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Standard Operating Procedure for drop administration by eye clinic staff Outpatients Page 1 of 29 Document Control Title Standard Operating Procedure for drop administration by eye clinic staff Author Author’s job title Clinical Nurse Specialist Directorate Surgery Department Team/Specialty Outpatients Ophthalmology Version Date Issued Status Comment / Changes / Approval 0.1 Dec 2020 Draft Initial version for consultation 0.2 Aug 2020 Draft Medicines Management Group 1.0 Dec 2020 Draft Ophthalmic Clinical Governance Main Contact Eye OPD Level 2 Exmoor suite North Devon District Hospital Raleigh Park Barnstaple, EX31 4JB Tel: Direct Dial Tel: Internal Email: Lead Director Director of nursing Document Class Standard Operating Procedure Target Audience All Nurses/Orthoptists/Opticians/SHCA’s/ Imagining technicians/Orthotic assistants within the ophthalmology department at NDDH and associated community hospitals. Distribution List Ophthalmology clinical leads Distribution Method BOB Superseded Documents Drop Administration by HCA’s in eye clinic Standard Operating Procedure PGD Drop Administration by trained nurses Standard Operating procedure HCA/Imaging technicians/Orthoptic Drop Administration Issue Date Dec 2020 Review Date Review Cycle Three years Consulted with the following stakeholders: (list all) Ophthalmic Consultants Divisional Nurse Manager Nurse Manager Ophthalmology Lead Orthoptist Lead Optician NMP Lead Pharmacist Contact responsible for implementation and monitoring compliance: Clinical Nurse Specialist Education/ training will be provided by: Clinical Nurse Specialist Approval and Review Process Divisional Governance
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Page 1: Document Control Standard Operating Procedure for drop ...

Standard Operating Procedure for drop administration by eye clinic staff

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Document Control

Title Standard Operating Procedure for drop administration by eye clinic staff

Author

Author’s job title Clinical Nurse Specialist

Directorate Surgery

Department Team/Specialty Outpatients Ophthalmology

Version Date

Issued Status Comment / Changes / Approval

0.1 Dec 2020

Draft Initial version for consultation

0.2 Aug 2020

Draft Medicines Management Group

1.0 Dec 2020

Draft Ophthalmic Clinical Governance

Main Contact Eye OPD Level 2 Exmoor suite North Devon District Hospital Raleigh Park Barnstaple, EX31 4JB

Tel: Direct Dial – Tel: Internal – Email:

Lead Director Director of nursing

Document Class Standard Operating Procedure

Target Audience All Nurses/Orthoptists/Opticians/SHCA’s/ Imagining technicians/Orthotic assistants within the ophthalmology department at NDDH and associated community hospitals.

Distribution List Ophthalmology clinical leads

Distribution Method BOB

Superseded Documents Drop Administration by HCA’s in eye clinic Standard Operating Procedure PGD Drop Administration by trained nurses Standard Operating procedure HCA/Imaging technicians/Orthoptic Drop Administration

Issue Date Dec 2020

Review Date

Review Cycle Three years

Consulted with the following stakeholders: (list all)

Ophthalmic Consultants

Divisional Nurse Manager

Nurse Manager Ophthalmology

Lead Orthoptist

Lead Optician

NMP Lead

Pharmacist

Contact responsible for implementation and monitoring compliance: Clinical Nurse Specialist

Education/ training will be provided by: Clinical Nurse Specialist

Approval and Review Process

Divisional Governance

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Local Archive Reference G:Learning and development Local Path Public G Drive Filename Policy Template (NHSLA) v1.16 20Jul11.doc (right click above text, to update to new filename)

Policy categories for Trust’s internal website (Bob) SOP/Ophthalmology/eye clinic

Tags for Trust’s internal website (Bob) Drop Administration/HCA/SOP

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CONTENTS

Document Control ............................................................................................................... 1

1. Background .................................................................................................................. 4

2. Purpose ........................................................................................................................ 4

4 Clinics included and pre workup required ................................................................. 6

5. Location ........................................................................................................................ 9

7 Procedure ..................................................................................................................... 9

8 References.................................................................................................................... 11

9 Associated Documentation ......................................................................................... 11

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1. Background

1.1. Ophthalmology departments experience rapid throughput in outpatient activity and as a result clinical practices and professional levels of responsibility have been devolved down the grading structure to try and meet the demand. To meet new service needs within NDDH and associated community services it is necessary to allocate certain key practical skills to well-trained healthcare workers within the team.

