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Their trust would be further hit. Within two weeks, the Star reported that health-care companies are allowed to mix drugs for hospitals without federal or provincial oversight, prompting top health officials — Ontario health minister Deb Matthews and federal health minister Leona Aglukkaq — to scramble to close that regulatory grey area.

Since the crisis, all the hospitals involved have stopped outsourcing gemcitabine and cyclophosphamide mixtures and brought it in-house, mixing their own medications.

The federal government has new rules defining who can be a drug producer, adding that any facility supervised by a licensed pharmacist can do the job. The province has said that hospitals can only purchase drugs from accredited suppliers.

The Ontario College of Pharmacists has passed legislation that allows it to inspect any premises where a pharmacist works — not just licensed pharmacies.

All of the changes taken together would have seen Marchese Hospital Solutions still able to supply drugs as it did but subject to inspection by the college.

This week Jake Thiessen, the founding director of the University of Waterloo school of pharmacy, submitted a final report of his investigation into the issue. There has been no formal indication when it will be made public. Hospital administrators say they have been told it will be two to three weeks before they or the public see this report.

There is very little clinical evidence to indicate what might happen to a cancer patient who receives an underdose of chemotherapy.

At the same time, many of the more recent advances in chemotherapy have been in drugs that alleviate side effects like nausea.

In an oncology pharmacy, strange is not good. And on March 20, one week before Marley’s last cyclophosphamide treatment, Craig Woudsma, a 28-year-old pharmacy assistant, and a colleague at the Peterborough Regional Health Centre, had a bad feeling.

In this case, it was a shipment of new gemcitabine chemotherapy bags that required refrigeration, according to the label. Previous batches, from a different supplier, had not.

When preparing the solution, staff at Marchese Hospital Solutions, in Mississauga, Ont., dissolved the medication into a pre-filled 100 mL bag of saline. These bags typically contain between 3 to 20 per cent more solution than 100 mL,

The new bag’s label did not contain enough information for him to accurately mix the patient’s dose. He needed to know the specific concentration.

Woudsma noticed more differences. The bags from Marchese only had a total volume and concentration on the label — 4 grams of gemcitabine in 100 mL of saline — instead of the specific concentration, the amount of drug per single mL of saline, as the old bags indicated.

“I told the pharmacist in the area. And then it kind of went above me at that point ... They came to me saying, this is kind of a big deal; teleconferencing with the minister of health, that kind of stuff,” said recently, sitting on the front steps of his red-brick, semi-detached home in the village of Millbrook, Ont. “It’s kind of a foreign concept, to think that what we do, in our corner of the hospital, is going to get that kind of exposure.”

referred to in the industry as overfill, included to account for possible evaporation.

People have asked Woudsma why he was able to catch a problem that went undetected at other hospitals for more than a year. Simple, he says. He had something to compare it to.

The company’s pharmacy workers did not remove the known overfill when mixing the medication because they thought each bag was going to a single patient

This means that the bag Woudsma was holding contained 4 grams of gemcitabine in more than 100 mL of solution. The concentration of the medication wasn’t what the label would have made him think. It was weaker than advertised.

The hospital had switched that very day to a new supplier — Marchese Hospital Solutions. A bag of the old supply from Baxter CIVA was still on site.

Medbuy, a group purchasing company for hospitals, starting in 2008, had a contract with Baxter Central Intravenous Admixtures to provide drug-mixing services. The two drugs in question, cyclophosphamide and gemcitabine, were outsourced because they come in powder form and are tricky to mix. It takes about four hours to reconstitute them in liquid, and in that time they must be shaken every 20 minutes.

As that contract was about to expire, Medbuy issued a request for proposals for drug-mixing services: Baxter CIVA, which wanted its contract renewed, Quebec-based Gentes & Bolduc and Marchese all stepped forward.

Marita Zaffiro, president of Marchese, testified at Queen’s Park that the Medbuy contract did not indicate the hospitals wanted the labels on these drugs to cite a specific concentration. The reason she included it that way in the RFP was simply to show what could be done.

The details of the new arrangement remain known only to Medbuy. It was founded in 1989 to get better deals for hospitals buying products like scalpels, bed pans and even some medications in bulk. The company’s 28 member hospital organizations in Ontario, New Brunswick and Prince Edward Island spent a combined $626-million on contract purchases in 2012.

Sobel ran the calculations in his office. For a single patient to require a 4,000 mg dose of cyclophosphamide, on a common breast cancer treatment regime, that patient would need to be about 7 feet tall and weigh 2,200 lbs.

