Transcript SCI2003 Template - American Pharmacists Association

The Role of
Drug Names and Packaging
in Medication Errors
Learning Objectives
• Describe potential errors caused by
confusing look-alike or sound-alike (LASA)
drug products
• Explain ways to decrease the potential for
LASA medication errors
• Discuss the role of practitioners in
decreasing LASA medication errors
Magnitude of the Problem
• The Institute for Safe Medication Practices
(ISMP) has reported over 1,000 drug pairs of
confusing drug names
• Confusion related to product names is one of
the most common causes of errors reported
to the U.S. Pharmacopeia (USP), Food and
Drug Administration (FDA), and ISMP
Institute for Safe Medication Practices. http://www.ismp.org/Tools/confuseddrugnames.pdf.
Starr CH. Drug Topics. May 15, 2000;144(10):49–58.
Examples of Errors
Reported to ISMP
• Daptomycin and Dactinomycin
– Generic names are similar, both are once
daily administration, both are lyophilized
powders, both are yellowish in color
– Error detected prior to reaching patient
attributable to differences in dosing
• Purinethol and Propylthiouracil
– A child missed 6 months of chemotherapy
because propylthiouracil, an antithyroid drug,
was dispensed instead of purinethol
Preventing Errors Involving
Similar Drug Names
Name Changes
• Levoxine and Lanoxin
– Similar brand names, both are tablet forms, both
available as 0.125 mg tablets, both once daily
administration
• Losec (omeprazole) and Lasix
– Similar brand names, both dosed at 20 mg, names look
similar when written in cursive
• After reports of errors arose, FDA and ISMP
advocated name changes
– Levoxine changed to Levoxyl
– Losec changed to Prilosec
Use of TALL-Man Letters
• Use of mixed-case or enlarged letters to
emphasize the differing portions of two drug
names:
zyPREXA
zyRTEC
hydrOXYzine
hydrALAZINE
DOBUTamine
DOPamine
• Use required by the FDA in 16 generic name
pairs
– For complete list, see Table 6-1 in textbook
– For examples of name pairs on product labels, see
Figures 6-2 and 6-3 in textbook
Lists of Similar Name Pairs
• Limitations of some lists
– Too long for practitioners to remember
– Confirmation bias
– Some name pairs may be on the list because
of packaging, not name
– No way to distinguish between pairs with
frequent reports of confusion versus pairs with
a single report
Lists of Similar Name Pairs
• Overcoming limitations
– The Joint Commission and ISMP compiled
three smaller lists
• Reviewed by an expert panel
• Each pair includes recommendations to prevent
confusion within that specific pair
– For potentially problematic name pairs encountered in
inpatient and outpatient care settings, see Tables 6-2,
6-3, and 6-4 in textbook
Lists of Similar Name Pairs
• Overcoming limitations
– To comply with The Joint Commission 2009
standards for hospitals, organizations must:
• Choose at least 10 pairs of LASA medications from
LASA tables listed on The Joint Commission Web
site http://www.jointcommission.org
• Annually review the organization’s list of LASA
medications and take actions
Generic Name Selection
• The World Health Organization (WHO)
International Nonproprietary Names (INN)
committee
– Advocates for worldwide names
• The U.S. Adopted Names (USAN) Council
assigns generic names in the United States
– Multidisciplinary group
• WHO INN designates first, then USAN
Generic Name Mix-Ups
• 9 of 10 pairs of potentially problematic names on
the The Joint Commission list include generic
names
• The Joint Commission and ISMP encourage the
use of both generic and brand name
– Avoids confusion
– Adds to redundancy
• Inclusion of “indication for use” can further
decrease confusion
– Most LASA products have different uses
Look-Alike and
Sound-Alike Drug Choices
Name Pairs
Cisplatin
Carboplatin
Potential
Consequences
Safety Strategies
Doses for carboplatin usually
exceed maximum safe dose of
cisplatin. Severe toxicity and
death reported.
