United States of America. The ISMP is concerned about a draft guidance of the US Food and Drug Administration that would allow companies to place prominently on approved FDA drug product labels a product’s therapeutic equivalence code, based on the listing in Approved Prescription Drug Products with Therapeutic Equivalence Evaluations List (also known as the Orange Book). The guidance applies to brand and generic manufacturers and its intent is to promote accurate and safe selection of therapeutically equivalent forms of a product and to differentiate them from drug products with the same generic name, sometimes with overlapping strengths, but with different pharmacokinetic profiles. Brand name manufacturers could also mention on the label that their product is not equivalent to certain other products. The rule would apply only to prescription drug labels, including injectables, but not OTC products.
The ISMP considers that this information will detract from the primary purpose of a drug label: to assist the user in proper identification of the product contents. On already crowded labels, it will make some labels that are already difficult to read even worse, and therefore increase the risk of medication errors due to misidentification. The ISMP also questions the rule’s necessity. The Orange Book information is readily available, including on-line on the FDA website, or the information could appear in the package insert. Relevant information could also be included by pharmacy database vendors with their regular updates, especially since the information is dynamic and subject to changing conditions.
Reference: ISMP Medication Safety Alert! Vol. 3, Issue 5, 10 March 1999.