Updatirg the BeersCriteria for Potentially InappropriateMedication Use in Older Adults

Resultsof a US ConsensusPanel of Experts

DonnaM.Fich,PhD,RN;lamesW.Cooper,PhD,RPh;WilliamE.Wade,PhannD,FASHP,FCCP; JenniJerL. Waller, PhD;J, RossMaclean, MD; Marh H. Beers,MD

Bcckground: Medication toxic effectsand drug- Reruhr: This study identified 48 individual medica- relatedproblems can have profound medical and safety tions or classeso[ medicationsto avoid in older adults consequencesfor older adults and economically affect the and their potential concernsand 20 diseases/conditions health caresystem. The purpose of this initiative was to and medicationsto be avoidedin older adultswith these reviseand update the Beerscriteria for potentially inap- conditions.Of thesepotentially inappropriate drugs, 66 propriate medicationuse in adults 65 yearsand older in wereconsidered by the panelto haveadverse outcomes the United States. of high severity. lYlcthcdr: This study used a modified Delphi method, a Concludonr: This study is an importantupdate of pre- setof proceduresand methodsfor formulating a groupjudg- viously establishedcriteria that have been widely used ment for a subject matter in which precise information is and cited. The application of the Beerscriteria and other Iacking. The criteria reviewed covered 2 types of state- tools for identifying potentially inapproprlate medica- ments: (l) medicationsor medicationclasses that should tion use will continue to enableproviders to plan inter- grnerally be avoidedin persons 65 years or older because ventionsfor decreasingboth drug-relatedcosts and over- they are either ineffective or they pose unnecessarilyhigh all costsand thus minimize drug-relatedproblems. risk for older personsand a saferalternative is availableand (2) medicationsthat should not be usedin older persons known to have specificmedical conditions. Arch InternM ed,2003 ;1 63 :27 1 6-27 24

oxlc EFFEcTSof medica- to costthe nation $8 biilion annually.5In tions and drug-relatedprob- 2000, it is estimatedthat medication- lems can have profound relatedproblems caused I06000 deaths medical and safety conse- annuallyat- a cost of $85 billion.6Others + quencesforolderadultsand have calculatedthe cost of medication- economically effect the health care sys- relatedproblems to be $76.6billion to am- tem. Thirty percentof hospitaladmissions bulatory care,$20 billion to hospitals,and in elderly patients may be linked to drug- $4 billion to nursinghome facilities.2'7'8If relatedproblems or drug toxic effects,rAd- medication-relatedproblems were ranked versedrug evens (ADEs)have been linked asa diseaseby causeof death,it would be From the Departmentof to preventableproblems in elderly pa- the fifth leading causeof death in the Medicine,Center Health Jor tientssuch asdepression, constipation, falls, United States.eThe preventionand rec- CareImprowment (Drs Ftch and hip frac- ognition of drug-relatedproblems in el- and Maclean);and OlJiceof immobility, confusion, derly patientsand other vulnerablepopu- Bio statistics (Dr Waller), rures.l'2A 1997 study of ADEs found that health care MedicalCollege of Georgia, 35o/oof ambulatory older adults experi- Iations is one of the principal Augusta;Department of encedan ADE and 29olorequired health care quality and safetyissues for this decade. Vet er ans AJJ air s M edi c al services(physician, emergency depart- Center,Augustd (Dr Fich); ment,or hospitalization)lor theADE.] Some CME courseavailable at DepartmentoJ Clinical and two thirds of nursing facility residens have ww w . dr chinternme d. c om Administrativ e Pharmacy, ADEs overa 4-yearperiod.s Of theseADEs, Pharmacy, Collegeof I in 7 resultsin hospitalization.a The aforementionedIOM report has Untuersityof Georgia,Athens, Recent estimatesof the overall hu- focusedincreased attention on finding so- (Drs CooperandWade); and medication practices, Merch6 Co Inc,West Point. man and economicconsequences of medi- lutions for unsafe Pa (Dr Beers).The authors cation-relatedproblems vastly exceedthe polypharmacy,and drug-relatedproblems (IOM) There are many haveno relevantJinancial findings of the Institute of Medicine in the care of older adults. interestin this article. on deathsfrom medical errors,estimated ways to define medication-relatedprob-

