BHB: We have policy on using contrast dye
Bermuda Hospitals Board has gone public on its use of a contrast dye which is being investigated in the United States for potential harmful effects.
The board, which recently apologised and paid compensation to widower Allan DeSilva for administering the gadolinium-based substance to his wife Sylvia for an MRI scan in March 2008, said yesterday it introduced a formal policy on how the dye should be used a month after it was given to Mrs DeSilva.
A spokeswoman said King Edward VII Memorial Hospital followed recognised best practice and now only ever used gadolinium when clinically necessary, screening every patient beforehand for potential kidney issues which could react badly with the dye.
Mrs DeSilva, a diabetic, developed the rare and debilitating illness nephrogenic systemic fibrosis (NSF) after having four doses of gadolinium — two at KEMH and two at Brigham and Women’s Hospital in Boston. She died aged 72 in August 2012, leaving her husband and daughter Donna bereft.
The US Food and Drug Administration (FDA) warned doctors in 2006 and 2007 to carefully assess the need for performing MRI scans with gadolinium-based contrast agents (GBCAs) in patients with advanced renal failure.
Mrs DeSilva, who had a history of kidney problems, was given the drug at KEMH the following year, which the BHB spokeswoman admitted yesterday should not have happened.
She would not comment on why the patient was given gadolinium after the warnings were issued, as she said it would breach patient confidentiality.
The spokeswoman said: “BHB has already agreed with Mr DeSilva that his wife should not have had the test in March 2008. BHB has apologised to Mr DeSilva and his family for this and entered into an agreement as reported in detail in The Royal Gazette last week.
“In March 2008, BHB was aware of gadolinium concerns for a small group of patients and, while it was in the process of finalising its formal policy, which was signed in April 2008, patients with kidney disease who had increased risks for MRI tests using gadolinium should not have had the test.
“Given that another US hospital also gave Mrs DeSilva the same test twice the year before, however, it is not possible to know at what point Mrs DeSilva developed NSF.”
The BHB spokeswoman said she could not comment on who was responsible for sharing FDA warnings with KEMH staff at the time the drug was administered to Mrs DeSilva.
“This is a constant and ongoing process,” she said. “There is no one person responsible for all advisories, but managers and clinical educators in different areas have to constantly inform staff of updates.
“Certain advisories come from vendors, others through professional associations. Healthcare advisories and best practices constantly change.”
In 2010, the FDA advised medics not to use three branded GBCA drugs in patients with chronic, severe kidney disease and in July this year it announced it was investigating the risk of brain deposits following repeated use of GBCAs for MRIs.
The BHB spokeswoman said the board was assisted by Johns Hopkins Hospital in Baltimore in developing a formal gadolinium policy, which was in place by April 2008.
“This was not a simple response,” she said. “Gadolinium is still a standard for many MRI tests and so the guidance had to help physicians and diagnostic imaging staff assess patients and balance the clinical urgency of the test against the risks.”
She added: “The warning can only advise of potential adverse reactions. A clinical assessment has to balance whether a patient could be more adversely impacted by not being tested and so not receiving appropriate treatment based on the results, or the risk of the test itself. This is true of all diagnostic tests.”
BHB’s formal policy now ensures patients take a kidney function test and sign a consent form before gadolinium is administered. MRI scans using contrast agents are only conducted with a physician’s referral.
The spokeswoman said BHB followed the FDA’s July 2015 advice to limit the number of tests using gadolinium to only those that are clinically required.
“We are the only diagnostic imaging provider in Bermuda who, over the last two years, has implemented clinical guidance around tests specifically to address over use and repetitive exposure to either radiation or contrasts,” she added.
BHB conducted 3,019 MRI scans in 2014 and 15, compared to 5,137 in 2010 and 11. The board attributes the reduction in part to stricter guidelines on carrying out scans only when clinically necessary and on competition on the Island.
Last week, gadolinium was used in 33 of the 108 scans conducted at KEMH.
