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23 February 2007

Getting started in therapeutics
Author: Nick Rumney

Part 2 - How should I plan my strategy? In the second part of our new series, Nick Rumney examines the rationale for moving towards a prescribing role and looks at some of the practicalities of preparing for therapeutic practice

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Since the inception of the NHS, the UK optometrist has traditionally been trained to carry out refraction and identify abnormalities in the eye and adnexa. The registration of the profession took place nearly 50 years ago, and over time there has been a considerable expansion of the services that optometrists provide which, in essence, has constituted an ever more detailed examination of the eye. For example, it is now clear that optometrists are functioning as diagnosticians.

Optometry has moved well beyond the simplistic role of informing medical colleagues of the presence of abnormality. Optometrists now state what that abnormality is, what relevance this is to the patient's well-being and indicate priorities and timescales for proposed treatment.

Indeed, cases of professional indemnity are frequently brought on these very issues. In many cases, optometrists are actively co-managing anterior segment conditions with the general practitioner issuing the suggested prescription. In certain locations this has developed into formal protocols. This change in role has been recognised with the advent of new referral rules1 which came into force in 2000.

Part 1 of this series (January 26) reviewed the status of optometric prescribing as it presently stands and presented data from a wide-ranging survey of the attitudes of the profession towards prescribing. This article reviews the practical reasoning behind a move toward prescribing and presents a personal view as to how one might plan such a strategy.

First, let us examine some of the reasons to move your practice towards a prescribing role.

Referral: the optometrist as gatekeeper

Part 2 - How should I plan my strategy? In the second part of our new series, Nick Rumney examines the rationale for moving towards a prescribing role and looks at some of the practicalities of preparing for therapeutic practice

There are many reasons why one might take on a prescribing role. For me, the starting point is the provision of an appropriate service to the patient. For a developed country, the UK has one of the lowest ratios of ophthalmologists to the general population. Access to trained personnel and clinical equipment requires the patient, in many instances, to jump through hoops to achieve appropriate care, which may not be timely for obvious reasons.

As a general rule, ophthalmologists or ophthalmically trained doctors are not found in a primary care setting − apart from in accident and emergency departments − and patients need referral.

As optometrists, we have all witnessed the frustration of referring to the hospital eye service a patient with an undiagnosed anterior uveitis that has been managed by self-medication, pharmaceutical advice or even a GP prescribing for a presumed infection. Many of us may have experienced a contact lens-associated corneal ulcer with delayed diagnosis or, even worse, exacerbation through inappropriate steroid use.

Fundamental, therefore, to an optometric prescribing role is ensuring that patients with acute eye disease see a professional who is accessible, adequately trained and equipped, and clinically sound at differential diagnosis, to determine when secondary care under an ophthalmologist is appropriate. Our traditional role as gatekeeper to ophthalmological advice for visual and posterior segment-related eye problems is behind the drive for therapeutic access to better serve patients with symptomatic anterior segment eye disease.

This role is recognised in the 'core competencies' of a registered optometrist and is one which forms the basis for entry to the profession. Historically, however, the contract underpinning the 'sight testing' role has been predicated by a concentration on an ad hoc assessment for asymptomatic disease detected while undertaking a refraction-based assessment of the patient.

Clearly, the optometrist will never have the experience or training of the ophthalmologist, but this comparison is specious as it is not comparing like with like. The comparison is at the primary care level and the comparator ought to be the GP. The argument turns on its head when it is clear that the use of valuable ophthalmologist time to manage simple eye conditions or perform confirmatory diagnosis of self-limiting conditions is highly inefficient.

The inadequacy of this role at a public health level has been recognised in Wales and Scotland, where an optometric examination according to the clinical needs of the patient takes precedence over refraction. This has not been accepted as such in England (except in principle and in a few isolated areas) which serves as continued embarrassment to a Department of Health constrained by financial paralysis as much as anything else. Clearly, though, the intention is there.2 The move towards therapeutics fits the third level of primary eye care proposed by the College of Optometrists.3

Contact lens practice

A second reason for deciding to move towards a therapeutic role arises from the elevated risk of infection and adverse events associated with contact lens wear. As an optometrist responding to the demands of patients to wear contact lenses I am, in my opinion, bound clinically, ethically and morally to reduce the risk of such events and manage the outcome when they arise.

