Pharmacy Division Ramathibodi Hospital


Identifying Clinically Significant Preventable Adverse Drug Events Through a Hospital's Database of Adverse Drug Reaction Reports

Almut G. Winterstein, Randy C. Hatton, Ricardo Gonzalez-Rothi, Thomas E. Johns, Richard Segal

Am J Health-Syst Pharm 59(18):1742-1749, 2002. © 2002 American Society of Health-System Pharmacists

Abstract and Introduction


The ability of a hospital's adverse drug reaction (ADR) database to identify common and repeated patterns of preventable adverse drug events (ADEs) was analyzed.

ADR reports collected from 1994 through 2000 were extracted from a teaching hospital's ADR database. Reports were assessed concurrently in accordance with seven previously published explicit criteria for preventability. Only cases considered clinically significant were included in this analysis. Events that occurred in the ambulatory care setting were excluded. Preventable ADEs were categorized by drug or drug class, type of medication error, and the subsequent adverse outcome. Novel in this analysis was the linking of these three descriptors.

Of the 2571 ADR reports assessed, 415 ADEs were deemed preventable. Of the preventable ADEs, 98 were not analyzed because they occurred in the ambulatory care setting, leaving 317 preventable ADEs in 275 inpatients (mean age ± S.D., 48.5 ± 23.9 years) for analysis. Although 93 drugs were associated with these ADEs, only 10 drugs accounted for more than 60% of the events. Analysis and categorization by type of error and outcome suggested that three high-priority preventable ADEs accounted for 50% of all reports: (1) overdoses of anti-coagulants or insufficient monitoring and adjustments (according to laboratory test values) were associated with hemorrhagic events, (2) overdosing or failure to adjust for drug drug interactions of opiate agonists was associated with somnolence and respiratory depression, and (3) inappropriate dosing or insufficient monitoring of insulins was associated with hypoglycemia.

Analysis of a hospital ADR database identified prevalent and preventable clinically significant ADEs.


The widely recognized Institute of Medicine (IOM) report on patient safety has challenged medical facilities to systematically investigate and reduce medical errors.[1] It recognizes that preventable adverse drug events (ADEs) are some of the most common consequences of medical errors. Inappropriate drug therapy and medication errors are responsible for at least 3% and as many as 9% of hospital admissions (median, 4.3%) and result in preventable ADEs in up to 4% of patients during their hospital stay.[2]

The IOM mandate for a reduction of medical errors is reflected in new patient safety standards established by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).[3] These standards require institutions to ensure that the actual performance of processes identified as "error-prone" or "high-risk" regarding patient safety are measured and analyzed and, when significant variation is identified, appropriate corrective actions are taken to enhance the system or systems.

Determining institution-specific high-risk or high-priority areas for preventable ADEs can be difficult for health care organizations. Preventable ADEs can result from errors involving a large number of processes related to patient care, involve various drugs, and manifest in a variety of adverse patient outcomes. A study by Bates and colleagues[4] found that no single drug accounted for more than 9% of all ADEs. These investigators concluded that interventions for preventing drug-related injuries must target many drugs to have a major impact on the overall number of events. Another study by Hallas et al.[5] stated that a major concern is the diversity of preventable ADEs, as "a high degree of intervention will be required to produce a measurable change."

Published studies that involved a systematic analysis of ADEs have lacked the necessary detail to describe the nature and frequency of specific preventable ADEs. For example, many studies discuss only major drug classes that caused preventable ADEs (e.g., cardiovascular drugs) or major organ systems affected (e.g., gastrointestinal problems). Other means to find more specific information are sentinel event alerts, as published by the Institute of Safe Medication Practices and JCAHO, but these events may be rare or may not pose a significant problem for an individual institution. Thus, by focusing improvement strategies on sentinel event alerts alone, health systems might neglect a considerable number of more prevalent, more severe, or more costly preventable ADEs. Medication safety officers or committees in health systems face a very difficult task in describing and selecting high-risk areas for preventable ADEs that could be targeted for most efficient quality improvement strategies.

