ASTM D6398-2001e1 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 01e1Standard 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 num

2、ber in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTEFigure 1 was corrected editorially in August 2001.1. Scope1.1 This practice covers the shape, size, color, layout,typeface, and barcoding on dr

3、ug container labels intended forprescription 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, second-ary, or tertiary finished goods containers.1.2 T

4、his practice does not apply to over-the-counter drugproduct labeling.1.3 This practice does not apply to retail product labeling.2. Referenced Documents2.1 ASTM Standards:2D 996 Terminology of Packaging and Distribution Environ-mentsD 4267 Specification for Labels for Small-Volume (100 mLor Less) Pa

5、renteral Drug ContainersD 4774 Specification for User Applied Drug Labels inAnesthesiology2.2 Other Documents:21 CFR 429.12 Packaging and Labeling of Insulin321 CFR 201.66 Format and Content Requirements forOver-the-Counter (OTC) Drug Product Labeling3ISO 3864 Safety Colors and Safety Signs43. Termi

6、nology3.1 General definitions for packaging and distribution envi-ronments are in accordance with Terminology D 996.3.2 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 f

7、inal form.4. Significance and Use4.1 Medication errors occur when users are confused by thesimilar size, shape, color, 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 type

8、face in the initial recognition of alabeled drug. (See 9.1-9.3.) The use of this human visualsystem has been described 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

9、objective of this practice is to provide guidance forthe design of drug labels which will enable users to easilydistinguish between drugs of differing action or potency.55. Label RequirementsPanel Shape, Color, andContrast5.1 Differing combinations of label shape and color, withdiffering layouts and

10、 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

11、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 April 10, 2001. Published June 2001.2For referenced ASTM standards, visit the ASTM

12、 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 Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA

13、19111-5094, Attn: NPODS.4Available from American National Standards Institute, 11 W. 42nd St., 13thFloor, New York, NY 10036.5For specific requirements for these labels and other features of labels for OTChuman drugs, see 21 CFR 201.66.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C70

14、0, 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 not be used for the id

15、entification 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 text and the backgr

16、ound 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 in accordance with Section 8 ofSpecification D 4267.7.2 Recognition of the drug name:7.2.1 Upper and lower case lettering for the drug

17、 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 strengths of the same compound area

18、vailable, 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

19、).8. Barcoding8.1 Critical information, for example, name of drug, dosage,concentration per unit, 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.FIG. 1 Labels to D

20、istinguish Three Different Concentrations of a Local AnestheticFIG. 2 Labels to Show Initial Syllable of Name in Larger CapitalLettersD639801e128.3 Human readable characters shall be printed above,below, or adjacent to the barcoding to allow for confirminginspections.9. Rationale9.1 Experiments in a

21、ccordance with Professor A. Treismanand colleagues, Department of Psychology, UC Berkeley (1, 2)showed that the visual processing towards identification of anobject passes throughout several phases. Initially, the entirevisual field is taken in simultaneously, and than an object isseparated from its

22、 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 object and its surroundings isimportant. Thu

23、s, 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 speeding up the process of identifica-tion.9.2

24、Attneave (Ref 3) found that people do better in identi-fication when different colors are combined with differentshapes. Therefore, a red square, green triangle, or blue circlewould be easier to identify than red, blue, green, purple,orange, or black squares or red squares, triangles, circles, stars

25、,ellipses, and rectangles.9.3 Kosslyn (Ref 4) has pointed out that mental imagerymay occur 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 anticip

26、ates it will see rather than theactual object visible.9.4 Chang (Ref 5) states that the most common abnormalityof color vision is X-linked red-green “color blindness” whichis present in approximately 8 % of males and is due to anX-linked congenital deficiency of one specific retinal photore-ceptor.

27、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. 114-125.(2) Treisman, A., “Features And Objects,” Quarterly Journal of Experi-mental Psychology,

28、 40A (Vol 2), 1988, pp. 201-237.(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. 1621-1626.(5) General Ophthalmology,12thEd., D. Vaughan, T. Asbury, and K. F.Tabbara, eds., Norwalk, CT,Appleton or through the ASTM website(www.astm.org).D639801e13