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Doug Allan

No oversight of diluted chemo drugs? | Globalnews.ca - 0 views

  • Preparing medications for hospitals — which they would usually do themselves — is a relatively new business model, said Dr. Supriya Sharma, senior medical adviser at Health Canada.
  • “If the activities that they were doing were done under a hospital setting, that usually falls under provincial supervision,” she said in an interview.
  • “But because this is a new business model, we need to take a look at it to get a different approach to see what jurisdiction it falls under.”
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  • “It does get a bit complex because under one roof with the operations, they actually have different areas that are doing different activities, and those different activities may actually be under different jurisdictions,” she said.
  • Marchese Hospital Solutions is technically not a pharmacy, which means it doesn’t fall under the oversight of the provincial government or the college.
  • “So it’s possible that we need to make sure that oversight and regulations are up to date.”
  • archese has a pharmacy in Hamilton, Ont., which was inspected by the college in January. Sharma said Health Canada had not visited any of Marchese’s businesses before the diluted drugs came to light, but paid a short visit after.
  • Outsourcing of medication preparation is a new trend and now’s the time to start looking at how it should be done in Canada, said Sylvia Hyland, chief operating officer of the Institute for Safe Medication Practices Canada.
  • However, the college is responsible for pharmacists and technicians, including those who may have been working independently for the company.
  • Marchese has said its products weren’t defective, and suggested that the problem wasn’t how the drugs were prepared but how they were administered at the hospitals.
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    Lack of oversight for privatization behind chemo scandal, at least in part
Doug Allan

Health minister says it's not clear who is responsible for inspecting chemo drugs | Tor... - 0 views

  • The fact the Marchese Hospital Solutions, which producers the drug, operates without federal or provincial oversight was first revealed by Toronto Star.
  • “Health Canada has jurisdiction (over manufacturers), the Ontario College of Pharmacist has jurisdiction over pharmacists practicing in this province and pharmacies, hospitals have responsibility for the security of their drugs, There is collective responsibility but there is lack of clarity over who has ultimate authority,” Matthews told reporters after being grilled in the legislature.
  • “Here we have drugs that are being provided by a private company to hospitals going to patients and nobody is . . . making sure that those drugs are the appropriate drugs, nobody is monitoring the companies. It’s like the Wild West.
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  • 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.
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    Chemo drug responsibility in doubt
Govind Rao

Lack of awareness is troubling | Windsor Star - 0 views

  • Sep 19, 2013 - 3:21 PM EDT
  • Re: Hospitals had concerns about chemo solution supplier, by Claire Brownell, Sept. 13.
  • Your story notes that hospitals had concerns about the private company supplying the problematic chemotherapy mixtures. That is as it should be. But it is very troubling that the affected hospitals were “unaware” of the lack of regulatory oversight of the private supplier.
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  • The same lack of awareness was also true of provincial government. That is a shocking lack of due diligence. But unfortunately, this is not the first time our government has rushed in to privatization, leaving us to pick up the pieces. Almost all of the recent scandals the government has faced are connected with its drive to privatize public services: the secrecy and costs associated with the commercialization and privatization of Ornge, the scandalous payments to private contractors at e-Health, and the absurdly high penalties and interest costs arising from the cancelled public-private partnership gas plants. MICHAEL HURLEY, President, Ontario Council of Hospital Unions/CUPE, Toronto
Doug Allan

Ontario, N.B. premiers discuss diluted chemo drugs | Globalnews.ca - 0 views

  • Marchese, a Mississauga, Ont.-based company, was contracted to prepare the chemotherapy drugs for four hospitals in Ontario and one in New Brunswick, where about 186 patients received the weaker-than-prescribed drugs. Too much saline was added to the bags containing cyclophosphamide and gemcitabine, in effect watering down the prescribed drug concentrations by up to 20 per cent. Some patients were given the drugs for up to a year
  • Neil Johnson, vice-president of cancer care at the hospital, said oncologists reviewed the cases and “they are confident that there is no causal link between the underdosing and the deaths,” Matthews said in the legislature. “He’s saying it didn’t contribute to their deaths,” she added.
  • The company falls into a jurisdictional grey area, with the Ontario College of Pharmacists and Health Canada unable to agree on who was responsible for the facility.
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  • 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.
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    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.
Govind Rao

