ASTM D6398-2008 288 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: D 6398 08Standard Practice toEnhance Identification of Drug Names on Labels1This standard is issued under the fixed designation D 6398; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numbe

2、r in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 forprescription product packa

3、ging 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, second-ary, or tertiary finished goods containers.1.2 This practice does not apply to over-the-counter drugproduc

4、t labeling.1.3 This practice does not apply to retail product labeling.1.4 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are for informationonly.2. Referenced Documents2.1 ASTM Standards:2D 996 Terminology of Packaging and Distribution Environ-ments

5、D 4267 Specification for Labels for Small-Volume (100 mLor Less) Parenteral Drug ContainersD 4774 Specification for User Applied Drug Labels inAnesthesiologyD 7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation2.2 Other Documents:21 CFR 429.12 Pa

6、ckaging and Labeling of Insulin321 CFR 201.66 Format and Content Requirements forOver-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 D 996.3.2 Defini

7、tions 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, typefac

8、e, 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 in 21 C

9、FR 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 easilydistinguish be

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

11、 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 backgroundshould b

12、e provided.1This practice is under the jurisdiction of ASTM Committee D10 on Packagingand is the direct responsibility of Subcommittee D10.32 on Consumer, Pharmaceu-tical and Medical Packaging.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 2001. Last previous edit

13、ion approved in 2001 as D 6398 01e1.2For 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 page onthe ASTM website.3Available from Standardi

14、zation 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.org.1Copyright ASTM International, 100 Barr Harb

15、or Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6. Color6.1 If applicable, manufacturers should use the colors speci-fied for the specific drug groups in accordance with Specifica-tion D 4774 or refer to ISO 3864 for guidance concerningsafety colors.6.2 Pastel colors should no

16、t 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 bright saturated colors contrastingwith the

17、 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 D 7298.7.1.1 If the instrumentation called for in Test MethodD 7298 is unav

18、ailable, copy legibility shall be measured in alight of 215 lx (lux) 20 fc (foot candles) at a distance of 500mm (19.7 in.) by a person with 20/30 unaided or correctedvision. A contrasting background may be used.7.2 Recognition of the Drug Name:7.2.1 Upper and lower case lettering for the drug names

19、hould 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 strengths of the same compound areavailab

20、le, 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 larger-sized capital letters (see Fig.2).FIG.

21、 1 Labels to Distinguish Three Different Concentrations of a Local AnestheticFIG. 2 Labels to Show Initial Syllable of Name in Larger CapitalLettersD63980828. Barcoding8.1 Critical information, for example, name of drug, dosage,concentration per unit, or total contents shall be encoded in anappropri

22、ate 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 confirminginspections.9. Rationale9.1 Experiments in accordanc

23、e 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 simultaneously, and than an object isseparated from its surroun

24、dings 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 object and its surroundings isimportant. Thus, a cur

25、ved 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 speeding up the process of identifica-tion.9.2 Attneave

26、 (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 red squares, triangles, circles, stars, ellipses, an

27、drectangles.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 brainrecords the object that it anticipates it will see r

28、ather 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 specific retinal photore-ceptor. For more detail, consu

29、lt 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 of Experi-mental Psychology, Vol 2, No. 40A, 1988

30、, 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) Chang, D. F., “Ophthalmologic Examination,” in General Ophthal-mology, 12th ed., edited by D. Vaughan, T. Asbury, and K. F. Tabbara,Appleton or through the ASTM website(www.astm.org).5The boldface numbers in parentheses refer to a list of references at the end ofthis standard.D6398083