HESA Committee Report

Recommendation 1

The Government of Canada/Minister of Health enhance voluntary reporting of adverse drug reactions by incorporating the key elements listed above as well as providing accessible information such as the Health Canada 1-800 number and Web address to all areas of interaction between health professionals and consumers.

Recommendation 2

The Government of Canada/Minister of Health in conjunction with provincial and territorial counterparts support educational training programs for health professionals aimed at increasing adverse drug reaction reporting, while respecting provincial jurisdiction.

Recommendation 3

The Government of Canada/Minister of Health establish a specific transition fund to provide money to existing initiatives and to establish other pilot projects across the country to build evidence on effective adverse drug reaction reporting in hospitals.

Recommendation 4

The Government of Canada through the Federal Healthcare Partnership examine ways to enhance reporting of adverse drug reactions in all health institutions that serve federal health client groups (i.e. Department of National Defence health centres on bases, Health Canada health centres on First Nations reserves, Veterans Affairs Canada contract hospitals and Correctional Services Canada facilities).

Recommendation 5

The Minister of Health immediately initiate work on adverse drug reaction reporting within Health Canada’s First Nations on-reserve health centres and nursing stations.

Recommendation 6

The Government of Canada/Health Canada ensure that all pilot projects to build adverse drug reaction reporting incorporate funding for technological tools required to increase reporting by health professionals (physicians, pharmacists, nurses, etc.) in their daily practices.

Recommendation 7

Health Canada take measures to efficiently analyze the adverse drug reaction data collected through the MedEffect Web site and make the analyses available in a form that is accessible to health professionals and the public.

Recommendation 8

The Government of Canada/Health Canada enforce the existing mandatory requirement for the pharmaceutical industry to report serious adverse drug reactions both within Canada and internationally, increase efforts to acquire reports on suspected adverse drug reactions and make all the information available publicly.

Recommendation 9

The Government of Canada/Minister of Health immediately establish the drug effectiveness and safety network, a national network of pharmaceutical research centres to operate under the Canadian Institutes of Health Research as outlined in the 2007 business plan.

Recommendation 10

The Government of Canada through the Canadian Institutes of Health Research encourage the network’s research to be multi-disciplinary, to reflect innovative research such as pharmacogenetics and pharmacoepidemiology and to incorporate sex/gender analysis.

Recommendation 11

The Government of Canada, as the fourth largest pharmaceutical provider in Canada, examine the possibility, through the Federal Healthcare Partnership, of a centre of excellence for drug effectiveness and safety assessments for the six federal health client groups.

Recommendation 12

The Minister of Health establish a separate analysis and dissemination unit to analyze and to report regularly on post-market pharmaceutical surveillance data including findings, implications, subsequent actions, etc.

Recommendation 13

The Government of Canada build the electronic database capacity among its six federal formularies and facilitate linkages for analysis with respect to post-market drug safety and effectiveness.

Recommendation 14

The Government of Canada fund the ongoing engagement of professionals and the public in the study of privacy issues relevant to post-market surveillance.

Recommendation 15

The Government of Canada increase investments in Canada Health Infoway in order to accelerate the development of electronic health records and e-prescribing with the inclusion of diagnostic information.

Recommendation 16

The Government of Canada/Minister of Health allocate additional new funding for post-market pharmaceutical activities sufficient to:

·        build adverse drug reaction reporting requirements including but not limited to database development and maintenance, training, and communication strategies,

·        establish monitoring and research for pharmaceutical effectiveness and safety,

·        follow-up on advertising restrictions for pharmaceuticals,

·        increase scrutiny of counterfeit pharmaceuticals including but not limited to investigations of adverse drug reactions, enforcement efforts, etc.

Recommendation 17

The Government of Canada/Minister of Health allocate additional new funding specifically to increase post-market inspection and enforcement capacity for pharmaceuticals.

Recommendation 18

Health Canada explore the possibility of further distancing the human and financial resources required for pre-market activities for pharmaceuticals from those required for post-market activities.