Fierce lobbying by British representatives will take place over the summer in the UK and Europe to ensure British practitioners can carry on caring for patients in a sensible, safe and efficient manner. But there will not be a hint of Brexit in the air.
These negotiations will be about simple strips of paper impregnated with a dye which are used by contact lens fitters to assess the patient’s tear film. Fluorescein strips are wetted with a sterile saline solution and touched on the tear film. Under cobalt blue light the dye fluoresces allowing the moisture layer to be visualised so the practitioner can optimise the fit. But this familiar and important procedure is at risk following a decision four years ago about the classification of the humble fluorescein strip.
The lobbying, led in the UK for the Optical Confederation by the Federation of Ophthalmic and Dispensing Opticians (FODO) and the Association of Contact Lens Manufacturers (ACLM), is seeking to have the strips designated as a medical device, based on the argument that F strips demonstrate the anatomy of the eye and do not act in a diagnostic capacity or produce any pharmacological effect.
Fluorescein first flared up as an issue back in March 2013 when, following the decision of the European Medicines Agency to classify fluorescein strips as medicinal products. Bausch + Lomb decided to cease the only supply of F strips, branded Fluorets, which were CE marked as a medicinal product.
As far as day to day use in the UK was concerned other non-medicinal product, CE marked, fluorescein impregnated strips were available. However, in line with the European decision, the UK’s competent body, the Medicines and Healthcare products Regulatory Agency (MHRA) had classified Fluorets as a medicinal product and the withdrawal of B+L from the market meant in the UK there was no longer a licensed fluorescein strip available.
The profession was faced with the prospect of having to use minims of fluorescein for tear film monitoring. This would mean using vials of fluorescein in practice. This is a process in which instillation is harder to perform, has the potential for over-instillation of fluorescein to the eye and encourages storing of opened vials for later use. The use of minims is accepted as being a much more costly option, and with re-use likely, it was argued this was also a more risky option for the patient. More crucially, while optometrists could use minims of fluorescein, contact lens opticians could not.
With the supply of licensed F strips removed following B+L’s business decision to cease Fluorets in May of 2013 the Optical Confederation issued advice to the profession to use 1% fluorescein minims while the problems of fluorescein strips were resolved, but the supply of 1% fluorescein minims had also run out.
In September of that year a panel of experts convened by the Optical Confederation, led by FODO and the ACLM advised the professions to continue use of paper impregnated fluorescein strips until further notice, having identified that the CE marked medical devices posed minimal risk.
At the time the OC’s panel said ‘failure to use fluorescein when clinically indicated in a primary care setting due to non-availability of a suitable pharmaceutical preparation will put patients at risk through a failure or delay to recognise sight-threatening ocular conditions’.
It went on to point out that paper strip instillation made minimal instillation more achievable.
BioGlo brand fluorescein strips
The OC added that optometrists and contact lens opticians in the UK could use a CE marked medical device fluorescein strip, permitted in the UK by MHRA, as an alternative to a fluorescein sodium unit dose until further notice. This would be reviewed should new information come to light on the classification, clinical use or safety of fluorescein.
In anticipation of a further ruling that October, the MHRA, recognising the potential consequences on patients, decided not to take enforcement action against suppliers of CE marked medical device fluorescein strips to the UK market until the EU position was clarified, therefore permitting their sale in the UK. The GOC followed suit by stating they would not prosecute registrants using the strips until the issue was resolved at EU level.
This was always a temporary arrangement because although the European Medicines Agency determined that fluorescein strips were a medicinal product, there was also recognition that they could potentially fall under the definition of a medical device for certain usages, such as contact lens fitting. The issue was therefore referred to the Borderline Classification Working Group, which is now expected to reach a decision on the classification of fluorescein strips at a meeting on November 17.
Neither the evidence base nor the risk has changed since 2013. Despite world-wide use of F strips no incidents have been reported and the clinician’s professional duty to put the interests of the patient above all others remains. However, there is now a real risk that a decision will be made to classify fluorescein strips, along with unit doses, as medicinal products, at which point the temporary arrangements allowing for use of strips CE marked as medical devices will cease.
Ann Blackmore (pictured left), director of policy and strategy at the Federation of Dispensing and Ophthalmic Opticians, has been central to negotiations with the European bodies seeking to persuade the Working Group to classify fluorescein strips as medical devices solely for the purposes of contact lens fitting.A position paper has been produced on the issue which spells out the need for fluorescein strips to be used by contact lens fitters and the ramifications of licensing all products which involve fluorescein, as a medicine. The paper has been produced by the European Council of Optometry and Optics (ECOO), EuromContact (the European Association of the contact lens and lens care products manufacturers) and ECFLIN (European Federation of Contact Lens Industries). The UK is a member of ECOO (through the Joint Optical Committee of the EU (JOCEU), which is ABDO, AOP, FODO, the College of Optometrists and the GOC). The UK is represented on Eurom-Contact through the ACLM. The make up of this coalition may be complex but its raison d’etre is simply to support the medical devices classification of fluorescein strips.
They argue that fluorescein strips simply visualise the tear film and do no act pharmacologically, they allow for safe contact lens fitting and meet the medical devices definitions. The classification of F strips as medicines would have a serious negative impact on patient health as fitting would become less effective. It also argues that classifying fluorescein strips as medicines would affect the supply as no manufacturers are currently certified to supply the product as a medicine.
This means that if fluorescein strips are simply classified as medicinal products there will, once again, be no legal supply available in Europe. Blackmore says while a manufacturer could seek a medicines licence for F strips currently designated as medical devices it is unlikely they will do so because the market would be so small. Even if one did, it would take time and there would be disruption to supply and the product could become a lot more expensive in future.
‘Fluorescein strips are the most effective and safe way to fit contact lenses,’ says Blackmore. ‘We have never seen a reported instance of adverse effect on a patient from use of fluorescein strips. Without them, fluorescein drops would have to be used in fitting contact lenses. But there is a real risk that this would result in higher concentrations than necessary being used on patients, it would be more expensive and could only be used by optometrists, because CLOs are not entitled to use fluorescein when classified as a medicine.’
‘We understand from colleagues in Brussels that the Working Group is inclined to leave the classification as a medicine – this is because patient safety rules apply to medical classifications and operate on the principle that you apply the classification for the highest use, not the lowest. But this will have serious implications which we do not believe have been properly understood and this is why we are working hard to lobby for change.’
While the decision on classification is taken by the Borderline Classification Working Group, it is the competent authorities in each member state that make up that group and therefore influence the decision. The position paper is being used in each member country to seek to convince the local competent authority of the grouping’s argument.
In the UK Blackmore and Simon Rodwell of the Association Contact Lens Manufacturers plan to meet with the MHRA shortly. The outcome of that meeting, she says, will determine what more needs to be done in terms of lobbying. The Irish optical bodies, led by FODO, will also be lobbying their regulatory bodies on this issue in advance of the November 17 meeting.
If the group’s efforts are in vain the nature of contact lens fitting across Europe could change forever, and not in a good way.