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home:mp:off-label [10.13.2018] – [Off-label prescribing is common] sallieqhome:mp:off-label [09.14.2022] (current) – external edit 127.0.0.1
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 ====== Off-label prescribing of Marshall Protocol medications  ====== ====== Off-label prescribing of Marshall Protocol medications  ======
  
-Many of the Marshall Protocol (MP) medications are prescribed "off-label", which is to say that they are employed for a purpose outside the drug's approved label. Other countries have different policies, but the US FDA has issued [[http://www.fda.gov/OC/OHRT/IRBS/offlabel.html|clear Policy Guidance]] on off-label prescriptions, clearly stating that it is up to the physician's individual judgment to decide whether an off-label drug should be used.+Many of the Marshall Protocol (MP) medications are prescribed "off-label", which is to say that they are employed for a purpose outside the drug's approved label. Other countries have different policies, but the US FDA has issued [[https://www.fda.gov/OC/OHRT/IRBS/offlabel.html|clear Policy Guidance]] on off-label prescriptions, clearly stating that it is up to the physician's individual judgment to decide whether an off-label drug should be used.
  
 <blockquote>Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well-informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner __when the intent is the "practice of medicine"__ does not require the submission of an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE) or a review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.</blockquote> <blockquote>Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well-informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner __when the intent is the "practice of medicine"__ does not require the submission of an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE) or a review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.</blockquote>
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 ===== Off-label prescribing is common ======    ===== Off-label prescribing is common ======   
  
-Off-label prescribing is very common.(({{pubmed>long:22507695}})) Almost every physician will prescribe off-label occasionally, most will not even realize it.+Off-label prescribing is very common.(({{pmid>long:22507695}})) Almost every physician will prescribe off-label occasionally, most will not even realize it.
  
  
  
 {{tag>MP}}   {{tag>MP}}  
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 ===== Notes and comments ===== ===== Notes and comments =====
  
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-===== References =====+===== References =====</nodisp> 
home/mp/off-label.1539389564.txt.gz · Last modified: by sallieq
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