the nurse-led service. They also felt the experience was less stressful in the outpatient cleanroom setting as opposed to an operating theatre environment.
It is relatively easy to train experienced nurse practitioners as the principle of injection remains essentially the same for all intravitreal injections. The time and resources needed are minimal and costs are reduced by allowing the clinicians time for other activities. Furthermore, since intravitreal dexamethasone injection is not an operation, it can be safely performed in a clean room as with anti-VEGF injections.
It is worth noting that the Royal College of Ophthalmologists, the professional body for ophthalmologists in the UK, supports AHPs delivering intravitreal injections within a robust clinical governance framework.
However, the pharmaceutical industry does not advocate injection by non-clinicians in their summary of product characteristics either for anti-VEGF or steroid implants. With more safety data being published and with the widespread adoption of nurses and AHPs delivering intravitreal injection of different delivery systems, this will probably change.