Symptoms Occurring in a Cluster of Patients
Symptoms Occurring in a Cluster of Patients
BY FARID EGHBALI, OD, FAAO; QUANG CHUNG, OD; & CYNTHIA ARATA, OD
Have you ever had weeks or months in which certain types of patients with similar symptoms presented in close proximity to each other? This could occur as three young patients who all work at a nearby power plant recently developing cataracts, or six epidemic keratoconjunctivitis patients presenting in one week from the same school, or a dozen patients reacting to a particular contact lens solution over a period of several months.
We are trained to look at each patient or situation and to develop a management and treatment strategy based on the findings at hand. What if we see the same findings in several patients in a short period of time in a cluster? Do we need to think or act differently? A public health issue may need to be addressed for the safety of those who haven't yet been affected. As healthcare practitioners, what steps should we take when we face such circumstances?
We will present a series of patients from our private practice setting who presented with similar complaints relating to the same potential source. We will also review the recommended procedure that you should follow once you note such an event.
Despite advances in contact lens materials and solutions technology and attempts at improved compliance through better patient education, patients may still develop contact lens-related complications. This is especially the case as new products are introduced. An FDA approval doesn't guarantee that a product has passed the test of time. It's one thing to see sporadic occurrences of complications, side effects or adverse reactions, but it's different when you notice a similar problem repeatedly relating to the same product or situation.
Figure 1. Infiltrates resulting from solution hypersensitivity.
Since mid-September 2006, we had seen close to a dozen patients presenting to our private practice with similar complaints. All of the patients wore disposable soft lenses on a daily wear basis and were using Complete MoisturePlus (Advanced Medical Optics) multipurpose solution. Their symptoms ranged from pain, irritation, burning sensation, light sensitivity and foreign body sensation to redness and itching. The type of symptoms and the severity varied among the patients. The following summarizes two of the cases.
Patient #1 A 16-year-old female presented with complaints of pain, photophobia, foreign body sensation and redness. This longtime lens wearer was currently fitted with Focus Monthly Torics (CIBA Vision). She had no previous history of adverse reactions or complications.
Upon questioning, we discovered that the patient had recently run out of contact lens solution and purchased a twin pack of Complete MoisturePlus from a local warehouse store. Slit lamp examination of the anterior segment revealed mild bilateral superficial punctate keratitis with mild bulbar and palpebral conjunctival injection OU. We diagnosed a possible contact lens solution hypersensitivity reaction and subsequently switched her to Opti-Free Replenish (Alcon). At the one-week follow-up visit all symptoms and adverse signs had resolved.
Patient #2 A 43-year-old female presented with complaints of pain, photophobia, foreign body sensation and redness. The patient had been fitted with Acuvue Advance (Vistakon) contact lenses with Complete MoisturePlus. A day earlier, she learned of the partial recall through the local news station. A subsequent phone call to AMO revealed that she was in possession of one of the units being recalled. Slit lamp examination revealed moderate (2+) palpebral and conjunctival staining. We switched her to Opti-Free Replenish, and at one week all symptoms and adverse signs had resolved.
All of the other patients had similar symptoms to these two as well as biomicroscopy changes such as conjunctival injection, corneal staining and, in some cases, small peripheral sterile corneal infiltrates (Figure 1).
On Nov. 21, 2006, AMO initiated a partial, nationwide, voluntary "consumer level" recall of its Complete MoisturePlus multipurpose contact lens solution citing manufacturing issues. According to the press release by AMO, approximately 183,000 units were affected by this particular recall. It's important to note that the voluntary recall was limited to bottles manufactured at several of AMO's auxiliary production lines in China and not the original production line in Spain. This formulation was subsequently recalled completely from the market in May of this year for an unrelated reason.
|TABLE 1 Steps to Take When Symptoms Appear in Clusters in Your Practice|
- Maintain a list of patients in question.
- Contact the company for any similar reported cases.
- Contact your local company representative.
- Contact your colleagues and doctors in your area.
- Complete an Adverse Experience Report from the company in question.
- Maintain a communication level with your patients.
This partial recall prompted us to do a limited investigation of our patients' files retrospectively and through telephone inquiries. We found that the patients with the questionable diagnosis of solution reaction were in possession of the Complete MoisturePlus bottle(s) involved in the recall. It's noteworthy that we saw some of the affected patients prior to and some after the recall.
The plan of action taken for all of the patients was to discontinue the solution in question and replace it with another compatible lens care system. Additionally, in several patients we prescribed a mild steroid to reduce the inflammatory response caused by the solution in question. All patients demonstrated a complete resolution of their symptoms and clinical signs at their follow-up visit.
As eyecare professionals, our patients depend on us to be advocates for their visual health. This requires us to keep them up-to-date with new products and innovative technology and to keep them informed when something goes awry. As part of a case history, you should ask contact lens patients about the brand of solution they use. A system in which you can cue up pertinent information to identify targeted patients would be immensely helpful in disseminating necessary information during such an event as we've described. That being said, the enormous number of patients in an optometric practice and the volume of information that needs to be processed often make it difficult if not impossible to reach everyone in a timely manner.
Therefore, encourage patients to be proactive in their eye care. If they learn that a product they use has been recalled, instruct them to visit the company's Web site to obtain information on the recall or to use the company's toll free number for making inquiries. You can also put a notice on your practice Web site and/or send e-mails to patients.
In addition to asking our patients to be proactive, we too need to be proactive in identifying potential problems when we observe unusual trends. This could include calling your local company representative to express concerns or calling other doctors in the area to inquire if they are observing similar trends. Table 1 summarizes steps you can take in such a situation. Effective communication between all parties involved would facilitate prompt identification of potential problems and necessary actions to correct the problem. CLS
For references, please visit www.clspectrum.com/references.asp and click on document #145.
Dr. Eghbali is in private practice in Beverly Hills and Burbank, Calif. He is also an assistant clinical professor in ophthalmology at UCLA, assistant professor at Southern California College of Optometry and director of clinical care at the Maloney Vision Institute.
Dr. Chung is in private practice in Santa Monica, Calif., and is a staff optometrist at the Harbor UCLA Medical Center.
Dr. Arata is in private practice in Los Angeles.
Contact Lens Spectrum, Issue: December 2007