By Evra Taylor

What do you do when consumer convenience and best health practices collide? You turn to the government for guidance and legislation. But what if “the” government turns out to be “many” governments? This is the situation in Canada, where many health issues are provincially, rather than federally, regulated, obviating a uniform, harmonized healthcare landscape.

Charlottetown, PEI Senator Percy Downe is a leading voice in the fight against the sale of cosmetic contact lenses in Canada; his views are consistent with those who protest the Internet sale of prescription eyeglasses and contact lenses. Those who share this viewpoint claim that the outcome of such sales is bad for consumers and often results in harmful ocular effects and injury.

Senator Downe is an advocate for Bill C-313, which would amend the Food and Drugs Act regarding cosmetic (non-corrective) contact lenses. The bill would ensure that Health Canada approves the product and that the proper medical device and establishment licences are in place before these products are manufactured and distributed to retailers. This would make them subject to the requirements of the Food and Drugs Act in the same way as corrective contact lenses.

However, having a licence has nothing to do with preventing harmful effects: while cosmetic lenses do not pose a problem in terms of being manufactured to the wrong prescription (which is an issue with online eyeglass and prescription lenses), the fact that they interact with the eyes creates significant potential problems for both wear and care. Optometrists point out that what is missing from these “self-serve” lenses is their input in sizing and lens care.

“Eyeballs come in different shapes and sizes; lenses have varying curvatures,” says Dr. Sheldon Salaba, president of the Ontario Association of Optometrists. “If contact lenses don’t fit properly and don’t move correctly, the cornea will swell and weaken.” From red eyes to blindness, “a whole host of complications can develop,” he adds.

What if you go the “lowest-price-on-the-shelf, no-name brand” route? If the lenses are from an unknown supplier, you could be headed for disaster. In that case, the risk of serious ocular problems like corneal scarring and blindness is 12 times greater than for those who buy from a known supplier, says Dana Cooper, director of governmental relations and public policy at the Canadian Association of Optometrists.

Health Canada Class II devices require the manufacturer’s declaration of device safety and effectiveness. However, because cosmetic lenses are not listed as Class II medical devices under the Food and Drugs Act, they are not subject to regulation by Health Canada. Sudbury, ON Member of Parliament Glen Thibeault, along with other consumer advocates, has described the lack of regulation in this area as, “a gap in consumer protection.”

“Health was mainly a provincial responsibility under the constitution when Canada was formed in 1867,” said Senator Downe. “Nobody foresaw sales of online items. I spoke on this issue in the Senate in the context of a proposal to ban “party contact lenses,” the coloured and designed contacts that are available at any party store or discount store.

“The internet is useful for buying everything from lawnmowers to automobiles, but when you’re dealing with health products, you need to ensure that the drive for savings is not offset by an increased possible health risk. In this case, we require national regulations to protect Canadians from businesses that were set up in a third-world nation, for all we know – and advertise online with a fancy web site – and you don’t know where they are, what the products are made of or what (level of) safety is involved.”

The consensus among Bill C-313 supporters is that the drive by certain contact lens companies to provide products that circumvent the scrutiny of professional bodies is motivated by profit. For his part, Senator Downe and like-minded individuals are committed to pushing for federal legislation that would help protect the eye health of all Canadians.

By Evra Taylor

Amid growing concern about access to patient information, questions have been raised about how to protect patients’ privacy in terms of information gathering, record keeping and safeguarding confidentiality.

David Fraser, a Halifax-based privacy lawyer with the firm of McInnis Cooper is familiar with the ins and outs of Canada’s privacy laws and their application for optometrists and opticians. He points out that one cannot refer to “a privacy act” in Canada because the laws that govern privacy in this country are a patchwork of provincial and federal acts and updates that compose a tapestry of legislation.

Interestingly,Quebec was the first province to enact privacy legislation. However, the legislative principles are the same across the country and Canada’s privacy regulations are quite comprehensive, according to Fraser. The laws encompass patient information from the moment it’s collected, through its lifecycle in a professional’s practice.

