NEW BAR-CODE RULE TO COST DRUGMAKERS MILLIONS, SAVE HEALTHCARE SYSTEM BILLIONS
Drugmakers will have to affix linear bar codes to the labels of most of their hospital prescription drug products under a new FDA regulation expected to cost the industry $28.1 million in the first two years of implementation but projected to save the healthcare system billions of dollars in prevented medication errors.
The FDA’s 196-page final rule on bar codes, effective 60 days from release, requires drugmakers to put bar codes on both exterior labeling and interior unit-dose packaging. As the rule is written, the bar-coding requirements apply to most Rx and certain OTC drugs commonly used in hospitals and other healthcare settings. The rule does not require bar codes on all human drugs, but rather covers those drugs that are most likely to be involved in medication errors.
The new system is expected to cut down on medication errors by 85 percent, said FDA Commissioner Mark McClellan. When fully implemented, the bar-code rule will prevent nearly 500,000 adverse events over 20 years and save $93 billion in healthcare and related costs, he added.
The FDA’s final rule on bar-code label requirements is available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/2002n-0204-nfr0001.pdf.
