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Delisting of PBS products due to unavailability

Before listing a new brand of an existing Pharmaceutical Benefits Scheme (PBS) drug, the manufacturer is required to provide a written assurance that stock of the product will be available on the proposed date of listing in the Schedule of Pharmaceutical Benefits.

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19 September 2006

It is always a concern when particular pharmaceuticals are unavailable, for whatever reason.

Before listing a new brand of an existing Pharmaceutical Benefits Scheme (PBS) drug, the manufacturer is required to provide a written assurance that stock of the product will be available on the proposed date of listing in the Schedule of Pharmaceutical Benefits. It is certainly in a manufacturer’s commercial interests to ensure that this happens.

However, five products listed on the PBS as from 1 August 2006, produced by two manufacturers, have experienced supply problems.

Four PBS-listed products manufactured by Ranbaxy Australia Pty Ltd were not available on 1 August 2006. These products are:

• Ozvir® (aciclovir tablets 200mg), used to treat some herpes conditions;
• Rancef® (cephalexin capsules 250mg), an antibiotic;
• Ozcef® (cefaclor tablets 250mg), an antibiotic; and
• Ulcaid® (ranitidine Hcl 150mg and 300mg), for gastric ulceration and reflux.

Ranbaxy Australia provided an assurance to the Department of Health and Ageing that stocks of these products would be available by the listing date of 1 August 2006. However, the company subsequently advised that circumstances beyond its control had delayed the manufacturing schedule at its manufacturing sites.

While Ozvir, Rancef and Ozcef are now available, Ulcaid will be de-listed from the PBS as of 1 December 2006, due to continuing supply problems.

Another drug listed on the PBS on 1 August 2006 – octreotide, a hormonal treatment manufactured by Mayne Pharma Pty Ltd – was also not available on the listing date.

Mayne Pharma provided an assurance in advance of the intended listing date, 1 August, that octreotide would be available. The company later advised that octreotide would not be available in the foreseeable future. As a result, the Department decided that this product would be de-listed from 1 December 2006.

Patients have not been disadvantaged by the supply problems with these products, because other brands of the same medications have been available. Patients have not been subject to extra costs.