Tejal K. Gandhi, M.D., M.P.H., Saul N. Weingart, M.D., Ph.D., Joshua Borus, B.A., Andrew C. Seger, R.Ph., Josh Peterson, M.D., Elisabeth Burdick, M.S., Diane L. Seger, R.Ph., Kirstin Shu, B.A., Frank Federico, R.Ph., Lucian L. Leape, M.D., and David W. Bates, M.D.
Background Adverse events related to drugs occur frequentlyamong inpatients, and many of these events are preventable.However, few data are available on adverse drug events amongoutpatients. We conducted a study to determine the rates, types,severity, and preventability of such events among outpatientsand to identify preventive strategies.
Methods We performed a prospective cohort study, including asurvey of patients and a chart review, at four adult primarycare practices in Boston (two hospital-based and two community-based),involving a total of 1202 outpatients who received at leastone prescription during a four-week period. Prescriptions werecomputerized at two of the practices and handwritten at theother two.
Conclusions Adverse events related to drugs are common in primarycare, and many are preventable or ameliorable. Monitoring forand acting on symptoms are important. Improving communicationbetween outpatients and providers may help prevent adverse eventsrelated to drugs.
Adverse drug-related events, defined as injuries due to drugs,occur frequently among inpatients.1,2,3,4 In one study, 6.5percent of hospitalized patients had an adverse drug event,and 28 percent of the events were preventable.5 Adverse drugevents often lead to hospital admission. A meta-analysis6 estimatedthat in 1994 more than 1 million Americans were hospitalizedbecause of adverse drug events, accounting for 4.7 percent ofall admissions. Even though most prescribing occurs in outpatientsettings, much less is known about outpatient adverse drug eventsthan about inpatient events. Annual estimates of the proportionof outpatients with an adverse drug event range from 5 percentto 35 percent.7,8 In a recent retrospective study, 17 percentof outpatients reported a problem related to a prescribed medication,9and in another recent study, involving Medicare enrollees livingin the community, the rate of adverse drug events was 5 percentper year.10 However, few prospective data are available on theincidence of adverse drug events in the ambulatory care setting.
Several factors account for the dearth of information aboutadverse drug events among outpatients. Such patients obtainand administer their own medications. Since contact with physiciansis intermittent, communication about problems may be infrequent.Inadequate documentation of outpatient care and high costs limitthe usefulness of chart review, which is most commonly usedto ascertain adverse drug events among inpatients.11 These factorsmake it difficult to identify adverse drug events among outpatients.
We performed a study to determine the frequency, type, severity,and consequences of adverse drug events among outpatients. Inaddition, we assessed the preventability of such events andidentified strategies to keep them from occurring or to amelioratethem.
Methods
Sites
We studied four adult primary care practices in Boston, allof which were affiliated with academic medical centers. Twopractices were hospital-based and staffed by full- and part-timeteacher-clinicians, and two practices were community-based andstaffed by full-time primary care physicians. One of each typeof practice used a basic computerized system for prescribingdrugs, and one of each type used a manual system. The computerizedsystems provided printed prescriptions and information in requiredfields (drug, dose, quantity, and duration) but did not offerdefault doses in most cases and did not perform automatic checksfor allergies or drug interactions. Data were collected betweenSeptember 1999 and March 2000. The institutional review boardapproved the study. Patients were considered to have given informalconsent if they completed the survey.
Physicians
All physicians at three of the sites (6 physicians at each oftwo sites and 5 at the third) participated in the study; 6 of27 physicians at the fourth site were randomly selected to participateand agreed to do so. They were not blinded with respect to thepurpose of the study. Once the study had begun, a seventh physicianat the fourth site was added to augment the total number ofpatients. All physicians were board-certified internists (Table 1).
Table 1. Characteristics of Physicians at the Four Clinical Practices.
Patients
Patients older than 18 years who received any prescription fromparticipating physicians during a clinic visit (the index visit)were enrolled once during the study period (a four-week enrollmentperiod per site). Patients were excluded if their physiciansthought they were too ill or had a hearing impairment that wouldinterfere with their participation or if they were unable tospeak English or Russian. (Some of the clinics had a large numberof Russian-speaking patients.)
Data Collection
One day after the index visit, we sent patients a letter describingthe study as a project to improve the way in which medicationsare prescribed and requesting their participation in a telephonesurvey. Patients could decline to participate by postcard orwhen telephoned. Ten to 14 days after the index visit, we askedpatients who agreed to participate about specific symptoms;if symptoms were present, more structured questions followedabout timing and actions taken. We also asked patients to readthe labels on their prescription bottles to us. Three monthslater, we again telephoned the patients and asked about symptomsand their general health. Also at three months, a nurse examinedthe medical record of each survey participant to identify anyadverse drug events documented in the chart during that interval,drug allergies, and existing conditions.
