Medication errors can occur between brand names, generic names,
and brand-to-generic names like Toradol and tramadol. But sometimes, medication
errors involve more than just name similarities. Abbreviations, acronyms, dose
designations, and other symbols used in medication prescribing also have the
potential for causing problems.
For example, the abbreviation "D/C" means both "discharge"
and "discontinue." The National Coordinating Council for Medication
Error Reporting and Prevention (NCCMERP) notes that patients' medications have
been stopped prematurely when D/C--intended to mean discharge--was misinterpreted
as discontinue because it was followed by a list of drugs.
Illegible handwriting, unfamiliarity with drug names, newly
available products, similar packaging or labeling, and incorrect selection of
a similar name from a computerized product list, all compound the problem. And,
although some drug names and symbols may not necessarily sound alike or look
alike, they could cause confusion in prescribing errors when handwritten or
communicated verbally, according to the United States Pharmacopeia (USP).
For example, Holquist says that several errors have occurred
involving mix-ups with the oral diabetes drug Avandia and the anticoagulant
Coumadin. Although they don't look similar when typed or printed, the names
have been confused with each other when poorly written in cursive. The first
"A" in Avandia, if not fully formed, can look like a "C,"
and the final "a" has appeared to be an "n."
The XYZs of Naming Drugs
Names are part of developing a new drug. And coming up with
a catchy, snappy moniker that distinguishes one drug from another isn't easy.
For the most part, drug companies want a name that will boost sales, while consumers
long for some indication from the name of what the drug does. The FDA, however,
won't allow names that imply medical claims, suggest a use for which a drug
isn't approved, or promise more than they can deliver.
Naming a drug can be as complicated as creating a rhythmic cacophony
of unpronounceable syllables and emphatic-sounding letters, such as C and P.
Other naming strategies include letters that when strung together sound like
something high-tech--think Zyprexa, Lexapro, and Xanax.
But whether it's the sound of certain letters that manufacturers like, or the
vision that a name conjures up, the FDA says that selection must take into account
concerns for reducing errors and for avoiding trademark infringement.
Because of today's tough trademark requirements, many drug companies
are turning to a growing industry of "naming" consultants for the
task. These consultants are charged with creating a unique name that will appeal
to both doctors and patients, particularly given the recent surge in direct-to-consumer
advertising.
"Global companies want a name to be a worldwide mark,"
says Doug Kapp, vice president of brand strategy at RTi-DFD, a market research
company in Stamford, Conn. In helping pharmaceutical companies set their products
apart from others, Kapp says his company recognizes that the name must resonate
with the market target and also must pass worldwide trademark requirements.
That recognition, he says, drove his company to develop "relational
asemantics," a name-generation process that assists physicians in identifying
the nature of a drug. Just as the erectile dysfunction drug Viagra might suggest
vitality and vigor, two of RTi-DFD's successes include Advair, linked to "advantage
air for asthma," and Amerge, named for "emerging from the pain of
a migraine." Kapp says that regardless of how good a name seems, it must
be reviewed for potential confusion with other drugs so that "any other
associations would not harm the patient in the event of an error."
Satisfying the FDA
Every drug usually has three names: chemical, generic (NonProprietary),
and brand (proprietary), and each is subject to different rules and regulations.
The chemical name specifies the chemical structure of the drug. It is not preapproved
by any organization, nor is it recognized in any standard manuals, such as USP
publications. Therefore, chemical names are primarily used by researchers, but
not in medical practice.
The FDA requires that either the established, or official, name
or in the absence of an official name, the common or usual name, appears on
labels and labeling of a drug product. The common name, loosely referred to
as the generic name, must accompany the brand name, if there is one. The established
name for a drug substance is usually found in the originating country's pharmacopeia,
an official book or list of drugs and medicines and the standards established
for their production, dispensation, and use.
The generic name is usually created for drug substances when
a new drug is ready for marketing. It is selected by the United States Adopted
Names (USAN) Council, whose expertise is recognized by the FDA, according to
principles developed to ensure safety, consistency, and logic. These names are
typically used by health care professionals.
Generic names are coined using an established stem, or group
of letters, that represents a specific drug class. For example, the USAN stems
include suffixes like -mab for monoclonal antibodies, such as infliximab, or
prefixes like dopa- for dopamine receptor agonists. The arthritis medications
celecoxib, valdecoxib, and rofecoxib are generic names containing the -coxib
stem. Each belongs to a class of drugs known as the COX-2 inhibitors.
Names that include such stems, chemistry roots, or any other
coded information are easier to remember, and give clues about what a drug is
used for. These names, however, typically sound or look so much alike that they
contribute to medication errors, especially if the products share common dosage
forms and other similarities.
The brand name, also called trademark, can be created as soon
as a generic name has been established. Only brand names of products subject
to a new drug application or an abbreviated new drug application must be approved
by the FDA first. This requirement distinguishes them from generic names.
According to a report in the January-February 2004 issue of
the Journal of the American Pharmacists Association, there are more than 9,000
generic drug names and 33,000 trademarked brand names in use in the United States.
Fixing the Problems
To minimize confusion between drug names that look or sound
alike, the FDA reviews about 400 brand names a year before they are marketed.
About one-third are rejected. The last time the FDA changed a drug name after
it was approved was in 2005, when the diabetes drug Amaryl was being confused
with the Alzheimer's medication Reminyl, and one person died. Now the Alzheimer's
medicine is called Razadyne.
Generic name confusion also has led to regulatory action, as
well as to pharmacy practice recommendations. For example, the USP and the USAN
changed the drug name "amrinone" to "inamrinone" after receiving
reports of serious outcomes from medication errors involving the similar name
pair "amrinone/amiodarone." The generic drug industry also has responded
to requests from the FDA to use a mixture of uppercase and lowercase letters
to highlight differences in similar generic names, such as vinBLAStine and vinCRIStine.
This step also encouraged manufacturers to supplement their new drug applications
with revised labels and labeling that visually differentiated their generic
names with the so-called "tall man" letters. And the NCCMERP recommendations
encourage doctors to write both brand and generic names on prescriptions.
A number of other efforts are under way to reduce the incidence
of medical errors stemming from similar-looking or similar-sounding names. The
FDA, for example, is encouraging people to talk with their physicians to ensure
that they have a complete understanding about their prescription before leaving
the doctor's office, and to verify the information with the pharmacist before
the medication is dispensed.
FDA health professionals also are requested to interpret both
written prescriptions and verbal orders through weekly in-house studies, in
an attempt to simulate the prescription-ordering process. Holquist says that
these studies are a valuable tool used in every review of proposed brand names.
It is important, she adds, to be able to detect any potential sound-alike, look-alike
confusion with proprietary names before a new drug application is approved.
Other efforts strongly encouraged for physicians include writing
prescriptions more clearly, printing in block letters rather than writing in
cursive, avoiding the use of abbreviations, and indicating the reason for the
drug.
According to the FDA, pharmacists can help by keeping look-alike,
sound-alike products separated from one another on pharmacy shelves, by avoiding
stocking multiple product sizes together, and by verifying with the doctor information
that is not clear before filling a prescription.