Health Canada should regulate hospital pharmacies CBC - 0 views

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    Health Canada should regulate hospital pharmacies, study finds Ontario wants College of Pharmacists to inspect, license hospital pharmacies The Canadian Press Posted: Aug 7, 2013 6:57 AM ET Last Updated: Aug 7, 2013 3:20 PM ET Health Canada should regulate all entities that mix drugs outside a licensed pharmacy, an expert that looked into the chemotherapy drug scare that rocked two provinces recommended Wednesday. It also urged Ontario to bring in stronger rules for licensed pharmacies, by inspecting and licensing those in the province's clinics and hospitals as well as pharmacies that prepare large volumes of drug mixtures. The recommendations come four months after it was discovered that 1,202 patients in Ontario and New Brunswick - including 40 children - received diluted chemo drugs, some for as long as a year.
Govind Rao

Hamilton's Marchese Health Care cleared in chemo drugs scandal - Latest Hamilton news -... - 0 views

  • Ontario committee report on diluted chemotherapy drugs places blame with Medbuy
  • Apr 02, 2014
  • Marchese Health Care in Hamillton allegedly supplied four hospitals in Ontario and one in New Brunswick with watered down chemotherapy treatments, according to Cancer Care Ontario.
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  • National group purchasing organization Medbuy is ultimately responsible for 1,202 cancer patients in Ontario and New Brunswick receiving diluted chemotherapy drugs in 2012, an Ontario legislative committee has concluded. The company didn't do its due diligence in arranging a $2.6-million contract with Marchese Health Care, which provided the diluted drug mixtures, the all-party committee said in a report released late Tuesday.
Govind Rao

Doctor faces jail time for health care fraud, including giving chemo to healthy patient... - 0 views

  • 07 July 2015
  • A Detroit doctor is facing up to 175 years in prison for health care fraud, money laundering and conspiracy which enabled him to file claims with Medicare amounting to $225 million over six years.
Govind Rao

Bill 78 expands health-care accountability - Infomart - 0 views

  • The Sudbury Star Fri Mar 27 2015
  • Nickel Belt MPP France Gelinas' private member's bill to expand accountability in Ontario health care services unanimously passed second reading Thursday in the Ontario legislature. "After the ORNGE air ambulance fiasco and the diluted chemo drugs scandal, everyone wants to see more accountability in our health-care services," said Gelinas. "With this bill, Ontarians can be assured of public accountability in their vital health-care services in hospitals and those services that have been moved out into the community. It will ensure that scandals in our healthcare system are prevented from happening." Bill 78, the Transparent and Accountable Health Care Act, will enact recommendations from two committees that investigated the ORNGE and diluted chemotherapy drug scandals. The act expands the mandate of the ombudsman and the auditor general to any health organization that receives more than $1 million a year from the province. The bill would also extend the Broader Public Sector Accountability Act to all health-sector entities receiving more $1 million in public funding annually.
  • It would apply to Local Health Integration Networks, Community Care Access Centres, boards of health, ORNGE, independent health facilities, long-term care homes, out-of-hospital premises and professional corporations that bill OHIP. Bill 78 will ensure these health-care services get the same oversight as hospitals, said Gelinas, the New Democrats' Health and Long-Term Care critic. "We know where things went wrong with the diluted chemo drugs and ORNGE, and we made some targeted recommendations to prevent it from happening again." Bill 78 also expands the Sunshine List to all major health organizations, mandating publication of the salaries of employees earning over $100,000 per year.
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  • It would also require the Ministry of Health to publish a statement of the amount each physician receives through OHIP billings, explaining the figures do not represent a physician's net income. "Had the sunshine list been applied to ORNGE and had the ombudsman been allowed oversight, we would not have witnessed the tragedies that resulted from the destruction of our air ambulance services," said Gelinas. "The people of Ontario deserve assurances they can trust their health-care services whenever and wherever they need it."
Doug Allan

