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Medication Errors: Drug Labels Used for Clinical Trials

The way drug manufacturers label drugs used for clinical trials (“investigational drugs”) can lead to medication errors. The following is from the November 2007 Institute for Safe Medication Practices newsletter:
  1. Many investigational drugs are labeled using a very small font size; in most cases, a magnifying glass is needed to read the information (see Figure 2 in the PDF version of the newsletter). The same font size is often used throughout the label, and there is little use of bold type, color, tall-man letters, or other strategies to help differentiate products. Thus, drug packages look remarkably similar, which can lead to confirmation bias when products are selected from the shelf.
  2. The labels may not include the drug strength or concentration, even if there are multiple drug strengths/concentrations in use.
  3. If the drug is involved in an international study, the directions may be printed in two or more languages on the same label. Labels may also include error-prone abbreviations or dose designations (e.g., 5IU, which looks like 51 Units, or trailing zeros [1.0 mg]).
If you are taking an investigational drug (a drug that is part of a drug trial or clinical trial) and there are adverse affects, you need to contact an attorney immediately. If you retain our law firm to represent you, one of our experienced lawyers will review your medical records and other records relating to the clinical trial to determine if you have a case against the company sponsoring the clinical trial and others. To contact Pritzker | Ruohonen, please call toll-free at 1-888-377-8900 or submit the firm’s online consultation form found at the top-right corner of this page.

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