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Consider Patient Safety, Outcomes Risk before Prescribing “Off-Label”
What is the story with off-label drug use? I have seen some other physicians in my group use dabigatran for VTE prophylaxis, which I know it is not an approved indication. Am I taking on risk by continuing this treatment?
—Fabian Harris, Tuscaloosa, Ala.
Dr. Hospitalist responds:
Our friends at the FDA are in the business of approving drugs for use, but they do not regulate medical practice. So the short answer to your question is that off-label drug use is perfectly acceptable. Once a drug has been approved for use, if, in your clinical judgment, there are other indications for which it could be beneficial, then you are well within your rights to prescribe it. The FDA does not dictate how you practice medicine.
However, you will still be held to the community standard when it comes to your medical practice. As an example, gabapentin is used all the time for neuropathic pain syndromes, though technically it is only approved for seizures and post-herpetic neuralgia. Although the FDA won’t restrict your prescribing, it does prohibit pharmaceutical companies from marketing their drugs for anything other than their approved indications. In fact, Pfizer settled a case in 2004 on this very drug due to the promotion of prescribing it for nonapproved indications. I think at this point it’s fairly well accepted that lots of physicians use gabapentin for neuropathic pain, so you would not be too far out on a limb in prescribing it yourself in this manner.
For newer drugs, I might proceed with a little more caution. Anyone out there remember trovofloxacin (Trovan)? It was a new antibiotic approved in the late 1990s, with a coverage spectrum similar to levofloxacin, but with even more weight toward the gram positives. A wonder drug! Oral! As a result, it got prescribed like water, but not for the serious infections it was designed for: It got prescribed “off label” for common URIs and sinusitis. Unfortunately, it also caused a fair amount of liver failure and was summarily pulled from the market.
Does this mean dabigatran is a bad drug? No, but we don’t have much history with it, either. So while it might seem to be an innocuous extension to prescribe it for VTE prevention when it has already been approved for stroke prevention in afib, I think you carry some risk by doing this. In addition, some insurers will not cover a drug being prescribed in this manner, so you might be exposing your patient to added costs as well. Additionally, there’s nothing about off-label prescribing that says you have to tell the patient that’s what you’re doing. However, if you put together the factors of not informing a patient about an off-label use, and a patient having to pay out of pocket for that medicine, with an adverse outcome ... well, let’s just say that might not end too well.
Ultimately, I think you will need to consider the safety profile of the drug, the risk for an adverse outcome, your own risk tolerance, and the current state of medical practice before you consistently agree to use a drug “off label.” Given the slow-moving jungle of FDA approval, I can understand the desire to use a newer drug in an off-label manner, but it’s probably best to stop and think about the alternatives before proceeding. If you’re practicing in a group, then it’s just as important to come to a consensus with your partners about which drugs you will comfortably use off-label and which ones you won’t, especially as newer drugs come into the marketplace.
Consider Patient Safety, Outcomes Risk before Prescribing “Off-Label”
What is the story with off-label drug use? I have seen some other physicians in my group use dabigatran for VTE prophylaxis, which I know it is not an approved indication. Am I taking on risk by continuing this treatment?
—Fabian Harris, Tuscaloosa, Ala.
Dr. Hospitalist responds:
Our friends at the FDA are in the business of approving drugs for use, but they do not regulate medical practice. So the short answer to your question is that off-label drug use is perfectly acceptable. Once a drug has been approved for use, if, in your clinical judgment, there are other indications for which it could be beneficial, then you are well within your rights to prescribe it. The FDA does not dictate how you practice medicine.
However, you will still be held to the community standard when it comes to your medical practice. As an example, gabapentin is used all the time for neuropathic pain syndromes, though technically it is only approved for seizures and post-herpetic neuralgia. Although the FDA won’t restrict your prescribing, it does prohibit pharmaceutical companies from marketing their drugs for anything other than their approved indications. In fact, Pfizer settled a case in 2004 on this very drug due to the promotion of prescribing it for nonapproved indications. I think at this point it’s fairly well accepted that lots of physicians use gabapentin for neuropathic pain, so you would not be too far out on a limb in prescribing it yourself in this manner.
