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26 January 2007

Getting started in therapeutics: Part 1
Author: John Lawrenson, Justin Needle, Roland Petchy

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Beginning a major new series, Prof John Lawrenson, Dr Justin Needle and Dr Roland Petchy set the scene with a review of current therapeutic practice and the results of a recent survey carried out by the City University for the College of Optometrists

Eye disease is managed in a variety of settings. Eye problems present commonly in general medical practice and most GPs are happy to manage a range of minor eye complaints.1 Community pharmacists also provide advice and/or treatment for a similar range of conditions, eg minor infections, allergic conjunctivitis and dry eye. More urgent cases, particularly those involving trauma, are generally managed by the accident and emergency department of the local general hospital.2  Thus, a significant amount of 'first contact care' is provided by non-specialist staff who may lack the knowledge and dedicated equipment required for accurate diagnosis.

Optometrists' expertise in the eye and visual system, together with the accessibility of optometric services in the high street, puts them in a position to play a key role in ophthalmic primary care. There are several good examples of community-based optometric triage schemes that have been well audited. With very little further training, accredited optometrists operating within these schemes have provided a safe and cost-effective service.3-5

One practical difficulty with the management of eye disease by community optometrists is the narrow range of therapeutic agents available to them and, more significantly, their inability to write an NHS prescription. Recent changes to medicines legislation have granted access to a wider range of therapeutic drugs through exemptions to the Medicines Act6 and also provided an opportunity for optometrists to train as supplementary prescribers. Furthermore, the Department of Health is currently consulting on the introduction of independent prescribing for optometrists.7

This article − the first in a major 10-part series − presents the background to UK optometrists' current therapeutic practice and describes the results of a recent scope of therapeutic practice survey carried out by the Centre for Allied Health Professions Research at City University, London.

Treatment versus referral of injury or disease of the eye

One of the most frequent barriers cited by optometrists wishing to participate in therapeutic prescribing is confusion over their professional obligation when making a decision about treatment or referral. The Opticians Act (1989) is the primary statutory legislation which determines the optometrist's legal responsibility. This is augmented by professional guidance from the College of Optometrists which reflects its view of 'good practice'.

GOC rules relating to injury or disease of the eye

The General Optical Council has the power under the Opticians Act to make rules governing particular aspects of optometric practice. The Rules Relating to Injury or Disease of the Eye8 removed the requirement to refer every patient who appeared to be suffering from an injury or disease of the eye to a registered medical practitioner. The decision whether or not to refer is now based on the clinical judgement of the optometrist, taking into account the patient's personal circumstances and clinical needs, and on local protocols. In the case of a decision not to refer a particular abnormality, the following information should be documented in the patient's clinical record:

● A sufficient description of the injury or disease from which that person appears to be suffering

● The reason for deciding not to refer on that occasion

● Details of advice or medical or clinical treatment tendered to the patient.

Furthermore, if appropriate and with the consent of the patient, the patient's GP should also be informed. The 2005 amendments to the rules introduced the option of referral to another optometrist with the relevant expertise.

College of Optometrists guidance on the management of ocular disease

Professional guidance is provided by the College in the Framework for Optometric Referrals9 and the Code of Ethics and Guidance for Professional Conduct10 (available at www.college-optometrists.org). As with other healthcare professionals, it is up to the individual optometrist to assess his or her competence to treat a specific ocular abnormality or carry out a particular clinical procedure. The College says that no practitioner should 'advise, prescribe or engage in any procedure beyond his or her competence and training'. Practitioners should be aware of their limitations and refer to a more competent colleague as necessary.

Medicines legislation and the optometrist

The other frequent cause for confusion among optometrists is knowing precisely which therapeutic agents they are able to use and, more specifically, the regulations that govern their supply. The rules regulating the use and supply of medicines in the UK are laid down in the Medicines Act (1968). Optometrists have traditionally been granted exemptions from the general rules laid down in the Act to allow them to use certain prescription-only medicines (POMs) in the course of their professional practice and, in particular circumstances, to supply them to their patients.

