What does Off-Label Drug Prescribing mean?
The process for a drug to be available for prescription use is first determined to be safe for use for humans. Once this is done then there is further testing to see if the drug is effective for the symptoms, conditions or diseases for which the drug company wants to market the drug. Whatever conditions it is deemed effective in treating become the Label Use because the FDA only approves drugs for specific uses.
When a drug is deemed safe and released to the market for a specific condition, providers may begin prescribing it to their patients. Many drugs after being approved for a specific condition will be used by physicians for other conditions because the drug companies cannot afford to go back through the process for each new indication the drug has been found to be effective.
I have prescribed drugs Off-Label for different symptoms, conditions and diseases since the first day I could legally write prescriptions over 30 years ago. It has never been an issue until the last 4 years. My position is that if the FDA has determined a drug is safe for use (it shouldn’t be on the market and only used in clinical trials if absolutely needed and the risks are explained) I should be able to prescribe Off-Label it for other conditions as I have for decades.
I will give you an example. Azithromycin (a commonly used antibiotic) has according to electronic prescribing software has 11 different Indicated Label Uses and 14 Off-Label uses listed. The public is being told that Off-Label prescribing is bad and only misinformed doctors would prescribe Off-Label.
I would contend that any doctors that have written any significant amount of prescriptions have written many Off-Label.
It is my duty to treat my patients with whatever drugs that have been approved as SAFE by the FDA regardless of their indications approved by the FDA as long as I explain the potential risks, benefits, side effects, and alternatives available to the patient, and obtain their informed consent for use.
If you have a condition you feel might benefit from Off-Label Prescription medications please call our office at (405) 348-8850 for your Free Consultation.