CLS AND THE INTERNET
Purchasing Lenses from Online Lens Retailers
Will the "Fairness to Contact Lens Consumers Act" ensure that patients receive regular eye exams?
By Kerrie L. Padilla, OD, Terresa R. Harrington, OD, RN, and William Edmondson, MAT, OD
Recent trends in contact lens purchasing show that an ever-increasing number of patients are obtaining their lenses from mail-order and Internet vendors. This method of buying lenses is quick and convenient, but potentially harmful adverse effects may go undetected when patients fail to return to their practitioners for evaluation of contact lens fit and performance.
We'll review the literature on mail-order and Internet lens purchasing and reveal data from a study we conducted during the summer and fall of 2002 of 23 online providers from which we ordered lenses with prescriptions that were out of date. We'll also review new federal regulations regarding contact lens prescriptions.
A Look at Purchasing Trends
Before manufacturers introduced planned replacement lenses, patients typically purchased a new pair of lenses approximately once each year. Now, most practitioners prescribe hydrogel lenses that patients replace on a schedule ranging from daily to quarterly. This shift to disposable and planned replacement lenses expanded a large market for mail-order and online businesses to sell replacement lenses. Because these providers offer a quick and convenient way to order and receive lenses, their business has dramatically increased in recent years. A leading Internet lens seller states that it earns more than $2.5 million in contact lens sales each week.
Patient perception about contact lenses has shifted in response to the shorter replacement schedules and their availability through lens retailers. The Food and Drug Administration (FDA) classifies contact lenses as medical devices. However, many patients now view them as consumer items that carry no health consequences. Practitioners report that patients are increasingly foregoing ocular health exams while obtaining replacement lenses from online providers. In the past, lens providers rarely consulted with prescribing practitioners, and their lax policies regarding prescription verification may contribute to trivializing of follow-up exams.
Did Past Litigation Improve Verification?
In the mid 1990s, 32 state attorneys general filed a lawsuit against a number of contact lens manufacturers, the American Optometric Association (AOA) and several optometrists for allegedly colluding to not sell contact lenses to mail-order houses and other alternative distributors and for allegedly conspiring to withhold contact lens prescriptions from consumers. Bausch & Lomb and CIBA Vision settled out of court and admitted no wrongdoing, and they've henceforth sold lenses to many mail-order companies in recent years. Many other manufacturers didn't sell directly to mail-order houses, but the mail-order businesses purchased their lenses on the gray market.
The AOA also settled out of court in 2001, agreeing to not oppose the release of lens prescriptions and to not discourage manufacturers from selling to online establishments. Interestingly, a stipulation of the Vistakon agreement from that same year required online providers to obtain doctor information and verify prescription parameters before dispensing lenses to consumers (News Spectrum 2001).
In early 2003, Vistakon settled a lawsuit with 1-800 Contacts that required them, as part of a contract, to verify prescriptions, and in mid-February 2003, 1-800 Contacts became a distributor of Vistakon lenses. Failure by 1-800 Contacts to verify Acuvue lenses with practitioners for current prescription parameters could result in Vistakon refusing to ship lenses to 1-800 Contacts. A recent study (Teague et al 2003) found that of 422 attempted contact lens purchases made without a valid prescription, companies routinely verified those for Vistakon products with the prescribing practitioner. Yet, between 89 percent and 96 percent of all orders from other manufacturers were ordered, shipped and received without a valid prescription. All manufacturer brands included in this study were widely and readily available through mail-order and Internet companies. The companies also substituted private-label lenses with the manufacturer's branded equivalent.
However, the companies in this study dispensed only eight percent of Vistakon products ordered using invalid prescriptions. These results seem to indicate that Vistakon's contract to sell lenses to mail-order firms, which requires that the seller verify prescriptions, results in greater compliance in verifying prescriptions with the prescribing practitioner.
Certainly the new Fairness to Contact Lens Consumers Act will affect this issue in the future.
Designing Our Study
In the summer and early fall of 2002, we set out to determine how readily we could obtain contact lenses when we ordered them online without a valid prescription, subsequent to the 2001 Vistakon agreement mentioned earlier. We selected a popular hydrogel contact lens from a leading manufacturer for online ordering. We conducted a thorough Internet search and selected 30 companies as potential online providers. To make the most of our allotted budget, we ordered from companies that had the lowest prices for one-box orders first; then we placed orders with vendors who offered the cheapest prices on a two-box minimum.
We created an online patient profile using the factual personal information of one of the researchers, including name, age, mailing address, e-mail address and credit card data. However, we fabricated the exam date (February 2000) and prescription parameters (power 2.00 DS, base curve 8.7mm and diameter 14.2mm). A local optometrist agreed to serve as our patient's practitioner, and his staff fielded telephone calls from companies attempting to verify prescription and patient information. We asked this practitioner's office to inform each contacting company that the prescription was out of date and that the patient was due for an eye exam.
