For the record
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## Canadians frustrated with a health system that doesn’t work, CMA says

Canada’s health care system is failing patients, particularly vulnerable groups such as children, the elderly, Aboriginal people, people in rural areas and those with mental illness, the Canadian Medical Association’s public consultations on health care transformation have revealed.

Canadians from coast to coast complained of unacceptable wait times, crowded hospitals and a system that does a poor job of transitioning patients from one level of care to another, according to an association report, *Voices to Action*, that summarizes six town hall meetings and more than 4000 online comments ([www.cma.ca/multimedia/CMA/Content\_Images/Inside\_cma/Advocacy/HCT/HCT\_townhalls\_en.pdf](http://www.cma.ca/multimedia/CMA/Content\_Images/Inside_cma/Advocacy/HCT/HCT_townhalls_en.pdf)).

“Without a doubt, concerns about our health care system run deep,” CMA president Dr. Jeff Turnbull stated in the report. “We heard that there is a ‘moral imperative’ to fix the system, but that our biggest adversary is apathy.”

Thousands of Canadians who participated in the CMA’s national dialogue on health care transformation over the past year say the country’s health care system may be good at providing “Humpty Dumpty medicine” for acute illness and injury, but is much less effective at caring for the elderly and others with long-term or chronic illness.

They also complained of a lack of preventive care to address some of the social factors that affect health, such as education and income, in addition to the high cost of drugs and inequities in coverage between provincial health plans.

In a bid to cover some of these gaps, Canadians who participated in the consultations suggested a litany of health services for expanded coverage under the Canada Health Act, including dental care, eye care, long-term, home and hospice care, and alternative medicine.

An overwhelming majority also called for some kind of national drug or pharmacare plan.

The input gathered during the public consultations was scheduled to be reviewed by delegates attending the CMA’s annual general council meeting in August and will be used to inform the association’s new “strategic vision” of what a transformed health care system should look like. — Lauren Vogel, *CMAJ*

## Canadians want more accountability in health care system, survey says

Most Canadians feel the health services available to them have stayed the same or gotten worse over the past eight years, and would prefer a system that is national in scope and would hold provinces more accountable for the care they provide, according to the Canadian Medical Association’s *11th Annual National Report Card on Health Care*.

The accountability measures should include the appointment of an independent ombudsman to handle complaints about poor health service, the publication of comparative provincial statistics about complaints and adoption of a patient health charter, according to the telephone survey of 1000 Canadians and online survey of 1026 Canadians conducted by Ipsos Reid ([www.cma.ca/multimedia/CMA/Content\_Images/Inside\_cma/Media\_Release/2011/reportcard/2011National-Report-Card\_en.pdf](http://www.cma.ca/multimedia/CMA/Content\_Images/Inside_cma/Media_Release/2011/reportcard/2011National-Report-Card_en.pdf)).

Some 47% of Canadians surveyed say the health services they receive are unchanged since the 2004 federal-provincial Health Accord was signed, while 36% say they have gotten worse. Only 15% report services improving.

About one-third of Canadians reported receiving poor health care services. Such complaints are typically linked to quality (46%) or wait time problems (33%), rather than problems of access to care (10%).

“Patients too often are lost in the shuffle in health care,” said CMA president Dr. Jeff Turnbull in a press release ([www.cma.ca/multimedia/CMA/Content\_Images/Inside\_cma/Media\_Release/2011/reportcard/Reportcard-release\_en.pdf](http://www.cma.ca/multimedia/CMA/Content\_Images/Inside_cma/Media_Release/2011/reportcard/Reportcard-release_en.pdf)). “Canadians want their territorial, provincial and federal governments to get together and create a system that revolves around the patient, rather than the other way around, and they favour practical steps that can move us forward in that direction.”

A majority of Canadians also think that the health system should follow a national model that first and foremost takes into account the collective needs of all Canadians, rather than a system that focuses primarily on the individual needs of each province or territory, the report states.

Moreover, more than half of Canadians would like to see future federal–provincial accords that are national in scope, with all provinces coming to a single agreement, rather than negotiated separately with each provincial jurisdiction.

Under such agreements, some 49% of Canadians believe provinces and territories should spend their allocated funding as they see fit, while 46% would choose a model whereby a portion of the funding would be held back until performance targets are met. If targets are not met, some of the monies would be redistributed to other provinces and territories, and some would be used to fund service for out-of-province patients unable to receive care in their own jurisdiction.

Some 93% of Canadians also agree they would like their provinces to adopt patient health charters to ensure accountability and responsibility for the quality of care received.

