Use of mydriatic eye drops in the NHS diabetic eye screening programme
Published 6 September 2023
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1. Use of mydriatic eye drops in the NHS diabetic eye screening programme
Diabetic eye screening (DES) requires the pupil of the eye to be as dilated (wide) as possible to facilitate retinal screening. This is achieved by instilling medication (drops) into the eye. This is known as mydriasis.
2. Informing individuals attending screening
The DES service should inform individuals before screening appointments that:
- eye drops will be used (unless contraindicated)
- eye drops may affect vision
- it will not be safe to drive home for at least 4 hours after the appointment because of these side effects.
In line with standard healthcare practice, screeners should make sure that individuals attending screening are informed of and understand the potential adverse side effects of the eye drops and the actions to be taken if they occur.
Screeners should give individuals information on who to contact/what to do in case they need further advice or, if they experience any unexpected side effects. An emergency, out of hours process for medical advice should be provided. This information should also be added to the service’s out of hours answerphone message.
Further guidance is available for people with diabetes who drive to appointments.
3. Individuals unable to have eye drops
If an individual is unable to have eye drops instilled, due to a pre-existing condition or contraindication, for example acute angle glaucoma, allergy to eye drops, or anxiety disorder, photographs can be attempted without mydriasis. The reason for not instilling drops must be included within the individuals notes on the DES software.
The individual should be informed that if the screener cannot assess the images (unable to view the back of the eye) they will be referred for another appointment using different equipment called Slit Lamp Bio-microscopy.
4. Individuals unwilling to have eye drops
If an individual is unwilling to have drops instilled before screening, the screener should first:
- explain that screening requires mydriasis to enable the best possible view of the retina
- encourage the individual to discuss their concerns with their diabetic care team or DES service
- book a further appointment no more than 2 months after the initial appointment, to allow time for a discussion.
If the individual still does not consent to dilation, the service should inform them of:
- their choice to opt out of screening via completion of an opt out form
- the risks associated with opting out
- their ability to opt back in at any time by contacting the DES service.
If the local DES service does not receive an opt out form it should continue to invite the individual for routine digital screening. By giving the advice outlined above, the service has provided reasonable opportunity for the individual to make an informed decision about declining drops and eye screening.
The GP should be notified of any person’s decision to opt out using the programme opt out letter templateIf the local DES service does not receive an opt out form it should continue to invite the individual for routine digital screening. By giving the advice outlined above, the service has provided reasonable opportunity for the individual to make an informed decision about declining drops and eye screening.
The GP should be notified of any person’s decision to opt out using the programme opt out letter template.
5. Mydriatic agents
To improve the quality of captured images, a mydriatic agent such as tropicamide 0.5% or 1.0% is usually instilled before retinal photography. In some cases, phenylephrine 2.5% may also be required.
6. Purchase and administration of tropicamide and phenylephrine 2.5%
Tropicamide 0.5% and 1.0% are a prescription only medicine (POM).
The wholesale supply of POMs is restricted to specified classes of healthcare professionals and organisations such as NHS trusts, doctors , and pharmacists. Optometrists are also included in the wholesale supply of Tropicamide (Rules for the sale, supply and administration of medicines - GOV.UK (www.gov.uk))
Phenylephrine 2.5% is a Pharmacy (P) medicine. P medicines may be obtained by anyone for administration in the course of a business provided they are to be used within their licensed indications.
7. Who can administer eye drops as part of the NHS Diabetic Eye Screening Programme?
the following guidance on who can administer eye drops as part of the NHS DES programme was most recently reviewed by the MHRA in 2021 to ensure current legislation is complied with. Medicines & Regulatory products Regulatory Agency (MHRA)
7.1 Retinal Screeners
A retinal screener within the DES programme is as an individual performing the competencies required for the identification of sight threatening diabetic retinopathy in a screening programme for diabetic retinopathy within the NHS. This includes:
- visual acuity measurement
- mydriatic drop instillation
- data collection (demography and diabetes care)
- photography and retinopathy grading
Individuals performing these roles may include optometrists, health care assistants, medical photographers, trained nurses, GPs, diabetologists, ophthalmologists and retinal screeners/graders who are employed within the NHS or the independent sector working within a commissioned NHS DESP service.
7.2 Administration of eye drops
The MHRA advises that the administration of non-parenteral drugs in the circumstances described above for the purposes of diabetic retinal screening is not in breach of the Medicines Act and no amendment to medicines legislation is required. They have confirmed that:
- retinal screeners can legally instil guttae tropicamide 0.5%, and guttae tropicamide 1.0% (prescription only medicines - there is no requirement for a Patient Group Direction in this situation)
- the same advice applies to phenylephrine 2.5% (a pharmacy medicine)
This applies throughout the UK. However, if in the future there was a change to extend the role of retinal screeners further to include the administration of a parenteral medicine this may require a change in the law.
