Programs to optimize adherence in glaucoma

Programs to optimize adherence in glaucoma

Optometry (2010) 81, 339-350 Programs to optimize adherence in glaucoma Dianne Kowing, O.D.,a,b Dawn Messer, O.D.,c,d Scott Slagle, O.D.,e,f and Alyo...

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Optometry (2010) 81, 339-350

Programs to optimize adherence in glaucoma Dianne Kowing, O.D.,a,b Dawn Messer, O.D.,c,d Scott Slagle, O.D.,e,f and Alyon Wasik, O.D.,g,h: V-POAG Study Group a

William Chappell Veterans Affairs Outpatient Clinic, Daytona Beach, Florida; bNova Southeastern University College of Optometry, Ft. Lauderdale, Florida; cDepartment of Ophthalmology and Vision Science, The University of Arizona, Tucson, Arizona; dSouthern Arizona Veterans Affairs Health Care System, Tucson, Arizona; eSalem Veterans Affairs Medical Center, Salem, Virginia; fEdward Via Virginia College of Osteopathic Medicine, Blacksburg, Virginia; gSouthern Arizona Veterans Affairs, Tucson, Arizona; and hSouthern California College of Optometry, Fullerton, California.

KEYWORDS Glaucoma; Adherence; Education; Dosing aids and devices; Electronic monitoring

Abstract PURPOSE: This study was designed to raise awareness of the materials, devices, and Internet resources available to improve adherence to use of medications for the treatment of glaucoma and to review new devices under development. METHODS: A review of current indexed literature and Internet resources was conducted. RESULTS: A variety of educational brochures, pamphlets, and fact sheets promoting adherence to ocular hypotensive medications are available through multiple organizations and are easily accessed and ordered on the Internet. Video and Web-based patient educational tools have been designed to support patient adherence to glaucoma management plans and promote open dialogue between patients and providers. Reminder and recall systems that integrate with office software can be sent to cell phones as well as e-mails and personal digital assistant (PDAs), alerting patients to upcoming appointments and reminding them to instill their drops. Bottle devices with dosing support (timers with audible and visual signals and dispensing aids) and electronic monitoring have been shown to promote adherence. New products currently under development to improve the delivery of medications include nanoparticles, punctal plugs, and contact lenses that release glaucoma medications. CONCLUSIONS: Many educational materials, services, Internet resources, and devices are available to optometrists to encourage patient adherence to glaucoma treatment and management. Optometry 2010;81:339-350

Limited adherence to the proper use of ocular hypotensive eye drops is a major barrier in the management of glaucoma, which is a chronic disease.1-5 Although there is not a cure for glaucoma, lowering of intraocular pressure has been shown to prevent progression of vision loss.6-8 Estimates indicate that there will be 60.5 million people with open-angle and angle-closure glaucoma diagnosed Corresponding author: Dianne Kowing, O.D., Veterans Affairs Outpatient Clinic, Optometry, 551 National Health Care Drive, Daytona Beach, Florida 32118. E-mail: [email protected]

worldwide in 2010, increasing to 79.6 million by 2020, and, of these, 74% will have open-angle glaucoma.9 The estimated prevalence worldwide of bilateral blindness for people with open-angle glaucoma diagnosed in 2010 is 4.5 million, increasing to 5.9 million in 2020.9 In the United States, there will be 2.79 million people with open-angle glaucoma by 2010.9 (The estimates were determined by a review of published data with use of prevalence models [constructed by age, sex, and ethnicity] that were combined with United Nations world population data.9) A study by Bramley et al.,10 examining Medicare claims data, estimated the overall annual non–eye-related and eye-

1529-1839/$ -see front matter–This is a U.S. government work. There are no restrictions on its use. Published by Elsevier, Inc. on behalf of the American Optometric Association. doi:10.1016/j.optm.2009.09.021