1.2. There are three main reasons why patients are dilated prior to their consultation or procedure and those patients are booked into specific clinics easily recognisable by the trained staff, healthcare assistants, orthoptic assistants and image technicians who facilitate them. Fundoscopy, imaging and laser treatment. At present all the patients need individually prescribing these drops in the notes or via PSD’s (Patient Specific Direction)/PGD’s (Patient Group Direction).

1.3. There is one reason why lidocaine and flouresceine drops are used within the eye department and that is prior to Goldman Applanation Tonometry (GAT). They are instilled by highly trained STAFF i,e. ophthalmic practitioners to check the accuracy of a high I-care pressure or by orthoptists, or orthoptic assistants running glaucoma monitoring clinics to accurately measure Intraocular pressure. At present all the patients need individually prescribing these drops in the notes or via PSD’s/PGD’s.

1.4. There is one reason why proxymetacaine or oxybuprocaine is used within the eye department and that is prior to intravitreal injections. Proxymetacaine is instilled to every patient requiring an intravitreal injection. Oxybuprocaine is used for patients when the Proxymetacaine does not provide effective anaesthesia. At present all the patients need individually prescribing these drops in the notes or via PSD’s/PGD’s.

1.5. The UKOPG (United Kingdom Ophthalmic Pharmacy Group) recognised in 2006 that it was not illegal for staff within ophthalmology to administer eye drops as long as a trust specific protocol exists to allow safe administration of eye drops for these patients.

1.6. The RCOphth have written a document see pages 9-13 highlighting how it is legally possible for unregistered staff and non-prescribers to give eye drops within the current legal and regulatory systems without Prescriptions or PSD,s.

1.7. Non-registered staff members can access the medications required for the purpose of the delegated tasks within this Sop, which they have been trained for, in line with the trust secure medication policy.

1.8. The drops will be obtained and receipted by a registered staff member and kept in a secure medicine cupboard with a key pad whose code will be changed in line with the trust’s safe and secure storage of medication policy

2. Purpose

This Protocol is for use by staff employed by the Northern Devon Healthcare Trust who have achieved the agreed clinical competencies to work under the protocol by attending the 3 hour Drop administer training programme covering;

Intended learning outcomes

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Identify the basic anatomy and physiology of the eye

List the three dilating drops used in the Ophthalmic OPD

List the three anaesthetic drops used in the Ophthalmic OPD

Identify the drop used for Goldman Applanation Tonometry

Identify the different adverse reactions from the drops

Demonstrate how to accurately record adverse effects/reactions from these drops

Demonstrate an understanding of who to refer to if problems occur

Demonstrate an understanding of the escalation process Demonstrate how to carry out a safe and effective drop administration

technique

Programme:

Basic anatomy and physiology of the eye

Adverse drug reactions

Storage issues, Health education

The law, drugs and record keeping

Pre-administration drug checks to promote safe drop administration

Pharmacology of the common drops used in the Ophthalmic OPD

Condition specific directive in Ophthalmology

Standard Operating procedure for drop administration by SHCA/Imaging and Orthoptic Technicians in the eye clinic

NDDH Drop administration Competency Sheet

Staff competency should be reassessed every 12 months and documented in the competency in eye clinic

3 Scope

3.1 This SOP relates to patients requiring dilating drops prior to imaging, fundoscopy and laser treatment to ensure a good view of the internal structures and fundus when attending for the following reasons:

Medical Retina

Cataract one stop

Laser post cataract surgery

Glaucoma monitoring

Uveitis

Retinal laser

Imaging

3.2 This SOP also relates to patients requiring diagnostic staining and anaesthetic drops combined prior to Goldman Applanation Tonometry when the requested I-care is above 21 or when attending for the following reasons. Glaucoma monitoring

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3.3 This SOP also relates to patients requiring local anaesthetic drops prior to intravitreal injections.