8. Retinal Screener employed by NHS providers
Legal advice provided by the MHRA confirms retinal screeners working in the NHS DESP employed by NHS bodies, such as foundation trusts, can access eye drops obtained by those bodies for administration in the course of their business. No prescription, patient group direction (PGD), patient specific direction (PSD) or other order is required.
The MHRA suggests that agency staff working under close supervision within a trust undertaking retinal screening in a DES service and covered by the trust’s insurance may be in a similar position. However, advice from the Trust’s lawyer should be sought first.
Trusts subcontracting the retinal screening element of the DESP pathway to another provider (that is not part of their organisation) should be aware that unless they have a wholesale dealer’s licence, they cannot legally supply stocks of POM and P medicines to that sub contracted provider.
Trusts subcontracting to independent sector healthcare providers that employ registered health professionals (such as nurses and optometrists) to administer eyedrops as part of the diabetic retinal screening programme, could enter into an arrangement to do this under a Patient Group Direction (PGD). The PGD would need to be authorised by the trust concerned. In these circumstances, the company can obtain wholesale supplies of the medicines to be administered under the PGD.
Registered health professional status does not apply to retinal screeners who have obtained the Health Screener Diploma or City and Guilds Qualification
9. Optometrist-based providers
An optometrist may lawfully obtain stocks of tropicamide as well as P medicines for administration in the course of their business. The optometrist could allow employees to access these medicines for administration only, for example, in retinal screening procedures. There may be a question as to whether this is appropriate in terms of the optometrist’s professional practice, but this will be a matter for the professional body, the General Optical Council.
See guidance developed by the College of Optometrists and the General Optical Council.
If the optometrist is not instilling the drops themselves, they should make sure they are on the premises while it is being done so they can intervene if necessary.
10. Independent sector healthcare providers
There are no other specific provisions in medicines legislation for independent companies providing diabetic eye screening and grading services that are not registered to obtain wholesale supplies of POMs. However, doctors, pharmacists and optometrists employed by an independent company are entitled to order and receive wholesale supplies of tropicamide. Legal advice obtained by the MHRA indicates that these supplies can be distributed to screeners employed within the same company provided the healthcare professional purchasing the drops retains responsibility for the screeners and the medicines. Legal and professional practice (GOC) advice should be sought in these scenarios .
The following guidance has also been developed by the Royal College of Ophthalmologists: Eye-Drops-Instillation-by-Unregistered-Health-Care-Professionals-for-use-within-NHS-Ophthalmic-Services.pdf (rcophth.ac.uk)
11. Training and competencies required for administering drops within the NHS DES programme
All staff should undertake and pass the modules in the Health Diploma relevant to their role before administering drops unsupervised( Diploma for health screeners rules of combination). This provides assurance that individuals have appropriate training and competencies required to an agreed national standard. A training and competency record must be maintained for every individual who is required to administer drops .
The following guidance documents set out good practice to follow when delegating the medicines to a non-registered healthcare professional:
-
[Delegating medicines administration Care Quality Commission (cqc.org.uk)](https://www.cqc.org.uk/guidance-providers/adult-social-care/delegating-medicines-administration) -
[Accountability and delegation Royal College of Nursing (rcn.org.uk)](https://www.rcn.org.uk/professional-development/accountability-and-delegation)
Observations by a clinical lead or delegated individual should take place regularly to make sure the screener is still competent. The observations should be formally recorded and available for audit.
DESP provider infection, prevention and control (IPC) measures should be followed, and mandatory IPC training should be accessed as required by the trust.
Audits on ungradable rates by screeners should be undertaken in line with the audit schedule to highlight and address high ungradable rates and dilation practices (Pg 31 Diabetic eye screening: assuring the quality of grading - GOV.UK (www.gov.uk))
12. Standard operating procedures
Clear, written processes and protocols regarding the instillation of drops and mydriasis should be maintained within the DES screening programme in a place easily accessed by the screeners.
This should include :
- what to say to the individual about the drops and their instillation
- IPC information
- any exclusion or contraindication criteria1
- correct dosage1
- information about adverse reactions1
- details regarding how the user can seek further advice if needed, including access to medical advice in an emergency.
- what to do if the individual attending for their screening appointment refuses/is unsuitable for drops or has driven2
- who the screener can contact if they are unsure whether drops can be administered
- how to document the treatment episode in the screening encounter
- what to do and who to contact if something goes wrong.
References