Coroner: Unlicensed drugs must be regulated

A CORONER called yesterday for better policing of “off-licence” drugs, often used in chemotherapy treatments, after a cancer patient died after a dosage error.

Cork city coroner Dr Myra Cullinane said she will bring the issue to the attention of Health Minister Mary Harney.

Cork Coroner’s Court heard how Eileen Noonan, 53, from Kilmallock, Co Limerick, was given a massive overdose of the chemo- therapy drug Idarubicin, after a pharmacist at Cork’s Mercy University Hospital (MUH) misinterpreted dosage directions.

The error last June was the fourth Idarubicin dosage error involving Irish cancer patients who subsequently died, the inquest was told. The overdoses were associated with two of those deaths.

While the Irish Medicines Board was informed of the MUH error, it said it did not fall within its remit because the drug was part of an unlicensed treatment regime.

Dr Cullinane said she was concerned that there was no regulation of off-licence medication by a statutory body: “There needs to be a formalised reporting structure for incidents such as this so steps can be taken to prevent future, similar tragedies.”

Idarubicin is used with another drug as part of a chemotherapy treatment known as Z-DEX.

Ms Noonan began Z-DEX for multiple myeloma, a cancer in cells in bone marrow, on June 6 last.

MUH specialist registrar in haematology, Dr Andrea Malone, phoned a hospital pharmacist for details on the Z-DEX protocol, who in turn consulted the Oxford Handbook of Clinical Haematology.

Patients are supposed to get a 40mg dose of Idarubicin over four days — 10mg daily.

But the pharmacist misinterpreted the dosage wording in the handbook and told Dr Malone it was 40mg every day for four days.

Ms Noonan was given 40mg each day for three days — a total of 120mg which is three times the required amount.

Ms Noonan’s condition worsened and she died on June 27.

Dr Malone and MUH’s chief pharmacist, Elizabeth Barron, said they could see how the mistake was made.

However, consultant haematologist Dr Michael Madden said the Z-DEX protocol has been interpreted correctly by thousands of doctors.

He said the overdose was just one of a number of factors which ultimately led to Ms Noonan’s death.

But Harold Brooks BL, for Ms Noonan’s husband, Pat, said: “Whatever resistance she had before the overdose, all resistance she had went out the door when she got three times the dose of a fairly potent form of chemotherapy.”

MUH has made several changes since the incident, including changing potentially confusing wording in its protocol.

Mr Noonan declined to comment afterwards but welcomed the changes.

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