The contact lens industry has progressed incredibly, and now presents high-quality materials and designs to minimise risk and enhance comfort, safety and visual quality. Additionally, optometrists involved with contact lenses have always been at the forefront of training, clinical equipment levels and continuing education years before it became compulsory.

How strange it is, then, that a patient with contact lens-related problems attends an A&E department to be assessed by largely junior doctors at senior house officer level (in an eye unit), or house officer level in a non-ophthalmic unit for advice on such a complex interaction.

While medical intervention is absolutely essential for high-risk, sight-threatening infection such as Acanthamoeba, it is entirely inappropriate for issues such as contact lens overwear, solution intolerance or toxicity, abrasion, desiccation or hypoxia. As a general rule I would contend that the average ophthalmologist's opinion of soft lenses is entirely coloured by the over-attendance of poorly educated patients wearing inappropriate lenses. This leads to a conflict of advice that is directly counter-productive to the optometric profession.

While a majority of conditions arising out of contact lens wear can be managed in practice by refitting, patient education and so on, it is inevitable that some will require therapeutic management with lubrication, anti-allergic or anti-infective agents.

Therefore, I believe that it is incumbent on contact lens practitioners to equip themselves with the means to manage adverse reactions by being clinically competent diagnosticians and good clinical decision-makers, reducing the inconvenience of patients attending A&E departments. This will require recourse to pharmaceutical agents on occasions. Returning to the point on timely diagnosis, this is even more important for any practitioner fitting patients with extended wear lenses, almost universally regarded with contempt in ophthalmology.

As an aside, the large numbers of contact lens qualified dispensing opticians who provide clinical contact lens care should, in my opinion, pay careful attention to the quality and suitability of optometric diagnosis that should be available to them for exactly the same reasons as outlined above. This is not least because it is not always known by patients exactly what type of optician is attending to them.

The need for the optical profession to manage its contact lens patients is more profound now that anti-infective eye drops have become available over the counter as P (pharmacy) medicines in the form of chloramphenicol. There is clear evidence that some pharmacists are exceeding their remit by supplying such medicines to contact lens wearers without first referring them back to their practitioner.

Business aspiration

All successful businesses and organisations need a vision − this describes to all employees the aims and aspirations of the organisation, which can in turn be communicated to the outside world. For me, this vision of optometry is to have an optometric practice that is a 'one-stop shop' for the management of eye and visual difficulties.

I could set out my stall as the cheapest provider of spectacles or the most exclusive provider of designer eyewear and forego a clinical presence, but this does not feel comfortable to me. In placing more emphasis on the importance of the clinical aspect of our role, I can present services to the public that hinge on offering the most clinically appropriate eye care.

My intention is that optometric practice should increasingly be seen as the primary source of advice on all eye-related problems, even if referral is ultimately required.

Many optometrists have enhanced their practices clinically by offering exceptional diagnostic capability, visual and ocular assessment, and other specialist services, such as children's vision and low vision. Therapeutic prescribing is the next obvious step to take.

I do not see any conflict in offering high-quality clinical care and high-quality, and high-value, dispensing advice and care. Incumbent on this is a fee structure that transparently separates the charge for clinical and dispensing services.

The next steps

When setting your strategy for therapeutic practice it is worth considering, in general terms, the types of condition this may involve.

The delivery of primary eye care by optometrists in the UK can be considered as the diagnosis, treatment and management of eye conditions that are uncomplicated, namely those that are likely to follow a predictable course that can be monitored in an uncomplicated fashion using typical practice equipment.

