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Submission to the Ministry of Health Services, Province of British Columbia, in Response to a Request for Consultation on New Eye Care Regulations Submitted by the Opticians Association of Canada June 11, 2004 “It is the belief of the Opticians Association of Canada that visionary leadership identifies innovative pathways to good public policy that result in better results and greater choice for consumers. The new regulations for optometrists and opticians announced by the BC government are reflective of this concept.” 1 TABLE OF CONTENTS 1. 0 2.0 Executive Summary Background: 2.1 Stand Alone Sight Testing is Safe 2.2 Automated Sight Testing is Accurate 2.3 Improved Health Outcomes 2.4 Public Education 2.5 Appropriate Referral 2.6 Regulation/Legislation Enables Safe Choices 2.7 Historical Perspective 3.0 Specific Commentary: Optician’s Regulation 3.1 Definitions 3.2 Reserved Titles 3.3 Reserved Acts 3.4 Limitations on Practice 3.5 Auto-refraction or Automated Sight Test 3.6 Schedule – Limitations on the Use of ‘Auto-Refractors’ 4.0 Overview of Key Public Issues 4.1 The Basic Training of an Optician Provides the Appropriate Underpinning 4.2 Sight Testing Opticians Must Be Required to Have Specialty Training to Perform This Service 4.3 Opticians Have Demonstrated the Reliability of the Results of the Sight Testing They Perform 4.4 There Is a Consumer Need for Optician Performed Sight Tests 4.5 There Has Been No Injury to Consumers as a Consequence of Optician Performed Sight Tests 5.0 Conclusion 2 1.0 EXECUTIVE SUMMARY The Opticians Association of Canada has a mandate to advocate on behalf of the profession of opticianry, particularly as it relates to the provision of safe and effective services to vision care consumers. Public safety is at the forefront of our thoughts as we provide the following comments to the British Columbia government regarding new regulations governing automated sight testing by opticians. Scientific and experiential evidence concludes sight-testing service as provided by opticians using automated suites of equipment is a safe procedure that will result in positive vision health outcomes for British Columbians. Although sight testing is not a reserved activity, opticians have recognized that as vision care professionals they must ensure the public understands the limitations of the process and have requested regulation to enforce common standards and guidelines. Further, opticians believe this service will provide a unique opportunity to provide general education about eye health to consumers. These four factors – safety and accuracy of using the technology, improved health outcomes for consumers, opportunities for public education, and enforcement of standards – have been adequately considered and allowed for by the British Columbia government. 2.0 BACKGROUND: 2.1 Standalone Sight Testing is Safe Some would suggest that a sight test cannot be safely performed apart from an eye health examination. The Canadian Ophthalmological Society (COS) has defined sight testing as a non-medical procedure that can be performed by non-medical personnel separate and apart from an eye health examination.1 Although the recommended frequency of eye health examination differs from one professional group to another, the American Academy of Ophthalmology (AAO) standard2 is widely recognized as being a benchmark and is supported by the Canadian Ophthalmological Society (COS). According to the AAO schedule, whether they wear eyeglasses/contact lenses or not, adults between the ages of 20-39 need a comprehensive eye examination once throughout those years while those between the ages of 40-64 need be examined every two to four years. The recommendation is based on age and not on refractive errors. In other words, the AAO does not recommend a greater frequency of eye health examination for eyeglass wearers than it does for other adults. They make no connection between eye disease and the need for refractive correction. In reality, individuals in these age categories who do wear eyeglasses/contact lenses will need to replace their lenses or refurbish their appliance with much greater frequency than the schedule suggests. Ophthalmology recognizes this truth. The COS policy statement on eye examination states: “For the ultimate benefit of the public, a clear distinction should be made between a diagnostic eye examination and an examination for the purpose of refraction. A 1 2 Canadian Ophthalmological Society-Policy Statements and Guidelines “The Role of Ophthalmology” American Academy of Ophthalmology-Health Tips on How Often to Have an Eye Exam 3 diagnostic eye examination involves the practice of medicine and requires the highly specialized training of a physician. A refractive examination involves the taking of measurements from the visual system, which is simply a data-gathering procedure and involves no medical expertise.”3 Optometrists have taken the position that a sight test must be provided concurrent with an eye health examination. The majority of people seeking optometric services do so because they need new glasses or contact lenses and merely want to make sure they will not be spending money on lens powers that are too weak (see figure 23). As reproduced from the Health Canada Statistical Report on the Health of Canadians 1996-1997 Health Canada’s report on the Health of Canadians for the years 1996-1997 revealed the majority of Canadians over 12 years of age who sought eye examinations did so not because of job requirements (2%), or cataracts (3%), or Glaucoma (4%), or eye conditions (5%) or declining sight (6%). Reassurance – not complaint – was the main reason people went for an eye examination (50%) and the need for a prescription change was a close second (47%). (Some respondents answered in multiple categories.)4 For purposes of refreshing the lens powers or purchasing new product, individuals falling into those age categories and who require optical appliances should not be required to undergo and pay for an eye examination that is bundled with a sight test. To repeat a crucial point, a standalone sight test can be performed affordably without risk to consumer eye health. 