Response to a GOC stakeholder survey on illegal practice
Our response to the GOC's questions, June 2021
In May 2021 the GOC asked us and other stakeholders to answer a short survey about the risks associated with illegal practice in the optical sector. Our response was informed by a discussion about illegal practice and the GOC’s survey questions at the June 2021 AOP Council meeting.
Q1. Were you aware of the GOC strategy and protocol on tackling illegal practice?
Yes. The AOP has engaged regularly with the GOC about its approach to tackling illegal practice and its protocol for prosecutions in recent years. Our public position statement on illegal practice sets out our concerns about the GOC’s current approach and the changes we want to see.
Q2. Were you aware that the Opticians Act 1989 creates the areas of illegal optical practice set out above?
Yes. We have published guidance for AOP members about the definition of illegal practice in the optical sector.
Q3. Which areas of illegal optical practice do you think pose the highest likelihood of risk of harm and most severe risk of harm to the public and why?
Illegal practice in the optical sector poses numerous risks to the public. The 2014 Europe Economics report: health assessment for illegal practice - which the GOC commissioned when it last reviewed its approach to illegal practice - provided a robust assessment of the nature and likelihood of these risks at that time. The likelihood of illegal supply taking place has increased since the publication of the Europe Economics report as patients increasingly source optical appliances online; the COVID-19 pandemic is likely to have accelerated this shift.
We have set out our view of the current risks posed by the main areas of illegal practice under sub-headings below. In summary, our own monitoring of illegal practice and feedback from our members about their experience indicates that the greatest current risk of harm to the public is posed by the illegal sale of spectacles and contact lenses, including zero-powered and cosmetic lenses. Online marketplaces and platforms are likely to be the biggest source of unsafe and illegal optical appliances, but unregulated offline sales of cosmetic, leisure and zero-powered lenses also present risks to the public.
Contact lenses are currently the optical appliances most likely to be sold in breach of the requirements in the Opticians Act, with suppliers providing lenses without either requiring sight of or verifying the contact lens specification.
Unsupervised sales of optical appliances to restricted groups, particularly under 16s, is another area of significant risk. This is because children’s eyes are still developing and poorly fitting and inappropriate spectacles, provided without appropriate clinical oversight, can lead to discomfort and eye strain, and can even result in permanent sight loss through amblyopia.
We also think there is a significant risk of harm to the public because unregistered online suppliers of optical appliances often give the impression of being located in the UK, for instance by giving UK contact details or using a UK website domain. The public is (quite reasonably) likely to assume that such suppliers have to follow UK legal requirements on the supply of optical appliances, and that therefore the appliances and advice they provide can be trusted - even where the supplier has deliberately registered their business overseas to make it easier to avoid the UK requirements.
Supply without supervision or verification
In recent years the illegal supply of optical appliances has increasingly taken place online – typically supplying contact lenses without verifying the specification, or supplying spectacles without a valid prescription. We also continue to see problems with the supply of zero powered cosmetic lenses, in settings ranging from fancy dress suppliers to hairdressers and even pharmacies. In relation to contact lenses, this form of illegal practice creates risks for patients including:
- Using contact lenses without ever being fitted for them. GOC-registered practitioners fit contact lenses based on a thorough assessment, taking into account clinical measurements and the patient’s individual needs. Once the fitting is complete and patients have been taught how to insert, remove, handle, clean and store the lenses safely, practitioners typically arrange a further check to ensure the lenses are suitable before issuing a specification for supply. Some online suppliers are bypassing these safeguards and providing contact lenses to people who have never been fitted with them
- Using lenses that do not match a current specification. The consequences of this can include:
- lenses that cause mechanical damage to the cornea due to a poor fit, or lead to corneal damage as a result of physical characteristics of the lens, such as how well the surface stays hydrated
- the oxygen transmission of the lens may not be as anticipated by the prescribing practitioner when providing advice on how long it is safe to wear the lenses
- corneal damage can increase the risk of eye infections including potential sight-threatening diseases such as microbial keratitis
- Contact lenses that fit poorly can reduce visual acuity and lead to discomfort and eye strain – this is a particular concern with varifocal contact lenses which have more complex prescriptions
- Where a patient only just meets the required visual acuity standard for driving when vision is corrected by contact lenses, a contact lens which does not match a current specification could lead to the patient not meeting the required standard – leading to a risk of harm to the patient and the public
- Being unaware of the risks of harm from poor contact lens use and the need for contact lens aftercare – our members have told us that patients increasingly see contact lenses as purely a consumer purchase, rather than as medical devices which have to be used with care to manage risk
- Patients who have been prescribed lenses suitable for conditions such as dry eye may choose to purchase different, less appropriate lenses online because they are cheaper, and will not receive appropriate advice from the supplier about the eye care implications of this choice
- Receiving poor quality and unsafe eye care advice – our members have told us they are increasingly seeing inappropriate eye care advice being offered by online suppliers, including on social media
Contact lens substitution without appropriate clinical oversight
Suppliers of contact lenses sometimes swap or ‘substitute’ a different lens for the one that was originally specified for the patient. Such substitution may take place when patients need an urgent supply (for instance before going away on holiday) or a manufacturer has discontinued supply of a particular lens. Contact lens substitution is legal and appropriate when carried out with clinical oversight and in the patient’s interests, as our position statement on this topic explains. However, substitution can also take place online in unsafe and illegal ways when poor quality and clinically inappropriate lenses are substituted without the oversight of a registrant.
