Expert warns of more medicine shortages

As Australia's drug regulator yesterday worked to find sources of emergency supplies of penicillin because the country was down to one week's supply, a team of doctors and pharmacists said Australia was not prepared for shortages of many essential medicines.

It also emerged last night that the Therapeutic Goods Administration had issued a "please explain" to CSL because of concerns it waited until last week to notify the regulator of its penicillin shortage several weeks after it knew it was facing supply problems in late August.

"The TGA has written to CSL requesting urgent information about the supply shortage and what CSL knows about its causes, when it became aware of it, and what actions it has taken to deal with it," a TGA spokeswoman said.

Writing in the Medical Journal of Australia yesterday, Dr Simon Quilty and colleagues from John Hunter Hospital in Newcastle said the penicillin crisis was likely to be repeated with other drugs because of Australia's management of its stocks and position in a complex market and supply chain. They said a recent stocktake of drugs in a NSW health service revealed many in limited supply. Of 378 essential medicines, 3 per cent had less than seven days' reserve, 24 per cent had less than 30 days' reserve, and 26 per cent had more than three months' supply.

The Age believes that the TGA is working to secure supplies of several crucial drugs, including penicillin. However, a spokeswoman would not reveal details of the wider problem last night.

Dr Quilty said that while Australia had not experienced any other significant medication shortages to his knowledge this year, supply problems had increased globally in recent years, particularly in the US, which had 198 drug shortages over the past three months more than double what it experienced for the entire year of 2007. He said the reasons included increased demand, manufacturing delays, recalls, shortages of ingredients, natural disasters and the realities of business in a competitive international market.

Given some medicines are produced at only a few sites worldwide, mainly in India and China, Dr Quilty said supply chains could easily be broken, leaving Australia in need.

"Australia, which produces less than 5 per cent of the pharmaceuticals it consumes, is particularly vulnerable," he said.

Dr Quilty said the penicillin shortage had shown that Australia had no official mechanisms in place to predict and prepare for drug shortages. He said a monitoring system should be set up to forecast problems, along with laws that compel manufacturers and wholesalers to report compromise of manufacture or supply.

The TGA should also develop a list of essential drugs to be watched as a priority.

"[Pharmaceutical supply] is likely to become a more prominent global problem," Dr Quilty and his colleagues wrote.

A TGA spokeswoman last night said it had identified several potential suppliers of intravenous penicillin and was working with Australian suppliers to expedite supply of the drug to Australia. New supply is expected to be secured within weeks. She said it was normal for the TGA to manage fluctuating supplies of drugs and that it had systems in place.