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RESEARCH

Patient knowledge and use of


acetaminophen in over-the-counter
medications
Jason Hurwitz, Shannon Sands, Erica Davis, Joel Nielsen, and Terri Warholak

Received April 22, 2013, and in revised July


10, 2013. Accepted for publication August
10, 2013.

Abstract
Objectives: To evaluate patient knowledge of over-the-counter (OTC)
products containing acetaminophen and to determine patients accuracy in
dosing adult, child, and infant formulations.
Design: Cross-sectional study.
Setting: Six community pharmacies in Tucson, AZ, between February and
May 2011.
Participants: 88 adults aged 19 to 89 years.
Intervention: Investigator-administered, semistructured interviews.
Main outcome measures: Patient knowledge of and ability to safely use
OTC products containing acetaminophen, including understanding risks,
identifying products, and dosing different formulations.
Results: Although most (86%) participants heard of acetaminophen, only
68% understood at least one of its uses and only 9% knew the abbreviation
APAP. Virtually all knew that consuming too much acetaminophen in 1 day
could be harmful, but only 17% and 35% knew that overdoses could result in
death or liver damage, respectively. On average, participants correctly identified 80% (range 27100%) of products with and without acetaminophen
from a lineup of 11 OTC products. Although 38% (n = 84) of participants
correctly measured both the child and infant doses of acetaminophen, doses
ranged from one-half to twice the amount of the labeled child dose and onethird of the labeled infant dose. Findings from the regression analysis suggested that on average, women and those with college degrees had higher
overall scores, while participants age or parent status were nonsignificant
predictors.
Conclusion: Many patients remain confused about using acetaminophen
safely, signaling the need for greater patient education to prevent unintentional harm. The results further specify common misunderstandings to address during patient contact, which also includes replacing APAP with
acetaminophen on any prescription bottle labels or patient-directed information.
Keywords: Acetaminophen, nonprescription drugs, safety, administration,
dosage, packaging.
J Am Pharm Assoc. 2014;54:1926.
doi: 10.1331/JAPhA.2014.13077

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j apha.org

Jason Hurwitz, PhD, is Assistant Research Scientist, College of Pharmacy,


University of Arizona, Tucson. Shannon
Sands, PharmD, was a student pharmacist, College of Pharmacy, University of
Arizona, Tucson, at the time this study was
conducted; currently she is Managed Care
Resident, CVS Caremark, Irving, TX. Erica
Davis, PharmD, was a student pharmacist,
College of Pharmacy, University of Arizona,
Tucson, at the time this study was conducted; currently she is PGY-1 Pharmacy
Resident, Kingsbrook Jewish Medical Center, Brooklyn, NY. Joel Nielsen, PharmD,
was a student pharmacist, College of Pharmacy, University of Arizona, Tucson, at the
time this study was conducted; currently he
is Assistant Director of Pharmacy, Cardinal
Health Innovative Delivery Solutions, Tempe St. Lukes Hospital, Tempe, AZ. Terri
Warholak, PhD, BSPharm, is Associate
Professor, College of Pharmacy, University
of Arizona, Tucson.
Correspondence: Jason Hurwitz, PhD,
College of Pharmacy, University of Arizona,
1295 N. Martin Ave., PO Box 210202, Tucson, AZ 85721. Fax: 520-626-5518. E-mail:
hurwitz@pharmacy.arizona.edu
Disclosure: The authors declare no conflicts of interest or financial interests in any
product or service mentioned in this article,
including grants, employment, gifts, stock
holdings, or honoraria.
Funding: Dr. Hurwitz received salary support as a Post-Doctoral Fellow in Health
Outcomes Research from the Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation while conducting
this study.
Previous presentations: (1) Hurwitz J,
Warholak T, Sands S, Nielsen J. Consumer knowledge of acetaminophen safety,
dosing, and identification [abstract]. J Am
Pharm Assoc. 2012;52(2):234. (2) Sands
S, Nielsen J. Consumer knowledge of acetaminophen use [abstract]. J Am Pharm Assoc. 2011;51(2):285.
Published online ahead of print at www.
japha.org on December 20, 2013.

