`
`https://www.reviewofoptometry.com/article/when-to-prescribe-an-otc-al...
`
`Leadership in clinical care
`
`Pub shed August 17 2010
`
`When to ʻPrescribeʼ an OTC Allergy Drop
`Optometrists have fought hard for the ability to write for prescription drugs. But for some allergy
`patients, the best medication is already on the drugstore shelf.
`Maria J. Mandese, O.D., Wesdon McCann and Valerie Croteau
`
`A four-year-old boy presented with his mother for evaluation of bilateral red, itchy eyes with concurrent nasal congestion that
`had begun two days prior. The mother stated that the child had seasonal allergies, but no other medical conditions.
`
`The child’s visual acuity, evaluated with Lea symbols, was 20/20 O.D., O.S. and O.U. Extraocular motility testing was full
`range of motion O.D. and O.S. Confrontation fields were full in both eyes. Pupils were round and reactive to light, without
`evidence of an afferent defect. He had no preauricular node upon examination.
`
`Slit lamp exam revealed large (3 to 4+) papillae in both inferior palpebral conjunctivae. Chemosis was evident in both bulbar
`conjunctivae. There was no corneal involvement in either eye. The rest of the anterior segment was intact.
`
`After ruling out the differential diagnoses of infectious conjunctivitis, blepharitis and dry eye, the diagnosis in this case was
`straightforward: allergic conjunctivitis.
`
`But determining the boy’s treatment was more complicated. The mother wanted her child to feel better, of course, but she
`had no insurance or money to buy him medication. So, our challenge was to make a decision on the patient’s treatment:
`over-the-counter or prescription medication?
`Match Treatment to Type
`When choosing a treatment strategy, the first maneuver to consider must be the elimination or avoidance of the allergen.
`Second, artificial tears help to wash the tear film and decrease the amount of the offending allergen within the eye. In
`addition, cool compresses are a noninvasive treatment that offer comfort with a mild anti-inflammatory mechanism.
`
`However, in order to choose a more specific type of treatment, we must consider the different types of allergic conjunctivitis:
`acute, seasonal or perennial.
`
`• Acute allergic conjunctivitis is characterized by severe itching, chemosis, tearing, lid edema and hyperemia at the onset of
`exposure to an allergen within the environment. It usually resolves with removal of the allergen within 24 hours.
`
`• Seasonal allergic conjunctivitis is more chronic and mild. The symptoms are predictable with the change of season and are
`usually associated with pollens, weeds and grass.
`
`• Perennial allergic conjunctivitis is chronic and associated with environmental allergens that usually cannot be avoided within
`a home, such as dust mites and mold.
`
`The determination as to whether the condition is acute or chronic may help to make a decision on which type of medication
`to choose.
`
`For non-chronic conditions that are relatively easy to self diagnose, over-the-counter medications are generally available and
`have a low potential for harm from abuse. Making medications available over-the-counter affects a large number of
`1
`stakeholders including patients, pharmaceutical firms, physicians, pharmacists, drug regulatory agencies and health funding
`organizations. Over-the-counter medications are most beneficial to patients who must pay full retail price or high copayments
`
`1 of 4
`
`8/22/2022, 3:49 PM
`
`Eye Therapies Exhibit 2130, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`When to ‘Prescribe’ an OTC Allergy Drop
`
`https://www.reviewofoptometry.com/article/when-to-prescribe-an-otc-al...
`
`for prescription medications plus the cost of a physician’s visit.
`What’s Available OTC
`Over-the-counter allergy medications include topical decongestants, oral antihistamines, topical antihistamine/mast-cell
`stabilizer combinations and topical decongestant/antihistamine combinations.
`
`2
`
`• Topical decongestants reduce chemosis and conjunctival hyperemia through an alpha-agonist mechanism. This in turn
`stimulates the alpha receptors in the blood vessels, resulting in vasoconstriction and decreased conjunctival edema. Topical
`decongestants are prescribed four times daily, typically work within minutes and last about two hours.
`
`Examples of over-the-counter topical decongestants include Refresh Redness Relief (phenylephrine HCl 0.12%, Allergan),
`Visine (tetrahydrozoline HCl 0.05%, McNeil), Visine L.R. (oxymetazoline HCL 0.25%, McNeil) and Clear Eyes (naphazoline
`HCl 0.12%, Prestige Brands).
`
`Side effects of topical decongestants include rebound redness, dilation, intolerance to the drug and masking of signs and
`symptoms of allergic conjunctivitis. Furthermore, topical decongestants are contraindicated in narrow angle glaucoma, and
`chronic use of vasoconstrictors can lead to toxic, follicular reactions or possibly a contact dermatitis.3 These medications are
`usually reserved for acute reactions and should only be used for less than two weeks, after which the patient’s condition
`should be reassessed.
