The Current Status of OTC Labels: A Systematic Look at Pediatric OTC Liquid Medications

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Darlene Terry
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1 The Current Status of OTC Labels: A Systematic Look at Pediatric OTC Liquid Medications H. Shonna Yin, MD, MS Michael S. Wolf, PhD, MPH Lee M. Sanders, MD, MPH Benard P. Dreyer, MD Ruth M. Parker, MD IOM Roundtable on Health Literacy The Safe Use Initiative and Health Literacy: A Workshop Tuesday, April 27, 2010

Inconsistency & Medication Labeling Inconsistency and variability in medication labeling is a source of confusion for patients IOM Workshop

2 Inconsistency & Medication Labeling Inconsistency and variability in medication labeling is a source of confusion for patients IOM Workshop Standardizing Medication Labels: Confusing Patients Less (Oct 2007) Confusion increases risk for error Health literacy and patient safety issue

3 Why Pediatric OTC Medications? First attempt to systematically look at variability in OTC products Pediatric focus chosen Prevalence of OTC medication use in children Unique challenges of dosing liquid medications Findings likely to be reflective of sample

4 National Initiatives with Implications for Pediatric Medication Safety FDA Safe Use Initiative / Guidance for Industry: Dosage Delivery Devices for OTC Liquid Drug Products (11/09) CDC PROTECT Initiative CHPA Guidance (11/09) No prior systematic assessment of inconsistencies

5 Product Selection Product list obtained from Health Top selling OTC medications over prior year 200 top-selling OTC products selected using these inclusion criteria: Oral liquid medication Analgesic, cough/cold, allergy, or GI product Dosing directions for child <12 years of age

6 Products By Category (n=200) 22% 11% analgesic 8% cough / cold allergy GI 59%

7 Products By Age Group (n=200) 1% 12% infant = <2 years child = >2 to <12 years adult = >12 years 41% 22% infant only infant + child infant + child + adult child only 24% child + adult

8 Issues Identified in FDA Guidance

9 Issues Identified in FDA Guidance #1 No dosage delivery device for nonprescription liquid formulation products

10 Issues Identified in FDA Guidance #1 No dosage delivery device for nonprescription liquid formulation products #2 Inconsistency between label and dosage delivery device (within product variability) A. Superfluous markings on device B. Missing necessary markings on device C. Markings for unit(s) of measurement do not match D. Format of numeric text (decimals / fractions) does not match

11 Issues Identified in FDA Guidance #1 No dosage delivery device for nonprescription liquid formulation products #2 Inconsistency between label and dosage delivery device (within product variability) #3 Inconsistency across products (between product variability) A. Nonstandard abbreviation for milliliter (not ml ) B. Nonstandard abbreviation for teaspoon (not tsp ) C. Units of measurement other than milliliter, teaspoon, and tablespoon D. Inconsistent use of numeric text (decimals / fractions)

12 Issues Identified in FDA Guidance #1 No dosage delivery device for nonprescription liquid formulation products #2 Inconsistency between label and dosage delivery device (within product variability) #3 Inconsistency across products (between product variability) #4 Lack of consumer guidance on appropriate use A. No definition(s) of abbreviations for unit(s) of measurement B. No strategy to ensure delivery device used with drug product C. No statement about appropriate use of device when physician-recommended doses do not match dose amounts on device

13 Issues Identified in FDA Guidance #1 No dosage delivery device for nonprescription liquid formulation products #2 Inconsistency between label and dosage delivery device (within product variability) #3 Inconsistency across products (between product variability) #4 Lack of consumer guidance on appropriate use

14 #1. No dosage delivery device for nonprescription liquid formulation products 25% of products did not include a device 2% 1% 11% 25% no dosage delivery device dosing cup dropper oral syringe other 61%

15 #2. Inconsistency between label and dosage delivery device (within product variability) 99% had one or more inconsistencies Type of inconsistency % Superfluous markings on device 81% Missing necessary markings on device 22% Markings for unit(s) of measurement do not match Format of numeric text (decimals / fractions) does not match 89% 53%

16 #2. Inconsistency between label and dosage delivery device (within product variability) Example missing necessary markings superfluous markings

17 #2. Inconsistency between label and dosage delivery device (within product variability) missing necessary marking superfluous markings

18 #2. Inconsistency between label and dosage delivery device (within product variability) Example = 52% inconsistent in text used for milliliter D E V I C E L A B E L ml ml ML ml ml ML 0 0 0