2.2 Automated Sight Testing is Accurate Accuracy is not an issue with automated sight testing. The technology currently being used in Canada underwent a year of field-testing and has since been used successfully in Canada for eight years. With approximately over ½ million tests having been provided in that time frame, the margin for error was slightly less than ¼ dioptre, which is totally 3 4 Canadian Ophthalmological Society-Policy Statements and Guidelines “The Role of Ophthalmology” Statistical Report on the Health of Canadians /Determinants of Health /Health Services/Eye Examinations 4 within industry standard tolerances and comparable to sight tests performed by optometry and ophthalmology.5 2.3 Improved Health Outcomes The sight testing service offered by opticians has a limited and narrow purpose, and it is vital that consumers understand this. It provides consumers with an easy, affordable method of upgrading or fine-tuning their visual acuity. In a model where sight tests and eye health tests are bundled and the burden of payment is not borne by the health care system, consumers often delay visits to a eye care professionals in order to save money. Many times, this results in gradually reduced visual acuity. This introduces to the debate a facet of the safety issue far different from the risk of eye disease focused upon by stakeholders opposing optician sight testing services. Compromised visual acuity represents danger on the job, at home and on the roads. It is difficult to assess the impact of de-insurance on the frequency with which consumers will seek sight tests and eye health examinations. We can only draw inference from researching a variety of statistical reports. In Health Canada’s 1996-1997 Report Statistical Report on the Health of Canadians6, 29% of British Columbians (1,036,650) stated they had had an eye examination 3+ years ago or never. There is no data to break that number into age groups or to determine how many fall into the ‘never’ category. It is, nonetheless, an alarming statistic. The Health Canada figures were developed prior to the de-listing in B.C. of eye examinations as an insured service. The British Columbia MSP Information Resource Manual for 2002-20037 (compiled after de-insurance) indicates that for that year optometrists billed for 334,991 fewer services than they had in years when the service was insured. In other words, 334,991 fewer people attended optometric offices for Medicare-covered eye examinations. The average for the four years preceding de-listing was 887,206 services. (Ophthalmology services actually increased by 40,676 in the reporting period 2002-2003.) We have no method of determining whether those 334,991 citizens were forced into the optometric marketplace and paid for their own eye examinations, or delayed getting their eyeglass/contact lenses upgraded or if they need to be added to the ‘3+ years or never’ category in the next Health Canada study. Optician-performed sight testing services would definitely be a safer option than the latter. Subsequent to government de-listing of optometric services, the price of an optometristperformed eye examination was revealed in a survey commissioned by the OAC to be an 5 Journal of Telemedicine and Telecare Vol.6 Supplement 2-A Fully Automated Remote Refraction System Statistical Report on the Health of Canadians-Determinants of Health/Health Services/Eye Examinations 7 MSP For Medical and Health Care Practitioners/Billing Procedures for Physicians/MSC Payment Schedule/Ophthalmology 6 5 average of $70 with a high of $1008 as compared with the $48.909 that is paid to an ophthalmologist for a basic eye examination under the current B.C. government payment schedule. When a consumer needs to purchase a new pair of glasses or contact lenses, the price of an optometric eye examination clearly acts as a deterrent to updating the lens powers with the only recourse being to duplicate a previous pair of lenses or put up with reduced visual acuity. As previously mentioned the latter choice represents a risk of harm both to the individual requiring correction and to others. 2.4 Public Education Whether out of curiosity, need, or budgetary restraints, consumers take advantage of standalone sight testing services. The first benefit for them is improved visual acuity to perform daily functions such as driving and work requirements. As well, the standardized and regulated process of interview and selection that takes place prior to an optician providing the sight test acts as a means of providing vision health care education and referral as appropriate. The College of Opticians of British Columbia has consulted with stakeholders on the development of their Standards of Practice document and the required interview protocol. The OAC has been part of that dialogue. The OAC believes the resulting College documents are not only effective tools for eliminating those individuals who are not appropriate candidates for an optician-performed sight test, but will serve as triggers for discussion through which the optician can answer questions and provide direction. 2.5 Appropriate Referral Opticians are frequently the first professionals selected by consumers when information about vision care is required. Opticians are accessible and approachable in widely spread retail settings. As regulated professionals, opticians routinely recognize questions and complaints that lead them to suggest specialized attention to clients. A study that was reported in The International Journal of Pharmacy Practice (2001)10 is instructive. Most customers in the study were found to consult for advice on managing their eye complaint rather than asking for a product. Difficulty in accessing the GP was the main driver for customers to consult a pharmacist. Others considered the complaint too trivial to trouble their doctor with. This parallels the experience of opticians whose clients are often unsure if their complaint is minor or serious. In the same study, 34% of consumers were conditionally referred to another health professional and 15% were directly referred, usually to a GP. It was concluded that the referrals were appropriate as all but one customer received a prescription from the GP. The College of Opticians Guidelines for Referral are clear in not only requiring opticians to retrieve health history from clients but also to recognize articulated complaints that are typical to symptoms of eye disease or other eye-related conditions. Front-line health care 8 OAC Survey of Cost of Eye Examination in British Columbia Optometric Practices 2003 B.C. Medical Services Commission-Ophthalmology/Guidelines for Billing Eye Examinations 2003 10 International Journal of Pharmacy Sept. 2001-Responding to Red Eye 9 6 service providers are without question effective in serving as a conduit to both information and referral. The Ontario government has recently de-listed optometric services. Ontario Health Minister George Smitherman has stated that a Family Physician referral may eventually become necessary to access OHIP-covered eye exams.11 A Family Practitioner-centred vision care model is consistent with the AAO guidelines for frequency of eye examination as well as with the conclusions drawn by Dr. Steven R. Shields, assistant professor of ophthalmology, Saint Louis University School of Medicine, and director, Glaucoma Service, Saint Louis University Eye Institute. In his paper, which appeared in the peer-reviewed journal Postgraduate Medicine Dr. Shields found, “Periodic visual acuity testing is adequate screening for persons up to age 40 who are at low risk for occult eye disease.”12 Dr. Shields further suggests that a Snellen test (an ordinary eye chart) is adequate testing for low risk individuals between the ages of 6 and 40 years. Once opticians have been formally integrated into the vision-screening network, Family Practitioners can more effectively and economically triage patient needs by referring for standalone sight tests when required. 