Weak chemo treatments a 'national' problem: minister - Infomart - 0 views

  • "Health Canada has responsibility for the manufacturing of drugs. The College of Pharmacists have the authority to oversee prescribing," she said. "There is this newish business model where drugs are being compounded outside of the hospital and outside of what we would all consider to be pharmacies. So that is where the grey area is. "Health Canada has pretty clear abilities to move into that area," Matthews said.
  • Hospital budgets are being squeezed by the government and officials are looking to outsource to save money, she said.
  • "One of those things is mixing drugs. The work is done somewhere else and the oversight doesn't get outsourced," Horwath said. The NDP leader said the health ministry still does not have a clear handle on which hospitals are turning to private companies in this way.
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    Deb Matthews suggests Health Canada should oversee private drug mixers
Doug Allan

Diluted chemotherapy supplier regulations are unclear - Toronto - CBC News - 0 views

  • "Marchese Hospital Solutions does not have a licence," as an accredited pharmacy, Lori DeCou, manager of communications for the Ontario College of Pharmacists, said Wednesday.
  • There also questions about federal jurisdiction regarding whether Marchese was operating as a drug manufacturer.
  • "We're looking into the activities that Marchese Hospital Solutions performs, and we're looking to see which activities of which part of this company actually falls under provincial versus federal jurisdiction," said Dr. Supriya Sharma, a senior medical advisor at Health Canada in Ottawa. "We're still in the process of finding that out."
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  • "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."
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    "Marchese Hospital Solutions does not have a licence," as an accredited pharmacy, Lori DeCou, manager of communications for the Ontario College of Pharmacists, said Wednesday.
Doug Allan

No 'ultimate authority' over mixing of drugs: minister - Infomart - 0 views

  • Ontario's health minister acknowledged there is no agency overseeing the regulation of companies mixing medications such as Hamilton-affiliated Marchese Hospital Solutions, which watered down cancer drugs given to 1,176 patients.
  • The college said last week that it accredited the facility and last inspected it in January. But this week it's now saying it only regulates the affiliated Mississauga pharmacy and not the facility where the drugs were mixed.
  • Company owner and operator Marita Zaffiro, a former Hamilton citizen of the year, maintains the pharmacy did nothing wrong and met all contract requirements. She continues to refuse repeated interview requests and refers questions to the ministry.
Doug Allan

Inside Ontario's chemotherapy scandal | Toronto Star - 0 views

  • Claudia den Boer Grima, vice-president of cancer services for the hospital and the region, is on the other end of the line. “There is a problem with a chemo drug,” she says. “It looks like the wrong dose has been given. We don’t know how many.”
  • Peterborough Regional Health Centre, where the problem that affected all four hospitals had been discovered exactly seven days earlier.
  • It would be another seven days before she would learn that all her treatments involving this drug had been diluted by as much as 20 per cent.
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  • Since the crisis, all the hospitals involved have stopped outsourcing gemcitabine and cyclophosphamide mixtures and brought it in-house, mixing their own medications.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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,
  • “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.”
  • 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.
  • 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
  • referred to in the industry as overfill, included to account for possible evaporation.
  • 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.
  • 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.
  • 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.
  • 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.”
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    Since the crisis, all the hospitals involved have stopped outsourcing gemcitabine and cyclophosphamide mixtures and brought it in-house, mixing their own medications. 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. 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."The chance of 1,200 patients getting 4,000 mg exactly - it's just impossible." Marchese 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. Medbuy, Marchese and Jake Thiessen have maintained that cost was not a factor in the error.
Govind Rao

Treating patients in the comfort of their homes; Community-care nurses help people heal... - 0 views