Install maximum-dose warnings in
computer. Use stickers provided by
cisplatin manufacturer. Do not store
these drugs next to each other. Use
generic names when prescribing.
Hydromorphone Some prescribers have
mistaken hydromorphone for
Morphine
the generic of morphine.
Equianalgesic conversions
result in significant overdose
and even death.
Stock strengths that are dissimilar,
e.g., stock hydromorphone 1 mg
unit-dose cartridges and morphine
2 mg unit-dose cartridge. Ensure
providers know these products are
not interchangeable.
For additional LASA name pairs, see Tables 6-2 and 6-3 in textbook
Trademark Suffixes
• FDA requires each new formulation of a drug
to be distinguished by a suffix
• Inconsistent use of suffixes may cause errors
– Example
• Wellbutrin SR (sustained release) is given twice daily,
Dilatrate SR is once daily, Wellbutrin XL is once daily
• Misinterpretation of brand name suffixes may
result in errors
– Examples
• Percocet-5 to designate Percocet 5 mg, misinterpreted as
Percocet 5 tablets
Ad Hoc Abbreviations
• Avoid the use of abbreviations
• Interpretation of abbreviations
– Varies person-to-person
– May be dependent on handwriting
– Leads to confusion and errors
• Examples
– “Norflox” for norfloxacin mistaken for Norflex
– “HCT” for hydrocortisone mistaken for
hydrochlorothiazide
– “Adria” for Adriamycin mistaken for Aredia
Nonprescription
Brand-Name Line Extensions
• Federal regulations do not prevent nonprescription
drugs from being marketed without FDA approval of
product names
• Companies can capitalize on a well-known and
trusted brand name
– Product may not include any of the active ingredients of the
original branded product
– Product may even be used for an opposing indication
• ISMP opposes brand name extension unless at least
one ingredient from original product is present in the
new product
Brand-Name Extensions
Original Kaopectate formulation:
antidiarrheal
A newer Kaopectate formulation:
contains docusate, thus it is a
stool softener
Same brand name for
opposing indications
Foreign Drug Names and
Impact of Reimportation
• No clearinghouse for worldwide brand names
• Depending on the country:
– Same brand names may have different active
ingredients in the United States versus foreign
countries
– For examples of U.S. brand names with different
active ingredients in Europe, see Table 6-5 in the
textbook
– Suffixes are not standardized worldwide
Foreign Drug Names and
Impact of Reimportation
• Increasing problem attributable to:
– Internet pharmacies
– Reimportation of less expensive medications
• Instruct patients traveling abroad to keep a
list of medications by generic and brand
name
U.S. Brand Names With
Different Ingredients in Europe
Brand
Name
Dilacor
Active Ingredient in
United States
Diltiazem
Active Ingredient
in Europe
Digoxin
– angina, hypertension – CHF, arrhythmia
Norpramin
Ambyen (U.K.)
Ambien (U.S.)
