1. No category

One Meeting House Square, Middleton, MA 01949
Tel: 978.646.0091 Fax: 978.646.0092
www.gatesconsult.com
How to design and print a ‘safer’ prescripƟon
container label for safe medicaƟon use.
Report for Epson America, Inc.
3840 Kilroy Airport Way
Long Beach, CA 90806
http://www.pos.epson.com/healthcare
January 5, 2013
IntroducƟon
Harm can occur if a pa ent and/or their caregiver cannot read and understand the content on their prescrip on
container label. They may not be able to iden fy the medica on or understand how to use it safely and effec vely.
This document presents guideline informa on concerning how a be er designed label can be used to make dispensed
products safer for pa ents.
Background- Literacy Issues
The 2006 Ins tute of Medica on report highlighted several issues involving pa ents using their own medica ons
incorrectly. Problems with prescrip on container labeling were cited as the cause of a large propor on of outpa ent
medica on errors and adverse drug reac ons (ADEs).Pa ents may uninten onally misuse a prescribed medica on
due to improper understanding of instruc ons. Recent health literacy research has highlighted the alarmingly high
prevalence of pa ents misunderstanding seemingly simple instruc ons and warnings placed on prescrip on container
labels. The elderly, those with limited literacy skills, and individuals managing mul ple medica on regimens were
found to be at greater risk for making errors in interpre ng prescrip on container label instruc ons.
Half of all pa ents say that the prescrip on informa on and instruc on they receive is wri en in language that is hard
to read and understand. One-third say the instruc ons are complicated .
The following table (1) gives an example of how pa ents misunderstand what pharmacists believe to be simple
prescrip on container label direc ons:
The issue is low health literacy. Low health literacy is defined as “The ability to read, understand and act
on health informa on” and basically anyone in the US, is at risk for it. Table 2 highlights a recent study on what low
health literacy means for pa ents:
Ethnic minority groups are dispropor onately affected by low health literacy. Older pa ents, recent immigrants,
people with chronic diseases and those with low socioeconomic status also endure it. However it may be surprising
to most that the majority of people with low literacy skills in the US are white, na ve-born Americans. Health literacy
affects self-administra on of prescrip on in medica ons. Since a person’s ability to understand prescrip on container
label instruc ons is cri cal, low health literacy becomes a medica on safety concern. This is especially true since
other sources of pa ent medica on informa on are insufficient. Supplementary sources (Consumer Medica on
Informa on, Med Guides) are too complex and wri en at a reading level unsuitable for the majority of pa ents to
comprehend. As a result, these materials are o en ignored by pa ents.
Table 3 illustrates the growing concerns between a person’s literacy level and their safe medica on use.
NavigaƟng PrescripƟon Container Labels
A White Paper Commissioned by the American College of Physicians Founda on (ACPF) was presented to the Ins tute
of Medicine Roundtable on Health Literacy on October 12, 2007 . The report indicates that pa ents have trouble
naviga ng labels, which vary by pharmacy, due to state labeling requirements. Labeling of dispensed medicines must
be clear and legible and include the details required by the labeling regula ons. State boards of pharmacy control
label format, and are not uniform in their requirements. However, at the 2012 annual mee ng of the Na onal
Associa on of Boards of Pharmacy (NABP), a resolu on was passed to address these inconsistencies and work
towards a unified requirement solu on. (NABP resolu on 108-1-12 Uniform Out Pa ent Pharmacy Prescrip on
Container Labels Designed for Pa ent Safety).
Prescrip on Container Label Design Elements
The United States Pharmacopeia (USP) , the NABP and the Ins tute for Safe Medica on Prac ces (ISMP) have
all weighed in on how to design a ‘safer’ label. Their combined guidelines are offered here. The most important
informaƟon should stand out the most using bold font, highlights and color. Currently the greatest emphasis is
placed on provider-directed content, i.e., pharmacy name and address and logo, which is NOT the most important
informa on for the pa ent. See picture below.
Ghost logos or watermarks can obscure essen al informa on. The example below clearly demonstrates a label with a
ghost logo. See picture below.
The prescrip on container labels should include essen al pa ent informa on plus addi onal informa on for safer
dispensing such as the product descrip on, photo, image, shape or smell of the medica on. See sample picture below.
Font Size and Weight
Using one size and weight of font makes it difficult to find most important informa on. A standard minimum font
size (12 point) should be used for pa ent name, drug name, and specific dosage-usage instruc ons. Health literacy
and adult educa on researchers recommend the use of Sans-Serif font (i.e. Arial) to more clearly present print text
informa on to new adult learners. The use of all capital le ers should be avoided; the first le er of words in text
should be capitalized. Currently many pharmacy computer labels do not have the ability to print in mixed upper and
lower case in the pa ent instruc on field; see pictures 1-3, above. All community pharmacies should ensure that their
applica on and printers support both upper and lower case fonts and any characters which drop below the lower line
(example lower case y, g).
