US Pharm. 2009;34(iv):12-15.

The introduction of hydrocortisone to the nonprescription market in 1979 was a revolutionary move past the FDA.1,2 It marked the first time that a corticosteroid had been judged sufficiently rubber for use without a medico's supervision. How was hydrocortisone judged safety enough for consumer self-apply?

The Path to Nonprescription Condition

Hydrocortisone was first marketed as a prescription medication in 1952.one In 1956, the FDA was petitioned to switch hydrocortisone to nonprescription condition. According to the agency, two factors were critical in denying the petition. Showtime, at that place was insufficient evidence that consumers could safely cocky-medicate with hydrocortisone. 2d, the agency was concerned most percutaneous absorption.

In 1979, the FDA OTC review procedure was ongoing. The Advisory Console on Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and Treatment Drug Products (the Topical/External Analgesics Console) began meeting in 1973, and through 70 subsequent meeting days considered hydrocortisone (acetate) and other ingredients.2 The panel was equanimous of half-dozen physicians and a chemist/PhD who was serving as dean of a school of pharmacy.

In 1979, the FDA published the results of its deliberations in the Federal Register every bit "External Analgesic Drug Products for Over-the-Counter Human Utilise; Establishment of a Monograph and Notice of Proposed Rulemaking."2 This groundbreaking document was the beginning to extensively explore potential self-care uses of hydrocortisone. The experts concluded that hydro cortisone 0.25% to 0.5% and its acetate common salt would be safety and effective for use as nonprescription antipruritics. Addressing a affair of paramount concern to the FDA in its negative 1956 decision, the panel concluded on the basis of current research that hydrocortisone did non cause hypothalamus-pituitary-adrenal (HPA) centrality suppression in patients with chronic skin illness. Based on this study, the FDA allowed OTC sales to proceed.3 In only two years, this movement saved patients as much every bit $600 1000000 in medical costs.4

In the tardily 1980s, the FDA received a citizen'due south petition to allow hydrocortisone 1% to gain nonprescription status. A 1990 Observe of Proposed Rulemaking alerted the nation's health intendance professionals that the bureau would allow the stronger concentration to exist marketed if correctly labeled.five This amendment was finalized, and patients were able to benefit from the enhanced efficacy of the 1% products.

Physician Attitudes

Whether or not hydrocortisone should be bachelor on a nonprescription basis was debated by the American Academy of Dermatology in 1965 and 1975.four At both times, the dermatologist society concluded that the risks to unsupervised use were likewise compelling, outweighing whatsoever potential benefit. Among their concerns take been masking the development of skin cancers or other serious conditions, thereby delaying their diagnosis, equally well as such adverse reactions equally atrophy, striae, and steroid-induced rosacea. A 2007 paper in the Archives of Dermatology concluded that the earlier opposition had been unwarranted and that the switch was justified.iv

Current Hydrocortisone Labeling

Hydrocortisone carries numerous instructions and warnings that must be read carefully, thoroughly understood, and scrupulously followed to ensure condom use.6-viii When patients buy powerful pharmacologic agents such as hydrocortisone in nonpharmacy outlets, they must rely on their own skills to ensure safety use. However, when a pharmacist is involved in the interaction, the patient can accept reward of a trained professional person's ability to explain whatsoever section of the characterization that is unclear.

The age of the patient is important for the chemist to ascertain. Hydrocortisone is not safe for whatever patient under the age of two years.vi-8 Thus, whether or not the babe has a hydrocortisone-responsive condition, he or she must be referred to a medico for proper care. Patients anile 2 years or older are directed to use the product to the affected area three to iv times daily.

Hydrocortisone is approved to self-treat a variety of dermatologic conditions. These include insect bites; allergic reactions (e.k., to soap, detergents, cosmetics, or jewelry); rashes; poison ivy, oak, or sumac; eczema; psoriasis; seborrheic dermatitis; and external genital or anal itching.six-eight

The FDA does non allow hemorrhoid products to exist labeled for those under the historic period of 12 years and advises that a doctor should be consulted when treating external anal itching in this age-group.6-8 Furthermore, patients over age 12 years are cautioned on hydrocortisone labels to terminate use and seek a medico if rectal bleeding occurs and are advised not to insert hydrocortisone into the rectum using the fingers or any type of applicator.