The vast majority of Canadians also support making such a charter a requirement for governments as part of the upcoming 2014 federal–provincial agreement, and half agree that jurisdictions that do not set up patient health charters within a reasonable time frame should receive less funding under the new agreement.

Support for the charters as an accountability mechanism is driven by a belief that a charter would help shorten wait times, increase quality of care and allow access to care when needed, the report card states. — Lauren Vogel, *CMAJ*

## WHO unveils psychological first aid guide

Look, listen and link. They are three core principles which should govern the actions of those who come across distressing events such as accidents, fires, natural disasters or sexual violence, according to World Health Organization guidelines for providing “psychological first aid” (PFA) during crises.

The principles “will help guide how you view and safely enter a crisis situation, approach affected people and understand their needs, and link them with practical support and information,” the WHO states in its *Psychological first aid: Guide for field workers* ([http://whqlibdoc.who.int/publications/2011/9789241548205_eng.pdf](http://whqlibdoc.who.int/publications/2011/9789241548205_eng.pdf)).

The agency distinguishes between “psychological first aid” and “psychological debriefing,” and asserts that the former is “an alternative to ‘psychological debriefing’ which has been found to be ineffective. In contrast, PFA involves factors that seem to be most helpful to people’s long-term recovery (according to various studies and the consensus of many crisis helpers). These include: feeling safe, connected to others, calm and hopeful; having access to social, physical and emotional support; and feeling able to help themselves, as individuals and communities.”

The report argues that the scope of the disaster should not change the nature of the assistance, or psychological first aid, that is provided. It is a “humane, supportive response to a fellow human being who is suffering and who may need support. PFA involves the following themes: providing practical care and support, which does not intrude; assessing needs and concerns; helping people to address basic needs (for example, food and water, information); listening to people, but not pressuring them to talk; comforting people and helping them to feel calm; helping people connect to information, services and social supports; (and) protecting people from further harm.”

The guide also offers a host of tips on providing psychological first aid, such as “try to protect the person from exposure to the media for their privacy and dignity” and “don’t impose your beliefs, or spiritual or religious interpretations of the crisis, on the person.”

“Someone who has been through a distressing event may want to tell you their story. Listening to someone’s story can be a great support. However, it is important not to pressure anyone to tell you what they have been through. Some people may not want to speak about what has happened or their circumstances. However, they may value it if you stay with them quietly, let them know you are there if they want to talk, or offer practical support like a meal or a glass of water. Don’t talk too much; allow for silence. Keeping silent for a while may give the person space and encourage them to share with you if they wish,” the guide adds. — Wayne Kondro, *CMAJ*

## FDA unveils regulatory science plan

Call it an ambitious methodological agenda. Arguing that increasing complexity in the development of drugs, biologics and medical devices is compromising the regulatory capacity to oversee safety, the United States Food and Drug Administration (FDA) has unveiled a strategic plan to develop new tools that would allow the agency to do its job.

The plan identifies a raft of agency needs, including new means of gauging human susceptibility to adverse drug reactions; refined methods of assessing clinical trial design and statistical methods of analysis; and new computational methods for determining human risk.

The strategic plan, *Advancing Regulatory Science at FDA*, defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products” ([www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf](http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf)).

The plan identifies eight broad priority areas in which the FDA plans to funnel “available resources.” Those priorities:

*   “Modernize Toxicology to Enhance Product Safety

*   Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes

*   Support New Approaches to Improve Product Manufacturing and Quality

*   Ensure FDA Readiness to Evaluate Innovative Emerging Technologies

*   Harness Diverse Data through Information Sciences to Improve Health Outcomes

*   Implement a New Prevention-Focused Food Safety System to Protect Public Health

*   Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security

*   Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products.”

The strategic plan is remarkably and repeatedly candid in outlining current FDA limitations. For example, it notes that “critical gaps exist in our understanding of the relationship between patient response and preclinical toxicology findings.”

“For example, non-clinical safety assessment is often conducted in normal healthy test systems and tends to be exposure-based; it does not attempt to evaluate the possible risk of rare or idiosyncratic responses that may arise from potential interactions with the presence or progression of disease or the genetic background or other exposures of patients and consumers. Also, in some cases, the true predictive accuracy of many toxicology models and safety assays remains uncertain and in need of more rigorous validation against actual human and animal adverse event data to define their reliability and possible limitations.”

FDA Commissioner Dr. Margaret A. Hamburg argued that modernization of the agency’s methodological tools is critical. “The breadth and scope of FDA’s regulatory oversight is extraordinary, touching the lives of every American, through the food they eat, the medicines they take, and the medical devices they use,” she said in a press release ([www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268293.htm](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268293.htm)). “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard.” — Wayne Kondro, *CMAJ*