Spontaneous reporting of adverse drug reactions (ADRs) and, more recently, medication errors provides an opportunity for institution-specific analyses. Although spontaneous ADR reporting is not comprehensive and may be biased, it probably generates the most common and comprehensive database on ADEs.[6, 7] FDA has promoted the voluntary reporting of ADRs since the 1960s.[8] In the 1970s, the regulatory mandate of JCAHO to define and review all significant ADRs made ADR reporting mandatory in the hospital setting.[9]

The objectives of JCAHO's and FDA's reviews of ADRs are fundamentally different. FDA is primarily interested in serious reactions, which are often idiosyncratic (unpreventable), whereas JCAHO stresses quality improvement. Therefore, monitoring potentially preventable ADEs is more the purview of the JCAHO mandate. Consequently, many medical care facilities began emphasizing preventability as a key quality indicator for ADRs in the 1990s.[10] As a result, current ADR databases not only include idiosyncratic reactions (i.e., adverse reactions caused by medications that were appropriately given) but also ADEs following medication errors or inappropriate care, such as drug overdoses, contraindications, or insufficient monitoring.

Previous studies have analyzed hospital ADR databases to estimate ADR frequency and costs and to identify high-risk drugs; however, these studies did not focus on preventable events[11, 12] or did not provide sufficient detail to identify highly prevalent preventable ADEs.[13, 14] For example, while published studies may report major drug classes and major organ systems affected, rarely do such reports link these two components or attempt to describe the associated errors that caused the event. We used a novel approach to analyze preventable ADE reports by linking types of drugs, types of associated adverse outcomes, and types of errors to organize ostensibly unrelated and disparate preventable ADEs.

This study explored whether a systematic analysis of data extracted from an existing ADR database could help identify common and repeated patterns of preventable ADEs during a patient's hospital stay. The specific objectives were to develop a systematic method for analyzing ADR reports that could be adopted by other institutions and identify high-priority areas of preventable ADEs in health systems.


This is a descriptive analysis of preventable ADE reports accumulated in an ADR database at an academic teaching hospital in Florida. The reporting hospital is a universitybased, tertiary referral center with approximately 25,000-28,000 inpatient admissions annually that specializes in oncology, cardiovascular medicine and surgery, neurologic medicine and surgery, pediatrics, and transplantation.

The ADR database was developed in 1988 to enable systematic analyses of reported ADRs.[6] The database includes ADRs collected at the institution's drug information center from spontaneous reports by health care professionals and from a tracer drug search (i.e., screening of pharmacy medication databases for orders of antidotes or drugs commonly used to treat ADRs). Spontaneous reports are submitted on an institution-specific ADR report form, which is available online, or via telephone hotline. Most of the spontaneous reports (>92%) were submitted by pharmacists. The pharmacy also has an active tracer drug program with which the pharmacy medication database is daily screened for patients who received specific drugs that are frequently used to treat ADRs and drug toxicities.[15, 16] Whether detected patients truly had an ADR is verified by medical chart review, usually conducted concurrently by pharmacy students and supervised by pharmacists or pharmacy residents. The tracer drug list includes antidotes (e.g., naloxone, phytonadione) and drugs used to treat allergies, hypotension, and hypoglycemia (appendix).

Each report is reviewed by a drug information pharmacist, who determines whether the ADR was reported to FDA,[17] classifies each report by type of drug and organ system affected, and assesses causality with a modification of the Jones algorithm.[18] Since January 1994, each ADR has been further categorized as to whether it was potentially preventable with a modification of the criteria published by Schumock and Thornton.[10] The explicit descriptions of the modified criteria and their frequencies for all analyzed ADRs are listed in Table 1.

The database includes all variables required by FDA's MedWatch program.[17] Additional information collected includes the area where the error occurred, the medical service responsible for the error, profession of the reporter (e.g., nurse, pharmacist, physician), and the reason why the reaction was reported.

