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    Pediatrics
    October 2016, VOLUME 138 / ISSUE 4
    Article

    Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment

    H. Shonna Yin, Ruth M. Parker, Lee M. Sanders, Benard P. Dreyer, Alan L. Mendelsohn, Stacy Bailey, Deesha A. Patel, Jessica J. Jimenez, Kwang-Youn A. Kim, Kara Jacobson, Laurie Hedlund, Michelle C. J. Smith, Leslie Maness Harris, Terri McFadden, Michael S. Wolf
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    • FIGURE 1
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      FIGURE 1

      Medication labels and dosing tools tested. A, Comparison of randomization group characteristics. Unit label and dosing tool pairings were chosen because they represent the most common current standard practices used to display dose amounts on medication labels and dosing tools. The combination of units on labels and dosing tools applied to 3 different dosing tools given to each person (2 oral syringes [1 0.2-mL increment and 1 0.5-mL increment] and 1 cup); each subject measured 3 doses with the 3 tools, for a total of 9 doses. aExample of group 2 medication label is shown in Fig 1B. Teaspoon units on English-language medication labels were translated into Spanish, consistent with recommended pharmacy practices. The abbreviation tsp was displayed as cdta on Spanish-language medication bottle labels, and teaspoon was displayed as cucharadita on the Spanish-language medication bottle labels. bDosing tools had units marked in English only, as is standard practice in the United States. For dosing tools, mL and tsp tools are most commonly used and were therefore included for the majority of groups. See Fig 1C. cThe milliliter-only system is endorsed by the AAP, the Centers for Disease Control and Prevention, and other national organizations. B, Example of group 2 medication label (English). C, Dosing tools tested.

    • FIGURE 2
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      FIGURE 2

      Study enrollment flowchart. aRan out of time after signing consent.

    • FIGURE 3
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      FIGURE 3

      Dosing errors by tool type across the 3 doses tested.

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    • TABLE 1

      Characteristics of Study Population (n = 2099)a

      Entire PopulationGroup 1Group 2Group 3Group 4Group 5P
      Label UnitmLmL and tspmL and teaspoonmLteaspoon
      Dosing Tool UnitmLmL and tspmL and tspmL and tspmL and tsp
      N = 417N = 425N = 421N = 418N = 418
      Mean (SD) or n (%)Mean (SD) or n (%)Mean (SD) or n (%)Mean (SD) or n (%)Mean (SD) or n (%)Mean (SD) or n (%)
      Child characteristics
       Age, y, mean (SD)2.0 (2.2)2.1 (2.2)2.3 (2.3)2.0 (2.1)2.0 (2.1)1.9 (2.1).2
       Gender, n (%) female987 (47.0)206 (49.4)210 (49.4)196 (46.6)181 (43.3)194 (46.4).4
       Chronic medical problem treated with medication, n (%)b352 (16.8)74 (17.7)64 (15.1)64 (15.2)76 (18.2)74 (17.7).6
      Parent characteristics
       Age, y, mean (SD)30.0 (7.3)29.9 (7.1)30.2 (7.5)29.1 (7.1)29.8 (7.5)29.5 (7.5).3
       Gender, n (%) female1930 (91.9)384 (92.1)397 (93.4)391 (92.9)384 (91.9)374 (89.5).3
       Relationship to child, n (%) mother1881 (89.6)376 (90.2)384 (90.4)379 (90.0)375 (89.7)367 (87.8).8
       Marital status single, n (%)c803 (38.7)160 (38.8)166 (39.6)157 (37.7)167 (40.3)153 (37.0).9
       Income, n (%).02
        <$10 000497 (23.7)113 (27.1)99 (23.3)85 (20.2)104 (24.9)96 (23.0)
        $10 000–$19 999554 (26.4)94 (22.5)114 (26.8)144 (34.2)107 (25.6)95 (22.7)
        $20 000–$39 999583 (27.8)109 (26.1)122 (28.7)107 (25.4)111 (26.6)134 (32.1)
        ≥$40 000255 (12.1)55 (13.2)47 (11.1)48 (11.4)56 (13.4)49 (11.7)
        Unknown or missing210 (10.0)46 (11.0)43 (10.1)37 (8.8)40 (9.6)44 (10.5)
       Country of birth: non-US born, n (%)d1031 (49.5)203 (49.2)230 (54.4)201 (48.2)201 (48.2)196 (47.3).3
       Race or ethnicity, n (%)e.9
        Hispanic1140 (54.8)224 (54.4)227 (53.8)225 (54.2)241 (57.8)223 (53.9)
        Non-Hispanic
         White, non-Hispanic79 (3.8)14 (3.4)14 (3.3)15 (3.6)18 (4.3)18 (4.3)
         Black, non-Hispanic695 (33.4)141 (34.2)146 (34.6)134 (32.3)134 (32.1)140 (33.8)
         Other, non-Hispanic166 (8.0)33 (8.0)35 (8.3)41 (9.9)24 (5.8)33 (8.0)
       Language Spanish, n (%)f736 (35.1)157 (37.6)158 (37.2)134 (31.8)145 (34.7)142 (34.0).4
       Education, n (%)g.9
        Less than high school graduate638 (30.7)132 (32.0)137 (32.5)118 (28.3)128 (30.8)123 (29.7)
        High school graduate or equivalent674 (32.4)127 (30.8)141 (33.4)138 (33.1)138 (33.3)130 (31.4)
        Higher than high school graduate769 (37.0)154 (37.3)144 (34.1)161 (38.6)149 (35.9)161 (38.9)
       Health literacy, n (%)h.04
        Low740 (36.0)148 (36.5)139 (33.4)142 (34.6)157 (38.1)154 (37.2)
        Marginal843 (41.0)166 (40.9)191 (45.9)167 (40.7)175 (42.5)144 (34.8)
        Adequate475 (23.1)92 (22.7)86 (20.7)101 (24.6)80 (19.4)116 (28.0)
      Site characteristics
       Emory690 (32.9)137 (32.9)140 (32.9)138 (32.8)137 (32.8)138 (33.0).97
       New York University701 (33.4)141 (33.8)141 (33.2)140 (33.3)139 (33.3)140 (33.5)
       Stanford708 (33.7)139 (33.3)144 (33.9)143 (34.0)142 (34.0)140 (33.5)
      • ↵a Characteristics not different between enrolled subjects and those eligible who did not enroll (P > .05 for all).

