Investigational Drugs Need Clearer, Safer, Naming And Labeling: ISMP

New drugs that have made it to the clinical trial stage often carry insufficient labeling and warnings, according to a warning issued by a group of drug safety experts. 

The Institute for Safe Medication Practices issued a press release on April 20, warning that medications known as “investigational drugs” are not being adequately labeled, named or packaged, despite the fact that they are experimental and may carry higher risks of serious side effects and injuries.

At issue are experimental drugs that have received approval by the FDA to move forward to clinical trials on human test subjects, which could include thousands of patients. However, the drug makers have not established that they are safe and effective for full FDA approval.

The ISMP warned that one of the main problems is that during the early phase of research, the drugs are usually identified with an abbreviation for the drug manufacturer and a number. Since many clinical sites often test different drugs by the same company, the only way to tell the drugs apart on the label may be that number, and often only the last digit is different.

In some cases, those numbers can be 25 characters long, and computer screens may shorten them, adding to the potential confusion.

In addition, when a medication is finally named, some labels on packing slips and boxes may get the generic name, while some labels on the medication continue to carry the identifier number, and that number could even change if the company is bought out or merges with another manufacturer during the drug’s testing period, the ISMP warns.

In some cases, investigational drugs are shipped to clinical sites with no label at all on the actual vials or pill bottles. The report showed cases where two different drug injections were shipped in labeled boxes, but once taken out of the box the two different drug syringes were identical. The same often occurs with pill bottles and other drug products, according to the report.

The ISMP also warned that the drugs often do not indicate the strength or concentration, different formulations, do not include bar codes to help verify dispensing information, have unsafe abbreviations and dose expressions that are prone to error, and often are missing the lot numbers and expiration dates.

“Many drugs being tested in clinical trials are considered high-alert medications that are more likely to cause harm when used in error, and yet little regulatory oversight exists to standardize their labeling, packaging and nomenclature,” the ISMP press release states. “This increases the risk for errors that may cause serious harm to patients and leads to inaccurate data about the drug’s safety and efficacy.”

The statement indicates that the report was the first of two on investigational drug dangers, with the second report coming early next months.