4 Clinics included and pre workup required

4.1 Medical Retina includes:

Wet Age-Related Macula Degeneration –WAMD

Diabetic Macula Oedema -DMO Diabetic Retinopathy -DR

Retinal Vein Occlusions -RVO Central Serous Retinopathy -CSR Other Medical Retina -OMR

Clinic Codes: for Macula disease

MD1 New/f/up WAMD, DMO, RVO, CSR, OMR MD2 F/up WAMD, DMO, RVO, OMR MD3 F/up WAMD FA SC New WAMD RETIN-WAMD imaging in Barnstaple BID-WAMD imaging in Bideford

Pre workup

Test visual acuity using a Logmar chart

Test intraocular pressure using the I-care

Dilate both eyes with Tropic amide 1%

Enter information on medisoft and in medical notes

Put notes in appropriate tray for OCT

DC1 New/f/up DR DC2/3 F/up DR Pre workup

Test visual acuity using a Snellen chart

Test intraocular pressure using the I-care

Dilate both eyes with Tropicamide 1%

Enter information on medisoft and on green sheet in medical notes

Put notes in appropriate tray for OCT

4.2 Cataract one stop

Clinic Code CA1

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Pre workup

Test visual acuity using a Snellen’s chart

Measure glasses if worn using focimetry if not test auto refraction

Calculate intraocular pressure using the I-Care

Calculate the Biometry measurements using the IOL Master or Contact A-scan machine

Dilate both eyes with Tropicamide 1%

Enter information on medisoft and in the patient notes

Put notes in the appropriate place in the pile for the doctor

4.3 Laser post cataract surgery for capsulotomy

Clinic code

CAP Pre workup

Test visual acuity using a Snellen’s chart

Test intraocular pressure using the I-care

Dilate with Tropicamide 1% to affected eye

Enter information on medisoft and in patients notes

Put notes in appropriate place for the Docto

4.4 Glaucoma clinics

Clinic code OA Pre workup

Test visual acuity using Snellen’s chart

Measure glasses (if worn) using the focimeter

Test visual fields using Humphreys field analyser

Test intraocular pressure using the ORA (Ocular Response Analyser)

If IOP breached targets instil lidocaine and fluorescein prior to GAT

Perform GAT

Dilate both eyes with Tropicamide 1%.

When dilated perform glaucoma imaging Clinic Codes GMC

Pre workup

Test visual acuity using Logmar

Measure glasses (if worn) using the focimeter

Test visual fields using Humphreys field analyser

Examine anterior segment Instil lidocaine and fluorescein prior to GAT

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Perform GAT

Examine disc, if no view

Tropicamide 1% to appropriate eye(s) (but not if GAT outside of target)

When dilated examine fundus

If GAT outside of target add treatment as per protocol or refer to MDT or virtual clinic

Clinic Codes GMC3 Pre workup

Test visual acuity using Logmar

Measure glasses (if worn) using the focimeter

Test visual fields using the Humphreys field analyser

Examine anterior segment

Instil lidocaine and fluorescein prior to GAT

Perform GAT

Instil Tropicamide 1% to appropriate eye(s)

When dilated perform disc assessment and glaucoma imagining

4.5 Uveitis clinics

Clinic Code

UV1

Pre workup

Print recent blood results

Test visual acuity using Snellen’s chart

Test intraocular pressure using the I-Care

Dilate both eyes with Tropicamide 1%

When dilated put in trolley for macula imaging

4.6 Retinal Laser Procedures

Clinic Codes AR1 PRP

Pre workup

Test visual acuity using Snellen’s chart.

Test intraocular pressure using the I-Care

Dilate both eyes with Tropicamide 1% and Phenylephrine 2.5%.

Put notes in appropriate place for the Doctor

4.7 Imaging clinic

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Clinic Code 1M Pre workup

Test visual acuity using Snellen’s chart.

Dilate both eyes for fundal imaging with Tropicamide 1%

Take scans as requested.

4.8 Intravitreal injections Clinic Code IN Pre workup

Instill Proxymetacaine 0.5% as guide instructions attached, if documented not effective use Oxybuprocaine as instructions attached.

5. Location

5.1 This Standard Operating Procedure (SOP) can be implemented in all clinical areas where there is competent staff available to undertake this role including the associated community hospitals.

5.2 Staff undertaking this procedure must demonstrate continued competence as per the organisations policy on assessing and maintaining competence.

6. Equipment

Tissues

Appropriate drops

Access to Medisoft and patients notes to record drop administration

Medicine information resources

British National Formulary and North and East Devon Formulary on Trust Intranet website, BOB

The Summary of product characteristics (SPC), via the electronic medicines compendium website

7 Procedure

7.1 Check exclusion criteria and do not instil drops if patient is in this category. Inform the Clinician who is due to see the patient to obtain further instructions.