“Some pharmacies, for example, have consulting rooms so that if the client has questions about their prescription, they can address them privately. If such a room isn’t available, that may be an infraction,” he explained. In addition, the practitioner must obtain the individual’s consent for disclosure of personal information. The optician or optometrist must collect and disclose only the minimum amount of information about patients and their practice must have safeguards in place against the loss or misuse of patient records.

One of the most important privacy requirements is that an optician with a retail practice is obliged to designate an individual who is responsible for privacy regulation compliance. This can be the optometrist-owner, an administrator or an office manager. Fraser points out that in the case of a multi-location optical chain, it makes sense to have someone responsible for compliance onsite at each location; this is essential in creating accountability.

Staff training – and refresher sessions – in issues relating to safeguarding patient information are crucial, he adds. In fact, this training is recommended by Jennifer Stoddart, the Privacy Commissioner of Canada. “In my experience, people become de-sensitized and deal with private data quite casually. Sometimes you lose sight of how sensitive this information is,” explains Fraser.

Naturally, any healthcare professional needs to be aware of their reputation. If an optician becomes known for not caring about consumer privacy, their practice will no doubt suffer. And for regulated professionals, engaging in unprofessional conduct can expose them to discipline by a regulator.

A highly publicized breach of privacy occurred in 2010 when a Canadian optical firm disclosed a client’s personal information without his consent and subsequently failed to provide him with access to that information. The firm didn’t suffer any real consequences; as Fraser points out, the Privacy Commissioner doesn’t have any powers to levy fines or to issue orders. “The worst consequence in a case like this is to name and shame the company.”

Is Canada’s privacy legislation adequate? “Yes,” Fraser contends. “If the legislation is followed, it’s adequate”. That’s a big ‘if’, however. “Breaches occur every day. Awareness of privacy issue laws isn’t high, particularly in smaller practices, which probably are not even aware of them and most likely inadvertently breach these laws all the time.”

Fraser advises optical practitioners to take time to educate themselves about their obligations.Canada’s Privacy Commissioner has helpful resources, “and people should also be looking to their provincial regulators and associations. Some of them have made the effort to put together materials for opticians,” notes Fraser, adding, “Complying with Canada’s privacy legislation is not that difficult.”

For more information on Canada’s privacy legislation, visit the Office of the Privacy Commissioner of Canada’s web site at www.priv.gc.ca.

By Evra Taylor

The proliferation of eyeglass frames, contact lenses, and ophthalmic equipment and devices comes with the potential hazards of poor workmanship and compromised safety. It is a comfort, therefore, to know that the Standards Council of Canada (SCC) has developed criteria that promote product reliability and best practices in the optical and ophthalmic industries.

The SCC is a member of the International Standards Organization (ISO), an umbrella group made up of more than 160 member countries worldwide. ISO standards encompass everything from agriculture to medical devices and the ISO designation signifies a global consensus on the state of the art in the technology or good practice concerned. To ensure high quality in the eyeglass industry, the ISO has developed a standard outlining fundamental manufacturing requirements.

The standards document known as ISO 12870 applies to eyeglass frames for all prescription lenses and includes such items as protection against low-quality production and hazardous materials. ISO 12870 states: “This International Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer. This International Standard applies to all spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames, as well as spectacle frames made from natural organic materials.” The standardization process involves in-depth product testing and evaluation of such elements as construction, clinical evaluation, tolerance on screw threads, mechanical stability and resistance to perspiration.

Dr. Ralph Chou is an optometrist and associate professor at the School of Optometry and Vision Sciences at University of Waterloo and a member of the SCC Mirror Committee for ISO, a group that has active input into the development of these criteria. He explained that the 12870 standard is relatively old and that the recently announced document is a revamping of the guidelines to reflect technology changes. “The standards system helps protect consumers because it provides common specifications that help ensure the quality of imported and exported products,” Dr. Chou said.

He also serves on ISO technical working groups that study the requirements for tints in ophthalmic lenses and the technical requirements for lensometers.

