Doi:10.1016/j.genhosppsych.2006.12.002

General Hospital Psychiatry 29 (2007) 156 – 162 Medication safety in a psychiatric hospital Jeffrey M. Rothschild, M.D., M.P.H.a,b,4, Klaus Mann, M.D.a,c, Carol A. Keohane, B.S.N., R.N.a, Deborah H. Williams, M.H.A.d, Cathy Foskett, R.N.a, Stanley L. Rosen, R.P.H., M.H.A.e, Linda Flaherty, A.P.R.N., B.C.f, James A. Chu, M.D.g,h, David W. Bates, M.D., M.Sc.a,b,d aDivision of General Medicine and Primary Care, Brigham and Women’s Hospital, Boston, MA 02120-1613, USA bDepartment of Medicine, Harvard Medical School, Boston, MA 02115, USA cDepartment of Psychiatry, University of Mainz, Mainz, Germany dClinical Quality and Information Systems, Partners Healthcare, Wellesley, MA 02481, USA ePharmacy Department, McLean Hospital, Belmont, MA, USA fDepartment of Nursing, McLean Hospital, Belmont, MA 02478-9106, USA gDepartment of Psychiatry, McLean Hospital, Belmont, MA 02478-9106, USA hDepartment of Psychiatry, Harvard Medical School, Boston, MA 02115, USA Received 6 October 2006; accepted 4 December 2006 Objective: We sought to assess the epidemiology of medication errors (MEs) and adverse drug events (ADEs) in a psychiatric hospital.
Methods: We conducted a 6-month prospective observational study in a 172-bed academic psychiatric hospital. Errors and ADEs were foundby way of chart review, staff reports and pharmacy intervention reports. Physicians rated incidents as to the presence of injury, preventabilityand severity of an injury. Serious MEs were nonintercepted MEs with potential for harm (near misses) and preventable ADEs.
Results: We studied 1871 admissions with 19,180 patient-days. The rate of ADEs and serious MEs were 10 and 6.3 per 1000 patient-days,respectively. Preventable ADEs accounted for 13% of all ADEs (25/191). The most common classes of drugs associated with ADEs wereatypical antipsychotics (37%). Nonpsychiatric drugs accounted for only 4% of nonpreventable ADEs but were associated with nearly onethird of all preventable ADEs and near misses. MEs were most frequently associated with physician orders (68%), but there was also a highrate of nursing transcription errors (20%).
Conclusions: ADEs and serious MEs were common among psychiatric inpatients and similar to rates in studies of general hospital inpatients.
Medication safety interventions targeting psychiatric care need further study.
D 2007 Elsevier Inc. All rights reserved.
Keywords: Medication errors; Psychiatry; Psychopharmacology; Patient safety adverse drug events (ADEs) continues to be an importantproblem. Furthermore, the psychiatric population is growing The pharmacologic treatment of psychiatric disorders has older (reflecting the demographics of the overall popula- improved in recent years. Specifically, many new psycho- tion), and many of these patients are receiving many other pharmacologic agents have been developed; some of which nonpsychiatric medications that may be unfamiliar to have proved to be highly effective. As a result, many acute and chronic psychiatric illnesses can now be treated much In 1999, the groundbreaking report of the Institute of more effectively than a decade ago. However, while these Medicine (IOM) brought national attention to the problem of new agents have better side-effect profiles than many of the preventable adverse events including many due to medica- older drugs, the potential for medication errors (MEs) and tions While substantial information regarding thefrequency and prevention of MEs and ADEs in hospitalizedpatients is available most of these studies have 4 Corresponding author. Division of General Medicine, Brigham and included few or no psychiatric patients. Specific populations Women’s Hospital, 1620 Tremont Street, Boston, MA 02120-1613, USA.
such as critically ill patients and ambulatory oncology Tel.: +1 617 732 4825; fax: +1 617 732 7072.
E-mail address: [email protected] (J.M. Rothschild).
patients have been demonstrated to pose particular challenges 0163-8343/$ – see front matter D 2007 Elsevier Inc. All rights reserved.
doi:10.1016/j.genhosppsych.2006.12.002 J.M. Rothschild et al. / General Hospital Psychiatry 29 (2007) 156 – 162 to safe medication use [6,7]. The limited data available of every 7 days of a patient’s hospitalization. Diabetes suggest that the psychiatric inpatients represent management flow sheets, standardized supplemental insulin risk population who pose particular challenges [8]. We sliding scale order forms and anticoagulation (warfarin) previously found that ADEs were disproportionately frequent dosing and test result flow sheets were not in use at the time on psychiatric units compared with medical and of the study. Desktop computers were not readily available units; moreover, these ADEs were especially costly [2].
for drug information lookups, although some physicians However, to date, few medication studies have been used handheld computers [or personal digital assistants conducted in psychiatric hospitals [9]. A more recent IOM (PDAs)] with drug reference guides as resources. Pharma- report, Improving the Quality of Health Care for Mental and cists did not routinely round with physicians but were Substance-Use Conditions, found only a bhandful of studiesQ available for telephone consultations.