340 related cost of glaucoma at $8,157 for no vision loss, $13,162 for moderate vision loss; $15,312 for severe vision loss; and $18,670 for blindness (2007 U.S. dollars). The analysis by Bramley et al.10 showed that patients with any degree of vision loss had 46.7% higher total costs compared with patients without vision loss. In their analysis, the cost categories included were the amount reimbursed to the provider (excluding deductibles and copay), inpatient, outpatient, rehabilitation, office-administered pharmaceutical, laboratory, skilled nursing facility care, hospice, and home health care costs.10 They did not include outpatient prescription drug costs because they were excluded from Medicare coverage at the time of the study.10 Therefore, in addition to quality-of-life incentives, there are cost incentives to exploring tools and programs that facilitate improved adherence to the use of glaucoma medications and treatment regimens. In the general interest of patient welfare as well as cost incentives, efforts have been focused on improving patient adherence or compliance to a prescribed glaucoma regimen. Compliance is a term that, in the past, was used more often than adherence. The term compliance focuses on patient behavior, whereas the preferred term, adherence, is considered more accurate because it implies and recognizes that patients have more autonomy and choice in their medical treatment. To assess glaucoma medication adherence, Friedman et al.2 scrutinized large datasets drawn from health maintenance organizations and suggested that actual adherence to glaucoma medications may be well under 50%. One method of quantifying adherence is to measure the medication possession ratio, or MPR, which is the ratio of the days of supply of medication dispensed divided by the days between refills as shown by insurance claims.2 In the GAPS (Glaucoma Adherence and Persistence Study) patient survey, 89% of patients reported they took their medication ‘‘every day,’’ but the average medication possession ratio (MPR or days of supply of medication dispensed divided by days between refills) calculated by examining claims was 0.64, and half of the patients interviewed had an MPR of 0.61 or lower.2 Patients who are perfectly adherent to their prescribed medication regimen would be expected to have an MPR of 1; anything less would be an indirect indication that the patient is not taking the medication at the prescribed frequency. For example, if a patient was prescribed a 30-day supply of drops but refilled in 45 days (instead of 30 days as expected) then the MPR would be 30/45 or 0.67 for that patient. In a comparable study, Stein et al.11estimated the proportion of subjects filling glaucoma medications using Medicare data and interviewed people from that dataset with diagnoses of glaucoma or glaucoma suspect. He found 71% of those with primary open-angle glaucoma appeared to be receiving medicine in a given year.11 The significance of these data is limited by the lack of verification that the eyedrops were instilled in the eye. Obtaining refills in a timely fashion would strongly suggest adherence, but it is an indirect measurement method.

Optometry, Vol 81, No 7, July 2010 Health care providers can improve patient adherence by enhanced patient education.12 Some clinicians may be unaware of the glaucoma patient education materials available online, in print, or on CD, which can be used to promote adherence. In addition, products that physicians can use to recall and remind patients to instill their drops are now more available with the plethora of electronic messaging systems. Many Internet resources were identified using the PubMed database with search terms such as patient education or compliance or adherence and glaucoma and medications or drug therapy. Searches were also done using MeSH headings such as medication adherence and glaucoma/drug therapy. A Google search was completed using similar search terms. Some of the devices at this time are used primarily in clinical research, some are promotional and obtained through the respective company representatives, but others are inexpensive and readily available. The authors do not endorse any of these products or suppliers and do not claim to include all available products but aim to raise awareness of the materials and devices available.

Brochures, pamphlets and fact sheets The National Eye Institute publishes several brochures or pamphlets in English and Spanish. A small 7-page accordion-type pamphlet (4’’ ! 9’’), National Institutes of Health (NIH) Pub. No 07-3252, is titled ‘‘Don’t lose sight of glaucoma’’ and reviews 7 major topics about glaucoma. The topics include what causes glaucoma and how it is treated. Photographs simulate glaucomatous visual field loss, a diagram shows the ocular anatomy, and there is a list of 7 different resources including address, phone number, and Web address. Their larger and more comprehensive color brochure (8’’ ! 12’’), ‘‘Glaucoma, What you should know,’’ NIH Publication No: 08-651, is available in English and Spanish. It is a 19-page document containing information designed to educate patients on glaucoma, including a page on how to properly instill eye drops. For a complete list and prices of all National Eye Institute (NEI) and National Eye Health Education Program (NEHEP) publications, visit http://catalog.nei.nih.gov. Prevent Blindness America offers a 7-page color pamphlet (4’’ ! 9’’) titled ‘‘Open-Angle Glaucoma.’’ The pamphlet emphasizes who is at risk for glaucoma and what can be done to prevent blindness. For additional information, visit www.preventblindness.org. Pfizer Ophthalmics (www.pfizerpro.com) has developed downloadable materials including diagnostic screeners and patient support and adherence programs. For the patient, they provide a credit card–sized intraocular pressure (IOP) tracker card where the last 6 IOP measurements are recorded for each eye. The resources that are available online for download only include the adherence diagnosis questionnaire, the adherence profile questionnaire, a

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glaucoma informational sheet, a ‘‘Don’t Stop Your Drops’’ brochure and poster, and a patient education brochure. The American Optometric Association (AOA) has a (6’’ ! 3.5’’) accordion-type pamphlet available titled ‘‘Answers to Your Questions About Glaucoma.’’ The pamphlet introduces glaucoma and explains symptoms, causes, and modes of treatment. In addition, it offers fact sheets (8.5’’ ! 11’’), ‘‘Glaucoma’’ and ‘‘Using Eye Drops and Ointments Correctly.’’ All of the informational literature is also available in Spanish. To view the pamphlets and prices, visit www.aoa.org. Eye care providers can register for a basic free Epocrates Online account to access patient medication instructions available in English and Spanish at www.epocrates.com/ products/online/. The instructions address common concerns such as how to take the medication and possible side effects.