2.6 Regulation/Legislation Enables Safe Choices It is clear that all governments recognize the need for change in existing eye care models to support the Canadian universal health care concept. Studies have been done both in the United States and Canada, reflecting on ways to contain costs while respecting the need for continued high standards of care. British Columbia’s Seaton Royal Commission Report (1991) parallels the recommendations of all. The considered advice evolving from these several commissions and task forces is to discover methods of maximizing existing human resources. In other words, before engaging in additional expenditures, make the most of what you have. The Pew Commission Report on Reforming Health Care Workforce Regulation13 is well respected and often quoted with reference to the re-shaping of health professions. The Commission produced 10 recommendations (attached) all of which are captured by B.C.’s Health Professions legislation. In summary, these recommendations promote competency standards, regulatory oversight including public representation, public education about the profession, professional mobility, safety of performance, enabling mechanisms to allow professions to evolve their scope of practice and requirements for practitioners to demonstrate their competence throughout their careers. It is for this reason that new legislation for health care professionals focuses on regulatory governance structures that ensure uniform public accountability and allow for flexibility 11 Toronto Sun Newspaper-May 29, 2004 They Just Don’t See Eye To Eye Post Graduate Medicine Oct 2000-Managing Eye Disease in Primary Care/How to Screen for Occult Disease 13 Pew Health Professions Commission-Considering the Future of Health Care Workforce Regulation (1997) 12 7 in assignment of reserved activities. These legislative principles are mirrored in the Ministry’s decision to regulate opticians who perform sight tests. It is always a challenge for government, professions and members of the public to shift to new models of health care delivery, particularly when there are overlapping scopes of practice. The dilemma has been aptly put by Barbara Safriet, a member of the Pew Commission, speaking to the National Summit on State Regulation of Health Professionals in the 21st Century.14 “The real issue is we have an increasing disjunction between legal authority and clinical ability. The law says who is allowed, but it has not kept up very well with the question of who is able.” And she further stated, “The law always drags behind developments.” This is particularly true in the matter at hand since emerging technology and professional education have outstripped the commitment of legislators to implement the fundamental spirit of umbrella legislation that has already been enacted. It is the belief of the OAC that visionary leadership identifies innovative pathways that make good public policy and result in greater choices and better results for consumers. The new regulations for optometrists and opticians announced by the BC government are reflective of this concept. 2.7 Historical Perspective British Columbia opticians have earned the confidence the BC government has placed in them. They have historically demonstrated their commitment to serve the public interest and to be responsible members of the vision care community. Opticians in British Columbia have taken a deliberate path toward higher standards of education, uniformity of service and career progression. There has been provincial opticians legislation in Canada for 50 years, the earliest being Manitoba in 1954. B.C. was the last provincial government to create optician regulations. As vision care professionals working almost entirely in a retail environment, and realizing the importance to their clients of a strong professional responsibility quotient, B.C. opticians organized themselves and joined with the Canadian community of opticians to voluntarily train themselves through educational and examination programmes accredited by other provincial regulatory bodies. The OAC and its predecessor (the Canadian Guild), have been involved in delivering opticians education programs through those early years and can note that B.C. had the highest enrollment of students in any opticians program in any province. B.C. opticians petitioned the government for many years before being granted a regulation in 1996. They participated actively in developing the College structure and by-laws, and endorsed the requirement that every optician practicing in B.C. prior to regulation regardless of length of service must successfully challenge a qualifying examination. Automated refracting devices were introduced to vision care professionals at least a decade before B.C. opticians started sight testing. Shortly after being granted regulation 14 CLEAR (Council on Licensure, Enforcement And Regulation)-National Summit on State Regulation of Health Professionals in the 21st Century-May 1999 8 B.C., opticians became aware of new automated technology that incorporated all the components of objective and subjective sight testing and that produced highly accurate and repeatable results. This equipment blends a combination of assessment modules and produces data that can reliably be used to produce optical products. B.C. opticians began offering sight-testing services to clients using the automated sight testing suite and a telehealth concept of sending the resulting data to a physician for review. Responding to complaints from optometrists the College of Opticians of British Columbia followed its regulatory duty by challenging its sight testing members through the B.C. Courts. The Supreme Court of British Columbia in the case of The College of Opticians of British Columbia v. the Moss brothers15, found in favour of the respondent affirming the right of opticians to offer this service to consumers. Both the College and sight testing opticians acknowledged the necessity for consumer education and careful selection of appropriate candidates for this new sight testing service. Consequently the College established, in consultation with physicians, Standards of Practice for sight testing opticians. These standards continue to be enforced by the College until the consultation period has been completed and revised standards come into effect. 3.0 SPECIFIC COMMENTARY: OPTICIAN’S REGULATION Our commentary on the optician’s regulation will include suggestions related not only to the new text being introduced but also to some of the existing wording. 