Adverse Drug Events
Possible adverse events were reviewed independently by two ofus (both physicians). The reviewers determined the likelihoodthat the event was related to a medication (thus meriting classificationas an adverse drug event) and classified the event accordingto its severity and preventability. The reviewers consideredthe timing of symptoms, whether the patient attributed the symptomsto the drug, and the strength of published data on the relationbetween the symptoms and the drug. Each adverse drug event wasclassified as "fatal or life-threatening," "serious," or "significant."12Events were also classified as "nonpreventable," "preventable,"or "ameliorable." Preventable events were those due to errorsthat could have been entirely avoided. Ameliorable events werethose whose severity or duration could have been substantiallyreduced had different actions been taken. The reviewers determinedpreventability on the basis of the physician's presumed knowledgeat the time the drug was prescribed. If insufficient informationwas available, the reviewers assumed that the physician's decisionwas correct. If an event was preventable or ameliorable, thereviewers specified the type of error and how it might havebeen prevented.
Confidence about the classification of events was rated on asix-point scale (1, little or no confidence; 2, slight-to-moderateconfidence; 3, less than 50 percent confidence but a close call;4, more than 50 percent confidence but a close call; 5, strongconfidence; and 6, virtually certain). Events were excludedif the score for the confidence level was less than 4 (i.e.,less than 50 percent confidence). This cutoff point was selecteda priori. Differences between the two reviewers' judgments aboutthe classification of events as drug-related and about the severityand preventability of such events were resolved by discussion.Interrater agreement (determined on the basis of the ratingsbefore a consensus was reached) was high for the classificationof events as drug-related (kappa, 0.89; 95 percent confidenceinterval, 0.79 to 0.99), their severity (kappa, 0.72; 95 percentconfidence interval, 0.59 to 0.87), and their preventability(kappa, 0.70; 95 percent confidence interval, 0.62 to 0.78).
Statistical Analysis
We used Student's t-test to compare continuous data; the resultsare presented as means ±SE. The chi-square test was usedto compare categorical data; the results are presented as counts,with percentages. All reported P values are based on two-tailedtests of significance.
The association between the characteristics of the patientsand the number of adverse drug events was determined with aPoisson regression model. Only variables with a univariate associationof P<0.25 were introduced into the multivariate model. Clusteringof variables according to the physician was accounted for withthe use of a generalized estimating equation.13 All analyseswere conducted with SAS software (SAS Institute) and MicrosoftExcel.
Results
Response Rates
Of 1202 patients enrolled, 661 (55 percent) completed the surveyat two weeks and of these patients, 600 (91 percent) completedthe survey at three months. Chart reviews were completed for653 of the 661 patients (99 percent). The 541 nonparticipantsincluded 168 who refused to participate when contacted by telephone,139 who opted out by postcard, 205 who could not be contacted,24 who had language or hearing problems, and 5 with other reasonsfor not participating. The characteristics of the 661 patientswho participated in the survey are shown in Table 2.
Table 2. Characteristics of Patients According to Whether or Not They Reported Adverse Drug Events.
Rates of Adverse Drug Events
Of the 661 patients surveyed, 162 had adverse drug events (25percent; 95 percent confidence interval, 20 to 29 percent),with a total of 181 events (27 per 100 patients). Twenty-fourof the events were serious (13 percent; 95 percent confidenceinterval, 7 to 19 percent), 20 were preventable (11 percent;95 percent confidence interval, 6 to 16 percent), 51 were ameliorable(28 percent; 95 percent confidence interval, 19 to 37 percent),and 11 were serious and either preventable or ameliorable (6percent; 95 percent confidence interval, 2 to 10 percent) (Table 3).None of the events were fatal or life-threatening. The meannumber of medications was significantly higher for the patientswho had adverse events than for those who did not; none of theother characteristics of the patients differed significantlybetween the two groups (Table 2). Of the 181 adverse drug events,166 (92 percent) were identified by surveying patients, 50 (28percent) by reviewing charts, and 35 (19 percent) by both means.The events identified by survey and those identified by chartreview did not differ significantly in terms of severity, preventability,or type of symptom; however, ameliorable events were more likelyto be identified by survey than by chart review (P=0.01). Theoverall rate of adverse events did not differ significantlybetween clinics with computerized prescription systems and thosewith manual systems (25 percent and 30 percent, respectively;P=0.29).