Primary eye care at this level does not need laboratory-based pathology testing to establish diagnosis, nor equivalent follow-up tests to establish resolution of the condition. The delivery of primary eye care can also be considered to include mild-to-moderate eye diseases, and those which do not require secondary ophthalmological intervention. The delivery of primary eye care by optometrists − by necessity − means they will already have had clinical experience to allow them to differentiate eye disease.

The terms sight-threatening and non-sight-threatening have been used in the past in this context. With optometrists in the HES managing glaucoma, a number of co-management schemes nationally and an integral role proposed in the national eye care plan for glaucoma, this terminology is imprecise because, ultimately, glaucoma is sight-threatening.

For practical purposes, the intention is to accept all or any red eye or symptomatic patients, review history, examine and manage the condition either to self-limiting completion, within practice treatment, or referral, as appropriate.

Basic hardware

Later in this series we will examine the instrumentation required for a move into anterior disease management and the specific drugs to be stocked and supplied. However, even before introducing simple aspects, such as the provision of ocular lubricants or lid hygiene measures, you will need to audit your practice and premises to ensure you are prepared.

A thorough knowledge of basic hygiene and the immediate accessibility of hand-washing facilities in the consulting room is essential to send the correct message to patients, staff and colleagues. Hands should be washed between patients, using an appropriate type of scrub with disposable hand towels close by. This should be available for the patients too and they should be encouraged to use the facilities if, for example, they are inserting and removing contact lenses.

Other areas that should be addressed here are the accumulation of clinical waste, such as discarded lenses and tissues. It is not yet clear whether optometrists need any form of licensing for the disposal of such waste but it is certainly a possible future development. Thought may also be given to systems for cleaning and sterilising instruments, such as epilation forceps, the use of latex gloves when touching infected eyes or lids, and the use of clinical grade (as opposed to commercial) paper tissues.

Most optometrists are familiar with Minims which have been around for many years. What facilities are there for storage and review, so that drugs are kept appropriately and discarded when past their use-by-date? Robust systems for monitoring this negate the need to record batch numbers and expiry dates on clinical records.

Few practices have dedicated fridges for drug storage and those medicines requiring refrigeration can often be found among the staff yoghurts and milk. This is wholly inappropriate. Pharmaceutical fridges with lockable doors and externally reading thermometers are readily available from wholesalers.

Optical practices frequently order their pharmaceutical supplies through a wholesaler such as Mid-Optic, which now produces a specific therapeutic catalogue including all of its diagnostic, therapeutic and wholesale items. Other wholesalers used to supplying clinical practices, dental surgeries and health centres include Williams Medical (www.wmsplc.co.uk).

Relationship with pharmacists

Although we may be sure that the average pharmacist, even a prescribing pharmacist, is less competent than us at differential diagnosis of eye conditions, there is one area in which they do have an advantage and that is the storage, handling and dispensing of medicines.

There is a clear ethical division in medicine between prescription and dispensing that historically does not exist in optometry. It is one of the long-standing bones of contention between old school ophthalmology and optometry, and the reason why ophthalmologists tended to team up with dispensing opticians in 'medical eye centres'.

Although some GP practices do dispense (mostly in rural areas), this is generally a case of expediency over design. As we move towards prescribing we will need to look to this aspect carefully.

Many conditions do indeed self-limit and so prescribing a medicine is entirely inappropriate. Nowhere is this more the case than in viral conjunctivitis where so often an antibiotic is prescribed. There should be a clear separation between the funding for assessment and the remuneration for supply in order that there is no conflict against the interests of the patient.

In my opinion, although GSL (general sales list) and P medicines can be stocked and supplied by practices, now that the emergency provision has been removed, signed orders (private prescriptions in all but name) and actual prescriptions (FP10) should be dispensed by a pharmacist unless there is some reason - for example emergency provision - that might delay the patient accessing the treatment.

