Medications cannot be marketed in the United States without an FDA determination that they are safe and effective for their intended use. To obtain such certification, pharmaceutical companies submit their products to rigorous scrutiny (eg, in vitro studies, animal studies, human clinical trials) and present the subsequent data to the FDA, which determines whether the medication in question is safe and effective for a specific purpose. FDA approval comes with specific labeling requirements for the product, including the approved indications for use, the appropriate dosing, and the specific populations for its use. Once a medication has been approved for a specific use, physicians and other prescribers are permitted to prescribe the medication for conditions not covered by the approved use.
Several recent studies have demonstrated that off-label prescribing is very common among physicians, particularly among psychiatrists. Legal scholars have estimated that approximately 40% to 60% of prescriptions are for off-label use.1 In one important study, researchers examined office-based prescribing patterns for 160 commonly prescribed medications and determined that approximately 21% were for off-label use. In this study, off-label use was most common for cardiac medications (46%), anticonvulsant medications (46%), and asthma medications (42%). The investigators also found that most off-label use (73%) had limited or no scientific support.
The greatest disparity in the percentage of scientifically supported versus unsupported off-label use occurred with psychiatric medications. In 96%, the off-label use was determined to have little or no sound scientific evidence for the condition for which the drug was prescribed.2
READ MORE @ PSYCHIATRIC TIMES
Showing posts with label off-Label Prescribing. Show all posts
Showing posts with label off-Label Prescribing. Show all posts
Friday, May 1, 2009
Saturday, April 25, 2009
Study: Medicaid patients get wrong drugs
Drugs designed to treat severe mental illnesses are being prescribed to Medicaid patients at inappropriately low doses, at considerable expense and for conditions where their benefits haven't been proven, a team of mostly Oregon researchers reports.
Scientists from the Oregon State University College of Pharmacy, Oregon Health and Science University and Columbia University's psychiatry department reviewed records for 830 Oregon Medicaid patients who had been given antipsychotic medications approved for conditions such as schizophrenia and bipolar disorder. The researchers found the majority of those patients did not have the underlying mental conditions for which the drugs were approved for prescription. Instead, they were given to patients to treat health concerns such as depression, anxiety, post-traumatic stress disorder or insomnia.
READ MORE @ STATESMAN JOURNAL
Scientists from the Oregon State University College of Pharmacy, Oregon Health and Science University and Columbia University's psychiatry department reviewed records for 830 Oregon Medicaid patients who had been given antipsychotic medications approved for conditions such as schizophrenia and bipolar disorder. The researchers found the majority of those patients did not have the underlying mental conditions for which the drugs were approved for prescription. Instead, they were given to patients to treat health concerns such as depression, anxiety, post-traumatic stress disorder or insomnia.
READ MORE @ STATESMAN JOURNAL
Wednesday, November 26, 2008
Study Calls for Greater Scrutiny of 'Off-Label' Drug Use Doctors often prescribe medicines for conditions that haven't been studied thoroughly
It's called "off-label" prescribing, and it's the common practice of doctors prescribing a drug to treat a disease or condition that's different from the one studied by federal regulators that led to the drug's approval in the first place.
Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found.
The study by American researchers has identified 14 widely prescribed medications that they think need additional study to see how effective and safe they are for off-label use. Many of the drugs are antidepressants and antipsychotics.
"Off-label prescribing is not based on the same level of evidence as on-label prescribing," said study lead researcher Surrey Walton, an assistant professor of pharmacy administration at the University of Illinois at Chicago.
Most patients aren't aware that once a drug is approved for one use, any doctor can prescribe it for any other use, Walton explained. Doctors may turn to a drug for off-label use, because studies or evidence suggest that it might benefit a patient with a disease or condition that was not studied when U.S. Food and Drug Administration regulators approved the drug in the first place.
READ MORE @ U.S. NEWS & WORLD REPORT
Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found.
The study by American researchers has identified 14 widely prescribed medications that they think need additional study to see how effective and safe they are for off-label use. Many of the drugs are antidepressants and antipsychotics.
"Off-label prescribing is not based on the same level of evidence as on-label prescribing," said study lead researcher Surrey Walton, an assistant professor of pharmacy administration at the University of Illinois at Chicago.
Most patients aren't aware that once a drug is approved for one use, any doctor can prescribe it for any other use, Walton explained. Doctors may turn to a drug for off-label use, because studies or evidence suggest that it might benefit a patient with a disease or condition that was not studied when U.S. Food and Drug Administration regulators approved the drug in the first place.
