The manufacturer of a chemotherapy drug, batches of which were recalled today, has said it regrets any upset caused to patients.
Around 200 patients have been contacted after a number of batches of the drug, which were manufactured by Fannin Compounding Limited between September 29 and October 12, were recalled, according to the HSE.
“Fannin Compounding has been working closely with the Health Service Executive (HSE) and Health Products Regulatory Authority (HPRA) in relation to a precautionary recall of a number of batches of chemotherapy medicines manufactured between September 29 and October 12, 2015,” the company stated today.
“The recall relates to a sterility assurance issue, identified by Fannin Compounding, affecting one of its chemotherapy isolators (production equipment).
“Our investigations are ongoing as to how this issue arose and immediate corrective actions have been implemented, including taking the isolator in question out of use.
“The Health Products Regulatory Authority has advised that, whilst there is no evidence at this point to suggest an issue with any of the medicines recalled, the patients who have received the relevant products have been contacted by their hospitals as a precautionary measure, informed of the situation and offered a medical appointment.
“We regret any upset to patients in relation to this precautionary recall.”
The HSE has apologised to the patients “for any anxiety they may experience as a result of this issue” and said there is no indication from the company at this time that any drug has been affected.
Donal Buggy, head of services with the Irish Cancer Society, has said it is essential patients can have full confidence in the treatment they are being given.
“So far the HSE seem to have taken immediate and appropriate steps by contacting all of those involved, offering consultant support,” Mr Buggy said.
“Cancer treatment can be a very anxious time for patients and their families and the HSE need to be very cognisant of that and need to take steps to ensure that the concerns of these patients are dealt with in a way that is appropriate, immediate and addresses all of their concerns.”
The Health Product Recall Authority (HPRA), the body with overall responsibility for overseeing recall activity, advised that there is no evidence at this point to suggest an issue with any of the medicines recalled.
It stated that an issue was identified by the manufacturer when carrying out its daily assessments of the manufacturing process using a test product.
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," according to the HPRA statement.
The 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 September 29 were recalled.
“As of today, the 14-day incubation period for the test products produced up to October 2 has been completed successfully and no contamination has been found,” the HPRA stated.
“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.
“The contaminant in the single unit of test product has been identified and this information has been communicated to the hospitals concerned so that prescribers can choose the best treatment in the event of any patient presenting with infection.”
According to the HPRA, no issues have been identified with other production equipment which are also subject to the same daily test.