ISO standards updates are not the result of a manufacturing  problem; rather, they are a matter of process. Most standards undergo a technical review every three to 10 years, depending on the industry. With ophthalmic goods and materials, the review interval is roughly five years. Some stipulations are mandatory, others are optional. Certain items,  like quality of construction that prevents rough surfaces or sharp edges that might cause injury, are mandatory. An example of the new provisions is a section pertaining to nickel release in eyeglass frames, which can cause health problems in some individuals. This standard, which is mandatory, stipulates a maximum level of nickel that can be leached out of the frame.

Other standards organizations are at work in the optical sector elsewhere in the world. The CE Mark, abbreviated from Conformité Européenne, or “European Conformity,” indicates that a product conforms to European Union (EU) legal requirements, including safety standards. While not all products are required to bear the CE mark, medical devices, some types of machinery, toys and PCs are subject to CE standardization. Numerous Mutual Recognition of Conformity Assessment Agreements exist between the EU and countries including Canada, the U.S., Japan, Australia, New Zealand and Israel. As a result, the CE mark is now found on many products from these countries.

As an OD who is conversant with standardization in the optical industry, Dr. Chou is not certain that Canadian opticians have a high degree of awareness of ISO standards. “I mention them to optometrists and sometimes discuss them with my students. Like many things, this is an aspect of the industry that is not touched upon much in the education process,” he stated. “In the case of nickel release, for example, dispensers need to be more conversant and aware that the ISO standard exists as a safeguard.”

Dr. Chou views ISO standardization as “relatively effective. The ISO world is eventually going to become the way in which the ophthalmic market will be governed internationally. They have an entire system of standards that deal with eyeglass frames, contact lenses, aberrometers and other items. ISO standards are also becoming extremely important in intraocular lenses and dry eye implants.”

In Dr. Chou’s opinion, raising awareness is paramount. He emphasized that ophthalmic dispensers should ask sales representatives if their products conform to ISO standards as a way of ensuring product durability and safety for the end user. “Regardless of the price point, the product needs to perform to expectations. It’s important that Canadian professionals support the development of ISO standards and keep up to date with changes over time,” he noted.

(Part two of a two-part series)
By Evra Taylor

Part one of this series examined the changing relationship between the worlds of optometry and ophthalmology and the concept of fee-splitting. As in Quebec and other parts of Canada, professional associations in the U.S.have taken a strong stand against this dubious practice, which relegates the needs of patients to less than top priority.

The American landscape

A number of medical and ophthalmological organizations in the U.S.have implemented guidelines stipulating that the surgeon is responsible for postoperative care, which can only be ceded in uncommon circumstances. A joint position paper of the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS) on ophthalmic postoperative care states, in part: “The operating surgeon has the responsibility for the postoperative care and disapproving if economic considerations drive the decision to transfer the care of a patient following surgery.

Although this obligation may be ethically ceded to another healthcare provider, it is anticipated that this will be an exceptional, rather than a routine, occurrence. If the reason for sharing postoperative care with another provider, however well trained, is economic, specifically as an inducement for surgical referrals, or the result of coercion by the referring practitioner, it is patently unethical and, in many jurisdictions, illegal”.

The position paper highlights one of the most important concerns, namely, “The transfer of care must not occur unless it is clinically appropriate and in the patient’s best interest”.

Patient co-management: a new norm

As guidelines and regulations disallowing fee-splitting have been instituted, a shift to more “normalized” – and ethical – patient-co-management has taken place. The practice of medicine in general, including the eyecare sector, has transitioned from a lone practitioner model to one based on a collaborative team of professionals. A new paradigm has emerged in light of the fact that optometrists network with ophthalmologists, and that they see more patients on a more frequent basis than do their surgeon colleagues.

In one practice model, optometrists would refer patients to ophthalmologists whenever surgical intervention was necessary, and they would “keep” the patient since their primary revenue stream is the six-month eye check-up. This applies especially in the case of older patients for whom they would likely do a pressure check for glaucoma and examine the back of their eyes for diabetes, for example.

In the above scenario, the eyecare cost would be split. With a glaucoma patient, for instance, the optometrist would charge for patient visits and the ophthalmologist would assess how far the glaucoma had spread and whether surgical intervention was warranted. The ophthalmologist would charge for his or her portion; the patient would return to their optometrist for regular visits and the optometrist would bill accordingly. This is not fee-splitting: it’s co-management or, as some professionals have deemed it, “patient splitting.” In co-management, the patient is being managed by both sides, with each one charging their respective fee.