ARCHINTERN MED/VOL 163. DEC 8/22.2003 WWW.ARCHINTERNMED.COM 2716 Downloader@ill0lAmerichirft[ndicdlcAcsotldtiomsft!ofglttridq€flvddly 24,2008 (REPRINTED WITH CORRECTIONS) lems in elderly patients, including the use of lists contain- Beloware the Beers criteria published in 1997. In parts 1 and2, we are firsl ing specificdrugs to avoid in the elderly and appropriate- askingyou t0 rateyour level 0f agreement onthese 1997 criteria. nessindexes applied by pharmacistsor clinicians.l'10'11 Pl€aseanswer the f0llowing questions regarding the use of medicationslnadults Systematicreview of the evidence-basedliterature on medi- 65yearc ot oldBr. cation use in eiderly patients is another approach to de- Pleasegive one of the following answers: fining the problem,but the number of controlledstudies 1=StronglyAgre€2=Agree 3=Unsure 4=Disagree s=StronglyDisagree on medicationuse in elderlypatients is limited. 0=Unableto offer an opinion The useof consensuscriteria for safemedication use 1) Propoxyphene(Darvon) and combination products (Darvon with ASA, in elderiypatients is one approachto developingreliable Darvon-N,and Darvocet-N) should be avoided. and explicit criteria when preciseclinical information is 123450 Iacking.The two most widely usedconsensus criteria for Samplesurvey question. medicationuse in older adults are the Beerscriteria and the Canadiancriteria.r2-ra The Beerscriteria are basedon expert consensusdeveloped through an extensivelitera- facility populations older than 65 years in the United ture reviewwith a bibliographyand questionnaireevalu- States.There were 3 main aims: (1) to reevaluatethe ated by nationally recognizedexperts in geriatric care, 1997 criteria to include new products and incorporate clinical pharmacology,and psychopharmacologyusing a new information available from the scientific literature, modified Delphi technique to reach consensus. The (2) to assign or reevaluatea relative rating of severity have been Beerscriteria used to survey clinical medica- for eachof the medications,and (3) to identify any new tion use, analyzecomputerized administrativedata sets, conditions or considerationsnot addressedin the 1997 and evaluateintervention studies to decreasemedication criteria. problemsin older adults.The Beerscriteria were also adoptedby the Centerslor Medicare& MedicaidSer- vices (CMS) in July 1999 for nursing home regulation. Previousstudies have shown these criteria to be useful There were 5 phasesin the data collection for this study: (1) in decreasingproblems in older adults.r5-1eThese crite- the review of the literature, (2) creation and mailing of the round I questionnaire,(3) ria, though controversialat times,have been widely used creation of the second-round question- naire based on round I and expert panel feedback,(4) con- over the past l0 yearsfor studying prescribingpatterns vening of the expert panel and panel responsesto the second- within populations,educating ciinicians,and evaluating round questionnaire,and (5) completionand analysisofa third health outcomes,cost, and utilization dau.20-21 and final mailed questionnairethat measuredthe severityrat- A recently published study of potentially inappro- ings of the PIMS to createthe final revisedlist. priatemedication (PIM) usewith the Beerscriteria in a The criteria reviewed covered 2 types of statements:(1) Medicare-managedcare population found a PIM preva- medicationsor medication classesthat shouldgenerally be lenceo[ 23%(541/2336). Those receiving a PIM hadsig- avoidedin persons 65 years or older becausethey are either nificantly higher total, provider, and facility costsand a ineffective or they pose unnecessarily high risk for older per- (2) highermean number oI inpatient,outpatient, and emer- sons and a safer alternative is availableand medications that should not be in persons gencydepartment visits than comparisonsafter control- used older known to have spe- cific medical conditions.The 2 statements each used a 5-point ling for sex,Charlson Comorbidity Index, and toralnum- Likert scaleand ask respondents to rate their agtee*ent oi dis- ber of prescripti.ons.20Other studieshave found that specific agreementwith the statement from strongly agree (1) to PIMs such as nonsteroidal anti-inflammatory drugs strongly disagree(5), with the midpoint (3) expressingequivo- (NSAIDs)and benzodiazepineshave been associated with cation. The second type of question asked the respondents to adverseoutcomes and increasedcosts.ls In contrast,a re- evaluate the medication appropriateness given certain condi- centstudy on the relationshipbetween inappropriate drug tions or diagnoses (Flgurc). All questions included an option use, functional statusdecline, and mortality in 3234 pa- to not answer if the respondent did not feel qualified to tients from the Duke cohort did not find an association answer. This methodology was similar to that used by Beerset with mortality and inappropriatedrug useas determined a|r in the creation o[ the first 2 iterations of the criteria.The methodology by the Beerscriteria after controlling for covariates.2a used in the third irerarion of the Beerscrireria only differed in the number of panelists(13 in I99t; in In summary,these criteria have been used exten- 6 1997; and 12 in 2002) and the use of a third-round survey for sively for evaluatingand intervening in medicarion use the severityratings, which was done (in person) in the 1997 in olderadults over the pastdecade. However, with the update of the criteria. continuous arrival of new drugs on the market, in- creasedknowledge about older drugs, and removal of RESEARCH DESIGN older drugs from the market, thesecriteria must be up- dated on a regular basisto remain useful. Sincethe cri- The modified Delphi method is a technique to arrive at a group teria were publishedin 1997, there has beenan increase consensusregarding an issue under investigation that was origi- in the number of scientific studies addressingdrug use nally developedat the RAND Corporation (SantaMonica, Calif) by Olaf Helmer and appropriatenessln older adults, but there is still a and Norman Dalkey.25The Delphi method is a set of proceduresand methods for formulating a group judg- lack of controlledstudies in the older populationand par- ment for a subjectmatter in which preciseinformation is lack- ticularly in patientsolder than 75 yearsand parienrswirh rr ing (such asmedication use in older aduls). The Delphi method multiple comorbidities, provides a means to reach consensuswithin a group of ex- The purpose of this initiative was ro revise and perts.The method relieson soliciting individual (often anony- update the Beerscriteria for ambulatory and nursing mous) answers to written questions by survey or other type of