Videos and Web-based patient education Pfizer has a Web-based vision simulator that helps teach patients about 6 common eye conditions, including glaucoma, and how they progress over time, www.visionsimulator.com. Also available on the Pfizer Web site is a video, Understanding Glaucoma and the Role of High Eye Pressure. Eyemaginations (www.eyemaginations.com) is a 3-dimensional (3D) animated software program designed to enhance patient communications. Through the use of narration, music and 3D animation, this interactive program can educate patients on a variety of topics, including glaucoma. The examination room personal computer can be a ‘‘virtual educator’’ and can also act as an interactive sketchpad, drawing overtop of moving 3D animation. Printouts can be generated from the information presented on the software. The AOA (www.aoa.org) provides limited access for patients to the Eyemaginations software on its Web site. Eyemaginations also offers 3D-Eye Home, which is a Webbased patient education system that delivers 3D animated narratives directly into the patient’s home. It can be delivered via e-mail before or after an office visit to reiterate instructions and explain conditions (including glaucoma) and treatment options. Ocutouch (www.ocutouch.com) is another software program with graphics and animation to enhance patient communications. The software is designed for use in a clinical setting, such as a consult room. X-Plain Patient Education Institute (www.patient-education.com) publishes X-PlainÔ, a library of interactive multimedia software for patient education. X-Plain includes interactive multimedia tutorials, Webcasts, and illustrated handouts for 30 medical specialties, including optometry/ ophthalmology. They recommend a touch screen monitor, as there is a higher completion rate if one is used; however, it is not required. The American Academy of Optometry (www.aaopt.org/ publicinfo/) Web site provides a link to the NetWellness center, which is a nonprofit comprehensive consumer health

341 Web site that provides high-quality information on diseases including glaucoma. Eye and vision care questions are answered by Fellows of the American Academy of Optometry who are faculty at The Ohio State University College of Optometry. Patients can ask questions anonymously and receive answers from an expert. They can view the questions posed by other patients and the answers they received. The Academy also supports AllAboutVision (www.allaboutvision.com), which is a Web site providing detailed information on glaucoma. A News Alert section summarizes journal, trade, and popular press articles about glaucoma in an easy-to-read format. The articles are reviewed by eye care professionals and are updated regularly. The American Academy of Ophthalmology (AAO) supports EyeSmartÔ, a Web site with information on multiple eye diseases, including glaucoma. A link is available from the AAO’s Web site to EyeSmart as well as to EyeCare AmericaÒ, the foundation of the AAO, which maintains a patient information section on its Web site. Eye Central News (ECN) (www.eyecentralnews.com), a product of VisionScience Software, Inc., is new concept in patient education that provides real-time United Press International news and AccuWeather reports combined with eye health, general health, well-known motivational quotes, and trivia. Both Ocutouch and Eyemaginations programs can be integrated into their layout. ECN is designed to run silently and relies on a dynamic visual presentation and interesting content to keep the attention of the patient audience. ECN includes promotion of the informational brochures available in the doctor’s office and can be custom designed. Patients are motivated to learn more by visiting the EyeCentralNews.com portal to obtain additional information on products, services, and organizations featured in the program. ECN provides secure content updates via broadband connection.

Clinician education Two free videos are available online and as DVDs for clinicians who present strategies and tools to help patients manage their health problems and their health behaviors. These videos are produced by the California Healthcare Foundation and include information regarding an action planning process to ensure patients take their medications, including details to help patients change behaviors that would be potential barriers to adherence. The patients in the video are dealing with diabetes and hypertension, but the coaching tips are also appropriate for promoting glaucoma medication adherence. The links for previewing the videos are: www.chcf.org/topics/chronicdisease/index.cfm?item ID5133717 and www.chcf.org/topics/chronicdisease/in dex.cfm?itemID5124673. Pfizer Ophthalmics (www.pfizerpro.com) has developed a downloadable small booklet, ‘‘i2i, Conversations to Enhance Adherence.’’ This booklet educates providers and technicians on the Ask/Tell/Ask method. This method

342 aims to improve assessment and education related to glaucoma medication compliance.

