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Wednesday, December 8, 2010

Drug Safety and Effectiveness in Canada – Charles Hain, Canadian Patient Coalition

The Health Council of Canada – Keeping An Eye on Prescriptions - report is to be commended for bringing forward the idea of a protocol for drug safety messages and their dissemination to stakeholders.

Earlier in 2010, a group of about 30 patient health organizations came together to host the first ever Canadian Patient Summit.  Over the course of two days at the end of March, more than 100 Canadians living with chronic health conditions discussed the future sustainability of healthcare policy in Canada from their vantage point.

While the Summit was not specifically convened to address pharmaceutical issues in Canada, drugs, medical devices and supplies were identified as costly out-of-pocket expenses for patients and a barrier to compliance to prescribed therapies.  For patients with chronic conditions, prescription medications and clinically prescribed therapies are often what helps them to live well, and outside of our hospital system or care facilities.

One critical observation made during the Summit was that in Canada, the patient is left out of any discussion leading to healthcare policy and implementation.  This includes, of course, the absence of an informed patient voice (their concerns, needs, and abilities) with respect to pharmaceutical development, approvals, surveillance and safety to name only a few of the issues.
No one disputes the need for greater after-market surveillance and reporting, nor could anyone desire anything less than rapid and broad disclosure of warnings after adverse drug reactions.  What is often lacking in this area is the process to include patients in discussions earlier in the development and deployment of surveillance protocols.

While MedEffect Canada is laudable, it continues to languish underutilized and perhaps misunderstood.  The sense among patient groups is that the public does not know of the existence of MedEffect rather than their lack of understanding or support for it.  Compliance in reporting adverse reactions would be higher if patients were involved in designing the forms, the process for reporting and for identifying what is important to report.  We have a tendency to blame patients when they don’t act upon the advice of experts.  Perhaps experts need to think more about whether what we are asking is overwhelming or difficult for patients to act upon.  Perhaps we need to ask patients what would work more effectively.

 A final thought has to do with jurisdiction.  In Canada’s federal system, it is not always clear which level of government has or should have the responsibility for various aspects of health care.  A national pharmaceutical program would be welcome by the majority of the public.  Likewise, the Canadian Patient Coalition, which arose from the Summit, advocates for a single electronic patient record which would allow experts to collect and analyse information on adverse reactions through a real-world surveillance of pharmaceutical therapeutic use, for example.

But the greatest positive contribution to sustainable healthcare policy in Canada is to increase patient and public engagement in these critical discussions.

For more information about the Canadian Patient Coalition:
Charles Hain
Public Affairs, Canadian Association of Wound Care & Coordinator,
Canadian Patient Coalition

1 comment:

  1. In the U.S., the government's Food and Drug Administration (FDA) must approve any drug - whether it's prescription or over-the-counter - before it can be sold. The FDA evaluates the safety of a drug by looking at side effects, how it's manufactured, results of animal testing and clinical trials, and more. The FDA also monitors a drug's safety after approval.

    For you, drug safety means buying online from only legitimate pharmacies and taking your medicines correctly.