      • ↵b Missing for 56 children overall (16 in group 1, 11 in group 2, 12 in group 3, 5 in group 4, and 12 in group 5).

      • ↵c Missing for 25 parents (5 in group 1, 6 in group 2, 5 in group 3, 4 in group 4, and 5 in group 5).

      • ↵d Missing for 15 parents (4 in group 1, 2 in group 2, 4 in group 3, 1 in group 4, and 4 in group 5).

      • ↵e Missing for 19 parents (5 in group 1, 3 in group 2, 6 in group 3, 1 in group 4, and 4 in group 5).

      • ↵f Language of survey administration.

      • ↵g Missing for 18 parents (4 in group 1, 3 in group 2, 4 in group 3, 3 in group 4, 4 in group 5).

      • ↵h Health literacy measured with the Newest Vital Sign (low = score 0–1, marginal = 2–3, adequate = 4–6). Data missing for 41 subjects who did not complete the Newest Vital Sign (11 in group 1, 9 in group 2, 11 in group 3, 6 in group 4, and 4 in group 5).

    • TABLE 2

      Dosing Error by Dosing Tool Type and Randomization Group (n = 2058)

      Dosing Error (>20% Deviation)Large Dosing Error (>2 Times the Dose)
      % Trials With Errors/ParentaPbaORc95% CIP% Trials With Large Errors/ParentaPbaORc95% CIP
      GroupLabel UnitTool Unit
      Unit of measurement pairing on label versus dosing tool
       1mLmL25.3.0021.0RefRef2.9.081.0RefRef
       2mL and tspmL and tsp22.8—0.90.7–1.04.12.7—1.00.7–1.4.9
       3mL and teaspoonmL and tsp22.9—0.90.7–1.03.13.0—1.10.8–1.6.7
       4mLmL and tsp25.4—1.00.8–1.2.83.5—1.20.8–1.7.4
       5teaspoonmL and tsp29.6—1.21.01–1.4.043.6—1.40.97–1.9.08
      Dosing tool type
       Cup43.0<.0014.64.2–5.1<.0015.8<.0013.83.1–4.7<.001
       Syringe (0.2-mL increment, 10-mL capacity)16.7—1.00.96–1.1.41.8—1.00.8–1.3.9
       Syringe (0.5-mL increment, 10-mL capacity)16.2—1.0RefRef1.8—1.0RefRef
      • Ref, referent.

      • ↵a Percentage of trials with errors per parent.

      • ↵b Type 3 χ2 from full model.

      • ↵c Full model adjusting for randomization group, tool type, dose amount, dosing order, language, and health literacy.

