Solution Recalls: Opportunity in Adversity
Solution Recalls: Opportunity in Adversity
BY KIRK L. SMICK, OD
Over the years, contact lens cleaning systems have evolved considerably. Thirty years ago, our patients mixed their own solutions from saline tablets. Inconsistency in the strength and sterility of the solution and the lack of preservatives contributed to relatively high rates of infection. Boiling lenses certainly helped eliminate contaminants, but it also destroyed a lot of lenses, especially as newer polymers entered the market.
Manufacturers then turned to chemical disinfectants, hydrogen peroxide systems and enzymatic cleaning products, but problems continued with patient compliance and lens/solution interactions.
The Advent of MPS Systems
By the early 1990s, all seemed to be right in the world of contact lens solutions. The disinfectants and the preservatives used in them had become much more sophisticated. Several products had gained approval as multipurpose solutions (MPSs), making it possible for patients to clean, store and wet their lenses with a single bottle of solution. An FDA contact lens classification system was created to test materials with solutions to control compatibility problems. Infection rates were low and patient satisfaction with the ease and convenience of MPS systems was high, especially with the introduction of "no rub" cleaning.
By this point, the industry's main concern was adding buffers and other ingredients to MPS systems to improve comfort and wettability. Doctors were thrilled with efforts to postpone contact lens dropout due to discomfort.
Recalls Raise Questions
Fast forward to May 2007, when Advanced Medical Optics (AMO) announced a voluntary recall of its Complete MoisturePlus solution due to an association with an outbreak of Acanthamoeba keratitis (AK) cases in the United States. Almost exactly one year previously, Bausch & Lomb had permanently withdrawn one of its major MPS systems when the company's ReNu with MoistureLoc formulation was shown to be associated with Fusarium fungal keratitis.
After two major recalls, it's no surprise that patients and practitioners alike are questioning whether MPS systems are safe. "Where do we go from here?" is the big question.
My existing contact lens wearers haven't been scared away by the recalls, although they are concerned. Where we have really seen an impact is in the decision making of potential contact lens wearers — and especially in the parents of children and teens who would be considered good candidates for contact lenses. News of the recalls has made them a bit more hesitant about contact lens wear.
The silver lining, of course, is that a climate of heightened awareness about corneal infections presents us with a teaching moment. If we've learned anything from these recalls, it's that patients, practitioners and industry all have a role to play in getting back to the basics of safe contact lens wear and care.
Reinforcing Lens Rubbing
We know that patients desire and request simplicity. This is the need that MPS care systems meet, and it isn't going away. What probably will go away is the no rub concept. AMO has introduced its new Complete Multi-Purpose Solution Easy Rub Formula, and the package insert instructs consumers to rub the lenses even though the formulation has had no-rub approval since it first entered the market several years ago. Other manufacturers have eliminated or downsized the words "no rub" on their packaging, yet they stand by the safety of no-rub regimens.
Many practitioners including myself have always told patients to rub their lenses no matter what the package says. But the reality is that patients haven't listened — whether it's because of the "no rub" wording on the package or just because of general poor compliance.
And if we're honest with ourselves, I think most practitioners have to admit that we haven't been spending as much time educating patients about contact lens care as we should have been. We've all gotten busier, and with the convenience of boxed lenses in inventory, we're often guilty of dispensing lenses on the fly, without the education and training that used to go along with a new contact lens prescription.
|TABLE 1 Preventing Corneal Infections: A Three-Part Solution|
|Although we can never completely eliminate contact lens-related infections, these steps by lens wearers, practitioners and industry can help.|
Contact lens wearers
- Always rub contact lenses on both sides, rinse and store in the solution recommended by your eyecare practitioner.
- Clean the case after each use; keep it clean and dry until refilling with fresh solution.
- Replace the case at least once every three months and preferably once a month.
- Do not top off old solution.
- Remove contact lenses before swimming, showering or engaging in other water-based activities.
- Follow recommended wearing and replacement schedules.
- Work on patient flow so that the doctor and/or technician spend time providing each contact lens patient with care instructions.
- Remind patients that water, even clean water from the tap, can contaminate their lenses and increase the risk of infection.
- Demonstrate how to rub lenses, and have patients practice in the office.
- Provide written instructions in simple, clear language for patients to take home with them.
- Make use of guidelines and tools provided by the AOA and lens and solution manufacturers, including videos, Web sites and brochures.
- Fully test solutions and each new ingredient against a wide variety of organisms.
- Continue to make available and expand the range of patient education materials available to practitioners.
The fact that patients can order their contact lenses by phone or online from a separate service — and can often obtain a full year's supply shortly before the prescription expires — means that we may not see patients for their annual visit until nearly the two-year mark, further reducing opportunities for education.
Revitalizing Patient Education
In our practice and in many others I'm aware of, we have significantly increased the emphasis on contact lens wear and care instruction since the MPS recalls. We're showing patients how to rub the lenses and reminding them to follow all of the American Optometric Association's guidelines for lens care (www.aoa.org/contact-lenses.xml). We're also recommending that higher-risk groups — such as our youngest patients, those who are known to be noncompliant, and those whose jobs or hobbies increase their risk — use hydrogen peroxide solutions or one-day contact lenses.
We can never prevent infections 100 percent. But we can reduce the incidence through better education and better compliance (Table 1). Solution manufacturers can help by encouraging, rather than discouraging, lens rubbing and by carefully testing new additions to the tried-and-true formulations. While I applaud manufacturers' efforts to boost comfort, a back-to-basics approach may be what is called for now.
We have a critical window. The largest generation since the Baby Boom is coming of age. Members of the Echo Boom or Generation Y, as they are sometimes called, are in their teens and early 20s. Now is our chance to increase compliance and confidence in contact lens and lens care technology in this critical demographic group. CLS
Dr. Smick is in private practice at Clayton Eye Center in Morrow, Ga. Contact him at (770) 968-8888 or email@example.com.
Contact Lens Spectrum, Issue: April 2008