Firm in cancer drugs scare at centre of two other recalls since June
The company at the centre of the recent scare over potentially contaminated chemotherapy drugs also had to recall suspect products in recent months which were given to 168 patients, the Irish Independent has learned.
The firm has been ordered by safety regulators to put in place more rigorous investigations for possible contamination.
A spokeswoman for Fannin Compounding Ltd in Dublin confirmed machines, known as isolators, which produce other forms of cancer therapy, were found to be contaminated by bacteria during tests in recent months. She said there was no evidence that any medicine had been contaminated.
The Health Products Regulatory Authority (HPRA), the medicines watchdog, said 144 patients were given the potentially contaminated medicines before the first recall in June.
Another 24 patients had to be contacted following a second recall relating to a contaminated machine in September.
It emerged last week that some 200 cancer patients had to be contacted after the isolator at Fannin which mixes chemotherapy was found to be contaminated with a potentially lethal bacteria during tests on Monday.
The HSE confirmed yesterday that although the alert was raised by the company on Monday, it took several days to contact some patients.
They included Mary Murphy (pictured), a breast cancer patient from Kilcullen, Co Kildare, who received a potentially contaminated dose of chemotherapy in St James's Hospital last Wednesday week - but was not informed about the scare until last Thursday.
The HPRA said it had carried out four inspections of the company's manufacturing plant since the beginning of the year.
"During these inspections, the HPRA identified a number of areas for improvement of the site's contamination control strategy," it said.
They included instigating a more thorough quality risk management strategy.
The watchdog also told the company it should increase the robustness of its disinfection of the surfaces of containers of medicines prior to and during their transfer into the isolator machine where medicines were mixed. "The isolator involved in the production of the recently recalled chemotherapy products, as well as another isolator, has been taken out of use. This will remain so for the foreseeable future."
A spokeswoman for the HPRA said that, notwithstanding the company's ongoing environmental monitoring programme in place, it was asked to step this up further.
The company said corrective actions included improved cleaning and environmental monitoring.
It had not received any notifications of patients receiving contaminated products.
Mrs Murphy (68), who said she received conflicting information about when she was given the suspect dose, was upset because she was not told about the risk sooner. She believed she had been given a dose of the suspect chemotherapy after it was recalled on Monday.
A spokesman for the HSE said in hindsight the HSE should have contacted Mrs Murphy after she aired her fears on RTÉ's 'Liveline' on Friday.