Dozens of brand name, private brand and generic ocular lubricants, antihistamines, vasodilators/decongestants and contact lens wetting solutions are now available for purchase over-the-counter (OTC). These agents are sold without prescriptions, in part because the Food and Drug Administration (FDA) considers some ocular conditions self-limiting and amenable to self-diagnosis and treatment.1 Thus, the FDA mandates that the packaging of OTC ophthalmic medications provide information that is critical for their proper use, including the products’ active and inactive ingredients.1
But, despite these labeling provisions, it is inevitable that some patients will use OTC drugs inappropriately. Incorrect self-diagnosis may lead to the use of an OTC drug that is ineffective, only partially effective for the patient’s condition or potentially harmful to the patient.2 For example, patients experiencing itching and redness from ocular allergies may find OTC ketotifen fumarate 0.025% inadequate—although it is a highly effective treatment for itching, ketotifen is not indicated to reduce ocular redness.3 In addition, inefficient overmedication is a possibility. Some ophthalmic solutions have several active ingredients to simultaneously treat dry eye, red eye and itchy eye, but may not adequately address the symptom of greatest concern.
As part of a complete medical history, it is important to capture patients’ contact lens wearing habits, list any ocular symptoms and record all patient medications, including OTC ophthalmic solutions. Additionally, at the time of regularly scheduled check ups and other exams, eye care practitioners should take every opportunity to educate their patients regarding OTC ophthalmic product use. A visual aid can assist in patient educational efforts by describing the ophthalmic product classes such as antihistamines, decongestants (vasoconstrictors), ocular lubricants and lens rewetting solutions, so that patients will understand which conditions each of these products treat, as well as the risks and benefits of choosing one product over another.
Once practitioners recognize the conditions that need relief and identify the possible treatment products, they must emphasize the importance of using OTC products as described on the label. Patients should be advised to return to the office if symptoms persist or new symptoms appear, and to always consult with their eye care practitioner prior to starting, stopping or changing their OTC regime.
Cost of Generics
The purchase of generic products is an excellent opportunity for consumer cost savings when buying OTC medications. In a 1996 study involving pharmacy interns working as purchasing consultants, 42.6% of pharmacy customers changed their intended purchase and reduced their expenditure by purchasing lower priced generic or private label products over brand name drugs.4 Such price-driven OTC product switches save the patient money, but may potentially contradict the recommendations of the patient’s eye care provider, leading to additional office visits and poor patient outcomes.
Although generic OTC products are often marketed as similar to brand names, eye care providers and consumers must compare active and inactive ingredients and concentration levels closely and recognize the actual product attributes and not simply the brand attributes. Many similar products have unidentical active ingredients or different concentrations of active ingredients. Moreover, in cases where generic and brand name products have identical active ingredients, the formulations may differ in terms of inactive ingredients that can impact product efficacy.
Consider OTC solutions for dry eye—the most prevalent chronic ocular surface disease. Systane (Alcon) ocular lubricants (Systane, Systane Ultra, Systane Balance) are used for dry eye and contain the active ingredients polyethylene glycol 400 and propylene glycol, as well as the inactive ingredient HP-guar. Under specific conditions, HP-guar creates a gel that is retained in the microenvironment of the corneal surface.5 Studies have demonstrated that HP-guar improves tear film stability and comfort in individuals with dry eye.5 Thus, patients should know that store brand and name brand OTC products may not be identically formulated nor similarly efficacious.
Many brands of ocular decongestants are available for OTC purchase, such as naphazoline, tetrahydrozoline and phenylephrine. Care must be taken when using these agents, which can temporarily and mildly blanch scleral tissues, potentially masking an underlying pathology. Thus, only after an eye care practitioner has confirmed that the patient’s red eyes are not due to disease should decongestants become a treatment option.6 However, ophthalmic decongestants can induce tachyphylaxis, which can appear as rebound vasodilation and redness.7 So, patients’ OTC decongestant use, including frequency of dosing, should be reviewed at each appointment. To minimize the potential for inappropriate decongestant use, patients should be reminded that these products do not alleviate eye dryness or itchiness and are only effective for the reduction of ocular redness.