Exemptions from the general rules laid down in the Medicines Act

The list of drugs to which exemptions apply had changed little in the years since the establishment of the Medicines Act however, in 2005 significant changes to medicines legislation occurred. These included:

● An update to the list of POMs available to all registered optometrists (Level 1 or 'entry level' exemptions)

● A relaxation of the rules governing the supply of pharmacy (P) and general sales list (GSL) medicines by optometrists

● The establishment of a list of extra POMs that can be used and supplied by optometrists who have completed further training, termed 'Additional Supply Optometrists' in the legislation.

Level 1 or 'entry level' exemptions

The list of POMs currently available to all registered optometrists is given in Table 1. Drugs in the first group are for 'use and supply', while those in the second group (all topical anaesthetics) are for 'use only'. The legislation concerning the supply of medicines can be confusing. Basically, an optometrist has two options: to supply the POM directly to the patient, or indirectly via a signed order. Direct supply is reserved for emergency situations (not defined in legislation). This restriction is to maintain the traditional separation between the prescriber and supplier. In non-emergency situations the optometrist should use a 'signed order', which can be given to the patient and dispensed by the pharmacist.

The most significant change to the list is the addition of the anti-microbial agent fusidic acid (Fucithalmic), which is licensed for the treatment of bacterial conjunctivitis, although it has been shown to be effective in managing infective blepharitis and as prophylaxis following superficial corneal trauma.

Relaxation of the rules governing supply of P and GSL medicines

Under previous legislation, optometrists were able to use P and GSL medicines in the course of their professional practice, but their sale or supply was restricted to emergency situations. This emergency restriction has now been removed for these over-the-counter (OTC) medicines, allowing their direct supply to patients. The College of Optometrists has recently updated its guidance on the supply of therapeutic drugs,11 which states:

● Practitioners using or supplying therapeutic drugs should maintain their competence to do this. The competencies are identified in the 'Competency Framework for Prescribing Optometrists' developed by the GOC and the National Prescribing Centre (available online from the GOC website at www.optical.org)12

● In order to separate prescribing and supply it is good practice for the supply of therapeutic agents to be made by pharmacists wherever possible

● If they are supplying therapeutic drugs to their patients, practitioners have a duty to ensure that the drug is appropriate for the patient. This will mean the optometrist has to make a diagnosis of the patient's condition. Supply should normally only be made following an eye examination, or within a reasonable time afterwards

● Patients should be made aware of the need to have their condition periodically reassessed to determine whether or not the drug is still appropriate.

Additional supply

Legislation which came into effect on June 30 2005 defined the 'additional supply' list of POMs that could be accessed by suitably trained and accredited optometrists ('additional supply optometrists'). The choice of therapeutic agent was condition-led and designed to give optometrists access to a comprehensive formulary to enable them to manage a range of common non-sight-threatening ocular conditions, including infective and allergic conjunctivitis, blepharitis, dry eye and superficial injury. A list of additional supply drugs is given in Table 2.

Supplementary prescribing

The concept of a supplementary prescriber (then called a 'dependent' prescriber) was one of the main recommendations of the Crown report on the Review of Prescribing, Supply and Administration of Medicines.13 Supplementary prescribing is defined as 'a voluntary partnership between an independent prescriber (a doctor or dentist) and a supplementary prescriber to implement an agreed patient-specific clinical management plan with the patient's agreement'.14 The plan sets out how much responsibility should be delegated and refers to a named patient and to their specific condition. Agreement to the plan must be recorded by both the independent and supplementary prescriber before supplementary prescribing begins. Both prescribers must also share access to a common patient record.

Supplementary prescribing was initially introduced for nurses and pharmacists and in July 2005 the concept was extended to include optometrists and certain allied health professionals. Although there are no legal restrictions on the clinical conditions that supplementary prescribers can treat or the medicines that they can prescribe, since this type of prescribing requires a prescribing partnership with an independent prescriber and an agreed clinical management plan before it can begin, it is most useful when dealing with long-term medical conditions, such as glaucoma.

The GOC has developed a curriculum for supplementary prescriber accreditation. However, this does not specify the necessary knowledge and skills to manage glaucoma rather, it defines the generic skills required to prescribe safely and effectively. Training for supplementary prescribing is therefore intended for those who already possess the competencies required to manage glaucoma, in which case supplementary prescriber accreditation would provide the legal framework for the optometrist to manage the disease therapeutically, either in a community setting or hospital eye service. It could therefore complement existing schemes for glaucoma co-management.