7.2 To prepare the patient for the administration of eye drops you need to:

Apply standard precautions for infection control and any other relevant health and safety measures.

Before the clinic commences have the clinic specific eye drops available

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Choose the correct eye drop according to the specific condition direction

Check and confirm the identity of the patient who is receiving the medication using 3 checks, i.e. Name, address and D.O.B before administering it.

Understand what the eye drop is administered for and explain the effects to the patient

Obtain patient consent and offer information, support and reassurance throughout the procedure

7.3 To administer, report and monitor patients medication you need to:

Select the correct eye

Safely administer the medication in line with legislation and local policies in a way that minimises pain, discomfort and trauma to the individual

Report any immediate problems with the administration

Monitor the individuals condition throughout the administration, recognise any adverse effects and take appropriate action without delay

Clearly and accurately enter relevant information in the correct notes/ESR

Maintain the security of the medication throughout the process and dispose of the used single dose items appropriately

Monitor and rotate stocks of the eye drops, maintain appropriate storage conditions and report any discrepancies to the registered nurse

Dispose of expired and part used medications in accordance with legal and organisational requirements

Maintain confidentiality of the patient’s notes at all times.

7.4 The below guidance gives details of areas to be covered in the training programme and for staff to be assessed as competent.

Relevant staff may include: person in charge of the clinic, nursing and medical staff, and the pharmacist.

Check identity may include: verbally with the individual, other communication methods if language barrier or deafness, or confirming with the person with them.

Immediate problems may include: lack of co-operation from the patient, inability to open the eye properly or excessive blink reaction.

Adverse effects may include: transient stinging, raised intraocular pressure above 21, allergic conjunctivitis is not uncommon with some dilating drops. These include transient

bradycardia (followed by tachycardia, palpitations and arrhythmias), photophobia, dry

mouth, flushing and dryness of the skin. Occasional confusion, (particularly in the elderly), nausea, vomiting and giddiness.

Chloramphenicol and some anaesthetic drops can cause stinging and conjunctival Injection.

Appropriate action may include: call for help, deal with collapse, and reassure the

patient.

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8 References

Janet Marsden (2007) Ophthalmic Care.

British National Formulary BNF online or via BNF App’ latest addition

9 Associated Documentation

Northern Devon Healthcare NHS Trust Policies for:

https://ndht.ndevon.swest.nhs.uk/wp-content/uploads/2018/04/HCA-Imaging-Technician-orthoptist- Drop-Administration.pdf

NDDH Drop administration handbook, 2014

Conditions requiring dilating drops routinely, 2020

https://ndht.ndevon.swest.nhs.uk/standard-infection-control-precautions-policy/

https://ndht.ndevon.swest.nhs.uk/discretionary-medicines-standard-operating-procedure/

https://ndht.ndevon.swest.nhs.uk/safe-and-secure-storage-of-medication-policy

Medicines Management: An overview for nursing RCN 2020

Professional Guidance on the administration of Medicines in Healthcare Settings RPS Jan 2019

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UKOPG

Ophthalmic Services Guidance

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Eye Drop Instillation by Unregistered Health Care Professionals for use within NHS Ophthalmic

Services

November 2020

Aim

The aim of this document is to provide a framework for ophthalmic services to facilitate the

administration of necessary and appropriate eye drops by unregistered health professionals to

patients under the care of the ophthalmic department. It outlines how this is possible and legal within

the currently legal and regulatory systems.

Background

Ophthalmology is the highest volume outpatient specialty in the NHS, providing more than 8 million

appointments a year. Many patients are seen in high volume assessment or diagnostic clinics which

require the use of anaesthetic and pupil dilating drops to complete. This model of care makes it

impractical for all dilating and anaesthetic drops to be prescribed for each patient and to continue

delivering care it is recognised that numerous unregistered healthcare professionals are currently

required to administer eye drops within the ophthalmic setting, including health care assistants,

ophthalmic science practitioners, diabetic eye screeners and clinical scientists. Ophthalmology has

long standing capacity issues leading to recurrent episodes of harm and serious loss of sight.

Numerous publications have highlighted this and made recommendations for much more care to be

delivered in efficient face-to-face diagnostic pathways and virtual clinics based on high quality dilated

imaging of the eye requiring drops ( GIRFT, RCOphth, NHS England High Impact Intervention (HII) and

EyesWise, HSIB). With the recent cessation and ongoing reduction in capacity in ophthalmology due to

COVID-19, it will be crucial to significantly increase this mode of delivery to maintain patient safety.

