Pharmacy & Therapeutics - September 2008 - (Page 553)

Pharmaceutical Approval Update proteins control the biosynthesis of potent mediators of inflammation and pain, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Warnings and Precautions: Increased intraocular pressure. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve and defects in visual acuity and field of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. Cataracts. The use of corticosteroids may result in posterior subcapsular cataract formation. Delayed healing. The use of steroids after cataract surgery may delay healing and may increase the incidence of bleb formation. In diseases that cause thinning of the cornea or sclera, perforations have occurred with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit-lamp biomicroscopy and, when appropriate, fluorescein staining. Bacterial infections. Prolonged use of corticosteroids may suppress the host’s immune response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or may enhance existing infection. If signs and symptoms do not improve after two days, the patient should be re-evaluated. Viral infections. Great caution is required when a corticosteroid is given to patients with a history of herpes simplex. The use of ocular steroids may prolong the course and may exacerbate the severity of viral infections of the eye (including herpes simplex). Fungal infections. Fungal infections of the cornea in particular tend to occur coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration when a steroid has been used or is in use. A fungal culture should be taken when appropriate. Dosage and Administration: Difluprednate is supplied in an opaque plastic bottle with a controlled-drop tip and a pink cap. Two sizes are available: 2.5 mL in a 5-mL bottle (NDC 42826-601-25) and 5 mL in a 5-mL bottle (NDC 42826-601-05). One drop is instilled into the conjunctival sac of the affected eye four times daily beginning 24 hours after surgery and continuing throughout the first two weeks of the postoperative period, followed by two times daily for a week. The dose is then tapered according to the patient’s response. Commentary: Rapid resolution of inflammation and pain is very important following ocular surgery. In phase 3 studies, patients were treated for the first time after ocular trauma from surgery. The study results demonstrated that the emulsion is a powerful option for postoperative care, especially in eliminating postoperative pain. As a difluorinated derivative of prednisolone, this emulsion is the first innovation in the class of strong steroids of more than 35 products and the first steroid to be indicated for treating postoperative pain. A topical ophthalmological steroid drug that acts against pain and inflammation after ocular surgery gives physicians a more complete treatment approach. Source: www.durezol.com I Copays and Oral Antidiabetic Drugs continued from page 540 ing and health. JAMA 2007;298:61–69. 18. Taira DA, Wong KS, Frech-Tamas F, et al. Copayment level and compliance with antihypertensive medication: Analysis and policy implications for managed care. Am J Manag Care 2006;12: 678–683. 19. Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol 1992;45:613–619. 20. Cramer JA, Benedict A, Muszbek N, et al. The significance of compliance and persistence in the treatment of diabetes, hypertension, and dyslipidaemia: A review. Int J Clin Pract 2008;62: 76–87. 21. Willey CJ, Andrade SE, Cohen J, et al. Polypharmacy with oral antidiabetic agents: An indicator of poor glycemic control. Am J Manag Care 2006;12:435–440. 22. Cohen FJ, Neslusan CA, Conklin JE, et al. Recent antihyperglycemic prescribing trends for U.S. privately insured patients with type 2 diabetes. Diabetes Care 2003;26:1847–1851. 23. Wysowski DK, Armstrong G, Governale L. Rapid increase in the use of oral antidiabetic drugs in the United States, 1990–2001. Diabetes Care 2003;26:1852–1855. 24. Gross R, Tabenkin H, Porath A, et al. The relationship between primary care physicians’ adherence to guidelines for the treatment of diabetes and patient satisfaction: Findings from a pilot study. Fam Pract 2003;20:563–569. 25. Krupat E, Stein T, Selby JV, et al. Choice of a primary care physician and its relationship to adherence among patients with diabetes. Am J Manag Care 2002;8:777–784. I CALL FOR PAPERS P&T is now accepting article submissions from its readers. We welcome a wide variety of manuscripts, including drug class reviews, disease state management reviews, pharmacoeconomic analyses, strategies for coping with medication errors, outcomes research evaluations, DUEs, P&T committee experiences, commentaries, book reviews, and letters to the editor. We are also interested in receiving articles for both continuing education (CE) and continuing medical education (CME) credit. Articles to be considered for dual accreditation should provide an overview of topics that are directly relevant to health care practitioners. Please see our author guidelines at PTCommunity.com. You can contact the editor, Sonja Sherritze, via telephone: 267-685-2779, or e-mail: ssherritze@medimedia.com. Vol. 33 No. 9 • September 2008 • P&T® 553 http://PTCommunity.com http://www.durezol.com

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - September 2008

Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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