American Glaucoma Society

Position Statement on Color Coded Caps for Glaucoma Drops

 

May 19, 2011

To Whom It May Concern:

On behalf of the members of the American Glaucoma Society (AGS), we are writing to strongly support the continued use of the color code cap system for identification of classes of ophthalmic medications. The American Glaucoma Society is comprised of over 700 ophthalmologists who are fellowship-trained glaucoma specialists and surgeons.  The AGS has been in support of the American Academy of Ophthalmology (AAO) Position Statement supporting eye drop packaging color-coding. The Position Statement has been in place since 1983, and was most recently re-endorsed by the AAO in 2010. The standardized color-coding of bottle caps for eye drop medications has been a very effective aid for patients, their families, and practitioners to easily identify topical ophthalmic medications. In fact, the color-coding has been essential to enable visually impaired patients to independently manage and administer their own eye drop medications for chronic diseases such as glaucoma and uveitis.  In addition, using the color code system enhances patient – provider communication when assessing patient adherence with medication regimens.  We strongly advocate for maintenance, strengthening, and regulatory enforcement of the cap color-coding requirements currently in place.

We have learned that The American Association of Eye and Ear Centers of Excellence has initiated a proposal to eliminate the cap color coding of ophthalmic medications. This proposal, as articulated in a January 2010 letter to the Commissioner of the Food and Drug Administration, argued the opposition to ophthalmic color coding on grounds of patient safety. Citing examples of medication errors by pharmacists, hospital and clinic personnel, the AAEECE ascribes the “Look Alike Sound Alike (LASA)” issue to not only the labeling and bottle type of ophthalmic medications but also the color-coding of the caps. Although we understand that similarities in bottle shape and labeling (e.g. name and label font similarities) are a potential source of medication error, we strongly believe that color-coding of bottle tops actually enhances, not diminishes patient safety. We do, however, support enhancements to bottle and package labeling with larger font size for visually impaired patients.

In addressing patient safety issues in hospitals, pharmacies and healthcare facilities, attention is indeed necessary in the selection, use and handling of ophthalmic medications. Proper training for ophthalmic personnel, pharmacists, and nursing staff in the names, mode of action, and potential side effects of ophthalmic medications could be enhanced. For instance, personnel should be educated to recognize the differences in effects of the various dilating drops with red caps, and should be continually re-educated to habitually read the labels prior to administration or dispensing. In fact, reading the labels of all medications prior to administration or dispensing to a patient is an important safety precaution that should not be skipped, no matter what the color of the eye drop packaging.  In handling medications there is no replacement for appropriate education and training of health care workers at all levels.

Finally, while there have been case reports in the literature of patients inadvertently using non-ophthalmic medications in place of their ophthalmic preparations, errors were ascribed to bottle, bottle top shape, and label similarity,. This issue has been addressed by placing red tips on bottles of drops that should not be administered in the eye, again providing a visual cue to the patient or care-giver.

For patients who take multiple topical medications with eye disease such as glaucoma, color-coding of the bottle tops is essential in assisting the patient in accurate administration of the medication. Patients who take multiple glaucoma medications or have other eye diseases may have significant vision loss and be unable to read labels accurately and must rely on top colors. Patients undergoing eye surgery are routinely prescribed several different postoperative eye drops and need to rely on eye drop color codes while their vision recovers. In addition, there are a significant number of Americans who are illiterate and may be unable to maintain adherence to their regimen without color-coded tops.  Color codes also allow for ophthalmic technicians and physicians to confirm which class of medications patients actually take, even if the patient cannot recall the medication name. Physicians routinely provide patients with medication schedule aids that reference the color codes as a way to enhance patient understanding and compliance. 

In summary, color-coding is used routinely and effectively by patients and physicians in clinical practice. Eliminating the important patient compliance aid of color-coded eye drop medications to avoid medication errors by properly trained health care workers seems misguided. While we are very concerned about the patient safety issue of inadvertent misuse of ophthalmic medications, the the American Glaucoma Society feels strongly that the color-code system for ophthalmic medications is a useful and necessary aspect of medication packaging which enhances patient safety, adherence, and outcomes. We support efforts to further differentiate packaging of ophthalmic preparations from other non-ophthalmic drops, but we do not support elimination of the color codes for topical ophthalmic medications.

Please contact us if you would like to discuss this issue further, or if we can provide any additional information. 

Sincerely,

Jeffrey Liebmann, MD                                    Cynthia Mattox, MD

President, American Glaucoma Society          Chair, AGS Patient Care Committee

Policy Statement: Color Codes for Topical Ocular Medications, 2010, American Academy of Ophthalmology 

Fraunfelder, F.T. Drug-Packaging Standards for Eye Drop Medications. Arch Ophthalmol 1988;106:1029. 

Ling, RTK et al Inadequacy of Current Labeling of Nonophthalmic Drops N Engl J Med 1989;320:62

Budenz, D.L. A Clinicians Guide to the Assessment and Management of Nonadherence in Glaucoma. Ophthalmology 2009;116:s43-47