3.1 Definitions: In this section several definitions cause us some concern. The term “eyeglasses” as currently framed does not including contact lenses or low vision aids. “Contact lenses” are integrated into the regulation under the definition of “contact lens fitter” whereas low vision aids do not appear anywhere else under definitions. This may be oversight however the dispensing of low vision aids is gradually becoming an extremely necessary component of vision care rehabilitation due to the aging of the population and the increase in incidence of low vision problems associated with degenerative ocular disease. Typically ophthalmology and optometry are focused on detection and treatment of disease and ocular conditions whereas opticians are specialists in the selection and use of rehabilitative products. The definition of ‘eyeglasses’ is very specific in outlining that it does not include contact lenses and low vision aids. Taken together with the fact that contact lenses are then managed via another definition one could conclude that opticians are not entitled to dispense low vision aids within their regulation. Alternatively this might be interpreted to mean that any person regardless of training may dispense low vision aids. We look for 15 Reasons for Judgment of the Honourable Mr. Justice Oppal- College of Opticians of British Columbia and Robert Moss, Jr., John Melvin Moss and Clearbrook Optical Ltd. Doing Business as United Optical 9 guidance on this issue and suggest that the definition be changed by adding low vision aids to the list of products dispensed by opticians. The OAC questions the text within the definition section of the word “prescribe” (b). The wording suggests that in noting the power of lenses required to bring the individual to an acceptable visual acuity, the prescriber can also specify what type of appliance should be dispensed. “…authorize a person to dispense the appliance or device for use by a named individual.” When prescribing a therapeutic drug the optometrist would naturally name the drug and specify the dosage. With respect to writing a prescription for an optical product the responsibility of the optometrist is to note the power of lenses at the refracting distance that will provide best vision for the individual. It is up to that individual and the optician to decide what modality of product will be used to provide that correction. The OAC recommends a change in wording to read: “…authorize a person to produce an appliance or device based on the stipulated numbers for use by the named individual.” The definition of “prescription” (b) includes a category for contraindications. We believe this should not be part of the definition. It has been well documented that many optometrists use printed designations on their prescription forms that indicate the prescription is ‘not for contact lenses’.16 This is interpreted by the public to be a contraindication to contact lens wear but amounts in fact to no more than a restrictive trade practice. The current text of the definition provides regulatory authority for this practice where none, we believe, was intended. We recommend removal of the word ‘contraindication’ from the definition. The definition of “supervision” b (ii) is somewhat confusing. The text in b (ii) removes the ability of a certified contact lens fitter to participate in the training of student contact lens fitters since “only a prescriber can supervise the fitting or dispensing of contact lenses by a person other than a prescriber or contact lens fitter…”. The practical application of the clause works against the current system of intern education. We recommend that the clause be modified to include both prescriber and contact lens fitter as qualified supervisors. 3.2 Reserved Titles The OAC agrees with the Minister’s assessment that public education is the major key to safe sight testing practice by opticians. Opticians have undertaken a variety of public awareness measures including educational brochures and in-store signage describing the difference between a sight test and an eye health examination and the differences between services offered by opticians, optometrists and ophthalmologists. Media advertising and public access websites are also methods of educational outreach. 16 Prescription from The Optometric Centre 10 We believe sight-testing opticians should also have a title identifying their designation as separate and apart from a contact lens fitter or an optician since only those who have met the College of Opticians of British Columbia requirements will be allowed practice. We would suggest a reasonable reference to be ‘Refracting Optician’ and that a definition of such should be included in the Definitions section of the regulation. 3.3 Reserved Acts 4(4) indicates that a contact lens fitter may not use the results of an auto refraction to fit or dispense contact lenses. The OAC believes that this presents an unnecessary handicap for consumers who wear contact lenses. Currently contact lens fitters are trained, qualified and regulated to provide care for contact lens wearers. People who wear contact lenses are carefully monitored and properly advised of the necessity for routine eye health examinations. However, contact lens wearers require changes to lens power between eye health examinations. 4(4) will legislate the necessity for that contact lens wearing consumer to pay for a complete oculo-visual examination each time a change is required. The proposed regulation will provide the ability for opticians to make adjustments to existing prescriptions, an act that is common practice for contact lens fitters seeking to fine tune visual acuity. Initial selection of the contact lens is based on the original prescription however due to eccentricities in contact lens material, shape, design and thickness visual acuity results may not be optimally achieved. When this happens the contact lens fitter uses over-refraction techniques to arrive at a final lens specification. B.C. contact lens fitters are trained in slit lamp biomiscroscopy. This enables them to view the corneal surface under extreme magnification. Corneal anomalies are highlighted by a variably positioned light source. Contact lens fitters routinely refer to ophthalmologists and optometrists contact lens wearers with corneas that appear other than normal. B.C. contact lens fitters are also trained in keratometry. A keratometer measures the curvature of the central area of the cornea. When proceeding with a contact lens fitting the contact lens fitter takes base measurements to use as a benchmark. At each interface with the contact lens wearer, new keratometer readings are recorded. In this way the fitter is able to note extreme changes that may indicate a suspicious steepening of the cornea, which in turn may be a precursor of occult eye disease. As with anomalous corneal appearance, contact lens fitters are trained to refer appropriately when such conditions occur. Of all the consumers wearing ophthalmic appliances, contact lens wearers come under the most scrutiny from vision care professionals. They are normally seen every 6 months for regular check-ups and even more frequently if they order replacement lenses. At each encounter the contact lens fitter performs the same routine assessment: observation of the cornea with the biomiscroscope and notation of the current keratometer readings. 