Because the database does not formally differentiate between ADEs that resulted from ambulatory care versus inpatient treatment, two strategies were used in the present study to exclude ADEs that occurred before or led to hospitalization. The full-text description of each report was searched for the term "ED" or "emergency," and respective cases were reviewed by the authors. ADEs occurring in the ambulatory care setting were excluded from the analyses. Further, if the reports indicated that the ADR was the reason for admission, the case was excluded. A new variable, "inhouse (Y/N)," was added to the database in 2001 to facilitate future analyses.

Only cases considered clinically significant were included in the analyses. Relevant cases included the following variables: patient died (3 cases), reaction was permanently disabling (2 cases), reaction was life-threatening (34 cases), reaction prolonged hospitalization (42 cases), reaction required change in drug therapy (123 cases), and reaction required additional therapeutic intervention (252 cases). Drug serum concentrations beyond the target range and other associated abnormal laboratory test results were considered clinically significant because they represented an increased risk for patient injury. For example, an International Normalized Ratio (INR) of 6 may in itself not indicate an adverse event, but it indicates a patient's high propensity for bleeding. For all other cases, adverse outcomes were associated with significant symptoms or complications.

To develop a systematic method for analyzing the database cases, the available data elements and theoretical work that provided definitions for preventable ADEs were reviewed. ADEs have been defined as injuries related to the use or nonuse of medications.[19] They are considered preventable when they are preceded by an inappropriate pattern of care or medication error that could have been detected, predicted, controlled, and avoided.[20] Using these definitions, we chose the following unique descriptors of a preventable ADE to categorize the extracted reports: (1) the type of drug or drug class involved in the preventable ADE, (2) the type of medication error or inappropriate care that caused the preventable ADE, and (3) the type of adverse outcome or patient injury associated with the medication error. The designation of "types of medication errors" was based on the preventability criteria listed in Table 1. Medications were organized into drug classes by using a modification of the American Hospital Formulary Service (AHFS) code.[21] If a drug class was represented by only one drug, the specific drug was reported. This study was approved by the institution's investigational review board.


Of 2571 ADR reports collected over the six-year study period, 415 (16.1%) ADRs were considered potentially preventable; 98 cases were excluded because the ADR occurred in the ambulatory care setting and led to a hospital admission. Therefore, 317 reports of preventable ADEs in 275 patients were analyzed. The mean ± S.D. age of the patients who had these preventable ADEs was 48.5 ± 23.9 years (median, 54 years), and 52% were female.

Analysis by drug class. A total of 93 different drugs were associated with the 317 preventable ADEs reviewed; however, 10 drugs accounted for more than 60% of all reports. They included the anticoagulants warfarin (28.7% of reports) and heparin (3.8%), the opiate agonists morphine (8.5%) and meperidine (1.9%), insulin (6.9%), midazolam (3.5%), digoxin (2.2%), phenytoin (2.2%), cyclosporine (1.6%), and promethazine (1.6%).

Almost three quarters of all reports were accounted for by 10 major drug classes (Table 2). Organizing drugs into major drug classes did not affect the high-priority areas: anticoagulants, opiate agonists, insulins, benzodiazepines, hydantoins, and digoxin continued to cause the most problems. Excessive anticoagulation or hemorrhagic events accounted for one third of all preventable ADEs, and another third was described by central nervous system problems, such as excessive sedation or respiratory depression. Reports associated with inappropriate use of anticoagulants were the only cases that frequently listed abnormal laboratory values (elevated activated partial thromboplastin time [aPTT] or INR values) without other clinical manifestations. However, even when minor events (e.g., echymosis, skin lesions) and major hemorrhagic events (e.g., gastric or intracranial hemorrhage) were considered separately, anticoagulants still remained within the top 10 problem areas.

