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ORIGINAL CONTRIBUTION

Evaluation of Consistency in DosingDirections and Measuring Devices for Pediatric Nonprescription Liquid MedicationsH. Shonna Yin, MD, MS

Michael S. Wolf, PhD, MPH, MA

Benard P. Dreyer, MD

Lee M. Sanders, MD, MPH

Ruth M. Parker, MD

IN NOVEMBER 2009, THE US FOOD

andDrugAdministration(FDA) re-leased new voluntary guidelines toindustry groups responsible for

manufacturing, marketing, or distrib-uting over-the-counter (OTC) liquidmedications, particularly those in-tended for use by children.1 Theseguidelines were developed in re-sponse to numerous reports of unin-tentional overdoses that were attrib-uted, i n par t, to pr o ducts w i thinconsistent or confusing labels andmeasuring devices.1 At roughly thesame time the FDA guidance was re-leased, the Consumer Health Prod-ucts Association (CHPA), a grouprepresenting manufacturers of OTCmedications, issued a similar set of vol-untary guidelines for its members.2

The FDA recommendations in-clude the following provisions: (1)all OTC liquid drug products shouldinclude a measuring device, (2) agiven product’s device and directionsshould use the same abbreviations

a n d u n i t s o f m e a s u r e m en t , ( 3 )devices should bear only necessarymarkings and should not hold sig-nificantly more than the largest dosedescribed, (4) abbreviations shouldconform to standards and should be

defined, (5) decimals or fractionsshould be used with care, and (6)

studies should be done to confirmaccurate use by consumers (BOX).1

We systematically assessed the clar-ity and consistency of dosing direc-tions and measuring devices amongthe top-selling pediatric OTC prod-ucts in the United States at the timethe FDA issued its guidelines, as nobaseline data exist.

Author Affiliations: Department of Pediatrics, NewYorkUniversity School of Medicineand Bellevue Hos-pitalCenter, NewYork,New York (Drs Yinand Dreyer);

Health Literacy andLearningProgram,Center for Com-munication in Healthcare, Division of General Inter-nal Medicine, and Institute for Healthcare Studies, Fein-berg School of Medicine, Northwestern University,Chicago, Illinois (Dr Wolf ); Department of Pediat-rics, Miller School of Medicine, University of Miami,Miami, Florida(Dr Sanders); andDepartment of Medi-cine, Emory University School of Medicine, Atlanta,Georgia (Dr Parker).Corresponding Author: H.ShonnaYin,MD,MS, De-partment of Pediatrics, New York University Schoolof Medicine, 550 First Ave, NBV 8S4-11, New York,NY 10016 ([email protected]).

Context In response to reports of unintentional drug overdoses among children givenover-the-counter (OTC) liquid medications, in November 2009 the US Food and DrugAdministration (FDA)released new voluntary industry guidelines that recommend greater consistency and clarity in OTC medication dosing directions and their accompanyingmeasuring devices.

Objective To determine the prevalence of inconsistent dosing directions and mea-suring devices among popular pediatric OTC medications at the time the FDA’s guid-ance was released.

Design and Setting Descriptive study of 200 top-selling pediatric oral liquid OTCmedications during the 52 weeks ending October 30, 2009. Sample represents 99%of the US market of analgesic, cough/cold, allergy, and gastrointestinal OTC oral liq-uid products with dosing information for children younger than 12 years.

Main Outcome Measures Inclusion of measuring device, within-product incon-sistency between dosing directions on the bottle’s label and dose markings on en-closed measuring device, across-product use of nonstandard units and abbreviations,and presence of abbreviation definitions.

Results Measuring devices were packaged with 148 of 200 products (74.0%). Withinthis subset of 148 products, inconsistencies between the medication’s dosing direc-tions and markings on the device were found in 146 cases (98.6%). These included

missing markings (n= 36, 24.3%) and superfluous markings (n =120, 81.1%). Acrossall products, 11 (5.5%) used atypical units of measurement (eg, drams, cc) for doseslisted. Milliliter, teaspoon, and tablespoon units were used for doses in 143 (71.5%),155 (77.5%), and 37 (18.5%) products, respectively. A nonstandard abbreviation for milliliter (not mL) was used by 97 products. Of the products that included an abbre-viation, 163 did not define at least 1 abbreviation.

Conclusion At the time the FDA released its newguidance, top-sellingpediatric OTCliquid medications contained highly variable and inconsistent dosing directions and mea-suring devices.

