"Pharmacies to be audited to supply Di-Gesic Analgesics containing dextropropoxyphene will remain on the Australian Register of Therapeutic Goods (ARTG) after a recent hearing, but pharmacies will have to conform to new rules if they wish to stock them. Following a decision announced by the Administrative Appeals Tribunal of Australia, the PSA is set to draw up guidelines for the dispensing of Aspen Pharmacare Australia’s Di-Gesic and Doloxene (dextropropoxyphene) analgesics. Tribunal papers reveal the guidelines will outline pharmacists’ obligations "not to dispense the good (on the fi rst dispensing) unless the pharmacists have obtained a ‘Prescriber Confi rmation’ from an ‘Australian Prescriber’”. As part of the conditions for the registration of Di-Gesic and Doloxene, their manufacturer, Aspen Pharmacare Australia, has been required to enter into arrangements with pharmacies and to conduct pharmacy audits to ensure the products are not dispensed in the absence of appropriate confi rmation. Initially, the audits will take place every six months in the fi rst three years from the “implementation date” of the conditions – which has yet to be confi rmed – with annual monitoring and auditing being introduced from the fourth year onwards. Pharmacies that have been found to have repeated a “serious breach” of the conditions risk having their supply of Di-Gesic suspended, or “in the worst cases” terminated. Aspen has also been told to send a letter to pharmacists advising if they “wish to stock Di-Gesic and Doloxene after [a date two months after the implementation date]” they must agree to a series of terms, which will be outlined in the letter.Pharmacists will be able to agree to the terms by either providing written confi rmation to Aspen, or by ordering stock of the two medicines. Under the conditions set out by the Tribunal the PSA will be requested to draw up guidelines for the profession." Adapted from PharmacyNews.
Posted on: Fri, 13 Sep 2013 17:39:02 +0000
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