ASTM D6398-2008(2014) 0110 Standard Practice to Enhance Identification of Drug Names on Labels《增强标签上药物名称的识别的标准实施规程》.pdf

1、Designation: D6398 08 (Reapproved 2014)Standard Practice toEnhance Identification of Drug Names on Labels1This standard is issued under the fixed designation D6398; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last r

2、evision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers the shape, size, color, layout,typeface, and barcoding on drug container labels intended forprescriptio

3、n product packaging such as might be used inhospitals, pharmacies, and nursing centers.1.1.1 This practice does not apply to bulk product shippingcontainers; in-process transfer containers; or primary,secondary, or tertiary finished goods containers.1.2 This practice does not apply to over-the-count

4、er drugproduct labeling.1.3 This practice does not apply to retail product labeling.1.4 The values stated in SI units are to be regarded asstandard. The values given in parentheses are for informationonly.2. Referenced Documents2.1 ASTM Standards:2D996 Terminology of Packaging and Distribution Envir

5、on-mentsD4267 Specification for Labels for Small-Volume (100 mLor Less) Parenteral Drug ContainersD4774 Specification for User Applied Drug Labels in Anes-thesiologyD7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation2.2 Other Documents:21 CFR 42

6、9.12 Packaging and Labeling of Insulin321 CFR 201.66 Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labeling3ISO 3864 Safety Colors and Safety Signs43. Terminology3.1 General definitions for packaging and distribution envi-ronments are in accordance with Terminology D996.3.2

7、 Definitions of Terms Specific to This Standard:3.2.1 shape of labelshape of the label wherein is writtenthe name of the drug, the dosage, and the total contents of thedrug in its final form.4. Significance and Use4.1 Medication errors occur when users are confused by thesimilar size, shape, color,

8、typeface, and layout of labels that areused for a range of a manufacturers drugs with widelydissimilar actions or potencies. The human visual system usesshape, size, color, and typeface in the initial recognition of alabeled drug. (See 9.1 9.3.) The use of this human visualsystem has been described

9、in 21 CFR 429.12 for the labeling ofinsulin. Using the similar label design, color, and typefacethroughout a product line makes identifying an individual drugmore difficult.4.2 The objective of this practice is to provide guidance forthe design of drug labels which will enable users to easilydisting

10、uish between drugs of differing action or potency. SeeNote 1.NOTE 1For specific requirements for these labels and other features oflabels for OTC human drugs, see 21 CFR 201.66.5. Label RequirementsPanel Shape, Color, andContrast5.1 Differing combinations of label shape and color, withdiffering layo

11、uts and text face should be used to provide areadily recognizable combination for each group of drugs withdifferent actions or potency within a manufacturers range ofproducts. (See Fig. 1.)5.2 High contrast between the margin of the label and itssurroundings and between the drug name and backgrounds

12、hould be provided.1This practice is under the jurisdiction of ASTM Committee D10 on Packagingand is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical, Medical, and Child Resistant Packaging.Current edition approved April 1, 2014. Published April 2014. Originallyapproved in

13、2001. Last previous edition approved in 2008 as D6398 08. DOI:10.1520/D6398-08R14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary pag

14、e onthe ASTM website.3Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http:/www.dodssp.daps.mil.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.or

15、g.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States16. Color6.1 If applicable, manufacturers should use the colors speci-fied for the specific drug groups in accordance with Specifica-tion D4774 or refer to ISO 3864 for guidance concern

16、ing safetycolors.6.2 Pastel colors should not be used for the identification ofdrugs, since approximately 8 % of the male population havecongenital X-linked “color blindness” which diminishes theirability to distinguish between pastel shades of red, green, andbeige (see 9.4).6.3 Color contrasts with

17、 bright saturated colors contrastingwith the text and the background should be used.6.3.1 Suggested color contrasts are as follows:Text BackgroundBlack WhiteBlue YellowWhite BlueBlue White7. Copy Legibility7.1 Label copy shall be measured in accordance with TestMethod D7298.7.1.1 If the instrumentat

