Unexpected drug toxicities occurring years after prescription drug approval
MCLEAN, Va., Feb. 12, 2013 /PRNewswire/ — Every person taking a prescription drug should be able to trust that the recommended dose is safe. This may not always be the case according to Dr. Dorothy L. Smith, President and CEO of Consumer Health Information Corporation. In the last ten years, many patients have developed unexpected toxicities from prescription drugs that have been on the market for 5-10 years. FDA has responded by cutting the doses of several drugs in half and withdrawing others. During this same time period, patient adherence in the general population has been increasing due to media attention and improved patient education by health professionals.
"Why have there been so many unexpected toxicities in the last 10 years after these drugs have been approved? Why are approved doses later being cut in half? Could there be a link to patient adherence?" To try to answer these questions, Dr. Smith reviewed the last 20 years of the patient adherence research in clinical trials. The findings were shocking:
- Between 1997-1999, patient adherence was not monitored in 53% of clinical trials. Many of these drugs are still on the market.
- Up to 30% of study patients do not take the full dose of the study drug.
- Study patients cannot understand 35% – 94% of Informed Consent documents.
- At least 50% of study patients do not tell the study team they missed doses.
- Many study patients do not realize that missing doses could endanger the lives of millions of people after the drug is approved.
- Poor patient adherence that is undetected in clinical trials may result in a dose that is inaccurate and too high.
Unexpected adverse drug reactions and toxicity could occur when patients in the general population are more adherent than those in the clinical trial. Dr. Smith urged clinical trial investigators to:
#1 Develop a patient adherence strategy for each clinical trial and integrate behavior modification.
#2 Determine how many doses of every study drug can be missed without jeopardizing the therapeutic outcome.
#3 Include patient adherence results as an outcome of the clinical trial and publish in the Package Insert.
#4 Create Informed Consent and patient-friendly programs that patients will understand and make it easier for them to take the study drug.
#5 Gain patient trust so they provide honest feedback about any problems they had taking the study drug. Always ask, "How would I want to be treated if I were the study patient?"
Dr. Smith concluded, "Patient adherence in clinical trials must always be higher than that of the general population. Our challenge is to get patient adherence in clinical trials up to 95% so patients can be assured it is safe to take the FDA-approved dose."
About Consumer Health Information Corporation
Consumer Health Information Corporation specializes in the development of patient adherence programs that help people learn how to manage their medications and prescribed treatments safely and wisely. President and CEO, Dorothy L. Smith, Pharm.D. is internationally recognized for her leadership in patient education and has delivered over 200 presentations to professional audiences in the United States, Canada and Europe. She is the author of 23 books on the safe use of medicines.
CONTACT:
Dr. Dorothy Smith
Consumer Health Information Corporation
McLean, VA
703-734-0650
Email
www.consumer-health.com
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