JAMA. 2010;304(23):2595-2602 www.jama.com

For editorial comment see p 2641.

©2010 American Medical Association. All rights reserved. (Reprinted) JAMA, December 15, 2010—Vol 304, No. 23 2595

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METHODSSelection of Pediatric

Nonprescription Liquid

Medication Products

The inclusion criteria were as follows:

medication was a liquid to be takenorally; dosing directions were pro-vided for a child younger than 12 years;and the product was categorized as an-algesic, cough/cold, allergy, or gastro-intestinal. Data for US retail stores, ex-cluding Internet and phone orders, forthe top-selling nonprescription medi-cations categorized as analgesic,cough/ cold, allergy, or gastrointestinal prod-ucts for the 52 weeks ending October30, 2009, were obtained from the IMSHealth Medicine Cabinet database. IMS

Health is a provider of market intelli-gence to pharmaceutical and health careindustries; the FDA and other profes-sional health care associations do notcollect or provide this type of informa-tion. The list of medications providedby IMS Health was ordered from high-est to lowest market share (based onnumber of products sold). Products not

meeting inclusion criteria, or whichwere discontinued, were excluded, andthe top medications that made up 99%of US market share for these productswere chosen for the final sample.

The list included products classi-fied as “private label,” which did notidentify a specific manufacturer andrepresent a number of store-brand non-prescription medications of the sametype sold by chain and retail pharma-cies. Because no specific identifying in-formation was provided(eg,“Privatela-bel Cough/Cold; Cold relief/analgs”),a representative product was selectedfrom 1 of 4 top US retail pharmacychainsfor each of the private-labelprod-ucts listed (ie, Walgreens, CVS, RiteAid, Walmart).3,4

Identification of Variables

for Analysis

Product packaging was independentlyassessed by 2 investigators (H.S.Y. and Jennifer King) following the FDA’s cri-teria (Box).A third investigator (B.P.D.)reviewed any instances in which there

was not agreement between raters, andfinal results reflected the agreement of 2 of the 3 investigators.

The following data were abstractedby the 2 investigators from the prod-uct label and any enclosed measuring

device: presence and type of device, nu-meric dose amounts (eg, 0.5 mL, 11 ⁄ 2tsp), exact text and abbreviations usedto specify units of measurement (eg,mL, teaspoonful, cc) associated withdoses, presence of definitions for ab-breviations of units of measurement (eg,tsp= teaspoon, tablespoon [TBSP]),andformat of decimals and fractions. Forall products listing a numeric doseamount less than 1 in decimal format,doses were assessed for use or nonuseof a leading zero before the decimalpoint (ie, 0.x or .x). For products using

fractions, doses were categorized asusing small numeral font size offsettext(eg, 1 ⁄ 2) or horizontally displayed regu-lar-size text (eg, 1/2).

Products were also examined forthe presence of elements designed toguide consumers on appropriate use,including (1) a strategy to ensurethat the measuring device is usedonly with the associated product (eg,inclusion of written statement orpresence of a mechanism to securethe device to its product, such as a

dropper that also serves as a cap forthe bottle), and (2) a statementwarning about appropriate use of themeasuring device if the physician’srecommended dose does not matchdoses marked on the device.

Outcome Measurement

and Analysis Plan

Data were analyzed using SPSS ver-sion 17.0 statistical software (SPSS Inc,Chicago, Illinois). A 2-tailed P valueՅ.05 was considered to be statisti-

cally significant.Analyses were performed to docu-ment conformity with the draft FDAguidance.1 For each product packagedwith a device, descriptive analyses wereperformed to document within-product inconsistency between the dos-ing directions on the bottle label andenclosed measuring device. For all

Box. Food and Drug Administration Recommendations to Industry

for Over-the-Counter Liquid Medications

Presence and Type of Measuring Device• Measuring devicesshouldbe included for all over-the-counter liquid medications.

Within-Product Inconsistency Between Labeled Dosing Directions

and Measuring Device• Devices should be marked with calibrated units of measure that are the same as

those specified in the labeled dosage directions.

• Abbreviations used on devices should be the same as those used in directions.

• Devices should not bear extraneous or unnecessary markings.

• Devices should not be significantly larger than the largest dose described.

Across-Product Variability

• Abbreviations should conform to international or national standards.

