YELLOWKNIFE — The Northwest Territories government says it’s changing its rollout plan for a fourth dose of a COVID-19 vaccine due to limited supply of a vaccine targeting the Omicron variant in Canada.
The territory said in July it planned to wait until an Omicron-specific vaccine was available before expanding access to a fourth dose, or second booster, to all adults.
Only those age 50 and older, as well as immunocompromised people who are at least 12 years old, can access a fourth shot in the territory.
The Northwest Territories says it is planning a fall vaccine campaign, including phased rollout of the bivalent vaccine and expanded eligibility for a fourth dose.
As it will not have enough of the new vaccine for all residents, the territory says it will likely be offering booster shots of the original vaccines to those who are not considered high risk.
This report by The Canadian Press was first published Sept. 2, 2022.
The Canadian Press
Genomic testing and medico-legal risk | InSight+ – MJA Insight
INTEGRATING genomics into mainstream health care has many benefits, but also presents challenges. One challenge is ensuring that doctors and patients can safely and sustainably benefit from genomic medicine without increased medico-legal risk.
While the number of legal cases in Australia is still relatively small, this moment in time represents an opportunity to develop tools, training and support so doctors and their patients can safely and sustainably benefit from the advancing capabilities without increased medico-legal risk.
Over the past 2 years, we have been exploring the practical and medico-legal risks associated with genomic medicine, particularly in the context of antenatal care. Through our work, we identified that informed consent to test and workforce and funding issues are significant barriers to more effective use of genomics in health care. What we are seeing and how these medico-legal risks can be addressed through tools, training and support are explored below.
Informed consent to test
At the centre of consultations involving genomic medicine are individuals and families grappling with complex and often life-altering decisions. Many people need support both to understand the issues involved and to deal with the consequences of their decisions.
The consent process for people considering genomic testing presents specific challenges compared with other testing and treatments.
Advancing technologies and the increasing availability of expanded screening and testing mean that the practitioner and the pregnant person need to discuss and understand more complex information and face value-laden choices even before deciding whether to go ahead with a test.
Concepts such as “chance” of a condition developing (and the severity of that condition) or “variants of uncertain significance” are somewhat unique to the field of genomics and can be difficult for doctors to explain and for patients to understand.
To put this issue into the antenatal context, guidelines from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Royal Australian College of General Practitioners (RACGP) state that information on carrier screening for the most frequent autosomal or X-linked genetic conditions should be offered to all women planning a pregnancy or in the first trimester of pregnancy. The Colleges also state that all women should be provided with information and have timely access to screening tests for fetal chromosome and genetic conditions.
Guidelines play an important role in outlining the standard of care expected of doctors. Therefore, it is incumbent on practitioners working in this field to be equipped with the knowledge, expertise and tools to have comprehensive and comprehensible consent discussions with their patients about genomic testing.
An additional challenge for the consent process is that technology often develops at a much quicker pace than laws and guidelines. The emergence of expanded screening for autosomal and X-linked conditions and for fetal chromosome conditions can present challenges for doctors and their patients. “Expanded” screening can test for over a thousand conditions, many of which would have very little impact on a person. Explaining the potential impact of a variant of uncertain significance in terms of the chance of a condition developing in a person is inherently difficult.
The well established principles of consent require a doctor to give the person enough information for them to make an informed decision about the test or treatment being offered. This is a patient-centred test, requiring a doctor to discuss not only what a reasonable person in the patient’s position would want to know but also what the particular patient wants to know. The doctor is also ethically and legally obliged to recognise whether the patient has understood this information.
It is also important to ensure that a patient’s choice to have genomic testing is voluntary. An article published in the MJA in 2021 noted that patients may feel foolish to reject a test that is on offer and that a “normalisation” of testing has begun.