Supply of ready readers (outside the scope of the Opticians Act exemption) and adjustable focus spectacles
The Opticians Act exempts ‘ready readers’ from the requirement for spectacles to be sold only when a valid prescription is provided1. In 2017 the GOC published a statement saying that it would not take action against unsupervised sellers of adjustable focus spectacles within the adjustment range 0 to +4 dioptres. The GOC has said it considers that such products benefit from the ‘ready reader’ exemption, although the Opticians Act makes no such provision. Many companies in the UK now sell adjustable focus spectacles in the 0 to +4 dioptre range.
However, in the last two years we have seen an increasing number of cases of adjustable focus spectacles outside this range being offered for sale online, often through major platforms such as Amazon and eBay. Some of these adjustable focus spectacles include negative power lenses for the correction of myopia, increasing the likelihood that they will be used for safety-critical distance vision tasks such as driving, posing a risk both to the patient and the public. We have drawn these cases to the attention of the GOC, which has had some success in getting them removed from sale.
Recently we have noticed cases of varifocals in the range 0 to +4 additions (with a plano distance portion) being supplied online without a prescription. We referred these cases to the GOC, which initially considered that enforcement action was unnecessary because the spectacles were within the 0 to +4 dioptre range, but changed its position after we highlighted the patient safety risks arising from selling varifocals without a prescription.
1The Act defines 'ready readers’ as spectacles which have two single vision lenses of the same positive spherical power not exceeding four dioptres
Q4. How, if at all, do you expect these risks to change in the next five years?
In our view the factors likely to drive changes to risks over the next few years include:
- Further growth in online sales of optical appliances, accelerated by consumer behaviour changes during the pandemic, and the mistaken perception that contact lenses and spectacles are consumer goods rather than bespoke medical devices
- Emergence of online refraction and unregulated optical care services
- Possible weakening of the current legal requirements, following the UK Government’s planned review of the future scope of healthcare regulation
Growing online sales of optical appliances
Given recent trends and the impact of COVID-19, we expect the shift to online supply of optical appliances to continue. This is borne out by Mintel’s recent optical goods retailing reports, and by the GOC’s 2021 public perceptions research which found evidence of channel shift in purchasing as a result of the pandemic, particularly among younger patients. This shift is likely to include higher levels of online supply of varifocal lenses with more complex prescriptions, with a growing risk of inaccurate or inappropriate supply without appropriate clinical supervision, and associated risks of harm to patients. This trend will heighten the prevalence of the range of risks discussed in our response to question 3.
Increasing (and effectively unregulated) online supply could also affect the optical sector and professional practice in ways that could create further risks of public harm. For instance: our members are concerned that growing levels of online illegal sales could lead some practices to move out of contact lens care provision. This is because it will become uneconomic to provide contact lens services if patients have a contact lens fitting in the practice and then go online to source contact lenses from suppliers which don’t comply with the UK legal requirements.