18、ion called for in Test Method D7298is unavailable, copy legibility shall be measured in a light of215 lx (lux) 20 fc (foot candles) at a distance of 500 mm (19.7in.) by a person with 20/30 unaided or corrected vision. Acontrasting background may be used.7.2 Recognition of the Drug Name:7.2.1 Upper a

19、nd lower case lettering for the drug nameshould be used.7.2.2 The initial capital letter of the drug name may be givenadded emphasis in bold type.7.2.3 To facilitate legibility, extra space should be providedaround the drug name to separate the name from the rest of thelabel copy.7.3 Where different

20、 strengths of the same compound areavailable, the concentration per unit should be prominentlymarked in large figures (see 21 CFR 201.66 for examples).7.4 Where groups of drugs have names with similar endingsthat may cause confusion, the initial syllable of the name maybe printed in 2 or 4-point lar

21、ger-sized capital letters (see Fig.2).FIG. 1 Labels to Distinguish Three Different Concentrations of a Local AnestheticFIG. 2 Labels to Show Initial Syllable of Name in Larger CapitalLettersD6398 08 (2014)28. Barcoding8.1 Critical information, for example, name of drug, dosage,concentration per unit

22、, or total contents shall be encoded in anappropriate location on each item of labeling.8.2 Adequate space may be needed to allow for the additionof a bar code by the pharmacist or user.8.3 Human readable characters shall be printed above,below, or adjacent to the barcoding to allow for confirmingin

23、spections.9. Rationale9.1 Experiments in accordance with Professor A. Treismanand colleagues, Department of Psychology, UC Berkeley (1,2)5showed that the visual processing towards identification ofan object passes throughout several phases. Initially, the entirevisual field is taken in simultaneousl

24、y, and than an object isseparated from its surroundings for subsequent detailed exami-nation. The ease with which key information is separated, andtherefore quickly identified, depends in part upon contrast incolor and brightness. Also, the contrast between the outlineshape of the boundary of the ob

25、ject and its surroundings isimportant. Thus, a curved outline stands out from regularlystriped surroundings or an outline at a 45 diagonal willsimilarly stand out from vertical or horizontal stripes. Thesefeatures will help an object to “snap out” from its surroundings,greatly facilitating and speed

26、ing up the process of identifica-tion.9.2 Attneave (3) found that people do better in identificationwhen different colors are combined with different shapes.Therefore, a red square, green triangle, or blue circle would beeasier to identify than red, blue, green, purple, orange, or blacksquares or re

27、d squares, triangles, circles, stars, ellipses, andrectangles.9.3 Kosslyn (4) has pointed out that mental imagery mayoccur in which the brain recalls an image, without sensoryinput, so that the subject “sees with the minds eye.” This maybe responsible for the “expectancy effect” in which the brainre

28、cords the object that it anticipates it will see rather than theactual object visible.9.4 Chang (5) states that the most common abnormality ofcolor vision is X-linked red-green “color blindness” which ispresent in approximately 8 % of males and is due to anX-linked congenital deficiency of one speci

29、fic retinal photore-ceptor. For more detail, consult Ref (6).10. Keywords10.1 color contrasts; labeling; labels; legibilityREFERENCES(1) Treisman, A., “Feature and Objects in Visual Processing,” ScientificAmerican, November 1986, pp. 114125.(2) Treisman, A., “Features and Objects,” Quarterly Journal

30、 of Experi-mental Psychology, Vol 2, No. 40A, 1988, pp. 201237.(3) Attneave, F., Applications of Information Theory to Psychology, Hold,Rinehart, and Winston, New York, NY, 1959.(4) Kosslyn, S. M., “Aspects of a Cognitive Neuroscience of MentalImagery,” Science , Vol 240, 1988, pp. 16211626.(5) Chan

31、g, D. F., “Ophthalmologic Examination,” in GeneralOphthalmology, 12th ed., edited by D. Vaughan, T. Asbury, and K. F.Tabbara, Appleton or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).5The boldface numbers in parentheses refer to a list of references at the end ofthis standard.D6398 08 (2014)3