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The Role of Drug Names and Packaging in Medication Errors.

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1 The Role of Drug Names and Packaging in Medication Errors

2 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

3 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. Starr CH. Drug Topics. May 15, 2000;144(10):49–58.

4 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

5 Preventing Errors Involving Similar Drug Names

6 Name Changes Levoxine and Lanoxin –Similar brand names, both are tablet forms, both available as 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

7 Use of TALL-Man Letters Use of mixed-case or enlarged letters to emphasize the differing portions of two drug names: zyPREXAzyRTEC hydrOXYzine hydrALAZINE DOBUTamineDOPamine 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

8 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

9 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

10 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 Annually review the organization’s list of LASA medications and take actions

11 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

12 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

13 Look-Alike and Sound-Alike Drug Choices For additional LASA name pairs, see Tables 6-2 and 6-3 in textbook Name PairsPotential Consequences Safety Strategies Cisplatin Carboplatin 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 Morphine Some prescribers have mistaken hydromorphone for 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.

14 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

15 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

16 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

17 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

18 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

19 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

20 U.S. Brand Names With Different Ingredients in Europe For additional U.S. brand names with different active ingredients abroad, see Table 6-5 in textbook Brand Name Active Ingredient in United States Active Ingredient in Europe DilacorDiltiazem – angina, hypertension Digoxin – CHF, arrhythmia NorpraminDesipramine – depression Omeprazole – GERD, peptic ulcer Ambyen (U.K.) Ambien (U.S.) Zolpidem – insomnia Amiodarone – arrythmias

21 Role of the FDA Premarketing review of proposed trademarks Postmarketing surveillance and risk management

22 Premarketing Review of Proposed Trademarks FDA Office of Drug Safety, Division of Medication Errors and Technical Support (DMETS) reviews all trademarks

23 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

24 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

25 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

26 Recommendations for Preventing Drug Name Mix-Ups

27 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

28 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

29 Role of Practitioners and Organizations Change appearance of LASA drugs on computer screens, ADCs, bins, carts, and labels by using TALL- man 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)

30 Role of Drug Packaging and Labeling

31 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

32 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

33 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

34 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


36 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

37 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.

38 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”

39 ISMP Recommended Hierarchy of Information on Front Panel of Prescription Drug Labels 1.Brand name—bold, sans serif type –Consider TALL-man lettering 2.Generic name 3.Dosage form 4.Strength (metric units) 5.Suggested route 6.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

40 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

41 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

42 Uses of Color Color coding

43 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

44 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

45 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

46 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

47 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

48 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

49 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

50 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

51 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

52 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

53 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

54 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

55 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

56 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”

57 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”

58 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

59 Additional Information on Bar Coding Available in Slide Deck for Chapter 15

60 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 Y- sites 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)

61 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

62 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

63 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

64 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

65 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 Provides information about shortages and how to manage them

66 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

67 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

68 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, Available at: confuseddrugnames.pdf Starr CH. When drug names spell trouble. Drug Topics. May 15, 2000;144(10):49–58.

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