Table 4 has sample fonts and why they should or should not be used on prescrip on container labels.
Low Vision Readers
For people with low vision use the largest font size the label will allow, minimum of 18-point type. Most standard
prescrip on label size will not accommodate the required labeling informa on in 18-point type. Therefore, the
American Founda on for the Blind recommends that pharmacy systems are able to:
1. Provide “duplicate labels” (prescrip on and auxiliary) printed in a minimum of 18-point type on paper stock.
2. If pictograms or photo are used, these should also be provided in “large print” format and high contrast (saturated
black on white background).
3. The “duplicate labels” should be matched in some way to the prescrip on container, such as by using a large-print
number or colored s cker on both the duplicate label and the corresponding medica on container.
4. Use sans serif, standard font (not narrow or condensed), such as Arial, Verdana, or obtain APHont™ (pronounced
Ay’-font). APHont™ was developed specifically for low vision readers and embodies characteris cs that have been
shown to enhance reading speed, comprehension, and comfort for large print users. Available free at:
www.aph.org/products/aphont.html
PrescripƟon Container Label Format
Label layout format should include larger font, lists, headers, whitespace, simple language and logical organiza on
to improve readability and comprehension . White space is o en perceived by older pa ents as having greater
readability. When applicable, use numeric vs. alphabet characters . Use typographic cues (bolding and highligh ng)
for pa ent content only. More explicit instruc on, pace reading, improves comprehension i.e., ‘Take 2 tablets in the
morning and take 2 tablets in the evening’ be er than: ‘Take two tablets twice a day’.
Only include horizontal text on the label. Several na onal pharmacy chains place text for warning and instruc on
messages ver cal to the prescrip on container label, requiring the pa ent to turn the bo le to read the warnings.
This may create further difficulty among older adults.
Pa ent-directed informa on must be organized in a way that best reflects how most pa ents seek out and understand
medicine instruc ons. Text that is centered is more difficult to read than le -aligned text. Pa ent-directed content
should be at the top of the label, while provider-directed content will be placed at the bo om of the label. Specifically,
drug name and specific dosage/usage instruc ons should be placed in greatest prominence. See picture below.
Label format should group text into separate conceptually related sec ons (chunking) to facilitate search and
acquisi on of informa on to the pa ent. Provider directed content (Pharmacy logo, Pharmacy number, Pharmacy
address and phone number) should be placed away from dosage instruc ons. Auxiliary labels (pa ent warning labels
or PWLs) should be consistent in loca on for pa ent rou ne expecta on. Drug name and dose should be highlighted
and dosage/usage instruc ons bolded. See examples below.
The United Kingdom
The United Kingdom (UK) has done extensive research on designing safe prescrip on container labels. The pictures
below indicate what the UK report deems to be safe in terms of label size, font selec on and font size, as well as, the
number of characters that need to be used for be er reading comprehension.
Prescrip on container labels should be no smaller than 35mm x 70mm to enable the use of font sizes that can be
easily read. The choice of font size should indicate the importance of the informa on. The direc on on how to take
the medicine is the most important informa on on the label and should be in the largest font size (at least 12pt).
The name of the medicine is the next most important informa on.
Paper Quality
Label paper quality has significant impact on readability. Poor paper choices include yellowing paper and thin or see
through paper. If thin paper label is applied over unit of use packaging the see through aspect will make the pa ent
specific label difficult to read. See picture below of the thin paper from the UK report.
PrinƟng Quality
Prin ng quality also makes a difference in terms of designing ‘safer’ labels. Dot matrix printers produce very poor
labels. Prin ng from a dot matrix printer can become very faint if the ribbon is not changed regularly. Laser or thermal
printers produce be er labels. Printers must be able to print in different size fonts on the same label.
Faint prin ng due to overused ribbon
Dot Matrix
PrescripƟon Warning Labels
Many pharmacy systems automa cally print out PWLs, however recent studies show that these labels which are
intended to increase pa ent understanding of dosing or warnings actually can do just the opposite. PWLs are not
regulated, and many have not been updated since the 1960s; pictograms, no ma er how simple can be misinterpreted
and result in unsafe medica on administra on prac ces.
Wolf study on label comprehension assessed pa ent understanding of the instruc ons on prescrip on medica on
labels. The research assistant asked, “How would you take this medicine?” and observed if they no ced, read and
acted on the PWLs also on the vial. PWLs such as these were used in the study.
