Kate Kelly, PharmD

Most error-reduction effortsbegin in response to a seriouserror. Individuals and practicesites have become accustomed to reactingto an error after it has occurred.Unfortunately, only then do they considerhow to prevent the same error frombeing repeated.Would it not be useful tobe able to predict the types of errors thatcould occur and 

All too often, error potential is notincluded in decisions about which medications,devices, or technology to purchase.Instead, decisions are guided bycost, third-party formulary restrictions,contractual agreements with purchasinggroups or vendors, and pharmaceuticalmarketing efforts. Input and evaluationfrom those who will be using the productsmay not be sought, and error potentialmay not be considered ahead of time.The ultimate result is unforeseen safetyissues and errors once the product is inthe hands of clinical users or health careconsumers.

Failure Mode and Effects Analysis(FMEA) systematically identifies areas ofpotential failure and gauges what theeffects would be before an error actuallytakes place. This 

process canbe employed to examine the use of newmedications and products, as well as thedesign of new services and processesthat may affect work flow. FMEA is bestemployed 

to purchase and implementation,so that preemptive action canbe taken.

To cite just one example, FMEA couldbe used to assess the potential for errorwith new medications when they are firstmarketed or before they are prescribedor added to your inventory:

A process-flow diagram wouldbe designed. Then the ways the intendedproduct would be prescribed would beexplored. Who would prescribe it and forwhich patients? What clinical patientinformation would be important beforethe product is prescribed? How would itbe procured, stored, and used, fromacquisition through dispensing andadministration? Who would prepare anddispense it? What information would needto be given to the patient or caregiver?How would the product be administered?

Potential failure modes (ie, howand where systems and processes mayfail and what can go wrong) would beidentified while considering how the productwould be used. Questions to be askedwould include the following: Does thedrug name look or sound like anotherdrug name? Would a similarly spelled drugname be listed in close proximity to theintended product on computer orderentry screens? Does the package labelclearly express the strength or concentration?Would the product be stored near, orcould it be mistaken for, another similarlypackaged product? Are dosing parameterscomplex?

For example, an FMEA performed onquetiapine (Seroquel) might have predicteda high likelihood of mix-ups with nefazodone(Serzone). These 2 medicationsare likely to be prescribed by the sametype of physician and for patients withsimilar diagnoses; are available in overlappingdosage strengths; often areadministered at the same frequency; andare likely to be stored together and toappear on computerized lists in closeproximity, alphabetically by brand name.Although Serzone is no longer marketed,these types of errors are still likely,because generic formulations of nefazodoneare available and may be prescribedas "Serzone." 

For each failure mode, staffmembers would then determine the likelihoodof making an error, as well as thepotential consequences. What wouldhappen to the patient if the drug weregiven at the wrong dose, at the wrongtime, or by the wrong route? What wouldhappen if a patient received the wrongmedication or if the wrong patient receivedthe medication?

Staff members would considerthe severity of the outcome and identifyany preexisting processes in place thatcould help eliminate or detect the errorbefore it reached the patient. Eachprocess would then be evaluated for itseffectiveness, based on what was learnedin previous steps. For example, wouldobtaining additional patient information orusing computer alerts, bar coding, or adouble-check process catch these errorsevery time? Numerical values could beassigned to determine the likelihood ofthe occurrence, its severity, and thechance that it would be detected beforecausing patient harm.

If failure modes reveal errorswith significant consequences, actionswould be taken to prevent the error,detect it before it reached the patient, orminimize its consequences. Suchactions might include improved communicationof orders by listing the indicationon prescriptions or differentiatinglook-alike products by ordering themfrom different manufacturers or by storingthem separately.

Although industries outside of medicinehave developed elaborate FMEA scoringsystems to rank items for action, a simplifiedFMEA process as described abovecan be an efficient, proactive risk managementtool. 

ISMPMedication Safety Alert!Community/Ambulatory CareEdition.