Desipramine
Omeprazole
– depression
– GERD, peptic ulcer
Zolpidem
Amiodarone
– insomnia
– arrythmias
For additional U.S. brand names with different active ingredients abroad, see
Table 6-5 in textbook
Role of the FDA
• Premarketing review of proposed
trademarks
• Postmarketing surveillance and risk
management
Premarketing Review of
Proposed Trademarks
FDA Office of Drug Safety, Division of Medication Errors
and Technical Support (DMETS) reviews all trademarks
Premarketing Review of
Proposed Trademarks
• DMETS has recommended disapproval of
trademarks for the following reasons:
–
–
–
–
Names are too similar to existing names
Misleading, incorrect, or unsafe elements
Claims not supported by clinical data
Prefixes and suffixes may be confused with a common
medical abbreviation
– Inclusion of dosage form or regimen in the proprietary
name
– Similarities in storage environment
– Unacceptable similarity between generic and brand
names
Postmarketing Surveillance
and Risk Management
• Phase IV Medication Error Monitoring
Program
– Part of an NDA approval letter
– Similar to a probationary period
– Gives FDA and manufacturers time to
determine if a theoretical risk materializes
into a true risk
Role of the
Pharmaceutical Industry
• Trademarks must:
–
–
–
–
–
Be free of bad meanings or connotations
Be relatively easy to pronounce
Not add to medication errors
Not infringe upon other products
Undergo considerable scrutiny
•
•
•
•
•
Linguistics algorithms
Cultural checks
Searches for similar names
Market studies with providers and consumers
Analyses of potential errors
Recommendations for
Preventing Drug Name Mix-Ups
Role of Prescribers
• Maintain awareness of LASA drug names
• Clearly specify dosage form, drug strength, and
complete directions on prescriptions
• Use both brand and generic names when writing a
prescription
• Include the purpose of the medication in the
prescription
• Alert patients to the potential for mix-ups
• Encourage patients to ask nurses or pharmacists about
unfamiliar medications they may be given
• Avoid verbal orders; if used, require staff receiving
order to read back the order
Role of Practitioners
and Organizations
• Determine purpose of medication prior to dispensing
• Limit verbal orders; require read back of the transcribed
order (not “repeat back” of the spoken order)
• Consider confusion potential when a medication is added
to the formulary
• Computerize prescribing; if not, use pre-printed orders
• List brand and generic names on medication
administration records and in automated dispensing
cabinet (ADC) screens
• Use independent double checks
Role of Practitioners and
Organizations
• Change appearance of LASA drugs on computer
screens, ADCs, bins, carts, and labels by using TALLman lettering, highlighting, color, or boldface
• Install and use computerized alerts
• Configure computer screens to prevent LASA drugs
from appearing consecutively
• Affix name alert stickers
• Do not store LASA drug pairs together
– Separate drug products in pharmacy, nursing units, OR, etc.
• Encourage reporting of errors and potentially
hazardous conditions (near misses)
Role of
Drug Packaging and Labeling
Factors Affecting Packaging
and Labeling Errors
•
•
•
•
•
•
•
•
•
Human factors
Confirmation bias
Look-alike packaging
Readability
Color
Two-sided labels
Lack of contrast
Blister strips
Expression of:
–
–
–
–
Concentration
Strength
Company name, logo
Product expiration dates
• Typeface
• Excessive use of
warnings
• Use of symbols
• Nonstandard terminology
• Unsafe abbreviations
• Bar codes
• Container design
• Protective overwraps
• External carton labels
• Promotional materials
• Drug shortages
Label-Specific Factors
Contributing to Errors
• Information in an
inconspicuous place
• Ambiguous
presentation
• Information
overshadowed by less
important information
• Stylized graphics
• Positioning of
corporate logos
• Print of suboptimal:
– Size
– Boldness
– Contrast
• Labels read in less
than ideal conditions:
– Low light
– Stressful situations
Human Factors
• Human and environmental factors play a
major role in medication safety
• Simple modifications enhance readability:
– Optimize lighting (significant reduction of errors at
146 footcandles versus 102 footcandles of light)
– Using magnifying lenses
– Printing information in exaggerated fonts
– Regular eye exams
– Rearranging work stations
Confirmation Bias
• Definition: seeing or hearing what is familiar or
what a person wants to see or hear, rather than
what is actually there
• Factors adding to confirmation bias
–
–
–
–
–
Similar packaging
Difficult to read labeling
Similar shape and size
Similar color
Stored in the same location
• For example of overcoming confirmation bias,
see Figure 7-2 in the color photographs section
of textbook
PARIS IN THE
THE SPRING
Examples of Look-Alike
Packaging
• These ampuls are two different products
– External cartons are different
– Internal amber packaging makes them difficult to
distinguish
– Small writing and identical colored ampul neck rings add to
confusion
Look-Alike Packaging
• CDC reported 100 patients in 21 states received tetanus
toxoid instead of purified protein derivative for tuberculin
skin testing (PPD) during 2004
• Owing to look-alike packaging, tetanus toxoid was
administered by the wrong route:
– Administered intradermally versus intramuscularly
• Packaging was very colorful with stylized logos and writing
– Practitioners distracted by color and style
– Did not stop and read
• Manufacturer changed packaging to reduce confusion
• For examples of look-alike packaging, see Figures 18-4
and 18-5 in textbook
Centers for Disease Control and Prevention. MMWR. 2004;53(29):662–4.