ADR tracer program. Almost two thirds (62.5%) of all ADRs reviewed were identified by the ADR tracer program. The remainder of cases were generated by spontaneous reports to the drug information center. Even though the proportion of preventable ADEs that could be explained by the top 10 drug classes became smaller when the reactions identified by the tracer program were deleted, the most prevalent classes remained the same when only spontaneous reports were considered: opiate agonists, benzodiazepines, hydantoins, digoxin, anticoagulants, cyclosporine, antineoplastics, cephalosporins, aminglycosides, and tacrolimus were most often associated with preventable ADEs (in descending order). The only difference between cases identified by tracer searching or spontaneous reporting was the absence of insulin-induced hypoglycemia within spontaneous reports. Only one insulin-induced hypoglycemic event was spontaneously reported, while 21 cases were identified through the ADR tracer program (using a trigger for chart review of patients who received 50% dextrose injection).

Analysis by type of error and preventability code. A total of 436 preventability codes were assigned to the 317 reports (Table 1). When multiple codes were assigned to single cases, they were often code 2 or 3. Code 2 (inappropriate route, dose, or frequency) was assigned to 68.1% of all ADRs. These ADRs included a variety of different drugs and outcomes and did not show a specific pattern. In contrast, preventability code 3 (therapeutic drug monitoring and laboratory tests not performed or performed infrequently) was dominantly associated with inappropriate monitoring or testing of INR and aPTT with anticoagulants (70%), serum creatinine with potentially nephrotoxic drugs (10%), blood glucose with insulin (6%), and digoxin serum concentrations (6%). Of these four high-risk areas, three were already highlighted by the top 10 drug classes identified. The lack of renal monitoring for patients receiving potentially nephrotoxic drugs, such as aminoglycosides, vancomycin, methotrexate, and cyclosporine, was an additional high-risk area for preventable ADEs.

In addition, six reports (5.0%) of preventable ADEs were caused by health care providers not considering a patient's allergy history when choosing drug therapy (preventability code 4). Drug types varied in this category, with the largest proportion of preventable allergies associated with antimicrobials.

Of 80 ADEs resulting from drug-drug interactions, 30 were associated with psychoactive drugs and led predominantly to somnolence or respiratory depression (opiate agonists, benzodiazepines, antidepressants, hydantoins, skeletal muscle relaxants, promethazine, and diphenhydramine).

The other preventability codes were rarely used.

Analysis by adverse outcome. Analysis by adverse outcome (Table 3) confirmed the same high-risk circumstances identified by analysis of major drug categories. The most frequent outcomes were excessive anticoagulation and major and minor bleeding events, which were mainly associated with anticoagulants (three with nonsteroidal antiinflammatory drugs [NSAIDs], two with alteplase and abciximab). The second most frequent outcomes categories were respiratory depression or arrest and excessive sedation or somnolence associated with opiate agonists, benzodiazepines, and other psychoactive drugs. Renal problems were associated with aminoglycosides, vancomycin, methotrexate, cisplatin, angiotensinconverting-enzyme inhibitors, and tacrolimus. Analysis by outcome identified two additional preventable ADE high-priority circumstances that were not highlighted by the analysis by drug class or preventability code. The first was seizures associated with imipenem (three patients), cyclosporine (three), tacrolimus (two), ciprofloxacin, theophylline, meperidine, desmopressin, epoprostenol, and fluconazole (one each). Preventability codes associated with seizures involved drug-drug interactions or patient histories of seizures that were not considered. The second most frequent preventable ADEs not identified by previous analyses were extravasation, necrosis, and edema associated with inappropriate administration and infiltration of sympathomimetics, amrinone, and calcium.

Table 4 lists the 10 most common preventable ADEs identified by the ADR report database by type of drug or drug class, underlying medication error, and associated adverse outcome. Almost 251 (80%) of all ADEs could be explained by these 10 unique preventable ADE high-priority areas. Of these, 88 events (35%) were asymptomatic and only identified by abnormal aPTT and INR values. The 251 high-priority preventable ADEs identified were identified and reported in approximately 150,000 admissions between 1994 and 2000, indicating a preventable ADE (from spontaneous reporting) rate of 0.2%, or 2 of every 1000 hospitalized patients.