The current reality is that in some instances, “shared care” is a function of lack of resources. In rural areas where people don’t have easy access to ophthalmologists, postoperative surgical care is handled by optometrists. Some practitioners hold that optometrists should be able to handle it: in light of optometrists’ current advanced level of training, they maintain the point of view that either an OD or an MD is equipped to handle patient follow-up.

Conclusion

While fee-splitting represents the “bad news” of the day, the response of various governmental bodies and professional associations in both Canada and the U.S.represents “good news”. These groups have provided clear guidelines that outline the framework within which optometrists and ophthalmologists divide and share patient care.

Given that the Hippocratic Oath includes the promise “to abstain from doing harm,” and in light of the aging population and increased stress on the healthcare system in Canada, patients must be assured that their health and safety is at the forefront of every practitioner’s mind and practice.

By Evra Taylor

The rights of the visually impaired and their access to services commonly available to sighted individuals often intersect with technology as new devices are introduced to make life easier and more streamlined.

While the sighted world celebrates the convenience and ease of global positioning system (GPS) technology to guide it through city roads and highways, the technology has no meaning to the visually impaired who cannot drive a car.

However, scientists at the Georgia Institute of Technology in Atlanta have developed an audio navigation system called SWAN, or the System for Wearable Audio Navigation, to help those with visual impairment navigate their surroundings and recognize what is in their immediate environment along the way.

The person wears a backpack containing a small laptop, and a series of beeps guides them, with different sounds indicating objects like park benches or obstacles such as fire hydrants.

Bruce Walker, assistant professor at Georgia Tech’s School of Psychology and College of Computing, developed the SWAN system with computer science expert Frank Dellaert and several colleagues. “At this point, SWAN is a research project only. We have been studying how such a device could be designed to help blind and low vision people move from place to place. We have a very sophisticated, fully functioning system, but it is only a prototype.”

Walker and his team are also working on a universal set of audio cues. For example, a knocking sound might signal an office door or a series of chords could indicate a skyscraper. SWAN is currently limited to the outdoors but developers are looking at using cameras to make it work inside, as well.

While SWAN represents a major advance in technology for the visually impaired, it is only one of several acoustical GPS systems. The Sendero Group (www.senderogroup.com) began developing accessible GPS in 1993 and their software is now at the core of four of six accessible GPS systems, including BrailleNote, Mobile Geo, Braille Sense and the Pac Mate/StreetTalk. In 2010, Sendero Group expanded on their available platforms and added the Sendero LookAround GPS application for the iPhone. What makes this company special is that most staff are visually impaired. They know from experience that orientation and mobility skills and tools for blind folks are essential to living a successful life.

Another form of adaptive technology for the visually impaired is the Assistance Sensor, an ultrasonic sensor system that improves mobility by detecting and signalling obstacles as one walks along the street. Three wearable sensors are clipped to the user’s clothing and connect to a small battery pack; wires worn under the clothing connect the sensors to the battery pack. The sensors send signals to the receiver housed in an adjustable wristband, which vibrates every time the sensors detect an obstacle — the closer an object, the more intense the vibration.

The Assistance Sensor, which is currently at the prototype stage, was developed by Ursulla Uelzhoeffer of Roselle Park, NJ. “This is a fantastic aid for the visually impaired,” she noted in a statement. “It is a sophisticated and cost-effective means of improving their mobility. The Assistance Sensor is compact, lightweight and wearable, and provides a hands-free navigation tool which is vitally important for the person who needs this device.” Visit www.virtual-prototype.com/?id=3502 for more information.

Basic abilities the sighted take for granted – such as reading street signs and signals, navigating their environment and overall ease of mobility – represent major hurdles for the visually impaired. Some of these challenges have been addressed by governmental bodies, researchers and disability activists with the goal of making the world an easier place for those who lack sight.

The Canadian Council of the Blind (http://ccbnational.net/content/) has lists of blindness organizations, blind-related links and technology products with useful information eyecare practitioners can share with their patients and their families.

