A Prescription for Disaster

Study: MD many times Prescribe Drugs for Unproven, Unapproved Uses

In November 2003 the KnightRidder of recent origins service conducted an investigation of a phenomenon known as "off-label prescribing," in which medical doctors write prescriptions for remedys for uses other than those approved through the Food and Drug Administration. Based upon its analysis, Knight-Ridder estimated that doctors write up to 115 million prescriptions through year for off-label or unapproved uses, and that between 8000 and 80000 race may suffer serious adverse reactions as a be derived of taking an off-label prescription.1

A fresh analysis of prescription drug use has lay the foundation of that the number of prescriptions written for off-label use is flat higher. According to the analysis, published in the May 8th issue of the Archives of Internal Medicine, more than single in five prescriptions written in the United States - as many as 173 million each year - are for unapproved or unproven uses, and as many as single in seven drug prescriptions are written for reasons that have "little or no scientific support."2

Off-label prescribing is the boundary for a drug that is prescribed for a use other than the drug's approved use upon its FDA label. For example, a doctor might prescribe a medicine that is approved by the FDA to treat individual condition, such as cancer, for another condition, of the like kind as hypertension. Changing a drug's approved dosage or duration of treatment, or prescribing a medicine approved by the FDA for adults and giving it to a child, are other examples of off-label prescribing.

Once a physic has received approval from the FDA to be marketed for the treatment of at least individual specific ailment, it can be legally prescribed to treat other ailments. The FDA does not require medicine manufacturers to obtain approval for all conditions for which a particular physic may have value. In addition, while medical doctors normally are required to obtain informed concurrence from their patients before providing prescribed treatments, no law in any state specifically requires a doctor to inform his or her patient that a medicine is being prescribed for off-label use.

The American Medical Association has been an ardent supporter of off-label prescribing. According to AMA policy H120-988 "The AMA confirms its able-bodied support for the autonomous clinical decision-making authority of a physician and that a physician may lawfully use an FDA approved medicine product or medical device for an unlabeled indication when of that kind use is based upon entire scientific evidence and sound medical opinion." In March 2005 Dr Cecil Wilson, a member of the AMA board of trustees, testified before the U Senate Committee upon Health, Education, Labor and Pensions regarding medicine safety recommendations and stated that the FDA should "ensure that physicians' ability to prescribe remedys off-label not be impeded."4

In the Archives of Internal Medicine analysis, researchers examined the prescription patterns for 160 drugs: the 100 greatest in quantity popular drug medications in the U according to the 2001 National Disease and Therapeutic Index, or NDTI, and 60 additional medications pitch uponed at random. Altogether, the remedys in the analysis accounted for approximately 56 percent of all estimated prescription medicine use in 2001. The researchers then compared each prescription, or "drug mention," with the top 40 diagnoses associated with each medication, to determine whether the prescriptions implacable into one of three categories: FDA approved; off-label, on the other hand with strong scientific support for the off-label use; or offlabel, with limited or no scientific support.

Analysis of the NDTI data lay the foundation of that a total of 725 million remedy mentions were written for the 160 medicines used in the sample in 2001 While the majority of the remedy mentions were for FDA-approved indications, a substantial number (estimated at 150 million, or 21 percent) "lacked FDA approval for the condition they were used to treat." Furthermore, a filled 15 percent of the remedy mentions in the analysis "lacked scientific evidence for the indication they were used to treat."

Off-label prescriptions were greatest in quantity common among two classes of drugs: cardiac medications (such as antianginals, antiarrhythmatics and anticoagulants) and anticonvulsants. For the two classes of drugs, 46 percent of all prescriptions for these remedys were considered offlabel prescriptions. In bourns of sheer numbers, the greatest in quantity off-label prescriptions were written for antimicrobials (355 million) and medicines for "psychiatric therapies" such as antidepressants, anxiolytics and antipsychotics (17 million). Combined, these sum of two units classes accounted for more than individual third of all off-label prescriptions in the analysis.

The physic with the highest proportion of off-label prescriptions (83 percent) was gabapentin, an anticonvulsant medication approved to treat certain kinds of epileptic seizures, on the other hand which also is used with other remedys to treat nerve pain caused by means of the herpes virus. Furthermore, sole 20 percent of the off-label prescriptions written for gabapentin were backed by dint of strong scientific support for like uses - an important fact when single considers that in 2004, gabapentin's manufacturer pleaded guilty to sum of two units counts of criminal fraud and agreed to pay a adjustment of more than $430 million to reduce criminal charges and civil liabilities. Other medicines with disproportionate off-label prescriptions included an antidepressant, amitriptyline hydrochloride (81 percent) and the oral version of dexamethasone, a steroid.