Articles

FMEA Can Help Prevent Errors

The Institute for Safe MedicationPractices (ISMP) has received numerousreports of mix-ups involving metronidazoleand metformin. In one report, a familypractice physician in a communityhealth center prescribed metformin 500mg bid to a newly diagnosed patient withdiabetes who did not speak English.When the patient returned to his physician'soffice a few months later, hebrought his medications with him, asrequested. His physician quickly noticedthat metformin was missing. Instead, thepatient had a prescription bottle labeledas metronidazole, with directions to take500 mg twice a day. The prescription hadbeen refilled several times. Luckily, thepatient's diabetes had remained stable,and he seemed to suffer no adverseeffects from 2 months of unnecessaryantimicrobial therapy.

The physician notified the pharmacy ofthe error and asked the pharmacist tocheck the original prescription. It hadbeen written clearly and correctly formetformin. Upon further investigation,the pharmacist found that the computerentry screen for selecting these medicationsincluded "METF" (for metformin)and "METR" (for metronidazole). Apparently,one of the pharmacy staff membershad entered "MET" and selectedmetronidazole instead of metformin.

In another community pharmacy, thesame mix-up happened twice, on successivedays. In one case, metformin wasinitially dispensed correctly, even thoughthe prescription had been entered intothe computer incorrectly as metronidazole—again, when the wrong mnemonicwas chosen. The pharmacist who filledthe prescription clearly understood thatthe physician had prescribed metformin,so he filled the prescription accordingly.He failed to notice the order entry error,however, because he did not comparethe prescription vial label with the manufacturer'slabel. Unfortunately, the initialorder entry error led to subsequent erroneousrefills of metronidazole, as statedon the pharmacy label.

In the second mix-up at this pharmacy,bulk containers of the medication wereavailable from the same manufacturer,both with similar highly stylized labels.Thus, confirmation bias contributed toselection of the wrong drug. After reading"MET" and "500" on the manufacturer'slabel, the staff member believed thathe had the correct drug.

Unit-dose tablets also can be problematic,because the label information is verysmall and contains bar codes, adding totheir similar appearance. In a hospitalpharmacy, unit-dose tablets of metronidazole500 mg and metformin ER 500mg were accidentally mixed together inthe metronidazole storage bin. This errorresulted in dispensing metformin insteadof metronidazole. Fortunately, a nurse recognizedthe error before giving a patientthe wrong medication. Both were genericproducts, although the brand name versionsof metformin (Glucophage) andmetronidazole (Flagyl) also are available.

Mix-ups involving metronidazole andmetformin could be serious, consideringthe different indications and the potentialfor drug interactions. Prescribers shouldbe sure that patients are aware of themedication's purpose and should includethis purpose on the prescription. Considerprogramming computer order entryscreens to display the specific brandnames along with the generic nameswhenever the "MET" stem is used as amnemonic, or apply tall-man lettering tothe drug names. In addition, pharmacistscould consider writing the correspondingbrand name on generic manufacturers'containers. Purchase these medicationsfrom different manufacturers, and underlineor highlight the unique letter charactersin the drug names.

During the dispensing process, drugnames listed on written prescriptionsshould be matched with pharmacy labelsand manufacturers' products. As an additionalcheck, match the National DrugCode number of the product with thatwhich appears in the computer databaseand subsequently on the printed pharmacylabel.

Verify the purpose of the medicationwith the patient. Because metformin isused to treat a chronic condition, andmetronidazole is more likely to be usedfor an acute condition, outpatient refillsfor metronidazole are less common and,therefore, deserve a second look. We atISMP have asked the FDA to add thesedrugs to the list of nonproprietary namesthat would benefit from the use of tallmanletters.

The reports described here were receivedthrough the USP Medication Errors ReportingProgram, which is presented in cooperationwith the Institute for Safe Medication Practices(ISMP). ISMP is a nonprofit organization whosemission is to understand the causes of medicationerrors and to provide time-critical errorreductionstrategies to the health care community,policy makers, and the public. Throughoutthis series, the underlying system causes ofmedication errors will be presented to helpreaders identify system changes that canstrengthen the safety of their operation.If you have encountered medicationerrors and would like to report them, youmay call ISMP at 800-324-5723 (800-FAILSAFE)or USP at 800-233-7767 (800-23-ERROR). ISMP's Web address is www.ismp.org.