ARCHINTERN MED/VOL 163, DEC 8/22,2003 WWW.ARCHINTERNMED.COM 2717 Downloade&f&00SrA,nreridairfttodiedbAssaddniomsfrIcf$ttridcD@yddly 24,2008 (REPRINTED WITH CORRECTIONS) included the state- communication. A series of iterations provides each indi- yearsand older. The second-roundsurvey addedby the vidual with feedbackon the responsesof the others in the group. ments included from round I and any statements round and the face- The final responsesare evaluated for variance and means to de- exDertsfrom the first round. In the second information about termine which questionsthe group has reachedconsensus about' to-iacemeeting, the respondentswere given of the other mem- either affirmatively or negatively. their answers and the anonymous answers bers of the group and were given the opportunity to recon- LITERATURE REVIEW sider their previous response. After analyzing the responses from the first round of the The selection of articles for formulating the survey involved 3 survey,we examinedeach question for inclusion or exclusion in the sec- steps and was phase I of the study. First, we identified litera- in the revised criteria or for further consideration We calculatedthe mean rating and ture published sinceJanuary 1994 in English, describing or ond round of the survey. (CI) state- analyzing medication use in communityJiving (ambulatory) corresponding95% confidenceinterval of each o[ the older adults and older adults living in nursing homes. From ment or dosing question collected from the first round CI that, we createda table and bibliography. We used MEDLINE, survey.Those statementswhose upper lirnit of the 95olo Those searching with the following key terms adversedrug reactions, was lessthan 3.0 were included in the updated criteria. of the 95o/o adversedrug events,medication problems, and medicationsand statementsor dosing questions whose lower limit from the updated cri- elderly for all relevant articles published betweenJanuary 1994 Cl was greater than 3.0 were excluded and December 2000. Second,we hand searchedand identified teria.Statements whose 95okCl included the value of 3.0 were additional referencesfrom the bibliographies of relevant included for further determination in the second-roundface- articles. Third, all the paneliss were invited to add references to-facemeeting. and articles after the first survey to add to the literature review. The face-to-facemeeting was convenedon DecemberI0, Each study was systematically reviewed by 2 investigators 2001, in Atlanta, Ga. Each panel memberwas given the re- (from using a table to outline the following information: type of sultsof the first-round surveyand the addedmedications study design; sample size; medications reviewed; summary of the other panel members) to review approxirnatelyI0 daysbe- results and key points; quality, type and categoryof medica- fore the meeting. For statementsthat needed further exami- tion addressed;and severity of the drug-related problem. nation (neitherincluded or excludedduring round I), eachrater wasgiven his or her previous rating and the mean rating of the group expertsin the secondsuNey. EXPERT PANEL SELECTION o[ Any additional statementsor dosing questionsthat had beenmade on the open-endedportion of the first round of the The panel of members were invited to participate via letter by survey by any expert was included in the survey for the sec- the 4 investigatorsand a consultant and representeda variety of ond round. Forty-four questionswere addedby expert panel- experienceand judgment including extensive clinical practice, iss during round 1 of the survey, and 9 questionswere added extensivepublications in this area,and/or senior academicrank. during the round 2 in-person survey and voted on during the They were also chosen to represent acute, long-term, and com- in-personmeeting. These questions/medications made up part munity practice settings with pharmacological, geriatric medi 5 of the survey.Twenty-four questionsfrom parts 3 and 4 had cine, and psychiatric expertise. Lastly, they were selectedfrom Cls greaterthan 3.0 after the round I suwey. During the geographicallydiverse parts of the United States.We initially in- 95o/o second-roundface-to-[hce rneeting, the group debatedthese re- vited (via regular mail) 16 potential particiPantswith nation- mainingstatements and then reratedthem using thesame Likert ally and/or internationallyrecognized expertise in psychophar- scale.The mean rating and 95o/oCI were calculated.The tech- macology, pharmacoepidemiology,clinical geriatric nioue used for the first round for inclusion or exclusionof the pharmacology,and clinical geriatric medicine to completeour rtui.-"trt or dosing question in the updated criteria was used. survey. Our responserate for the initial invitation to participate Those statementswhose 95o/oCl included 3.0 were excluded as a panelist was 75o/o (12/16). Our final panel thus consisted of from the updated criteria. Lastly, in 2002, we sur- 12 expertswho completedall rounds of the survey. January veyedpanelists on a 5-point scalefor the severityof the poten- medication problem. DATA COLLECTION tial AND ANALYSIS

We usedthe systematicreview of the literature to constructthe first round questionnaire.The first-round survey contained The final criteriaare listed in Toble I and Tnble 2. Table Parts 4 sections.Parts 1 and 2 reviewedthe latest 1997 criteria. I contains48 individual medicationsor classesof rnedi- medicationsadded for the 2002 update lor medi- 3 and 4 were cations to avoid in older adults and their potential con- cationsalone (part 3) and medications consideringdiagnoses cerns.Table 2 lists 20 diseasesor conditions and medi- and conditions.Parts 3 and 4 included 29 new questionsabout in older aduls with theseconditions. medicationsor medication classesand conditions. The last ques- cationsto be avoided were tion in part 4 asked panel members to add medications to the Sixty-six of thesepotentially inappropriate drugs list. The panel was then surveyed via Delphi technique to de- coniideredby the panel to haveadverse outcomes ofhigh termine concordance/consensuswith the round I survey and severity. New conditions and diagnosesthat were ad- invited to add additional medications prior to and during the dressedthis time included depression,cognitive impair- second-round meeting. ment, Parkinsondisease, anorexia, and malnutrition.syn- We createdthe secondand third questionnaires(sevedty drome of inappropriate antidiuretic hormone secretion, previous round ratings) from panel input and the results of the and obesity. mailed and face-to-facerounds be- survey.We completed all A total of l5 medications/medicationclasses were tween October 200I and February 2002. We constructedthe droppedor modified from the 1997to the 2002update from questionnairestatements according to the original Beerscri- Most of the medicationsdropped since teria published in 1991 and the updated criteria published in theiound I survey. or con- 1997.The instructions accompanyingthe survey askedthe re- 1997were thosethat were associatedwith diagnoses sDondentsto considerthe use of medicationsor'rly in adults 65 ditiorn. The following medicationswere voted to be dropped

ARCHINTERN MED/VOL 163, DEC 8/ZZ,2OO3 WWW.ARCHINTERNMED.COM 2718 DownloadeG&s0srdmerichirMndiedbArsotldtiossfrlt ofglttridEqoxvddly 24, 2008 (REPRINTED WITH CORRECTIONS) Table1. 2002Criteria for Potentially Inappropriate Medication Use in 0lderAdults:Independent ofDiagnoses orCondilions