Emergence of unregulated online refraction and optical services
Late diagnosis of conditions such as glaucoma often leads to irreversible sight loss, damaging patients’ quality of life and imposing significant wider costs on society. The 2014 Europe Economics risks assessment concluded that “misdiagnosis of diseases has both a high severity of an adverse event, and a medium-high likelihood of an adverse event occurring under illegal practice”. The report was referring to misuse of titles, and these same risks could become more prevalent in the future if patients begin to use unregulated online services for refractions, supply and even eye health advice. As with current online optical appliance suppliers, patients may not be aware that these services are unregulated.
Changes to the scope of regulation
The risks discussed above could be amplified significantly if the UK Government’s planned review of the future scope of healthcare regulation results in a narrowing of the definition of illegal practice in the optical sector, or in reduced capacity for regulators to tackle illegal practice.
Q5. How do you think the GOC could improve its strategy on tackling illegal optical practice and what impact do you think this will have?
As noted in our response to question 1, we have published a policy position statement on illegal practice which sets out our view of what we believe needs to change to ensure the public is adequately protected. The changes we are calling for include:
- Robust enforcement action to encourage suppliers to follow the rules. The current DHSC work on reforming the healthcare regulators’ legislation may provide an opportunity for the GOC to pursue a wider range of enforcement powers if necessary
- The GOC should change its current enforcement protocol, which says a complaint will be closed with no action if the supplier is based overseas. Where an overseas business appears to be supplying illegally to people in the UK – and particularly where its website gives the impression the business is based in the UK – we think that as a minimum, the GOC should contact the supplier and, where relevant, local enforcement authorities to try to resolve the matter. We understand the GOC intends to review its enforcement protocol as part of its current review of its illegal practice strategy, which provides an opportunity to make this change
- The GOC should also publish information for patients and the public in the UK about the benefits of sourcing contact lenses from suppliers that comply with UK legal requirements. This could include explaining:
- the role of optical professionals and sight testing in identifying eye disease
- how buying optical appliances from unregulated sources can lead to risks of harm
- how to identify eye care providers and suppliers that meet UK legal requirements
We think it would also be helpful to share messages about the risks of illegal optical practice with healthcare professionals outside the optical sector. Our members tell us they sometimes hear of other healthcare professionals giving poor and uninformed eyecare advice to their patients – one recent example is a paediatrician advising a patient’s parents to obtain spectacles for the child online to save money.
The GOC may wish to consider working with the AOP and other optical sector bodies to raise wider public awareness of this issue. Since illegal optical practice has long been a significant concern to AOP members, and the changes discussed in our response to question 4 are likely to increase the risks it poses, we are planning to run a public-facing campaign on the risks of illegal practice in the second half of 2021.
In addition to the changes proposed in our position statement, we think there are two further areas where the GOC could usefully do more to tackle illegal optical practice; updating its evidence base, and working with registrants.
Updating the evidence base
As discussed in our response to question 3, the 2014 Europe Economics report gave a good overview of the risks associated with illegal optical practice at that time, and highlighted some areas where there was little evidence available. Since online supply and other technological changes have advanced quickly since 2014, we think it would be helpful if the GOC commissioned an update on this work (we understand the GOC is already planning to commission a literature review). An updated report would provide additional evidence to inform the GOC’s future strategy on tackling illegal practice. It should also inform the GOC’s discussions with DHSC about potential changes to the GOC’s underpinning legislation, rules and powers.
Working with registrants and patients
Many of our members have little awareness of how the GOC seeks to tackle illegal practice or of the practical challenges it faces in doing so, particularly when dealing with online suppliers based overseas. We think it would be helpful if the GOC did more to engage with registrants and their patients on this issue, including:
- Making it easier for registrants and their patients to identify and refer cases of suspected illegal practice, for instance through an easy-to-use online referral system
- Encouraging registrants to talk to their patients about the risks associated with sourcing optical appliances from overseas suppliers online and the importance of choosing suppliers that comply with the UK’s legal requirements, which are there to protect the public.
Q6. What would help you feel more informed about the GOC’s strategy, and action taken, on tackling illegal practice? [Please tick as appropriate]☐ e-bulletin ☐ regular statistics on our website ☐ tweets ☐ other [please specify]
We know from our members’ feedback that they use a variety of channels to keep up to date with developments in optics, so all these options could be helpful. We would be happy to work with the GOC to help communicate key messages on illegal practice and the GOC’s work to our members.