15 minute read
Long-term care
Pharmacovigilance: Committing to safety for Canadians – The case of COVID-19 vaccine
By Victoria Bugaj, Jacob Poirier, and Certina Ho
We can all agree that the year 2020 can be summarized with one word: unprecedented. The same velocity with which COVID-19 swept throughout the world, medical experts and pharmaceutical industry scientists worked diligently to provide a solution. There has never been more interest, expertise, or upfront investment dedicated to providing the world with a vaccine. In less than one year from the onset of the global pandemic, Canada has approved the first COVID-19 vaccine for use in December 2020.
In today’s society where it can be difficult to identify and verify credible sources of information, it is not surprising that the public perception on the safety of a new drug or a new vaccine may be divided. What everyone may not be fully aware of, however, are the rigorous systems that are in place to ensure the safety of Canadians before and after a drug product or a vaccine is approved.
The Clinical Trials Database is managed by Health Canada. It provides a public listing and source of information related to phase I, II and III clinical trials in patients involving human pharmaceutical and biological drug products: • Phase I clinical trials are usually performed on healthy volunteers to find out the pharmacological actions of and the safety (i.e. side effects) associated with increasing doses of the drug. • Phase II clinical trials are meant to assess the efficacy of the drug in patients with medical conditions to be treated/diagnosed/prevented, and to find out the safety (i.e. side effects) and risks associated with the drug. • Phase III clinical trials are intended to collect additional information to confirm the clinical efficacy and safety under the proposed conditions of use for the drug. In other words, these trials evaluate the drug’s efficacy, safety, and effectiveness (i.e. how well it works) in people.
The evaluation of safety and efficacy of a drug product or a vaccine does not stop when the product is approved; in fact, once a drug or a vaccine becomes available in the market, it is constantly being monitored and evaluated for safety. In addition to phase I, II and III clinical trials, what may be lesser known is Phase IV clinical trials: • Phase IV clinical trials are studies performed within the approved indication after the drug has been approved. This is part of post-market surveillance and reflects the combined effort of the pharmaceutical industry and Health Canada to continuously survey for adverse reactions related to the drug or the vaccine once it is approved. This process ensures every approved drug product or vaccine is continuously monitored for rare adverse events that may not have been captured in previous phases of clinical trials.
THE COVID-19 VACCINE
Although, the COVID-19 vaccine was developed and approved in less than a year, one must keep in mind that the abundance of resources available for this to occur was unparalleled. As a result, the multiple phases of clinical trials took place simultaneously with Health Canada’s review of the incoming data and evidence.
Drug manufacturers are obligated to relay any reported adverse events to Health Canada by performing risk monitoring activities, post-marketing studies and encouraged expedited reporting of possible adverse events associated with their products. For example, as with all drug products, the COVID-19 vaccines are subject to Good Pharmacovigilance Practices (GVP) Guidelines. According to the guidelines, the manufacturer is required to report serious adverse drug reactions (with respect to the drug) to Health Canada within 15 days after receiving or becoming aware of the information. Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals to Health Canada is also effective as of December 16, 2019. In addition, under the Health Canada’s Canada Vigilance Program, an online portal is available where anyone can report a side effect to a drug, a vaccine, or a health product. When combining reports from all sources, it allows for the opportunity to identify and highlight potential safety concerns, including those that may have been previously unrecognized.
Although the speed at which the COVID-19 vaccines entered the market has been unprecedented, rest assured the safety and reporting standards to which they are upheld are no different than any other drug products or vaccines. In fact, in response to the pandemic, Health Canada made a commitment to increase the monitoring and assessment of any vaccine safety issues via amplified collaboration and data sharing between global health partners, including the World Health Organization. This diligent monitoring of adverse reactions is an ongoing process, which ultimately helps to ensure safe administration of the COVID-19 vaccine for all Canadians. For further information, please refer to the “Vaccines and treatments for COVID-19: Safety after authorization” website at https://www.canada.ca ■ H
Spiritual care promotes employee well-being
By Sarah Quadri
Bonnie Jennings is joyfully playing peak-a-boo with her daughter – for the first time in 33 years.
It’s a feeling she’s savouring while working from home and caring for her daughter at the same time. But this joy is only a recent development for Jennings, after many long and difficult days, since the pandemic began.
“My daughter Sarah is non-verbal and has a disability; she usually attends a day program while I’m at work every day,” says Jennings, an Ontario-based former Personal Support Worker (PSW) turned Service Coordinator at SE Health – a not-for-profit social enterprise and one of Canada’s largest health care organizations specializing in home care. “When the pandemic hit, all of Sarah’s programs stopped; my husband and I were working fulltime and we don’t have help. I have a very strong work ethic and it was extremely hard for me to balance everything – it was a huge adjustment and I felt overwhelmed. I cried every day for three months.”
