Brassil hits out at handling of drug recall

FIANNA Fáil TD John Brassil has slammed the HSE and the Health Products Regulatory Authority (HPRA) over their handling of a pharmacy-level recall of some products containing blood-pressure regulator Valsartan, saying it has caused concern to patients, pharmacists and GPs.

The HPRA said last Thursday that “an impurity was identified in the Valsartan active substance” used in some medicinal products. The impurity has been classed a probable human carcinogen.

While there is no evidence it has harmed any patients, the recall was carried out as a precautionary measure while an investigation is being carried out.

Mr Brassil TD, himself a pharmacist, said most pharmacists and doctors heard about the recall through a news alert. But he said “no tangible or useful information has been given to GPs or pharmacists by the authorities.

“They are completely in the dark as to what is the best course of action,” he said.

“While there is no immediate risk to health, the recall is very worrying for patients – many of whom are unsure as to whether they should continue taking their medication.

“Pharmacists have alternative blood pressure medicines but, unlike in some other jurisdictions, they do not have the authorisation to prescribe the alternative. That requires a GP visit.

“This is something that should have been planned for. Product recalls take place quite regularly and protocols should be in place for issue to pharmacists and GPs to speed up the replacement procedure.

“The impact of this announcement on patients, and the uncertainty that it has caused, could have been predicted.”

He added that patients are worried about the quality of other generic medicines, and he has sought assurance that this is a one-off incident.

The HPRA has said patients should not stop taking their valsartan abruptly.

Patients are asked to consult their pharmacist for alternative medicine, and in the event of a pharmacist being unable to dispense an alternative, these patients should see a doctor.

They are also asked to bring their current medication with them when visiting their pharmacist or doctor.

The list of affected products is available at www.hpra. ie/docs/default-source/Safety-Notices/valsartan/final-valsartan-recall-letter-05-07-2018. pdf?sfvrsn=2. Further information is available at www. hpra.ie.

John Brassil TD, who has hit out at the HPRA and HSE handling of a recall of some medicines.