SeverityRating Drug Concern (Highor Low) Propoxyphene(Darvon) and combination products 0f{erslew analgesic advantages over acetaminophen, yethas the adverse Low (Darvonwith ASA, Darvon-N, and Darvocet-N) effectsof other narcotic drugs. Indomethacin(lndocin and lndocin SR) Ofallavailable nonsteroidal anti-inflammatory drugs, this drug produces High themost CNS adverse effects. Pentazocine(Talwin) Narcoticanalgesic that causes more CNS adverse effects, including High confusionand hallucinati0ns, more commonly than other narcotic drugs.Additionally, it isa mixedagonist and antagonist. Trimethobenzamide(Tigan) Oneof the least ellective antiemetic drugs, yet it cancause extrapyramidal High adverseeffects. l\4usclerelaxants and : methocarbamol Mostmuscle relaxants and drugs are poorly tolerated by High (Hobaxin),carisoprodol (Soma), chlorzoxazone (Paraflex), elderlypatients, slnce these cause adverse effects, metaxalone(Skelaxin), (Flexeril), and sedation,and weakness. Additionally, their eflectiveness atdoses (Ditropan). Donot consider the extended-release toleratedbyelderly patients isquestionable. DitropanXL. Flurazepam(Dalmane) Thisbenzodiazepine hypnotic has an extremely long half-life inelderly High patients(olten days), producing prolonged sedation and increasing the incidenceoflalls and fracture. Medium- 0r short-acting benzodiazepinesarepreferable. (Elavil), chlordiazepoxide-amitriptyline (Limbitrol), Becauseol its strong anticholinergic andsedation properties, amitriptyline High andperphenazine-amitriptyline (Triavil) israrely the ofchoice for elderly patients. (Sinequan) Becauseol its strong anticholinergic andsedating properties, doxepin is High rarelythe antidepressant ofchoice f0r elderly patlents. Meprobamate(Miltown and Equanil) Thisis a highlyaddictive and sedating anxiolytic. Those using High meprobamateIorprolonged periods may become addicted and may needto bewithdrawn slowly. Doses0f short-acting benzodiazepines: dosesgreater than Becauseol increased sensitivity to benzoadiazepines inelderly patients, High lorazepam(Ativan), 3 mg; oxazepam (Serax), 60 mg; smallerdoses may be effective aswell as safer. Total daily doses should alprazolam(Xanax),2 mg; temazepam (Restoril), 15mg; rarelyexceed the suggested maximums. andtriazolam (Halcion), 0.25 mg Long'actingbenzodiazepines: chlordiazepoxide (Librium), Thesedrugs have a longhalf-life inelderly patients (often several days), High chlordiazepoxide-amitriptyline(Limbitrol) producingprolonged sedation and increasing the risk of falls and clidinium-chlordiazepoxide(Librax),diazepam (Valium), fractures.Short- and Intermediate-acting benzodiazepines areprelened quazepam(Doral), halazepam (Paxipam), and chlorazepate if a benzodiazepineisrequired. (Tranxene) Disopyramide(Norpace and Norpace CR) 0f allantiarrhythmic drugs, this is the most potent negative inotrope and High thereforemay induce heart lailure in elderly patients. lt is also strongly anticholinergic.Other antiarrhythmic drugs should be used, Digoxin(Lanoxin) (should not exceed :"0.125 mg/d except when Decreasedrenal clearance may lead to increasedrisk of toxic eflects. Low treatingatrial arrhythmias) Short-actingdipyridamole (Persantine). Donot consider the Maycause orthostatic hypotension. Low long-actingdipyridamole (which has better properties than the short-actinginolder adults) except with patients with artitjcial heartvalves Methyldopa(Aldomet) and methyldopa-hydrochlorothizide l\4ay cause bradycardia andexacerbate depression inelderly patients. High (Aldoril) Reserpineatdoses >0.25 mg Mayinduce depression, impotence, sedation, and orthostatic hypotension. Low Chlorpropamide(Diabinese) lt hasa prolongedhalf-lile inelderly patients and could cause prolonged High hypoglycemia.Additionally, it isthe only oral hypoglycemic agent that causesSIADH. Gastrointestinalantispasmodic drugs: dicyclomine (Bentyl), Glantispasmodic drugs are highly anticholiner0ic andhave uncertain High (Levsin and Levsinex), propantheline etfectiveness.These drugs should be avoided (especially for (Pro-Banthine),belladonna alkaloids (Donnatal and others), long-termuse). andclidinium-chlordiazepoxide (Librax) Anticholinergicsandantihistamines: chlorpheniramine Allnonprescription andmany prescription antihistamines mayhave potent High (Chlor'Trimeton), (Benadryl), hydroxyzine anticholinergicproperties. Nonanticholinergic antihistamines are (Vistariland Atarax), (Periactin), preferredinelderly patients when treating allergic reactions. (Phenergan).tripelennamine, (Polaramine) Diphenhydramine(Benadryl) Maycause confusion and sedation. Should not be ussd as a hypnotic,and High whenused to treat emergency allergic reactions, it should be used in thesmallest possible dose. Ergotmesyloids (Hydergine) and cyclandelate (Cyclospasmol) Havenot been shown to beeffective inthe doses studied. row Fenoussul{ate >325 mg/d Doses:'325 mg/d do not dramatically increase the amount absorbed but Low greatlyincrease the incidence ol constipation, Allbarbiturates (except phenobarbital) except when used to Arehighly addictive and cause more adverse effects than most sedative 0r Hioh controlseizures hypnoticdrugs in elderly patients.