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cetaminophen is the most commonly used medication among U.S. adults and is consumed by approximately 19% of the population each week.1 It can be
used in both adult and pediatric populations and can be
an effective analgesic and antipyretic to relieve symptoms associated with injury, viral and bacterial infections, and headaches.2,3 Although considered safe when
taken as recommended, liver toxicity can occur with
doses greater than 4 g or when used in patients with preexisting liver dysfunction.1,4
Acetaminophen toxicity is the most common cause
of acute liver failure in the United States and is the
most common reason for calls made to poison control
centers.2, 5 It has been estimated that overdose with acetaminophen leads to more than 56,000 emergency department visits, more than 2,600 hospitalizations, and
approximately 400 deaths from acute liver failure every
year.2
Acetaminophen is found in more than 600 overthe-counter (OTC) and prescription products.6 It is the
single active agent in products such as Tylenol (McNeilPPC) and Triaminic (Novartis OTC) and in combination
with other agents in products such as Nyquil Cold and
Flu (Procter & Gamble), Excedrin (Novartis OTC), and
Theraflu (Novartis OTC). Acetaminophen is available in
multiple dosage forms, including oral pills and liquids,
suppositories, and even intravenous formulations in

At a Glance
Synopsis: Acetaminophen safety has been under close scrutiny in recent years by the Food and
Drug Administration and has received attention
from the mainstream media. Acetaminophen
overdoses in children have resulted in the removal
of higher-concentration infant formulations from
the market in order to standardize the concentration of available over-the-counter (OTC) liquid
products containing acetaminophen. However,
limiting acetaminophen concentration alone cannot adequately mitigate risks of acetaminophen
toxicity and overdose without additional intervention. This study indicates that many patients
remain confused about using acetaminophen safely, signaling the need for greater patient education
to prevent unintentional harm.
Analysis: Patients need to be aware of ingredients
listed in OTC and prescription products to avoid duplication of acetaminophen therapy. Health care providers will be able to use these results to better understand
their patients and provide optimal directions for medication use and safety information. Disseminating information about how to better educate patients can assist
in avoiding accidental acetaminophen overdoses.

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some hospitals. Because of its presence in so many different products, patients may not recognize which products contain acetaminophen. An estimated 15% of acute
liver failure cases result from patients who unknowingly consumed multiple acetaminophen-containing
preparations simultaneously and more than 100 deaths
annually are caused by unintentional overdose.2,3
Measuring devices included with medications may
be difficult for patients to understand, or patients may
be unable to recognize the appropriate mark on the device to which they should measure.7,8 A 1997 study by
Simon et al.8 asked caregivers to determine and measure
a dose of acetaminophen for their child. They found that
only 30% of participants were able to both calculate and
measure a correct dose. In the years following that research, the Food and Drug Administration (FDA) issued
several recommendations for labeling of OTC pain relievers. In 2006, FDA proposed adding a new warning
for liver damage and making the active ingredient more
prominent on the packaging.9 These changes were finalized in 2009 with some additional requirements.10 The
new regulations require the liver warning to be present
on the immediate container and the outer carton labeling. In addition, a warning appears stating that patients
should not use acetaminophen with warfarin and that
they should ask a physician or pharmacist if they are
unsure whether a medication contains acetaminophen.
Examining the effect of these changes on patient knowledge of acetaminophen safety, dosing, and identification is important.
In May 2011, manufacturers of OTC acetaminophen
products announced that they will no longer produce
concentrated infant drops and only will produce childrens liquid acetaminophen in a standardized concentration of 160 mg/5 mL.11 On behalf of the manufacturers, the Consumer Healthcare Products Association reported that the changes were aimed at reducing dosing
errors.12 In addition, syringes with dose restrictors will
be included with products for infant use and measuring cups will continue to be included for dosing of older
children.
Better identification of gaps in patient knowledge
regarding the presence of acetaminophen in OTC medications is needed. This will facilitate development of
interventions to increase patient safety, prevent overdoses, and guide patients in obtaining appropriate care
following an overdose.

Objectives
The purpose of this study was to evaluate patients
knowledge about OTC acetaminophen-containing
products and to determine patients accuracy in dosing
adult, child, and infant formulations (i.e., before manufacturers voluntary concentration standardization of
child and infant formulations).