For newer drugs, I might proceed with a little more caution. Anyone out there remember trovofloxacin (Trovan)? It was a new antibiotic approved in the late 1990s, with a coverage spectrum similar to levofloxacin, but with even more weight toward the gram positives. A wonder drug! Oral! As a result, it got prescribed like water, but not for the serious infections it was designed for: It got prescribed “off label” for common URIs and sinusitis. Unfortunately, it also caused a fair amount of liver failure and was summarily pulled from the market.
Does this mean dabigatran is a bad drug? No, but we don’t have much history with it, either. So while it might seem to be an innocuous extension to prescribe it for VTE prevention when it has already been approved for stroke prevention in afib, I think you carry some risk by doing this. In addition, some insurers will not cover a drug being prescribed in this manner, so you might be exposing your patient to added costs as well. Additionally, there’s nothing about off-label prescribing that says you have to tell the patient that’s what you’re doing. However, if you put together the factors of not informing a patient about an off-label use, and a patient having to pay out of pocket for that medicine, with an adverse outcome ... well, let’s just say that might not end too well.
Ultimately, I think you will need to consider the safety profile of the drug, the risk for an adverse outcome, your own risk tolerance, and the current state of medical practice before you consistently agree to use a drug “off label.” Given the slow-moving jungle of FDA approval, I can understand the desire to use a newer drug in an off-label manner, but it’s probably best to stop and think about the alternatives before proceeding. If you’re practicing in a group, then it’s just as important to come to a consensus with your partners about which drugs you will comfortably use off-label and which ones you won’t, especially as newer drugs come into the marketplace.
Consider Patient Safety, Outcomes Risk before Prescribing “Off-Label”
What is the story with off-label drug use? I have seen some other physicians in my group use dabigatran for VTE prophylaxis, which I know it is not an approved indication. Am I taking on risk by continuing this treatment?
—Fabian Harris, Tuscaloosa, Ala.
Dr. Hospitalist responds:
Our friends at the FDA are in the business of approving drugs for use, but they do not regulate medical practice. So the short answer to your question is that off-label drug use is perfectly acceptable. Once a drug has been approved for use, if, in your clinical judgment, there are other indications for which it could be beneficial, then you are well within your rights to prescribe it. The FDA does not dictate how you practice medicine.
However, you will still be held to the community standard when it comes to your medical practice. As an example, gabapentin is used all the time for neuropathic pain syndromes, though technically it is only approved for seizures and post-herpetic neuralgia. Although the FDA won’t restrict your prescribing, it does prohibit pharmaceutical companies from marketing their drugs for anything other than their approved indications. In fact, Pfizer settled a case in 2004 on this very drug due to the promotion of prescribing it for nonapproved indications. I think at this point it’s fairly well accepted that lots of physicians use gabapentin for neuropathic pain, so you would not be too far out on a limb in prescribing it yourself in this manner.
For newer drugs, I might proceed with a little more caution. Anyone out there remember trovofloxacin (Trovan)? It was a new antibiotic approved in the late 1990s, with a coverage spectrum similar to levofloxacin, but with even more weight toward the gram positives. A wonder drug! Oral! As a result, it got prescribed like water, but not for the serious infections it was designed for: It got prescribed “off label” for common URIs and sinusitis. Unfortunately, it also caused a fair amount of liver failure and was summarily pulled from the market.
Does this mean dabigatran is a bad drug? No, but we don’t have much history with it, either. So while it might seem to be an innocuous extension to prescribe it for VTE prevention when it has already been approved for stroke prevention in afib, I think you carry some risk by doing this. In addition, some insurers will not cover a drug being prescribed in this manner, so you might be exposing your patient to added costs as well. Additionally, there’s nothing about off-label prescribing that says you have to tell the patient that’s what you’re doing. However, if you put together the factors of not informing a patient about an off-label use, and a patient having to pay out of pocket for that medicine, with an adverse outcome ... well, let’s just say that might not end too well.
Ultimately, I think you will need to consider the safety profile of the drug, the risk for an adverse outcome, your own risk tolerance, and the current state of medical practice before you consistently agree to use a drug “off label.” Given the slow-moving jungle of FDA approval, I can understand the desire to use a newer drug in an off-label manner, but it’s probably best to stop and think about the alternatives before proceeding. If you’re practicing in a group, then it’s just as important to come to a consensus with your partners about which drugs you will comfortably use off-label and which ones you won’t, especially as newer drugs come into the marketplace.