Readability of
Labels and Packages
• Items may be correctly labeled, but if label is too
cluttered it cannot be easily read (Figures 7-4 and
7-5)
– Leads to confirmation bias
– Bias compounded if containers stored in same location,
or stocked incorrectly
– Common source of this type of error, IV stock solutions
(Figures 7-6 and 7-7)
•
•
•
•
Same volume sizes often stored together
Packaging is typically identical
Little variation in text color
Excessive writing on the bag because it serves as its own
“container”
ISMP Recommended Hierarchy of
Information on Front Panel of
Prescription Drug Labels
1. Brand name—bold,
sans serif type
– Consider TALL-man
lettering
2.
3.
4.
5.
6.
Generic name
Dosage form
Strength (metric units)
Suggested route
Warnings (if no space,
note where information
can be found)
7. If injectable, note whether
single-use, multi-dose,
etc.
8. Manufacturer, distributor,
packager information
– Never place at top of
container because logos
can be distracting and are
not considered necessary
for dispensing
9. “Rx only” statement and
other federal requirements
Uses of Color
• Color coding: systematically applying color to aid
in classification and identification
– Relies on remembering what each color means
– Example: ophthalmic preparations, color identifies
drug category
• Color differentiation: color used to make
elements stand out or distinguish between items
– Concern that practitioners may rely only on color and
not read labels
– Example: pediatric formulation packaged in light blue,
adult version in orange
Uses of Color
• Color matching: colors have no special
meaning, used to match one item to
another
– Example: a blue plug attaches to a blue
receptacle
– Example: Broselow tape for pediatric
emergencies
• For photograph of Broselow tape, see Figure 7-9
in textbook
Uses of Color
• Color coding
Problems With Uses of Color
• Should not distract from drug name and strength
• Use color coding with caution
– Slight color changes may be difficult to discern
– Colorblind employees
– American Society of Health-System Pharmacists
(ASHP), ISMP, and FDA oppose the use of color
alone to identify drug products
• No single variable should be relied upon to
prevent errors, including color
Problems With Uses of Color
• Problem extends beyond medication packaging
– Syringe and needle packages also problematic
– Overdoses have resulted
• For example of syringe packaging, see Figure 7-12 in textbook
• Possibly included in department specific
procedures
– Anesthesia
– Labels indicate a drug category, not a specific drug
• For examples of color-code scheme, see Table 7-2 in textbook
– User must add drug name and dose to avoid confusing
the end products
Need for Two-Sided Labeling
• Most common with IV fluids or piggyback
medications
• Problem
– Premixed IV bags look identical to one
another when stored face down
– Foil overwraps have the same risk associated
with them
– For examples of front and back package
labeling, see Figures 7-13 and 7-14 in
textbook
Contrast
• Examples of difficulty achieving contrast
– Printing on glass ampuls (Figure 7-15)
– Labeling on aluminum foil–wrapped packaging
• Glare off packaging affects readability
– Small package sizes do not allow room for contrast
(Figure 7-16)
– Labeling on low-density polyethylene (LDPE) plastic