`
`• Oral antihistamines are a popular choice for patients with concurrent allergic rhinitis, but these drugs have a superficial
`drying effect on the ocular surface. The mechanism of action is inhibition of H1 receptors in the lacrimal gland, which
`decreases tear production.4 Examples of over-the-counter oral antihistamines include Benadryl (diphenhydramine, McNeil),
`Chlor-Trimeton (chlorpheniramine, Schering-Plough), and Claritin (loratadine, Schering-Plough). These third-generation
`antihistamines are generally well tolerated and non-sedating.5
`
`• Topical antihistamine/mast-cell stabilizer combinations are all different brands with the same active ingredient, ketotifen
`0.025%. Brand-name products include Alaway (Bausch + Lomb), Claritin Eye (Schering-Plough), Refresh Eye Itch Relief
`(Allergan), Visine All Day Itch Relief (McNeil) and Zaditor (Novartis). These generally work faster than oral antihistamines at
`relieving ocular symptoms. The antihistamine quickly relieves itching. The mast-cell stabilizer prevents itching for an
`extended period of time, usually 12 hours. Late phase reactions are terminated by blocking the release of eosinophils.
`Dosing is two times daily. Now that this type of medication is available over the counter, it has become less expensive for
`patients without insurance to afford true long-term allergy relief.
`
`• Ocular decongestant/antihistamine combinations incorporate the mechanisms of action of both decongestants and
`antihistamines. Examples of decongestant/antihistamine combination eye drops include Opcon-A (naphazoline HCl
`0.03%/pheniramine maleate 0.32%, Bausch + Lomb), Naphcon-A (naphazoline HCl 0.025%/pheniramine maleate 0.3%,
`Alcon) and Visine-A (naphazoline HCl 0.025%/pheniramine maleate 0.3%, McNeil). The dosing is up to four times daily
`6
`during acute symptoms.
`
`The price of these OTC medications range from approximately $5 to $15. (See “Pricing for Over-the-Counter Allergic
`7
`Conjunctivitis Relief Medications.”)
`
`Pricing for Over-the-Counter Allergic Conjunctivitis Relief Medications
`7
`Topical decongestant
`Antihistamine/Mast-cell stabilizer combination Decongestant/Antihistamine combination
`Refresh Redness Relief, 15ml$8.99 Alaway, 10ml
`$12.99 Opcon-A, 15ml
`$7.19
`$4.99 Visine All Day Itch Relief, 5ml
`$10.99 Visine-A, 15ml
`$5.99
`Clear Eyes, 15ml
`$7.99 Zaditor, 5ml
`$14.99 Naphcon-A, 15ml
`$10.99
`Visine, 30ml
`Compare OTC to Rx
`Compare the cost of prescription vs. OTC medications for acute and chronic allergy relief. The cost for the prescription
`medications range from approximately $40 to greater than $100. (See “Minimum Pricing for Prescription Allergy Relief
`8
`
`2 of 4
`
`8/22/2022, 3:49 PM
`
`Eye Therapies Exhibit 2130, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`When to ‘Prescribe’ an OTC Allergy Drop
`
`https://www.reviewofoptometry.com/article/when-to-prescribe-an-otc-al...
`
`Medications.”)
`
`Minimum Pricing for Prescription Allergy Relief Medications
`8
`Mast cell stabilizer
`Antihistamine
`Antihistamine/Mast-cell stabilizer combination
`Alamast, 10ml $101.33 Emadine, 15ml $70.01 Bepreve, 10ml
`$84.90
`Alocril, 5ml
`$85.99
`Elestat, 5ml
`$95.74
`Alomide, 10ml $89.74
`Optivar, 6ml
`$107.36
`Crolom, 10ml $41.02
`Patanol; Pataday - 5ml; 2.5ml
`$94.63
`
`The three categories of prescription allergy medications include mast-cell stabilizers, ocular antihistamines, and combinations
`of the two.
`
`• Mast-cell stabilizers block the first step in the allergic cascade by inhibiting mast-cell degranulation. They are used for
`chronic itching such as in perennial allergic conjunctivitis. Alamast (pemiroloast 0.1%, Vistakon Pharmaceuticals), Alocril
`(nedocromil 2.0%, Allergan), Alomide (lodoxamide 0.1%, Alcon) and Crolom (cromolyn 4.0%, Bausch + Lomb) are all mast-
`cell stabilizers that are used for mild, chronic itching, and are dosed twice daily.
`
`• Ocular antihistamine reversibly blocks histamine receptors in the conjunctiva and eyelids. This type of medication, which
`includes Emadine (emedastine 0.05%, Alcon), is used for short-term, acute symptoms of itching.
`
`• Combination antihistamine/mast-cell stabilitizers, Bepreve (bepotastine 1.5%, ISTA), Elestat (epinastine HCl 0.05%,
`Allergan), Patanol (olopatadine 0.1%, Alcon), Pataday (olopatadine 0.2%, Alcon) and Optivar (azelastine 0.05%, Meda), are
`the preferred medications for chronic recurrent episodes of allergic conjunctivitis. This is generally defined as more than two
`episodes per month. The advantage of these combination medications is the quick onset of relief and the long-lasting effect
`of reducing redness, tearing and burning.