• Abbreviations should be defined on devices and/or label directions.

• Decimals and fractions should be used with care and conform to recommenda-tions, including use of leading zeros before decimal points to avoid 10-fold er-rors and use of small font size for numerals in fractions (eg, 1 ⁄ 2 rather than 1/2).

Consumer Guidance on Appropriate Use• Consumers should be encouraged to use measuring devices only with the prod-ucts with which they are included.

• Consumers should be directed to consult a health care provider when a physician-recommended dose is not marked on the enclosed measuring device.

• Usability studies should be done to confirm understandability and accurate use.

CONSISTENCY OF DIRECTIONS AND DEVICES IN PEDIATRIC OTC MEDICATIONS

2596 JAMA, December 15, 2010—Vol 304, No. 23 (Reprinted) ©2010 American Medical Association. All rights reserved.


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products, descriptive analyseswereper-formed to document across-productvariability in units of measurement, ab-breviations, andformats of numerictextas well as whether the product pro-vided consumer guidance on appropri-

ate use.Within-Product Inconsistency. Foreach product packaged with a measur-ingdevice,evidenceof inconsistencywasdefined as any of the following: devicemissing necessary markings (ie, dosespecifiedin directions notmarkedon de-vice), superfluous markings on device(ie, dose marked ondevicebut notspeci-fiedin directions), or inconsistentuseof units of measurement (ie, text used forunit of measurement on device differ-ent from that used in label directions).

Across-Product Variability. Across

all products in the sample, variabilitywas assessed for each of the following:atypical unit of measurement (ie, otherthan milliliter, teaspoon, or table-spoon), nonstandard abbreviations of the unit of measurement (mL is thestandard abbreviationfor milliliter usedby the Joint Commission and the USPharmocopoiea 1,5,6; tsp is the FDA-suggested standardabbreviation for tea-spoon1; no standard abbreviation fortablespoon exists butTBSP is most com-monly used), no definition for an ab-

breviated unit of measurement, andnonstandard use of numeric text (ie,leading zero before a decimal point isthe Joint Commissionstandardto avoid10-fold errors,1,5 use of small numeralfont size offset text format [eg, 1 ⁄ 2] isthe FDA-recommended standard1).

Thedegreeof interrater agreementforeachoutcome ofinterest wasdeterminedbycalculationofthestatistic. Subgroupcomparisonswerepreplanned.2orFisherexact tests (2-tailed) were performed toexamineassociationsbetweeninclusion

of measuring device and manufacturertype, medication category, and targetedagegroup,andtoquantifythestrengthof associationsbetweenthe presenceof in-consistencyandmanufacturertype,medi-cation category, and targeted age group.

Manufacturers were categorized aslarge (Ͼ2.5% market share each), small(Ͻ1% of market share each), or pri-

vate label (store brand). Medicationswere categorized as analgesic, cough/ cold, allergy, gastrointestinal, or com-bination products (ie, products con-taining analgesic and cough/coldingredients).7,8 Targeted age group was

characterized by whether dosage direc-tions were provided for infants and/orchildren only or included adults.

No adjustment was made for mul-tiple comparisons. Using the Bonfer-roni adjustment, the corrected level of significance would have been .008. Be-cause all of the significant results weresignificant at PϽ .001, no adjustmentwas necessary.

RESULTS

The processfor product selection beganwithapreliminarylistof732OTCprod-

uctsgeneratedbyIMSHealth(FIGURE 1).Thefinal sample consistedof 200 pedi-atricOTCanalgesic,cough/cold,allergy,andgastrointestinaloralliquid products,including 58private-labelproducts, thatrepresented 99% oftheUS marketsharefor these products.

Product characteristics are de-scribed in TABLE 1. Baseline confor-mity with the recommendations out-lined in the FDA’s voluntary guidelinesis summarized in TABLE 2. Across out-comes of interest, interrater agree-

ment was high (=0.91-1.00). Six out-comes without a of 1 (involving a totalof 9 products) required assessment bythe third rater.