Using a personal home computer, we ordered lenses Sunday through Thursday, with most orders placed in the evening. We submitted only one order if an online supplier required the prescribing doctor's name and phone number; otherwise we placed orders with additional companies until doctor information was either optional or required. We used this method to better track the efforts of companies that contacted the practitioner for verification.
The researchers received the lenses, dated them upon receipt and verified one lens from each box.
Figure 1. Performance of 23 selected online contact lens vendors in filling online
Of the 23 online companies from which we ordered contact lenses, less than half (11 out of 23) required the prescribing doctor's name and/or phone number when ordering lenses (Figure 1). Nine companies didn't even provide a section to input any doctor information. Providing doctor information was optional when we ordered from three additional online companies. One of these charged a $10 fee to obtain the prescription from the doctor's office.
Ultimately, only four providers contacted the doctor to verify the prescription parameters and prescription date. However, only two, including the vendor we paid to obtain the prescription, contacted the office during business hours. When the doctor's office advised these two companies that the contact lens prescription was out of date, both processed and dispensed the order as requested. The remaining two verifying companies contacted the office after business hours and processed the order without confirmation of prescription validity.
Figure 2. Average costs and shipping times for online
Prices for one six-lens box ranged from $16.95 to $36.50, with an average price of $19.91 (Figure 2). Shipping and handling costs ranged from $4.50 to $7.95, with an average of $6.25. Two companies did not charge for shipping, and we excluded them from the average cost of shipping.
Lens delivery times ranged from two days to 17 days, with an average of 5.7 days. We considered lenses that we ordered before noon as ordered on that date. All other orders we considered as ordered on the next business day.
We ordered six-lens multi-packs from each company. We verified one lens from each box, and all were accurate for prescription parameters and within the expiration date.
How Consumers View Online Lens Purchasing
We also distributed a survey among mostly college-aged participants to assess their opinions and habits regarding online contact lens purchasing. We administered the survey at the student center of Northeastern State University. One hundred-thirteen participants completed the survey (Figure 3).
Seventy-three percent of respondents felt regular eye exams are very important, while 26 percent considered regular appointments only somewhat important. The remaining one percent of participants said that regular eye exams aren't important.
Figure 3. Responses of survey
Twelve respondents indicated that they currently order contact lenses online. Two other participants stated that they've obtained lenses online in the past. Before conducting our survey, we suspected a larger percentage of young adults purchased contact lenses over the Internet. Patients who had ordered lenses via the Internet reported cost and convenience as the primary reasons for ordering online. They were not only happy with the service provided, but everyone who had used the Internet for contact lens purchases gave an overall satisfaction rating of good to excellent for Internet contact lens companies. In addition, other practitioners found that many patients used the Internet for purchasing contact lenses using invalid prescriptions. Also, 43 percent felt online vendors' prices were equivalent to doctors' office prices, while 57 percent felt that online lenses were less expensive. This suggests that convenience, not cost, is the primary driving factor for half of online lens ordering.
Eye Health Not a Top Priority
Harris et al (2001) reported ordering lenses from five online companies using contact lens prescriptions with fictitious doctor names and phone numbers. The companies filled all of the orders and made no attempt to verify the prescription. The investigators also found that 60 percent of the companies' operators gave advice over the telephone about switching lens-cleaning systems without consulting patients' doctors. Company representatives also advised patients about lengthening lens replacement schedules and increasing lens wearing time without contacting patients' eyecare providers.
According to Barr and Harris (2001), one online lens supplier admitted in its company literature that one-third of its lens sales don't comply with regulations for the sale and delivery of contact lenses. The company CEO reported that his company's practice was to complete the sale and ship the lenses regardless of whether it could verify the prescription.
However, Spencer (1993) reported that another prominent online provider dispensed only lenses that an eyecare professional had fit and checked, and that it required a hard copy of the prescription or doctor verification. This company reportedly denies approximately 20 percent of all potential orders because it can't obtain the prescription or the patient doesn't actually have a prescription.
Our study's objective was to determine if a valid prescription is required to successfully obtain contact lenses from online suppliers. We felt that re-addressing this issue was important to determine if any change in vendors' policies had occurred since the 2001 settlement that included Vistakon's stipulation about verifying prescriptions. Vendor attitudes toward prescription verification is an important aspect of evaluating the outcome of this judgment.
Our study revealed that all 23 online contact lens providers supplied lenses and disregarded the validity of the contact lens prescription. Only four of the 14 companies that received doctor information made contact with the practitioner's office, while nine companies ignored the legal necessity of doctor information for prescription verification altogether.