(continued)

ARCHINTERN MED/VOL I63, DEC8/ZZ,2QQ3 WWW,ARCHINTERNMED.COM 27t9 DownloadedePr00lv,{meridairtMoficdlcAssotldtiomsftfof$itridqorvddly 24, 2008 (REPRINTED WITH CORRECTIONS) Table1. 2002Criteria lor Potentially lnappropriate Medication Use in 0lderAdults: Independent ol Diagnoses orConditions (cont)

SeverityRating Drug Concern (Highor Low) Meperidine(Demerol) Notan effective oral analgesic indoses commonly used. May cause High confusionand has many disadvantages to other narcotic drugs. Ticlopidine(Ticlid) Hasbeen shown to be no betterthan aspirin in preventingclotting and Hi0h maybe considerably more toxic. Safer, more effective alternatives exist. Ketorolac(Toradol) lmmediateand long-term use should be avoided inolder persons, since Hiqh asigni{icant number have asymptomatic Glpathologic conditions. Amphetaminesandanorexic agents Thesedrugs have potential forcausing dependence, hypertension, High angina,and myocardial infarction. Long-termuse of full-dosage, longer hall-lile, Havethe potential toproduce Gl bleeding,renal lailure, high blood High non-C0X-selectiveNSAIDS: naproxen (Naprosyn, Avaprox, oressure.and heart failure. andAleve), oxaprozin (Daypro), and piroxicam (Feldene) Dailyfluoxetine (Prozac) Longhalf-life ofdrug and risk ol producingexcessive CNS stimulation, Hish sleepdisturbances, andincreasing agitation. Safer alternatives exist. Long-termuse of stimulantlaxatives: bisacodyl (Dulcolax), Mayexacerbate bowel dysfunction. High cascarasagrada, and Neoloid except in the presence ol opiate analgesicuse Amiodarone(Cordarone) Associatedwith 0T interval problems and risk ol provokingtorsades de Hiqh pointes.Lack of efficacy inolder adults. 0rphenadrine(Norllex) Causesmore sedation and anticholinergic adverse ef{ects than sa{er High alternatives. Guanethidine(lsmelin) Maycause orthostatic hypotension. Sa'fer alternatives exist. High Guanadrel(Hylorel) Maycause orthostatic hypotension. High Cyclandelate(Cyclospasmol) Lackol efficacy. Low lsoxsurpine(Vasodilan) Lackof eflicacy. Low Nitrolurantoin(Macrodantin) Potentialfor renal imoairment. Safer alternatives available. High Doxazosin(Cardura) Potentialfor hypotension, drymouth, and urinary problems. Low Methyltestosterone(Android, Virilon, and Testrad) Potentiallor prostatic hypertrophy and cardiac problems. High (Mellaril) Greaterpotential for CNS and extrapyramidal adverse el{ects. High (Serentil) GNSand extrapyramidal adverse etfects. High Sh0rtacting nifedipine (Procardia and Adalat) Potentialfor hypotension and constipation. High Clonidine(Catapres) Potential{or orthostatic hypotension and CNS adverse eflects. Low Mineraloil Potentiallor aspiration and adverse effects. Safer alternatives available. High Cimetidine(Tagamet) CNSadverse effects including conlusion. Low Ethacrynicacid (Edecrin) Potentiallor hypertension andfluid imbalances. Saler alternatlves Low available. flocinnelod thvrnid High vvw,wvslww u'r'v'v Concernsabout cardiac effects. Saler alternatives available. Amphetamines(excluding methylphenidate hydrochloride CNSstimulant adverse effects. High andanorexics) Estrogensonly (oral) Evidenceofthe carcinogenic (breast and endometrial cance0 potential L0w ol theseagents and lack ol cardioprotectiveeflect in older women.

Abbreviations:CNS,central nervous system; C0X, cyclooxygenase; Gl,gastrointestinal; NSAlDs, nonsteroidal anti-inflammatory drugs; SIADH, syndrome of inappropriateantidiuretic hormone secretion.

-l-hc or modiliedfrorn the criteriaby thepanelists since the 1997 that are ofl the market. expcrt panelists could not publication:phenylbutazone, oxybuqmin chloride,[3-block- reach consensus about adding questions regarding set- ers, corticosteroidswith personswith diabetes;sedative- ting maximurn dosageslor sedative-hypllotics,antipsy- hlpnotics in personswith chronic obstructivepuhnonary chotics, selective serotonin reuptake inhibitors, and tri- disease;$-blockers in personswith asthma;f3-blockers in cyclic thaL do uclt have specilic personswith peripheralvascular disorder; p-blockersin recommendations from the manufacturer, though there personswith syncopeand falls;narcotics in personswith was agreement that consideration of changes in pharma- bladderoutflow obstruction;and theophyllinesodium gly- cokinetics were important in older patients in prevent- cinatein personswith insomnia (Tcrble 3). Oxybutinin ing problems caused by excessive dosages and usage. was modified by not including the extended-release[or- This uodate alsoincludes severaltne dications that have mula, which the panel believed had fewer adverse new information or have come to market since the last study effects.Reserpine was changedto be avoided only at of the Beers criteria was published (1997), lncluding se- dosesgreater than 0.25 mg, and disopl'ramidephosphate lective serotonin reuptake inhibitors, amiodarone, and avoidancenow only refers to the non-extended release fiuoxetine hydrochloride . The panel also votecl to add rne- formulation. New information about [3-blockersin thyltestosterones, amphetamines, and bupropion hydro- elderly patientsled the panel to drop this classof drugs chloride to the list o[ medlcations to be avoided in older from the list. The other criteria dropped involved use o[ aduits. Tables 1 and 2 statewhy medications were added drugs in the setting of a comorbid condition or drugs since 1997, and Table 3 summarizes all the changes to the