A standardizedmeasuring device wasprovided for 148 products (74.0%).Dosing cups were provided for 83.1%,droppers wereprovided for 13.5%, and2.7% had oral syringes. Small manu-facturers were less likely to include adosing device (37/80, 46.3%) com-pared with large manufacturers (59/ 62, 95.2%) or private-label companies

(52/58, 89.7%) (2

2 =53.8, PϽ .001).Gastrointestinal products were leastlikelyto include a measuring device(21/ 42, 50.0%) compared with analgesics(22/23, 95.5%), cough/cold products(64/90, 71.1%), allergy medications(18/ 20, 90.0%), and combination prod-ucts (23/25, 92.0%)(2

4=25.4,PϽ.001).Products with a targetagerange that in-

cluded only infants and children weremore likely to include a measuring de-vice (74/78, 94.9%) compared withproducts with dosing instructions foradults (74/122, 60.7%) (2

1 =29.0,PϽ .001).

Figure 1. Product Selection

200 Included in analysis (representingtop 200 products with the highest USmarket share based on number sold)

340 Eligible for analysis

569 Assessed using additional eligibility criteria

732 Products categorized as analgesic,cough/cold, allergy, and gastrointestinalproducts on list from IMS Health

229 Excluded

164 No dosing instructions forchild younger than 12 years

65 Discontinued or could notbe obtained

163 Excluded (nonoral liquid medication)

We requested from IMS Health a list of over-the-counter analgesic, cough/cold, allergy, and gastroin-testinal products. IMS Healthperformed the initial re-viewto remove someknownadult-onlyand nonliquidmedications, resulting in thefirst list of 732products.

Table 1. Product Characteristics (N = 200)

CharacteristicProducts,

No. (%)

Manufacturer typea

Small 80 (40.0)

Large 62 (31.0)

Private label 58 (29.0)

Medication type Analgesic 23 (11.5)

Cough/cold 90 (45.0)

Allergy 20 (10.0)

Gastrointestinal 42 (21.0)

Combination productb 25 (12.5)

Age categoryInfants only 2 (1.0)

Infants and children only 27 (13.5)

Infants, children, and adults c 41 (20.5)

Children only 49 (24.5)Children and adults onlyc 81 (40.5)

a Manufacturerscategorizedas large(Ͼ2.5%market shareeach), small (Ͻ1% of market share each), or private la-bel(store brand);includes 32 smallmanufacturers (totalcombined market share, 3.0%), 6 large manufacturers(total combined market share, 55.7%), and 4 private-label store brands (combined market share, 40.7%).

bRefers to products containingboth analgesic andcough/ cold ingredients.

c “Anyadult” dosing category refers to combination of “in-fants,children, andadults” and“children andadults only.”




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Nearly all products examined(98.6%) contained 1 or more inconsis-tencies between the labeled directionsand the accompanying device with re-spect to doses listed or marked on thedevice, or text used for unit of mea-

surement. FIGURES 2, 3, and 4 are ex-amples selected to highlight inconsis-tencies between instructions anddevices that may contribute to dosingerrors. These problems were evidentacrossmanufacturers,medicationtypes,

and targeted age groups without sig-nificant differences.

Almosta quarter of products (24.3%)lacked necessary markings. Among themeasuringdevices,81.1% included1 ormoresuperfluousmarkings.Thetextused

Table 2. Level of Industry Adherence in Study Sample With FDA Recommendations1

Area of Concern Relevant Product Sample

Rate Among Surveyed Products

bNo./Total No.a % (95% CI)

No standardized measuring device All 52/200 26.0 (20.1-32.7) 1.0

Within-product inconsistency between directions andmeasuring devicec

Measuring device included 146/148 98.6 (95.2-99.8) 1.0

Inconsistent doses listed or marked Measuring device included 122/148 82.4 (75.3-88.2) 1.0

Missing necessary markings on device Measuring device included 36/148 24.3 (17.7-32.1) 1.0

Superfluous markings on device Measuring device included 120/148 81.1 (73.8-87.0) 1.0

Inconsistent text used for unit of measurement d Milliliter, teaspoon, or tablespoonexpression on both label and device

121/136 89.0 (82.5-93.7) 1.0

Inconsistent text for milliliter Milliliter on both label and device 40/78 51.3 (39.7-62.8) 0.97

Inconsistent text for teaspoon Teaspoon on both label and device 91/105 86.7 (78.6-92.5) 1.0

Inconsistent text for tablespoon Tablespoon on both label and device 6/7 85.7 (42.1-99.6) 1.0

Across-product variabilitye All 172/200 86.0 (80.4-90.5) 1.0

Atypical units of measurement (other than milliliter,teaspoon, or tablespoon) f

All 11/200 5.5 (2.8-9.6) 1.0

“Nonstandard” abbreviations for unit of measurement Abbreviation used for milliliter, teaspoon,or tablespoon