“The chance of 1,200 patients getting 4,000 mg exactly — it’s just impossible.”

Four Marchese pharmacists who played a role in the new contract work revealed to the Queen's Park committee in June that they had either limited or no background in oncology.

Marchese Hospital Solutions began as Marchese Pharmacy, a Hamilton-area community drugstore that expanded beginning in 1998 when Zaffiro became president. In 1999 the company obtained a contract to supply the Hamilton Niagara Haldimand Brant Community Care Access Centres, business they did until the contract expired in 2011, shortly before it was awarded the Medbuy contract.

It lost the CCAC contract in 2011, shortly before the Medbuy deal, and shed employees. Fifty-seven were either laid off or left the company during this troubled time, according to internal newsletters. But then things started looking up.

Zaffiro attempted to get accreditation for the site, according to her Queen’s Park testimony, approaching both the Ontario College of Pharmacists and Health Canada, neither of which took steps to regulate the fledgling business because each thought the other had jurisdiction.

Medbuy, Marchese and Jake Thiessen have maintained that cost was not a factor in the error. Marchese’s bid on the request for proposal came in at about a quarter of the cost of previous supplier Baxter Corporation. Bags from Marchese cost from $5.60 to $6.60; Baxter charged $21 to $34.

CEO David Musyj thinks about what went wrong. The problems, he says, go far beyond Marchese and Medbuy. “All of us are culpable,” he says. “We could have done some things internally that could have prevented this. We could have weighed the bags when they came in.”

"This is a new way of doing business so we need to sort which activities are being done and then who has the overall oversight over them."

"My reaction was, 'I can't believe this happened to me'," Kaiman said from her dress shop in Woodstock, Ont. "They told me my chemo was watered down and that basically he thinks it may not affect me, but there are no guarantees."

Marchese has said the problem arose not from how the bags were prepared but in how they were administered at the hospitals.

We need answers and I am going to make sure the College of Pharmacists gets the tools they need."

And more than a dozen pharmacists in Saskatchewan billed the province for one drug but dispensed an alternative in exchange for rebates and other discounts from the manufacturer.

Tory Leader Tim Hudak said it is the role of the government to protect it citizens, not throw up their hands and blame someone else for the chemo drug not being effective.

Manufacturing includes producing or selling a product by a third party, it said. The paper suggests that if there’s a question about whether the activity is manufacturing or compounding, it should be raised with federal or provincial bodies, who can then determine who’s responsible.

The college oversees pharmacists, including those who may have worked independently for Marchese Hospital Solutions. Health Canada oversees drug manufacturing. But Marchese wasn’t considered a pharmacy or a drug manufacturer. The need for clarity about who is responsible for what is an issue Health Canada has been dealing with for more than a decade.

A 2009 policy paper by Health Canada cited “a need to develop a Canada-wide consistency in approach to ensure that drug compounding and manufacturing are each regulated by the appropriate authorities.”

“In situations where the provincial/territorial regulatory authority decides that an activity does not fall within its jurisdiction, the activity is likely to be manufacturing and the parties involved must follow the federally regulated drug approval process for manufacturing drugs,” it said.

The services provided by Marchese to hospitals appear to be something that has been traditionally done within a hospital pharmacy, which would fall under provincial supervision, said Health Canada spokeswoman Leslie Meerburg. “This non-traditional business model takes a different approach,” she said in an email.

In the meantime, the college is stepping in to provide oversight of new compounding facilities like Marchese.

The proposed changes were prompted by the recent discovery of under-dosing of chemotherapy drugs supplied by an independent company to four hospitals in Ontario and one hospital in New Brunswick.

It was a jurisdictional grey area, with both the college and Health Canada unable to agree on who was responsible for the facility.

The crisis has also raised questions about whether the privatization of health care has gone too far. The bags containing the chemotherapy drugs were filled with too much saline, watering down the medication by as much as 20 per cent. Some patients received the drugs for as long as a year. It's a grave warning that privatization has to stop, said New Democrat health critic France Gelinas.

"As those new companies spring up all over to do for-profit services for hospitals, the government basically stayed asleep at the switch," she said.

"They never looked at who was picking up this work to make sure that the level of oversight, the level of quality assurance that we had before were being transferred over. The work got transferred, the oversight did not."

