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Time for Glaucoma Compliance
How to set an alarm in patients so that they adhere to glaucoma therapy.
BY ROCHELLE NATALONI, CONTRIBUTING EDITOR

Relatively symptom-free ophthalmic disease states such as glaucoma suffer ridiculously high rates of medication regimen non-compliance. "Part of the problem with glaucoma is that the patient really doesn't have symptoms until the later stages," says Eve J. Higginbotham, M.D., professor of ophthalmology and chair of the Department of Ophthalmology and Glaucoma Service at University of Maryland Medicine.

This is in direct contrast to retinal disease, which is often characterized by rapid loss of visual acuity. "Most retina patients are usually very compliant because the cause – disease — and the effect – blindness are very evident," says retinologist Paul E. Tornambe, M.D., of Retina Consultants of San Diego. "Glaucoma patients may not use their prescribed drops because they see 'OK' and figure, 'so what if I miss some drops'. Retina patients on the other hand find out quickly that if they are not compliant bad things happen," he said. For example, following pneumatic retinopexy, patients find out that if they don't maintain the appropriate head position the fluid returns and they can't see. "Most retina patients know they are losing vision quickly and are neurotic [about following orders], while loss of vision with glaucoma can be like watching paint dry," says Dr. Tornambe.

Trillions of dollars are spent on developing new classes or drugs, says glaucoma specialist Alan Robin, M.D., "but if the patients don't take the medicine we're wasting money." Dr. Robin is an associate professor of ophthalmology at the Wilmer Eye Institute at Johns Hopkins in Baltimore. "Whether the cause is cost, denial, avoidance of side effects, forgetfulness or because they are already taking too many other drugs," he points out, "the end result is the same: non-compliance."

Is it possible to improve compliance — that is, set an alarm in patients so that they take their glaucoma medications as prescribed? The prospects appear better than ever. Pharmaceutical companies have begun to address the issue through devices that aid compliance. And in practices, compliance may take great strides through improved communications. This article will discuss advances and provide steps for setting that "compliance alarm" in patients.

Shift from "Compliance" to "Adherence"

The language used to describe this behavior is evolving, and using the word "adherence" in place of "compliance" may help patients become active participants in controlling their disease. Dr. Higginbotham, like many others, has made the transition to "adherence" to describe a patient's behavior with respect to following a prescribed regimen. The turning point came after reading a recent New England Journal of Medicine article in which Drs. Osterberg and Blaschke [Drug Therapy: Adherence to Medication. N Eng J Med August 4, 2005, 353 (5):487-497] reported that, the word adherence is preferred because compliance suggests that the patient is passively following orders and that the treatment plan is not based on an alliance or contract established between the patient and the physician. "The language used to describe how patients take their medications needs to be reassessed ... "Regardless of which word is preferred, it is clear that the full benefit of the many effective medications that are available will be achieved only if patients follow prescribed treatment regimens reasonably closely... Unfortunately, applying these terms to patients who do not consume every pill at the desired time can stigmatize these patients in their future relationships with healthcare providers," the article stated.

Build a Strong Physician/Patient Bond

While the literature shows that there are no characteristics that can be used to profile the typical non-compliant – or non-adherent – patient, there are several commonalities on the physician side among patients who follow their prescribed regimen, according to behavioral psychologist Deborah Roter, M.P.H., Johns Hopkins School of Public Health. "A good physician/patient relationship contributes to good adherence in several ways," says Dr. Roter. "The more specific the information the physician gives, the higher the compliance rate. The more engaged the physician is with the patient in terms of responding to a patient's emotions, the more willing the patient is to 'partner' with the physician. If a patient is afraid, and a physician responds with empathy and recognizes the fear, the greater the likelihood of the patient trusting and implementing the physician's recommendations," she explains. Another key to an adherence-affirming physician/patient relationship lies in the physician providing reassurance when reassurance is reasonable to give, says Dr. Roter. "It's not just a matter of 'hand-holding.' The patient needs to be able to really trust the physician — not just trust that the physician is qualified, but to trust that they have some connection to the physician." She stresses that "patients want to feel like they're known, like they're not going to be confused with another patient."

Partnership is the final piece of the physician/patient puzzle that adds up to effective regimen adherence. "This comes about when the physician tries to engage the patient in playing an active part in the visit. The physician actually asks the patient their opinion with phrases like – 'what do you think, does this make sense for you, are you with me?' Many studies show that this technique is a good predictor of compliance," says Dr. Roter. "If at the end of the visit, the physician says something like, 'We talked about a lot of things; tell me exactly what you are going to do,' this increases compliance," says Dr. Roter. "It engages the physician and patient in a kind of partnership. So combining that 'review' with the giving of information and responding to emotions are all things that predict better patient compliance," she explains.

Provide Clear, Concise Guidance

The way in which the regimen information is provided plays a role, as well. "There's a lot of missed opportunity to be very clear and concise. Building a relationship and also providing information and guidance to a patient can be done much more efficiently than it is now," Dr. Roter points out. "The earlier in the prescribing process this is accomplished, the better. If you've preempted the trouble that often results in non-compliance than that means less time is spent later on figuring out why the patient's eye pressure isn't being controlled," she adds. 

Scaring patients does not help, says Dr. Roter. She performed a meta-analysis of non-compliance literature that indicated that telling patients that they're going to go blind if they do not take their drops does not effectively enable people to overcome the barriers to adherence. "Showing them how to use the eye drops, helping them implement ways of remembering to take the drops, identifying problematic side effects and brainstorming about solutions, all help," says Dr. Roter.