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Methods
This study involved administration of a cross-sectional
interview to a convenience sample of patients at six
pharmacies in Tucson, AZ, between February and May
2011. Approval for this research involving human participants was granted through an expedited review by
the University of Arizona Institutional Review Board,
and each of the participating sites permitted data collection on their premises. The sites included one university student health center and five community chain
pharmacies located within stores. The interviewers (two
student pharmacist researchers) received training and
demonstrated ability to reliably administer the surveys.
The interviewers set up a booth inside participating
community pharmacies and invited patrons to participate in a 10- to 15-minute survey. Consenting adults
aged 18 to 89 years who were fluent English speakers
and did not have professional training to handle medications (e.g., physician, nurse, pharmacist) were eligible
to participate. Participants received acetaminophen
educational materials upon completion of the interview.
The semistructured survey (Appendix 1; electronic version of this article, available online at www.
japha.org) developed for the study contained 24 items,
with a variety of verbal and physical response options
(i.e., open ended, yes/no, pointing to pictures, simulated dosing of medications). The interview items were
grouped into seven sections: (1) demographic data/inclusion criteria; (2) recognizing the APAP abbreviation; (3) understanding acetaminophens purpose; (4)
identifying OTC products containing acetaminophen;
(5) acetaminophen safety awareness; (6) dosing adult,
child, and infant formulations; and (7) responding to potential acetaminophen poisoning.
Interview sections 1, 2, 3, 5, and 7 consisted primarily
of open-ended knowledge questions. Sections and items
were ordered to minimize any influence on answers in
subsequent sections. In section 2, for example, the first
real interview question asked participants whether they
knew the term APAP that appeared on the prescription drug label handed to them.
Section 4 involved life-sized, unaltered color photos of 11 brand-named OTC medication packages. Interviewers placed the photos on the table in alphabetical order and then asked participants to identify which
products contained acetaminophen. All products listed
the active ingredient(s) on the package, including acetaminophen, though the size and placement of the listing
varied.
Section 6 involved a dosing simulation for adult
extra-strength pain relief caplets, childrens pain relief
suspension, and infant pain relief concentrated suspension. Actual generic OTC cartons and bottles were used
with simulated inert contents. For example, breath mint
caplets were used for the adult pill formulation and food
coloring mixed with water and corn syrup simulated the
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color and viscosity of the child and infant liquid formulations. Specifically, participants received an index card
stating the age and weight of a hypothetical person for
whom they were asked to administer a dose (i.e., to relieve the headache of the adult and to reduce the fevers
of the child and toddler). All participants received the
same instructions and dosed formulations separately in
the same order using the same measuring devices (i.e.,
medicine cup for childrens suspension, syringe for infants concentrated suspension). Participants were allowed, but not required, to study the package labels to
aid dosing. Participants handed the measured amount
to the interviewer who checked and recorded it. Participants also had access to the packages when asked
(1) when the hypothetical person could take another
dose and (2) if and what would be the maximum daily
amount of the product.
Participants received no help from interviewers or
others in their responses during the interview. Further,
interviewers refrained from any subtle response feedback (e.g., good job, sorry) but could repeat questions or directions if requested.
Data analysis
Investigators initially entered and analyzed descriptive
data using Microsoft Excel 2010 (Microsoft, Redmond,
WA). The validity of dichotomized interview responses
were assessed by examining construct variance and construct representation.1318 Rasch measurement was used
for this process.1923 When the data fit the model, participant responses for a particular instrument produced a
summative score that could be used as an indicator of
the degree of an underlying attribute. That is, objective
evidence would be provided illustrating that all items
measured one construct, produced interval-level data,
and determined the probability of the person responding to an item without dependence on the other items.24,25
In principle, it must be confirmed that each item of the
instrument provided information about the construct
of interest (i.e., acetaminophen knowledge). When assessing the value of the instrument via Rasch analysis,
construct variance and representation were determined
according to prevailing methods.26 An in-depth discussion of Rasch analysis is beyond the scope of this article
but is described elsewhere.2733 The Rasch dichotomous
model was used to assess the acetaminophen questionnaire.25 Rasch analysis was conducted with WINSTEPS
software (Linacre, Chicago). An a priori alpha of 0.05
was established for all statistical tests for significance.
Finally, a multiple linear regression analysis was
used to identify variables that might predict overall
knowledge and use of acetaminophen. The outcome
variable in this model is the continuous summary score
produced through the Rasch analysis. The predictors included one continuous variable (age [centered at mean])
and three binary variables (gender [men/women], obj apha.org

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tained 4-year college degree [yes/no], and parent [yes/


no]). Preliminary analysis suggested that the standardized residuals for the outcome variable are normally
distributed. For this analysis, SPSS version 21 (IBM, Armonk, NY) was used.

