FDA Should Follow Health Canada's Lead and Permit Direct Access to MedWatch Adverse Reaction Reports
Health Canada has announced it is now allowing direct access to the latest reported adverse reactions to prescription drugs and other health products contained in Health Canada's Canadian Adverse Drug Reaction Information System (CADRIS) by means of a new, searchable online database.
The new database can be searched by using one or more of the following criteria: the name of the drug or the drug's active ingredient; the date an adverse reaction report was received by Health Canada; subject patient age and/or gender; and, the medical outcome of the reported adverse drug reaction.
As background, the information source for the new Health Canada database is derived from Health Canada's Adverse Reaction Monitoring Program. Suspected adverse drug reaction reports which the agency has received from consumers, health care professionals and product manufacturers are entered into the CARDIS database. With the new, searchable online database which Health Canada announced on May 26, 2005, the public -- patients, advocacy groups, medical professionals, researchers, and pharmaceutical companies -- will now have direct access to the CARDIS adverse reaction reports.
Before the launch of Health Canada's new online database, adverse drug reaction reports from CADRIS were available to the public only by a request submitted to the agency, with responsive information being produced to the requesting party no sooner than two weeks, and often longer.
The adverse drug reactions contained in this new, searchable database will be updated by Health Canada on a quarterly basis. This database can be viewed using this link:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/cadrmp-pcseim/index_e.html
During our experimentation with this new Health Canada database, we found that there are still a few bugs and quirks that need to be resolved. For example, on sporadic occasions the Health Product Name Lookup pop-up box had problems displaying the list of alphabetized drug names by which you can initiate a query. Regardless of these minor (and, presumably, temporary) flaws, this step by Health Canada to bring an increased degree of transparency to drug-safety monitoring is commendable.
Hopefully, the FDA will take note of this development in Canada and move toward establishing a similar web site allowing direct and immediate access to adverse drug reaction reports made to the MedWatch program, here.
(Posted by: Tom Lamb)