11 The OAC’s survey of B.C. optometric offices in 2003 revealed that 64.3% of the 305 offices polled charged an additional fee for a prescription when the customer indicated he/she wanted to take the prescription to another provider to purchase contact lenses.17 Contact lens wearers, like all other consumers who require vision correction, will require refinements to their lens powers over time. If they do not have access to opticianperformed sight tests they will be compelled to have an optometric eye examination for which, as the study shows, they are likely to be charged an extra fee for their prescription. This places a legislated financial hardship of this group of people. Contact lens wearers as a group are not more at risk for degenerative eye disease than any other group of consumers. Under the care of a regulated contact lens fitter the contact lens wearing consumer is regularly monitored for adverse signs of contact lens wear such as insult to the cornea or surrounding ocular structures. Opticians routinely refer wearers who are at risk as a result of contact lens wear to optometrists and ophthalmologists. The OAC believes that there is no reason to limit the use of the auto-refraction results to the manufacture of eyeglasses and recommends the removal of 4(4) from the regulation. 3.4 Limitations on Practice Nowhere does the regulation define an automated sight test or describe the ability of an optician to perform this activity. That is reasonable since sight testing is not a restricted activity and as such may be performed by any person. Clearly the intention of the Ministry based on the announcement made by the Minister on March 30th, 2004 was that opticians would be able to offer this service. Section 4 (1.1) eliminates the requirement of oversight by a physician in order to use the results of auto-refraction to manufacture eyeglasses. The Minister’s statement coupled with 4 (1.1) provides the necessary legislative authority for opticians to perform sight tests and to produce eyeglasses based on data derived from those tests. However, section 6 (3) introduces confusion into this regulation. It says that no registrant may alter a prescription without the express prior authorization of the prescriber. In reality, if a consumer wishes to have an eyeglass prescription updated, and the sighttesting optician has to observe the conditions of 6(3), prior authorization will never be given. Due to the dwindling supply of ophthalmology specialists (estimated at approximately 800 in Canada), most eye examinations in today’s vision care environment, are performed by optometrists. The negative commentary, misdirection and highly engineered backlash streaming from optometric groups since the Minister’s announcement should give clear warning that there would be no cooperation forthcoming from optometrists in giving force to the regulation’s intent. The OAC strongly urges the Minister to remove 6 (3) from the regulation, as it will have the potential to neutralize the regulation and prevent the service from being made available to British Columbians. 17 Opticians Association of Canada Study of Prices Charged for Prescriptions in B.C. Optometric Offices 2003 12 In section 6(5) the regulation states that a registrant must offer to the client, without charge, a copy of a prescription. Coupled with the definition of a prescription and the reference to the results of an auto-refraction in 4(1.1) as an assessment, the OAC concludes that 6(5) does not refer to the data produced by the sight test. We conclude from our reading of the regulation in its entirety that the Ministry does not intend the same definition of an assessment as it has given to a prescription. We seek guidance on this issue. 3.5 Auto-refraction or Automated Sight Test Reference is made throughout the regulation to an auto-refraction. Sight testing as it is currently being performed by British Columbia opticians would more properly be termed an automated sight test. The auto-refraction is only one component of the testing that is done. Although an auto-refraction will result in a set of numbers that may be turned into an optical product, the other pieces of technology offer support for safety considerations. In addition, the autolensometer takes a measurement of the current eyewear and transmits it to the system computer. The autophoropter holds the test lenses that are displayed to the client in sequence with the results sent to the computer for comparison with the current prescription. The suite of machinery that is currently in use also performs a red/green assessment the results of which can also trigger referral. A computer software program collects and collates the results of the other automated tests and produces recommended lens values. Reference to the procedure as an auto-refraction without a requirement within the Standards and Guidelines for the other assessments to be performed may not be what the Ministry has in mind. 3.6 Schedule – Limitations on the Use of ‘Auto-Refractors’ The College of Opticians of British Columbia has reached out to stakeholders for input into the development of their Standards and Guidelines. The OAC has submitted its recommendations to the College and has had the opportunity to review the resulting draft document. . • Age restrictions – The OAC supports the Minister’s recommendation of 19 through 65 as suitable to exclude a significant portion of those individuals who are not suitable for automated sight testing. o Age is the greatest risk factor for the diseases described by the Canadian National Institute for the Blind as the leading causes of visual impairmentAge Related Macular Degeneration, Cataract and Glaucoma and Diabetic Retinopathy18. Studies have shown that the incidence of these diseases is greater after age 65. Consequently the regulation will eliminate those individuals as candidates for optician-performed sight testing. The COBC has provided other screening categories (commented on elsewhere in this 18 Canadian National Institute for the Blind Submission to the Commission on the Future of Health Care in Canada 13 document) that have sensitivity to eliminate the small number of consumers between 50 and 64 who may require specialized screening. 