120/165 72.7 (65.3-79.4) 0.99

Any nonstandard abbreviation for milliliter (not mL)g Abbreviation used for milliliter 97/143 67.8 (59.5-75.4) 0.97

Any nonstandard abbreviation for teaspoon (not tsp)h Abbreviation used for teaspoon 69/110 62.7 (53.0-71.8) 1.0

Abbreviation used for tablespoon other than mostcommon (not TBSP) i

Abbreviation used for tablespoon 7/22 31.8 (13.9-54.9) 1.0

Missing Ն1 definitions of abbreviations for unit of measurement (eg, tsp = teaspoon)

Ն1 Abbreviations used j 163/165 98.8 (95.7-99.9) 1.0

Ն1 Definitions present for abbreviation for unit of measurement

Ն1 Abbreviations used j 152/165 92.1 (86.9-95.7) 0.96

Unclear use of numeric text (decimals/fractions) Decimal doseϽ1 or fraction used 76/147 51.7 (43.3-60.0) 1.0

No use of leading zeros before decimal for doseϽ1 Decimal doseϽ1 used 5/40 12.5 (4.2-26.8) 1.0

Use of large font size fornumerals in fractions (eg, 1/2instead of 1 ⁄ 2 )

Fraction used 71/110 64.5 (54.9-73.4) 1.0

Lack of consumer guidance on appropriate usek Measuring d evice i ncluded 148/148 100.0 (97.5-100.0)

No strategy to ensure measuring device used only withits product


No statement that only enclosed device be usedwith its product


No mechanism securing measuring deviceto product

Measuring device i ncluded 143/148 96.6 (92.3-98.9) 1.0

No warning about use of appropriate delivery device whenphysician-recommended doses do not match a doseamount marked on enclosed device

Measuring device i ncluded 148/148 100 (97.5-100.0)

Abbreviations: CI, confidence interval; FDA, Food and Drug Administration.a No. represents the number of products that do not adhere to the FDA recommendation; Total No. represents the total number of products relevant to the area of concern.b Degree of interrater agreement for each outcome of interest determined by calculation of the statistic; product packaging was independently assessed by 2 investigators. No was

calculated when No./total No.= 1; however, there was 100% agreement between investigators in these instances.c Any inconsistency between directions and measuring device with respect to doses listed or marked, or text used for unit of measurement.d Formilliliter, teaspoon, andtablespoon units of measurement. Inconsistencywas definedas different forms of theabbreviationused in thelabeled dosingdirections compared with that

used on the measuring device, as well as when full text was used in one location and an abbreviation used in the other location.e Across-product variability involving use of atypical units of measurement, use of nonstandard abbreviations for unit of measurement, absence of 1 or more definitions of abbreviations

for unit of measurement, or unclear use of numeric text.f Units of measurement considered atypical, including drams, cc, fluid ounces.g Among products using a milliliter abbreviation, use of ml, mls, or ML rather than the standard term, mL.h Among products using a teaspoon abbreviation, use of tsps or TSP rather than the standard term, tsp.i Among products using a tablespoon abbreviation, use of Tbsp, tbsp, or TBS instead of TBSP (most commonly used abbreviation). j Milliliter, teaspoon, or tablespoon abbreviations.k Either no strategy to ensure measuring device used only with the product with which it was included, or no warning about use of appropriate delivery device when physician-

recommended doses do not match a dose amount marked on the enclosed device.




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for units of measurement was inconsis-tent between theproduct’s label andtheenclosed device in 89.0% of products.

A total of 11 products (5.5%) usednonstandardunitsof measurement,suchas drams, cubic centimeters, or fluid

ounces, as part of thedoses listed. Acrossproducts,milliliter (143, 71.5%) and tea-spoon (155, 77.5%) were the most fre-quently used units of measurement.Tablespoon was used in 37 products(18.5%). Seventy products (35.0%)specified all doses using 1 measure-ment unit (eg, milliliter only), 111(55.5%) used 2 units (eg, milliliter andtablespoon only), and 19 (9.5%) speci-fied doses using 3 or more differentunitsof measurement.

Among the products that used mil-liliter, teaspoon, or tablespoon as units

of measurement, most included 1 ormore nonstandard abbreviations(Table 2). Among products using theseabbreviations, only 2 provided defini-tions (eg, tsp= teaspoon) for all units of measurement used.