  • Toronto Star Sat May 9 2015
  • Roushad Omar-Ali is relaxing on his comfy sectional watching a cooking show as the doorbell rings and Lesley Rodway lets herself in. "How are you feeling today?" the registered nurse asks cheerily as she studies the chart with his health data. "She's pretty good at what she does," Omar-Ali offers when Rodway disappears to set up his dialysis machine in the bedroom. The Ajax resident has had his share of hospital stays for a stroke, a bad fall and a pacemaker implant. And there's no doubt where he'd rather be for his daily dialysis treatment.
  • The good thing about this is you get to hook yourself up whenever you want," he says. "At the hospital, you sit there and wait and wait whereas at home, as soon as it's done, I disconnect myself." It's thanks to nurses like Rodway that Omar-Ali can be treated in the comfort and convenience of his own home. Arranged through Community Care Access Centres (CCAC), government-funded visits by registered nurses and registered practical nurses provide a range of services including post-surgical, wound and palliative care, IV antibiotics, dressing changes and cancer treatment. (University-educated RNs care for patients with more complex needs while RPNs, who have attended community college, take on less complex cases.) "Patients don't really want to be in hospital," says Dianne Martin, executive director of the Registered Practical Nurses' Association of Ontario (RPNAO). "At home it feels good, they feel in control and more like they're in the driver's seat." They tend to heal faster and are safer from infections, Martin adds. It is also far cheaper to treat someone at home: an average of $42 per visit compared to $842 per day for a hospital bed.
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  • And the cooking's good here," jokes Donna Fox as Rodway stops in at the well-kept bungalow she shares with Bob, her husband of 62 years. Rodway, who's worked for ParaMed Home Health Care for 17 years, manages his symptoms and keeps him comfortable during his terminal illness. "It's very important because I couldn't exist without someone looking after me," Bob, a former marathon runner, says from the raised bed where he watches sports on TV or the awakening of spring outside his window. Suzanne, a Whitby breast cancer patient, credits a home-care nurse for possibly saving her life by sending her to hospital for a swollen hand caused by a blood clot. Now she gets shots of blood thinner at home.
  • "You're near the end, that's awesome," Rodway tells her after administering the day's needle, the 90th in a series of 100 prescribed injections. "You've been a trooper," she adds as Suzanne says, through tears, that her last chemo treatment is just days away. "There are many times I've cried with a client," Rodway says later. "People are appreciative because you're helping them feel better." Rodway, a mother of two young children, sees five or six patients a day in Whitby and Ajax. She says working 25 or 30 hours a week gives her a good balance of career, volunteer work and home life. "I get a lot of satisfaction." For RPN Max Hamlyn, it's all about the personal touch. "You've got the ability to spend time with the person and develop a closer bond," unlike hospitals where staff are too rushed, he says. "It's more than just running in and changing a dressing. I'll ask, 'How are you doing, are you eating OK?' And I say, 'What's the most important thing I can do for you today?' "
  • Hamlyn, who works in Ottawa for the government branch of Bayshore Home Health, covers up to 100 kilometres a day, seeing eight to 10 patients in private homes, retirement residences, detention centres and halfway houses. After 38 years in the profession - doing community care for the last 13 - he maintains "people do much better in their home" than in hospital. "I love it. I think home care is an amazing place for RPNs to work," says Hamlyn, whose youngest client is 23 and oldest, 102. He recalls the year he spent caring for a woman with colon cancer, meeting all her children and grandchildren and always staying for coffee and cake. "You become part of the family," Hamlyn says of many of his clients. "I get along really well with my people. I have a lot of fun with them - we laugh, we joke. They're such lovely people."
Govind Rao

Cancer patient sells business to afford meds; Health-plan coverage doesn't include expe... - 0 views

  • Ottawa Citizen Wed Apr 1 2015
  • Pierrette Breton has been diagnosed with two types of cancer. But instead of concentrating on her extraordinary health challenges, the Ottawa businesswoman has been forced to focus on the financial implications. That's not something she says she expected in Canada. "I thought in Canada we didn't have these problems. We are supposed to be a country that covers these things." "These things" are the drugs she must take to treat neuroendocrine cancer. While cancer drugs administered in hospital - intravenous chemo, for example - are provided at no cost, patients must pay for many drugs they take at home, sometimes costing tens of thousands of dollars a year. A coalition of health groups called CanCertainty wants Ontario to close gaps in coverage that leave some cancer patients with massive bills because they are being treated with drugs at home rather than in the hospital.
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