Off-Label or Unauthorised Use of Drugs – Is It (I)Legal?
14 Pages Posted: 20 Mar 2012
Date Written: March 16, 2012
Abstract
Objective: To clear terms off-label, unlicensed use, unauthorized use of drug and use of drug for unathorised indication, method or route of administration. To expose some medical and legal problems, connected with of drug for unathorised indication, method or route of administration.
Study methods: Review of medical and legal literature dealing with the problem of drug use for unathorised indication, method or route of administration.
Conclusion: EU legislative environment is flexible enough also for so called orphan drugs. So there is no need that in cancer treatment still exist so high percentage of drug usage for unathorised indication, method or route of administration. In the case that there is a need of such treatment, all actors should be included before drug use for unathorised indication, method or route of administration. Special attention should be given to the patient involvement. Proposed procedure could reduce the possibility for the lawsuits. It should be noted that with drug use for unathorised indication, method or route of administration the doctor could be easily found in the court.
Keywords: off label use of drug, unathorised use of drug
JEL Classification: I18, K42
Suggested Citation: Suggested Citation