Provider and patient reminder and recall systems New, Internet-based software solutions are available as a service that will integrate with office management systems. The automated sync can interface with office software and update all changed or added information to manage patient communications. This includes systems that automatically send personalized, real-time messages to cell phones, e-mail, pagers, and BlackBerriesÒ. The GAPS found that patients who reported that their physicians used telephone appointment reminders had higher MPRs.2 Software systems can include appointment reminders/confirmations, medication refill reminders, e-newsletters, and e-patient surveys. One such service is Smile Reminder, www.smilereminder.com. Transmedia (www.transmediaweb.com) telephone appointment reminder system features calls during evening hours, which addresses patients by name, calls back 5 times if the line is busy or there is no answer, and gives patients the option to confirm or reschedule appointments. The call can include customized instructions and is HIPPA-compliant. Epill’s Web site (www.Epill.com) has a selection of personal reminder devices available for the patient to purchase. These devices include vibrating pendant jewelry medication reminders, multialarm pill timers, and keychain reminders. Additional devices include once-a-day medication reminder discs that attach to smooth surfaces and that can be turned clockwise 1 step after the medication is taken with a ‘‘last taken’’ indicator pointing to that day’s dose. They also sell the MeDose 6-alarm vibrating watch.

Blogs promoting adherence Alignmap (www.Alignmap.com) is a blogging Web site with the motto ‘‘Pointing Out the Obvious Online Since 2006’’ that discusses some of the latest information promoting adherence. It provides ‘‘theatre’’ links to videos that popularize patient adherence and provides links to companies promoting devices. For instance, it posts a discussion of a new edible chip that activates in the stomach and releases medication. AlignMap’s mission is to ‘‘.focus on aligning patients, clinicians, and other stakeholders with their health care systems to improve the proportion of successfully implemented treatment plans and, consequently, increase clinical effectiveness and efficiency, decrease costs and improve outcomes.’’

Bottle devices Bottle devices are available that include microprocessors to track compliance, delivery aids attached to the bottles to improve the accuracy of drop instillation, and aids with timers and lights to remind patients to instill their eye drops.

Optometry, Vol 81, No 7, July 2010 Patient registration on Pfizer’s Web-based program, www.xalatan.com/visionmatters/, includes free Xal-Ease Delivery Aid and an automated daily reminder phone call option. The Xal-Ease Delivery Aid is designed to help accurately dispense a single drop of XalatanÒ every time and reduce the frustration of instilling eye drops. The Xal-Ease device is provided free by Pfizer for any Xalatan user who registers for its free ‘‘Vision Matters’’ program. In addition to the Xal-Ease device, this program provides information and savings for managing elevated intraocular pressure. Advantages of the Xal-Ease device include its facilitation of easy drop instillation by providing a levered mechanical advantage, such that a drop is easier to instill. The device also contains a cuplike guide to rest on the orbital rim for accurate drop instillation. The disadvantage of the device is that it is only designed to work with Xalatan eye drops. Other tools that Pfizer provides to help support long-term patient success include multipack (3 bottles, 90-day supply) of Xalatan, savings cards for eligible patients offering discounts off Xalatan, and programs that may help pay or even provide free medications. For more information, visit www.pfizerpro.com/xalatan. The TravatanÒ Dosing Aid (TDA) by Alcon, www. Alcon.com, attaches a microprocessor-controlled monitor to eye drop bottles and may be a useful tool for identifying noncompliant patients and assist in improving compliance. This device contains sensors that measure temperature, force applied to the bottle, and vertical position of the bottle.13,14 Data are downloaded to a computer, and the medication usage can be plotted against the recommended schedule and the amount of time between doses. The TDA offers 3 advantages for the patient: it emits reminders, both audible and visual (an image of a drop on an LCD screen); has an easy-to-use lever, which helps express drops from the bottle with greater ease; and contains a guide to help with drop placement into the eye (see Figure 1).15 In an assessment regarding the effectiveness of the TDA’s audible alarm function, Holly and Kothy16 found a tendency for further improvement of adherence occurred when the TDA also had an audible signal as compared with adherence measures for the same patient before the activation of the alarm signal. The drawback of this device is that it is designed to only fit Travatan bottles and not other glaucoma products.15 After the setup, the TDA automatically records the date, time, and number of drops dispensed on each occasion of use.16 Although the TDA is no longer produced, it is still available through Alcon at this time at no cost to the provider. Kass et al.17 in 1986 used the first eye drop monitor and measured compliance with pilocarpine therapy. In the study, the patients were masked as to whether their bottle contained a monitoring device. They found that 97.2% of the patients reported adherence, but the monitor found only 76% were adherent and greater than 50% were taking extra doses.17 Okeke et al.18 conducted a study of 196 participants with glaucoma who were being treated with travaprost and who used the TDA device. They concluded that nearly 45% of

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Figure 1

The TravatanÒ Dosing Aid (known as TravalertÒ Dosing Aid in some countries). (Printed with permission from Alcon, Inc.).

patients using an electronic monitoring device who knew they were being monitored and were provided free medication used their drops less than 75% of the time.18 Participants adhering to less than 50% of expected doses started increasing their doses directly after the office visit and just before the return visit at 3 months.18 Allergan’s LumiganÒ compliance aid features a light timed to flash when a dose is due. The bottle is placed in this device, which, in addition to the light that is timed to flash, also has an optional sound alarm if the bottle is not removed from the cradle for 24 hours (see Figure 2).15 The device resets for the next reminder after the bottle is placed back in the cradle.15 The advantages to this device are that it provides both audible and visible reminders to prompt patients to use their medication. It will also accommodate all Lumigan bottle sizes (cylindrical bottle available in 3 mL, 5 mL and 7 mL) and is available at no charge to providers.