Metronidazole and Metformin Prone to Mix-ups

When prescribing, dispensing, oradministering formoterol fumarate(Foradil Aerolizer) or tiotropium bromide(Spiriva HandiHaler), consider the distinctpossibility that these medications maybe swallowed mistakenly rather thaninhaled through their accompanyingdevices. Formoterol fumarate is a longactingbeta

agonist used in the treatmentof asthma and chronic obstructivepulmonary disease (COPD), and tiotropiumbromide is an anticholinergic bronchodilatorused for COPD. Each medicationis available as a dry powder within acapsule, and the capsules are packagedin blister cards. When used correctly, thecapsule is removed from the blister cardand placed into the inhaler device. In thedevice, the capsule is punctured to allowthe medication to be dispersed into thelungs as the patient inhales through theinhaler mouthpiece.

Because capsule dosage forms usuallyare associated with oral administration,formoterol fumarate and tiotropium bromidehave been swallowed by mistake.The Institute for Safe Medication Practices(ISMP) has received numerousreports describing situations wherepatients have received these medicationsby the ineffective oral route. Mostof the reports have come from hospitalsand long-term care (LTC) facilities. A fewreports, however, have involved communitypharmacy patients.

Reports have cited the following contributingfactors:

—Prescriptionsmay be communicated ambiguously. Forexample, a prescription with the instructions"Foradil one capsule orally every 12hours" was received and dispensed by apharmacy. These instructions led thepatient to believe that the medicationwas to be swallowed. Also, medicationadministration records (MARs) may listthese medications along with other oralmedications. Such instructions oftenbegin with the phrase "1 capsule," leadingnurses to think that the product is anoral medication.

—Patients and practitionerswho are unfamiliar with this dosage formmay mistakenly administer the medicationorally.

—These products may bestored along with other oral medicationsin patient homes or in medication drawersand automated dispensing cabinets inLTC facilities. If the inhaler device is separatedfrom the capsules, caregivers arelikely to assume (due to the dosage form)that the capsules are to be swallowed.

—Packaging issimilar to that of other oral unit-dosemedications, and blister labeling is inadequateto protect against oral use.

To prevent similar errors with thesemedications, consider the following:Products should be ordered andentered into computer systems as"Foradil Aerolizer" and "SpirivaHandiHaler" to better distinguish themedication when it prints out on apatient's MAR or pharmacy label.

Instructions for both patients and staffmembers must clearly express the needfor the medication to be inhaled: forexample, "Inhale the contents of onecapsule every 12 hours using Aerolizer."Avoid using instructions that begin with"One capsule?" or that include the word"oral," which may be misinterpreted. If aprescriber's instructions are nonspecific(eg, "1 capsule bid" or "use once daily"),pharmacists should express the instructionsin a manner that clearly states howthe medication is to be used.

Shortcuts could be programmed intocomputer systems to ensure that theseproducts are ordered and dispensedwith the proper instructions. For example,if the word "Spiriva" is entered in theinstructions field, the phrase "Inhale thecontents of 1 capsule once daily usingHandiHaler" would be printed.

Auxiliary messages stating "FOR USEONLY WITH INHALER. DO NOT SWALLOWCAPSULE" or "FOR INHALATION ONLY" should print out prominently on MARs.Similar auxiliary labels could be placedon boxes and blister labels to help differentiatethese capsules from other oralmedications that may be stored in thesame place. Otherwise, these productsshould be stored separately from oraldosage forms.

Patients, caregivers, and staff membersmust be educated regarding theproper administration of these medicationsbefore they are dispensed oradministered. Training kits containing aninhaler device, placebo capsules, andpatient education materials are availablefrom each manufacturer.

Capsules should be stored in the boxprovided along with the inhaler device.Do not dispense the capsules separately.In LTC facilities, put the patient's name onthe inhaler device to ensure that it isreturned to the correct patient's box ofmedication.

