Off Label

Off-Label is a term used to describe the use of a medicine for uses not approved by the Food and Drug Administration (FDA) and not recommended by the pharmaceutical company. It refers to any of the following:

• Using unapproved dosing
• Using a medicine for unapproved conditions
• Prescribing a medicine for an unapproved age group

Despite contrary belief, prescribing medications off label is perfectly legal in the United States.  This is a good thing because it allows doctors a right to use a medicine to its full potential and this greatly benefits patients.

Albuterol is a good example. It's approved for use every 4-6 hours for asthma. However, it is often used in much higher doses in emergency rooms. Some asthmatics use it more often at home, and this is okay.

Albuterol also is not approved for use in pediatrics. This is because most pharmaceutical companies don't do studies on children under the age of 12. Still, doctors are not going to deny these patients a medicine they know will help them.

To gain approval by the FDA a pharmaceutical company must perform studies and make recommendations for use of a medicine.  This is basically for liability purposes.  Once FDA approved, a doctor may legally prescribe the medicine at any dose and for any other diagnoses.  But, by making such recommendations, the pharmaceutical company is not held liable for off-label uses of their medication.

I can give a couple other examples. Both Advair and Breo were both initially approved for asthma. They were both used for COPD long before this was FDA approved. Spiriva was FDA approved for COPD. But, some doctors prescribe it for asthma. This is okay. It's legal.

Off-Label has its benefits. 

Using a medicine off-label is an option when all other options for treating a disease have been exhausted.  It's done to the benefit of the patient by allowing another option to be tried. But, it also benefits patients who may need such a medicine for an off-label indication in the future. 

It's also a neat way for doctors to decide what's best for their patients, rather than pharmaceutical companies. If there's a medicine approved for COPD, they can decide if it's worth trying on their asthmatic patients. 

No medicine works the same for every patient

Every once in a while I get involved in an intelligent discussion with one of my patients that I have a difficult time plucking myself away from. Like I have a choice, when my beeper tends to take care of certain things for me.

While my patient was puffing away on her pipe, her husband was talking to me about medicine. He started by asking some intelligent questions like, "How do you know that medicine in that pipe is working?"

I told him how I would determine that, which basically involves asking the patient, assessment and the infamous peek flow meter.

He seemed impressed by my answer, or the excitement in my answer when I did so. I could tell almost immediately that these were intelligent people who were directly involved in their care, as opposed to most patients I work with on a nightly basis.

Then this guy went further, telling me there are some doctors who treat every person the same way with the same drug, when, in reality, no medicine works for all people. That is, despite pharmacy companies marketing that their product is the cure all for this illness.

"Some doctors buy into it," he said, "but others fail to realize that there is no medicine that is the cure all for any illness. The most you can expect out of any such medicine is that it will work for about 6 out of 10 people it's used for. And, if it doesn't work, some other therapy should be tried."

"Yet it's still used for everybody with a certain illness or symptoms regardless," I said.

"Exactly.

"You know what," I said, "This medicine I'm giving your wife right now would be a perfect example. I talk all the time how it is used for every annoying lung sound, for all people that are SOB. But it only works on a those patients that are having bronchospasm."

"Yep. That's exactly what I'm talking about." He looked gleeful, like he was really entertained by this intelligent discussion. "The company probably marketed it as the ideal medicine for any pulmonary problems."

"And when we try to tell a doctor that it isn't working for a patient, they don't listen to us. They say the patient has bad lungs sounds, or the patient is short-of-breath, and therefore a bronchodilator is indicated. In fact, most of the time, they order this medicine simply out of habit, rather than by actually assessing the patient. I don't just think that, I have watched it with my own eyes."

"Exactly. As you are in here every four hours to assess my wife, you know more than anyone whether this treatment is really indicated."

"Wow," I said, "You could have my job. You know exactly how the medical field works. I wish more of my patients were as intelligent as you guys. I spend hours discussing how frivoluos some of the therapies we do are, most of the time I feel as though I'm just blowing against the wind."

"That's why you have to be careful who you choose as a doctor," I said, thinking of my own quest to find a doctor I clicked with. "You have to find a doctor who fits your style, and your personality."

This guy has to have some connection with the medical community, I thought at this point.

"Exactly," he said, "I had the same doctor for 50 years," he said right on cue. "I don't like change much. But when he died, it was a stuggle to find a new doctor."

Turned out he was best friends with a doctor who worked in this area for over 50 years and has since expired. Turned out he and his wife had been through the rigmarole of various illnesses with themselves and their children. So it only made sense that this couple has formed the same opinion of medicine as myself; as many of my medical co-workers.

I wish that more people had the common sense to see that doctors are not gods, that they do not have all the answers, and that there is no such thing as a cure all medicine for any particular disease or symptom, as the pharmacy companies will have us believe.


There are patients who rush to the hospital begging to try some miracle drug, and too many doctors willing to prescribe based on what they heard on TV. It goes both ways.


Yet, still, too many doctors order based on habit. Every person with any adventitious lung sound gets a bronchodilator treatment, every person with this disease gets this drug or this therapy.


It simply doesn't work in the real world. Yet, in the real world, however, this is what we have to deal with.

Is it too much to ask for a little more common sense when it comes to medicine? Perhaps then we could cut back on a good portion of wasteful medical expenses.