By Evra Taylor

Cell phones and high-definition television are forms of communication and entertainment that have become integral parts of our lives. But what happens when the disabled among us can’t access the technology that most of us take for granted?

A close look at accessible technology for the visually impaired and blind reveals that we’re not all on a level playing field. As John Rae, first vice-president of Alliance for Equality of Blind Canadians, stated, “Technology was supposed to become our great equalizer, but in fact, it’s become a double-edged sword.” In other words, what good is developing a service if some individuals are excluded from its use?

When it comes to the Internet, for example, the issue of making content available to all has created more of a “web entanglement” than an enhancement of what existed before. While an increasing amount of information is available via the Internet, a large part of it isn’t accessible to visually impaired individuals. A lot of the information posted on the Internet remains available in PDF format only. An additional challenge is that one alternative format – Braille – is being used less and less by the blind community.

Two other types of technology that are high on the priority list of accessibility rights advocates are described video (DV) and the “user-friendliness” – or lack thereof – of cell phones. In described video, which applies to television as well as to movies, a separate audio track fills in a description of certain scenes in which either there is no dialogue or the dialogue doesn’t convey what is taking place on screen. The company providing the description decides how much of the visual content should be described and creates the text. They also assume the cost.

The Canadian Radio-television Telecommunications Commission (CRTC) is an independent public organization that regulates and supervises Canadian broadcasting and telecommunications systems; as such, DV and cell phone usage fall under its aegis. The CRTC has mandated a minimum of four hours of DV per week for television, an allotment deemed far too little to satisfy rights for the disabled activists. TheAlliancefor Equality of Blind Canadians has met with CRTC officials on several occasions and has participated in a number of hearings in an effort to expand DV services. However, a ruling in August confirmed the Commission’s unwillingness to do so for the moment. Said Rae: “While we’re seeking this for the visually impaired and blind, a lot of sighted people find that they derive more from a movie with described video because sometimes those extra descriptions point out things viewers might miss. Our objective is equal access to enjoyment of television and movies.”

Martine Vallee, director of social and consumer policy for the CRTC, stated that in 2001, the CRTC began imposing DV requirements on conventional English television stations, extending this in 2004 to English pay and specialty services whose content was comprised of 50 per cent or more of drama, documentary or children’s programming. In such cases, the four-hour per week requirement becomes what is known as a “condition of license” at the time of first issue or renewal.

The CRTC has held hearings in the past few years to review the issue of described video. The organization maintains that the current requirements are sufficient, citing, in part, financial considerations. In December 2011, the Commission will be holding a hearing on DV for French television and Vallee reports that a mandate will be established for that sector, as well.

While the CRTC holds a tight reign on DV services, Vallee emphasizes that it has been active in other areas of accessibility. In 2009, the Commission asked the television industry to develop a working group comprised of broadcasters and representatives of organizations for the blind to examine ways in which to facilitate access. “As cable and satellite to home companies’ licenses come up for renewal, they will be required to provide clear labelling of the described video service on remote control devices.” The CRTC is also trying to find ways to increase the amount of information available to the public about DV and to inform viewers about which programs are going to be described. Stated Vallee: “We will be developing a series of recommendations and solutions, and publishing a report at the end of this year.”

For his part, Rae feels that creating greater access requires greater regulation. “The current government position is to impose less regulation in favour of having the marketplace solve its own problems, a stance that does not favour the needs of the disabled segment of Canadian society. We are extremely disappointed that the CRTC has not increased the described video requirement”. TheAlliancefor the Equality of Blind Canadians is seeking incremental increases in the amount of described programming, with the goal of reaching 100 per cent coverage within 10 years.

Marc Workman, director without portfolio of the Alliance for Equality of Blind Canadians, is equally concerned about the accessibility of cell phones. Hardware and platform accessibility covers such items as touch screens that are too small or grouped too closely together, and improving access to cell phone applications through designs that take into account the needs of the visually impaired and blind. Workman praised Apple for doing just that with an iphone featuring a screenreader voiceover that tells the user which key they’ve just touched. By contrast, he stated that Android phones provide some accessibility, but that their functions for the blind don’t run as smoothly.