Figure 2

Lumigan Compliance Aid. Available at: http://www.revophth. com/index.asp?page51_870.htm. (Reprinted with permission.)

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Figure 3

Unidoser by Mystic Pharmaceuticals. Available at: http:// www.revophth.com/index.asp?page51_870.htm. (Reprinted with permission.)

The limitation of this device, however, is that it is designed to accommodate only medications dosed once daily and bottles with the same dimensions as the Lumigan bottle. 15 In addition, the device is not designed to provide assistance with drop instillation. Unidoser by Mystic Pharmaceuticals (www.mysticpharmaceuticals.com) uses a patient-replaceable cartridge system to deliver metered unit doses of ophthalmic medication to the ocular surface. This is designed to separate and organize a multiday supply of eye drops in unit dose quantities.19 A dose number on the Unidoser cartridge, both visible and in Braille, makes it easy for patients to count how many doses they have taken and how many remain. The device provides a 15-mL precision dose (up to 60 doses) into the eye. The drug is administered in a gentle stream of droplets to the eye with the push of a button. The devices operate from normal head and hand orientation, aid in holding open the eyelid during administration, and have a compliance tracking system that tracks the number of doses used and remaining. The devices are compact and designed to be carried in a purse or pocket (see Figure 3). The MEMSÒ (medication electronic monitoring system) device, www.aardexgroup.com, is a monitor with integral electronic microcircuitry designed to compile the dosing histories of ambulatory patients’ prescribed medications. Each monitor (see Figure 4) consists of a conventional medicine bottle fitted with a special cap that records the time and date of each opening and closing of the container through integrated microcircuitry. Monitors are designed to be used by 1 patient with 1 drug. An electronic reader transfers the dosing history data from the MEMS monitor to an Microsoft Windows–based computer (see Figure 4). The main advantage of this device is that it provides a tracking system as an indication of compliance, which can be used with any eye drop medication. It can also be used to determine factors that may influence compliance for an individual patient, such as twice a day compared with 3 times a day dosage or multiple medication

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Figure 4

MEMSÒ device downloading data from the cap to the Reader to a computer. Magnified views of the cap and the Reader. Available at: www. aardexgroup.com/.../MEMS%20TrackCap. (Printed with permission from AARDEX Ltd.)

usage. A study by Robin et al.20 found that adherence measured with a MEMS cap (prostaglandin bottle within a MEMS bottle) was higher (70% missing 0 to 2 drops per week) for a single prostaglandin analog medication regimen than for a second, nonprostaglandin medication without a MEMS cap (43% with 0 to 2 drops missed). The disadvantage of this device is that it provides an indirect measure of compliance and is only able to detect actions of the cap on the container for which the eye drop is placed. In addition, it is not designed specifically to provide reminders to patients to use their medication. However, the MEMs-6 does display the number of doses taken during a day along with the time since the last dose was taken. The device is not designed to assist with drop instillation.

with impaired hand strength. The device is intended to ensure that the patient does not waste any medication and to increase patient independence (see Figure 6). Averns et al.23 investigated the efficacy of the OpticareÒ eye drop dispenser in assisting rheumatoid arthritis patients with eye drop adminstration.23 The Opticare statistically and significantly improved the ability of the patient with rheumatoid arthritis to squeeze out drops and get them in the eye.23 A limitation of this device is that it provides no assistance with cap placement/replacement on the medication.

Administration devices As many as 50% of patients report difficulty in administering their eye drops, and almost 25% report omitting doses as a result.21 Some use potentially harmful methods to instill drops, such as touching the tip of the dropper to the eye.22 Elderly patients with arthritis, limited dexterity and hand strength, or other physical limitations may be unable to hold or squeeze the bottles and get the drops in the eyes. Several devices that aid in drop administration are made by OpticareÒ. The Eye Drop DispenserÒ helps to keep the eye open and get the drop in the eye on the first attempt (see Figure 5). The dispenser is available in a variety of colors to allow the patient to choose different colors for different eye drops. The dispenser is opened from the side and the eye drop bottle placed in the dispenser. The hinged side is closed to snugly position the bottle in the device. The patient pulls down his or her lower lid and positions the eye piece on the brow. The rim of the eye piece helps to keep the upper lid open. The drop is dispensed by gently squeezing the side paddles on the device together. The Eye Drop Dispenser can be used with most eye drop bottles, including 5 mL, 10 mL, and 15 mL round and oval bottle shapes. The dispenser comes with a collar adaptor that fits around the smallar eye drop bottles. The Opticare OrthoÒ with longer lever arms is designed for patients with severe arthritis or

Figure 5

Opticare Eye Drop Dispenser. (Printed with permission from Cameron Graham, Ltd.)