`
`These medications are usually prescribed two times daily, except for Pataday, which is dosed once-daily for prevention of
`symptoms. These medicines may be used up to four times daily for moderate to severe symptomatic patients and are most
`commonly used in combination with a mild steroid, such as Lotemax (lotepredol 0.5%, Bausch + Lomb) or Alrex (lotepredol
`0.2%, Bausch + Lomb), to decrease inflammation.
`
`Is Writing an Rx for OTC Medications Important?
`Writing a prescription for an OTC medication is important because it indicates what medication you as the doctor think is best. It also
`serves as a document that can be presented to a pharmacist if the patient needs assistance in finding the exact medication.
`
`Simply write out the prescription (and write clearly!) on your Rx pad with the name of the medication, and how you would like your
`patient to use it. Some companies o�er these instructions on pamphlets as coupons. This is just as helpful. The important goal is that
`the patient purchases the appropriate medication that you prescribe.
`More Points to Consider
`The decision to prescribe over-the-counter medications should be made on an individual, case-by-case basis. As stated
`above, the first steps are to avoid the allergen and to use artificial tears to rinse away the allergen from the tear film. Then,
`for relief from acute intermittent reactions, an over-the-counter topical antihistamine/mast-cell stabilizer should be sufficient
`for relief.
`
`Additional points to consider for patients with ocular allergy:
`
`• Decongestants do reduce redness but can also incite a rebound effect, which causes the relief to be short lived. In general,
`educate patients against using OTC ocular vasoconstrictors.
`
`• Long-term use of topical decongestants is not recommended. So, in cases of chronic itching, prescribe a mast-cell stabilizer
`instead.
`
`• For patients with episodes more frequent than twice monthly, consider a combination antihistamine/mast-cell stabilizer.
`Additionally, when patients present with a moderate to severe reaction, add a pulse therapy of a mild steroid to the regimen.
`
`3 of 4
`
`8/22/2022, 3:49 PM
`
`Eye Therapies Exhibit 2130, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`When to ‘Prescribe’ an OTC Allergy Drop
`
`https://www.reviewofoptometry.com/article/when-to-prescribe-an-otc-al...
`
`• Verbally instructing a patient to purchase OTC medications at the pharmacy can often lead to confusion and/or
`mismanagement of a patient’s condition. Instead, write a prescription for OTC medications to emphasize the value of this
`treatment. (See “Is Writing an Rx for OTC Medications Important?”) This OTC Rx also directs patients to the appropriate
`medication and dosing for their specific needs.
`
`Over-the-counter allergy medications are cost effective, so if your patient has financial concerns, recommend an OTC drop
`for relief of symptoms. However, if your patient has seasonal or recurrent episodes of allergic conjunctivitis, and has a health
`insurance plan to cover most of the cost, then prescription medication is generally preferable.
`
`The patient in this case did not have insurance, so we recommended an OTC antihistamine/mast-cell stabilizer. We also
`initially prescribed a corticosteroid drop to use concurrently to decrease the inflammation. He now uses the OTC drop as
`maintenance therapy, and his symptoms are under control.
`
`Dr. Mandese is a full-time faculty member at Nova Southeastern University College of Optometry. Mr. McCann and Ms.
`Croteau are third-year students at Nova Southeastern University College of Optometry.
`
`1. U.S. Food & Drug Administration. Center for Drug Evaluation and Research. Regulation of Nonprescription Products. Available at: www.fda.gov/AboutFDA
`/CentersOffices/cder/ucm093452.htm. (Accessed May 28, 2010.)
`2. Cohen JP, Paquette C, Cairns CP. Switching prescription drugs to over-the-counter. BMJ. 2005 Jan 1;330(7481):39-41.
`3. Soparkar CN, Wilhelmus KR, Koch DD, et al. Acute and chronic conjunctivitis due to over-the-counter ophthalmic decongestants. Arch Ophthalmol. 1997
`Jan;115(1):34-8.
`4. Abelson MB, Weston, JH. Antihistamines. In: Lamberts DW, Potter DE, eds. Clinical Ophthalmic Pharmacology. Boston: Little Brown; 1987.
`5. Ten Eick AP, Blumer JL, Reed MD. Safety of antihistamines in children. Drug Saf. 2001;24(2):119-47.
`6. Fiscella R, Jensen M. Ophthalmic Disorders. In: Bernardi R, Newton G, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington, DC:
`American Pharmacist Association; 2006: 577-603.
`7. www.drugstore.com (Accessed July 15, 2010).
`8. www.destinationrx.com (Accessed June 1, 2010).
`
`Copyr ght © 2022 Jobson Med ca nformat on LLC un ess othe w se noted.
`A r ghts reserved. Reproduct on n who e or n part w thout perm ss on s proh b ted.
`
`4 of 4
`
`8/22/2022, 3:49 PM
`
`Eye Therapies Exhibit 2130, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`