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 PritzkerOlsen, 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.

Labels: attorney, clinical trial, drug trial, medication error lawyer

The way drug manufacturers identify drugs used for drug trials (“investigational drugs”) can lead to medication errors:

1. If investigational drugs are identified using a number preceded by an abbreviation of the sponsoring company’s name (e.g., BMS104579 for a drug sponsored by Bristol-Myers Squibb), organizations that participate in multiple drug trials sponsored by the same company could confuse one drug with another sponsored by that company.
2. If a letter/number designation on an investigational drug is too long (some are up to 25 characters long) or are described with multiple words, pharmacies may be forced to truncate the code name due to field size limitations.
3. If a letter-number-code (see above) is used and then the investigational drug gets a generic or common name, the code name may remain on the product label while the research team refers to the drug by its new generic name. This could cause confusion on the part of the person administering the medication.
4. If the sponsoring company is part of a merger or the sponsoring company or the product is sold, the code name could change—the abbreviation at the beginning of the code might change to the abbreviation of the new sponsoring company.
   

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. Drug companies are not going to be forthcoming with medical records and other information. It will take what is called “discovery” to get the records needed to determine if there was a medication error. If there was a medication error, you have the right to sue all responsible parties for compensation. Please contact a medical error litigation attorney at PritzkerOlsen for a free consultation. Our toll-free number is 1-888-377-8900. If you call after hours, please leave a message for the on-call attorney, who will return your call as soon as possible, usually within a few hours.

Information in the November 2007 Institute for Safe Medication Practices newsletter was used for this article.

Labels: clinical trial, drug trial, medication error lawyer