Serious adverse drug events included symptomatic bradycardia,symptomatic hypotension, and gastrointestinal bleeding. Table 4lists all 24 serious events, classified according to whetherthey were preventable or ameliorable. An example of a preventableserious event was an allergic rash in a patient for whom anantibiotic had been prescribed despite a documented allergy;an example of an ameliorable serious event was prolonged sexualdysfunction in a patient whose provider failed to discontinuea selective serotonin-reuptake inhibitor despite this symptom.Examples of significant ameliorable events include a protractedcough in a patient who continued to be treated with an angiotensin-converting–enzymeinhibitor despite the availability of alternative therapy, andprolonged sleep disturbance in a patient who was taking an antidepressantand whose physician was unaware of this symptom because thepatient did not report it.
Table 4. Description of Serious Adverse Drug Events.
The most frequent type of adverse drug events and the most frequentpreventable or ameliorable events were those related to thecentral nervous system (33 percent and 35 percent, respectively),gastrointestinal events (22 percent and 25 percent), and cardiovascularevents (18 percent and 18 percent). Of the 162 patients whohad an event, 26 (16 percent) reported that their symptoms requireda visit to a clinical facility (19 visited an urgent care clinic,3 went to an emergency room, and 4 went to another type of facility).Preventable or ameliorable events accounted for 9 of the 26visits (35 percent; 6 to an urgent care clinic, 1 to an emergencyroom, and 2 to another type of facility).
Table 5. Medication Classes Most Frequently Associated with Adverse Drug Events.
Ameliorable Adverse Drug Events
Of the 51 ameliorable events, 32 (63 percent) were attributedto the physician's failure to respond to medication-relatedsymptoms and 19 (37 percent) to the patient's failure to informthe physician of the symptoms. The rate of ameliorable eventsdid not differ significantly between clinics with computerizedprescription systems and those with manual systems (47 percentand 53 percent, respectively; P=0.87).
In this study of four primary care practices, we found thatone quarter of outpatients had adverse drug events during athree-month period. Of these events, 13 percent were serious,39 percent were either ameliorable or preventable, and 6 percentwere serious and preventable or ameliorable. Ameliorable adversedrug events were attributed to poor communication: the physician'sfailure to respond to symptoms reported by the patient or thepatient's failure to report symptoms to the physician. Preventableadverse drug events were due to prescribing errors, one thirdof which could have been prevented by the use of advanced computerizedsystems of prescribing medications. The characteristics of thepatients were not significantly associated with adverse events,except for the number of medications taken. This finding issimilar to that among inpatients14 and suggests that strategiesto improve the processes of care for all patients will be moreeffective than strategies that target high-risk groups.
The rate of adverse drug events in our study (27 per 100 patients)was about four times as high as that reported in studies ofinpatients (about 6 per 100 admissions).1,5 However, these inpatientstudies did not directly survey patients to identify events.In our study, patients reported three times as many events as did trained chart reviewers.The longer duration of exposureto medications among outpatients than among inpatients may contributeto the higher rate of events. The proportion of events thatwere serious was lower in our study (13 percent) than in oneinpatient study (43 percent, including life-threatening andfatal events).5 However, the percentage of outpatients in ourstudy who had serious events was actually higher than the percentageof hospitalized patients who had serious events (3.5 percentvs. 2.6 percent), because of the higher total rate of outpatientevents.
In a recent study by Gurwitz et al., the frequency of adversedrug events was 5 percent per year in a population of outpatientswho were 65 years of age or older.10 In that study, events weredetected with a variety of approaches, including clinicians'reports, searches of computerized data for indicators of possibleevents, and computerized searching of electronic notes, butpatients were not directly contacted. The current study includespatients who sought care and received a medication, and thesepatients were much younger (mean age, 52 years, vs. 75 in thestudy by Gurwitz et al.). The medications prescribed in thisyounger population also differed, with selective serotonin-reuptakeinhibitors playing a larger part. Even though the study by Gurwitzet al. included older patients, who would be expected to beat higher risk for adverse events because such patients takemore medications, and included a year of surveillance ratherthan three months, the event rate in the current study was fivetimes as high as the rate in the study by Gurwitz et al., suggestingthat chart-based approaches result in a major underestimateof the true rate. Gurwitz et al. did not make the distinctionbetween events that were preventable and those that were ameliorable,but the overall proportions of patients with preventable eventswere similar in the two studies. In the current study, communicationissues were much more important, probably in part because suchproblems cannot be readily detected by chart review alone.
