Report: Up to 4 million patients may have received unapproved drugs
NEW YORK The number of patients receiving unapproved prescription drugs appears to be in the millions, according to published reports.
The New York Times reported Friday that as many as 4 million patients may have received nitroglycerin tablets, which are placed under the tongue to stop heart attacks. Drug Store News had reported earlier in the month that the Food and Drug Administration had ordered generic drug makers Glenmark Generics and Konec to stop manufacturing and marketing the tablets.
The FDA’s move came as part of its Unapproved Drugs Initiative, which it started in 2006 to address the issue of prescription drugs marketed without FDA approval. The drugs are also known as “grandfathered drugs” because they entered the market before the FDA adopted its current drug-safety standards, in 1938, and have largely existed in a sort of regulatory limbo since then.
FDA committee to review Qnexa
MOUNTAIN VIEW, Calif. A Food and Drug Administration committee will review a drug by Vivus for obesity, the drug maker announced Friday.
The company said the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee was tentatively scheduled to review its application for Qnexa (phentermine and topiramate) on July 15. Vivus submitted its approval application for the drug in late December and expects the FDA to complete its review in October.
“Review by the advisory committee represents a critical milestone for Qnexa and for Vivus,” Vivus CEO Leland Wilson said in a statement. “We believe Qnexa, if approved, could become a treatment option for obese patients.”
Op-ed on healthcare reform calls for expanded role of nurse practitioners in Texas
SAN ANTONIO An opinion piece written for the San Antonio Express-News urges health reform in Texas and the need for nurse practitioners to be "given the right to diagnose and prescribe on their own," as done in retail clinics.
"Texas has only a few retail clinics; San Antonio doesn’t have any. The problem is cost," David Hendricks wrote Tuesday. "In Texas, state law requires doctors to be on site for 20% of operating hours in urban areas. In rural and designated medically underserved areas, a doctor must review 10% of a clinic’s charts every 10 days. The cost of physician oversight is too high for [the Walgreens and CVS chains], along with the retail clinic companies, to roll out full market coverage in Texas."
Hendricks does, however, point out retail clinics’ cost-effectiveness, citing the acceptance of health insurance plans, with fees capped at less than $100.
"Healthcare reform won’t mean as much as it could in Texas until this change (expanding the role of nurse practitioners and clinical nurse specialists) happens," Hendricks concluded.
To view Hendricks’ piece, click here.