The involvement of non-registered health care professionals in the instillation of drops in eye

outpatients will be central to undertaking this and will need to underpin the planned NHSE& I eye care

restoration and transformation programme and the RCOphth ophthalmology COVID-19 recovery

guidance.

It is hoped that this document will help centres to optimise patient safety and experience whilst

ensuring that dilation and anaesthesia can be undertaken in a timely manner.

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Legal background and precedents

The Human Medicines Regulations 2012 (HMRs) consolidate the law of the United Kingdom

concerning medicinal products for human use. This includes most of the Medicines Act 1968.

Section 58(2) of the Act provided that no person shall administer a prescription only medicine (POM)

unless he is an appropriate practitioner or a person acting in accordance with the directions of an

appropriate practitioner. The provision is now reflected in Regulation 214 (2) of the HMRs. This

states that

A person may not parenterally administer (otherwise than to himself or herself) a

prescription only medicine unless the person is

(a) An appropriate practitioner other than an EEA health professional; or

Acting in accordance with the directions of an appropriate practitioner

An “appropriate practitioner” includes a doctor, dentist and a range of registered healthcare

prescribers including nurse and pharmacist independent prescribers. The restriction in the Act no

longer applies to non-parenteral medicines. In this context, parenteral administration is defined as

administration by breach of the skin or mucous membrane.

As eye drops and other topical ocular medications are not administered parenterally, the

administration restriction above does not apply to the topical administration of eye

preparations.

The NHS National Diabetic Eye Screening Programme (DESP) which utilises dilating drops in

their population screening of over 4 million diabetics annually in England sought clarity from

the MHRA regarding what impact this had on the instillation of eye drops as part of their

service without a patient group direction or a patient specific direction (PSD). In 2006 the

MHRA agency confirmed that it is not against the law for POM eye drops to be administered by

healthcare workers in the absence of a prescription, Patient Group Direction (PGD), Patient Specific

Direction (PSD) or other orders. This was subject to the requirement that the medicines had been

lawfully obtained by a healthcare body, for example, a hospital. They advised that it is important,

whatever the model of delivery, that safe systems of work are in place governing the administration

of eye drops.’ Therefore, there are no legal restriction on who can administer/instil eye drops

such as tropicamide and phenylephrine for the purposed of dilating the pupil for screening.’

The DESP uses pupil dilating drops (Tropicamide 1%) instilled by a Band 3 retinal screener

for all patients without any PSD or individualised directive. The diagnosis of diabetes is the

directive. The following extract from the DESP National Screening Committee Workbook

(Appendix 1) explains the legal clarification:

The Medicines and Healthcare products Regulatory Agency (MHRA) advises as follows:

a) Is Tropicamide 0.5% and 1.0% a prescription only medicine (POM)?

Yes. However the medicines legislation regulates the requirement for a prescription in

different ways depending on whether the eyedrops are being sold, supplied, administered

parenterally (by injection) or externally.

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b) Is Phenylephrine 2.5% a POM as well?

No. 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.

c) Does that mean that screeners can only administer eye drops if there is a prescription or

other order such as a Patient Group Direction (PGD) or Patient Specific Direction (PSD)?

Not necessarily. The MHRA says that medicines legislation places no legal restriction on who

can administer/instil eye drops such as tropicamide 0.5% and 1.0% and phenylephrine 2.5%,

for the purposes of dilating the pupil for screening. This advice, however, is limited to

administration only and not to the sale or supply of tropicamide. It is the wholesale

acquisition, sale and supply of these eye drops that is restricted by the legislation and this

might affect which organisations and individuals can legally acquire eye drops.

d) So who can legally acquire eyedrops?

The wholesale supply of medicine is regulated by medicines legislation. Generally, the

wholesale supply of POMs is restricted to specified classes of persons / establishments such

as NHS Trusts, doctors and pharmacists. Some registered health professionals may also

obtain certain POMs on a wholesale basis. This includes the wholesale supply of tropicamide

to optometrists (but does not extend to dispensing opticians).

e) So how does that affect screening programmes in practice?

The following paragraphs are intended to provide information about the legalities of

common scenarios involving the use of eye drops in retinal screening programmes. They are

not definitive and while the MHRA is happy to offer further clarification where necessary,

organisations should also be prepared to obtain their own legal advice.

i) NHS Organisations

Retinal screeners employed by NHS bodies such as hospitals and Primary Care Trusts can

access eye drops obtained by those bodies for administration in the course of their business.

