sec.128Dispensing generic medicine

sec.128 Dispensing generic medicine

This section applies if a medicine (the prescribed medicine ) is prescribed for a patient using an approved name or brand name but the medicine (the generic medicine ) is also available under another brand name or without a brand name. A dispenser must not dispense the generic medicine for the patient instead of the prescribed medicine unless— the generic medicine is, in the reasonable opinion of the dispenser, physiologically equivalent to the prescribed medicine in its clinical effect and has the same active ingredients; and a medicine approved by the Therapeutic Goods Administration for sale as a generic medicine to substitute for a brand name medicine a medicine flagged in the ‘Schedule of pharmaceutical benefits’ as biosimilar or equivalent to another medicine the prescriber of the prescribed medicine did not specifically state that only the prescribed medicine is to be dispensed; and the patient asks for, or agrees to, the dispensing of the generic medicine instead of the prescribed medicine. Subsection (2) (b) and (c) does not apply if the medicine is dispensed to the patient at a public sector hospital. See also the Therapeutic Goods Act 1989 (Cwlth) , sections 30EK and 30EL about pharmacists dispensing scarce medicines. (sec.128-ssec.1) This section applies if a medicine (the prescribed medicine ) is prescribed for a patient using an approved name or brand name but the medicine (the generic medicine ) is also available under another brand name or without a brand name. (sec.128-ssec.2) A dispenser must not dispense the generic medicine for the patient instead of the prescribed medicine unless— the generic medicine is, in the reasonable opinion of the dispenser, physiologically equivalent to the prescribed medicine in its clinical effect and has the same active ingredients; and a medicine approved by the Therapeutic Goods Administration for sale as a generic medicine to substitute for a brand name medicine a medicine flagged in the ‘Schedule of pharmaceutical benefits’ as biosimilar or equivalent to another medicine the prescriber of the prescribed medicine did not specifically state that only the prescribed medicine is to be dispensed; and the patient asks for, or agrees to, the dispensing of the generic medicine instead of the prescribed medicine. (sec.128-ssec.3) Subsection (2) (b) and (c) does not apply if the medicine is dispensed to the patient at a public sector hospital.

• (a) the generic medicine is, in the reasonable opinion of the dispenser, physiologically equivalent to the prescribed medicine in its clinical effect and has the same active ingredients; and Examples of medicines that may be physiologically equivalent— • a medicine approved by the Therapeutic Goods Administration for sale as a generic medicine to substitute for a brand name medicine • a medicine flagged in the ‘Schedule of pharmaceutical benefits’ as biosimilar or equivalent to another medicine