Saturday 3 December 2016

HSE says no Irish patient received contaminated chemotherapy following its recall on Monday

Grandmother Mary Murphy had feared she got treatment for breast cancer days after recall of chemotherapy treatment had begun

Published 17/10/2015 | 02:30

Our Lady of Lourdes Hospital, Drogheda
Our Lady of Lourdes Hospital, Drogheda
Cancer sufferer Mary Murphy pictured in the garden of her home in Kilcullen, Co Kildare. Below: Our Lady of Lourdes Hospital in Drogheda, where one patient’s husband rang Liveline seeking information

The HSE has today released a statement to clarify that no Irish patient received contaminated chemotherapy following its recall on Monday.

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This evening, the HSE moved to assure patients who have not been contacted by their oncology teams with concerns, that they have not been given the contaminated treatment.

“The potentially contaminated chemotherapy was used in the treatment of cancer patients on the week 2nd October to 9th October only,” the HSE said today.

“Once the HSE became aware of the situation, on Monday October 11th, immediate and co-ordinated action was undertaken by all oncology teams throughout the country to contact all 200 patients concerned.”

“All patients and/or their families were informed of the situation throughout the next number of days. All patients were informed that the batch related to one period only (2nd October to 9th October).”

Yesterday, a grandmother battling breast cancer told of her shock that she may have received a contaminated chemotherapy treatment - days after it should have been recalled.

Mary Murphy (68) of Kilcullen, Co Kildare, believed she was one of 200 patients who fear a potentially life-threatening infection from the infusion of chemotherapy they were administered in public and private hospitals.

She said last night: "I was told the chemotherapy I received in St James's Hospital on Wednesday could have been contaminated.

"I was contacted on Thursday and asked if I had any symptoms. It was a shock."

Today, the HSE said it wished to clarify matter.

The alert was raised after internal testing discovered chemotherapy units mixed at Fannin Compounding in Sandyford in Dublin were made in an isolator which was contaminated with bacillius cereus.

The bacteria is mostly linked to food poisoning - but it can also lead to potentially fatal infections, which can be particularly severe for cancer patients whose immune systems are low.

However, in a statement today the HSE said it "wishes to assure these patients, if they have not been contacted by a member of their oncology team at this juncture, they have not been treated with the chemotherapy in question."

The HSE added that it wishes to apologise to all of the patients and their families for the distress that this incident has caused.

"Patients and their families should be reassured that the HSE is working closely with the HPRA and the chemotherapy supplier to avoid such incidents in the future."

"Should any patient or family member require further information or reassurance, please contact your local oncology unit," a statement by the HSE said.

The company which makes the product insisted last night that it alerted the medicines' watchdog the Health Products Regulatory Authority (HPRA) "first thing" on Monday morning last about the need to recall all batches of the product made since September 29.

Hospitals were also notified and told to contact any patient who may have received suspect product to determine if they were suffering any adverse symptoms.

A spokesman for the HPRA said around 100 patients who would have been administered 120 of the 297 units under suspicion had yet to get the all clear.

Although most of the suspect products involved in this recall were for chemotherapy treatments, one was for an anti-viral unit.

The HPRA said that the treatment Ms Murphy received may have pre-dated the scare, but it could not confirm this.

It also emerged that this is the third recall of potentially contaminated products from Fannin in the last six months. However, the previous recalls were precautionary and there was no contamination found.

"While there is no evidence at this point to suggest an issue with any of the medicines recalled, the patients who have received the potentially implicated products have been contacted by their hospitals as a precautionary measure," said the spokesman.

The issue 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.

It said: "This test product is not a medicine and is not given to patients. On Monday October 12, a contamination was noted with 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.

"The HPRA is overseeing the recall and is continuing to investigate this incident and evaluate the manufacturer's onsite processes. The equipment used in the manufacture of these products has been taken out of use pending completion of the investigation."

However, some patients complained of a lack of clear information.

One man, whose wife is undergoing treatment in Our Lady of Lourdes Hospital in Drogheda, felt he had no option but to ring RTE's 'Liveline 'programme to find out what was wrong.

The company wrote to all doctors yesterday informing them about the tests which confirmed the kind of contamination involved.

It said that the problem only relates to one of its isolator machines which is part of its production equipment - and no issues were identified with any other machines it subjects to a daily test.

A spokeswoman for the HSE said all patients were made aware of the situation and offered appointments to meet with their clinical teams to discuss any possible concerns.

"All patients involved have now been contacted and offered an appointment.

"However, if in the interim, any of these patients experiences any unexpected symptoms differing from what they normally experience after treatment, they are being advised to attend at or contact their treating hospital," she said.

"The HSE would like to apologise to our patients for any anxiety they may experience as a result of this issue."

The medicines watchdog said this kind of contamination of equipment is relatively rare.

However, it has overseen two other similar precautionary recalls involving the same company in the last six months.

"No product was found to be contaminated," he said.

A spokeswoman for the company said it was working closely with the HSE and immediate corrective actions are in place to ensure safety of its products.

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.

The Irish Cancer society said it is concerned at anything which has an adverse effect on cancer patients and causes anxiety to patients and their families. It said it was of paramount concern to the Society. Its cancer nurseline is freephone 1800 200 700.

Irish Independent

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