The rate of correct interpreta on of PWLs ranged from 0% to 78%. With the
excep on of the label “Take with food,” less than 50% were able to provide
adequate interpreta ons of the warning labels’ messages.
No pa ents, 0 %, correctly interpreted the label “Do not take dairy products,
antacids, or iron prepara ons within one hour of this medica on.”
Most pa ents, especially those with low literacy, ignored the PWLs when
reading the prescrip on container label for direc ons on how to selfadminister the medica on.
The Dowse Study
The Dowse study reviewed what was
thought to be simple pictograms used
in the US with pa ents in South Africa.
A sample is provided in the picture
below. Eighty (80) % of the study group
interpreted the pictogram correctly
but others misinterpreted for ‘Take 3
Ɵmes only during day (not at night)’.
Or ‘Take when you see the sun and the
moon’. Or ‘Take 4 Ɵmes per day.’
The study showed that cultural
issues can affect how a pa ent
understands a picture. For example,
the researchers showed the pa ents
the picture below. South African
respondents did not associate the
glass styles (i.e., cocktail glass, beer
mug or wine glass) with alcohol
contents.
The local image was then drawn with
wine bo les and beer cans as seen
below. This change in the image
improved the correct interpreta on
of this label from 51% to 84%. When
using pictures to guide appropriate
medica on use, pharmacists should
consider the limited reading ability
and visual skills of their target
audience, as well as their beliefs
about health, cultural values, ea ng
habits and lifestyles.
Barcoding on PrescripƟon Container Labels
The Food and Drug Administra on (FDA) published a final rule requiring certain human drug and biological products
approved on or a er April 26, 2004, to include on their packages a linear barcode that contains, at a minimum, the
drug’s Na onal Drug Code (NDC) number (21 CFR 201.25) by April 26, 2006. The NDC number includes the drug’s
manufacturer, the name and strength of the drug, and the size of the package. Scanning both the stock bo le’s
specific barcode and the barcode on the pharmacy generated prescrip on container label verifies the accuracy of
the product selected for dispensing by matching the NDC of the prescrip on medica on entered into the pa ent’s
medica on profile to the stock bo le.
Imbedding addi onal items into the barcode can facilitate other pharmacy processes. The bar code should contain
two secondary iden fiers: the lot number and the expira on date. A unique lot number that is used in the event of
a recall iden fies each manufacturing batch. Inclusion of this lot number within the bar code will ensure that those
lots subject to a recall can be readily iden fied. Inclusion of the expira on date within the bar code will ensure that
the pa ent does not receive a medica on that is beyond its expira on date. Addi onal uses of barcode scanning
technology include bioterrorism preparedness (moving products to areas of need), the capture of aggregate data
to monitor drug frequency distribu on, purchasing and inventory management and returned goods and possible
medica on safety issues based on mismatches when product barcodes are scanned.
Barcode scanning technology to verify product selec on could soon become the standard of prac ce in all pharmacies
to reduce liability exposure from dispensing errors. There are many studies tou ng the benefits of barcode
technology. In fact, studies have found that more than 5% of medica ons first selected to fill a prescrip on are wrong,
and that at least 75% of these wrong drug or wrong dose errors have been captured and corrected using barcode
technology.
Barcode technology for product verifica on is gaining a en on and applicability in the community pharmacy
marketplace as a means to increase prescrip on filling accuracy and efficiency. In 2003 the Na onal Community
Pharmacy Associa on conducted barcoding survey . The 664 survey respondents indicated a 35.6% u liza on of
barcode scanning in their pharmacy department. Of those who did not use the technology, 42.4 percent said they
thought the technology was too expensive, yet 78.2% of all the respondents believe that barcode technology is
‘somewhat’ or ‘very important’ to enhancing accuracy and efficiency. In 2009, the Ins tute for Safe Medica on
Prac ces (ISMP) conducted a na onal survey of community pharmacies to learn why they have either implemented or
not implemented barcode product verifica on systems. The most common reasons associated with decisions to NOT
implement the technology included:
•
•
•
•
•
•
Uncertainty regarding the ‘right’ vendor product for their prac ce site
Sa sfac on with the current system (without barcoding technology) because respondents had not analyzed
the need for this technology
Percep ons that the technology would result in inefficient use of staff me
Percep ons that the technology is not needed if prescrip on volumes are low
An cipated difficul es with staff training
Concern regarding customer service impact
‘Report on Findings Pharmacy Technology Assessment for Paperless Labeling Ini a ve’ conducted by The American
Society for Automa on in Pharmacy indicated that only two vendors include barcode scanners as standard equipment.