Unlike previously reported systematic analyses of preventable ADEs, our findings suggest that specific high-priority preventable ADEs can be identified and targeted for quality-improvement efforts. Over-anticoagulation associated with overdoses of warfarin and heparin and insufficient monitoring, oversedation and respiratory depression associated with overdoses and drug- drug interactions of opiate agonists or benzodiazepines, and hypoglycemia associated with insulin overdoses and insufficient monitoring accounted for more than half of the preventable ADEs recorded in this database.

The generalizability of the identified high-priority preventable ADEs to other hospitals is indirectly supported by previous studies that identified preventable ADEs in hospitals with systematic expert chart review.[4, 22, 23] Even though these studies do not provide explicit descriptions of the identified preventable ADEs, comparison with the reported drug classes supports our findings. Analgesics and opiate agonists (12-29%) and sedatives and psychotropics (11-23%) ranked within the top three drug classes associated with ADEs in all three studies. Bates and colleagues[4] found that analgesics, sedatives, antimicrobials, antipsychotics, and diabetes medications are most often associated with preventable ADEs.

However, the ADR database does not represent the universe of preventable ADEs and may omit other equally important areas. Moreover, ADR reports may represent only about 5-10% of all ADR occurrences.[24, 25] The decision to report events might depend on the severity of the ADR or litigation concerns.[26] Spontaneous reporting of ADRs and errors is also biased toward causal associations between drugs and events that are known and well established.[25, 27] For example, ADR reporting rates will increase independently of drug-prescribing rates because the reaction becomes more widely appreciated.

Similarly, ADR tracer programs can only identify preventable ADEs that are treated with specific drugs or antidotes. Since approximately two thirds of the preventable ADEs analyzed in this study were identified by a tracer program, the high-priority areas could have been systematically influenced, and spontaneous reports might better mirror the true heterogeneity of preventable ADEs. However, when only spontaneous preventable ADEs were considered, only hypoglycemia treated with 50% dextrose injection was excluded from the list of high-priority areas previously identified. Drug-induced hypoglycemia, although not routinely reported by health care practitioners, has been described as a common problem when assessed by expert audit.[28] Thus, the tracer drug program and spontaneous reports may complement each other to some extent.

It is important to note that ADR databases usually include only errors of commission, such as overdoses or the choice of a contraindicated drug.

Omission errors (lack of necessary drug therapy or undertreatment) are not well represented, even though they have been found to contribute substantially to preventable ADEs.[5] Studies have only recently begun including omission errors in their definition of ADEs, and examples of therapeutic failure and lack of access to drug therapy are comparably rare. Our review identified only three preventable ADE studies in hospital inpatients that specifically included omission errors (i.e., errors with a clear definition in their inclusion criteria or example cases).[4, 22, 29] The only omission cases that were relevant to our purposes included uncontrolled pain resulting from undertreatment with opioids, therapeutic failure associated with the selection of ineffective antimicrobials, and gastric bleeding in patients taking NSAIDs with lack of preventive comedication.

None of these adverse consequences of omission errors were identified in our analyses, probably because they were not reported and because the applied preventability criteria would not capture "lack of drug therapy" or "underdoses" as a preventable ADE. The inclusion of omission errors would provide a more comprehensive and balanced assessment of drug therapy quality and should be addressed with updated reporting and assessment criteria.

The data for these analyses were representative of only one particular hospital, and it could be argued that differences might be observed between academic versus community and tertiary versus primary care hospitals. However, the comparison of our results with published literature supports the identified high-priority areas as well described and very common across institutions. These high-priority areas are not representative of all possible preventable ADEs, but they are valuable areas in which to initiate systematic quality improvement. These areas need to be supplemented with reports and analyses of omission errors and other new medication errors as the definition of evidencebased guidelines evolves.

