How Safe Are Prescription Drug Doses





Dr. Dorothy Smith


"How Safe Are Prescription Drug Doses if Patients in Clinical Trials Did Not Take the Full Dose?" asks Dr. Dorothy L. Smith, President of Consumer Health Information Corporation

Patient adherence needs to be given higher priority in clinical trials to ensure patient safety.Patient counseling

McLean, VA, May 21, 2013 – 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 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, an internationally recognized clinical pharmacist with expertise in patient adherence and patient education. 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.  A respected clinical and educational source, Consumer Health Information Corporation has won major national and international awards for excellence in patient and consumer education programs that have significantly increased patient adherence. Dr. Smith is the author of more than 130 professional articles, 23 books and has delivered more than 150 professional and scholarly addresses.

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Experts in Patient Education and Adherence Since 1983
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