19 #3. Inconsistency across products (between product variability) 3A. Nonstandard abbreviation for milliliter (not ml )* 67% used a nonstandard abbreviation for milliliter 100 % Products ml* ml mls ML * USP standard, FDA recommended standard

20 #3. Inconsistency across products (between product variability) 3B. Nonstandard abbreviation for teaspoon (not tsp )* 63% used a nonstandard abbreviation for teaspoon 100 % Products tsp* tsps TSP * FDA recommended standard

21 #3. Inconsistency across products (between product variability) 3C. Units of measurement other than milliliter, teaspoon, and tablespoon 14% used other units of measurement eg. Drams, cc, fluid ounces, DSSP ( dessert-spoonfuls )

22 #3. Inconsistency across products (between product variability) 3D. Inconsistent use of numeric text (decimals / fractions) Decimals 13% lacked use of leading zero for decimal <1 Fractions 0.X is Joint Commission standard 64% did not use small font size for numerals Small (eg. ½, 1 ½)* Large (eg. 1/2, 1 1/2) * Recommended format

23 #4. Lack of consumer guidance on appropriate use 4A. No definition(s) of abbreviations for unit(s) of measurement Examples of definitions TBSP (tablespoon) tsp=teaspoon Only 7% had at least 1 definition Only 1% had all relevant definitions

24 #4. Lack of consumer guidance on appropriate use 4B. No strategy to ensure delivery device used with drug product 65% no statement to only use device with product 97% no mechanism which secures device to bottle

25 #4. Lack of consumer guidance on appropriate use 4C. No statement about appropriate use of device when physician-recommended doses do not match dose amounts on device 0% with statement

26 Summary Enormously high rate of inconsistency and variability in labels and devices for pediatric OTC liquid medications Variability and inconsistency sources of patient confusion and error Patient safety issue Efforts to standardize labels and dosing devices greatly needed

27 superfluous marking

28 missing necessary marking superfluous markings

29 missing necessary markings only tablespoon markings We can do better than this!

30 We can do better than this!

31 H. Shonna Yin, MD, MSc Department of Pediatrics NYU School of Medicine / Bellevue Hospital Center 550 First Avenue NBV 8S411 New York, NY 10016

32 Combination of Units of Measurement Used (n=200) 2% 1% 5% 2% 5% 2% 4% 2% 1% 1% 2% 46% 8% 18% 1% ml only tsp only TBSP only ml + tsp ml + TBSP tsp + TBSP ml + tsp + TBSP other only ml + other tsp + other TBSP + other ml + tsp + other ml + TBSP + other tsp + TBSP + other ml + tsp + TBSP + other

33 #3. Inconsistency across products (between product variability) # of different units of measurement Mean (SD) = 1.9 (0.9) # of different units of measurement %

34 #1. No dosage delivery device for nonprescription liquid formulation products GI products least likely to include a device 96% 76% 93% 51% analgesic cough/cold allergy GI 4% 24% 7% 49% No Dosage Delivery Device Device Included p<0.001

35 #1. No dosage delivery device for nonprescription liquid formulation products Small companies least likely to include a device 95% 90% 54% small 46% large private label 5% 10% No Dosage Delivery Device Device Included p<0.001

36 #3. Inconsistency across products (between product variability) Abbreviation for tablespoon other than one most commonly used (not TBSP ) 32% used abbreviation for tablespoon other than TBSP % Products TBSP Tbsp tbsp TBS

37 #4. Lack of consumer guidance on appropriate use 4A. No definition(s) of abbreviations for unit(s) of measurement 100% 96% milliliter teaspoon 55% tablespoon 45% 4% No Definition Definition Present

38 #2. Inconsistency between label and dosage delivery device (within product variability) Inconsistency in text used for units of measurement % with inconsistency milliliter 48% teaspoon 88% tablespoon 86% Any above inconsistency 89%

39 #3. Inconsistency across products (between product variability) 3D. Use of units of measurement other than milliliter, teaspoon, and tablespoon GI products most likely to use other units of measurement 46% 97% analgesic cough/cold allergy GI 3% Other Units of Measurement No Other Units of Measurement 54% p<0.001

40 #3. Inconsistency across products (between product variability) 3D. Use of units of measurement other than milliliter, teaspoon, and tablespoon Products with dosing for adults more likely to use other units of measurement 97% No adult dosing 3% 80% Adult dosing 20% Other Units of Measurement No Other Units of Measurement p=0.001

Guidance for Industry

Guidance for Industry Dosage Delivery Devices for OTC Liquid Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this