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End-of-life patients suffering unnecessarily due to pain med shortage

In the past year, at least six pain-relief products have become unavailable in Australia. The Australian & New Zealand Society of Palliative Medicine (ANZSPM) says the withdrawals have resulted in prescriptions for less-effective medicines and increased confusion over dosage and side-effects.

Shortages began when British pharmaceutical company Mundipharma announced they would no longer supply oral liquid morphine to the Australian market.

Dr Michelle Gold, ANZSPM president and director of palliative medicine at the Alfred Hospital, Melbourne, said patients currently receiving end-of-life care deserve better than they are getting.

“Patients who are reaching the end of their life are suffering additional distress and uncertainty due
to the ongoing shortage of morphine-based medicines in Australia," Dr Gold said.

The Australian palliative care sector has been aware of the issue for some time, flagging the looming crisis to government representatives. Key health bodies including ANZSPM, Palliative Care Australia (PCA), the Society of Hospital Pharmacists of Australia (SHPA), and Palliative Care Nurses Australia detailed their concerns in a joint letter at to the Health Minister Mark Butler at the end of last year.

The Royal Australian College of General Practitioners (RACGP) estimates that hundreds of thousands of scripts for the discontinued medications are dispensed annually.

"We have been alerting the TGA and the Minister of this looming crisis for close to a year now. We
have written directly to the Minister and the TGA and we have had meetings with department
officials. While the TGA are doing what they can to inform the professions and the public, they are
not responsible for ensuring supply of these much-needed medicines," Dr Gold said.

"The regulations and government policy surrounding the supply of essential medicines is complex,
but at the end of the day it is extremely frustrating that essential morphine-based medicines which
we prescribe daily in palliative medicine, are in such short supply or not available at all and that we
are being forced to use medicines or products which not only results in less effective pain relief, but
may lead to unwanted side effects."

The effect of the shortages is not limited to end-of-life care; those with chronic pain, cancer and anyone requiring significant pain relief are being forced to use alternatives.

ANZSPM says that the situation is worse in rural and remote communities that may already have barriers to accessing quality palliative care. Doctors have been advised to use opioid calculators in a bid to minimise risk when administering unfamiliar medications, while the shortages are now leading to an increased financial burden for patients.

"If a medicine is listed under s19A as being a substitute for the Pharmaceutical Benefits Scheme (PBS) listed medicine, this alternative may very well not have PBS listing, so that medicine is very expensive.

"For example, morphine liquid can be up to 10 times more expensive. Even worse is Hydromorphone SR (slow release). Previously, a pack of 100 x 32mg tablets of the Australian product would be $182. This has been removed from the market and the overseas alternative is $4209 for 100 tablets, which is 23 times more expensive," Dr Gold said.

Tom Simpson, president of the Society of Hospital Pharmacists of Australia (SHPA) said “the cost of alternatives sourced from overseas to replace locally-registered medicines is almost always higher, and this can be a barrier for many people and health services. There is no guarantee that the alternative product will be subsidised by the Pharmaceutical Benefits Scheme (PBS) either, which can easily quadruple the cost of the discontinued Australian registered product.”

“There have also been problems with labels written in foreign languages and the size of the deliveries we are receiving can make these alternatives hard to administer safely and cost effectively.”

Dr Gold said ANZSPM will continue to advocate for Australia's most vulnerable communities.

"ANZSPM is involved in providing our advice and concerns to the TGA and contributing to the reform. Some changes lie outside the TGA powers and relate to existing shortcomings in legislation and government policy. We shall be advocating for these changes and hoping that steps are taken to secure our nation’s supply of essential pain-relieving medicines in the future. Patients receiving end-of-life care deserve better than what we can offer today."

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