Drug Safety

The Institute of Medicine of the National Academy of Sciences in the United States issued a new report on September 22 2006 delivering a critical assessment of the US Food and Drug Administration’s (FDA) drug safety system. According to the IOM, there are at least 1.5 million preventable adverse drug events in the US each year and the true number may be much higher. The report, The future of drug safety: promoting and protecting the health of the public, makes several recommendations including tighter labeling requirements and advertising limits for newly approved medications, increased communication of information relating to marketed products’ risks and benefits and mandatory registration of clinical trial results and better public access to drug safety information.

The report comes at a time when Health Canada is undertaking a review to renew the Canadian federal drug regulatory system. Elements of the legislative and regulatory framework date back 50 years and are in need of modernisation. The 2003 federal budget allocated $190 million over five years to improve the timeliness of Health Canada’s regulatory processes with respect to human drugs. It aims to achieve significant improvements to drug review performance through the Therapeutics Access Strategy and through the National Pharmaceuticals Strategy to improve Canadians’ access to safe, effective, and affordable drugs through the health care system.

Lets hope for Canadians’ sake that the review will result in oversight of the drug approval process that acts at arm’s length from the pharmaceutical industry which has developed powerful marketing and public relations capabilities supported by the enormous cash flow created by drug sales. Particular emphasis should be placed on the need for clear labeling relating to instructions on use as well as risks.

A study report in the Annals of Internal Medicine found that many Americans, including those with college degrees, have trouble interpreting the instructions on prescription drug labels. Remarkably only 34.7 percent of people with lower literacy of grade level or below, interviewed for the study could determine the number of pills to take daily when faced with the instruction “take two tablets by mouth twice daily”. This only emphasizes the need for clear, simple instructions aided by visual cues to be standardized so that patients will receive consistent information as a minimum that does not vary by pharmacy or physician.
The conclusions of a U.S. government study published in the Oct. 18 2006 issue of the Journal of the American Medical Association found that while many people take their medications without a problem, as many as 700,000 Americans wind up in the emergency room each year because of adverse reactions to drugs they’ve taken, with 117,000 of those people hospitalized because of reactions.The Vancouver Coastal Health Research Institute is currently conducting a prospective study to characterize the problem in Canada and to identify strategies to reduce and prevent adverse drug-related events The implementation of strategies to reduce these events will not only improve patient safety but may ultimately reduce emergency department overcrowding, reduce morbidity as well as costs to the Canadian health care system. More initiatives are needed to develop practices that will avoid preventable adverse drug reactions.