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Letter to Therapeutic Goods Administration regarding drug shortages

Letter to Therapeutic Goods Administration regarding drug shortages

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Dr Brian Richards<br />

Acting National Manager<br />

<strong>Therapeutic</strong> <strong>Goods</strong> <strong>Administration</strong><br />

PO Box 100<br />

Woden<br />

ACT 2606<br />

7 th March 2012<br />

Dear Dr Richards<br />

Re: National shortage of critical medicines<br />

We are writing <strong>to</strong> draw your attention <strong>to</strong> the current serious shortage of a number of critical<br />

medicines in Australia. Medicines in critical short supply include a number of vital anti-cancer<br />

agents.<br />

These supply issues have resulted in changes <strong>to</strong> the treatment of patients with cancer.<br />

Whilst many of these medicines are usually available from a number of different sources, the<br />

disruption of supply from just one of those sources immediately places enormous pressure on<br />

the supply chain as a whole and the supply <strong>to</strong> individual hospitals and patients.<br />

It is imperative that the <strong>Therapeutic</strong> <strong>Goods</strong> <strong>Administration</strong> (TGA) works with all relevant<br />

agencies and organisations <strong>to</strong> devise a national strategy <strong>to</strong> ensure that direct patient care is<br />

not compromised.<br />

We request that a working group is established immediately <strong>to</strong> enable all relevant<br />

organisations <strong>to</strong> work with the TGA <strong>to</strong> implement a national strategy in order <strong>to</strong> mitigate the<br />

effects of the current <strong>drug</strong> <strong>shortages</strong>, and <strong>to</strong> devise a robust system for handling similar issues<br />

in the future.<br />

Membership of the working party should include representatives from: Department of Health<br />

and Ageing, TGA, Medicines Australia, Generic Medicines Industry Association of Australia,<br />

Clinical Oncological Society of Australia (Cancer Pharmacists Group), Society of Hospital<br />

Pharmacists of Australia, Medical Oncology Group of Australia, Council of Australian<br />

<strong>Therapeutic</strong> Advisory Groups and national consumer representation (including Cancer Voices<br />

Australia, Consumer Health Forum of Australia and Breast Cancer Network Australia).<br />

In brief, strategies that may address these issues include:<br />

• Enacting legislation that would require all anticipated and actual <strong>shortages</strong> of prescription<br />

medicines (of any dose / strength) <strong>to</strong> be reported <strong>to</strong> the TGA (as part of a national early<br />

warning system)<br />

• Development of a page in a professional section of the TGA website <strong>to</strong> display the<br />

information on all <strong>shortages</strong> reported <strong>to</strong> the TGA


• Email alerts <strong>to</strong> relevant organisations and healthcare professionals advising them of known<br />

or anticipated <strong>shortages</strong><br />

• Systems for fair and equitable distribution of medicines during times of national <strong>shortages</strong><br />

We look forward <strong>to</strong> working with the TGA <strong>to</strong> reduce the impact of medication <strong>shortages</strong> on<br />

patients across Australia.<br />

Please direct all correspondence <strong>to</strong>: Mr Dan Mellor c/o: Pharmacy Department, Peter<br />

MacCallum Cancer Centre, St Andrew’s Place, East Melbourne, Vic<strong>to</strong>ria 3002.<br />

Yours sincerely,<br />

Mr Dan Mellor<br />

Chair, COSA Cancer Pharmacists Group<br />

Ms Sue Kirsa<br />

President, Society of Hospital Pharmacists<br />

of Australia<br />

Prof Bodga Koczwara<br />

President, Clinical Oncological Society<br />

of Australia<br />

A/Prof Gary Richardson<br />

Chair, Medical Oncology group of Australia<br />

President, Private Cancer Physicians of<br />

Australia<br />

Dr Ian Roos OAM<br />

Chair, Cancer Voices Australia<br />

Ms Michelle Marven<br />

National Policy Manager, Breast Cancer<br />

Network Australia<br />

Cc.<br />

Department of Health and Ageing<br />

Cancer Australia<br />

Medicines Australia<br />

Generic Medicines Industry Association of Australia<br />

Australian Commission on Safety and Quality in Healthcare<br />

Consumer Health Forum of Australia<br />

Council of Australian <strong>Therapeutic</strong> Advisory Groups

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