LEADING doctors have backed a new national framework for off-label prescribing which recommends obtaining written patient consent and closely monitoring treatment outcomes. Developed by the Council of Australian Therapeutic Advisory Groups (CATAG), the framework provides guiding principles for hospital-based doctors to get through the ethical minefield of prescribing drugs for indications not approved by the Therapeutic Goods Administration, or involving non-approved patient groups or routes of administration. Professor Madlen Gazarian, co-chair of the expert advisory group that wrote the document, told MJA InSight the framework asked prescribers, drug and therapeutics committees and consumers to more rigorously evaluate the benefits and harms of off-label medicines before starting treatment. Read more…