Once doctors started using Avastin off label  for age-related macular degeneration there have been concerns over compounding regrading  the handling of the drug and inconsistent dosages. –MDA


NEW YORK (September 18, 2014) — Custom-made versions of a widely prescribed, low-cost drug used to prevent a leading cause of blindness in the elderly vary widely in their dosages, Weill Cornell Medical College scientists found in analyses of the eye injections. Investigators saw no evidence of impurities or contamination but found that many of the samples, which were prepared by pharmacists through a process called compounding, contained less medication than doses of the drug obtained directly from the manufacturer. The research, published today in JAMA Ophthalmology, is likely to increase scrutiny of compounding pharmacies, which tailor-mix drugs for individual patients, and to question whether eye-care specialists should continue to prescribe the cancer drug Avastin for age-related macular degeneration (AMD).

“Our evaluation showed significant differences in doses of compounded Avastin, as well as lower drug levels overall compared to Avastin that came from the manufacturer. This is troubling because the prescribed dosing regimen potentially won’t produce the desired therapeutic response, or may put a patient’s health at risk,” said lead author Dr. Szilárd Kiss, director of clinical research and an associate professor of ophthalmology at Weill Cornell Medical College. “Although there were no signs of contamination, these findings raise legitimate concerns about the quality practices of compounding pharmacies.”

Pharmacy compounding is the practice of creating customized, prescription medications to meet individual patients’ needs. At the request of a physician or other healthcare provider who is authorized to write prescriptions, a licensed pharmacist alters ingredients in drugs, such as removing allergy-causing dyes or preservatives or preparing an alternative dosage form to make it easier for patients to take their medications. An estimated 3,000 compounding pharmacies fill more than 30 million prescriptions a year in the United States…..Read more: http://weill.cornell.edu/news/pr/2014/09/study-shows-inconsistent-dosages-of-widely-used-eye-disease-drug-szilard-kiss-donald-damico.html

source: Weill Cornell Medical College

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