Results
A total of 88 patients completed the survey on acetaminophen knowledge and use. The mean (SD) age of
participants was 45.02 18.58 years (range 1989). More
than one-half of the participants were women (55%) and
parents (56%), and 28% of the sample had completed a
4-year college degree or higher.
Only 9% of participants were familiar with and correctly identified the APAP abbreviation (one person
cited acetaminophen, while the others cited Tylenol; Table 1). However, most participants heard of
acetaminophen (86%) and knew it was used to relieve
pain (65%), but only 27% knew that it reduced fever and
11% incorrectly believed it reduced swelling or inflammation. Table 1 also shows that most participants recognized that acetaminophen could be harmful in combination with other medications or alcohol. However,
few were clear about which other medications could be
harmful if taken together (e.g., 15% cited medications
that contained acetaminophen, 17% cited pain relievers
in general). About one-half of participants (48%) said
that they would know if they had taken too much acetaminophen, and of those, only 65% listed the appropriate symptoms. While most participants identified one
or more appropriate actions if they thought they had
consumed too much acetaminophen, 18% also cited inducing vomiting, which is dangerous, and none of the
participants suggested calling the toll-free phone number on the product label.
Participants also had some difficulty distinguishing
among OTC products with and without acetaminophen
(Table 2). Incorrect answers included those who wrongly identified an OTC product as containing acetaminophen when it did not, as well as those who did not identify an acetaminophen-containing product. Although
91% of the sample correctly identified Tylenol (McNeilPPC) as containing acetaminophen, only 77% and 69%
of the sample correctly identified Excedrin (Novartis
OTC) and Nyquil Cold & Flu (Procter & Gamble) as
containing acetaminophen, respectively. Likewise, the
top three products that most participants incorrectly
thought contained acetaminophen were Nyquil Cough
(Procter & Gamble; 36%), Sudafed (McNeil-PPC; 24%),
and Aleve (Bayer HealthCare; 23%).
Figure 1 displays the dosing for adult acetaminophen extra-strength caplets, childrens suspension,
and infant concentrated suspension. Although many
participants (n = 84 [38%]) correctly measured both the
child and infant doses of acetaminophen, doses ranged
from one-half to twice the amount of the correct child
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Table 1. Responses to select questions regarding acetaminophen


(n = 88)
Interview item
Do you know what APAP is? Yes
Defined correctly
Defined incorrectly
Do you know what APAP is? No
Have you heard of acetaminophen?
Yes
No
Can it be harmful to consume too much acetaminophen in one day? Yesb
Death
Liver problems
Other problems
Dont know
Can it be harmful to consume too much acetaminophen in
one day? No
Can it be harmful to take acetaminophen with other
medications?
Yes
No
Dont know
Can it be harmful to consume alcohol while taking
acetaminophen?
Yes
No
Dont know
Do you think you would know if you took too much
(acetaminophen)? Yesb
Gastrointestinal symptoms (e.g., nausea)
Neurological symptoms (e.g., sleepy, dizzy)
Other
Do you think you would know if you took too much
(acetaminophen)? No
What would you do if you took too much
(acetaminophen)?b
Call 911 or visit hospital/urgent care
Call or visit physician
Call or visit pharmacist
Call poison control
Induce vomiting
Other

No. (%)
14 (16)
8 (57)a
6 (43)a
74 (84)
76 (86)
12 (14)
87 (99)
15 (17)a
31 (35)a
30 (34)a
12 (14)a
1 (1)

74 (84)
10 (11)
4 (4)

79 (89)
5 (6)
4 (5)
42 (48)
24 (57)a
23 (44)a
13 (31)a
46 (52)

50 (57)
26 (30)
9 (10)
19 (22)
16 (18)
15 (17)

Proportion of yes responses.


Multiple responses permitted.

dose (10.13 2.56 mL; n = 86) and one-third of the correct infant dose (1.27 0.45 mL; n = 84). The childrens
acetaminophen product was dosed inaccurately by 44%
of participants. The recommended dosing for the hypothetical child weighing 52 lb was 10 mL. Doses 1 mL
were considered correct because they were within the
weight-based acetaminophen dosing recommendations
of 10 to 15 mg/kg for children.34 Similarly, the infant forJournal of the American Pharmacists Association

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Table 2. Participants ability to identify acetaminophen-containing OTC products (n = 88)


Product (manufacturer)
Advil (Pfizer)
Aleve (Bayer HealthCare)
Bayer Extra Strength (Bayer HealthCare)
Excedrin Extra Strength (Novartis OTC)a
Motrin PM (McNeil-PPC)
Nyquil Cough suspension (Procter & Gamble)
Nyquil Cold and Flu (Procter & Gamble)a
Pepto-Bismol (Procter & Gamble)
Robitussin Cough (Pfizer)
Sudafed (McNeil-PPC)
Tylenol Extra Strength (McNeil-PPC)a

Correctly identified
No. (%)
70 (78)
68 (77)
72 (82)
68 (77)
72 (82)
56 (64)
61 (69)
82 (93)
74 (83)
68 (76)
80 (91)

Incorrectly identified
No. (%)
19 (22)
20 (23)
16 (18)
20 (23)
16 (18)
32 (36)
27 (31)
6 (7)
16 (17)
21 (24)
8 (9)

Product contains acetaminophen.

mulation was dosed inaccurately by 48% of participants.


