Unexpected drug toxicities occurring years after prescription drug approval
MCLEAN, Va., May 21, 2013 /PRNewswire/ — In the last ten years, many people have developed unexpected toxicities from prescription drugs that had been on the market for several years. Researchers have been baffled. Dr. Dorothy L. Smith, a leading expert in the development of patient adherence programs, suggests unexpected toxicities could occur when patients in real-life have better patient adherence than the patients in clinical trials. In short, they took a higher dose.
In an article titled "Missing Link" published in the May 2013 issue of International Clinical Trials, Smith questioned whether poor adherence in clinical trials caused unexpected toxicities with such prescription drugs as Vioxx, Bextra, Celebrex, Zocor and most recently Ambien. FDA responded by either cutting the dose in half, requiring a warning box or completely withdrawing the drug from the market.
All of these drugs were approved in the 1990's when adherence was poorly monitored in clinical trials. "It's important to remember that patient adherence was also starting to increase around this time because of media attention and improved patient education by health professionals. If the patients who had unexpected toxicities were more adherent than the study patients, they could have taken a toxic dose," says Smith.
What needs to be changed? Patient adherence needs to be given higher priority in the clinical trial design and be included as an outcome. Instead of remaining confidential, this information needs to be available to health professionals and patients in the Package Insert. Patient adherence in clinical trials must be increased to 95% to ensure the general public their prescribed dose is safe.
How can this be done? Patients in clinical trials need better patient education so that they will be motivated to take the full dose of the study drug. Right now, up to 30% of patients in clinical trials are skipping doses, and many are afraid to tell the study team.
"The more I investigate patient adherence in clinical trials, the more concerned I am that we have a serious patient safety issue to address," says Dr. Smith. "I have spent my career developing programs to help patients learn how to manage their diseases and prescription drug therapies. Now we must work together to increase patient adherence so that it is always higher in clinical trials than in real-life."
About Consumer Health Information Corporation
Consumer Health Information Corporation was founded by Dorothy L. Smith, Pharm.D., internationally recognized for her leadership in patient education, patient adherence and patient engagement. The mission of Consumer Health Information Corporation is to help patients learn how to manage their diseases and prescribed treatments safely and wisely. The company has developed more than 4000 evidence-based patient education programs for medications, medical devices, disease management and Phase III clinical trials worldwide that increased patient adherence because they "meet the needs of patients".
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