New prescribing rules for Di-Gesic and Doloxene unclear
Medical Observer understands that lawyers for both the TGA and Aspen Pharmacare are seeking clarification on the interpretation of the conditions imposed by the AAT on prescribing the two DPP-containing analgesics.
The restrictions are due to come into force within 28 days. Within that timeframe, both parties must decide whether to appeal to the Federal Court against the conditions on points of law.
Under the new restrictions, pharmacists will not be allowed to dispense either drug for a first prescription unless they first obtain a prescriber confirmation form.
This form will indicate that prescribers have considered five things: that the product is only approved for use in patients who are not able to be adequately treated with other mild analgesics; that contraindications have been considered; that recent changes to the patient's clinical presentation or biochemical status have been considered; that the patient has been warned about