SCI2003 Template - American Pharmacists Association

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):4958. 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 organizations 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):6624. 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 namebold, 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 foilwrapped 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 manufacturers similar packaging for different products, see Figure 7-23

Solution ISMP hierarchy recommends that manufacturers 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

JN05might be interpreted as January or June 06 MAR 04might 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 others 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 toxoidcontaining vaccines instead of tuberculosis skin tests. MMWR. 2004;53:6624. Institute for Safe Medication Practices. ISMPs 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):4958.

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