No prescription, PGD, PSD or other order is required. It is possible that agency staff operating

within a Trust and under close supervision, and covered by the trust’s insurance may be in a

similar position but the MHRA suggest that individual trusts that intend to rely on this take

advice from the trust’s lawyer before doing so. NHS bodies entering into an arrangement

with an independent provider (or anyone else who is not part of their organisation) to

provide screening services should be aware that unless they have a wholesale dealer’s

licence, they cannot legally supply stocks of POM and P medicines to that provider.

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RCOphth have also approached the MHRA Policy Division, which confirmed that this

statement reflects their longstanding legal position in relation to administration of non-

injectable medicines which have been lawfully obtained by a healthcare body. In summary,

in order to facilitate the smooth and safe running of the service, unregistered health

professionals may administer eye drops without a prescription provided they have been

lawfully obtained by a healthcare body.

Risks of pupil dilatation (mydriasis)

There have been a number of large reviews of the use of pupil dilating drops and an

overview paper in the British Medical Journal in 2006 summarised these:

A systematic review reported that out of an estimated 600 000 individuals who received

mydriatic eye drops, 33 (0.006%) developed acute angle closure glaucoma, giving an

estimated risk of 1 in 20 000. The same review found that in almost 4000 people whose

pupils were dilated using tropicamide, none developed acute glaucoma as a result of the

dilatation. We are aware of only two cases of tropicamide-induced angle closure glaucoma

from the published literature. Thus, these studies place the risk of acute angle closure

glaucoma caused by pharmacological pupil dilation at 1 to 6 per 20 000 people in the

general population.

This review concluded that pupil dilation is important for thorough fundoscopy, and the risk

of precipitating acute angle closure glaucoma with routine use of mydriatics is close to zero.

Putting this into practice

Whilst it is correct that a prescription is not necessary in order to administer appropriate

eye drops within ophthalmic outpatient clinics it remains vital that an appropriate detailed

trust specific protocol exists to allow the safe administration of eye drops for these patients.

This should include indication, any patient exclusion or contraindication criteria, dosage

information, information about adverse reactions and details regarding how the user can

seek further advice if needed including as required access to medical advice in an emergency.

A formal process of education must also exist in order for the user to be signed off as

competent and this should be revalidated at appropriate time intervals. The user must also

be familiar with any side effects and patient advice that is relevant to the eye drops that are

being administered. A process should be agreed to ensure that the treatment episode is

documented appropriately. Patients should also be made aware of the risk with regard to eye

drops, actions they should take in the event of problems, and the fact that it will not be safe to

drive as after mydriatic eye drops their vision will be temporarily blurred.

References

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RCOphth Covid Recovery and Restoration Guidance. 2020.

https://www.rcophth.ac.uk/about/rcophth-guidance-on-restoring-ophthalmology-services/

GIRFT Ophthalmology report 2019. https://improvement.nhs.uk/resources/ophthalmology-

national-report/

NHS England High Impact Intervention Ophthalmology. https://www.england.nhs.uk/wp-

content/uploads/2019/01/ophthalmology-elective-care-handbook-v1.1.pdf

NHS England Eyes Wise. https://www.england.nhs.uk/elective-care-transformation/best-

practice-solutions/eyeswise/

NHS England and Improvement Eye care hub.

https://future.nhs.uk/ECDC/view?objectId=22317360

Lack of timely monitoring of patients with glaucoma. HSIB 2020.

https://www.hsib.org.uk/investigations-cases/lack-timely-monitoring-patients-glaucoma/

National Screening Programme for Diabetic Retinopathy Workbook version 4, Appendix 1.

Release 4.1, 2 August 2007 Page 21

Fundoscopy: to dilate or not to dilate? The risk of precipitating glaucoma with mydriatic eye

drops is very small. Liew G. BMJ. 2006 Jan 7; 332(7532): 3

Mydriasis and glaucoma: exploding the myth. A systematic review. Pandit RJ, Taylor R.

Diabetic Med. 2000;17: 693-9.

The risks of precipitating acute angle-closure glaucoma with the clinical use of mydriatic

agents. MBrooks AM, West RH, Gillies WE. J Aust 1986;145: 34-6.

The Human Medicines Regulations August 2012.