During these trying times, Jennings turned to one of the only places she knew she could – for comfort and support – her employer, where she’s worked for almost 20 years.
“I’m not a spiritual person but when I heard about the care services that SE Health is offering, I thought to myself, let’s try this to see if it will help me,” adds Jennings.
What Jennings discovered was even more than she hoped for and it helped her to see her situation in a different light.
“I found a wonderful woman by the name of Susan Morgan and after responding to me immediately, Susan told me that she has experience living and working with people who have disabilities. Right away, I felt a Bonnie Jennings with her daughter Sarah.
sense of relief – Susan knows what I’m going through. She was supportive, non-judgmental and kind; she really listened to me and was honest. Susan also encouraged me to realize that the situation I am experiencing isn’t just about me; it’s about Sarah, too. She helped me to see that Sarah’s routine also changed and that I needed to be aware of what she may be feeling. Susan earned my trust immediately and when she says she was going to check up on me, she was true to her word.”
“I understand that the focus of my role is to be a compassionate and listening presence – to reflect together with those I encounter. Human connection is impactful and can energize us,” says Susan Morgan, Spiritual Care Provider at SE Health. “As individuals, we already have what we need for our journeys, but in times of stress we doubt that. We do our best work when we do it together. In our spiritual care roles, our team is trying to model that; to encourage awareness of one another, the appreciation of our shared vulnerability and trust that we are stronger and more resilient when we work together.”
At SE Health, collaborating to promote the health and well-being of its employees and clients is paramount, especially during the pandemic – ensuring everyone is receiving the support they need, no matter what role they have in the organization. As part of that commitment to care, SE Health is proud to be the only home care organization in Canada to offer spiritual care, at no cost, to its employees and clients, in all its service delivery centres, across the country. Since the pandemic began, the shift to virtual spiritual care is having an enormous impact, benefitting many people.
“Virtual spiritual care is the cornerstone of SE Health’s commitment to its internal and external communities during COVID-19,” says Nancy Lefebre, Senior Vice President of Knowledge and Practice and Executive Director, Saint Elizabeth Foundation. “The need is greater than ever and our response remains steadfast – a wonderful team of spiritual
care providers, including Susan, who are dedicated to the well-being of our staff and clients, no matter their circumstance. SE Health is proud to be pioneering this vital service in home care.”
Last November, the SE Health Spiritual Care Team and the Saint Elizabeth Foundation were honoured to present at the Hospice Palliative Care Ontario (HPCO) Conference about the shift to virtual spiritual care and the impact this program is having across its organization.
“Before the pandemic, we offered direct one-on-one support, in-person,” adds Morgan. “Our team members would make visits to wherever the employee or client lives, over weeks, months and even years, depending on the situation.”
These visits also included caring for the staff and clients at Journey Home Hospice – an alliance involv-
ing and staffed by SE Health that improves equitable access to hospice palliative care for Toronto’s homeless community and provides patients with quality health care services and a safe, welcoming and caring environment for their end-of-life journey.
“While we can’t support in-person during the pandemic, we still want to be there to offer continuity of care, especially during a crisis like COVID-19,” Morgan adds.
When home spiritual care visits halted last March, Morgan and her colleagues seamlessly switched to Microsoft Teams to support staff and clients. During the pandemic this support has expanded, servicing calls from groups and teams across the SE Health system who are seeking a compassionate, listening ear.
“Susan’s words touch all of us and always come at the right time,” says Dawn Chetley, London, Ontario-based Health Services Supervisor at SE Health. “Susan’s messages about the importance of self-care and remaining resilient are critical for our teams to hear especially during the stress and burden of the pandemic. Susan takes the time to review self-calming practices and gives permission for our team members to spend time caring for themselves. As nurses we do an excellent job caring for others but often do a lousy job caring for ourselves.”
“My conversations with Susan helped so much,” adds Laura, an On-
Sarah Quadri is Director, Corporate Communications, SE Health. tario-based PSW who’s enjoyed working at SE Health for the last 14 years. “I am very thankful that I work for a company with heart and support. I always feel valued as an employee and hopefully I will be able to stay at SE Health until my retirement!”
Jennings feels the same way. With the support of her amazing colleagues and Morgan, she’s moved from feeling overwhelmed to enjoying every minute she has, working from home while spending time with her daughter.
“Some days are better than others, but this time together has bonded us more than ever. If I wasn’t at home, I may have missed the chance to play peak-a-boo with Sarah; I can’t imagine that, I am so grateful.”
