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Vol. No: 28:04 Posted: 4/15/03
Effectiveness of Auxiliary
Labeling in Community
Pharmacies
Candace W. Barnett, PhD
Andrea Michelle Ellington, PharmD
Diane Nykamp, PharmD
The required information on a prescription label may not provide sufficient
information for every circumstance.
1
The standard label does not include any
warnings about drug interactions, side effects, or how to store and administer
the medication. Because of this, pharmacists often use the auxiliary label as a
resource to advise patients about proper use, storage, and specific precautions
concerning the medication.
2
The majority of patients, however, do not read
auxiliary labels.
3

4
Despite this, studies have documented that the auxiliary
label improves compliance in certain populations (improved compliance cannot
be extrapolated to the general population).
4
-
7
Three studies were published in the 1980s to evaluate the effectiveness of
auxiliary labels. One study evaluated patients 65 or older., presenting new
prescriptions for a predetermined group of medications. The patients received
either counseling, auxiliary labels, both, or neither. With auxiliary labels, with or
without counseling, these patients were able to correctly recall supplementary
information more than 60% of the time compared to only 25% when auxiliary
labels were not provided.
5
Another study conducted in an outpatient hospital
pharmacy in Malaysia examined patients' comprehension of antibiotic
instructions including auxiliary labels. Almost 57% of patients could recall
auxiliary label information, but only 21% were able to comprehend the
information and administer the medication correctly_? The third study
randomized patients presenting new prescriptions for a predetermined group of
medications to a control or study group and evaluated ret;all at one week and
two months. The study group received an auxiliary label attached to the
medication bottle. With auxiliary labels, recall was improved during the
one-week period. However, after two months patients became overly cautious
about their medications, exaggerating information provided by the auxiliary
label to include precautions not present on the label.
4
Auxiliary labels must be
read, understood, and remembered to be effective; otherwise they do not
improve compliance.?-
10
It is possible to use key messages to help patients under.stand proper
medication use, but it must be done at an educational level all can
comprehend.
11
Currently the estimated reading level of auxiliary labels is

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between grades 4 and 8.
12
Traditionally these labels are of contrasting color
and carry an icon (eg, opened refrigerator door on the "refrigerate" sticker) to
give the patient a sense of warning.
5

12
These traditional labels are still widely
used. In addition, many software companies are now offering auxiliary labels
that can be printed along with the label. These are often a single color with
printed text only. more like the traditional auxiliary labels.
13
-
15
This study examined current auxiliary labeling practices in assisting patient
caregivers in the proper administration of liquid antibiotics. Current issues in
antibiotics that auxiliary labeling attempts to address include storage
requirements, coadministration with food, shaking suspensions prior to
administration, and duration of therapy.
Objectives
Specific objectives of the study were to determine if patients and caregivers 1)
noticed auxiliary labels on their prescription bottle; 2) were given information
similar to auxiliary label warnings by the pharmacist, either orally or via
counseling leaflet; 3) adequately stored their medications at home; 4)
administered medications with proper food requirements; and 5) shook
suspensions prior to use.
Methods
Patients or caregivers who presented prescriptions for oral liquid antibiotics in
18 Atlanta-area pharmacies (14 chain and four independent) were enrolled in
the study. Every patient or caregiver received an explanation of the study
without biasing results. Confidentiality was assured. Those agreeing to
participate were contacted by phone four days later to complete a brief
telephone survey. A single Pharm.D. student completed all phone surveys.
Pharmacists provided the study investigator with the drug name and a
duplicate of all auxiliary labels that were affixed to the prescription bottle.
The phone interview measured the following: 1) recollection of drug name; 2)
practices regarding storage location, whether the medication was to be shaken
before administration, and the amount of food coadministered with medication;
3) recollection of how information was received about medication
administration and storage (eg, pharmacist counseling, label, leaflet); 4)
recollection of auxiliary labels; and 5) comments regarding improvements to
auxiliary labels.
This information was analyzed using the STATISTIX program.
Results
The study sample consisted of 67 caregivers administering liquid antibiotics to
patients. Of all participants, 59 caregivers (88.1 %) were enrolled at the chain
pharmacy sites, while the other eight (11.9%) were enrolled at independent
pharmacies. They ranged in age from 21 to 51 with an average age of 33.64
years. Most participants were female (92.5%) with at least a college education
(82.1%) (TABLE 1). They had an average of two children at home. Current
work status of the caregivers was diverse, with 32 (47.8%) employed full-time
and 21 (31.3%) homemakers (TABLE 1). Health care professionals made up
10.4% of the sample (seven participants), and 23 (34.3%) had not been the
only person to administer the medication to the patients.
Table 1
Education and Employment
Status of Caregivers
Some Benign Breast
Disease Linked to Risk for
Breast Cancer
The Medicare Modernization
Act
Pharmacological
Management of Gestational
Asthma
; An Update on Eating
Disorders
Plan B: The Facts Behind
the Controversy
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College
High school
Middle school
Grade school
Employment Status of Caregivers
Full-time i 32
Homemaker 121
Part-time i 14
Number of caregivers = 67
(82.1%)
(14.9%)
(1.5%)
(1.5%)
(47.8%)
(31.3%)
(20.9%)
The 67 prescriptions represented 1 0 different liquid antibiotic suspensions. Of
these prescriptions, 37 (55.2%) were for amoxicillin and 10 (14.9%) for
amoxicillin/clavulanate (TABLE 2). Recall of pertinent information provided was
then measured after four days of therapy, and 56 (83.6%) correctly
remembered the name of the medication they were administering to the
patient.
Table 2
Antibiotic Prescriptions
Included in the Study
Medication
Amoxicillin
Amoxicillin/clavulanate
Cephalexin
Azithromycin
Cefprozil
Cefuroxime
Erythromycin
ethylsuccinate/sulfasoxazole
Ceftibuten
Erythromycin estolate
Cefadroxil
!Frequency
' ...... . .. .
37 (55.2%)
'10 (14.9%)
16 (9.0%)
14 (6.0%)
i3 (4.5%)
:2 (3.0%)
'2 (3.0%)
11 (1.5%)
1 (1.5%)
'1 (1.5%)
Caregivers were asked to provide information on how they were storing and
administering the medication. This was compared to published manufacturer
recommendations to determine correctness (TABLE 3). Of the entire sample,
two caregivers (3.0%) were storing the medication incorrectly. Both
medications were azithromycin, which was one of the antibiotics in the study
that required storage at room temperature. Storage information was obtained
by 32 caregivers from the auxiliary label, and 20 received this information from
the pharmacist (TABLE 4).
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Table 3
Manufacturer Recommendations
for Liquid Antibiotic Stability and Absorption
i DRUG NAME STORAGE I FOOD
'REQUIRED 'REQUIRED
.Ampicillin Either
-< !
'Amoxicillin Either i Either
i Amoxicillin/Ciavulanate
Refrigerate
'cloxacillin