ampuls for respiratory therapy medications
(Figure 13-3)
•
•
•
•
Writing is embossed in transparent, raised lettering
Virtually impossible to read
Exempt from FDA bar coding rules
New IV formulations and eye drops are available in LDPE
containers, leading to wrong route errors as a result of
packaging
Contrast
• American Society for Testing and Materials
standards requires:
– Contrast between drug names and amount of drug
per unit
– Legibility testing requiring
• Prevention of errors with LDPE
– Allow only pharmacy to order and stock respiratory
medications from wholesaler
– Manufacturers should ship products in well-marked
boxes
– Dispense ampuls in an outer package that can be
easily labeled
– Do not store different respiratory medications in the
same bin
Expressions of Concentration
and Strength
• Way in which strength is denoted may be
confusing
– Total volume displayed in small type size
– Total volume and concentration not displayed near
each other
– Expressions in concentration and ratios versus dose
can cause confusion
• Example: epinephrine 1:1,000 versus 1:10,000
– Unit-dose packages labeled as amount per tablet
versus amount per package
Expressions of Concentration
and Strength
• Errors have involved entire volumes of a
vial injected instead of the correct dose
– Example: gentamicin 40 mg/mL supplied in a
20 mL vial
– Correct dose is 40 mg (i.e., 1 mL)
– Error: full 20 mL injected mistaking the need
for entire vial to be used for the dose
– For photograph of package labeling, see
Figure 7-17 in textbook
Labeling of Blister Strips
• Nonprescription medications
– Product name and strength may appear in a
random pattern across strip
– Blisters may be cut and separated by patients
or for use in institutions
• Leaves medication with no label
Company Name, Logo, and
Corporate Dress
• Common logos or color schemes specific to a
company may lead to confirmation bias
• Interference with readability
–
–
–
–
Intricate patterns or color schemes
Lines, bars, stripes
Company logos
For example of a manufacturer’s similar packaging
for different products, see Figure 7-23
• Solution
– ISMP hierarchy recommends that manufacturer’s
name always be placed at the bottom of the label
Symbols
• Symbols may be misinterpreted by health
care providers and patients
– Roman numeral IV as in CIV
• Meant to be a controlled substance class 4
• Has been interpreted as intravenous
– Practitioners have crushed CIV tablets and injected them
intravenously
– Slash through a circle depicting a pregnant
woman
• Supposed to mean “Do not take this medication
while pregnant”
• Interpreted by patients to be a birth control pill
Nonstandard Terminology
• “Single-use” versus “single-dose”
– Nurses have misinterpreted “single-dose” to mean
administer all contents of container to a single patient
• Lack of standardization of unit-of-measure
– Example: magnesium could be ordered as:
• Percent (%), milligram (mg), gram (g), milliliter (mL),
milliequivalent (mEq) and milliosmole (mOsm)
• Nonstandard dose expression
– Example: phenytoin equivalents (PE) for fosphenytoin
is a nonstandard dose expression associated with
dosing errors
Label Reminders and Warnings
• Label warnings may decrease error
potential
– Warning statements may include:
• Danger, Warning, Caution, Notice, etc.
