Drug shortages need better response

AUSTRALIA needs a more centralised approach to managing shortages of prescription medication but is unlikely to face the same critical shortages seen recently in the US, an Australian expert says.

Pharmacist Ms Gill Sharratt, executive officer of the NSW Therapeutic Advisory Group, an independent group that advises NSW Health on pharmaceutical matters, said Australia’s regulatory framework meant it did not face the same risks as the US, where prescription drug shortages almost tripled between 2005 and 2010.

The US Food and Drug Administration (FDA) reported that the number of drugs affected rose from 61 to 178 in that period and has continued to increase in 2011. (1)

An article published last week in the New England Journal of Medicine described the shortages as “astounding”, affecting everything from antibiotics and anaesthetic agents to antihypertensive medications. (2)

“These shortages, which primarily affect injectable generic drugs, have forced physicians to prioritise patients, improvise standard regimens … and at times, choose unproven treatment options for patients with curable disease”, the article stated.

An article published online by the MJA called for international efforts to focus on sustainable supply of essential medicines and equipment, after Australian hospitals were caught up in a critical global shortage of benzylpenicillin due to international floods and disasters. (3)

CSL Limited, which supplies benzylpenicillin in Australia, announced recently that supplies of the drug were now ready for distribution.

US President Barack Obama last week ordered the FDA to require pharmaceutical companies to provide adequate notice of potential shortages and to expedite review processes, including of new drug suppliers.

Ms Sharratt said she did not believe Australia needed legislation requiring pharmaceutical companies to provide adequate notice of drug shortages because Australia’s National Medicines Policy, which included government, the Therapeutic Goods Administration (TGA) and industry, already encouraged this. (4)

However, she said drug shortages were still a regular occurrence in Australia and they could be managed better.

“For many, many years, hospitals have been managing, probably on a weekly or monthly basis, for a number of lines that go out of stock”, she said.

She said the response to drug shortages was often tackled at a local hospital level, which meant people at different hospitals were working in parallel to address the same issues. This duplication of effort, which was seen in response to the recent shortage of benzylpenicillin, wasted time and resources.

“What we need to see more of in Australia is a centralised approach — whether state-based or national. That’s what we need to emphasise in improving response to these drug shortages”, she said.

Ms Sharratt said her organisation was also concerned about cases where medications “fall off the market” because they are deemed “no longer viable” by sponsors — a problem which particularly affected high-cost, specialised drugs.

“I do wonder if some of the oncology drugs will go down this path in a few years”, she said.

Australia’s drug supply problems often stem from its remoteness, Ms Sharratt said. However, she praised the TGA for its mechanisms that allow for the emergency importation of drugs in times of short supply.

A TGA spokesperson told MJA InSight that Australia had better mechanisms for ensuring ongoing supplies than many other countries because it had relied on imported medicines for so long.

Additionally, pharmaceutical companies in Australia were contractually obliged to guarantee supply when products were first listed on the Pharmaceutical Benefits Scheme.

In the US, the drug shortages have led to reports of “price gouging”, with medications sold at grossly inflated prices in times of short supply. On this so-called grey market, vendors typically mark up pharmaceutical prices by 650%, according to a report cited by the FDA.

Ms Sharratt said she had not heard of any instances of price gouging in Australia.

- Sophie McNamara

1. US Food and Drug Administration: Drug shortages
2. NEJM 2011; 31 October (online)
3. MJA 2011; 195: 510-511

4. Australian Government: National Medicines Policy

Posted 7 November 2011