Sunday 4 December 2016

Alert issued after chemotherapy treatment for Irish cancer patients 'contaminated'

Patients told to watch for flu-like symptoms

Published 16/10/2015 | 11:27

A stock image of a drug used in chemotherapy treatment

An alert has been issued after the potentially life-threatening contamination of some chemotherapy treatment for cancer patients, the Irish Independent has learned.

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The treatments made by Fannin Compounding Ltd in Dublin have been recalled after it was discovered one of its manufacturing machines was contaminated with a form of bacteria that could cause serious and potentially fatal non- gastrointestinal-tract infections.

All medical oncologists have been alerted and patients were being notified today, the HSE said.

“Some 200 patients have been contacted in relation to the contamination.”

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The patients are in Connolly Hospital in Blanchardstown; Our Lady of Lourdes Hospital Drogheda; Rotunda Maternity Hospital; South Tipperary General Hospital; St Luke’s General Hospital Kilkenny; St Luke’s Radiation Oncology Network, Rathgar; Bantry General Hospital; Beaumont Hospital; Royal Victoria Eye and Ear Hospital; Naas General Hospital; Portiuncula Hospital in Ballinasloe; South Infirmary Hospital in Cork; and St James’s Hospital.

These patients are particularly vulnerable to infection due to a weakened immune system from the chemotherapy they have been receiving.

Speaking on RTÉ’s Liveline earlier today, the husband of the woman who was treated with the contaminated batch said he was told to watch for flu-like symptoms.

“They told us to check her temperature and keep an eye on how she is feeling,” said caller Michael.

He added that the A&E department and medical assessment unit at Our Lady of Lourdes Hospital, Drogheda had been briefed if his wife presented with problems.

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“My wife started her chemo therapy last Tuesday and we got a phone call here at lunch time on Thursday telling us the therapy she got could be contaminated,” he said.

“We were told the swab used that day in the lab to make the drug had a bug and they needed to send it to Scotland for testing.

“They told us they would not have any more information until the 28 October.”

Michael said he wanted to know why the swab had not been tested before the chemo batches were sent out to be used.

“What they’ve been unable to tell us, is why this batch was able to get out before it was tested.

“We still haven’t been told what the bug is or its long-term effects – we’ve a lot of unanswered questions.”

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The Irish Independent has learned that a letter sent by Fannins to specialists said it had recalled the treatments on October 12  and they have now identified the contaminant which affected one of its chemotherapy isolators.

The bacteria is bacillus cereus which is widely found in the environment.

While it is associated mainly with food poisoning it is being increasingly reported to be a cause of serious and potentially fatal non-gastrointestinal-tract infections.

It has been found to affect people whose immune system has been lowered and also newborn babies.

It has also been found to affect patients who have undergone surgery who have wound infections.

The letter said that investigations are ongoing at the plant to see how the problem happened.

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Immediate corrective actions have been implemented pending the completion of an investigation including putting the machine out of use since the sterility issue was identified.

The medicines watchdog, the Health Products Regulatory Authority (HPRA), confirmed today that a precautionary recall of a number of chemotherapy medicines has been undertaken. 

The problem was identified by the manufacturer when carrying out its daily assessments of the manufacturing process using a test product.

“This test product contains a substance which is used to aid in the detection of the potential presence of contamination. This test product is not a medicine and is not given to patients”

He said last Monday contamination was found in the test product for a day on which 37 units of medicine were filled and, of which, 15 have been recovered unused during the recall

” A contaminated test product does not automatically mean that the medicines produced are affected”.

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He said a test product, which is produced daily, must be incubated for 14 days to identify any contamination and, therefore, as a precaution all units manufactured from the September 29 were recalled.

As of today the 14 day incubation period for the test products produced up to the October 2 has been completed successfully and no contamination has been found.

This means that 132 of a total of 297 units filled over the 14 day period are not implicated. Additionally, 45 unused units have been recovered.

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