This was echoed in a recent Avant webinar, where medical and legal experts discussed issues of genetic testing and pregnancy. There was sentiment from the doctors who attended the webinar that the concept of voluntariness in genetic testing in pregnancy may be eroded by an “expectation” or social “normalisation” that women will accept each test offered. One participant said:
“… practitioners need to be careful to convey respect to women who choose against genetic screening in pregnancy. There is a risk that repeated discussion and repeated offers of testing sends a message that the woman has made an incorrect decision.”
We support the development of standard information and forms to be used as part of the consent process for genetic testing in pregnancy. This would help patients to understand what is involved and assist in their decision making, as well as alleviate some of the medico-legal risk for doctors.
Standard information used in consent discussions also helps to ensure information to patients is balanced, evidence-based and informative. This would lessen the burden on practitioners and means there is less room for allegations of bias in the information they were providing. It also has the potential to make clearer the blurred lines between clinical and research use of genomic test findings, which could, for example, add to the body of information that informs the significance of a rare variant that may have been identified.
It is therefore pleasing to see the National Model of Consent for Clinical Genomics Testing developed by the NSW Ministry of Health in accordance with Action 4A of the implementation plan for the National Health Genomics Policy Framework, on behalf of the Australian Health Minister’s Advisory Council Project Reference Group on Health Genomics. The Clinical Genomic Testing Consent Form developed to support the model can be adapted across jurisdictions and can be used in conjunction with patient information materials to assist patient understanding during the consent discussion. Consent material has also been developed by Australian Genomics.
Workforce and funding issues
Avant has also identified significant workforce pressures and gaps in funding for timely and sustainable care in genomic medicine.
We welcome the Medicare funding announced for genetic carrier screening for all couples, testing for carriers of cystic fibrosis, spinal muscular atrophy and fragile X syndrome from 2023. However, as genetic carrier screening becomes more accessible, there are some practical and medico-legal issues to consider.
With Medicare-funded testing available, the standards for carrier screening could change, with testing becoming the standard professional practice of doctors. More doctors will need to be equipped with the knowledge and communication skills to discuss carrier screening with their patients.
The complexity of these discussions should be reflected in appropriate Medicare item numbers for the consultations. The RACGP is calling for Medicare Benefits Schedule amendments to better support longer consultations for antenatal care that would support the use of time-based level C and D Medicare items for longer antenatal consultations. Such changes would better allow time for the detailed discussions that are required to take place around genetic screening. An alternative would be to introduce an additional cobilled item number specific to genomic testing and counselling which would recognise the complexity of these discussions with patients.
We believe Medicare-funded testing is likely to lead to more testing and, therefore, more people receiving positive results. Doctors we spoke with noted the importance of being able to engage with genetic specialists and counsellors. They reported that patients may need genomic expertise and mental health support. Currently, there can be lengthy delays and challenges accessing these practitioners. Time is of the essence in pregnancy, and workforce constraints could add pressure and stress to patients and doctors. Also, it is not clear that the newly announced funding for carrier screening includes costs associated with genetic counselling to discuss the results.
Research from the Deeble Institute has found that the workforce shortages in clinical genetics and genetic counselling are partly due to constraints on numbers of professionals being trained, which in turn are linked to limited workplace rotations available. While this may be the case with many specialties, particularly following the COVID-19 pandemic and workforce shortages due to burnout, the increased availability of and funding for genomic testing means that workforce shortages in clinical genetics and genetic counselling need to be addressed as a matter of urgency. This will help ensure that patients are given the information they need and alleviate doctors’ concerns about medico-legal risk.
The potential for genomic medicine is great, but the challenges it presents are also significant. Keeping up to date with rapidly advancing knowledge and ensuring patients have enough information so they are making informed decisions about testing are key concerns of doctors practising in this area.
Now is the time to develop tools, training and support so doctors and their patients can safely and sustainably benefit from the advancing capabilities without increased medico-legal risk.
Rocky Ruperto is a solicitor and Legal and Policy Adviser at Avant.
Dr Sally Parsons is a Medical Advisor and Claims Manager at Avant and Clinical Director and GP in Adelaide. Avant is Australia’s largest medical defence organisation.