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SeverityHating DiseaseorGondilion Drug Goncern (Highor Low) Heartfailure Disopyramide(Norpace), and high sodium content drugs Negativeinotropic effect. Potential topromote High (sodiumand sodium salts [alginate bicarbonate, lluidretention and exacerbation ofheart biphosphate,citrate,phosphate,salicylate,andsulfatel)lailure. Hypertension Phenylpropanolaminehydrochloride (removed from the Mayproduce elevation ol blood pressure High marketin 2001), pseudoephedrine; dietpills, and secondarytosympathomimetic activity. amphetamines Gastricor duodenal NSAIDSand aspirin (;.325 mg) (coxibs excluded) Mayexacerbate existing ulcers or produce High ulcers new/additionalulcers. Seizuresorepilepsy (Clozaril), (Thorazine), Maylower seizure thresholds. High thioridazine(Mellaril), and thiothixene (Navane) Bloodclotting disorders Aspirin, NSAlDs, dipyridamole (Persantin), ticlopidine Mayprolong clotting time and elevate INR High orreceiving (Ticlid),and clopidogrel (Plavix) valuesor inhibit platelet aggregation, anticoagulanttherapy resultinginan increased potential for bleeding. Bladderoutflow Anticholinergicsandantihistamines, gastrointestinal Maydecrease urinary llow, leading to urinary High obstruction antispasmodics,muscle relaxants, oxybutynin retention. (Ditropan),llav0xate (Urispas), , antidepressants,decongestants, andtolterodine (Detrol) Stressincontinence o-Blockers(Doxazosin, Prazosin, and Terazosin), Mayproduce polyuria and worsening of High antich0linergics,tricyclicantidepressants(imipramineincontinence. hydrochloride,doxepin hydrochloride, andamitriptyline hydrochloride),andlong-acting benzodiazepines Arrhythmias Tricyclicantidepressants ( hydrochloride, Concerndue to proarrhythmic elfects and ability High doxepinhydrochloride, andamitriptyline hydrochloride) t0produce 0T interval changes. Insomnia Decongestants,theophylline (Theodur), methylphenidate Concern due to CNS stimulant elfects. High (Ritalin),lVlA0ls, and amphetamines Parkinsondisease Metoclopramide(Reglan), conventional antipsychotics, and Concerndue to their antidopaminergic/ High tacrine(Cognex) cholinergiceffects. Cognitiveimpairment Barbiturates,anticholinergics, antispasmodics, andmuscle Concerndue to CNS-alteringellects, High relaxants.CNS stimulants: dextroAmohetamine (Adderall),methylphenidate (Ritalin), methamphetamine (Desoxyn),and pemolin Depression Long-termbenzodiazepine use.Sympatholytic agents: Mayproduce or exacerbatedepression. High methyldopa(Aldomet), reserpine, and guanethidine (tsmetin) Anorexiaand CNSstimulants: DextroAmphetamine (Adderall), Concerndue to appetite-suppressing elfects. High malnutrition methylphenidate(Ritalin), methamphetamine (Desoxyn), pemolin,and fluoxetine (Prozac) Syncopeorfalls Short-to intermediate-acting benzodiazepine andtricyclic Mayproduce ataxia, impaired psychomotor High antidepressants(imipramine hydrochloride, doxepin function,syncope, and additional falls, hydrochloride,andamitriptyline hydrochloride) S|ADH/hyponatremiaSSRIs: lluoxetine (Prozac), citalopram (Celexa), [Iayexacerbate orcause SIADH. Low fluvoxamine(Luvox), (Paxil), and sertraline (Zoloft) Seizuredisorder Bupropion(Wellbutrin) Maylower seizure threshold. High Obesity (Zyprexa) l\ilaystimulate appetite and increase weight gain. Low C0PD Long-actingbenzodiazepines: chlordiazepoxide (Librium), CNSadverse elfects. May induce respiratory High chlordiazepoxide-amitriptyline(Limbitrol), depression.May exacerbate orcause clidinium-chlordiazepoxide(Librax),diazepam (Valium), respiratorydepression. quazepam(Doral), halazepam (Paxipam), and chlorazepate(Tranxene). [.r-blockers: propranolol Chronicconstipation Calciumchannel blockers, anticholinergics, andtricyclic Mayexacerbate constipation. Low antidepressant(imipramine hydrochloride, doxepin hydrochloride,andamitriptyline hydrochloride)

Abbreviations:CNS,central nervous systems; C0PD, chronic obstructive pulmonary disease; lNR, international normalized ratio; MAQls, monoamine oxidase inhibitors;NSAlDs, nonsteroidal antj-inflammatory drugs; SIADH, syndrome ofinappropriate antidiuretic hormone secretion; SSRls, selectjve serotonin reuptake in hi bitors.

r6'20'22.2r'26'2e Beerscriteria since 1997,including medications thar were cited. The applicationof the Beerscriteria and added, dropped, or modified. other tools for identifying PIM use wiil continue to en- able providers to plan interventions for decreasingboth drug-relatedcosts and overall costsand thus minimize drug-relatedproblems.e'r0 Such tools are alsovitally im- This study is an important update of previously estab- portant to managed care organizations,pharmacy ben- lished criteria that have been widely used and efit plans, and both acute and long-terrnhealth care in-

ARCHINTERN MED/VOL 163. DEC 8/22. 2OO3 WWw'ARCHINTERNMED.COM 2721 Dowrrloadedef&ftO3vAmeddain&todicdlcArsotldtiotrsAl cf$ttrifuerrvddly 24,2008 (REPRINTED WITH CORRECTIONS) Table3. Summaryof ChangesFrom 1997 Beers Criteria lo New2002 Crileria