The primary error was that subtherapeutic doses were
prepared. Many particpants did not fill the oral syringe
a second time to 0.8 mL, though the package labeling for
the infant formulation recommends a dose of 1.6 mL for
a hypothetical infant weighing 27 lb between 2 to 3 years
of age. Doses 0.2 mL of the package recommendations
were accepted as correct because they also were accurate
when calculating based on weight (1015 mg/kg).
Validity of the measure and summary scores
A summative score can be used as an indicator of what
participating patients know about acetaminophen, if
the items fit the model and work together psychometrically. Rasch model fit statistics indicated that 27 of the
32 dichotomous questionnaire items measured the
same construct (were unidimensional) and were able to
be converted to interval-level data. The remaining five
items (whether acetaminophen is a cough suppressant
or expectorant, whether Excedrin or Nyquil Cough contains acetaminophen, whether taking acetaminophen
while taking other medications is harmful, and whether
you would know if you took too much acetaminophen)
were excluded from the Rasch analysis because they
contained a greater-than-acceptable amount of error.3539
Specifically, the fit statistics indicated that the items
were measuring something other than what was intended (i.e., a different construct) or were capturing more error than legitimate measurement.
The variable map in Figure 2 (electronic version of
this article, available online at www.japha.org) depicts
the hierarchical ordering of items and what can be expected from each person or item interaction for the acetaminophen knowledge instrument. This map is useful
because it presents a visual representation of construct
coverage that aids in the interpretation of the distribution of item calibration estimates, gaps in the measurement continuum, and population targeting. Each parJournal of the American Pharmacists Association

ticipants ability to select the correct answer on the acetaminophen knowledge assessment is depicted on the
left side of the item map (represented by the Xs). The
participants who were least able to select the correct answer are indicated toward the bottom of the map, and
the most able participants are shown toward the top
of the map. Likewise, each items difficulty calibration
value (in logits) is depicted on the right side of the map.
The right side of Figure 2 shows each items placement
in the measurement continuum, with items at the bottom being the easiest for participants to answer correctly
and items at the top being the most difficult. For example, item 7 (Can it be harmful to consume too much acetaminophen in one day?) was the easiest for participants
to correctly answer, whereas item 4 (Do you know what
APAP is?) was the most difficult.
No ceiling or floor effects were identified, and good
reliability was attained (Kuder-Richardson 20 = 0.81).
From the item/person map, gaps in the measurement
continuum (represented as the large white spaces between items on the right side of Figure 2) are apparent.
In addition, the distributions of person ability and item
difficulty are not perfectly aligned (mean person ability
= 1.58 logits; mean item difficulty = 0 logits), suggesting
that the questions were somewhat mistargeted to participant ability (i.e., items were too difficult for participants).
Overall knowledge and ability to use
acetaminophen safely
The results of the regression analysis suggested that the
model as a whole was a significant predictor of overall
summary scores (F = 4.175, df = 4, P < 0.01), with 13%
of the variance in scores explained by only four predictors (R2 = 0.169, adjusted R2 = 0.129). Specifically, after
controlling for other predictors in the model, men had a
mean (SE) summary score that was 0.65 0.308 points
lower than that for women (P < 0.05). In addition, parj apha.org

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ticipants with less than a 4-year college degree had a


summary score that was 0.99 0.330 points lower than
that for participants with a 4-year degree (P < 0.01). The
effects of age or parent status, however, were not significant predictors of summary scores.