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Figure 6

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Opticare Arthro 5 mL and 10 mL. (Printed with permission from Cameron Graham, Ltd.)

Devices no longer available

Devices in development

The Eye Drop Guide by Merck consisted of a transparent, plastic inverted funnel-shaped guide. This device was evaluated in a study in which participants were given instructions and a physical demonstration on the use, cleaning, and sterilizing of the Eye Drop Guide.24 After 1 week, 93 of 111 participants completed a questionnaire, and 71% did not wish to continue to use the guide. They complained of the long cleaning time and drop wastage.24 In the early 1990s, Allergan promoted a special cap, called a C CapÔ Compliance Cap, that fit onto its line of glaucoma medications.25 The cap had numbered stations that were revealed in sequence when the cap was rotated. After taking the medication, the patient rotated the cap to the new number as a reminder that the next drop would be the second, for example, of the day. Caps were also available labeled with the days of the week for drops that were to be taken daily. The cap increased the cost of the medication and is no longer available. Chang et al.26 evaluated the use of the C Cap and found significant improvement in adherence, reporting 67% compliance with the C cap compared with 41% compliance before using the C Cap.26

The AMIE (Automatically Medicated Instrument for Eyedrops), a device under development, consists of a small box that fits in a shirt pocket and flexible clear tubing connecting the box to 2 nozzles. The tubing and nozzles are mounted on the patient’s eyeglasses. The nozzles are aimed toward the nasal corners of the eyes but yet are far enough from the eye to prevent touching. The box consists of a drug reservoir containing eye drops, a pumping mechanism, a single chip microcomputer, and a 9-volt battery. When AMIE power is on, it automatically delivers eye drops at preset intervals; however, a patient can get additional drops at will by pressing a button. The volume of the ejected microdroplets is adjustable from 1 to 5 mL. The company, Technological Ophthalmic Instruments Inc. (www.ece.tufts.edu/wvanvo/amie.html), suggests that the device would be useful for patients using a computer and others experiencing dry eye symptoms as well as patients needing long-term treatment such as with glaucoma. The concept that visibility of an eye drop tip will facilitate improved adherence has been proposed and tested by Stack and McKellar.27 In their 2004 study, they investigated the effect of placing sterile black tape around the

Figure 7

Triggerfish sensor and microprocessor. Available at: http://www.sensimed.ch/E/index.htm. (Reprinted with permission from Sensimed.)

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Figure 8

Triggerfish monitoring system. (Reprinted with permission from Sensimed.)

bottle tip of timolol for 1 month. Eighty-eight percent found the black tipped bottles easier to use, 68% of the patients had fewer occasions in which a second drop had to be instilled, and 30% of the patients touched their lids less. The black tip aided the patients in visualizing the bottle tip with greater accuracy as it approached the eye and therefore improved adherence and reduced contamination. Although not available at this time, the authors encouraged a change in manufacturing practice by replacing the standard tips on glaucoma medications with black tips.27 The Nasolacrimal Sac Clamp (U.S. Patent Application 1996) is a device that clamps over the bridge of the nose to apply pressure over the fossa of the nasolacrimal sac before drop instillation to seal off the sac to help reduce drainage away from the eye. Because most drops drain out of the eye within 15 to 30 seconds, 80% of medications are lost through the nasolacrimal system. Other methods to decrease drainage include manual occlusion with fingertips, passive lid closure for 5 minutes with head tilted back, punctal plugs, punctal cautery, or laser. In 2007, a group of Emory University students submitted a project to the Global Social Venture Competition. The project was called PictureRx (www.mypicturerx.com) and was designed to be marketed to physicians. The Global Social Venture Competition is a student-led business plan competition that supports and promotes social venturesdenterprises that integrate both profits and social impact. PictureRx is a card consisting of a photo of each medication a patient is taking with instructions on the medication schedule, and dosage, and an explanation of the purpose of the medication. Because low literacy rates in adult Americans is thought to contribute to poor or incorrect use of medications, pictorial aids can be used to improve recall, comprehension, and adherence,

