(Dr. Copyright is off this month – although some might say that he’s always been a bit off – so our very own Dr. Trademark has stepped to the plate to hit more of your burning legal questions out of the park.)
Dear Doc.:
I was given a prescription for Noroxin to treat a UTI, but when I got back from Rite-Aid, the bottle they gave me contained Neurontin, which is used to treat epilepsy and pain. Somebody messed up, and from what I read, this could have been very dangerous. Why can’t someone keep this from happening by making sure that drug names are not confusingly similar?
Signed,
Confused Patient
Dear Confused:
Unlike regular trademarks for things like tractors, condoms and laundry detergent, names used on drugs are supposed to be unique, not confusing, and truthful. There is even an office at the US Food and Drug Administration (FDA) that is supposed to approve trademarks for drugs in an effort to prevent the over 1.3 million injuries each year that result from drug name confusion. Even though a drug company may be able to register a drug trademark with the Patent and Trademark Office (PTO), that does not mean that it will be approved by the FDA.
The FDA’s Division of Medication Error Prevention and Analysis (DMEPA) reviews all proposed names for confusing similarity to the names of other drugs or drug ingredients, including both trademarks and “established” or generic names. DMEPA typically rejects about one-third of all names reviewed. Some of the issues DMEPA hopes to avoid include names that suggest potentially exaggerated efficacy claims; names that could lead to erroneous prescriptions (e.g., wrong drug or dosage); and names that look or sound confusingly similar to other drug names.
According to the FDA, there are some ways to reduce the risk that a name will be found misleading during approval:
- Avoid names referring to an inactive ingredient in a way that suggests effectiveness;
- Avoid incorporating a generic name;
- Avoid names implying unique effectiveness (e.g., wonder or cure); and
- Avoid using terms that imply maximum strength, such as “Ultra,” “Max,” “Pro,” or “Super.”
Similar precautions can reduce the risk of using a name that the FDA will consider prone to cause medication errors such as names containing numbers. For example, some pharmacists interpreted “Percocet 5” to mean five tablets per dose. Similarly, companies should avoid using prefixes, suffixes, and letter combinations that may have specialized meanings in the pharmaceutical field – such as “bid”, or “PRN”.
The FDA regularly tests drug names by using volunteers to assess whether names are confusingly similar. The FDA advises that applicants consider the sound of the name when spoken, as if recording a verbal prescription into a voicemail system, consider the appearance of names as printed, and consider the appearance of a name as written by a physician.
Even after a drug name has been approved, DMEPA monitors reports of problems with marketed drugs and can order changes in drug names it has approved. Sometimes the FDA simply orders changes in labeling to eliminate confusion, rather than a complete name change.
Despite all of these precautions, there are still many drug names that are regularly confused. For a list, take a look here. The Doc, though, hopes that you seldom need more than a good night’s sleep to cure what ails you.
–Lawrence Husick, Esq.