Discussion
Although the APAP abbreviation often is included
in warnings on prescription labels, participants were
largely unfamiliar with its meaning (i.e., the item that
assessed knowledge of the APAP abbreviation was the
most difficult item in the interview). Unfamiliarity with
this abbreviation can lead patients to inadvertently ingest greater-than-recommended doses. To avoid confusion, the abbreviation APAP should be eliminated
and replaced with the complete spelling of acetaminophen on all prescription products. (The abbreviation
did not appear on any of the OTC products used in this
study.) This recommendation is supported by the National Council for Prescription Drug Programs, FDAs
Safe Use Initiative, and National Association of Boards
of Pharmacy.40,41 Nevertheless, only two-thirds of our
sample had heard of acetaminophen and indicated confusion about the drugs purpose.
When presented with images of product packaging,
participants were unable to reliably identify products
containing acetaminophen despite the active ingredients listed adjacent to the OTC product logo. This may
suggest a need for improved labeling or for better patient awareness of ingredient lists on labeling. Previous
studies have found similar results regarding the inabil-

ity of patients to recognize acetaminophen-containing


products and have suggested using icons.42,43 Even more
concerning are the results from a survey conducted by
Hornsby et al.4 on physician knowledge of acetaminophen. OTC Excedrin PM (Novartis OTC), Actifed Cold
and Sinus (McNeil-PPC; discontinued), and Triaminic
Cough and Sore Throat (Novartis OTC) were correctly
identified as containing acetaminophen by only 58%,
37%, and 37% of physicians, respectively. This is alarming considering that patients most often receive information or recommendations about OTC medications from
their physicians.8,42 Pharmacists can use the information from Table 2 to help identify OTC products among
which patients might have more difficulty differentiating. For example, identifying that Pepto-Bismol (Procter
& Gamble) did not contain acetaminophen was relatively easy for participants, but it was much more difficult
for participants to distinguish the active ingredients of
Sudafed (McNeil-PPC), Aleve (Bayer HealthCare, LLC),
Advil (Pfizer), and Nyquil Cold and Flu (Procter &
Gamble). This confusion is important for pharmacists to
know and to address when counseling patients.
Participants incorrectly dosed adult, child, and infant acetaminophen products despite access to product packaging with dosing directions. Considering the
dosing errors, the possibility of subtherapeutic or toxic
doses of acetaminophen exists and can be harmful.
These results are supported by a study by Simon and
Weinkle8 in which caregivers were asked to determine
and measure a dose of acetaminophen for their child.
They found that only 30% of participants were able to

100%

Underdose

Percent of participants

90%

Correct dose

80%

Overdose

70%

Don't know/no response

60%
50%
40%
30%
20%
10%
0%

Adult extra-strength caplets


(n = 88)

Children's suspension
(n = 86)

Infant concentrated
suspension
(n = 84)

Figure 1. Ability of participants to dose different formulations


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both calculate and measure a correct dose. The concentrated infants formulation of acetaminophen was voluntarily removed from the market in early 2011.11 This
was done to avoid dosing errors and overdose due to
the availability of multiple concentrations. The results
of our study indicated that only one-half of participants
dosed the infant formulation correctly, supporting the
decision for market removal. The results also indicated
that being a parent, which could be associated with
greater experience and investment administering childrens medications, was not a significant predictor of
participants overall knowledge of or ability to dose the
medications. Figure 1 provides valuable information
that pharmacists can use for counseling patients on dosing different acetaminophen formulations. For example,
Figure 1 shows that dosing acetaminophen caplets for
an adult was easier for participants than dosing suspension for a child. Correspondingly, it was easier to dose
childrens suspension using medicine cups compared
with dosing concentrated suspension for infants using
an oral syringe. Virtually all of the errors in using the
syringe stemmed from failing to fill and administer the
second half of the dose. Given the difficulty, parents and
caregivers may need additional counseling to ensure appropriate dosing.
Participants unreliable descriptions of signs and
symptoms of acetaminophen overdose and the appropriate action to take following an overdose demonstrate
the misunderstanding of acetaminophen toxicity. Although virtually all interviewees recognized the potential harm of consuming too much acetaminophen, only
35% knew that it could cause liver damage. Respondents to similar items on other surveys reported slightly
more awareness that acetaminophen toxicity causes
liver damage: from 48% of emergency department visits in a study conducted more than a decade ago to 50%
of outpatient visits in a more recent study.44,45 Education
of appropriate action in the event of a possible overdose
(either through product labels or counseling on dos
and donts) would benefit patients. This is especially
true regarding the importance of informing patients not
to induce vomiting.

