Time for Improved Transparency and Openness in Pharmaceutical Drug Regulation

Prescription pharmaceuticals have saved and improved many lives, but they can also be deadly. How can we make sure Canadians get the prescription drugs they need without causing unnecessary harm?

The federal government plays a vital role in pharmaceutical drug regulation. We have many reasons to be proud of the systems for drug safety already in place in Canada. Yet there’s room for significant improvement.

Over the course of nearly three years, the Senate Standing Committee on Social Affairs, Science and Technology has studied prescription pharmaceuticals in Canada, and our findings are summarized in the newly tabled report, Prescription Pharmaceuticals in Canada. We heard hundreds of hours of testimony from a wide range of experts in the field on the strengths of our regulatory systems, but there was also a strong chorus of criticism from those who believe we can do much better.

For example, we heard frequent testimony regarding Health Canada’s passive role in drug regulation, its lack of transparency in relaying safety information to the public, its inability to conduct adequate inspections at all phases of a drug’s life-cycles, and we witnessed, in some cases, the department’s failure to provide our Senate committee with reliable testimony.

But there’s room for optimism.

Over the course of our study, we made a number of recommendations for updated legislation and regulations, many of which are reflected in the newly adopted Vanessa’s Law (Bill C-17). Key to this new legislation are transparency provisions, including the introduction of a requirement for the public disclosure of clinical trial and drug safety information, improved mechanisms to collect post-market safety information, the power to recall unsafe products when necessary and new penalties for regulatory violations – all concerns raised during the course of our study.

These are very good first steps, but still more needs to be done on a number of fronts.

The Committee heard compelling evidence that there is an urgent need for substantially improved physician training in prescribing “off-label” and addictive pharmaceuticals.

“Off-label” refers to drugs that are prescribed for use beyond the approved criteria; our report reveals that the extent of off-label prescribing is not known and, in fact, physicians are frequently unaware that they are prescribing off-label. Consequently, little is known about the most common types of off-label use. We need improved data collection and for the Drug Safety and Effectiveness Network to take an active role in assessing off-label drug uses. We also need an enforcement of the prohibition on off-label drug promotion by drug manufacturers.

The report also emphasizes the need for regular and accessible “take back” programs to collect unused prescription drugs to keep them from being discharged improperly into the environment.

Drug shortages are not a new phenomenon, but they have been increasing in frequency and duration over the last decade. Our study recommends that more can be done by Health Canada to minimize the impact by requiring drug formularies to include therapeutic alternatives, to provide more notification of drug discontinuances, to provide improved drug shortages notification and implement more rapid multi-stakeholder response.

Throughout our study we identified the urgent need for improved electronic databases to help prevent unintended drug consequences, such as pharmaceutical drug abuse, misuse and addiction, but also for the dramatic improvement of post-approval monitoring of pharmaceutical drugs and for tracking off-label usage. The implementation of electronic health records and prescription drug databases must be accelerated, and the uptake of these databases should be encouraged with a pan-Canadian awareness.

We can make Canada a model pharmaceutical regulator on the world stage. We’ve taken the first steps, but let’s not let the journey end there. Canadians deserve safe, effective, accessible and reliable pharmaceutical drugs when they need them. The only way to do this is through perpetually improved systems framed by transparency and openness.

KKO Offical Photo 2012 High Res. official photo 2012By Senator Kelvin Ogilvie and Senator Art Eggleton

Kelvin K. Ogilvie and Art Eggleton are respectively the Chair and Deputy Chair of the Senate Standing Committee on Social Affair, Science and Technology.