The College of Optometrists' guidelines are clear on this point, stating: 'The optometrist has a duty to take due care in the use of drugs in optometric practice and to only supply drugs when it is appropriate to do so. It is good practice for the supply of drugs to normally be made by a pharmacist.'4

There is as yet no recognised or templated document that can be used as a signed order an optometrist issuing a signed order to obtain a prescription-only medicine under the exemptions should produce this on headed paper, including the date, name and qualifications of the optometrist (including GOC number and an indication of specialist registration if applicable), the name, address and date of birth of the patient and the drug indicated. This should include, in the correct order, which eye it is to be used on, the form of the medicine (drops or ointment), the name of the drug including its weight/volume percentage and dosage.

There are specific codes used in prescription writing, as there are for spectacle prescriptions, that should be adopted to avoid confusion. The British National Formulary has a guide to prescription writing, including Latin abbreviations for dosing, which is available online (www.bnf.org). Registration is easy and free of charge.

Many optometrists are beginning to view the ambiguity of the law as a licence to accelerate the process of obtaining therapeutic rights. It would be wise to take cognisance of the above and begin to follow a similar protocol to pharmacists in terms of recording what is done, when and to whom. Pharmaceutical dispensing will result in the product being labelled and supplied with identification and precise instructions on the use of the medicines.

Establishing contact and maintaining a good working relationship with local pharmacists should be seen as a useful step in setting your strategy for therapeutic practice. Our practice recently held an open evening and made a presentation that actually counted towards pharmacists' CPD points. Contact your primary care trust pharmaceutical adviser to find out who organises local meetings.

Information

There is a wealth of information on ophthalmic drugs and drugs legislation available to the interested practitioner (Table 1). The College continues to update guidance with which all optometrists, whether members or not, are expected by the regulatory body (the GOC) to be familiar.

As well as informing the optometrist, the patient will need good quality information, especially if managing a condition exacerbated by poor compliance, such as blepharitis or dry eye. If you already use practice leaflets, consider making them available as downloads in pdf format off your website and printing them as necessary to hand out. This removes the need for reprinting and re-ordering stocks and allows for ready updating and editing. A good source of ophthalmic advice written in lay language is available on the Good Hope Hospital website.5

Stock

Many practices have gradually built up a stock of medicines alongside their contact lens solution stock. In my own practice, the wider availability of solutions has encouraged rationalisation and reduced numbers of contact lens solution lines, so we have more shelf space devoted to wetting agents, lubricants and medicines. We use a single wholesaler and have a regular monthly order so that we do not carry enough to allow products to become out of date.

We also stock products that are not commonly found in pharmacies, for example lid hygiene products such as Lid Care and Supranettes. These proprietary sterile cleansing wipes encourage a much higher degree of compliance than the home-made baby shampoo instructions (although they are not necessarily more effective).

We try to carry a range of general sales list lubricants such as Systane and Vital Eyes. These are available in dropper bottles or single-dose units and are generally not found in other outlets. Disappointing for patients over 60, some GSL lubricants such as Systane are classed as a medical device and not a drug and so cannot be prescribed by the GP.

Table 2 lists typical products that might be stocked by all registered (entry level) optometrists.

Options available

Later in this series, we will look at the range of eye conditions that prescribing optometrists are likely to manage and treat, with and without further training, and the range of drugs available to optometrists under current medicines legislation. However, presenting this information in a different way may be of help to those unfamiliar with therapeutics, and perhaps daunted by the prospect of moving towards a prescribing role.

To show how therapeutic practice can fit into the everyday decision-making process, Table 3 lists a series of possible situations and scenarios, some of which many optometrists may be tackling already. These range from situations requiring no action to treatment and referral. Treatment options include the use and supply of various therapeutic drugs, either available to all registered optometrists, or to additional supply optometrists. It is a professional ethical obligation to ensure that one is competent to undertake an extension to the optometric role.

Litigation and remuneration

Any discussion on optometric therapeutics will eventually raise two important issues: litigation and remuneration. A future part of this series will deal in detail with the legal and ethical considerations of therapeutic practice, but it is worth confronting these issues when starting to plan your strategy.

