4 ms·

"Off-label" is the practice of doctors prescribing an already-approved drug, but for a different purpose than it was approved for. It is legal in the US.

dredmorbius 4y ago
Correct. Specifically: in the U.S., drugs are tested and approved for specific applications. That's the "label". "[U]sing an FDA-approved drug for an unapproved use [is] sometimes called an “off-label” use" https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://www.fda.gov/patients/learn-about-expanded-access-and... Once a drug is approved, the drug may not be advertised contrary to its label. It may however be prescribed at a doctor's discretion for largely any use. That's by the FDA's own guidance: From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. (Same reference.) "Off-label" may apply to the treated condition or to the dosing of a drug. Several examples at the link above. Use of a prescription drug without a prescription, whether through sharing / borrowing / stealing from a prescibed user, or through grey or black market access, is nonprescribed use. For scheduled narcotics, this may be illegal, including for commonly-used painkillers such as codein (often combined with paracetamol, a/k/a Tylenol) or other opiates.
- pizza 4y ago
  I agree with all this, but if that survey is reasonably accurate (and it's a big if, sure) but the true number of prescriptions is significantly less, it stands to reason that that suggests widespread nonprescribed use
  - dredmorbius 4y ago
    If the study and/or article mean "nonprescribed" when using the term "off-label", then the study and/or article are misleading. The survey cites numbers for children's prescriptions and estimates of adult off-label use. That latter would still be prescribed, but the study is claiming that the prescriptions aren't consistent with FDA certification, which would involve deviations from that certification as I've discussed above, citing FDA terms. Your preception may be accurate. But it would require either the survey reported on here being misrepresented, or a much larger nonprescription use, which does not appear to have been the study's focus. Either way, you're proposing a possibility without specific supporting evidence.

dredmorbius 4y ago

Correct. Specifically: in the U.S., drugs are tested and approved for specific applications. That's the "label". "[U]sing an FDA-approved drug for an unapproved use [is] sometimes called an “off-label” use" https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://www.fda.gov/patients/learn-about-expanded-access-and... Once a drug is approved, the drug may not be advertised contrary to its label. It may however be prescribed at a doctor's discretion for largely any use. That's by the FDA's own guidance: From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. (Same reference.) "Off-label" may apply to the treated condition or to the dosing of a drug. Several examples at the link above. Use of a prescription drug without a prescription, whether through sharing / borrowing / stealing from a prescibed user, or through grey or black market access, is nonprescribed use. For scheduled narcotics, this may be illegal, including for commonly-used painkillers such as codein (often combined with paracetamol, a/k/a Tylenol) or other opiates.

pizza 4y ago
I agree with all this, but if that survey is reasonably accurate (and it's a big if, sure) but the true number of prescriptions is significantly less, it stands to reason that that suggests widespread nonprescribed use
- dredmorbius 4y ago
  If the study and/or article mean "nonprescribed" when using the term "off-label", then the study and/or article are misleading. The survey cites numbers for children's prescriptions and estimates of adult off-label use. That latter would still be prescribed, but the study is claiming that the prescriptions aren't consistent with FDA certification, which would involve deviations from that certification as I've discussed above, citing FDA terms. Your preception may be accurate. But it would require either the survey reported on here being misrepresented, or a much larger nonprescription use, which does not appear to have been the study's focus. Either way, you're proposing a possibility without specific supporting evidence.