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March 18, 2004
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Reporting adverse drug reactions
Giving a voice to consumers
By Sharon Gray
A researcher in Memorial’s Faculty of Medicine has developed a Web-based technology to report adverse drug reactions for the consumer advocacy group PharmaWatch, Canada.

Dr. Ted Hoekman, Medical Informatics, has a long-standing interest in online reporting of adverse drug reactions using a Web interface. He began working on this about three years ago, quickly realizing that while the concept was elegant, his initial implementation was “deadly slow.” While on a partial sabbatical in Victoria, BC, in 2002 he directed a student to improve the responsiveness of the technology and structured the database so that all personally identifiable data would remain anonymous. The refining of the technology continues with other student programmers from MUN Computer Science Department.

“We have used a strategy to make the process of accessing the report site sufficiently challenging and information rich, to discourage people from making casual, non-informative reports,” explained Dr. Hoekman. “To use the reporting facility you have to register – we maintain completely separate databases for registrations and reports. Unless you choose to report in an identified fashion no name will associated with the report.”

Initially Dr. Hoekman developed the technology with the idea of producing a tool targeted at healthcare professionals. While in British Columbia he heard about PharmaWatch. “It was a bright idea just starting to happen – they were interested in developing direct consumer reporting of adverse drug reactions. I already had this in the back of my mind because my study of the literature revealed a major under-reporting of adverse drug reactions worldwide. Most optimistically, serious studies show that perhaps five to eight per cent of adverse reactions are being reported. Hence, if a particular reaction is a regular, but relatively rare, and dangerous event, the probability of picking it up before many people are killed or injured is very small.

The issue came to public attention in March, 2000, when 15-year old Vanessa Young of Ontario died after taking the prescription drug Propulsid. This was a widely-prescribed Johnson and Johnson drug used to prevent acid reflux and night time heartburn – but in some people it causes life-threatening heart rhythm abnormalities, even in those with no heart disease. Propulsid had already been associated with 80 deaths and hundreds of injuries, many among children, before Vanessa’s death. Propulsid was ordered off the market in the U.S. just three days after Vanessa’s death, yet her family had no warning that the drug was regarded as dangerous.

“I heard a talk by Terence Young, Vanessa’s father, and he is convinced that there are many times as many people who have died from Propulsid as have been reported,” said Dr. Hoekman. “It shows how insensitive our reporting system is for events that happen relatively rarely but are dangerous. If we can improve frequency reporting, we can save lives.

“It has been shown in comparative studies that consumer reporting is roughly equivalent to health professional reporting in detecting important drug reaction issues. Achieving an improvement in health professional reporting has been difficult – partly because these people are frequently overworked and submitting these reports is a time-consuming (and un-compensated) activity. In addition, the methodology used to report adverse drug reactions is cumbersome. Health Canada’s strategy is for the reporter to download a PDF form from their Web site, print it, fill it out by hand and mail or fax it to a reporting centre. Typically several weeks or months can pass between the time the report is submitted and its transcription into the data base where it has the possibility of triggering a warning.”

While the PharmaWatch Web site – which is being designed by Memorial’s Computing and Communication – is not yet up and running, its launch is imminent. The URL will be www.pharmawatch.net.

“The long-term plan is that anyone who registers with PharmaWatch, whether they report or not, will be able to query the database and receive a summary of reactions to drugs of interest,” said Dr. Hoekman. “My vision is that it will be a transparent public resource for health professionals, caregivers and patients.”

 


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