Strategic health authorities have specified funding available for non-medical prescriber training. To qualify for such funding, a service need has to be identified and, in the case of supplementary prescribing, a prescribing partnership with an independent prescriber established. While theoretically the independent prescriber could be any doctor, in most cases it is appropriate that the optometrist's prescribing partner is an ophthalmologist who makes the diagnosis and is involved in the development of the clinical management plan.

Independent prescribing

While supplementary prescribing is appropriate for the management of certain long-term ophthalmic conditions, much of the optometrist's workload involves acute presentations. In such cases the optometrist establishes a diagnosis and uses his or her clinical judgment regarding treatment or referral. The appropriateness of independent prescribing for optometrists was recognised by the Crown review, and the Department of Health and the Medicines & Healthcare Products Regulatory Agency (MHRA)7 have recently published proposals that will, if supported by the Commission on Human Medicines, enable optometrists to become independent prescribers.

Although a number of options have been presented by the MHRA, the most likely outcome is that optometrists will be allowed to prescribe for any ophthalmic condition from a formulary derived from the eye section (Chapter 11) of the British National Formulary.

Qualification in independent or supplementary prescribing is likely to be of benefit in local commissioning with primary care trusts for additional or enhanced optometric services under the new GOS contract.

The terms used in medicines legislation are summarised in Table 3.

Survey of current therapeutic practice by UK optometrists

The Centre for Allied Health Professions Research at City University, London, has recently carried out a Scope of Therapeutic Practice Survey on behalf of the College of Optometrists. The main purpose was to investigate current therapeutic practices in ocular disease management by UK optometrists and to elicit the views of the profession on an extended prescribing role. The survey also sought optometrists' opinions on communication with other providers of eye care (GPs and ophthalmologists).

The survey was web-based and 5,284 practising members of the College of Optometrists were invited via email to participate. Questions were divided into four sections covering:

● Mode of practice

● Proximity and relationship to other providers of eye care

● Scope of current therapeutic practice

● Future plans regarding prescriber training.

A total of 1,288 (full or partial) responses were received (a response rate of approximately 25 per cent). The demographics of respondents reflected that of the GOC register in terms of age, gender, year of qualification and geographical location. Over 90 per cent of respondents were community optometrists (Table 4).

In the remainder of this article, we present data derived from the survey on current therapeutic practices and also the views of the profession regarding an extended prescribing role.

Scope of current therapeutic practice

The survey invited optometrists to define their scope of therapeutic practice in terms of specific ocular conditions managed and therapeutic agents used. A list of conditions was provided and respondents were invited to indicate the frequency with which each condition was managed (frequently, occasionally or never). An auxiliary question asked which conditions could be managed provided further training were given.

The results are given in Figures 1 and 2. Non-sight-threatening conditions, eg dry eye and blepharitis/lid problems, were managed most commonly, with approximately 75 per cent of respondents frequently managing these conditions. Nine out of 10 optometrists said that, with appropriate further training, they would be happy to treat common non-sight-threatening ocular disease. By contrast, there was a reluctance to manage less common and potentially sight-threatening conditions, such as acute anterior uveitis and dendritic ulcer, with only 20-30 per cent of respondents believing that these conditions could be managed by optometrists, even with further training.

This supports the view that confidence to undertake management of a specific ocular condition is largely influenced by its perceived sight-threatening potential. Conversely, although small numbers of respondents (11 per cent) currently manage diagnosed primary open-angle glaucoma, nearly 80 per cent felt that they could manage this condition with further training.

In terms of therapeutic agents used, Figure 3 shows the frequency of antibiotic supply. Chloramphenicol has been available to optometrists for over 20 years for use in the course of their professional practice and for supply to patients (directly or via a signed order). Fusidic acid has only recently been added to the list of drugs that optometrists can use and supply.

