# Presentation: 001654

## Use of Color on  Pharmaceutical Packaging and LabelingMarch 7, 2005

- Eric B. Sheinin, Ph.D.
- USP
- Chief Science Officer

## U.S. Pharmacopeia

- Private, non-profit, standards-setting organization
- Established in 1820 by physicians to establish quality for drug products
- Legally enforceable standards of quality, strength, purity, packaging, labeling, storage, and nomenclature
- Mission to promote public health through the safe use of medicines

## Reasons USP does not support color-coding

- Color-coding could encourage healthcare professionals to rely solely on the color in selecting a product rather than reading the label.
- USP Medication Error Reporting Programs (MER and MEDMARX) have received reports where color similarities in labeling and packaging have caused or contributed to medication errors.
- There are only a limited number of colors in the spectrum, thus shades of color would likely begin to look similar to certain people.
- Some individuals are colorblind and cannot distinguish a difference in certain colors.
- Certain colors, in poor lighting, could begin to look like others and the products could be confused.

## USP Reporting Programs

**USP- ISMP Medication Errors** **Reporting (MER)**** ****Program**
- Spontaneous reporting by any health professional from any setting
- 9,000 reports since 1991
- Reports are enriched by dialogue with the reporter
**MEDMARX****SM**
- Anonymous, facility-based reporting by hospitals and their related health systems *(inpatient and outpatient)*
- Used as part of the internal quality improvement program
- 840,000 reports since 1998

## Color Coding Errors MER Program 11/15/1994 – 12/15/2004 (n = 360)

| Category Index | #
 Of Records | Percent
(%)  |
| --- | --- | --- |
| A | 181 | 50.3 |
| B | 101 | 28.1 |
| C | 58 | 16.1 |
| D | 3 | 0.8 |
| E | 7 | 1.9 |
| F | 2 | 0.6 |
| H | 4 | 1.1 |
| I | 4 | 1.1 |
| Total  | 360 |   |

## Severity of Error

| Category Index | Number of
Records | Percent
(%) |
| --- | --- | --- |
| A (No Harm) | 181 | 50.3 |
| B-D (Error, No Harm) | 162 | 45.0 |
| E-I (Error, Harm) | 17 | 4.7 |
| Total records | 360 |   |

## Node (Phase of the Medication Use Process where the error initiated)

| Node  | Number of Records | Percent
(%) |
| --- | --- | --- |
| Prescribing | 1 | 2 |
| Dispensing | 37 | 74 |
| Administering
 | 12 | 24 |
| Total unique records | 50 |   |

## Leading products – Error, harm (E-I) 

| Generic Name |
| --- |
| Heparin Sodium |
| Albuterol Sulfate |
| Dantrolene Sodium |
| Magnesium Sulfate |
| Potassium Chloride for Injection Concentrate |
| Warfarin Sodium |

##     Same Color Packaging Different Strengths

## Harmful Errors

**Nitrous Oxide given instead of Oxygen**
**Potassium Chloride instead of Heparin**
**Sufentanyl 75 mcg by mistake instead of 75 mcg Fentanyl**

## Black and White Labeling

## OTC Drugs

- Official 1999
- Standardizes format and content of OTC labeling
- Specific headings and subheadings in a standardized order
- Standardized graphical features
- Minimum standards for type size and spacing
- Principle Display Panel (PDP) reserved for manufacturer trade dress

**Notes:**
Standardized graphical features include type style, point size and use of bullets to introduce key information

## Food Labeling

- Official 1999
- Nutrients appear in the order as required
- Food labels printed must show the net contents in both metric (grams, kilograms, milliliters, liters) _**and**_ U.S. Customary System (ounces, pounds, fluid ounces) terms. For example, Net contents 1 gal (3.79 L)

**Notes:**
The area of the principal display panel (calculated in square inches or square centimeters) determines the minimum type size that is permitted for the net quantity statement (see next question). 
There are conspicuousness and prominence requirements:
Choose a print style that is prominent, conspicuous and easy to read. The letters must not be more than three times as high as they are wide, and lettering must contrast sufficiently with the background to be easy to read. Do not crowd the net quantity statement with artwork or other labeling (minimum separation requirements are specified in the regulation). 

www.cfsan.gov

## Color-coding

- USP supports the suggestion that _*the use of color-coding for pharmaceutical products*_ to prevent medication errors _*be used cautiously and on a case-by-case basis*_

- THANK YOU