Madam Chair, honourable members, ladies and gentlemen, thank you for the opportunity to present to you today. Merci pour l'occasion de présenter à votre comité aujourd'hui.
My name is Myrella Roy, and I am the executive director of the Canadian Society of Hospital Pharmacists. Before accepting this position, I spent 17 years as a hospital pharmacist and clinical manager with the Ottawa Hospital. The society is the national voice of hospital pharmacists in Canada. We are a not-for-profit organization committed to the advancement of safe, effective medication use and patient care in hospitals and related health care settings.
Today I wish to bring to the committee the perspective of our 3,000 members across the country on the issue of post-market surveillance of pharmaceutical products in Canada, both prescription and non-prescription. In particular, I want to comment on the proposal within Canada's food and consumer safety action plan to introduce hospital-based mandatory reporting of serious adverse reactions to federally regulated health products.
The action plan, as you know, proposes a new approach that helps prevent problems in the first place, targets the highest risks, and responds rapidly to protect the public.These are noble goals indeed, but we are concerned that the move to mandatory reporting of all adverse reactions could make it harder, not easier, to identify the highest risks and respond rapidly to protect the public.
l also want to share with you a proposal for how these goals could be achieved in relation to medication and patient care. Let me begin by making it clear that the Canadian Society of Hospital Pharmacists strongly supports measures to improve patient safety in Canada, and we do recognize the need to increase the percentage of adverse reactions to medications that are reported. We applaud the recent efforts by Health Canada to make online reporting possible, and we welcome the additional local and regional offices that will make it easier for health practitioners and consumers to report.
We are, however, quite concerned that the move to mandatory reporting of all serious adverse reactions will create an avalanche of data, and that searching for and finding the critical information within that data will be more difficult and more time-consuming. The additional time and effort, in the end, may contribute little to the overall body of knowledge on medications and adverse reactions. That's because much of the new data will come from adverse reactions to medication that are in fact well known and anticipated. Pharmacists and physicians know about these serious effects and anticipate them as an extension of the drug's therapeutic effect. We know, for example, that patients who receive warfarin, a commonly used blood thinner, may experience an increased risk of serious bleeding, or that patients undergoing chemotherapy may experience low blood cell counts.
Traditionally, these anticipated adverse reactions and the resulting hospital admissions are not reported, which helps explain why less than 2% of adverse reactions leading to hospital admission are reported to Health Canada. Making it mandatory to report all of these anticipated adverse reactions will not only create an avalanche of new data, it will also place considerable strain on the pharmacists, physicians, nurses, and other health professionals who work in Canada' s hospitals and related care settings. Given the shortage of these professionals and their already high workloads, it comes as no surprise that the workload required to report adverse reactions has been identified as a barrier to reporting in previous surveys. Any requirement to report all serious adverse reactions must consider the reality of shortages and growing workloads among Canadian health care professionals.
The greatest risk in creating so much new data from adverse reactions that we know of and anticipate is that the most valuable information will be lost or diluted by excessive amounts of information we already know. Instead, the society believes the reporting program should specifically target new adverse reactions for existing products and serious adverse reactions for new products. Focusing on these two types of new adverse reactions will provide health care professionals and consumers with quality information they can use and allow us to identify and respond to emerging risks more quickly.
Instead of moving to a new mandatory reporting program, we support enhancing the programs already in place to include reports of new serious adverse reactions. Diagnosing these adverse reactions and their causes will likely be very challenging, since there may be a number of active conditions being treated with a number of medications. It can also be difficult to detect whether symptoms are related to the medication or to the disease being treated. That's why we recommend a multi-disciplinary team approach to assess each case, including pharmacists, physicians, and nurses.
We also strongly support an expanded education and awareness program targeting health care professionals and students, designed to reduce or eliminate many of the motivational barriers to reporting that will not necessarily be addressed by the new action plan. Mandatory reporting does not address the motivational barriers that currently prevent health care professionals from reporting adverse reactions, such as the fear of negative feedback, questioning the purpose and usefulness of reporting, or the desire to publish findings independently. We are confident that an education campaign focused on reporting new serious adverse reactions will prove more effective in the long run than mandatory reporting.
Finally, there's a need to enhance information retrieval from the existing Health Canada adverse reactions database, called the MedEffect database. Consumers and health care professionals need greater access to the information contained in the database. They need this information in a format that allows them to make informed decisions. Currently the database can be searched by drug, but the details of each of the reports can only be accessed by looking at each one individually. This makes it much more difficult to assess any drug reactions.
In short, the Canadian Society of Hospital Pharmacists strongly supports the goals of Canada's food and consumer safety action plan. In many important ways those goals are aligned with the society's own mission and vision. We are concerned, however, that the move to mandatory reporting of all serious adverse drug reactions in Canadian hospitals will make it harder, not easier, to achieve those goals. Instead we call for a more focused approach that concentrates on information we can use: new adverse reactions to existing medications and adverse reactions to new medications. This focused approach will make better use of existing reporting programs and databases, make better use of the valuable time of Canada's hospital pharmacists, and when combined with a multi-disciplinary team approach to assessment, will generate higher-quality information with which we can protect Canadians.
Thank you for the opportunity to present our concerns and solutions. I would be pleased to answer any questions you might have.
I invite you to ask your questions in the official language of your choice.