Of the20.0% of products with a dosesmaller than 1 presentedin decimal for-mat, 12.5% (5/40) did not use a lead-

ing zero.Of the55.5% of productsusingfractions, 64.5% (71/110) used a non-standard format.

More than half of products (62.2%)lackeda statement thatthemeasuring de-vice should only be used with its asso-

ciated product. Only 5 products had anintegrated device. No product con-tained a warning about how to use thedevice if a physician-recommended dose

does not matchthe amounts marked onthe device.

COMMENT

Our study reveals that at the time theFDA issued its voluntary guidance, al-

most all commonly purchased pediat-ric nonprescription liquid medicationscontained dosing directions and mea-suring devices that were highly variable

Figure 2. Inconsistencies Between Listed Doses and Markings on Measuring Device

A Dosing directions from packaging B Measuring device (one view)

Missing markings(absent from measuring device)

Superfluous markings(not listed in dosing directions)

Figure 3. Use of Atypical Unit Markings on Measuring Device and Inconsistency With Listed Doses

B Measuring device (all views)

A Dosing directions from packaging

Missing marking(absent from measuring device)







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and inconsistent. This study providesbaseline data forassessing thedegree andpace of industry conformity with theFDA’s voluntary guidelines. Given thehighprevalence of baseline inconsisten-cies, regulatory oversight may be help-ful in accelerating adoption of the guid-ance recommendations.

Several Institute of Medicine (IOM)reports have identified variable andpoor-quality drug labeling as a lead-

ing root cause of consumer confusionwith a high potential to lead to unin-tentional misuse of products.9-13 Thepriorities set forth by the FDA recom-mendations are designed to make pe-diatricdrugdosingsafer by reducingthevariability and complexity of labels andassociated measuring devices.

The lack of standardization of label-ing and measuring devices has beencited as a contributor to confusion andmedication error.7,9,14-16 National stan-dards for medication-unit abbrevia-

tions (eg, mL) and numeric dosingformats (eg, leading zeros to prevent10-fold errors) may contribute to safemedication use.5,6 The Joint Commis-sion has made the adoption of thesestandards a key aim of hospital-basedefforts to ensure patient safety.17 In theoutpatient setting, lack ofclear andcon-sistent labels and devicesimpedescon-

sumer ability to understand and cor-rectly use medications.

The risks posed by confusing or in-consistent dosing directions on pediat-ricOTCmedication packagingandmea-suring devices may vary depending onthenature of the discordantlabeling,yetthe potential for harm is substantial.More than half of US children are ex-posedto 1 or moremedicationsina givenweek, and more than half of these are

OTC medications.18

Analgesics, cough/ cold medications, antihistamines, andgastrointestinal drugs account for morethan a quarter of medications adminis-teredto children.18 Liquid formulationsare typically relied on for young chil-dren.

In addition, 1 in 3 US adults19 and atleast 1 in 4 US parents20 have limitedhealth literacy; an even greater percent-age have poor numeracy.19 Decodingmedication labels and understandinghow to use measuring devices correctly

are health literacy tasks that many finddifficult.21-26 Studies report that 40% to60% of parents make errors when ad-ministering medications to their chil-dren,21,27-30 with caregivers whohave lowhealth literacy at greatest risk.20,31 Un-derstanding instructions for nonpre-scription medications can be particu-larly problematic for consumers, who

typically rely on their own health lit-eracy skills to determine how to cor-rectly administer an OTC medication,without counseling from a clinician.32

Supporting consumer comprehensionbyproviding clear, consistent, and stan-

dardizedinformation increases the like-lihood that consumers can safely and ef-fectively use OTC medications.

Our study documents a high preva-lence of deficits in medication label-ing and measuring devices within theareas highlighted in the FDA guid-ance. Specifically, problems were iden-tified in 3 critical areas.

