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Chemotherapy mix-ups raise red flags for health care

A total of 1,178 cancer patients at five hospitals in Ontario and New Brunswick received the incorrect dose of chemotherapy.

This is obviously a concern for those directly affected, but what does it tell us about the safety and efficiency of the health system more broadly?

Important details are still missing, but some red flags should go up immediately.

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First and foremost, this problem – patients given inadequate doses of two cancer drugs, gemcitabine and cyclophosphamide – persisted for more than a year, from Feb. 24, 2012, to March 20, 2013. A pharmacy technician at Peterborough Regional Health discovered it quite by accident.

Determining correct doses of chemotherapy can be complex. So can compounding, the preparation of these medications in specialized pharmacies. Mistakes can happen. But mistakes should not go undetected for weeks, months, or a year.

That is completely unacceptable and it is what should worry patients and health-care administrators above all.

Where is the quality control? Where are the checks and balances?

While it is too early to reach conclusions, there are uncomfortable echoes here of the hormone receptor scandal in Newfoundland. In that case, the pathology lab doing tests to determine if women with breast cancer could benefit from a specific treatment had no proper oversight; there was a disturbing lack of standards and monitoring. The debacle lasted from 1997 to 2005. A total of 383 women received incorrect results. Some died prematurely as a result.

One cannot not help also thinking of the scandal involving compounding pharmacies in Massachusetts, where improper sterilization of steroid shots led to an outbreak of fungal meningitis that sickened 730 people and killed 51. Compounding pharmacies are not monitored as strictly as other manufacturers of drugs.

In the most recent case, we don't know yet exactly what went wrong, except that some cancer patients at London Health Sciences Centre (665), Windsor Regional Health Centre (290), Oshawa's Lakeridge Health Centre (34), and Peterborough Regional Health Centre (1) in Ontario and Saint John Regional Health Centre in New Brunswick (186) didn't get optimal treatment.

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Cancer Care Ontario says it was a manufacturing problem, that the company preparing batches of chemotherapy drugs prepared them in the wrong doses. The manufacturer, Marchese Hospital Solutions, says it was a communications problem, that it was given incorrect or unclear information on dosage.

What matters ultimately is the impact on patients, and that is not clear. What we know is that they received doses of medication that were between 3 and 20 per cent weaker than they were supposed to get.

Chemotherapy drugs are highly toxic; they are watered down, quite literally, with saline solution so they can be infused into patients. This mixing – called compounding – is done in specialized pharmacies. The dose depends on a person's weight, type of cancer and how they are tolerating treatment. (Gemcitabine and cyclophosphamide damage the kidneys and liver.)

The challenge with chemotherapy is watering down the drug just enough so it won't kill the patient but ensuring it is potent enough to kill cancer cells. It is a delicate balance.

In this instance, they got the balance wrong for 1,178 patients. The most likely explanation is overfilling. Plastic IV bags come with some saline in them; the chemo drugs (a powder) are then reconstituted in saline and added to the bag. If the saline already there is not accounted for, it results in drugs that are too watered down.

We know too that underdosing, like overdosing, can be dangerous. Some research suggests that chemotherapy underdosing reduces a person's chances of recovery by about 20 per cent. That is significant.

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The good news here is that when the problem was discovered, authorities (Cancer Care Ontario) acted swiftly. The drugs were pulled and replaced and patients resumed treatment with the proper dosage.

The public was informed of the problem on April 2, almost two weeks after it was discovered. In Canada, transparency in health care is still not second nature.

But the take-home message is clear: Human error can occur. What is essential is that measures be in place to catch and mitigate errors before patients are harmed.

In this case the system failed. Oversight was lacking. And that's a symptom cancer patients shouldn't be burdened with.

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