Other issues Workman cited are the need for improved Bell Canada customer service training, and greater web access through online screenreader services that would enable users to access their bills online and compare phone plans.

A 2006 Statistics Canada survey reported that 836,000 Canadians identified themselves as having a “seeing disability”. With a growing number of Canadians experiencing some type of vision loss, caused in part by an aging baby boomer population, the National Coalition for Vision Health states that the total number of visually impaired and blind Canadians is projected to double over the next 25 years. In light of this, greater accessibility to various types of technology is a major social concern that merits the attention of all Canadians.

Looking Forward to Canadian Healthcare Reform
ByEvra Taylor Levy

It’s no secret that one of the major – and most-talked-about – issues inCanadais our healthcare system. Professionals working within the medical community, as well as those of us using its services, are feeling the effects of a national healthcare infrastructure struggling on life support.

In a speech to the Empire Club of Canada last February, Dr. Jeffrey Turnbull, President of the Canadian Medical Association (CMA), said, “Today, Canadians are saying that health care is as big a concern as the economy and they want action now,” and he asked the federal government to create a Health Care Action Plan based on Canada’s Economic Action Plan.

In December 2010, Turnbull launched an initiative he hoped would engage Canadians in a cross-country dialogue designed to inspire new ideas and solutions to the healthcare crisis that has crippled our ability to answer the needs of an aging population.

Turnbull’s grassroots approach was intended to spark conversations with healthcare consumers in what could, ideally, be deemed, “healthcare for the people, by the people”. The program began with a website asking Canadians to provide feedback on what a transformed healthcare system would look like to them. More than 50,000 hits confirmed Turnbull’s sense that the time was right for a community-based forum to discuss specific issues of interest to Canadians in their respective provinces.

As a second part of the action plan, town hall meetings were held in partnership with CPAC (Cable Public Affairs Channel), and Maclean’s and l’Actualité magazines. These events have been staged in cities includingHalifax,Edmonton,Toronto,Vancouver, andQuebec. Turnbull says he witnessed tremendous enthusiasm and a high turnout on the part of the public. In fact, each meeting was sold out.

The response in each city reflected its participants’ unique perspective. InEdmonton, the feeling was, “We need to have a grassroots social movement because the government won’t lead us in healthcare reform. We need to advocate for this change”. InVancouver, Turnbull said, there was a lot of energy around the idea of a publicly funded healthcare system. Torontonians expressed the need to address access to healthcare. Apart from those specifics, Turnbull said, the cities shared the same basic concerns.

The key issues discussed at these meetings were: access to clinic and hospital-based primary care; access to surgeons; availability of pharmaceuticals regardless of one’s ability to pay; and greater availability of preventive healthcare resources. All of these factors clearly are relevant to opticians and optometrists in their ongoing efforts to provide optimal care to their patients in both urban and rural settings.

One of the elements that surfaced was the need for a shift in thinking toward a paradigm in which consumers share responsibility for their own healthcare, and feel a sense of accountability. “We are examining the question, ‘what is the individual’s and family’s responsibility when it comes to healthcare?’ We have moved away from a curative, acute care model to one in which patients are engaged in their own health,” Turnbull stated.

Meetings were also convened with physicians across the country, who expressed the same concerns as healthcare consumers. A key discussion point was the growing need for long-term, home-based care, rather than community-based care. Said Turnbull: “This model offers many efficiencies including a financial saving. We also need to work on integrating various healthcare workers and resources, leading to a more comprehensive approach to care.” Montreal MDs expressed the need for greater radiology and diagnostic services, and raised the issue of the current shortfall in primary and long-term care facilities.

Turnbull summed up the town hall events as a reflection of Canadians’, “huge appetite for discussion on healthcare matters”. He will be gathering the information gleaned from the national dialogue and, together with an expert panel, the CMA will look at how to get to where they want to be. A report of Turnbull’s findings will be presented at the CMA annual meeting in August.

Given their major role in the medical community, Canadian ocular health professionals have an important stake in the discussions – and the outcome – of healthcare reform programs being considered under the aegis of the CMA and other concerned organizations. There is no doubt that healthcare is a priority for all Canadians and that a healthcare action plan is something to which we all look forward.