Patients are instructed to halt use of nonprescription hydrocortisone and run across a physician if the symptoms worsen, if they persist for more 7 days, or if they clear up and recur again within a few days.half-dozen-viii

Nonprescription hydrocortisone products should non exist practical to the optics or eyelids.8 Patients should not cover the hydrocortisone later application in an attempt to create an occlusive dressing, unless advised to do and so by a physician. Patients who are pregnant or nursing should only use hydrocortisone on the advice of a physician.8

Conditions That Should Not Exist Treated

The labels of hydrocortisone products warn patients against apply in diaper rash.7 The logic is obvious, in that hydrocortisone could be absorbed percutaneously through damaged pare, peculiarly when it is moistened by urine and carrion and covered by a diaper, which functions as an occlusive dressing.

Hydrocortisone is contraindicated if a female patient with genital itching besides has a vaginal discharge.6,7 In this instance, discharge indicates the presence of a vaginal infection (e.g., candidiasis, trichomoniasis). Hydrocortisone might provide symptomatic relief, giving the patient the idea that she is improve, and delaying her visit to a physician for an antibody or antibacterial.

Burns should not be treated with hydrocortisone, as information technology is not known to be effective in burned skin.7 In addition, burned peel is damaged to some degree, and depending on the depth of the burn down, hydrocortisone could exist captivated, leading to systemic bug.

Hydrocortisone is inappropriate as sole therapy for fungal conditions, such equally tinea pedis, tinea corporis, or tinea cruris.7 Corticosteroids used alone in these dermatophytic infections allow the tinea to spread and assume atypical forms, known medically as tinea incognito. Hydrocortisone is not known to be constructive or safe for treating such small conditions equally acne, dandruff, hair loss, warts, corns, calluses, or sunburn.7

Survey Reinforces Added Value of Pharmacist Intervention

The United States is one of the only countries without a widespread third grade of medications that would require pharmacist counseling (with the limited exceptions of pseudoephedrine, ephedrine, and Programme B).7 As a effect of this state of affairs, the vast majority of nonprescription products can exist purchased at whatever location without pharmacist intervention. Since professional intervention is not required in sales of nonprescription products, the label must contain every bit of data needed to ensure proper use by the cocky-medicating patient.

The FDA assumes that patients using nonprescription products volition read and heed all sections of the label, thoroughly understanding all of the information and acting exactly as the label directs. This supposition underlies virtually every decision made by the FDA regarding nonprescription products, only it is especially disquisitional in Rx-to-OTC switched products such as hydrocortisone. To verify or disprove this assumption, researchers must survey actual users of the products in question.

A British study explored that upshot for hydrocortisone products and the corticosteroid clobetasone (clobetasone has been bachelor as a nonprescription product in Britain since 2002).9 A group of researchers surveyed patients who purchased a topical steroid in 2003. The 315 respondents purchased the products intending to treat a variety of conditions, including eczema (61%), dermatitis (21%), insect bites (four%), sweat rash (4%), vaginal thrush (iii%), psoriasis (three%), tinea pedis (ane%), diaper rash (1%), acne (ane%), and other conditions (10%) (e.k., tinea, rosacea, otitis externa, shaving rash, pruritus vulvae or ani, dry out skin, unspecified rashes). Several patients were treating multiple conditions.

This tabulation illustrates the value of pharmacist intervention in advising against utilise where nonprescription corticosteroids are inappropriate (e.g., vaginal thrush, tinea pedis, diaper rash, acne, otitis externa).9 On further questioning, 39% of respondents were judged to be using the product for unlabeled uses, and thirteen% were judged to be using the products on the "deadline" of labeled employ, such as exceeding the 7-day use limit. Nine percentage used them for more than than vii days, and vi% had used them in excess of 14 days. Ten pct practical the products to the face, in direct opposition to clear label directions non to practise so. The diagnosis had been made by a doc in 53% of cases and by a pharmacist in simply 6% of cases. In 35% of cases, the patient had engaged in self-diagnosis. An interested pharmacist trained in recognition of minor dermatologic atmospheric condition might have been able to render a more reliable judgment of what blazon of condition was present in that large segment of shoppers.

Conclusion

Hydrocortisone is a nonprescription product that carries numerous critical instructions and warnings to help ensure that it is used safely and finer. However, inquiry in United kingdom confirmed that in that location are numerous instances when patients engage in incorrect use. Pharmacists can exist vitally important in ensuring that patients employ powerful OTC pharmacologic agents merely when advisable and that they heed all warnings and precautions.

Nonprescription hydrocortisone has been on the market for 30 years. It is available as several popular merchandise names, including Cortaid, Cortizone, Aveeno Hydrocortisone Anti-Itch Cream, and Crawling-Ten Anti-Crawling Moisturizing Balm.

What Can I Use Information technology For?