• Warnings may be highlighted by:
– Use of bold type, boxes, or color
– Example: undiluted potassium chloride
• Must have boxed warning for dilution on label
• Black caps and “must be diluted” added to collar
around rubber stopper
Typeface
• Sans serif is preferred typeface
• Serifs are additional short lines stemming from
basic letter form
• Sans serif means without serifs
– Plainer than serif fonts
– Best for conveying short pieces of information
– Letters with serifs take up more space
Example of Sans Serif
Example of Serif Type
E, A, b, 3, 4
E, A, b, 3, 4
Arial
Times New Roman
Expressing Product
Expiration Dates
• Expiration date placement on products is
regulated
• The way expiration dates are designated is not
regulated
– Examples of confusing expiration dating
• JN05—might be interpreted as January or June
• 06 MAR 04—might be March 4, 2006 or March 6, 2004
• International Organization for Standardization
(ISO) recommended format:
– YYYY-MM-DD
– Recommends against use of slash “/ ” in dates
because it may be mistaken for the number one “1”
Use of Unsafe Abbreviations
and Dose Designations
• The Joint Commission National Patient Safety Goal
prohibits use of “dangerous abbreviations”
– For Do Not Use list, see Table 8-1 in textbook
• Dangerous abbreviations may be found in medication
advertising or packaging
– Abbreviations may increase confusion
– QD “once daily” mistaken for QID “four times daily”
Bar Codes
• Bar code medication administration is a
recognized way to decrease medication
errors
– FDA requires linear bar codes on all new
products coming to market
Additional Information on
Bar Coding
Available in Slide Deck for
Chapter 15
Container Design
• Container design has led to administration
errors
– Prefilled syringes for IV admixture preparation
(and needing further dilution) have been mistaken
as immediate use products
• More than 40 deaths attributed to this error type
• 1 or 2 g of lidocaine were administered directly into Ysites instead of being further diluted (Figure 7-30)
– Containers requiring manual activation may result
in non-activated medication solutions
• Patient may receive only diluent with no active drug
(Figure 7-31)
Container Design
• Confirmation bias may be a factor in
container design
– Products not intended for ophthalmic use when
packaged in bottles or tubes that look like eye
drop containers
• Patients with poor eyesight have instilled “super
glue” into their eyes
– Irrigation containers confused with IV solution
containers
– Topical nitroglycerin packaged in tubes has
been used sublingually
Protective Overwraps
• IV medications with an overwrap should be
stored in the overwrap
– Once an overwrap is removed, fluid may
evaporate from the bag
• Evaporation leads to increased concentration
– Environmental factors may impact evaporation
• Avoid writing directly on IV bags
– Volatile chemicals from the ink may leach
through the bags and reach the solution
External Carton Labels
• Labeling on external cartons is as important as labeling
on immediate containers
• Avoid storing similar-looking containers near each other
• Carefully inspect contents of larger containers
– Example: box lids of saline and potassium looked very similar
and were confused resulting in death
Promotional Items and
Advertisements
• Promotional materials may closely resemble
actual products
– Pens in the shape of ointment tubes
• For example of look-alike promotional item and medication
package, see Figure 7-34 in textbook
– Bottles of antibacterial hand gel mistaken for
risperidone oral liquid
– Placebo products used for demonstration may
resemble the actual product with the exception of
“demo only”
• For example of ambiguous demo labeling, see Figure 7-35
in textbook
Drug Shortages
• Shortages disrupt the medication-use
process
– Pharmacists must communicate shortages to
other practitioners
– Communication about substitute products is
important
– ASHP and University of Utah maintain a drug
shortage Web site
• http://www.ashp.org/shortage
• Provides information about shortages and how to
manage them
International Efforts
• Foreign manufacturers may not necessarily
comply with U.S. safety recommendations
– Example: Losec changed to Prilosec in the United
States to avoid LASA errors
– The name Losec is still widely used outside the
United States
• The same may be true for U.S. products used in
other countries
• Countries must benefit from each other’s
lessons
Prospective Analysis to Prevent
Labeling and Packaging Problems
• Decrease potential look-alike packaging and
labeling through analyses conducted prior to
marketing
• ISMP recommends that prototype testing
include:
– Failure mode and effects analysis (FMEA)
• Include all steps of medication-use process
• Ordering, dispensing, administration, etc.
– Consider human factors engineering
References
Centers for Disease Control and Prevention.
Inadvertent intradermal administration of tetanus
toxoid–containing vaccines instead of tuberculosis
skin tests. MMWR. 2004;53:662–4.
Institute for Safe Medication Practices. ISMP’s List of
Confused Drug Names. Updated April 1, 2005.
Available at: http://www.ismp.org/Tools/
confuseddrugnames.pdf
Starr CH. When drug names spell trouble. Drug
Topics. May 15, 2000;144(10):49–58.