13
Sep
Off-label use of medicines: The need for good practice guidelines – the International Journal of Risk and Safety in Medicine
Article written by Dooms and Killick in which they present a set of guidelines for...
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For Patients
Over the past 50 years the European Union has developed a robust system which ensures that medicines undergo a thorough and comprehensive evaluation prior to being authorized to enter the market.
This system has been created with the aim of protecting patient safety and safeguarding public health.
Through the practice of off-label use, critically ill patients can receive a medication that has not gone through the authorization process for that specific condition but can save his or her life.
While this is clearly beneficial, especially in medical areas where authorized alternatives are lacking, the practice by definition entails an increased risk for patients compared to medications that have gone through the authorization process.
Patients must be made fully aware if they are being prescribed an unlicensed medication for their condition and the rationale behind the physician’s choice should be explained to them.