Disclaimer: This article is intended to provide commentary and general information. It does not constitute legal or medical advice. You should seek legal or other professional advice before relying on any content, and practise proper clinical decision making with regard to the individual circumstances.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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COVID Outbreak at Meno-Ya-Win in Sioux Lookout – ckdr.net
Sioux Lookout’s Meno Ya Win Health Centre has declared a Covid-19 Outbreak after two patients were diagnosed with the virus.
Both patients have been in-patients for a long period of time, which indicates they contracted COVID-19 while at the hospital.
Effective immediately, visitation will be limited at SLMHC to two (2) designated visitors per patient.
Contact tracing is also underway at SLMHC. Anyone who is identified as a risk has been contacted.
“We have processes in place to provide the safest possible environment for our patients, staff and physicians. Our priority is to see this outbreak contained quickly,” says Douglas Semple, SLMHC President and CEO.
In addition to continuing daily screening and adherence to personal protective equipment standards, such as masks and eye protection,
SLMHC’s housekeeping department is following policies relating to increased cleaning and proper handling of an outbreak.
Every 22 minutes a Canadian woman dies of a heart attack. Most of those deaths are preventable – CBC News
Every 22 minutes, a woman in Canada dies of a heart attack.
But the majority don’t have to, experts say, warning that more women will die unnecessarily if the medical community doesn’t tailor care to their needs.
“We have one of the best health-care systems in the world, and we’re not serving women,” said Dr. Paula Harvey, a cardiologist and head of the department of medicine at Women’s College Hospital in Toronto. “We have to do better.”
Heart disease is a top killer of women in Canada, and the push to change that is more urgent than ever. Harvey says more younger women are presenting with classic high risk factors for heart disease: high blood pressure, diabetes and obesity.
“There’s this trend to cardiovascular risk factors starting to be a problem at an earlier age, and I find that disturbing,” said Harvey. “I never used to see a woman in her 40s with high blood pressure. I’m starting to see that, and that’s going to mean that we’ll have more premature heart disease.”
How hormone levels affect heart health
Some studies have already found the heart attack rate among women aged 35-54 has gone up.
Lifestyle factors play a role in the trend, but the threat itself is broader — the majority of Canadian women have at least one risk factor for cardiovascular disease. Women with diabetes and those who come from certain racial or ethnic backgrounds are at higher risk, but fluctuating hormones can wreak havoc with any woman’s heart health, especially as they enter menopause and levels of the heart-protecting hormone, estrogen, start to drop.
That transition starts when women are in their 40s and can catch many off guard, Harvey said.
“I do think that a lot of that comes from the fact that women are still not being educated, they’re not being counselled, they don’t understand the impact of our changing biology with age that puts them at cardiovascular risk.”
Heart disease kills 5 times more women than breast cancer
According to the Canadian Women’s Heart Health Centre, at the University of Ottawa Heart Institute, 24,000 Canadian women die of heart disease every year. That’s nearly five times more deaths than from breast cancer.
Yet when it comes to heart health, experts say it’s still largely a man’s world: Women remain underdiagnosed, undertreated and unaware.
“It is a glass ceiling. It’s a glass ceiling for awareness, it’s a glass ceiling for research and for how we provide care,” said Karin Humphries, an associate professor at the University of British Columbia whose has researched gender and sex differences in the diagnosis, treatment and outcomes of patients with cardiovascular disease.
The basic medical model is still male-dominated and contributes to a general lack of awareness among women and health-care providers, Humphries said. And while awareness is growing, it’s not growing fast enough, she said.
“Everything in our culture emphasizes that cardiovascular disease is a man’s disease. I mean, think of Hollywood. Every time you see a heart attack, it’s on the male, right? You’re not watching a woman in a Hollywood movie having a heart attack.”
Heart attack symptoms more subtle in women
Part of the problem is that women’s symptoms can be different than those of men and can be attributed by both doctors and women themselves to stress and busy lives. For example, months before a heart attack, women may experience unusual fatigue, trouble sleeping, indigestion and anxiety.