The majority (93%) of the system vendors offer barcode scanners as an addi onal op on with their pharmacy
management systems.
Only 45% of the systems installed have scanners when it is an op onal item from the vendor. The reasons given for
this low percentage are that pharmacists do not want to incur the addi onal cost, and they find that old habits are
hard to change. Scanners are more likely to be found in high-volume pharmacies as a way to reduce errors in the filling
process. Many vendors (close to 60%) offer both keyboard wedge scanners and USB serial scanners. However, the
keyboard wedge is slightly preferred over the USB scanner (57% versus 43%). Seventy-five % of the installed scanners
are programmed to read one-dimensional barcodes. In addi on 75% of the vendors use scanners that can read the
na onal drug code in reduced space symbology (RSS).
The InsƟtute for Safe MedicaƟon PracƟces
The Ins tute for Safe Medica on Prac ces (ISMP) has developed ‘Assessing Barcode Verifica on System Readiness in
Community Pharmacies for those pharmacies (up to 46% of US retail pharmacies) that do not currently have barcode
verifica on technology. The ISMP readiness assessment suggests Specific Systems Capabili es—Prin ng Labels with
Readable Barcodes:
•
•
•
The system has the capability of prin ng labels with bar codes for pharmacy-prepared, returned to stock
products (filled prescrip ons not picked up by pa ent and returned to shelf for future dispensing to
another pa ent).
The system has the capability of prin ng labels for pharmacy-compounded prescrip on products.
The system has the capability of prin ng labels with bar codes for medica ons no longer stocked in and
removed from automated coun ng devices (i.e. Baker cells) and returned to shelves with main stock for future
drug selec on bar code verifica on.
The ISMP readiness assessment further suggests Specific Systems Capabili es—Scanning Barcodes:
•
•
The scanners chosen as possibili es can read 90 percent of barcodes and all symbology used by
pharmaceu cal manufacturers; purchasers realize that RFID technology is separate and dis nct from barcode
scanning technology and may need to be addressed in the future.
The system has the capability to scan mul ple stock bo les when more than one stock bo le is needed to
fulfill an order.
United States and Canada
In addi on to the recent push in the US, Canada is also undertaking barcode verifica on technology for the medica on
use system. In an effort to increase medica on safety, members of the healthcare industry are collabora ng to
implement standardized bar codes on pharmaceu cal products which have been approved for use in Canada. The
mul phase project has developed dra technical bar code (automated Iden fica on) requirements for Canadian
pharmaceu cals, based on the GS1 global automated iden fica on standard. Canadian na onal requirements include
Minimum So ware Func onality for pa ent care computer system and automa on.
Highlights of the Canadian project include:
•
•
•
•
•
The existence of a global Automated Iden fica on standard (coupled with advanced reduced-space bar code
symbologies or radio frequency iden fica on (RFID) chips) and the availability of reader technology connected
to intelligent so ware have allowed the healthcare industry to advance safety prac ces.
Bar codes may be one-dimensional or two-dimensional. The preference for two-dimensional GS1 DataMatrix
codes should be considered.
Database field lengths for the Global Trade Item Number (GTIN): The iden fica on key used by GS1 to iden fy
trade items. The key comprises a GS1- or UPC-defined company prefix, followed by an item reference number
and a check digit) should allow up to 14 characters.
The length of the GTIN may vary depending on the specific applica on and the environment of use, but it will
never exceed 14 characters. The database field must be capable of accommoda ng a 14-character GTIN code.
For sectors that are already planning for the GTIN data field, it is recommended that the GTIN be represented
in so ware applica ons as 14 digits, with right jus fica on and zero filling on the le , as appropriate.
Conclusion
Pa ent safety needs to be the number one priority in all pharmacies. Prescrip on container label design is a very
effec ve method of improving the safety, effec veness and efficiency of dispensed medica ons both for the
pharmacists and for their pa ents.
Contributors
RoperASW LLC Health Literacy and the Prescrip on Drug Experience: The Frontline Perspec ve from Pa ents, Physicians and Pharmacists info@roperasw.
com www.roperasw.com Sept 2002.
Wolf MS, et al. Pat Ed Counsel 2007; 67: 293-300.
Williams MV, Parker RM, Baker DW, et al. Inadequate Func onal Health Literacy Among Pa ents at Two Public Hospitals. JAMA 1995 Dec 6; 274(21):
1,677–82.
h p://www.health.gov/communica on/literacy/quickguide/factsbasic.htm Accessed 1-4-13.