MedicinesModified Since 1997 Beers Griteria 'L Reserpine(Serpasil and Hydropres)+ 3. lronsupplements >325 mgt 2. Extended-releaseoxybutynin (Ditropan XL)l 4. Sh0rt-actingdipyridamole (Persantine)f MBdicinesDlopped Since 1997 Beers Criteria Independentol Diagnoses 1, Phenylbutazone(Butazolidin) 6. l\4etoclopramide(Reglan) with seizures orepilepsy ConsideringDiagnoses 7. Narcoticswith bladder outllow obstruction and narcotics with constipation 2. Recentlystarted c0rtic0steroid therapy with diabetes B. (Norpramin) with insomnia 3. p-Blockerswith diabetes, C0PD or asthma, peripheral vascular 9. AllSSRIs with insomnia disease,and syncope orfalls 10.[.]-Agonists with insomnia 4. Sedativehypnotics with COPD 11, Bethanecholchloride with bladder outflow obstruction 5. Potassiumsupplements with gastric or duodenal ulcers MedicinesAdded Since 1997 Beers Criteria IndependentofDiagnoses 1. Ketorolactromethamine (Toradol) 15.Desiccated thyroid 2. (Norflex) 16.Ferrous sulfate >325 mg 3. Guanethidine(lsmelin) 17. Amphetamines(excluding methylpenidate andanorexics) 4. Guanadrel(Hylorel) 18.Thioridazine (Mellaril) 5. Cyclandelate(Cyclospasmol) 19. Short-actingnifedipine (Procardia and Adalat) 6. lsoxsuprine(Vasodilan) 20.Daily fluoxetine (Prozac) 7. Nitrofurantoin (l\4acrodantin) 21.Stimulant laxatives may exacerbate bowel dyslunction (except inpresence 8. Doxazosin(Cardura) ol chronicpain requiring opiate anal0esics) L Methyltestosterone(Android, Virilon, and Testrad) 22.Amiodarone (Cordarone) 10.Mesoridazine (Serentil) 23. Non*COX-selectiveNSAIDs (naproxen INaprosyn], oxaprozin, and 1'1.Clonidine (Catapres) piroxicam) 12.Mineral oil 24. Reserplnedoses ).0.25 mg/d 13.Cimetidine (Tagamet) 25. Estrogensinolder women 14.Ethacrynic acid (Edecrin) ConsideringDiagnoses 26,Long-acting benzodiazepines: chlordiazepoxide (Librium), 33"Decongestants withbladder outflow obstruction chlordlazepoxide-amitriptyline(Llmbitr0l), 34.Calcium channel blockers with constipation clidinium-chlordiazepoxide(Librax),diazepam (Valium), 35. Phenylpropanolaminewithhypertension quazepam(Doral), halazepam (Paxipam), and chlorazepate 36, Bupropion(Wellbutrin) with seizure disorder (Tranxene)with C0PD, stress incontinence, depression, andlalls 37.0lanzapine (Zyprexa) with obesity 27. Propanololwith C0PD/asthma 38. Metoclopramide(Reglan) with Parkinson disease 28.Anticholinergics withstress inc0ntinence 39.Conventional antipsychotics withParkinson disease 29.Tricyclic antidepressants (imipramine hydrochloride, doxepine 40.Tacrine (Cognex) with Parkinson disease hydrochloride,andamitriptyline hydrochloride) withsyncope or 41. Barbiturateswithcognitive impairment lallsand stress incontinence 42.Antispasmodics withcognitive impairment 30.Short to intermediate andlong-acting benzodiazepines with 43. Musclerelaxants with cognitive impairment syncopeor falls 44.CNS stimulants with anorexia, malnutrition, 31.Clopidogrel (Plavix) with blood-clotting disorders receiving andcognitive impairment anticoagulanttherapy 32. (Detrol) with bladder outflow obstruction

Abbreviations:CNS,central nervous system; C0PD, chronic obstructive pulmonary disease; C0X, cyclooxygenase; NSAlDs, nonsteroidal anti-inflammatory drugs;SSRls, selective serotonin reuptake inhibitors. *Reserpineindoses >0.25 mg was added to the list. fDitropanwas modi{ied torefer to the immediate-release formulation only and not Ditropan XL and iron supplements was modified toinclude only ferrous sulfate. {Donot consider the long-acting dipyridamole, which has better properties than the sh0rt-acting dipyridamole inolder adults (except with patients with artificial heartvalves). stitutions. However, to remain useful, criteria must be at timesas too slmplisticand limiting the freedomof phy- regularlyupdated and must take into accountlhe ever- siciansto prescribe.rr-35However, we believethat thought- increasing,evidence-based literature in the areaof medi- ful applicationof the updated2002Beerscriteria and other cationuse in older adults. tools for identifying PIM usecan enable providers and in- The argumentin favor of using explicit criteria inpre- surers to plan interventions aimed at decreasingdrug- scribingpractice is overwhelming:improvements in thera- relatedcosts and overallhealth care costs, while reducing peuticpractices and reduction in medication-relatedADEs ADE-relatedadmissions in elderlypatientse'iO and improv- will increasethe quality of careand enhancepatient out- ing care.The updatedBeers criteria will enableeveryone comeat the sametime as optimizing resourceutilization from individual physiciansto health caresystems to in- and promoting fiscal prudence. These criteria, though legratethe new criteria-basedprescribing recommenda- widelyused, have been controversial because of their adop- tionsinto their organic,mechanical, and electronic infor- tion by nursing home regulatorsand havebeen criticized matlon systems.

