No, this is not the next book on your toddler’s reading list. It’s something much more fun. And by fun, I mean completely boring, but really useful in the pharmacy world.
What is the Orange Book?
The Orange Book is a list of the drug products the FDA has approved as being equivalent to one another. The Orange Book approvals are based on safety, effectiveness, and “therapeutic equivalence”.
The FDA has added an online Orange Book search to its data base which can be accessed at:http://www.accessdata.fda.gov/scripts/cder/ob/
Why am I telling you about this?
Recently I’ve seen several comments on social media sites with anecdotes about pharmacies substituting an Epi Pen for other epinephrine injectors. However, these items are not considered therapeutic equivalents. The Orange Book is the pharmacists guide to therapeutic equivalence, but it is also available to you as another tool in being proactive about your health, or the health of the person you are caring for.
What is therapeutic equivalence?
Therapeutic equivalence is another way of saying that the medications contain the same active ingredient; they are the same strength, the same dosage form (tablet, capsule, etc.), and that they are administered the same way (by mouth, injection, etc.)
Medications that are considered “therapeutic equivalent” can vary in color, shape, markings, and inactive ingredients (preservatives, sweeteners, dyes, flavor additives, fillers, and so on).
What is a TE code in the Orange Book?
These are the codes that tell you if a product is therapeutically equivalent (TE).
An “A” code (codes beginning with the letter “A”) such as AB, AT, AO, AN are considered therapeutically equivalent.
A “B” code (codes beginning with the letter “B”) such as BX, BN, BC are, at this time, NOT considered to be therapeutically equivalent.
Why does this matter?
Pharmacists should not substitute products (without physician approval) that are not “A” rated.
A quick search of epinephrine in the Orange Book lists several products including EpiPen, Auvi-Q, and Adrenaclick. The TE code reveals a BX rating. That means that there are no approved drug products equivalent to those specific medications.
An EpiPen prescription cannot be filled with Auvi-Q and vice versa.
The Orange Book can be confusing because there is a TON of information in it to digest. You probably won’t use this often but it’s a super handy tool to have.
Now I suggest you read something a little more fun and a lot more racy: the phone book.
Note: Some states allow a pharmacist to substitute products despite a BX rating provided that certain criteria are met. Make sure, before you leave the pharmacy counter, that you have the medication you have discussed with your physician. Ask if it is an “A” rated substitution.