Labelling of medicines





FDA hearing 8 March 2005

Preliminary report


Pros and Cons of Color-coding Pharmaceuticals



The use of color on pharmaceutical product labels and packaging can play a

useful, if somewhat limited role in helping to prevent medical errors

according to a consensus of comments and expert testimonies provided to

FDA at a public hearing devoted to important considerations related to

"Use of Color on Pharmaceutical Product Labels, Labeling and Packaging,"

held 3/7 at the National Institutes of Health, Bethesda, MD. CDER Office

of Pharmacoepidemiology and Statistical Science director Paul Seligman,

said FDA does not currently have a policy pertaining to the use of colors

on drug product packaging, and he emphasized that the purpose of the

hearing was to obtain public input on the benefits and potential drawbacks

of applying color to drug packaging and labeling to help identify,

classify, or differentiate various pharmaceutical products.

CDER Division of Medication Errors and Technical Support director Carol

Holquist prefaced the hearing with a summary explanation of how color is

currently used in labeling/packaging of pharmaceutical products and

medical devices, with related definitions. According to Holquist, color

coding involves systematic application of designated colors to aid in the

classification and identification of products, which can allow users to

match colors on labels and packaging (and thus products) to particular

functions; color differentiation involves use of color to call attention

to certain important features on the package (i.e., product strength,

dosing intervals, special warnings); color branding is a relatively new

concept, by which a single manufacturer may utilize color to differentiate

products in its own portfolio (for example, to differentiate an insulin

analogue from another product containing a mix of insulin analogs); color

matching may be particularly useful in minimizing errors in the use of

medical devices as, for example, the use of like-colors for plugs and

their intended receptacles.

Testimony on behalf of the American Society of Health Systems

Pharmacists, representing hospital- and clinic-based pharmacists, was

delivered by Charles Meyers, a senior staff member with the organization.

Meyers stated emphatically that color-coding is "not a good idea." He

pointed out that hospital and clinic environments are highly complex, with

"thousands of drugs, each with individual strengths, concentrations,

routes and rates of administration." Moreover, he questioned, if products

are categorized by class, how would one be able to color code many of the

available combination products? Meyers said, in order to work at all, any

color-coding scheme must rely on hospital and clinic staffs who are

well-versed in the scheme, and he questioned whether this is feasible,

given the wide variation in training and education attained by nurses,

aides and other staff members. Indeed, he said, use of a color-coding

system could result in legal liabilities and litigation. Meyers admitted

some exception, however, to his general opposition to color-coding,

indicating it may be useful in ophthalmologic practice, for example, where

the number of drugs and the number of people who must be versed in the

color scheme are quite small.

Similarly, opposition to color-coding was voiced by Mary Baker and

Thomas Willer, representing the pharmaceutical manufacturer Hospira, Inc.

"The limited number of colors, their varied appearance under different

lighting conditions and proximity to other colors, all affect color

recognition," Baker said. She asserted that use of color-coding would tend

to discourage reading labels, a hazard in itself. On the other hand,

Willer indicated that Hospira supports the use of color on labels to

highlight such items as product names and key warnings. He indicated that,

for products Hospira markets as generics, the firm generally uses colors

on their labels that are similar to those used by the innovator, in order

to promote product recognition and minimize confusion.

The U.S. Pharmacopeia (USP) was represented by senior scientist Eric

Sheinin. Sheinin indicated that, while USP currently has no specific

policy regarding the use of color on labels, a consensus among USP

committees that have considered the issue appears to be that color-coding

is useful only in certain limited situations as, for example, the use of

color codes by anesthesiologists, who must distinguish among only a very

limited number of products. Sheinin pointed out that, if color codes are

applied by drug class, this could lead to unanticipated hazards. "For

example," he said, "The substitution of one statin for another with a

higher dosing profile could lead to liver toxicity." Sheinin said that a

medical errors reporting system maintained by USP in collaboration with

the Institute for Safe Medication Practices (ISMP) indicated that during

the period 1994-2004 at total of 360 adverse events occurred that were

related to color-coding methods and that, of these, four events resulted

in fatalities. ISMP president Michael Cohen stressed that use of

color-coding, color-differentiation, and color-matching techniques may

each be useful in individual applications, but one should never rely for

labeling on a single variable, such as color, but should also utilize

other variables such as package shape, size, type font, etc. to make

product distinctions or call attention to critical information. He

strongly recommended that label designs be subjected to "practitioner

input" before marketing, including use of focus groups, expert panels, and

consultations with CDER's Office of Drug Safety (ODS), with ODS having

final decision-making authority.

Other comments included testimonies by Novo Nordisk regulatory affairs

specialist Mary Ann McElligott, who said that differentiation of products

by use of color is favored by many practitioners, but that a search of the

literature finds no proof that use of color on labels leads to reduction

in medical errors; American Medical Association director of science

research and technology Joseph Cranston stated an AMA council has

recommended that any use of color on labels be considered on a

case-by-case basis, and has called for further research on the effect of

color-coding in reducing medical errors.

American Dental Association manager of regulatory and legislative

affairs Frank Kyle and American Academy of Opthalmology past president

Allan Jensen described successful use of color-coding for medications

employed in their respective specialties.

The hearing was concluded with testimony by James Broselow, a practicing

physician and developer of the Broselow-Luten System, an innovative method

for matching pediatric patients with the most appropriate medication

dosages, optimal-sized medical devices, and means to assure safe use of

radiation-emitting diagnostics. Broselow explained that the system is

based on measuring the pediatric patients' height, using a "yardstick"

consisting of horizontal bands of different colors (in place of inch or

centimeter marks). Depending upon the height of the patient (and thus, the

corresponding color band to which he or she is measured) the child may be

designated a "blue," "red," "green," (or other color code).

The Broselow-Luten System contemplates that all medications, medical

devices, and radiation-emitting instruments, could be optimally sized or

calibrated according to the full "spectrum" of patients (i.e., "blue,"

"red," or "green," etc.), and labeled as such. This might mean, for

example, that pediatric patients (or their parents) would be able to

select acetaminophen products or other OTC medications whose labels bear

color codes corresponding to the patient's "color," thus assuring the most

appropriate dosage.

Similarly, pediatric surgeries or emergency rooms could maintain

color-coded "crash carts" or storage cabinets with color-coded drawers

containing tracheal tubes or other instruments, injectables, etc. all

appropriately sized according to pediatric patients' "colors." Thus,

medical staff would be able to quickly and confidently select the most

appropriate instruments or medications for pediatric patients.

Although the Broselow-Luten System is useful for children over a

relatively wide range of height-to-weight, Broselow pointed out that it

may not be indicative of the most appropriate medication dosages for very

obese children (those whose weight is more than 30% over normal for height

and age). Broselow indicated the System is currently being evaluated in

several large U.S. clinics and medical centers.