ARCH INTERN MED/VOL 163,DEC8/22,2003 WWWARCHINTERNMED.COM 2722 DownloadedGf?00s4rneaieirefodiedlcArsoddniomsAltofglttrid6errYddly 24,2008 (REPRINTED WITH CORRECTIONS) The proponents of explicit criteria and evidence- clinical need remains a challengefor the information sys- basedprescribing are among the biggestplayers in the tems and information technology engineer,the behav- health careindustry: the IOM, the CMS, the Agency for ior changespecialist, and the medical profession.a2 HealthcareResearch and Quality (AHRO, and theAmeri- (AAHP), can Associationof Health Plans to name but Accepted.for publicationMarch 28, 2003. four.36'37Indeed, finding a voice of dissent is challeng- This researchwas supportedbya grantfrom theMedi- ing. In "Crossingthe Quality Chasm" the IOM38pre- cal Collegeof Georgia (Augusta) and,University of Geor- sentsa templatefor the future, when the traditional val- gia (Athens)Combined Intramural Grant Program. uesof physicianintegrity, altruism, knowledge,skill, and W e thanhJ udy J ohnson, MA T, R. C. Robinson, B S, and dedication to lifelong patient care are seamlesslyinte- AlisonMaclean,BA, for assistancewith datamanagement gratedinto an information era of point-of-care,comput- and manuscriptpreparation. We achnowledgethe follow- erized decisionsupport that facilitatesappropriate care ing individualsf or contributingtheir expertiseto thisstudy using the availableresources. The updated Beerscrite- as panel members:Maud.e Babington, PharmD (Babington ria are one component of that movement, enabling all Consulting,LLC, Boulder,Colo); ManjuT. Beier,PharmD parties,from providers to insurers, to integrateour rec- (The Untuersity of Michigan, Ann Arbor); Richard,W.Be- ommendationsinto their clinical information systems. sdine, MD (Brown University, Provid.ence,Rl); Jach Fin- Given the aforementioned,there appears to be a po- cham, PhD (University oJ Kansas,Lawrence); F. Michael tential niche for the Beerscriteria in fulfilling the mis- Gloth III, MD QohnsHophins University Schoolof Medi- sions of the IOM, CMS, AHRQ, and AAHP. However, cine,Baltimore, Md); ThomasJachson,MD(Medical Col- translating researchinto measurablequality improve- legeof Georgia, Augusta);J ohn E. Morley, MD (Saint Louis ment may be more challenging.In the first instance,de- UniversityHealth SciencesCenter, St Louis,Mo); Bechy spite the much-lauded public statementsabout quality Nagle,PharmD, BCPC (MedcoHealth Solutions,Franhlin by many (including the above organizations), there is Lahes,ND; Todd Semla,PharmD, MS (EvanstonNorth- widespreadrecognition that perhaps cost containment westernHealthcare, Eyanston, Ill); Marh A. Stratton, is the principaldriver of changein the healthcare world.3e PharmD (University of Ohlahoma,Ohlahoma City); An- Individual health care providers and organizationswill drew D. Weinberg,MD (Emory University Schoolof Medi- demand objective evidencethat implementation of the cine,Atlanta, Ga). updated Beerscriteria (or, indeed, other inappropriate Correspondingduthor and reprints:Donna M. Fich, medicationguides) will result in objective,quantifiable PhD, RN, Centerfor Heakh Care lmprovement,Depart- improvementsin the clinical effectivenessand cost- mentof Medicine,Medical College of Georgia,HB 201 0, 1467 effectivenessofhealth careservices. To date,despite ex- Harper St,Augusta, GA 30912(e-mail: [email protected]). tensiveliterature demonstratingassociation-based on retrospectivestudies on administrativedata-there is an absenceof rigorous,prospective research in this field.We (D.M.F.,J.L.W.,andJ.R.M.) are completing a random- ized controlled study among a Medicare managedcare 1. HanlonJT, Schmader KE, Kornkowski MJ,et al. Adverse drug events inhigh risk olderoutpatients. J Am Geriatr Soc.'1 997;45:945-948. population at this time, using the 1997 medicarion cri- 2. BoolmanJL, Harrison DL, Cox E. The health care cost of drug-related morbidity teria for older adults.Well-controlled studiesare needed andmortality innursinO tacilities. ,4rc, lntern Med.1 997;1 b7:2089-2096. that show prospectivelythat using thesecriteria make a 3. CooperJW. Probable adverse drug reactions ina ruralgeriatric nursing home differencein patientoutcomes.3l population:afour-year study. J Am Geriatr Soc.1 996;44:1 94-l 97. Thesecriteria havesome limitations, however,and 4. C0operJW. Adverse drug reaction-related hospitalizations ofnursing facility pa- tients:a 4-year study. South Med J.1999;92:485-490. must be regularly updated to remain useful to both cli- 5. KohnL, Corrigan J, Donaldson M,eds. To Err ls Hunan:Building aSafer Health nicians,health care administrators, and researchers.These Syslem.Washington, DC: National Academy Press; 1999. Available at:http: '14, criteria are meant to apply to the generalpopulation of //books.nap.edu/html/to_err_is_human/.AccessedMarch 2001. patients65 yearsand older, thus some that are not ap- 6. PerryDP. When medicine hurts instead ol helps.Consultant pharmacist. jgggi 14:1 326-1 330. propriate for significantly older or more frail personsdo 7, BatesDW, Spell N, Cullen DJ, et al, the Adverse Drug Events prevention not Study appearin this iist. Thesecriteria are nor. meant to regu- Gr0up.The costs of adverse drug events inhospitalized patients. JAMI. 1997; Iatepractice in a manner to which they supersedethe clini- 277:307-311. caljudgment and assessmentof the physician or pracri- 8. JohnsonJA, Bootman JL. Drug-related morbidity and mortality: a cost-of- tioner. In addition, defining inappropriate medications illnessmodel. Arch Intern Med 1995;155:1949-1956. 9. LazarouJ,Pomeranz BH,Corey PN. 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Arch lntern Med 1997;157:1531-1536. ria will come from the information systemsand infor- 13.Beers MH,0uslanderJG, RollingherJ, Reuben DB, BeckJC. Explicitcriterialor mation technology sector. Despite phenomenal ad- determininginappropriate medication use in nursing home residents. /4rc, /n- vancesin hardwareandsoftware, decision supportsystems ternMed. 1991;151:1 825-1 832. 14.Mcleod JP, Huang AR, Tamblyn RM. Detining inappropriate practices in pre- continue to have significant limitations, presenting and scribingfor elderly people: a nati0nal consensus panel. CMAJ.1 997;1 56:385- the right information to rhe right person at the point of 391.

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Error in "Results" Section. In the Original Investigationby Fick et al titled "Updating the BeersCriteria for Potentially Inappropriate Medication Use in Older Adults," published in the December8/22 issue of the ARCHTvES(2003; 163:2716-2724),an error occurredin the "Results"section on page 2720.The second full sentencein the left column should have read "Reserpinewas changed to be avoided only at dosesgreater than 0.25 mg, and disopyramidephosphate avoidancenow only relersto the non-extended releaseformulation." This cor- rection was made previously to online versionsof this article.

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