Kidney disease is rising in Bermuda — in March this year KEMH had 166 dialysis patients, compared to 54 in 2002 and 2003.
Mr DeSilva, 80, who founded Bermuda Healthcare Advocacy Group to press for more accountability for the Island’s only hospital, urged patients to find out the facts about gadolinium before consenting to an injection. Recalling his wife’s last days, he said he couldn’t forget how she held his arm and told him: “I don’t want to die alone”.
He added: “It’s just the sadness of losing someone before they should die. The last words she said to me, the day before her death, were ‘don’t let me die’.”
Asking a patient to sign a consent form before being given gadolinium for an MRI scan is not necessarily the one and only right thing to do, according to a US radiology expert.
Christoph Wald, professor of radiology at Tufts University Med School and interim chairman of radiology at Lahey Hospital & Medical Center in Boston, told The Royal Gazette: “We put the patient in a difficult position if we let the patient make the decision without the proper context.”
He explained to this newspaper the policy in place at Lahey for administering gadolinium-based contrast agents to patients, much of which tallies with Bermuda Hospitals Board’s policy for King Edward VII Memorial Hospital.
Both require a physician’s referral for an MRI scan to be conducted and for patients past a certain age (50 for Lahey and 45 for KEMH) to have a blood test for kidney function.
Where the two hospitals differ is in the responsibility they place on patients undergoing MRI scans using gadolinium. BHB has, since April 2008, asked patients to sign a consent form which warns that patients with poorly functioning kidneys are at risk of developing nephrogenic systemic fibrosis (NSF). Dr Wald said: “We do not currently have them sign consent forms. That puts the patient on the spot. I do not see how that alone would help the patient with making the best choice. I think it is critical that the physician [who ordered the scan] and the radiologist who approves it consider for each individual patient whether the benefits of the test outweigh the risks.”
He said it was a “very tricky business to generate the right level of medical understanding” in patients when they require medically necessary tests as they could not be expected to truly balance the benefit of the exam with the risk of harm from gadolinium themselves.
“NSF is super-rare,” he said. “We don’t want, out of fear, that people deny themselves the benefit of an important exam.”
Dr Wald added that “relegating any and all responsibility” to the patient — a lay person — was less safe than an “elaborate system” of cross-checking between the physician ordering the test, lab results and the radiologist prescribing the contrast and conducting it, but he acknowledged that hospitals’ policies on consent vary widely.
Gadolinium-based contrast dyes are used in the majority of MRI scans but the US Food and Drug Administration (FDA) has warned of the risks of giving the drug to patients with impaired kidney function. In March 2008, Sylvia DeSilva, a patient with kidney problems, was given the dye at King Edward VII Memorial Hospital. She developed NSF and died, aged 72, in August 2012. BHB apologised and paid compensation to her widower Allan DeSilva earlier this year.
Dr Wald said he could only comment on how tests are conducted at Lahey.
The physician said Lahey’s gadolinium policy had been in place since 2008. It requires a written order by a doctor for every MRI scan to “establish clearly and for the record the reason for the examination” and for a radiologist to “protocol” every request, which includes prescribing the contrast and calculating the right amount of gadolinium based on the patient’s weight in order to only give the necessary minimum.
“The radiologist looks at the order and decides whether that type of study is appropriate to answer the clinical question that’s being asked,” said Dr Wald. “The radiologist verifies that the examination is medically necessary and then decides how it’s going to be done.”
Patients aged 50 and over — and anyone else who could have impaired renal function — are given a test known as an eGFR (estimated glomerular filtration rate) to determine kidney ability. “Nobody with a reading over 30 has ever developed NSF based on my current understanding of the medical literature,” said Dr Wald. If the reading is less than 30 it indicates a serious kidney problem and the MRI needs to be approved by a radiologist immediately before the exam by special written order. Many times the radiologist will decide not to use gadolinium or recommend an alternative test.
“If you have a life-threatening condition that requires decision-making — if you have a aneurysm, say — you don’t want to deny patients life-saving tests,” said Dr Wald.