Section 58 (2)(b) of the Medicines Act 1968 absorbed into Article 9 of the 1997 Order No

1830 2012 Regulations

MHRA Advice on administering eye drops in retinal screening programmes 2006

Personal communication with MHRA Policy Division 2019 and 2020.

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APPENDIX B Tropicamide 1%

Indication Pupil dilation for fundoscopy in patients attending the clinics for review of the following conditions:

Diabetes

Age Related Macula Degeneration

Glaucoma

Uveitis

Cataracts for consideration of surgery

Fundus imaging

Patients undergoing YAG Capsulotomy

PRP(pan retinal photocoagulation)

Focal macula laser

Legal Class POM (Prescription Only Medication)

Exclusion Criteria Individuals under 16 years of age

Hypersensitivity to Tropicamide or any excipients

Tropicamide is contraindicated in untreated acute angle closure glaucoma

Previous precipitation of closed angle glaucoma by mydriatic drops

Location Outpatient eye clinics in NDDH and surrounding community hospitals.

Cautions; need for further advice

There is small risk of precipitation of closed angle glaucoma (0.03%). All patients should be made aware of this risk and advised to report

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any symptoms suggesting this immediately to the nurse treating them, or if they have symptoms on returning home, to the local emergency department. Symptoms can include the following:

1. Intense pain 2. Redness of the eye 3. Headache 4. Tender eye 5. Misty vision 6. Seeing haloes or rainbow like rings around

lights 7. Loss of vision in one or both eyes that progress

quickly 8. Nausea

Pregnancy and breast feeding safety not established therefore seek medical advice.

Method or route of administration

Topical to the eye

Formulation

1% minims

Dose and Frequency

One drop into lower fornix of eye(s) to be examined. Maximum of two doses per visit. Administer first dose prior to examination of the eye(s). If adequate dilation not achieved within 15 minutes a second dose may be administered.

Side effects Frequency not known Erythema, irritation, pain, headache, nausea, blurred vision, Photophobia Rarely syncope

Advice and information to patient/carer including follow-up

Unusual or life threating reactions require immediate medical attention.

There may be initial stinging on administration and blurring of vision will occur.

Patients should not drive or operate machinery until vision is clear.

They may need to wear dark glasses in bright sunlight as their pupils will be dilated.

Remove contact lenses and advise patients not to wear them for an hour after administration.

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APPENDIX C Phenylephrine 2.5%

Indications Pupil dilation prior to laser treatment

Legal Class P (Pharmacy)

Exclusion criteria Individuals under 16 years of age

Hypersensitivity to Phenylephrine or any excipients

Phenylephrine is contraindicated in untreated acute angle glaucoma

Previous precipitation of closed angle glaucoma by mydriatic drops

Location Outpatient eye clinics NDDH and surrounding community hospitals

Cautions: need for further advice

There is small risk of precipitation of closed angle glaucoma (0.03%). All patients should be made aware of this risk and advised to report any symptoms suggesting this immediately to the nurse treating them, of if they have symptoms on

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returning home, to the eye clinic or their local casualty department. Symptoms can include the following; 1 Intense pain 2 Red eye 3 Headache 4 Tender eye area 5 Misty vision 6 Seeing halos or rainbow-like rings around light 7 Loss of vision in one or both eyes that

progresses quickly 8 Nausea

Pregnancy and breastfeeding safety not established therefore seek medical advice

Method or route of administration

Topical to the eye

Formulation 2.5% minims

Dose and formulary One drop to the lower fornix of the eye(s) to be examined/lasered.

Side effects Frequency not known: Erythema, irritation, pain, headache, blurred vision, photophobia and rarely syncope.

Advice and information to the patient/carer including follow-up

Unusual or life threatening reactions require immediate medical attention

There may be initial stinging on administration and blurring of vision will occur.

Patients should not drive or operate machinery until vision is clear

They may need to wear dark glasses in the bright sunlight as their pupils will be dilated.

Advise patients who wear contact lenses to remove them and not to wear them for an hour after administration.

