Generic substitution is a common and necessary practice in pharmacies across the United States. According to the 2018 Generic Drug Access and Savings Report, 9 out of 10 dispensed drugs were generics, which saved patients a collective $265 billion in 2017.
Generic drugs are usually more affordable and accessible than their brand name equivalents, making them the more desirable option when dispensing. If a physician has prescribed a brand name drug but the pharmacy chooses to dispense a generic, pharmacists and technicians must refer to the FDA’s Orange Book to ensure the substitution they have selected is a therapeutic equivalent product to the brand name. Selecting a drug that is only a pharmaceutical equivalent without gaining the prescriber’s permission could lead to serious consequences from the state board of pharmacy if that pharmacy’s state has elected to abide by the FDA’s Orange Book.
When looking for a therapeutic equivalent, PioneerRx users may easily refer to the Orange Book Code (OBC) column, which is located to the far right of the screen when choosing the product in data entry. Therapeutic equivalents are already approved by the FDA for substitution and do not need clearance from the prescriber. Therapeutic equivalent codes, per the Orange Book, will always begin with the letter “A.” If a drug has an OBC that begins with “B,” it is not therapeutically equivalent. Products that have not been fully evaluated by the FDA are designated by codes beginning with “Z.”
Refer to the decision tree below when determining whether or not a generic drug is a therapeutic equivalent for its brand counterpart. If pharmaceutically equivalent drugs that are not therapeutically equivalent (i.e. “B” and “Z” codes) are the only products available to choose from, consult with the pharmacist and/or contact the prescriber for approval before dispensing.
For more questions regarding PioneerRx’s Orange Book Code column, send a call request to your Account Manager.