First, a standardized measuring de-vice should be included with all non-prescription liquid products. Failure touse a measuring device for nonpre-scription products has been cited as a

contributor to clinically significant dos-ing errors in children.7 Although it iswell established that use of a standard-ized device instead of a kitchen spoondecreases error,33-37 further evaluationis needed to examine which type of de-vice shouldbe included. Currently, dos-ing cups are the most common de-vices enclosed. Two recent studies haveraised concerns about parents’ abilityto dose accurately with cups. More thanhalf made errors in dosing, primarilyoverdosing.31,38

Second, within each product, con-sistency shouldbe ensured between thelabeled dosing directions and mark-ings on the associated measuring de-vice. Devices that lack necessary mark-ings make it harder to administer thecorrect dose. Devices with superflu-ousmarkings, especially of doses largerthan those listed in the directions, raisethe potential for overdosing. Minimiz-ing markings on the device to only thoserelevant to the recommended doses is1 strategy that may decrease medica-

tion errors.

39,40

Limiting doses to thoseassociated with 1 single unit of mea-surement on a measuring device thatmatches the units on the product la-bel has also been recommended to de-crease confusion.41

Although extra markings and addi-tional units of measurement on a de-vice may be helpful when clinicians rec-

Figure 4. Presence of a Listed Dose Not Shown on Measuring Device, Resulting in Need toMeasure More Than 1 Instrument Full of Medicine

B Measuring device A Dosing directions from packaging

Missing marking(absent from measuring device)

Superfluous marking(not listed in dosing directions)




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ommend a dose not listed in thedirections, nonprescription medica-tions are generally used without guid-ance from a medical professional.7 Therehas been limited study of whether extramarkings doinfact leadtoa greater num-

ber of errors. It is recognized, however,thatincreased complexityin medical in-structions may result in greater confu-sion. For example, significantly fewerpatientsunderstand multistep warning-label instructions on prescription labelscompared with 1-step instructions, withthose in the lowest literacy categoriesshowing the greatest relative deficit withincreased instruction complexity.23

Third, across products, measure-ment units, abbreviations, and nu-meric formats should be standard-ized. Using nonstandard units, such as

cubic centimeters and drams, may leadto improper dosing, especially when ameasuring device is not included or ismisplaced. Even frequently used termslike teaspoon and tablespoon may bemis-interpreted.41 Errors in understandingteaspoon vs tablespoon have been foundto contribute to 3-fold errors.39 Theuseof abbreviationsfor teaspoon andtable-spoon can be particularlyconfusing (eg,confusion between tsp and tbsp41,42).Moreover, terms like teaspoon and table-spoon endorse the use of kitchen

spoons, which are known to be asso-ciated with measurement error.33-37

There is also support for moving to-ward uniform implementation of met-ric volume measures for liquid medi-cations.2,41 Recognizing the importanceof this issue, the American Academy of Pediatrics recommends to parents thatmedications be dosed in milliliters,rather than in teaspoons or table-spoons.43

Terms like teaspoon and tablespoon,while problematic, do have the advan-

tage of providing the consumer with agrounded expression of thedose; a termlike milliliter may not be as easyfor con-sumers to interpret. Promoting millili-ters asthestandardunitfor pediatricdos-ing will likely require education of thepublic on proper dosing and the impor-tance of using standardized measuringdevices with appropriate markings.

Use of decimal points without lead-ing zeros may lead to unintended over-dosing, as can use of nonrecom-mended fraction formats. Confusionwith decimal points has been found tocontribute to 10-fold overdose (eg, ad-

ministration of 5 mL instead of 0.5mL),39 and Joint Commission stan-dards mandate the use of leading zerosin hospital prescriptions5; however, noequivalent oversight exists for nonpre-scription medications.Additional studyis needed to evaluate the implicationsof errors relatedto confusion about frac-tion formats.

There are limitations to our study. Al-though we found high rates of variabil-ity between labeled dosing instruc-tions and measuring devices that couldcontribute to confusion, we did not di-

rectly assess consumer understandingand use of these products. To ad-equately address best practices underthe FDA guidance, patient-centered re-search is needed to help define the im-pact of superfluous markings, abbre-viations for units of measurement, andfraction formats. We also limited ourdata abstraction to those variables speci-fied as areas of interest in the FDAguidance. Other aspects of packaging,such as the reading level, language, lay-outof directions, font type andsize, use

of pictograms, and use of color, mayalso be important but were not ad-dressed.16,21,44-46 This study also does notaddress other critical aspects of safemedication use such as weight vs age-based dosing, understanding of activeingredients, or maximum dosing. Fi-nally, developing a comprehensive listof top-selling US nonprescription prod-ucts was challenging. The list we ob-tained reported data related to private-label store-brandproducts in aggregateby product type rather than by indi-

vidual product. However, the sampleof products selected does represent 99%of US market share for pediatric OTCoral liquid analgesic, cough/cold, al-lergy, and gastrointestinal products.