Penicillin VK
Cephalosporins .... icefaclor

iCefdinir
i
1 Cefpodoxime
lcefprozil
Refrigerate
Room
temperature
............ +
Either
Empty stomach
i Ceftibuten Refrigerate I Empty stomach
Either
Macrolides
Cephalexin
'Cephradine
,Azithromycin
i Clarithromycin
,_ -----
:Erythromycin estolate
Erythromycin
ethylsuccinate
i Nalidixic acid
Minocycline
i Tetracycline
Vancomycin
Clindamycin
i Refrigerate
I Either

i Either Either
'Room Either
i temperature
.
!Room Either
i temperature
, Room Empty stomach
[temperature
' " +
i Refrigerate Empty stomach
1
Room Either
, temperature
................... ' ......... , .............................. .
Refrigerate Either
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Trimethoprim
8
Storage is specified as room temperature, refrigeration, or either (stable at
both room temperature and refrigeration)
b For best absorption, antibiotic should be taken with food, on an empty
stomach, or either (absorbed on empty stomach or with'food)
Package insert references available upon request
All caregivers reported that they regularly shook the medication before
administration. All suspensions in the study should have been shaken, so all
caregivers were correct in this practice (TABLE 3). According to information
provided by the study subjects, 40 (59.7%) of the caregivers knew they had to
shake the medication because they read the auxiliary label (TABLE 4).
Fifty-nine caregivers (89.4%) correctly administered the medication with the
appropriate intake of food (TABLE 3). The majority (58.2%) did not remember
being told if the medication needed to be given with or without food but gave
the medication at a time most convenient for them. The telephone interviews
revealed that 10 caregivers (14.9%) knew food requirements because they
read the auxiliary label (TABLE 4).
Table 4
Where Caregivers Obtain
Drug Information
Frequency
Storage Instructions
Auxiliary label
Pharmacist
Habit
Instructions to Shake the
Suspension
label
Habit
Pharmacist
Doctor
Dietary Consideration Instructions
Habit
label
Pharmacist
Leaflet
Doctor
Duration of Therapy Instructions
32
20
15
Doctor 31
label 26
HabH 5
Pharmacist 5
(59.7%)
(22.4%)
(16.4%)
(1.5%)
Length of therapy was recalled correctly by 58 (86.6%) caregivers and
incorrectly by nine (13.4%). The prescribing physician told 31 (46.3%) of the
study participants the length of therapy, and 26 (38.8%) read it on the auxiliary
label (TABLE 4).
Caregivers were asked to recall information provided by the auxiliary labels on
the prescription bottle. They correctly recalled 72.7% of the information on the
auxiliary labels. Of these caregivers, five (7.5%) recalled more information than
was given on their prescription bottle. On 16 (24.2%) prescription bottles the
pharmacy incorrectly placed auxiliary information or did not place all the
necessary auxiliary information. When asked to determine how noticeable the
auxiliary labels were, caregivers rated this feature at 4.2 out of 5 (Likert scale).
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At the conclusion of the experiment, 26 (38.8%) caregivers offered
improvements that could be made to the current auxiliary labeling practices.
The suggestions included brighter colors, larger fonts, and better placement on
the bottle itself (TABLE 5).
Table 5
Recommendations for Auxiliary Label
Improvements Made by Caregivers
Brighter color
Larger font
Better placement of label on bottle
Information clear in directions
Pictures
n = 26
Conclusion
Storage, dietary considerations, and length of therapy are critical factors to
ensure that the therapy regimen is not compromised. This study revealed that
more than 10% of caregivers are not doing at least one of these tasks
appropriately. Health care professionals need to make sure all caregivers are
educated so that patients receive their medication correctly.
Sometimes labels are overlooked because of poor color choice or small font
size. This could be improved by making the labels bright or using neon colors.
Furthermore, each auxiliary label on the bottle should be a different color. If