Depending on the severity of symptoms and compliance with labeling instructions, many patients will be satisfied with their experience using a given generic OTC ophthalmic product. But, some patients will not find relief and will seek alternative treatment either through self-choice or doctor recommendation. This is why, for a subset of patients, the utilization of generic OTC products as a first choice therapy may ultimately have higher cost implications via multiple product purchases or co-pays from doctor visits.
A large majority of patients treat their allergic ocular symptoms with OTC products. Patients suffering from allergic conjunctivitis have several OTC ketotifen ophthalmic solutions to choose from, including Zaditor (Novartis), Alaway (Bausch + Lomb), Refresh (Allergan), Claritin Eye (Schering-Plough) and Zyrtec itchy eye drops (McNeil). In 1999, Zaditor was originally developed as a prescription drug and made available OTC in 2006.8 Alaway was clinically developed as a prescription bioequivalent, which also went OTC.9 This is not true of Zyrtec and Claritin ophthalmic solutions, which are branded generic formulations of ketotifen fumarate. Patients may recognize these brand names as their OTC oral antihistamines cetirizine and loratadine, and could mistake the active ingredients in the antihistamine tablets with that of the OTC ophthalmic solutions. This incongruent use of brand names is potentially unsafe, particularly for patients with drug allergies.
When making recommendations of OTC ophthalmic products to patients, we must be very specific. A search of a pharmacy website identified nine distinct Visine brand products available for purchase—some of which had multiple formulations with several combinations of active ingredients. Other manufacturers have marketed “master brands” such as Clear Eyes (naphazoline, Prestige Brands), Blink (polyethylene glycol, Advanced Medical Optics) and Advanced Eye Relief (naphazoline, Bausch + Lomb), with several varying formulations for day or night, extended or high performance use. When buying an OTC product, this large variety of consumer options can be confusing.
After advising patients on their use of OTC ophthalmic solutions, it is important to reevaluate at the next appointment. Was the patient satisfied with the OTC product? Did it provide the needed relief for an adequate duration? If not, a reassessment of the patient’s symptoms and complaints will be necessary, as well as a follow up educational discussion.
1. Ophthalmic drug products for over-the-counter human use: Final monograph. Federal Register. 1988; 53(43):7076-93.
2. Brass EP. Changing the status of drugs from prescription to over-the-counter availability. New England J Med. 2001;345(11):810-16.
3. Zaditor (ketotifen furmarte) prescribing information. Duluth, GA. Novartis, Inc. 2002.
4. Sclar DA, Robison LM, Skaer’t TL. Pharmacy consultation and over-the-counter medication purchasing outcomes J Clin Pharm Ther. 1996;21:177-84.
5. Rolando M, Autori S, Badino F, Barabino S. Protecting the ocular surface and improving the quality of life of dry eye patients: A study of the efficacy of an HP-guar containing ocular lubricant in a population of dry eye patients. J Ocular Pharmacol Ther. 2009;25(3):271-8.
6. Abelson MB, Yamamoto GK, Allansmith MR. Effects of ocular decongestants. Arch Ophthalmol. 1980;98(5):856-8.
7. Soparkar CNS, Wilhemlus KR, Koch DD, Wallance GW. Acute and chronic conjunctivitis due to over-the-counter ophthalmic decongestants. Arch Ophthalmol. 1997;115:34-8.
8. Drugs @ FDA. Bethesda, MD: U.S. Health and Human Services, 1999. Available at: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. (Accessed August 2010).
9. Torkildsen GL, Abelson MB, Gomes PJ. Bioequivalence of two formulations of ketotifen fumarate ophthalmic solution: a single-center, randomized, double-masked conjunctival allergen challenge investigation in allergic conjunctivitis. Clin Ther. 2008;30(7):1272-82.