Consultation draft
Under the consultation purpose section (2.0); under current exemption legislation in the Human Medicines Regulations optometrists are permitted to sell or supply a limited range of prescription only medicines (POMs). In the course of professional practice, this is only possible in an emergency clinical situation. However, they may write a signed order for these POMs so the patient can obtain them from a pharmacy without the emergency caveat. This should be made clear where this phrasing is used future documents to avoid confusion on when writing a signed order is possible; as the current wording it implies this can only be done in an emergency.
Suggest: “WGOS enables NHS Wales Optometrists to sell or, supply or write an order for an extended range of POMs in an emergency and as part of their professional practice. The exemptions in the Human Medicines Regulations also permit pharmacists to supply these medicines to patients against a signed order written by an optometrist without it needing to be an emergency.”
Page 3/section 2.2/line 74
It is unclear what the functional difference is between tear-deficiency and dry eye. Dry eye is the clinically accepted diagnostic term for an inflammatory eye condition which includes a range of subtypes, including tear (aqueous) deficiency. While dry eye invariably is a mixture of evaporative and aqueous deficiency subtypes, the latter does not respond to eyelid hygiene measures as it results from primary loss or lack of tear production by the lacrimal gland. However, as the evaporative component is largely caused by Meibomian gland dysfunction (MGD), these may be appropriate for dry eye. For these reasons, suggest remove the term “tear deficiency”.
Evidence: TFOS DEWS II Definition and Classification Report - PubMed
Page 3/section 2.2/line 77
It is important to recognise that dry eye and blepharitis are typically chronic and lifelong conditions where the natural history involves periods of activity and quiescence over time. There is risk that patients cease these non-pharmacological interventions when symptoms resolve, only to seek care for the same symptom when they recur. Further, depending on severity, patients may need more or less frequent application as their symptoms improve but they should continue this treatment long-term. Complete eradication may not be possible using these methods, but long-term compliance should reduce symptoms and minimise the rate and severity of relapses/exacerbations.
Suggest: “…then once a day when the eye(s) begin(s) to feel better taper to a regimen that minimises symptoms. Patients should be informed regarding the chronic nature of these conditions and the importance for ongoing treatment.”
To align with The College’s Clinical Management Guidelines, other non-pharmacological advice should be considered such as avoiding cosmetics (e.g. eyeliner and mascara) during active episodes or exacerbations.
Page 3/section 2.2/line 79
Step 1 and Step 2 should be combined as both damp warmth from the compress and the massage technique are more likely to loosen crusts in anterior blepharitis and melt the abnormal meibum in posterior blepharitis (MGD). This would simplify the process and encourage compliance – this is important as there is evidence that long-term compliance with eyelid hygiene measures is poor.
Evidence: Interventions for chronic blepharitis - PubMed
Eyelid cleaning: Methods, tools, and clinical applications - PubMed
Blepharitis Preferred Practice Pattern® - PubMed
Page 3/section 2.2/line 80
The temperature of the water should be around 37-40°C (around bath temperature) to maintain effectiveness.
Evidence: The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction - PubMed
Blepharitis Preferred Practice Pattern® - PubMed
Page 3/section 2.2/line 97
While dry eye symptoms may be caused by blepharitis (usually posterior subtype, identified where there is Meibomian gland dysfunction (MGD); in the absence any type of blepharitis, dry eye is unlikely to respond to Step 3. Step 3 helps to wipe away bacteria and deposits from the lid margins, which occur in blepharitis.
Suggest: “Step 3: Where there is any blepharitis, eyelid margin hygiene:”
Page 6/section 3.3/line 158
There are only 3 manufacturers who produce single unit dose (minims) 2% sodium cromoglicate. These are less frequently available in community pharmacies and it is not clear the rationale for limiting the choice to this specific preparation. 2% sodium cromoglicate is available in a 10mL multi-dose bottle with wide range of generic/non-proprietary preparations which are less expensive than minims (both POM and P/GSL formulations). This medicine also has a very good safety profile. While minims may be helpful for long-term use, where contact lenses are used or there is a known allergy to benzalkonium chloride:
Suggest: adding 2% generic eye drops (P) 10mL pack size; and reserve the preservative free minims if clinically necessary.
Evidence: Sodium Cromoglicate - College of Optometrists
Page 10/section 3.7/line 219
Another widely available non-medicated ointment preparation for the same indications available as a P medicine is “Simple eye ointment” (non-proprietary/generic), which is a yellow soft paraffin. This should be added to the formulary listing as an alternative preparation - there is risk a pharmacy may not stock the current listing where a delay in accessing treatment could lead to worsening symptoms particularly for corneal erosion and trauma.
It is unclear what the rationale is for listing a single preservative free preparation when there is no evidence for any untoward effects, interactions or special precautions with Simple eye ointment.
Evidence: Paraffin, Yellow, Soft - College of Optometrists
Page 13/section 3.8/line 237
There are a very wide range of generic preservative-free multi-dose sodium hyaluronate preparations (currently n=42) available. However, only 10 are specifically available in 0.2% dose. To increase likelihood of availability and improve clinician recommendation (lower active ingredient doses may be more suitable for those at risk of hypersensitivity reactions; higher doses may be more suitable for more severe presentations), suggest providing a range of generic doses e.g. between 0.1 – 0.4%. There is little significant difference in cost between the different doses.
Evidence: Sodium Hyaluronate - College of Optometrists