19 The Estimated Specific Prevalence Rates for AMD as published by Prevent Blindness America (PBA), indicates • AMD affects .5% of the population over age 50. Between the ages of 50 and 75 the incidence of AMD is fairly stable running between 1-2 percent of that age group. The figures take a dramatic leap after age 75. The CNIB estimates that one in three Canadians will have clinical signs of AMD by age 75 and that figures leaps to one in two by age 90.20 • Cataract affects 6% of the general population. Starting at age 50 the incidence of cataract sits at about 2 per cent of that age group, and rises at age 60 to 10% of the age group. By age 80 between 60 and 75 percent of the age group will suffer from cataract. Cataract causes a thickening and clouding of the crystalline lens therefore negatively impacting visual acuity, which is a trigger for referral. • Diabetic Retinopathy occurs in 1.6% of the general population. It strikes approximately 1% of those people ages 40 – 49, and at age 50 begins to climb until it spikes at age 70 at slightly less than 6 per cent for whites and blacks, and 10% for Hispanics. This eye disease is best diagnosed by a physician 3-5 years after onset of diabetes • Glaucoma occurs in .6% of the general population. It strikes those between ages 50 – 64 at a rate of approximately 2%-4% of that age group and escalates dramatically after age 70. The population demographics and environmental circumstances are similar enough between the United States and Canada that we can safely extrapolate data that is equally applicable in this country. The government regulation eliminates individuals over 65 as candidates for a standalone sight test and the College of Opticians of British Columbia intends to educate the public to the AAO guidelines for frequency of eye examination. That document recommends an eye health examination every two to four years for people between the ages of 40 and 65. o There has been fair evidence that for healthy adults a vision chart was the best monitor of onset of eye disease. The OAC believes that the COBC protocols surrounding optician-performed sight tests will provide a more highly refined referral mechanism than that recommendation. This in turn should result in better eye health outcomes for British Columbians. 19 20 Prevent Blindness America – Prevalence of Vision Impairment and Age-Related Eye Disease in America Toronto Globe and Mail 2003-Health Supplement/Learning to Live With Vision Loss 14 o The lower age threshold in the regulation is reasonable. The major changes in physiology affecting vision take place from birth to 19. 21 Infants at birth are all farsighted (approximately 2 dioptres). This farsightedness ordinarily decreases in most by age 2 and levels off to zero by age 6. There is a greater prevalence of myopia after age 8 leveling off at puberty. Myopia typically worsens throughout the teen years and levels off in adulthood. The Department of Ophthalmology, Odense University Hospital, Denmark did a 2-year study on myopia progression in children 9 – 12 years of age. They revisited the same cohort of children 8 years subsequent to the study when the children were 17-20 years of age. They found the mean increase to be approximately 2.37 dioptres.22 Refraction has been found to be stable for adults between the ages of 20 and 40 at which point most people require vision correction for reading.23 • Illnesses and Conditions- Individuals should be excluded from an automated sight test who suffer from diabetes, high blood pressure, heart disease, glaucoma or who have a personal family history of eye disease unless a physician is treating their health condition. Once an individual suffering from any of these diseases is under care there is no valid reason why the supervision physician should not refer to an optician for an ophthalmic lens update. o An eye health examination is not an effective tool for diagnosing diabetes, high blood pressure or heart disease but it is an effective tool for monitoring those conditions once having been diagnosed. It is important for people with diabetes to have regular retinal examinations. Approximately 3% of the population suffers from diabetes. Half of those or 320,000 Canadians are at risk for sight threatening diabetic retinopathy. Uncontrolled diabetes can lead to glaucoma, cataracts, heart disease and diabetic retinopathy. People who require vision correction and who suffer from diabetes, glaucoma, cataracts, and heart disease may have need for changes in their lenses to improve visual acuity separate and apart from their regular visits to a physician or optometrist. Once under the supervision of a physician or optometrist these individuals should be able to access sight testing services from opticians. The COBC Standards and Guidelines will eliminate as candidates for optician-performed sight tests those individuals with diagnosed diabetes who are not under the care of a physician or optometrist. 21 Development of Refractive Error in Typically Developing Children and In Children With Down’s Syndrome 22 Myopia in teenagers- An eight-year follow-up study on myopia progression and risk factors. H. Jensen 23 Gross & Erickson 1987 15 • Symptoms – The Canadian Ophthalmological Society (COS) Policy Statement on ‘Appropriate Referral’24 provides guidance, which the OAC endorses as to symptoms that should trigger the optician to advise referral. With the exception of three, the listed symptoms are easily observable or notable without special equipment. The COS Policy states: o A nonmedical practitioner providing services to any person should refer that person to a licensed physician and surgeon for definitive diagnosis and treatment at any time the patient requests, when an eye disease or central nervous system disorder is suspected or when the nonmedical practitioner notes: Failure to achieve corrected 20/40 visual acuity in either eye, unless the cause of the impairment has previously been medically confirmed and appropriately treated (The COBC guidelines err on the side of caution by requiring 20/30 visual acuity to be achieved) Complaints of flashing lights, recent onset of floaters, haloes, transient dimming or distortion of vision, obscured vision, loss of vision or pain in the eyes, lids or orbits, double vision or excessive tearing (included in the COBC Standards and Guidelines). Reports of suspected or real permanent or temporary loss of any part of the visual field (included in the COBC Standards and Guidelines); Presence of a tumour (as reported by the client – OAC comment), swelling of the eyelids or orbit or protrusion of one or both eyes; Presence of detected opacities or abnormalities in the normally transparent media of the eye, the ocular fundus or the optic nerve (not observable by optician – OAC comment); Presence of inflammation of the lids, conjunctiva or globe (included in the COBC Standards and Guidelines); Strabismus or maligned eyes, whether permanent or transient (included in the COBC Standards and Guidelines); Rapid or unexpected changes in optical measurements, even though the vision may be fully correctable (included in the COBC Standards and Guidelines); Intraocular pressure suspected to be above normal (currently opticians are not able to measure intraocular pressure within their scope of practice. Automated tonometry (pressure reading) is available and could be provided by opticians in much the same way as blood pressure testing is provided in drug stores); Anisocoria (un-equal pupil size) (included in the COBC Standards and Guidelines) Any case that does not respond normally to routine testing (included in the COBC Standards and guidelines). 