space allows, each label should contain only one piece of information so that
the font can be larger and the information more noticeable. Commands like
"shake well" and "refrigerate" are less confusing than more complex phrases.
Computer label programs that automatically print auxiliary labels with the
prescription label are helpful if they meet the above conditions, because they
also prevent pharmacists and technicians from putting incorrect auxiliary
information on the bottle. These instructions could also be typed in the
prescription directions. For example, "Take one teaspoon by mouth three times
a day. Shake well. Refrigerate."
Auxiliary labels should be very clear and concise. An auxiliary label that says
"Finish all medication unless otherwise directed by prescriber" can be
confusing on liquid medications. With other antibiotic dosage forms, eg, tablets,
this usually applies to the entire prescription bottle. However, with liquid
antibiotics, very often the full course of therapy does not equal all the
medication in the bottle. This can confuse caregivers and patients as to length
of therapy.
It is especially important to label medications with specific requirements if they
are atypical of the majority of liquid antibiotic suspensions. For example,
clarithro-mycin and azithromycin must be stored at room temperature. Out of
habit, most caregivers will automatically store the medication in the refrigerator.
Half of the caregivers administering azithromycin in this study were storing it
incorrectly. Thus, for these medications, pharmacists must label them
appropriately and stress the information during counseling.
Limitations
Limitations of this study include factors that caused lack of diversity within the
sample. A large proportion of the study sample included college-educated
stay-at-home moms. These caregivers are more educated and may have more
time to read labels than the majority of caregivers. Also, more than half of the
prescriptions were written for amoxicillin, one of the few antibiotics that does
not have storage or food requirements based on published manufacturers'
recommendations.
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REFERENCES
1. Federal Food, Drug, and Cosmetic Act. Web site: http://www.fda.gov.
2. Wiederholt JB, Kotzan JA, Cooper JW. The effectiveness of auxiliary
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3. McKnight PT, Schneider PJ, Brier KL. Effect of label format on patient recall
in patients receiving prescription medications. Contemp Pharm Pract.
1981 ;82:225-8.
4. Brown CS, Solovitz BL, et al. Short- and long-term effects of auxiliary labels
on patient knowledge of precautionary drug information. 0/CP. 1988;22:470-4.
5. Gryfe-Becker BM, Segal HJ, Einarson TR. Effect of auxiliary labels on the
elderly ambulatory patient's drug knowledge. 0/CP. 1989;23:324-329.
6. Sharpe T. Patient compliance with antibiotic regimens. Am J Hosp Pharm.
1974;31 :479-84.
7. Hassan Y, Aziz N.A, et al. Comprehension of antibiotic instructions in an
outpatient Malaysian practice. Hosp Pharm. 1994;29:48-53.
8. Sariff A, Aziz NA, et al. A study of patients' self-interpretation of prescription
instructions. J Clin Pharm Ther. 1992;17:125-128.
9. Mazzullo JM, Lasagna L, Griner PF. Variations in interpretation of
prescription instructions: the need for improved prescribing habits. JAMA.
197 4;227:929-931.
10. Holt GA, Dorcheus L, et al. Patient interpretation of label instructions. Am
Pharm. 1992;NS32:58-62.
11. Friedman CP, Romeo D, Hinton SS. Healthcare decisions and product
labeling: results of a consumer comprehension study of prototype labeling for
proposed over-the-counter cholestyramine. Am J Med. 1.997;102:50-6.
12. Wilson J. Readability testing of auxiliary labels. 0/CP. 1983;17:54-5.
13. Warning Label Database. Web site: http://www.firstdatabank.com.
14. Scriptpro. Available at www.scriptpro.com.
15. Seacom Products. Web site: http:/1208.231.17.251/
seacom/products/center_pro_rxtechsoftmore_1.htm.
Vol. No: 28:04 Posted: 4/15/03
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