The survey found that chloramphenicol was frequently supplied by only 12 per cent of respondents and 45 per cent never supplied the drug. Independent practitioners tend to supply chloramphenicol more frequently than those working in multiples, or locums. Year of qualification does not appear to influence the rate of supply. Although to some extent the low rate of supply of fusidic acid may reflect its recent availability to optometrists, the data suggest that, in general, both antibiotics are supplied infrequently or never.

One possible explanation is the previously discussed confusion around the legislation concerning the supply of POMs. However, it may also be influenced by reported therapeutic practices. Antibiotics are often used for treating infections such as bacterial conjunctivitis and as prophylaxis following superficial corneal injury. Although evidence-based practice generally recommends antibiotics in most cases of bacterial conjunctivitis, Figure 1 shows that only 20 per cent of optometrists were frequently managing infective conjunctivitis. The decision to supply antibiotics as prophylaxis following corneal trauma is based on the size and depth of the lesion, and it is likely that the majority of abrasions seen in optometric practice are small and superficial and may therefore not require prophylactic antibiotics.

Non-prescription (ie OTC) medicines have traditionally been used to treat minor ailments and there is an increasing trend for medicines to be reclassified from POM to P or GSL. OTC preparations are available for the treatment of several non-sight-threatening eye conditions, including bacterial conjunctivitis, allergic conjunctivitis and tear deficiency. The survey asked about the frequency with which optometrists recommend or supply OTC medicines. The results are shown in Figure 4.

Significant numbers of optometrists frequently supply or recommend OTC medicines, particularly ocular lubricants. The data in Figure 4 should be read in conjunction with Figures 1 and 2, which show the frequency with which particular ocular diseases are managed. Ocular lubricants are indicated principally in dry eye conditions, which are commonly managed in optometric practice. Anti-allergy preparations (topical/systemic antihistamines and mast cell stabilisers) are also frequently recommended/supplied. Increasingly, optometrists are involved in the management of allergic eye disease (eg seasonal and perennial allergic conjunctivitis) which can be very effectively managed using medicines available OTC.

Future plans and attitudes towards prescriber training

Although optometrists have had the opportunity to train for additional supply and/or supplementary prescriber accreditation since July 2005, only 10 per cent of survey respondents indicated that they are currently in training. This probably represents an overestimate of the true figure anecdotal evidence from training institutions would suggest that the figure is closer to 5 per cent.

Table 5 gives a breakdown of respondents' intentions regarding training, according to mode of practice. This shows that the majority of early adopters are either hospital optometrists or independent practitioners. While the uptake of training so far is low, overall relatively few respondents agreed that they had no interest in prescribing or said that they had no intention of undergoing further training for prescribing. This is consistent with previous surveys of the attitudes of the profession to therapeutic prescribing.15,16

Many respondents agreed that there are significant barriers to undertaking a prescribing role, most notably remuneration, fear of litigation and the time and costs involved in training. A breakdown for each potential barrier is given in Table 6.

Renumeration

This was agreed to be a problem by 70 per cent of respondents, with 30 per cent strongly agreeing with the statement 'Lack of remuneration is a major barrier to an extended prescribing role'. Many also addressed the issue in their comments, especially concerns about securing funding through local PCTs and health authorities. Comments included:

'Does not add to my role as optometrist as unless the PCT is willing to fund or release budgets from GP practice to finance NHS prescribing my training could not be used. There is resistance from medicines managers within PCTs still coping with nurses and GP budgets for prescribing which could obstruct optometric progress.' Part-time, female sole practitioner, aged 31-40

'My local health authority stated that it is most unlikely that I would be able to claim any grant/monies to cover all or part of my course or examination fees even though I would be treating NHS patients and that to get payment for any patient I might treat that I would have to negotiate with the PCT.'  Full-time female locum, aged 41-50

Others worried that the demand would mainly come from people who would generate little income, and this would make optometrists' financial situation worse:

'Who has decided on the demand for such a service? Who is going to use this service? Who will pay for this service? I can see a large demand by the over 60s who will not want to pay for the consultation, nor for a prescription. The practice cannot support my chair time used for many clinical follow-up appointments. How much do consultants charge for their time?' Full-time female sole practitioner, aged 51-65

Fear of litigation

This was seen by 58 per cent of respondents as a problem, both for independent optometrists and groups:

