Researchers call for more scrutiny of off-label prescribing
NEW YORK Many doctors prescribe medications for uses other than those for which the Food and Drug Administration has approved them, and there needs to be more scrutiny of the practice, researchers wrote in a report last week.
The report, published in the Nov. 24 issue of the journal Pharmacotherapy, found 14 medications that doctors prescribe for off-label use. The researchers called for more studies of the drugs to ensure their safety and efficacy when used to treat diseases for which they have not been approved.
One example was AstraZeneca?s schizophrenia drug Seroquel (quetiapine), for which 76 percent of prescriptions were for diseases other than schizophrenia. Other drugs included antidepressants that doctors frequently prescribed for treating bipolar disorder.
Off-label prescribing by doctors is legal, but off-label marketing by drug makers is not. An investigation by the Government Accountability Office in July found that the FDA did not have sufficient full-time staff to monitor off-label marketing.
NOCA recognizes PTCB’s Corrigan with Certification Industry Leadership Award
WASHINGTON Melissa Murer Corrigan, executive director and chief executive officer of the Pharmacy Technician Certification Board, has received the 2008 Certification Industry Leadership Award from the National Organization for Competency Assurance, PTCB announced Tuesday.
PTCB said the award recognized Murer Corrigan’s leadership in the field of certification and licensure. She has certified more than 320,000 pharmacy technicians as the founding executive of PTCB.
“This award is a tribute to the hard work and dedication of all my colleagues and partners involved in making PTCB a success since our founding in 1995,” Murer Corrigan said in a statement. “The certification of pharmacy technicians in the U.S. has advanced the patient safety of millions of Americans, and I am so proud of the PTCB team and all of our certified technicians.”
FDA warns Shionogi to end unsupported Cedax claims
ROCKVILLE, Md. The Food and Drug Administration released a warning letter to Shionogi and Co. Tuesday regarding its antibiotic Cedax.
The FDA said the company made inflated claims about Cedax (ceftibuten) and downplayed the health risks associated with it. Promotional materials sent to doctors claimed the drug had “excellent tolerability,” even though data did not support the claim.
The drug is approved for treating mild to moderate bacterial infections.