To read more about the extensive spiritual care services SE Health offers to the wider community, across Canada, please visit www.reflectionroom.ca ■ H
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New report on aging calls for makeover of Canada’s approach to supporting seniors
By Don Drummond and Duncan Sinclair
The challenges of enabling our aging citizens to age well, particularly over the long-term, have become glaringly clear throughout the COVID-19 pandemic. Approximately 80 per cent of deaths from the virus have occurred in those aged 80 or older, waking Canada up to the reality that something has to change.
In late November, we released a report titled Ageing Well that calls for a drastic makeover of how Canada approaches support for seniors. In it, we propose a proactive, coordinated, and holistic model of care that considers four primary types of support – health and personal care, housing, lifestyle and social – as vital to ensuring our elderly population can age well.
CANADA’S CURRENT LANDSCAPE FOR SUPPORTING SENIORS
Canada’s health care model tends to focus on alleviating physical and mental limitations, with housing, lifestyle and social needs coming as secondary if at all. Yet, key to supporting seniors is acknowledging the role that age-inplace options, such as home care that allows seniors to stay and age in their homes and communities, can play in sustaining their health and happiness. Canada is an international outlier when it comes to investing in age-inplace options and the success stories from other countries demand our attention and re-evaluation of our own policy of institutionalization.
In Canada, between one-in-nine and one-in-five seniors in long-term care facilities could do well with a home care option, which is often a more appropriate and less expensive path. Many seniors move into long-term care because of frailty and dementia. However, integrating the additional pillars of housing, lifestyle and social needs can prevent or delay the onset of frailty and dementia and lessen their severity. The benefits of age-in-place options are not exclusive to any one age, condition, diagnosis or factor – all seniors deserve this consideration when choosing a care plan.
Ultimately, and as the evidence in our report points out, interweaving these additional pillars into the planning and delivery of care is necessary for our elderly population to age happier and healthier.
SO, WHAT’S NEXT?
Our goal in writing the Ageing Well report is to help actualize change. While we all have a role to play in ensuring the well-being of Canada’s seniors, policymakers in government will be responsible for leading the implementation of our policy recommendations. Policy change will also be required to make long-term care homes safe for residents and workers, which will be a significant and expensive shift in the status quo. But we do not ask policymakers to act alone – they will need to work hand-in-hand with local communities, hospitals, primary caregivers, and other stakeholders in order to effectively drive a transformation in seniors’ support that provides seniors with a quality of life of which we can be proud.
There are two mains steps our provincial and federal governments must take – in which relevant stakeholders should seriously engage – to turn the trajectory of our support for seniors around.
First is the need to deal with the COVID-19 crisis that has sickened and killed seniors in long-term care facilities across the country. There is both the immediate issue of addressing quality of care issues and now the major economic implications that will come with the post-pandemic reforms expected to take place across long-term care, including its position as a component of Canada’s broader health system.
Second, we need to put the issue into the broader context of what seniors truly want: to age-in-place. Many seniors do not want to go into long-term care homes. They want to age in their own homes or in related housing in their communities that enable them to exercise the greatest level of independence they can. We owe it to our elderly population to consider how they would like to live these years of their life, especially if that desire is beneficial to their health and well-being and makes economic sense.
At the government level, the issue of how we can better support seniors – like most policy issues – comes down to costs. Luckily, our report’s proposed approaches can be seen as a “win-win” for government and seniors, wherein where seniors can have what they want, and the government can too. Home care costs between $40 – $100 per day, which jumps to $200-plus per day for long-term care and $1,000-plus per day for those in hospitals receiving care that could be provided elsewhere, including home care. Clearly, age-in-place care does not necessarily lead to increased spending. Rather, it is a different approach to meeting the combined needs of seniors that would see both reduced costs and the betterment of seniors’ lives.
As we explain in Ageing Well, there is an obvious problem to address with how support is made available to Canada’s rapidly growing and ageing seniors population. With the stark increase in demand anticipated from the Baby Boomer generation in coming years, we must act now! We must dramatically change our policy direction, recognize the integral role of social, housing, and lifestyle needs in conjunction with health care needs play in a senior’s life, and pay attention to the insights offered by other countries around the world. We’d be foolish not to.
The system needs to be revolutionized – and we don’t have time to wait. ■ H
Don Drummond is the Stauffer-Dunning Fellow and Adjunct Professor at the School of Policy Studies at Queen’s University, former Chair for the Commission on the Reform of Ontario’s Public Services and author of the 2012 Drummond Report outlining how Ontario was to tackle debt levels. He is also the former Chief Economist for the TD Bank. Duncan Sinclair, a Member of Order of Canada and of the Canadian Medical Hall of Fame, is internationally recognized for his work in healthcare reform. He was the first non-MD to be Dean of Medicine in Canada, led the creation of North America’s first alternative funding program for academic medicine, and was Chair of Ontario’s Health Services Restructuring Commission from 1996 to 2000.