A pharmacy expert, Jake Thiessen, will review the province's cancer drug system, Matthews said. A working group that includes doctors, Cancer Care Ontario, Health Canada and others are also looking at the problem.

ealth Canada and the Ontario College of Pharmacists are working to close that ga

At Chartwell, a chain of 27 homes, chief operating officer Karen Sullivan said the pharmacy that services the chain, MediSystem, pays for "many additional valued-added services" such as employee education, nurse leadership sessions and conferences for leaders of homes. MediSystem also pays for Wi-Fi systems and therapeutic care equipment at the homes, Sullivan said in an email. The Star asked pharmacies what they are told the money is used for. Among the responses from pharmacies were "staff education," "resident programs" and payments toward Wi-Fi systems. Classic Care, a pharmacy, said the money it pays covers monthly rent of an area in the nursing home, staff education, technology and "donations and sponsorships" for conferences and other training. Other pharmacies, such as Rexall, say their fees have paid for diabetes education, for example. The largest pharmacies serving long-term-care homes in Ontario include Medical Pharmacies Group, MediSystem (owned by Loblaw), Classic Care (Centric Health) and Rexall. The fees are not new. Pharmacies have willingly offered money or agreed to demands for years. But there's a growing outrage among some who say homes are more interested in "inducements" than "clinical excellence" that pharmacies can provide seniors. Last year, after the Ontario government cut each dispensing fee by $1.26 (it is now $5.57 per prescription in nursing homes), sources said some pharmacies wanted to stop paying the fees. The problem was, the sources said, that the homes refused to give up the extra cash flow and other drug companies were willing to pay, so nothing changed.

It's usually the larger companies that can afford to pay. One insider said smaller pharmacies now ask the homes, "Do you want the money or do you want good service? Because we can't afford to give both." Sources said the Ontario Ministry of Health and Long-Term Care knows the money changes hands but does nothing to stop it. Instead, pharmacies are "held hostage" by the homes, the source said. One home that no longer charges the fees is John Noble Home in Brantford, a municipally operated 156-bed facility. The Star obtained a 2010 request for proposals (RFP) that noted "only proposals with a minimum rebate of $20,000 annually will be considered for the project." A spokesperson for the city said the RFP "references a previously approved practice employed by several long-term care homes." A recent RFP did not ask for a rebate, though some offered to pay. The city spokesperson, Maria Visocchi, said it chose a pharmacy that "demonstrated qualifications and experience, project understanding, approach and methodology, medication system processes and quality control." This pharmacy did not offer a rebate. Not all pharmacists pay. Teresa Pitre runs Hogan Pharmacy Partners in Cambridge and serves long-term-care homes that don't ask for money. Instead, she signed contracts with several homes in the People Care chain to provide a "highly personalized approach." Pitre sends a registered pharmaceutical technician into each home daily to relieve nurses of much of their work regarding medication, confusion over communications and extensive paperwork. Her company also puts a bookshelf-sized dispensing machine in each home, which holds medication (pain relievers, antibiotics or insulin) that residents need on short notice but, in the traditional system, often can't get for hours. "I really wanted our pharmacy to be a partner with homes instead of servicing them and just meeting the requirements," she said. Meadus says the added cost of bed fees means pharmacies have no reason to reduce their rates, either by lowering dispensing fees or not charging the $2 co-payment.

A recent Star story revealed that pharmacies serving nursing homes typically charge dispensing fees for drugs once a week, rather than once a month as they typically do in a community pharmacy. Long-term-care pharmacies told the Star they charge the weekly fee because the medication for frail residents can change weekly. That was a claim hotly disputed by some family members the Star spoke to, including Margaret Calver, who has spent years documenting the costs of dispensing fees at Markhaven Nursing Home, where her husband is a resident. "This needs oversight and that's the problem," she said. "Nobody is doing the checks and balances." Moira Welsh can be reached at mwelsh@thestar.ca.

Patients can also incorrectly take their chemotherapy drugs at home because they don’t understand the complicated instructions, adds Melissa Griffin, who has been conducting research on oral chemotherapy delivery with the HumanEra project. With the drug Temozolomide, a brain cancer drug, for instance, “there are multiple different strengths of the pills that patients have to put together to make up the dose,” she says.

Another reason dosing errors can occur is that patients can be given the wrong dose due to an error by the prescriber or pharmacist distributing the drug. Education for patients and family members, along with better standards to avoid prescribing errors, reduce the risk of over- or under-doses of chemotherapy. But the safety standards, as well as the level of education and support patients on oral chemotherapy receive, differs vastly depending on where they live.