24 COS Policy Statements and Guidelines-Appropriate Referral 16 • Previous Eye Health Examination – The OAC endorses, as does the Canadian Ophthalmological Society, guidelines for frequency of eye examination as set out by The American Academy of Ophthalmology (AAO). o The AOA recommends that adults between the ages of 20-29 should have an eye health examination once during that period. o Between 30-39 individuals should have two eye health examinations. o Between the ages of 40 and 64 an eye health examination is recommended every 2 to 4 years. The COBC has incorporated this recommendation into their Standards and Guidelines. • Rapid change of lens strength required – If the required lens power changes by 1.00 dioptres of strength or more over a 6-month time frame or if there is a change of 2.00 dioptres since the last prescription, the opticians should refer that client to a physician. This applies to spherical as well as cylindrical components. The natural refractive power of the eye is dependant on the curvature of the cornea, the power of the crystalline lens of the eye, the length of the eyeball from front to back and the radius of the eyeball. Any physiological changes in one or all of those components will result in changes in vision. Conditions that create pressure within the anatomy of the eye will have the affect of altering the physical optics and this will be reflected in the requirement for a change in vision correction. In the age group under consideration vision is normally stable with the major change taking place around age 40 when correction for reading is typically required. Between ages 40 and 45 most people will start requiring vision assistance for reading. The reading power will increase gradually over a period of 10 years and then level off at around +2.50 dioptres. This establishes a norm for reading power in the age group 40-50. o A study of refractive changes of individuals between the ages of 20 and 40 years revealed refraction changes very little during that period. Although it is normal for children to experience an increase of –0.50 to –1.00 dioptre of power per year, for an adult, an increase of –1.00 dioptre of power over a 6-month period would indicate a dramatic steepening of the cornea and raise concern about the possibility of kerataconus.25 Because the presence of Diabetes, Glaucoma, Age Related Macular Degeneration and Cataract have an influence on either the radial or axial length of the eyeball, the curvature of the cornea or the thickness of the crystalline lens, dramatic changes in required lens powers can signal concern and should trigger referral. 25 Primary Care Optometry-Grosvenor, 1977c 17 For example: o If the cornea becomes steeper, the physical optics of the eye will no longer bring light to a point of focus and the individual’s visual acuity will decrease. Refraction will reveal the necessity for a change in eyeglass/contact lens power. Increased intraocular pressure is a symptom of glaucoma and sudden onset can cause a progression of up to 1.50 D of myopia. Such occurrence would trigger referral for an eye health examination. People who are farsighted (called hyperopia) are at an increased risk for glaucoma because the anterior chambers of their eyes are shallow, reducing the ability of the eye to drain away tears. Should this become a problem the ocular pressure pushing outward would cause a change in the physics of the visual system resulting in compromised visual acuity and a change in refraction. Cataracts may start to develop around age 40-45. While it isn’t unusual for a myope to require small increments of negative power, it would be unusual for a hyperope to swing in the direction of less positive power. When cataracts start to form the crystalline lens will begin to thicken providing the eye’s natural vision system with more positive power than it previously had. The hyperope will begin to be more comfortable with less positive power. • High Minus or Plus Powers – Individuals whose lens powers are considered ‘high’ are more likely to develop glaucoma. A referral for an eye health examination should be triggered if the client requires lens powers exceeding –8.0026 dioptres or +8.00 dioptres. o Individuals with high myopia are at greater risk for conditions such as retinal detachment than those with lower lens powers due to the increased length of the eyeball as compared with average, and the resultant stretching and thinness of the retinal layer covering the back of the eyeball. o Individuals with high hyperopia are at greater risk for conditions such as certain types of glaucoma due to the shorter than average length of the eyeball and the resulting pressure placed on the ducts that drain tears. • History of Eye Surgery – Automated sight tests should not be performed on individuals who have had surgery for a detached retina, refractive laser surgery, corneal transplant, Inter-ocular lens implant. Visual Acuity-The measurement of visual acuity has been indicated by several authoritative bodies to be a sensitive bell-weather of eye disease. A Visual Acuity is the first measurement recommended for each of the eye diseases listed in the • 26 Ophthalmology-Journal of the American Academy of Ophthalmology – May 2001 18 AAO Summary Benchmarks For Preferred Practise Patterns.27 The COS Policy Statement on Referral recommends as its standard, failure to achieve a Visual Acuity of 20/40 in each eye. The OAC supports this standard. 4.0 OVERVIEW OF KEY PUBLIC ISSUES The purpose of all health regulations and legislation is to protect the public from risk of harm. Many provincial health acts have, in recent years, been restructured and refocused on several additional over-arching principles. These core principles include: • A scope of practice should not be exclusive to any group or groups of health care professionals. Instead, health commissions have recommended and governments have acted to legislate in favour of listing restricted or reserved ACTS. • As a corollary to this fundamental construct is the position that these restricted or reserved acts may be performed by ANY health professional who o Has the training to do so AND o Can demonstrate the ability to do so. Additionally, reports and recommendations of health commissions including the Schwartz commission Report, the Mazenkowski Report, and The Manitoba Law Reform Commission Report, in detailing ways to more effectively make use of health systems have uniformly recommended that it is in the public interest to: o Have a menu of choices for consumers seeking a health professional to perform a service o Make the most effective use of the existing array of health care providers o Make provision for the natural and desirable career progression of professionals. These concepts are clear and should be applied with an even hand to the regulation announced by British Columbia. The act of sight testing is not a restricted or reserved activity under B.C. legislation. This is not – or should not – be at issue. B.C. opticians are not asking for authority to perform a reserved activity. Sight testing as proposed in the regulation would allow opticians to fine tune existing lens powers under rigidly controlled standards and guidelines. The only matter under consideration is whether B.C. opticians have met the burden of responsibility required by the legislation. 