Taking Off- Label Medicine

Off-label use of prescription drugs is the widespread practice of physicians prescribing medication in a way that is not approved by the Food and Drug Administration (FDA). This is accepted and is legal.The drug cannot be marketed by the pharmaceutical company citing it's off-label usage. This is different from an unapproved drug. An unapproved medication has not been approved by the FDA for any use. They may be similar to an approved version by like they say, the devil is in the details, there still might be problems with their version.

Approved use of a medication means it has been approved by the FDA after significant testing, to be used in specific ways for specific diseases. It will be described in the drug label (or insert since it can be found inserted inside the box the medicine comes in.) The drug manufacturer can legally market the medicine citing the approved uses.

Once approval has been attained a medicine then can be used in a manner other than what it was approved for. The FDA states that it cannot regulate the practice of medicine thus it does not control how doctors use medications. Approximately one in five drugs are off-label and some medications are used mostly this way. Since children had previously not been a part of clinical trials, many prescriptions for them are off-label. Rare diseases, or diseases that affect less than 200,000 people in the U.S. depend greatly on off-label medication. Physicians will tell you that the practice is necessary in the treatment of their patients.

The problem here is that their evidence might just be anecdotal and not scientific. Basically it might not be evidence based medicine. Even if it doesn't harm you it might not help and be expensive.There is little economic incentive for the pharmaceutical companies to spend money on expensive testing when they have doctors already using their products and are generating good revenue. The prescribing physician is now legally responsible for any problems that ensue with this particular usage of the medicine.

The FDA has new guidelines that allows the drug company to distribute medical journals that describe non approved uses of approved drugs to physicians. Some advocates are leery about this practice. News broke about some companies authoring articles and paying physicians who had little to no input in the studies to sign on as if they wrote the articles. What's needed is some way to verify that articles being published in respected journals are indeed from independent and unbiased sources.

All drugs are not equal, some off-label usage have long histories and independent clinical trials behind them and are legitimately written up in peer reviewed journals. Using them might be considered appropriate standard of care. Others do not and so there is little to no clinical data to support the belief that the drug will be efficacious and the benefits will outweigh the risks. There might be a problem with reimbursement, especially if the drug usage has a minimal track record. There also might be legal exposure for the doctor if there is a negative outcome and the treatment is considered sub standard. Even after paying for treatment third party insurance companies and the government can sue to recoup monies paid out for non-approved drugs.

It is always wise to research any medication that you are prescribed and discuss with your doctor the reason he thinks it will benefit you. Legally he does not have to tell you if it is an unapproved use. And if it is an off-label medication ask for concrete evidence as to its safety and effectiveness in your particular case.

Check if the usage follows the manufacturers recommendation, and if not see if there are any studies behind the way its being used. Certain medications have short shelf lives once the bottle is opened. Others need to be constantly refrigerated or else they degrade faster. You might be encouraged to use it passed what the manufacturer recommends but be wary of that

Also be sure to check your medical records and make sure a new diagnosis doesn't show up. It has been known that because you are taking a certain drug, the diagnosis that it is known for shows up in your record. This can be a mistake of someone seeing the drug and assuming you have the ailment it is approved for. Or this can be justification for payment. Either way you would need to correct the error.
.