Litigation

With regard to litigation, at present there appears to be no differentiation in the type or scope of indemnity insurance cover on offer by the two principal providers (the Association of Optometrists and Federation of Ophthalmic and Dispensing Opticians), provided what is envisaged falls within the scope of practice of optometry. Thus, a practitioner trained to a higher degree and comfortable with more complex clinical diagnosis and decision-making, does not as yet pay a different premium to the optometrist content with the traditional role centred on refraction. With only a handful of prescribers, and their role not significantly different from that which exists at registration except in the access to certain medicines, this is early days.

It should be remembered that all such cover is underwritten by insurers and as such represents an informed decision as to risk. Ultimately, things might change and under certain circumstances the insurance held by some companies (not necessarily professional indemnity) may preclude therapeutic work. In particular, the employed optometrist should check carefully whether individual indemnity is required. The US experience has been paradoxical in that, where differentiation applies, therapeutically trained optometrists pay a lower indemnity premium precisely because they are considered less of a risk than those who are not. Initiating a treatment following a reasoned clinical assessment is deemed lower risk than failing to make an appropriate referral because of misdiagnosis.6

In so far as the GOC is concerned, the fitness to practise process could raise questions as to the clinical competence of an optometrist working 'as registered' or 'entry level' prescribing. However, making an incorrect decision per se is not a reason to question fitness to practise, especially if there is evidence of good records, an appropriate level of examination, an appropriate reasoning underpinning the decision, compliance with statutory regulations and appropriate disposal of the patient. Once again, and in apparent paradox, failing to examine thoroughly and making errors of diagnosis through poor record-keeping appears more common on the past record of fitness to practise cases.

A rarely discussed aspect of litigation is that of civil liability, in other words being sued for damages. In these cases, whether heard in court or settled out of court, the decision or the amount of damages is rarely made public. If you have concerns in this regard this is a matter for your indemnity provider. Nevertheless, and in spite of the above general advice, always check with your professional indemnity insurance provider that your envisaged scope of practice falls within the remit of the policy.

Remuneration

Remuneration is perhaps the aspect of therapeutic practice which troubles optometrists (and their employers) most. There are two aspects pertaining, respectively, to private practice and to the NHS.

In a private practice setting, one might make a case for offering a free service and offset the chair time by sales of optical appliances in the hope that patients are attracted by the wide-ranging services on offer while being prepared to pay the price differential. Whether this approach was ever clinically or professionally justifiable, it is clear that the writing is on the wall for this sort of behaviour in the days of internet supply of contact lenses and spectacles. In reality, many practices suffer from a crisis of self-confidence that a patient will purchase the examination or items of examination from a menu of possible services. Although the shackles of the NHS have been largely off since 1989, many cling to a single fee, single point of service that is as unsustainable as it is unrealistically low. That said, many others have embraced change by equipping and charging for services over and above the 'sight test' and there is really no difference between charging for specific items such as retinal photography or a red eye assessment.

Many practices that offer an inclusive direct debit professional fee for services, perhaps associated with contact lenses, cost in a specified number of unscheduled visits as part of the service, paid entirely separately from the supply of products.

If you intend to take on a therapeutic role, or even test the water before taking on additional training, it is essential to be clear about what you do and do not do. I would contend that this is a more important step than deciding what medicines whether GSL or P (or the two PoM antibiotics) to stock. Having made this decision, you might draw up a series of fees for perhaps red eye assessment, follow-up visits and so on.

Turning to NHS practice, there is no immediate prospect for a widening role into ocular therapeutics under a national contract in England or Northern Ireland. Clearly, Scotland and Wales will seek to build on their own new arrangements and this is likely to be the next logical development.

There has been no discussion at national government level on funding either to pay for training and development or for establishing a scheme and remuneration. The world moves on and this year has seen the NHS rarely out of the news with one funding crisis after another. It is not for this article to discuss the politics or rights and wrongs of this.