4.1 The Basic Training of an Optician Provides the Appropriate Underpinning o The training programmes used by opticians in British Columbia are well respected both nationally and internationally and continue to be accepted by eight Canadian provincial regulatory bodies as appropriate pathways to licensing and certification. The integrity of the COBC 27 American Academy of Ophthalmology, October 2003-Summary Benchmarks for Preferred Practice Patterns™ 19 registration examination has been affirmed as meeting a standard equivalent to that used by the 8 other regulatory bodes.28 4.2 Sight Testing Opticians Must Be Required to Have Specialty Training to Perform This Service o The College of Opticians of British Columbia has adopted a subset of the National Competency Matrix upon which the Automated Sight Testing training programme will be based. Every sight-testing optician will have to successfully challenge an advanced practice examination including those opticians who have previously performed sight-testing services prior to regulation. 4.3 Opticians Have Demonstrated the Reliability of the Results of the Sight Testing They Perform o Eyelogic Systems (the vendor of the automated sight testing suite currently in use by B.C. opticians) conducted a survey of its B.C. clients and found that with half of its operators reporting, it is estimated that since 1997 opticians have performed over 80,000 free sight tests for British Columbians. 4.4 There Is a Consumer Need for Optician Performed Sight Tests o The use of automated sight testing suites has not been widely broadcast in British Columbia due to the pushback their use received from other stakeholders who initiated litigation against the opticians operating the equipment. The College of Opticians of British Columbia as well was compelled due to official complaints from the Board of Examiners in Optometry to pursue this practise through the courts. In spite of that consumers indicated their approval for the service as noted above in the numbers that availed themselves of the service. 4.5 There Has Been No Injury to Consumers as a Consequence of Optician Performed Sight Tests o The OAC cannot speak to any official complaints that may have been generated by consumers unhappy with the service or who have had cause to seek medical attention as a consequence of their optician performed sight test. Investigation and disciplinary matters are the responsibility of the regulatory body and the College of Opticians of British Columbia is able to address that issue. In 2000, the OAC contacted the opticians’ and ophthalmologists’ regulatory bodies in the three provinces in which sight tests have been performed by opticians. At that time the only complaints that had been lodged were at the instigation of or by competing stakeholders. 28 Professor Ernest Skakun 20 5.0 CONCLUSION Since the Ministry of Health Services’ announcement in March 2004, there have been a few public statements of concern, suggesting that there is an inherent risk of harm in the announcement. The OAC has been attempting to address these statements of opinion with clear statements of fact. Some optometrists have suggested the risk of harm derives from the inability of an optician to detect eye disease. Optometrists maintain they are in a better position to perform sight tests because they combine sight tests with a complete oculo-visual examination and that through this oculo-visual examination they are better able to identify incipient disease. In other words, even if you are simply requesting an up-grade in your prescription you must have an accompanying physiological eye examination. The public has been told by various optometric groups that optometrists are able to detect diabetes, AIDS, high blood pressure and even cancer through a complete oculo-visual examination. Unfortunately, there is no evidence to support these claims. Worse, the OAC is concerned that these statements will lead to increased confusion and harm to the public. We believe that an eye health examination is an effective method of monitoring progressive vision deterioration brought on by related diseases but it is not an effective method for detecting and diagnosing those same diseases. The OAC is committed to public education, and will continue our efforts to ensure the public receives appropriate information that will help them make good choices regarding the care of their eyes. In our initial submission on the B.C. opticians regulation, the OAC submitted documentation pointing to the fact that individuals who are at risk for eye disease are easily identifiable and in any case are not captured within the age-restricted group that are eligible for an optician performed sight test. A philosophy that dictates that a sight test and an eye health examination must be performed in tandem presumes that the eyeglass wearing public is at greater risk for eye disease than the non-eyeglass wearing public since it is normally a reduction in visual acuity that triggers a request for a sight test. There is no evidence to suggest that eye disease occurs more frequently in eyeglass wearers. It does not seem reasonable to force the eyeglass wearing population to undergo the bundled services of sight test and oculo-visual examination in order to screen for the small number of people who are likely to have eye disease. Together, the province and opticians, optometrists and ophthalmologists must find a more effective screening device and a Family Practitioner-centred model. 21 If we are to discover eye disease in the at risk population, we need to find methods of reaching out to all 30 million Canadians and not just those Canadians who wear eyeglasses. With approximately 4000 optometrists across the country available to perform eye health exams, it would seem clear that in the best of all possible worlds, the work of attending to the sight testing requirements of the eyeglass wearing consumer who is not at risk can safely be placed in the hands of opticians. The OAC suggests that British Columbia opticians have met the burden of responsibility set out in the Health Act and they have performed due diligence. They have mandated appropriate training and they have demonstrated they are able to safely perform the act. The OAC believes that you have an opportunity before you to reaffirm a decision that will benefit consumers, AND that will add dimension to, and an enrichment of, the vision care system for British Columbians. We urge you to allow British Columbia opticians to implement the regulation. 22