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APPENDIX D Proxymetacaine 0.5%

Indications Topical Ocular anaesthetic prior to intravitreal injections

Legal Class POM (Prescription Only Medication)

Exclusion Criteria Hypersensitivity to proxymetacaine or any components of the preparation

Individuals under 16 years of age

Location Outpatient eye clinics, NDDH and surrounding community hospitals

Cautions: need for further advice

Ensure contact lenses are removed before instillation and not replaced for two days

Pregnancy and breastfeeding-safety not established therefore seek medical advice

A severe immediate hyperallergic reaction may rarely occur. This includes acute, intense,and diffuse

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epithelial keratitis: a grey ground-glass appearance: sloughing of large areas of necrotic epithelium: corneal filaments and sometimes, iritis with descemetitis (inflammation of descemet’s membrane on the posterior surface of the cornea.)

Method or route of administration

Topical to the eye

Formulation 0.5% minims

Dose and Formulary Several drops all around the eye for complete anaesthesia.

Repeat two minutes later.

A final minim used on a cotton bud for up to 2 minutes on the area to be injected.

Side effects Pupillary dilatation or cycloplegic effects have rarely been observed with Proxymetacaine hydrochloride preparations.

Irritation of the conjunctiva or other toxic reactions have occurred only rarely.

Transient irritation, stinging and blurring of vision may occur on instillation

Advice and information to the patient/carer including follow-up

Unusual or life threatening reactions require immediate medical attention

Do not rub or touch the eye.

Contact lenses not to worn for two days

Protect it from foreign bodies for up to an hour

after the procedure.

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APPENDIX E Oxybuprocaine (Benoxinate) Hydrochloride 0.4%

Indication Local anaesthetic prior to intravitreal injections if proxymetacaine not effective.

Legal Class POM (Prescription Only Medication)

Exclusion Criteria Hypersensitivity to Oxybuprocaine or any components of the preparation

Individuals under 16 years of age

Location Outpatient eye clinics in NDDH and surrounding

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community hospitals

Cautions need for further advice

Ensure contact lenses are removed before instillation a

Pregnancy and breastfeeding-safety not established therefore seek medical advice

Method or route of administration

Topical to the eye

Formulation 0.4% minims

Dose and frequency

Several drops all around the eye for complete anaesthesia.

Repeat two minutes later.

A final minim used on a cotton bud for up to 2 minutes on the area to be injected

Side effects Transient irritation, stinging and blurring of vision may occur on instillation.

In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances, anaphylactic shock).

Irritation of the conjunctiva or other toxic reactions have occurred only rarely.

Advice and information to patient/carer Including follow-up

Unusual or life threatening reactions require immediate medical attention

Patients should be advised not to drive or operate hazardous machinery until normal vision is restored

Do not rub or touch the eye.

Contact lenses not to be worn for two days

Protect it from foreign bodies for up to an hour

after

APPENDIX F Lidocaine and Flourescein

Indications Prior to Intraocular pressure testing with goldmans applannation tonography

Legal Class POM (Prescription Only Medication)

Exclusion Criteria Hypersensitivity to fluorescein, lidocaine and other amide-type local anaesthetics or any excipients

Individuals under 16 years of age

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Location Outpatient eye clinics in NDDH and surrounding community hospitals

Cautions need for further advice

Ensure contact lenses are removed before instillation and not replaced for at least 2 hours or until the fluorescein is no longer visable in the eye.

Method or route of administration Topical to the eye

Formulation Lidocaine hydrochloride 4% and Flourescein Sodium 0.25% minims

Dose and Frequency One drop into the lower fornix of the eye(s) to be tested

Side effects Symptoms of allergic type reactions and anaphalaxis have been reported following topical ophthalmic administration of fluorescein sodium such as

Allergic conjunctivitis, peri-orbital oedema

Immune system disorders:anaphylactic reaction

Skin and subcutaneous disorders:urticarial, rash

Advice and information for patient/carer including follow-up

Unusual or life threatening reactions require immediate medical attention

Do not rub or touch the eye.

Contact lenses not to be worn for two days

Protect it from foreign bodies for up to an hour after

APPENDIX G Escalation procedure If patient shows allergic reaction move to a private area. Inform another staff member what is happening. Record the reaction in the notes and on medisoft. Take baseline observations.

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Stay with patient. If limited to a local reaction around the eye advise to see the GP if it does not resolve or improve in 24 hours If condition deteriorates i.e. patient has difficulty breathing or collapses: At NDDH ask someone to ring 22222 In a community hospital ring 999 or ask a colleague to do so.

If the reaction proceeds to Anaphylaxis implement the Anaphylaxis policy as below.

Inform Next Of Kin Write up the episode and record the allergen if known inform the patient and GP of suspected allergen.

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