The manufacturers of both productsare aware of the errors that haveoccurred, and we at ISMP have askedthem to place a warning on the blistercards. The FDA also is aware of our concerns.These errors should serve as areminder that health professionals needto be very clear in their verbal and writteninstructions. 

Capsules for Inhalation May Be Mistaken for Oral Capsules

The Institute for Safe MedicationPractices has received reports from 2 differentoutpatient infusion clinics whereinfliximab (Remicade) and rituximab(Rituxan) were confused with eachother. In both cases, the reporters implicatedsimilarities in the products' genericnames. Both are monoclonal antibodiesthat are stored in the refrigerator, anddoses could possibly overlap. Remicadeis used in a variety of autoimmune disorders,including rheumatoid arthritis andCrohn's disease, whereas Rituxan is usedin non-Hodgkin's lymphoma. Both havewell-known, serious adverse drug reactions—even fatalities—associated withtheir use.

Prescribers should include the brandand generic names, as well as the indication,when ordering these products. Ifthis information does not appear on theprescription, pharmacists and nursesshould verify the medication and theindication with prescribers before dispensingor administering the drug.Consider placing "name alert"stickers onthe products and separating the productsin the refrigerator.

The following 2 errors involving lisinopriland lovastatin were reported by thesame pharmacy. In the first case, bothlisinopril and lovastatin were prescribedfor a patient at a dose of 40 mg per day.When the medications were refilled, thelovastatin was inadvertently dispensed inboth vials. The patient proceeded to takedouble the intended dose of lovastatin(and no lisinopril) for more than a monthbefore bone marrow suppression andrhabdomyolysis developed.

In the second case, a vial labeled"lovastatin 10-mg tablets"but containinglisinopril 10 mg was dispensed. Thepatient took the incorrect medication for17 days. Severe orthostatic hypotensiondeveloped, and emergency care wasrequired.

It is believed that these errorsoccurred because the products (whichare from the same manufacturer) werestored close together on pharmacyshelves and had similar-looking packaging.Both patients failed to question anychanges in tablet appearance.

Patients' ability to verify their medicationbased on tablet or capsule appearanceis compromised when pharmaciespurchase the same product from differentmanufacturers, especially on amonth-to-month basis. Under these circumstances,patients become accustomedto changes in product appearance,and thus an opportunity to catchan error is lost.

This pharmacy is now consistently purchasingthe 2 products from different,specific manufacturers. In addition, thepharmacy has separated the 2 drugs inthe storage area by placing them in differentaisles, added warning labels to theshelves, and educated the staff about thepossible mix-ups.

A patient brought the prescriptionseen here into a community pharmacyon a Saturday afternoon. The pharmacistinitially began processing it ashydralazine (due to the spelling and theqid dosing listed on the prescription)but questioned it after checking thepatient's profile and finding no otherantihypertensive listed. When the pharmacistasked the patient why she wentto the doctor, the patient said that shewas being seen for an ear infection, butthe doctor also said that her bloodpressure was a little high.

Due to the potential indicationsdescribed by the patient, the pharmacistwas suspicious as to whether the prescriptionwas for hydralazine or hydroxyzine.The pharmacist called the physician,and the prescription was clarified ashydroxyzine. The physician did not realizethat he had misspelled the drug name. Inthe future, he said that he would write"Atarax"instead.

Luckily, a potential error was avoidedbecause the pharmacist checked theprofile and spoke to the patient. As anadded safety precaution, pharmacistsshould encourage prescribers to includethe brand and the generic name as wellas the purpose on the prescription. 

The reports described here were receivedthrough the USP Medication Errors ReportingProgram, which is presented in cooperationwith the Institute for Safe Medication Practices(ISMP). ISMP is a nonprofit organization whosemission is to understand the causes of medicationerrors and to provide time-critical errorreductionstrategies to the health care community,policy makers, and the public. Throughoutthis series, the underlying system causes ofmedication errors will be presented to helpreaders identify system changes that canstrengthen the safety of their operation.If you have encountered medicationerrors and would like to report them, youmay call ISMP at 800-324-5723 (800-FAILSAFE) or USP at 800-233-7767 (800-23-ERROR). ISMP's Web address is www.ismp.org.