READ MORE @ U.S. NEWS & WORLD REPORT
Sunday, October 26, 2008
States Taking Pharma to Court for Risky Antipsychotic-Prescribing Spree
Certain antipsychotics are leaving legions of children and elderly in chemical straightjackets for treatment of conditions they didn't even have.
Some state legislators are mad as hell and not going to take it anymore.
They've seen state outlays for controversial antipsychotics like Zyprexa grow as much as twelvefold since 2000, with a corresponding growth in side effects like weight gain, blood sugar changes and cholesterol problems.
In March, Alaska won a $15 million settlement from Eli Lilly in a suit to recoup medical costs generated by Medicaid patients who developed diabetes while taking Zyprexa.
Last year Bristol-Myers Squibb settled a federal suit for $515 million charging that it illegally hawked the antipsychotic Abilify to children and the elderly, bilking taxpayers.
Now Idaho, Washington, Montana, Connecticut, California, Louisiana, Mississippi, New Mexico, New Hampshire, Pennsylvania, South Carolina, Utah, West Virginia, Arkansas and Texas are taking pharma to court over its antipsychotic prescrib-athon that has left the poor and mentally ill in even worse health and legions of children and elderly in chemical straightjackets for treatment of conditions they didn't even have.
The atypical antipsychotics Zyprexa, Risperdal, Seroquel, Abilify and Geodon can be thought of as the credit swaps of the pharmaceutical world.
READ MORE @ ALTERNET
Some state legislators are mad as hell and not going to take it anymore.
They've seen state outlays for controversial antipsychotics like Zyprexa grow as much as twelvefold since 2000, with a corresponding growth in side effects like weight gain, blood sugar changes and cholesterol problems.
In March, Alaska won a $15 million settlement from Eli Lilly in a suit to recoup medical costs generated by Medicaid patients who developed diabetes while taking Zyprexa.
Last year Bristol-Myers Squibb settled a federal suit for $515 million charging that it illegally hawked the antipsychotic Abilify to children and the elderly, bilking taxpayers.
Now Idaho, Washington, Montana, Connecticut, California, Louisiana, Mississippi, New Mexico, New Hampshire, Pennsylvania, South Carolina, Utah, West Virginia, Arkansas and Texas are taking pharma to court over its antipsychotic prescrib-athon that has left the poor and mentally ill in even worse health and legions of children and elderly in chemical straightjackets for treatment of conditions they didn't even have.
The atypical antipsychotics Zyprexa, Risperdal, Seroquel, Abilify and Geodon can be thought of as the credit swaps of the pharmaceutical world.
READ MORE @ ALTERNET
Tuesday, June 10, 2008
With Precautions, Psychiatrists Need Not Shun off-Label Prescribing
Fear of lawsuits should not stop psychiatrists from prescribing medications for off-label indications as long as they make patient-centered decisions based on evidence and talk to patients about risks and benefits.
By focusing on patient care and providing appropriate informed consent, consultation-liaison psychiatrists can protect themselves from liability lawsuits regarding the use of antipsychotics and other medications for indications not approved by the Food and Drug Administratio (FDA). So said experts who led a workshop for consultation-liaison (C-L) psychiatrists at APA's 2008 annual meeting in Washington, D.C., in May.
Off-label use includes prescribing medications not only for unapproved indications, but also for unapproved dosages and patient populations, some of which may be subject to specific warnings by the FDA, said Ramaswamy Viswanathan, M.D. He is the director of the C-L Psychiatry Department at the State University of New York Downstate Medical Center in Brooklyn, N.Y. Intravenous infusion of haloperidol and the use of antipsychotics to treat dementia-related agitation are only two notable examples.
READ MORE @ PSYCHIATRIC NEWS
By focusing on patient care and providing appropriate informed consent, consultation-liaison psychiatrists can protect themselves from liability lawsuits regarding the use of antipsychotics and other medications for indications not approved by the Food and Drug Administratio (FDA). So said experts who led a workshop for consultation-liaison (C-L) psychiatrists at APA's 2008 annual meeting in Washington, D.C., in May.
Off-label use includes prescribing medications not only for unapproved indications, but also for unapproved dosages and patient populations, some of which may be subject to specific warnings by the FDA, said Ramaswamy Viswanathan, M.D. He is the director of the C-L Psychiatry Department at the State University of New York Downstate Medical Center in Brooklyn, N.Y. Intravenous infusion of haloperidol and the use of antipsychotics to treat dementia-related agitation are only two notable examples.
READ MORE @ PSYCHIATRIC NEWS
Subscribe to:
Posts (Atom)
