Should nonclinicians inject dexamethasone implants?

Special to Ophthalmology Times®

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 become one of the most commonly performed ophthalmology procedures.

Related: Pearls for selecting a syringe for intravitreal injection

However, with an aging population in the western world requiring treatment for wet age-related macular degeneration and diabetes mellitus with its associated diabetic maculopathy projected to rise in the coming years, delivery of intravitreal injections remains a challenge.

With a publicly funded health service, as with the United Kingdom 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.

For example, in the United Kingdom, an approach that has been widely accepted and implemented that allows nurses and other allied health care professionals (AHP), including optometrists and orthoptists, to deliver anti-vascular endothelial growth factor (VEGF).

Initiated in 2009, the safety of this service has been amply demonstrated in many studies worldwide.^1,2

However, the role of nurses and other AHPs has not yet been expanded to the delivery of steroid implants for patients with macular edema due to diabetic maculopathy, retinal vein occlusion, and uveitis.

Related: Study results link frequent anti-VEGF injections, risk of cognitive impairment

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.

The dexamethasone intravitreal implant (Ozurdex, Allergan) delivery system uses a larger needle (19 gauge) than the fine-bore needle (30 gauge) used for anti-VEGF. Using this larger needle may 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 my unit.

However, although small, this ratio is significant in terms of logistics in service delivery and is 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.

Related: Probe of IRIS registry: Anti-VEGF injections key treatment for PDR

However, ophthalmic nurses had been doing minor invasive procedures such as meibomian cyst excision or subtenon injections of anesthesia for cataract surgery from the early part of this century.³

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 study results have shown comparable success and complication rates between clinicians and nurses.⁴

My experience
My impetus for encouraging nurses to deliver a dexamethasone implant arose from the protracted waiting time for patients after making the clinical decision to move forward with the procedure.

This waiting time sometimes exceeded 30 days.

Audit analysis of the delay revealed 2 reasons for this: firstly, dexamethasone injections were delivered in the operating theater by doctors, and secondly, the injections were scheduled as the last procedure on the theater list, meaning they were prone to cancellation when an emergency operation was needed.

Related: Investigators examine anti-VEGF medications in cases with ROP

I restructured my setup by moving the dexamethasone injection service from the theater to the cleanroom setting alongside the anti-VEGF service.

This move 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 dexamethasone implants.

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 a 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.

The safety of the service delivered was audited after the nurses performed 1000 injections, and there were no visually significant complications such as endophthalmitis, iatrogenic cataract, vitreous hemorrhage, or retinal detachment.

Related: Tool offers ultra-rapid cooling for intravitreal injections

There was only 1 case of incomplete penetration of the implant, but this resolved on conservative treatment with no sequelae.⁵

I believe the following may be some of the reasons for my low complication rate:

> I recruited nurses who were already experienced in intravitreal injections.

> The nurses’ self-audited personal safety profile and complication rate were very low.

> I have adopted a standard anatomical landmark (4 mm behind the limbus) for injection in patients irrespective of their phakic status.

> The framework of training and supervision is robust, and clinicians closely support the service.

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

Related: DME study documents robust efficacy of intravitreal dexamethasone implant

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.

Patients also felt the experience was less stressful in the outpatient cleanroom setting as opposed to an operating theater environment.

Cost savings
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 they also reduce costs by allowing the clinicians time for other activities.

And because intravitreal dexamethasone injection is not an operation, it can be safely performed in a cleanroom as with anti-VEGF injections.

It is worth noting that the Royal College of Ophthalmologists, the professional body for ophthalmologists in the United Kingdom, supports AHPs delivering intravitreal injections within a robust clinical governance framework.

Related: Considerations when using anti-VEGF for treating AMD

However, the pharmaceutical industry does not advocate injection by nonclinicians in its summary of product characteristics either for anti-VEGF or steroid implants.

But with more safety data being published and the widespread adoption of nurses and AHPs delivering intravitreal injection of different delivery systems, this will probably change.

--

Vasant Raman, MS, FRCS
e:vasant.raman@nhs.net
Raman is a consultant ophthalmologist at the Royal Eye Infirmary in Plymouth, United Kingdom. He specializes in medical retina and vitreoretinal surgery. He reports no financial disclosures.

--

References
1. Simcock P, Kingett B, Mann N, Reddy V, Park J. A safety audit of the first 10,000 intravitreal ranibizumab injections performed by nurse practitioners. Eye (Lond). 2014;28(10):1161-1164. doi:10.1038/eye.2014.153

2. Bolme S, Morken TS, Follestad T, Sørensen TL, Austeng D.. Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study. Acta Ophthalmol. 2020;98(1):139-144. doi:10.1111/aos.14187

3. Waterman H, Mayer S, Lavin MJ, Spencer AF, Waterman C. An evaluation of the administration of sub-tenon local anaesthesia by a nurse practitioner. Br J Ophthalmol. 2002;86(5):524-526. doi:10.1136/bjo.86.5.524

4. Williams J, Russell I, Durai D, et al. Effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET). BMJ. 2009;338:b231. doi:10.1136/bmj.b231

5. Sherman T, Raman V. Incomplete scleral penetration of dexamethasone (Ozurdex) intravitreal implant. BMJ Case Rep. 2018;11(1):e227055. doi:10.1136/bcr-2018-227055