Pharmacy assistant discovered diluted drugs

TORONTO – A pharmacy assistant at a small Ontario hospital discovered by accident that chemotherapy drugs administered to 1,200 cancer patients in two provinces were diluted, a legislative committee heard Tuesday.

The problem was caught March 20 when a pharmacy assistant at the Peterborough Regional Health Centre doubled-checked the label of a bag containing a mixture of saline and the drug gemcitabine from Marchese Hospital Solutions.

The assistant, who wants to remain anonymous, noticed that the label on the Marchese bag was different from the one from their previous supplier Baxter, said Laura Freeman, the chief financial officer of the 400-bed hospital.

It was the first day the hospital was using the bags from Marchese, which is why they still had some left over from Baxter, she said.

The assistant noticed that the Marchese label only listed the amount of the drug gemcitabine in the bag, not the final concentration of the drug per millilitre of saline. The Baxter label listed both, she said.

The drug is a powder that must be mixed with saline before it’s administered to a patient. Bags of saline usually contain a certain amount of “overfill” — or more liquid than labelled — to account for evaporation, the committee heard.

“It was not clear from the labelling on the Marchese bag if the overfill had been included in the determination of the final concentration,” Freeman said.

The pharmacy assistant alerted other pharmacists, who made a call to Marchese. The Marchese pharmacist told them the final concentration of the drug wouldn’t change because the entire contents of the bag would be administered to a single patient, Freeman said.

But the hospital — and four others — were extracting fluid from the bag to prepare chemotherapy treatments for different patients, unaware that the drug mixture had too much saline.

The hospital stopped using the Marchese products, Freeman said.

It’s now known that there was too much saline in the bags containing cyclophosphamide and gemcitabine supplied to the five hospitals, in effect watering down the prescribed drug concentrations by up to 20 per cent. Some patients were receiving the diluted drugs for as long as a year.

Marchese Hospital Solutions said it prepared the drugs the way it was asked to under its contract and under the supervision of a licensed pharmacist.

But the drug mixture Marchese was producing was completely different from the one the hospitals thought they were buying, the committee heard.

It’s not clear how the wires got crossed. Medbuy, a group purchasing organization, was the intermediary between the hospitals and Marchese. It put out the request for proposals and signed the contract with Marchese, with input from the hospitals, the committee heard.

Ontario and Health Canada have acknowledged that there was no oversight of the company and don’t know how many others like Marchese are operating in Canada.

Both the federal and provincial governments have taken steps to close the gap until a more permanent solution is found.

Health Canada said compounding and admixing can continue if it is done within a hospital meeting provincial requirements, outside a hospital under the supervision of a provincially licensed pharmacist, or in a manner that meets the licensing and manufacturing requirements of the Food and Drugs Act.

The Ontario government has posted a new regulation to ensure that hospitals purchase drugs only from accredited, licensed or otherwise approved suppliers.

The province also wants to give the college the power to inspect facilities where pharmacists and pharmacy technicians practice, including where drugs are prepared.