Hydrocortisone is useful for dissimilar types of dermatitis or skin inflammations caused past such allergens or irritants as lather, detergents, cosmetics, jewelry, and poison ivy, oak, or sumac. The skin affected with these problems may appear to have a rash, be broken out with blisters, be affected with raw areas, or accept a dry, scaly appearance. Hydrocortisone tin can assist stop itching of the skin and genital or anal areas, and information technology as well helps relieve the discomfort from insect bites. In addition, it is of some use in psoriasis or seborrheic dermatitis. The product should be applied three to four times daily.

Information technology is important to avoid wrong usage of this product. Hydrocortisone should not exist used for the following conditions without a doctor'due south advice: diaper rash, female itching when there is a vaginal discharge, vaginal thrush, whatever grade of fungal skin infection (i.east., athlete'southward foot, ringworm of the body, jock itch), burns, acne, dandruff, hair loss, warts, corns, calluses, sunburn, or whatever other condition not specifically mentioned on the label. Patients under the age of 12 years should not use information technology for rectal conditions such equally hemorrhoids without a doctor'southward advice. If y'all are using it for hemorrhoids, practise non try to place information technology into the rectum, whether using the fingers or any other type of applicator device.

Who Shouldn't Apply Hydrocortisone?

Using hydrocortisone without a medico's advice can be dangerous unless you read and follow all of the directions. For instance, you should never let it to be used on anyone nether the age of 2 years. Information technology should not be used in or near the eyes. If the status worsens or lasts longer than 7 days, you should end utilise and consult a physician. If the condition clears up but returns a few days later on, hydrocortisone is non appropriate and a medico appointment is the best motility. Pregnant patients and those who are breast-feeding should not use it unless advised to practice so by their physician.

Which Type of Product Is Best?

You lot will detect that hydrocortisone is available in several forms, such equally creams, ointments, sprays, and lotions. The selection is personal, every bit all products are effective. Creams have a smooth feel that some patients prefer, whereas ointments encompass the skin with a greasy or oily layer of active ingredient. Ointments are more than resistant to water removal, such every bit when one later washes the easily. Lotions spread over the skin more than smoothly than creams or ointments but are besides bailiwick to water removal. Sprays allow the user to cover the area without rubbing a product on. This is an advantage when rubbing or touching the afflicted area causes itching or hurting.

If after reading the OTC hydrocortisone labels you lot are still confused about which product to select, please do not hesitate to ask the chemist for a recommendation.

Call back, if you accept questions, Consult Your Pharmacist.

REFERENCES

1. Articulation NDAC/DODAC advisory committee meeting executive summary. March 24, 2005. FDA. www.fda.gov/ohrms/dockets/ac/ 05/briefing/2005-4099B1_01_ FDA-Backgrounder.pdf. Accessed Feb 26, 2009.
ii. Recommendations regarding the safety and effectiveness of hydrocortisone. Advisory panel review of OTC topical analgesic, antirheumatic, otic, burn, and sunburn protection and handling drug products. Dec 4, 1979. FDA. www.fda.gov/ohrms/dockets/air-conditioning/ 05/briefing/2005-4099B1_02_ FDA-Tab2.pdf. Accessed February 26, 2009.
3. Concurrence with the recommendation of the topical analgesics console. February eight, 1983. FDA. www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4099B1_03_FDA-Tab3.pdf. Accessed Feb 26, 2009.
4. Ravis SM, Eaglstein WH. Topical hydrocortisone from prescription to over-the-counter auction. Arch Dermatol. 2007;143:413-415.
v. FDA recognition that hydrocortisone is safe and effective as an OTC antipruritic active ingredient at concentrations up to 1.0 percent. February 27, 1990. FDA. www.fda.gov/ohrms/dockets/ac/ 05/briefing/2005-4099B1_04_ FDA-Tab4.pdf. Accessed Feb 26, 2009.
vi. Cortaid Maximum Strength Cream. Jonson & Johnson Consumer Companies, Inc. world wide web.cortaid.com/prod_cream. jsp#. Accessed February 26, 2009.
7. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
8. Oft asked questions. Cortaid. Johnson & Johnson Consumer Companies, Inc. www.cortaid.com/faq.jsp. Accessed February 26, 2009.
9. Rogers PJ, Wood SM, Garrett EL, et al. Use of nonprescription topical steroids: patients' experiences. Br J Dermatol. 2005;152:1193-1198.
10. Watsky KL, Warshaw EM. Allergic contact dermatitis: another agin effect of over-the-counter topical hydrocortisone. Arch Dermatol. 2007;143:1217.

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