Limitations
The small sample size of participants from six local community pharmacies in this study limits the generalizability of findings. The surveys also were conducted in
busy public areas with relatively more distractions than
one may encounter in the privacy of ones home. In addition, whether survey participants differed from those
who declined to participate is unknown. Therefore, one
should not interpret findings from this study as representing a national sample of patients.
Interviewers did not ask participants to announce
their intended doses before performing measurements.
This could have allowed the researchers to discern
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whether the incorrect doses resulted from erroneous calculations from the package directions, improper measuring technique, or both. Further research concerning
dosing intent could help determine the best approach
for educating patients to dose appropriately.

Conclusion
Greater education is needed for patients regarding acetaminophens purpose, the types of products containing
acetaminophen, and how to use acetaminophen safely
and manage toxicity. The APAP abbreviation should
be universally replaced with or accompanied by acetaminophen on product labels and other resources so
that patients can accurately identify medications containing acetaminophen. During patient contact, pharmacists and prescribers can play an important role in
educating patients on the appropriate use of products
containing acetaminophen. Manufacturers and FDA
also should continue to evaluate how and what labeling
information can increase the safe use of OTC products
containing acetaminophen.
References
1. Albertson TE, Walker V Jr, Stebbins MR, et al. A population study of the
frequency of high-dose acetaminophen prescribing and dispensing.
Ann Pharmacother. 2010;44(7-8):11915.
2. Lee WM. Acetaminophen and the U.S. Acute Liver Failure Study Group:
lowering the risks of hepatic failure. Hepatology. 2004;40(1):69.
3. Food and Drug Administration. FDA requires additional labeling for
over-the-counter pain relievers and fever reducers to help consumers
use products safely. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149573.htm. Accessed September 6, 2012.
4. Hornsby LB, Przybylowicz J, Andrus M, Starr J. Survey of physician
knowledge and counseling practices regarding acetaminophen. J Patient Saf. 2010;6(4):21620.
5. Lee WM. The case for limiting acetaminophen-related deaths: smaller
doses and unbundling the opioid-acetaminophen compounds. Clin
Pharmacol Ther. 2010;88(3):28992.
6. McNeil-PPC. Understanding acetaminophen. www.tylenolprofessional.com/assets/v4/understanding_acet_2p.pdf. Accessed September 6,
2012.
7. Cohen H. Helping patients and families avoid inadvertent acetaminophen overdose. J Emerg Nurs. 2007;33(3):24951.
8. Simon HK, Weinkle DA. Over-the-counter medications: do parents give
what they intend to give? Arch Pediatr Adolesc Med. 1997;151(7):654
6.
9. Food and Drug Administration. Recommendations for FDA interventions to decrease the occurrence of acetaminophen hepatotoxicity.
www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4429b1-02-FDA.
pdf. Accessed September 3, 2012.
10. Food and Drug Administration. Questions and answers on final rule
for labeling changes to over-the-counter pain relievers. www.fda.gov/
Drugs/NewsEvents/ucm144068.htm. Accessed September 6, 2012.
11. Consumer Healthcare Products Association. OTC industry announces
voluntary transition to one concentration of single-ingredient pediatric
liquid acetaminophen medicines. http://chpa-info.org/05_04_11_PedAcet.aspx. Accessed September 6, 2012.
j apha.org

JA N /FEB 2014 | 54:1 |

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RESEARCH

KNOWLEDGE AND USE OF ACETAMINOPHEN

12. Gever J. No more infant dose of OTC acetaminophen. www.medpagetoday.com/Pediatrics/GeneralPediatrics/26297. Accessed September
6, 2012.

29. Pesudovs K, Garamendi E, Keeves JP, Elliott DB. The Activities of Daily
Vision Scale for cataract surgery outcomes: re-evaluating validity with
Rasch analysis. Invest Ophthalmol Vis Sci. 2003;44(7):28929.

13. American Educational Research Association, American Psychological


Association, National Council on Measurement in Education (Eds.). Validity. In: Standards for educational and psychological testing. Washington, DC: American Educational Research Association; 1999:924.

30. Duncan PW, Bode RK, Min Lai S, et al. Rasch analysis of a new strokespecific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003;84(7):95063.

14. Cronbach LJ, Meehl PE. Construct validity in psychological tests. Psychol Bull. 1955;52(4):281302.
15. Downing SM. Threats to the validity of locally developed multiplechoice tests in medical education: construct-irrelevant variance and
construct underrepresentation. Adv Health Sci Educ Theory Pract.
2002;7(3):23541.