Kripalani et al 2006. Gazmararian et al 1999. Fang et al 2006. Davis et al 2006.
Michael S. Wolf, MA, MPH, PhD Health Literacy and Learning Program, Northwestern Univ. Report to FDA June 2007.
h p://www.nabp.net/members/resolu ons/ Accessed 1-2-13.
h p://www.usp.org/usp-nf/key-issues/usp-nf-general-chapter-prescrip on-container-labeling Accessed 1-4-13.
www.nabp.net/news/assets/08TF_Uniform_Presc_Labeling_Req.pdf Accessed 1-4-13.
h p://www.ismp.org/tools/guidelines/labelFormats/comments/default.asp accessed 1-4-13.
American Society of Consultant Pharmacists Founda on/American Founda on for the Blind. Guidelines for prescrip on labeling and consumer medica on
informa on for people with vision loss. 2008. Available on the Intranet at: h p://www.a .org/Sec on.asp?Sec onID=3&TopicID=329&DocumentID=4064.
Accessed 1-5-13.
Shrank, W., Avorn, J., Rolon, C., Shekelle, P. “Effect of Content and Format of Prescrip on Drug Labels on Readability, Understanding, and Medica on Use:A
Systema c Review”, The Annals of Pharmacotherapy 2007 May, Volume 41.
h p://www.ismp.org/tools/guidelines/labelFormats/comments/default.asp Accessed 1-2-13.
Wolf, M., Davis, T., Shrank, W. Rapp, D., Bass, P. Connor U., Clayman, M. Parker, R. “To err is human: Pa ent misinterpreta ons of prescrip on drug label
instruc ons” Elsevier Ireland Ltd. doi:10.1016/j.pec.2007.03.024.
Wogalter, M. Vigilante, W. “Effects of label format on knowledge acquisi on and perceived readability by younger and older adults” Ergonomics, 2003, Vol.
46, No. 4, 327 ± 344.
Design for pa ent safety: a guide to the design of dispensed medicines’ published by the Na onal Pa ent Safety Agency. h p://www.nrls.npsa.nhs.uk/
resources/?EntryId45=59829 accessed 1-3-13.
Design for pa ent safety dispensed medicines’ published by the Na onal Pa ent Safety Agency. h p://www.nrls.npsa.nhs.uk/resources/?EntryId45=59829
accessed 1-3-13.
Wolf MS, Davis TC, et al. Misunderstanding of prescrip on drug warning labels among pa ents with low literacy. Am J Health-Syst Pharm.
2006;63(1);1048–1055.
Dowse R, Ehlers M, Pictograms for conveying medicine instruc ons: comprehension in various South African language groups, South African Journal of
Science 100, November/December 2004.
US Department of Health & Human Services. HHS announces new requirements for bar codes on drugs and blood to reduce the risk of medica on errors.
News Release. February 24, 2004. Accessed at: www.hhs.gov/news/press/2004pres/20040225.html.
Promo ng and Standardizing Bar Coding on Medica on Packaging: Reducing Errors and Improving Care, Na onal Coordina ng Council Error for Repor ng
and Preven on, Adopted June 27, 2001.
Koutnik E. Bar coding: working toward error-free pharmacy. Pharmacy Times. Sept 1, 2003.
Ukens C. New study sheds light on medica on errors. Drug Topics. 2002;146(21):33.
Maviglia SM, Yoo JY, Franz C, Featherstone E, et al. Cost-benefit analysis of a hospital pharmacy barcode solu on. Arch Intern Med. 2007;167(8):
794.
788-
West DS, Carper B, Hoey D, et al. 2003 NCPA-Pfizer digest. Na onal Community Pharmacists Associa on and Pfizer Inc. 2003. Accessed on January 3, 2013
at: h p://www.ncpanet.org/members/pdf/2003digest.pdf.
Ins tute for Safe Medica on Prac ces. ISMP survey on barcode scanning technology for medica on selec on verifica on. Unpublished results. December
2009.
American Society for Automa on in Pharmacy (ASAP). Report on findings pharmacy technology assessment for paperless labeling ini a ve. Conducted by
ASAP for the Pharmaceu cal Research and Manufacturers of America. June 2008.
h p://www.ismp.org/default.asp Accessed 1-4-13.
Skrepnek GH, Armstrong EP, Malone DC, Abarca J, et al. Workload and availability of technology in metropolitan community pharmacies. J Amer Pham
Assoc. 2006; 46(2):154-160.
Joint Technical Statement on Canadian Pharmaceu cal Automated Iden fica on and Product Data Requirements”. Available at h p://www.ismp-canada.
org/barcoding/index.htm Accessed 1-4-13.