The novel systematic method used in this analysis to define and aggregate reports was effective in identifying high-priority preventable ADEs. Aggregation by preventability code or type of adverse outcome added new aspects to the analysis by drug class. Even though various drugs can cause allergies, the error of not considering a documented history of allergy makes this preventable ADE a unique problem. Each high-priority preventable ADE presents an indication (or contraindication) and a specific inappropriate pattern of care that is associated with an adverse patient outcome.

The risk of the identified medications has been well documented by previous studies. However, this risk seems to expand from the drug product to its use (i.e., these medications were also most often associated with inappropriate care and preventable ADEs). Moreover, most of these inappropriate patterns of care or medication errors were repeated despite known evidence-based standards or guidelines (as opposed to random slips or lapses). For example, published literature emphasizes drug- drug interactions with drugs that have additive sedative effects and suggests dosage reductions, but these adjustments were repeatedly not performed for various reasons. These reasons need to be explored in root-cause analyses to identify ways to improve the current drug-use system. A review of the reported hypoglycemic events suggested that insulin-dependent patients tend to miss meals because they are scheduled for diagnostic procedures, yet they received normal insulin dosages in expectation of normal food intake (e.g., extensive waiting times for x-rays or other procedures). Frequent causes of the identified high-priority preventable ADEs were lack of monitoring, insufficient consideration of drug dosing and drug-drug interactions, and insufficient documentation, access, and flow of patient and treatment information.

By combining elements of drug classes, ADEs, and error types, we identified common patterns of inappropriate care. Only a few high-priority areas could describe the majority of ADR reports assessed as preventable. Further efforts to enhance the information on the nature of preventable ADEs should focus on two areas: training of clinicians to improve the number and comprehensiveness of preventable ADE reports, and development and implementation of more advanced classification systems to identify common patterns and root causes of preventable ADEs.


Analysis of a hospital ADR database identified circumstances associated with clinically significant preventable ADEs.

Presented at a symposium at the ASHP Midyear Clinical Meeting, New Orleans, LA, December 4, 2001.


Table 1. Distribution of Preventability Codes Assigned to 317 ADR Reportsa

Table 2. Frequency of Preventable ADEs by Drug Class and Associated Adverse Patient Outcomesa

Table 3. Frequency of Adverse Outcomes Associated with Preventable ADEsa

Table 4. Ten Most Frequent Preventable ADEs and Their Causesa


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Sidebar: Appendix - ADR tracer drugs

Activated charcoal
Calamine lotion
50% dextrose injection
Topical corticosteroids (betamethasone, flunisolide, hydrocortisone, triamcinolone)

Funding Information

Supported by a grant from the American Society of Health-System Pharmacists Research and Education Foundation, Bethesda, MD, and the University of Florida, Research and Graduate Programs, Research Opportunity Fund, Gainesville, FL.

Reprint Address

Dr. Winterstein at the Department of Pharmacy Health Care Administration, College of Pharmacy, University of Florida, P.O. Box 100496, Suite P111, 1600 S.W. Archer Road, Gainesville, FL 32610 (

Almut G. Winterstein, Ph.D., is Clinical Assistant Professor, Department of Pharmacy Health Care Administration, College of Pharmacy, University of Florida (UF), Gainesville. Randy C. Hatton, Pharm.D., Bcps, is Co-Director, Shands at the University of Florida (SUF), Gainesville, and Clinical Professor, Department of Pharmacy Practice, College of Pharmacy, UF. Ricardo Gonzalez-Rothi, M.D., is Professor, Department of Medicine, College of Medicine, UF. Thomas E. Johns, Pharm.D., Bcps, is Manager, Clinical Practice Operations, Department of Pharmacy, SUF, and Clinical Assistant Professor, Department of Pharmacy Practice, College of Pharmacy, UF. Richard Segal, Ph.D., is Professor and Chair, Department of Pharmacy Health Care Administration, College of Pharmacy, UF.

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