31. OConnor RJ, Cano SJ, Thompson AJ, Hobart JC. Exploring rating scale
responsiveness: does the total score reflect the sum of its parts? Neurology. 2004;62(10):18424.
32. McHorney CA, Tarlov AR. Individual-patient monitoring in clinical
practice: are available health status surveys adequate? Qual Life Res.
1995;4(4):293307.

16. Messick S. Validity. In: Linn RL. Ed. Educational measurement. 3rd ed.
New York: MacMillan; 1989:13103.

33. Lai SM, Perera S, Duncan PW, Bode R. Physical and social functioning after stroke: comparison of the Stroke Impact Scale and Short
Form-36. Stroke. 2003;34(2):48893.

17. Messick S. The interplay of evidence and consequences in the validation


of performance assessments. Educational Researcher. 1994;23(2):13
23.

34. Gold Standard, Inc. Acetaminophen. http://clinicalpharmacology-ip.com/


Forms/Monograph/monograph.aspx?cpnum=4&sec=monindi&t=0.
Accessed April 8, 2013.

18. Nunnally JC, Bernstein IH (Eds.). Validity. In: Psychometric theory. New
York: McGraw-Hill,; 1994.

35. Wright B, Linacre J. Reasonable mean-square fit values. www.rasch.


org/rmt/rmt83b.htm. Accessed September 6, 2012.

19. Draugalis JR, Jackson TR. Objective curricular evaluation: applying


the Rasch model to a cumulative examination. Am J Pharm Educ.
2004;68(2):35.

36. Wright BD, Stone MH. Judging misfit: making measures. Chicago: Phaneron; 2004:1933.

20. Colliver JA, Williams RG. Technical issues: test application: AAMC.
Acad Med. 1993;68(6):45460.
21. Smith EV Jr. Evidence for the reliability of measures and validity of measure interpretation: a Rasch measurement perspective. J Appl Meas.
2001;2(3):281311.
22. Jackson TR, Draugalis JR, Slack MK, et al. Validation of authentic performance assessment: a process suited for Rasch modeling. Am J
Pharm Educ. 2002;66(3):23342.
23. Briggs AL, Jackson TR, Bruce S, Shapiro NL. The development and performance validation of a tool to assess patient anticoagulation knowledge. Res Social Adm Pharm. 2005;1(1):4059.
24. Rasch G. Probabilistic models for some intelligence and attainment
tests. Copenhagen, Denmark: Danish Institute for Educational Research; 1960.
25. Wright BD, Stone MH. Best test design: Rasch measurement. Chicago:
Mesa; 1979:124.

37. Wright B. Diagnosing misfit: Rasch measurement transactions.


1991:5(2):156.
38. Smith RM. Item analysis in the Rasch model: IPARM: item and person
analysis with the Rasch model. Chicago: Mesa; 1991:16481.
39. Linacre JM, Wright BD. Interpreting output tables: a users guide to
BIGSTEPS WINSTEPS Rasch model computer program. Chicago:
Mesa; 2001:94115.
40. National Council for Prescription Drug Programs. NCPDP recommendations for improved prescription container labels for medicines containing acetaminophen. www.fda.gov/downloads/Drugs/DrugSafety/
UCM266631.pdf. Accessed August 19, 2012.
41. Fritsch B. FDAs safe use initiative: reducing harm risk from acetaminophen. Pharmacy Today. 2010;16(9):61.
42. Stumpf JL, Skyles AJ, Alaniz C, et al. Knowledge of appropriate acetaminophen doses and potential toxicities in an adult clinic population. J
Am Pharm Assoc. 2007;47(1):3541.

26. Wright B, Panchapakesan N. A procedure for sample-free item analysis.


Educ Psychol Meas. 1969;29(1):2348.

43. King JP, Davis TC, Bailey SC, et al. Developing consumer-centered,
nonprescription drug labeling: a study in acetaminophen. Am J Prev
Med. 2011;40(6):5938.

27. Hambleton RK, Swaminathan H, Rogers HJ. Test construction: fundamentals of item response theory. 1st ed. Newbury Park, CA: Sage;
1991:99107.

44. Chen L, Schneider S, Wax P. Knowledge about acetaminophen


toxicity among emergency department visitors. Vet Hum Toxicol.
2002;44(6):3703.

28. Liao PM, Campbell SK. Examination of the item structure of the Alberta
infant motor scale. Pediatr Phys Ther. 2004;16(1):318.

45. Hornsby LB, Whitley HP, Hester EK, et al. Survey of patient knowledge related to acetaminophen recognition, dosing, and toxicity. J Am
Pharm Assoc. 2010;50(4):4859.

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