Let's say you are a leading clinician researcher in the area of auto-immune disorders and a new drug for rheumatoid arthritis has a risk management program attached to it that limits prescribing to patients with RA and to RA specialists. However because of the drug works on a particular pathway you, because of previous research, have a hunch, it will work fine on patients with lupus. Or what if you want to use a new antibiotic to suppress an infection in CF patients but the RIskmap plan limits it to organ rejection use. If you use it (or if you can even get it) for an off-the-map purpose are you liable, criminally or civilly? Could you lose your medical license? Do patients have to wait to enroll in a clinical trial for every novel use? Will medical innovation grind to a halt? Will patients die because they are not on The MAP?
Will RiskMap Criminalize Off-Label Prescribing
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