CONCLUSIONS

The FDA introduced the OTC DrugFacts Panel in 1999 to increase the con-

sistency and clarity of nonprescriptionmedicationinstructionsby setting a stan-dard format and order for content inOTC medication labels.47 The FDAguidelines released in 2009 are anotherstep toward the goal of providing clear,

consistent, andactionable medicationin-formation to consumers. Our findingsdocument that high levels of variabilityandinconsistency currently exist withinmedication labeling and measuring de-vices of OTC products. At this time, theFDA’s guidelines are voluntary, andcompanies have no legal obligation tofollow them. Subsequent systematicproduct analysesmay thereforebe help-ful to monitor progress, including as-sessing whether additional regulatoryoversight may be needed to ensureprac-tices that best support safe and effec-

tive use of OTC medications.

Published Online: November 30, 2010. doi:10.1001/jama.2010.1797Author Contributions: DrYinhadfullaccesstoallofthedata in the study andtakes responsibility for the integ-rity of the data and the accuracy of the data analysis. Study conceptand design:Yin,Wolf, Dreyer, Sanders,Parker.Acquisition of data: Yin.Analysis andinterpretationof data: Yin,Wolf, Dreyer,Sanders, Parker.Drafting of the manuscript: Yin, Dreyer.Critical revision of the manuscript for important in-tellectual content:Yin, Wolf,Dreyer, Sanders, Parker. Statistical analysis: Yin, Dreyer.Obtainedfunding: Yin,Wolf, Dreyer, Sanders,Parker.Administrative, technical, or material support: Yin,Dreyer, Parker.

Study supervision: Dreyer, Parker.Financial Disclosures: Dr Yin reported receiving fundsfrom Pfizer as part of its Fellowship in Health Literacy/Clear HealthCommunicationand havingserved as a paidconsultant to McKingConsulting Corporation.Dr Wolfreported receiving unrestricted research grant fundingfrom McNeil Consumer Healthcare and Abbott Foun-dationandhaving servedas a paid consultant toMcNeilConsumer Healthcare and AbbottLaboratories.Dr Sand-ers reported receiving unrestrictedresearch grantfund-ingfrom Pfizer aspart ofits Fellowship in HealthLiteracy/Clear HealthCommunicationand havingserved as a paidconsultantto Pfizer’s ClearHealth Communication pro-gram. Dr Parker reported receiving unrestricted re-search grant fundingfrom McNeil ConsumerHealthandAbbott Foundation and having served as a paid con-sultant to Johnson & Johnson and McKing ConsultingCorporation. No other disclosures were reported.Funding/Support: Dr Yin isfundedby a careerdevel-

opmentgrantthrough theRobertWood Johnson Phy-sician Faculty Scholars Program.Role of theSponsor: TheRobertWood Johnson Foun-dation had no role in the design and conduct of thestudy; in the collection, analysis, and interpretation ofthe data; or in the preparation, review, or approvalof the manuscript.Disclaimer: The statements, findings, conclusions,views, and opinions contained and expressed hereinare not necessarily those of IMS Health or any of itsaffiliated or subsidiary entities.Previous Presentation: Preliminary data from this




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study were presented at a meeting of the IOMRoundtable on Health Literacy, “The Safe Use Ini-tiative and Health Literacy: A Workshop”; April 27,2010; Washington, DC.Additional Contributions: We extend our thanks toArt Kellermann, MD, MPH, RAND Corporation;Alan Mendelsohn, MD, New York University Schoolof Medicine; Gail Slap, MD, MS, University ofPennsylvania School of Medicine; and Linda van

Schaick, MSEd, New York University School ofMedicine; for their critical review of this study. Wethank Jennifer King, MPH, Northwestern UniversityFeinberg School of Medicine, for abstraction ofproduct data, as well as our research staff whoassisted in the acquisition of products. We acknowl-edge Dan Kaniarasseril (freelance photographer) for the photographs used in Figures 2 through 4. Noneof these persons received compensation for thesecontributions. We also thank IMS Health for itsassistance in providing us with the list of top-sellingnonprescription medications categorized as analge-sic, cough/cold, allergy, or gastrointestinal productsfor the 52 weeks ending October 30, 2009 (Medi-cine Cabinet, IMS Health).

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