Nevertheless, there is - in theory at least - via the concept known as practice-based commissioning (PBC) the opportunity for a local group of optometrists to be contracted to provide a therapeutic or referral service and many areas are developing these alongside glaucoma monitoring, low vision and other schemes.2

Training

No-one doubts the value of undertaking CET in therapeutics. Even if you do not ultimately prescribe or aspire to prescribe, it remains incumbent on all optometrists to understand the treatment options and the likely outcomes. This is especially true of managing referral prioritisation.

I have been involved with the aspirations of the profession to achieve prescribing status for 10 years now. I have continued to undertake the voluntary and now mandatory requirements for CET and I choose to undertake much of my CET in the therapeutic and anterior disease area. However, like many others I have been patiently waiting for independent prescribing to be established and courses defined.

Were I a specialist optometrist in the HES sector, or actively co-managing glaucoma in the community, I would certainly be arranging to train as a supplementary prescriber, although as pointed out in Part 1 of this article, this trains one in prescribing and not in glaucoma management. It is inevitable that short conversion courses will be offered to step up to independent status when available and so large parts will not have to be repeated.

At present, the net gains achieved by attaining additional supply level, while small, are a definite indication of intention. The work in establishing clinic placements for additional supply and supplementary prescriber training will, of course, never be wasted. The value of regular clinic contact with experienced ophthalmologists is something many optometrists only experience at pre-reg level.

The requirements to convert from additional supply optometrist or supplementary prescribing optometrist to full independent prescriber are yet to be determined. Although course organisers have responded magnificently to the inevitable pressure to provide courses, the open-ended arrangements, without a clear end-game, have undoubtedly been frustrating for many. To paraphrase Churchill, we are well past the end of the beginning and there is clear light at the end of the tunnel.

In fact, the response to the independent prescribing consultation exercise is likely to be communicated while this series runs in Optician.

Personally, I am preparing my practice and my diagnostic skills and my experience and intend to move directly to full independent prescribing status when it becomes clear what is required.

Conclusion

The aim of this article is to set the optometrist thinking slightly wider than the immediate intention to become a therapeutic prescriber. It presents a rationale for moving towards a prescribing role and some of the practical considerations involved in planning a strategy for therapeutic practice.

Future parts of this series will look in detail at many of the issues raised, help practitioners gain confidence in prescribing and management, and show how therapeutics can become a part of everyday optometric practice.

In Part 3, Dr Niall Strang will review the courses, qualifications and CET currently available for optometrists and training likely to be provided in future.

References

1 The General Optical Council (Rules relating to injury or disease of the eye) Order of Council (1999). Statutory Instruments 1999: No 3267.

2 Commissioning Toolkit for Community Eyecare Services. www.dh.gov.uk/assetRoot/04/14/22/13/04142213.pdf

3 www.college-optometrists.org/index.aspx/pcms/site.News_and_Events.Press_Release_Archive.2006.2006_College_News.3tier/

4 Chapter 40. Use and supply of drugs or medicines in optometric practice (August 2006). Code of Ethics and Guidelines for Professional Conduct. College of Optometrists.

5 http://www.goodhope.org.uk/Departments/eyedept/index.htm

6 McAlister WH. Increased scope of practice: a survey of Missouri doctors of optometry. J Am Optom Ass, 199061:4:309-312.

7 Jones LWJ and Cullen A. Anterior segment eye disease. Part 1 - Disorders of the lids and ocular adnexa. Optician, 1999:5693:217:23-32.

8 Jones LWJ and Cullen A. Anterior segment eye disease. Part 2 - Disorders of the conjunctiva. Optician, 19995698:217:19-26.

9 Craig J and McGhee C. Anterior segment eye disease. Part 3 - Disorders of the cornea. Optician, 19995702:217:21-30.

Optometrist Nick Rumney practises in Hereford and is a member of the General Optical Council. The views expressed in this paper are personal views of the author. They do not necessarily represent the views of the GOC or any other organisation




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