Implement a Customized Strategy

Dr. Higginbotham says the best approach to improved adherence is a customized one – just like any other medical therapy management strategy. "A doctor or technician should be trained to determine what works best for the patient. You need to make the diagnosis on adherence and address the issues specifically for that patient — one size does not fit all," says Dr. Higginbotham.

If it is a technical issue, such as arthritis, or a movement disorder that prevents the patient from getting the drops in, then that needs to be addressed with an aid or a device to facilitate the process such as Xal-Ease (Pfizer, New York, N.Y.) the aid that is available with Xalatan (latanoprost, Pfizer). Xal-Ease is designed to help the patient open the bottle more easily and get the drop of Xalatan where it belongs. A similar aid, the Travatan Dosing Aid (Alcon Labs, Inc., Fort Worth, Texas) is available with Travatan (travoprost, Alcon Labs, Inc.).

If a cognitive problem inhibits adherence, then that might be alleviated through the use of pictures, rather than words, to explain when and how to administer the drops, or via a memory aide that reminds patients to take the drop, she explains. For example, Allergan recently introduced the Lumigan Compliance Device, which contains a light timed to flash and an optional alarm that reminds patients to apply Lumigan (bimatoprost).

Get Tough When Addressing Denial

A more challenging situation, says Dr. Higginbotham, is that which occurs in the glaucoma patient who is in denial about their disease. "They may not come back for follow-up visits, they might trivialize the disease or they just conveniently don't take the drops," she explains. "I have patients who are in denial who have severe glaucoma and they don't seem to respond to suggestions for more aggressive intervention, such as the recommendation for surgery," she says. Unlike Dr. Roter, Dr. Higginbotham says scare tactics do work with some patients — particularly those in denial. "You have to keep repeating the message to be consistent, but 'repeating' it in different ways to make them get the message that they can go blind," she asserts. 

For those in denial, some have found that pictures can be more persuasive than words. Using imaging technology, such as the HRT II (Heidelberg Retina Tomograph, Heidelberg) or the OCT3 (Optical Coherence Tomography, Carl Zeiss Meditec), physicians can improve patient understanding of the disease and illustrate the progression of glaucoma over time to patients who do not adhere to therapy.

Other strategies to overcoming adherence problems, according to Dr. Higginbotham, include: obtaining the help of family members, friends and community services; and considering more ''forgiving'' medications when adherence seems unlikely. "Forgiving medications would be those whose efficacy will not be affected by delayed or missed doses," says Dr. Higginbotham, "such as medications with long half lives, extended-release medications or even transdermal medications, when available." 

Joyce A. Cramer, B.S., recently reported that the gold standard for assessing glaucoma drug compliance is an electronic monitoring system that uses microprocessors embedded in medication containers to record how often patients instill eye drops. "The data are downloaded to a computer, where special software plots medication use against the recommended prescription schedule (eg, once or twice a day) and how much time lapsed between doses (dose precision). When merged with the known pharmacokinetic properties of the medication, this analysis shows whether the patient achieved adequate therapeutic coverage." Cramer is an associate research scientist in the Department of Psychiatry at Yale University School of Medicine; and co-editor of Patient Compliance in Medical Practice and Clinical Trials (New York: Raven Press, 1991. FALK: R727.43 P298 1991.)

Simplify Regimens When Possible

All agree that the simpler the regimen, the greater the adherence. In A systematic review of the associations between dose regimens and medication compliance (Clin Ther. 2001;23:1296-1310), Claxton, Cramer and Pierce found that patients took fewer doses as the number of prescribed doses per day increased. Compliance rates for common dosing schedules were 79% for once-a-day drops; 69% for twice-a-day drops; 65% for drops taken three times a day, and 51% for drops prescribed four times a day. A recent study by Dr. Robin, David Covert and colleagues (Ophthalmology.2005;112:863-886), sponsored by Alcon, found a decrease in therapy adherence with the addition of another therapy.

Measure Compliance, Don't Assume

One of the most fascinating points of interest in the compliance literature, according to Roter, is that physicians are no better than chance at identifying which patients are compliant and which are not. "It's really hard to get to the bottom of the patient's actual practice of putting the drops in," agrees Dr. Higginbotham. "Even in clinical trials where the patients are the most motivated, compliance or adherence is only 75% or 80%," she adds.

Direct and indirect methods of measuring compliance range from the simple – asking patients if they've been taking their drops — to the complex: measurement of the concentration of a drug in the patient's blood or urine. Others include electronic monitors capable of recording each time a bottle is opened. "Although certain methods of measuring adherence may be preferred in specific clinical or research settings, a combination of measures maximizes accuracy," writes Osterberg.

When to Consider Surgery

Filtering surgery might seem like the simplest way to avoid compliance concerns inherent in glaucoma treatment, However, Dr. Higginbotham says that is not necessarily the case. "You don't want to necessarily do surgery on the most non-adherent patient because you need to have that patient cooperate by using drops after surgery to maximize their success," she says. Dr. Robin concurs. "Surgery as first line of therapy doesn't circumvent the compliance issue completely because after surgery patients will be using steroids and if they didn't comply with their other medications, how can they be expected to comply with the steroids?" he asks.

That's where laser comes in. "In a way, laser – or non-incisional surgery — is a nice solution for all of these circumstances," says Dr. Higginbotham. "One of the benefits of laser surgery is you get the person's attention, which can result in improved adherence — but it's really hard to tease that outcome out," she adds.

Ultimately, unless the physician asks explicitly about compliance – in a non-rhetorical and non-judgmental way – they are missing an opportunity to uncover true behavior patterns and thereby have a critical impact on a patient's progress, Dr. Roter concludes.