    • TABLE 3

      Dosing Error by Dosing Tool Type and Randomization Group, Stratified by Health Literacy and Language (n = 2058)

      % Trials With Errors/ParentaDosing Error (>20% deviation)
      PbaORc95% CIP
      By Health Literacy
      Low health literacy (n = 740)
      Unit of measurement pairing on label vs dosing tool
      GroupLabel UnitTool Unit
      1mLmL32.4.031.0RefRef
      2mL and tspmL and tsp28.50.80.6–1.1.2
      3mL and teaspoonmL and tsp30.20.90.7–1.2.4
      4mLmL and tsp31.91.00.7–1.3.9
      5teaspoonmL and tsp38.71.30.98–1.7.07
       Dosing tool type
        Cup48.9<.0013.43.0–3.9<.001
        Syringe (0.2-mL increment, 10-mL capacity)24.91.10.98–1.2.1
        Syringe (0.5-mL increment, 10-mL capacity)23.61.0RefRef
      Marginal health literacy (n = 843)
      Unit of measurement pairing on label vs dosing tool
      GroupLabel UnitTool Unit
      1mLmL21.8.21.0RefRef
      2mL and tspmL and tsp21.50.90.7–1.2.6
      3mL and teaspoonmL and tsp22.20.970.7–1.3.8
      4mLmL and tsp24.51.10.9–1.5.4
      5teaspoonmL and tsp28.61.30.95–1.7.1
       Dosing tool type
        Cup43.1<.0015.64.8–6.6<.001
        Syringe (0.2-mL increment, 10-mL capacity)13.81.00.9–1.2.8
        Syringe (0.5-mL increment, 10-mL capacity)13.71.0RefRef
      Adequate health literacy (n = 475)
      Unit of measurement pairing on label vs dosing tool
      GroupLabel UnitTool Unit
      1mLmL20.3.21.0RefRef
      2mL and tspmL and tsp16.30.90.6–1.3.5
      3mL and teaspoonmL and tsp14.00.70.5–1.01.1
      4mLmL and tsp14.60.70.5–1.05.1
      5teaspoonmL and tsp18.80.90.7–1.4.7
       Dosing tool type
        Cup33.6<.0016.55.0–8.5<.001
        Syringe (0.2-mL increment, 10-mL capacity)8.20.90.7–1.2.4
        Syringe (0.5-mL increment, 10-mL capacity)8.81.0RefRef
      By Language
      English (n = 1334)
      Unit of measurement pairing on label vs dosing tool
      GroupLabel UnitTool Unit
      1mLmL25.60.21.0RefRef
      2mL and tspmL and tsp22.00.80.7–1.02.07
      3mL and teaspoonmL and tsp21.30.80.6–0.96.02
      4mLmL and tsp23.70.90.7–1.06.2
      5teaspoonmL and tsp25.20.90.7–1.1.4
       Dosing tool type
        Cup42.0<.0015.24.5–5.9<.001
        Syringe (0.2-mL increment, 10-mL capacity)14.21.00.9–1.1.8
        Syringe (0.5-mL increment, 10-mL capacity)14.31.0RefRef
      Spanish (n = 724)
      Unit of measurement pairing on label vs dosing tool
      GroupLabel UnitTool Unit
      1mLmL24.9<.0011.0RefRef
      2mL and tspmL and tsp24.11.00.8–1.3.9
      3mL and teaspoonmL and tsp26.51.10.8–1.4.7
      4mLmL and tsp28.71.20.9–1.6.2
      5teaspoonmL and tsp38.32.01.5–2.6<.001
       Dosing tool type
        Cup44.7<.0013.93.3–4.5<.001
        Syringe (0.2-mL increment, 10-mL capacity)20.81.10.98–1.2.1
        Syringe (0.5-mL increment, 10-mL capacity)19.51.0RefRef
      • Ref, referent.

      • ↵a Percentage of trials with dosing errors per parent.

      • ↵b Type 3 χ2 from full model.

      • ↵c Full model adjusting for randomization group, tool type, dose amount, dosing order, language, and health literacy. Models by health literacy adjusting for all except health literacy; models for language adjusting for all except language.

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    Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment
    H. Shonna Yin, Ruth M. Parker, Lee M. Sanders, Benard P. Dreyer, Alan L. Mendelsohn, Stacy Bailey, Deesha A. Patel, Jessica J. Jimenez, Kwang-Youn A. Kim, Kara Jacobson, Laurie Hedlund, Michelle C. J. Smith, Leslie Maness Harris, Terri McFadden, Michael S. Wolf
    Pediatrics Oct 2016, 138 (4) e20160357; DOI: 10.1542/peds.2016-0357

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    Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment
    H. Shonna Yin, Ruth M. Parker, Lee M. Sanders, Benard P. Dreyer, Alan L. Mendelsohn, Stacy Bailey, Deesha A. Patel, Jessica J. Jimenez, Kwang-Youn A. Kim, Kara Jacobson, Laurie Hedlund, Michelle C. J. Smith, Leslie Maness Harris, Terri McFadden, Michael S. Wolf
    Pediatrics Oct 2016, 138 (4) e20160357; DOI: 10.1542/peds.2016-0357
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