Even during a heart attack, the symptoms can be subtle. Women are more likely to have chest discomfort, shortness of breath and even neck, jaw or back pain.
“I was still, you know, two months after my event, still reeling from that shock,” said Risa Mallory, who had a heart attack four years ago at age 61.
Mallory had been experiencing discomfort in her chest for several days, she said, but it came and went and didn’t seem so bad — until it suddenly was.
“On the fourth day, I experienced chest pain. It had changed. It was much more severe. I was feeling nauseous and I had this sense of fight or flight,” she recalled. “I remember sitting in the car, rocking, and saying, ‘We gotta go, we gotta go, we gotta go.'”
Mallory ended up in the emergency room and got help in time. But it was a close call. Heart disease runs in her family, she was aware of her own risk, but she still almost missed the warning signs.
That’s something that happens often, according to a 2018 Heart and Stroke Foundation report. The report found that early signs of a heart attack were missed in 78 per cent of women.
“What it tells us is that there are still a lot of inequalities and biases at the community level and the health-care provider level,” said Dr. Thais Coutinho, a cardiologist and chair of the Canadian Women’s Heart Health Centre at the University of Ottawa Heart Institute.
Many women are in the dark, Coutinho said, in large part because much of the medical community is too.
Most cardiac research done with male patients
Even now, the majority of heart disease research is conducted on men — despite important physiological differences, she said. Women’s hearts and arteries are smaller, and plaque builds in different ways. Standard diagnostic tests like angiograms and stress tests are often not sensitive enough to detect heart disease in women.
“That assumption still permeates through the cardiovascular research community that women are small men,” Coutinho said. “I do a lot of sex- and gender-based research, or women-specific cardiovascular research, and it’s amazing the differences that you find if you look. All of the gaps that we know exist from awareness, diagnosis, treatment, care, rehabilitation, education, everything — it starts with knowledge.
“So if we don’t even know what the differences are, we don’t know how to manage them.”
‘There’s something wrong with my heart’
Samia Janna was 48 when she first went to her doctor in 2018 because of shortness of breath. The Ottawa-area woman was prescribed anti-anxiety medication and told to take it easy. But the symptoms persisted.
Janna went back to her doctor twice more, only to be given the same advice.
“At that time, I said, ‘No, I know it’s not anxiety,'” Janna says. “I know myself. There’s something wrong with my heart.”
Blood tests didn’t flag anything, but Janna insisted on an ultrasound to check her heart. It revealed Janna’s heart was enlarged and causing damage to her heart valves. She ended up having two open heart surgeries.
Janna says it was hard to let go of her anger about the fact that her concerns were initially dismissed. She joined a cardiac rehabilitation program and says it helped her regain her physical and emotional strength. “If it wasn’t for them. I would have been in a different place now, in a very dark place.”
Female patients less likely to get cardiac rehab
Research finds women are up to 50 per cent less likely than men to attend cardiac rehab programs, often because they don’t get referred to one or face other barriers to follow-up care, including a tendency to minimize their own needs.
It helps explain why women who have a heart attack are more likely to die or experience a second heart attack compared to men.
Harvey says research is beginning to uncover the biological, medical, and social reasons for this — and the hope is that new knowledge will lead to advances in tailoring prevention and treatment to women’s needs.
But she points out, 80 per cent of heart attacks can be prevented and women can decrease major risk factors by managing high blood pressure, not smoking and sticking to a healthy weight. Harvey says women should also urge their doctors to check their hearts.
“We need to be empowered,” she says. “Knowledge is power. Advocacy is power. And do what you can so that you are aware of cardiovascular risk.”
And though prevention is key, Humphries says women should not hesitate to get help if they feel something is wrong.
“Call 911 and ask for help. Don’t worry about, you know, taking up time for health-care providers. They’re there to help you. And if you find out there’s nothing wrong with you, that’s wonderful. But absolutely do not hesitate and call 911.”
Genomic testing and medico-legal risk | InSight+ – MJA Insight
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