Prescription drugs shortage hits Australia

Global shortages of prescription drugs have led to a spate of critical gaps in the supply of medication affecting thousands of Australians living with cancer, diabetes and blood pressure problems – and with local production declining, alternatives are scarce.

By MONIQUE FREER

DRUGS used to treat diabetes are in critically short supply in Australia – one of a spate of shortages affecting the treatment of thousands.

Supplies of Diabex – and similar drugs sold under different trade names – have been under pressure since October 2011.

Its scarcity is part of a worldwide shortage of medication that has included penicillin, blood pressure medication and chemotherapy drugs.

While shortage of essential medicines is not new, it is escalating in Australia in line with dramatic shortages in the United States – which has seen a 63 per cent increase in reported shortages in the past five years, the direct cause of two deaths – and the United Kingdom.

Medical experts believe lives could be at risk in Australia if urgent action to meet the shortfall is not taken.

Diabex, the most popular prescription anti-diabetic medication in Australia, has suffered a cycle of shortages, affecting different doses of the drug.

The slow release formulation, the 1000mg preparation, and the 500mg preparation of Diabex have all been in short supply because of problems in manufacturing their active ingredient, metformin.

Metformin is now in production at makers Alphapharm’s Carole Park plant in Queensland.

Pharmacists waiting for the drug have been told this will be a “global supply chain”, and have been assured by the company: “You will start to see the delivery of Diabex/Diaformin very shortly in the next few weeks.”

Pharmacist Tony Cox said that diabetes sufferers relying on the drug have been lucky that the shortages in the past 12 months did not all occur at once.

“We’ve always been able to do something because there’s all different strengths available. They all haven’t been unavailable at the same time so we’ve been really lucky that we’ve been able to swap one for the other.”

But he said swapping formulations, although relatively easy for pharmacists to do, still posed a risk for patients.

“One week they’ve got 500mg and they have to take two, the next week they’ve got 1000mg and they have to take one and then it’s not hard for them to start taking two of the 1000s and half of the 500s,” said Mr Cox.

“Compliance is a problem and we’ve come across people who’ve been taking the wrong thing. We really try hard when we swap people from one strength to the other, but sometimes it just doesn’t happen.”

The consequences of taking an incorrect dose could be severe. A higher dose could cause blood sugar levels to decrease, which can result in a “hypo” that causes dizziness, sweating and trembling, among other symptoms. A lower dose could result in patients’ blood sugar levels increasing, leading to damage to internal organs if sustained for long periods of time.

Shortages occur for a number of complex reasons, mainly related to the supply of medicines to drug companies.

Jamie Nicholson, media and communications manager for Medicines Australia, said interruption to production at large, international drug companies was a major problem.

“There are many different issues and they may be to do with market forces, they may be to do with pricing but more often they’re to do with unforeseen circumstances where, for example, there may be a fire in a factory, or unusual demand for a particular medicine that hasn’t been foreseen,” he said.

Limited domestic production of crucial medicines has put further pressure on supply.

Less than five per cent are produced in Australia, with the remainder sourced from international drug companies.

Though Alphapharm aimed to overcome this issue by building its Queensland plant, experts have predicted that widespread dependence on overseas companies meant it was likely the total number of drug manufacturing companies in Australia would decrease.

Dr Simon Quilty, of Newcastle’s John Hunter Hospital, warned: “There will be no reserve to fill gaps in shortages if there is any interruption to global supply.”

Experts have also warned that insufficient notification of drugs shortages caused as many problems as limited supply.

Carmela Corallo, formulary manager at Alfred Health in Melbourne, said there was “not a systematic approach to informing people”.

This was not only an “enormous headache”, Ms Corallo said, but also caused a financial burden, as alternatives were often more expensive. The Therapeutic Goods Administration (TGA) has repeatedly insisted that there are adequate measures in place to deal with shortages.

A spokeswoman for the Department of Health and Ageing (of which the TGA is a division) said measures employed by the TGA included “streamlining regulatory processes and identifying alternative overseas sources of medicines when necessary”.

She responded to concerns about sourcing of international medicines not registered in Australia to cover shortages, saying appropriate measures were always taken to ensure the drugs meet standards of safety, efficacy and quality.

“This may include assessment of the regulatory status of the proposed substitute medicine in countries with equivalent medicines regulatory framework, or applying the provisions in the Therapeutic Goods Act 1989 that allow doctors and patients to access medicines that are not approved in Australia,” she said.

Some experts believe that generic medicines – medicines that contain the same active ingredients as the brand drug but are sold at a considerably lower cost – could provide an alternative option for patients needing prescription drugs.

Generics can only be produced once a patent expires on the brand-name drug, however.

Dr Quilty said: “I think a lot of it comes back to the fact that society and the medical profession and pharmacists favour patented medicines which are marketed out very aggressively over pre-existing generic medicines. Generic medicines have very minimal profit for manufacturers.”

While there may be less profit for manufacturers, generic medicines have saved the Australian Government a considerable amount of money under the Pharmaceutical Benefits Scheme (PBS).

A recent example was Lipitor – a cholesterol-lowering drug that came off the patent list in May 2012. Use of the drug in generic form has been predicted to make savings to the Australian Government of $528.9 million in 2012-13 and $546.2 million for the following year.

The debate over generic medicines and drug shortages remains complicated, but pharmacist Mr Cox said the availability of generic medicines helped contribute to better management of patients during critical drug shortages.

“The good thing about generic medicines is that because multiple companies make them, if one company doesn’t make it you’ve got a backup with other companies,” he said.

“They’re only too happy to cover the supply of the other companies… there’s always a backup.”

A further, unreported, consequence of drug shortages is the impact it has on drug development.

Dr John Hill, medical director at US therapeutic drug company Amgen, said the global shortage of chemotherapy drug Doxil had resulted in the suspension of the company’s current clinical trial.

AMG386, a drug designed to block blood vessel growth in tumours, was being trialled in combination with Doxil but work on its development could not be continued during the current shortage.

“Not only is it costing you money to keep a study open that’s not doing anything, but then it’s potentially delaying when you might get approval,” Dr Hill said.

Health professionals have urged the Australian Government to respond by stockpiling essential medicines to ensure there is a supply during critical shortages.

“The Government could legislate that all drug companies need to keep three months supply minimum in warehouses,” said Mr Cox.

“Before it even goes onto the national health, you must commit that you have three months supply.”

But the Department of Health and Ageing said the TGA would not be stockpiling medicines in the near future.

Medicines Australia said it was continuing discussions with the TGA and the Department of Health and Ageing “at a very high level” to try to improve the response of the Australian health sector to drug shortages.