especially when used in combination with written or oral instructions. Nanoparticles are promising as a drug delivery mechanism for treating glaucoma. Nanoparticles can safely pass through the blood–brain barrier, making them effective nontoxic tools for drug delivery. Patil et al.28 state that although barely 1% to 3% of existing glaucoma medicines penetrate into the eye, earlier experiments with nanoparticles have shown not only high penetration rates but also little patient discomfort.28 The miniscule size of the nanoparticles makes them less abrasive than some of the complex polymers now used in most eye drops. Patil et al.28 created a specialized cerium oxide nanoparticle and bound it with a compound that has been shown to block the activity of an enzyme (hCAII) believed to play a central role in causing glaucoma. The Punctum Plug Delivery System (QLT Inc., Vancouverdalso responsible for manufacturing VisudyneÒ) is a glaucoma drug delivery system undergoing U.S. Food and Drug Administration clinical trials for safety and efficacy. The Punctum Drug Delivery System provides sustained time-release doses of glaucoma medication. In a multicenter, randomized Phase II clinical trial called the CORE study, the mean IOP reduction was 20% over a 12-week period.29,30 At 12 weeks, 89% of the patients reported ‘‘no awareness’’ of the plug, and 78% reported no tearing.29,30 More information on the QLT Punctum Plug Delivery System is available at www.qltinc.com. The Triggerfish system (not available for sale in the U.S.) is manufactured by a Swiss company focusing on the design and development of integrated microsystem medical devices. The Triggerfish system performs around-the-clock IOP checks and telemetry through a soft contact lens.31 The

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347

Products currently on the market to promote adherence

Type of resource

Organization

Web site

Tool/device

Cost

Brochures, pamplets, & fact sheets

NEI

catalog.nei.nih.gov

Don’t lose sight of glaucoma

Free for 1st 50 then $5 per 50

Glaucoma, What you should know* Open-Angle Glaucoma

1st copy free then $5 per 25 $34 for 100

IOP tracker card Adherence diagnosis questionaire Adherence profile questionaire Glaucoma informational sheet Don’t Stop Your Drops Patient eudcation brochure Answers To Your Questions About Glaucoma*

Free Free

3D-animated software program

$1,000 - 2,050; call company for exact pricing $1,000 - 2,050; call company for exact pricing Approximately $400 initially; call company for exact pricing Contact company for pricing Free Free Free Contact company for pricing Free

Prevent Blindness America Pfizer Ophthalmics

pfizerpro.com

Pfizer

Eyemaginations

eyemaginations.com

Epocrates

3D-Eye Home

Clinician education

Free

Free Free Free aoa.org AOA member prices: English $12/100; Spanish $14/100 Glaucoma and Using Eye Drops $15/100 and Ointments Correctly www.epocrates.com/products/ Epocrates online account* Free online/ visionsimulator.com Web-based vision simulator Free

AOA

Videos & Webbased patient education

preventblindness.org

Ocutouch

ocutouch.com

Software program

X-Plain Patient Education Institute AAO All About Vision AAOphthalmology VisionScience Software California Healthcare Foundation

patient-education.com

X-PlainÔ*

aaopt.org/publicinfo allaboutvision.com aao.org eyecentralnews.com

NetWellness AllAboutVision EyeSmartÔ* Eye Central News

Pfizer Opthalmics Provider & patient Smile Reminder reminder & recall systems Lifeclinic International, Inc.

www.chcf.org/topics/ 2 free videos online, chronicdisease/ DVDs for clinicians index.cfm?itemID5133717 chcf.org/topics/ chronicdisease/ index.cfm?itemID5124673 pfizerpro.com i2i, Conversations to Enhance Adherence smilereminder.com Smile Reminder software system lifeclinic.com

Software system for reminders

Free

Free Contact company for pricing Contact company for pricing (continued on next page)

348

Optometry, Vol 81, No 7, July 2010

Table 1

(continued)

Type of resource

Organization

Web site

Transmedia

transmediaweb.com

e-pill Medication Reminders

Epill.com

Tool/device

Cost

Once-a-day medication reminders, multialarm pill reminders, MeDose vibrating alarm watch Telephone appointment reminder system Alarm watches

Contact company for pricing

$19.95 - 39.95 $39.95 - 49.95 Free

Blogs

AlignMap

Alignmap.com

Bottle devices

Pfizer

pfizerpro.com/xalatan

Alcon

alcon.com

Keychain reminders Multialarm pill timers Blogs, ‘‘theatre’’ links to videos Xal-ease Delivery Aide, daily reminder phone call optional Travatan Dosing Aid (TDA)

Allergan

allergan.com

Lumigan Compliance Aid

Administration devices

Mystic Pharmaceuticals mysticpharmaceuticals.com

Unidoser

Aardex

MEMS Monitors: TrackCaps (without LCD) and SmartCaps (with LCD) MEMS Reader Software Bottle and caps Eye Drop GuideÒ

OpticareÒ

aardexgroup.com

www.camerongraham.co.uk/pages/ opticare-range.php

Eye Drop SqueezerÒ

Contact company for pricing $79.95 - 99.95

Free

Contact company for pricing Contact company for pricing Contact company for pricing $115 - 151

$122 $473 per license $0.98 - 2.36 per vial Contact company for pricing EUR 10.38; contact company for exact pricing

* Available in Spanish.