'We are living in litigious times and yet want to add to this risk? Why? I for one do not feel unfulfilled in my current role. It's not our place to get the NHS out of a hole.' Full-time locum

'Large corporations will not and do not encourage their optoms to do too much therapeutic admin for fear of litigation.'  Part-time male locum, aged 51-65

Some also worried that indemnity costs would rise:

'Insurance costs if we were prescribing and managing certain conditions will inevitably be higher. I feel that the increased responsibility in conjunction with what will inevitably be minimal remuneration is hardly worth it.'  Full-time male locum, aged 31-40

Expense and time needed for training

Lack of time for training was seen as a barrier by 63 per cent and costs of training by 61 per cent. There was some annoyance at the length of placements and the lack of reimbursement for training fees and time off work:

'There is a significant cost both financial and in time. No other NHS worker is expected to learn new skills without paid time allowed for training and course fees paid.' Full-time male in small group, aged 41-50

'I am always looking to expand my knowledge and skills within optometry, but am uncertain whether the extent and cost of further training in therapeutics can be justified when working in high street practices.'  Full-time male locum, aged 31-40

Some thought that the training would be too onerous or complicated:

'The course run through university is extensive and the exams taxing. The hospital experience is a good idea but to have further college exams at the end of the time seems excessive and makes the procedure of qualification seem very burdensome to an individual who may be thinking of commencing training.'  Part-time male partner, aged 41-50

Value of extended prescribing to optometrists' roles

Relatively few - 10 per cent - agreed that extended prescribing did not add to their role, with 2 per cent strongly agreeing and 30 per cent strongly disagreeing. However, nearly 30 per cent said they were not considering further training until independent prescribing for optometrists is available:

'When independent prescribing for optometrists is available I will enrol for training. I do not consider the range of drugs included in the additional supply register wide enough to make any significant impact on my mode of practice.' Full-time male in multiple, aged 21-30

'There is no point in having an extended prescribing role unless we can write NHS prescriptions as the majority of our patients are entitled to free NHS prescriptions due to their age.' Full-time female sole practitioner, aged 51-65

Conclusion

The survey provides evidence that significant numbers of optometrists are currently managing common non-sight-threatening eye disease in community practice using therapeutic agents accessible through Medicines Act exemptions. Allowing optometrists to train for extended prescribing (supplementary and independent) will further develop this role, enabling greater use of their skills and providing patients with quicker access to medicines.

Although the vast majority of optometrists see the value in an extended prescribing role, major barriers to its successful implementation remain. Forthcoming articles in this series will address many of these obstacles. Aimed primarily at community optometrists, the series will provide a step-by-step guide to building a therapeutic practice.

In Part 2, Nick Rumney will look at setting a strategy for getting started in therapeutic practice and preparing for an extended role in prescribing.

Acknowledgements

We wish to thank all College members who gave up their valuable time to respond to the Scope of Therapeutic Practice Survey.

References

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12 National Prescribing Centre and General Optical Council (2004). Competency Framework for Prescribing Optometrists, Liverpool/London: NPC/GOC (available at www.npc.co.uk/publications/optometrist/optometrist.htm).

13 Department of Health (1999) Review of Prescribing, Supply and Administration of Medicines, London: DoH (available at www.dh.gov.uk/assetRoot/04/07/71/53/04077153.pdf).

14 Department of Health (2005) Supplementary Prescribing by Nurses, Pharmacists, Chiropodists/Podiatrists, Physiotherapists and Radiographers within the NHS in England: A guide for implementation (updated May 2005), Gateway reference: 4941, London: DoH (available at www.dh.gov.uk/assetRoot/04/11/00/33/04110033.pdf).

15 Mason A and Mason J. Optometrist prescribing of therapeutic agents: findings of the AESOP survey. Health Policy 200260:2 185-97.

16 Ewbank A. Should optometrists treat eye disease? Optician 20025864:224 20-3.

John Lawrenson is professor of clinical optometry at the Department of Optometry and Visual Science, City University, London. Dr Justin Needle is a research fellow and Dr Roland Petchey is director of the university's Centre for Allied Health Professions Research




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