Raising Health Concerns
Because patients can obtain replacement lenses so easily from online providers, they commonly neglect follow-up exams. This trend of self-management can result in serious ocular health problems such as giant papillary conjunctivitis, corneal edema and neovascularization. A licensed practitioner could readily detect such conditions during a follow-up exam.
Practitioners are also concerned that online companies focus primarily on price and convenience in their advertisements, creating the impression that contact lenses are simply a commodity or a cosmetic device. In reality, extended wear lenses, a popular choice among contact lens patients, are class-three medical devices, which is the most highly regulated FDA medical device category. The FDA registers daily wear lenses as class-two medical devices. Unlike spectacles, which do not cause patient injury if incorrect lens parameters are supplied and worn, contact lenses are in direct contact with the cornea and have the potential to cause ocular damage.
Ideally, patients should return to their practitioners at regular intervals for eye health exams before reordering an annual supply of contact lenses. This would allow eyecare practitioners to make lens changes if they detect adverse conditions. However, with the competitive prices and vast availability that lens sellers offer, many practitioners feel that they're fighting an uphill battle. For most eyecare providers, the issue isn't where patients obtain their lenses but whether they can monitor the patients' ocular health.
Verification Methods of Online Providers
While planning our research methods with the participating practitioner, a primary concern we addressed was the manner in which online companies contact practitioners' offices to verify prescriptions. From his prior experience, some contact lens suppliers attempted to verify prescriptions by phone after business hours, when staff wasn't available to answer the call. Recorded messages often instructed the practitioner's office to respond within an allotted time frame; failing to contact the company within this period would result in the "assumption that the prescription was accurate."
He also experienced some instances in which verification inquiries were partially recorded. Incomplete messages appeared to result from the company's message being programmed to begin when the two lines connected. Therefore, important details such as company name and phone number as well as patient information often weren't recorded, making it impossible for the office staff to contact the lens provider. The question is whether this was the intent of the contact lens suppliers.
How Will the FCLCA Affect This Issue?
President Bush recently signed the "Fairness to Contact Lens Consumers Act" (FCLCA), which took effect on February 4, 2004. This new law should greatly affect the prescription verification practices of mail-order and Internet contact lens sellers. Beyond the requirement that practitioners must provide the prescription to the patient, the FCLCA:
- Prohibits companies from selling lenses without a prescription and from altering a prescription
- Prohibits unlicensed contact lens vendors from selling contact lenses to patients without direct communication with the prescribing eyecare provider. The provider must verify that the patient has a valid prescription for the contact lenses and confirm the accuracy of the prescription
- Requires sellers to include the patient's name and address, lens power, manufacturer, fitting curve and diameter, quantity of lenses ordered and date and time of the patient's request on prescription verification requests. The law also prohibits sellers from selling lenses when the prescriber says the prescription is no longer valid
- Requires sellers to provide prescribers with all necessary information to confirm the prescription and to provide reasonable time (such as eight business hours) to respond to prescription confirmation requests
- Provides practitioners with protections to ensure that they actually receive and have the ability to act on prescription verification requests before the seller provides lenses to the patient
- Stipulates that the Federal Trade Commission levy sanctions (up to $11,000 per offense) against both prescribers and sellers who don't comply
- Sets the duration of prescriptions at up to one year, or as determined by state law unless in the professional judgement of the prescriber a documented medical complication exists that would limit the expiration date
Keeping Eye Health in Mind
Our study confirmed that a determined patient could easily obtain lenses for one lens type for long time periods without returning to his practitioner for follow-up exams and without having a valid prescription. Patients can too easily forego regular ocular health exams and possibly risk their vision in exchange for the convenience of "click-of-the-mouse" shopping.
But Teague et al (2003) demonstrated that when prescription verification is required as part of a contract, contact lens sellers will attempt to comply. It remains to be seen if the FCLCA will have the same impact as Vistakon's contract with 1-800 Contacts to improve prescription verification nationwide and remind patients and lens sellers that contact lenses are medical devices that require regular monitoring by an eyecare professional.
To obtain references, please visit http://www.clspectrum.com/references.asp and click on document #103.
|Dr. Padilla graduated in May 2003 from Northeastern State University College of Optometry. She is currently employed as a civilian optometrist in Hinesville, GA.|
|Dr. Harrington graduated in 2003 from Northeastern State University College of Optometry. She is currently in primary care private practice in Enid, OK.|
|Dr. Edmondson serves as chief of the Contact Lens Clinic at Northeastern State University College of Optometry and as a clinical instructor in the Acute Eye Care Clinic at W.W. Hastings IHS Hospital.|