Triggerfish system is comprised of a disposable soft, hydrophilic silicone contact lens embedded with a sensor and microprocessor located outside the line of sight (see Figure 7) An antenna taped around the eye transmits data through a cable to a portable recorder that wirelessly uploads data to the clinician’s computer, according to an online Sensimed brochure (see Figure 8). The device is designed to monitor IOP continuously up to 24 hours during sleep and daily routines, enabling the clinician to make an early diagnosis and tailor treatment to the patient. Triggerfish is not yet commercially available in the United States. More information on Triggerfish Continuous IOP Monitoring system is available at www.sensimed.ch/E/index.htm. Extended and controlled release of drugs from a drugeluding contact lens in an experimental setting was demonstrated by Ciolino et al.32 When the lenses were placed in phosphate-buffered saline, they demonstrated controlled release of the drug studied for more than 4 weeks. The rate of drug release was controlled by changing the polymer molecular mass and the proportion of medication within the lens

coating. Their prototype contact lens design could be used as a platform for ocular hypotensive drug delivery, bypassing the need for patients to instill drops on a daily basis.32 Table 1 lists the materials, devices, and Internet resources discussed in this article.

Conclusions Adherence devices used in glaucoma therapy continue to evolve. Devices now combine monitoring with dosing support functions. With improved monitoring, using devices such as the Triggerfish, clinicians will be able to determine how well different therapies control IOP over 24 hours. Although mechanized adherence aids are helpful in improving therapeutic outcomes, basic and inexpensive aids also play an important role. Kharod et al.33 found that after written instruction, the accuracy of reporting glaucoma medication use improved by 8.46% and 23.36% in patients with or without high school education, respectively. This study found that even simple educational aids

Kowing et al

Issue Highlight

such as written instructions can be effective for adherence.33 In the future, Kahook envisions that patient medication adherence problems will be detected and corrected sooner due to the use of wireless communicating devices used by the treating doctor and the pharmacy.20 Kahook15 outlines forthcoming trends in adherence devices that he believes will continue on the path of the TDA. He discusses simplified treatment regimens including injecting slowrelease depots in the subconjunctival space or into the eye or delivery systems implanted externally or internally for slow release of IOP-lowering medications.15 The use of nanoparticles and contact lenses as hypotensive drug delivery systems for glaucoma are promising areas of research. Optometrists can play a pivotal role in promoting adherence through the use of educational materials, Internet-based software systems, and by utilizing dosing and monitoring devices.

Acknowledgments The authors deny any financial arrangement with any company whose products were discussed in this article. The authors wish to thank the sponsors of the 2008 Summer Invitational Research Institute (the American Optometric Association and the American Academy of Optometry) for their training in research design and methodology and their support of the V-POAG (Veterans Programs to Optimize Adherence in Glaucoma) study group. In addition to the named authors, the V-POAG study group includes Chris Johnson, Ph.D., University of Iowa, Department of Ophthalmology; Linda Zangwill, Ph.D., University of California, San Diego; Megan Hunter, O.D., Jesse Brown Veterans Affairs Medical Center; Kelly Thompson, O.D., Cinncinati Veterans Affairs Medical Center; Jennifer Goldberg, O.D., Louis Stokes Cleveland Veterans Affairs Medical Center Akron Division; Jeffery Joy, O.D., The Ohio State University College of Optometry and Salisbury Veterans Affairs Medical Center; and Pinakin Gunvant, Ph.D., Southern College of Optometry and Tennessee University of Louisville, Kentucky. The Medical and Patient Health Librarian at the Gainesville Veterans Affairs Medical Center, Marsha White, provided invaluable help performing Internet searches, and the authors appreciate her assistance.

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350 28. Patil S, Reshetnikov S, Haldar MK, et al. Surface-Derivatized nanoceria with human carbonic anhydrase II inhibitors and fluorophores: a potential drug delivery device. J Phys Chemistry C 2007;111(24):8437-42. 29. QLT Announces Encouraging Phase II Data from CORE Study Drug Delivery System. [Updated October 28, 2008; July 22, 2009]; Available at: http://www.drugs.com/clinical_trials/qlt-announces-encouragingphase-ii-data-core-study-punctal-plug-delivery-system-5966.html. Last accessed January 25, 2010. 30. Gedde SJ. ALT reports positive 12-week results from trial punctal plug delivery system: OSN SuperSite; [Updated November 13, 2008; July 22,

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