Most other previous studies of the frequency of adverse drugevents among outpatients have been drug trials. Such studiesprovide valuable data because they include control groups, membersof which often report many symptoms. However, these trials havelimitations: the patients are generally healthier and youngerthan members of the general population who take medications,and patients enrolled in trials may take fewer medications overall.Studies such as ours and that of Gurwitz et al., which includea cross-section of the general population, are an importantcomplement to clinical trials, though lack of a control groupmay lead to an overestimate of events.
We found that 39 percent of adverse drug events in primary carewere either preventable or ameliorable. Antidepressant and antihypertensivemedications were often implicated in these events, even afterwe accounted for the frequency with which they were prescribed.In contrast, analgesics, sedatives, and antibiotics are mostcommonly implicated in adverse events among inpatients.5 Educationabout these commonly prescribed medications and increased monitoringfor side effects could benefit physicians and patients. In ourstudy, most of the preventable events were due to prescribingerrors (an inappropriate choice of drugs, drug interaction,or drug allergy). Computerized checks for interactions and allergiescould have prevented both serious preventable events in thisstudy, although the overall benefit of computerized prescribingin reducing adverse drug events among outpatients remains tobe demonstrated.
Ameliorable adverse drug events, which were much more commonthan preventable events, occurred when physicians failed torespond to medication-related symptoms and when patients failedto inform physicians about such symptoms. Patients often hadsymptoms for months without any changes in their medications,and only a small percentage of patients reported that symptomsled to a visit to a physician. A prior study has shown thatpatients experience substantial anxiety and discomfort becauseof drug-related symptoms.9
Clearly, strategies to improve patient–doctor communicationare essential in the outpatient setting. These strategies couldinclude developing educational materials for patients, improvingtranslation services, and increasing patients' access to outpatientpharmacists (to discuss medications and side effects). Someinstitutions have developed Web sites for patients that provideinformation about medications and make it possible for usersto e-mail physicians.15,16 Such Web sites may enhance communicationabout medications.17 Improved strategies to monitor side effectscould also be developed; for example, a nurse or pharmacistcould call the patient after an office visit to inquire aboutany problems related to medications. Physicians' responses tosymptoms could be improved by making physicians more aware ofthe importance of monitoring symptoms, the prevalence and burdenof adverse drug events among outpatients, and the range of therapeuticalternatives. Finally, since we identified many more eventsby surveying patients than by reviewing charts, strategies toimprove communication should also include measures to improvedocumentation of adverse events in medical records.
The major limitation of our study was that it involved onlyfour primary care practices. Although we included hospital-basedand community-based practices, the results may not be generalizable.Despite the short study period, the sample was sufficientlylarge that our estimates of incidence are reasonably accurate.Another limitation was that we relied on patients' reports ofevents; however, we did confirm the reports by means of an independentreview by two physicians, and there was a high level of agreementin their judgments. That these reviewers were not the patients'physicians may have been beneficial in minimizing inherent biases.In addition, response bias could have affected our surveys,although the interviewers did not specifically state that thestudy concerned adverse drug events. Finally, we did not askpatients why they did not inform physicians of medication-relatedproblems, so we cannot identify underlying factors (e.g., lackof education about medications or inadequate access to physicians).Further research should focus on why patients do not reportsymptoms to physicians and why physicians fail to act on thereports they do receive.
Our results suggest that adverse drug events are common amongoutpatients, that they have important consequences, and thatmore than one third of such events are preventable or ameliorable.Improvements in monitoring for and responding to symptoms appearto be especially important for the prevention of adverse drugevents in outpatients. In addition, improved communication betweenoutpatients and their physicians may reduce the frequency ofthese events.
Supported by a grant from the Harvard Risk Management Foundation.
We are indebted to Russell Phillips, M.D., Steven Flier, M.D.,Philip Triffleti, M.D., Michael Benari, M.D., Karen Victor,M.D., and Ken Farbstein, M.P.P., for their help with this project;and to Erin Hartman, M.S., for her review of the manuscript.
Source Information
From the Division of General Internal Medicine, Brigham and Women's Hospital (T.K.G., J.B., A.C.S., J.P., E.B., D.L.S., K.S., D.W.B.); the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center (S.N.W.); the Harvard Risk Management Foundation (F.F.); and the Harvard School of Public Health (L.L.L.) — all in Boston.
Address reprint requests to Dr. Gandhi at the Division of General Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at tgandhi{at}partners.org.
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