of ADEs in inpatient psychiatric hospitals Recently, a task force of the American Psychiatric Association (APA) recommended focusing on medication We used definitions from prior inpatient medication safety as one of the initial patient safety activities with high safety studies MEs included errors during medication priority for psychiatric practice In order to develop ordering, transcribing, dispensing, administering and/or effective patient safety strategies, it is necessary to better monitoring. We excluded from analysis those MEs with understand the epidemiology of inpatient psychiatric med- little or no potential for harm. ADEs were injuries due to a ication safety; we therefore conducted a prospective study of medication and were classified as preventable (associated the incidence and nature of MEs and ADEs in the inpatient with an ME) or nonpreventable. An example of a non- preventable ADE would be initiating lamotrigine at recom-mended doses to a patient with no prior allergy history whothen develops a severe rash. An example of a preventable ADE would be administering lamotrigine to a patient with a The study was conducted prospectively between Sep- known allergy to the medication who then develops tember 1, 2004, and February 28, 2005. The institutional Stevens–Johnson syndrome. A near miss or potential review boards of the participating sites approved the study.
ADE was an ME that had the potential to cause harm butdid not because it was either intercepted before reaching the patient (intercepted near miss) or reached the patient and The study hospital was a 172-bed academic psychiatric fortuitously did not cause harm (nonintercepted near miss).
hospital in the New England area. The hospital pharmacy Serious MEs were those that reached the patient and had the receives nearly 70,000 medication orders and dispenses over capacity to cause injury and included nonintercepted near 740,000 units of medications during a 6-month period. The misses and preventable ADEs. Intercepted near misses were study was conducted on six patient care units (133 beds), excluded from this category because successful safety including an acute inpatient psychiatric satellite unit that interventions can be expected to result in an increase in was remote from the main campus. The on-campus study interceptions of these near-miss events.
units included a dissociative disorders and trauma unit, a 2.3. Data collection and medication incident determination schizophrenia and bipolar disorders unit, a geriatric unit, anacute psychiatric short-term unit and a dementia and Prior to study collection, nurse and physician leaders and the chief of pharmacy met with the research team to describe Medication orders were paper based. Both resident and the medication processes used in the study hospital. Nurse attending psychiatric physicians wrote orders. In addition, researchers with experience in chart abstraction underwent hospital-based internists were available for medical consul- training provided by study researchers with experience in tation and comanagement of complicated medical patients.
prior medication safety research and a psychiatrist with The main campus pharmacy was staffed during daytime and evening hours until 11 p.m. on weekdays and until 8 p.m. on Suspected MEs and ADEs or incidents were identified by weekends. The satellite unit used the main campus methods detailed in our prior work Briefly, three methods pharmacy for weekday delivery of medications. Staff nurses were used for finding suspected medication incidents. First, used unit-based pharmacy stock for urgently needed chart abstraction was conducted on alternate weekdays, and medications at the satellite unit and during the night at the findings were entered into structured data collection forms.
main campus. Patients requiring continuous intravenous Physician and nursing progress notes, medication orders, medications or telemetry monitoring required transfer to a MARs and pertinent test results were reviewed. Secondly, medical hospital for subsequent care.
solicited reports from both nursing and physician staff were Structured admission order forms were available at the also used to assist in incident finding. Lastly, nursing and time of admission. Medication administration records pharmacy intervention reports were reviewed. We used (MARs) were maintained by staff nurses. A new MAR institutional psychopharmacologic dosing guidelines, includ- was recreated using manual transcription at or near the end ing research protocols, to determine dosing errors.
J.M. Rothschild et al. / General Hospital Psychiatry 29 (2007) 156 – 162 Suspected incidents were presented to two physicians, including an internist with experience in prior medication safety studies (J.M.R., D.W.B.) and a psychiatrist (K.M., J.A.C.), to independently rate incidents as to the presence of an ME and/or ADE. Physician raters judged severity using a four-point Likert scale (significant, severe, life threatening, fatal) and preventability using a five-point Likert scale (prevented, definitely preventable, probably preventable, probably not preventable, definitely not preventable), with the preventability scale collapsed to preventable or not preventable prior to analysis. Rater disagreements were MEs were categorized as harmful or not and mapped to the National Coordinating Council for Medication Error Report- ing and Prevention Levels E–I and B–D, respectively All medication errors are intercepted and nonintercepted near misses Serious MEs were analyzed for injury severity or potential c Serious medication errors are nonintercepted near misses and severity as well as systems-related factors. ME stages were categorized as ordering, transcribing, dispensing, adminis-tration and monitoring. Error types such as wrong doses or The most common reasons for admission were mood known drug allergy were also identified. Incidents not rated disorders and schizophrenic disorders. The levels of as ADEs or MEs with potential for harm were excluded.
interrater agreement for incident type, ADE severity, near-miss potential severity and incident preventability were good to excellent (.85, .49, .57 and .97, respectively).
Incident rates were assessed as incidents per 1000 patient- days and per 100 admissions. Statistical programming wasperformed using SAS analytical software Interrater We found 191 ADEs including 25 (13%) that were agreement was assessed using the kappa (j) statistic.
preventable and 166 (87%) that were classified as non-preventable (The rate of ADEs was 10 per 1000patient-days and 10.2 per 100 admissions. The severity of harm for most ADEs was significant (66%) with fewer A total of 1559 patients with 1871 admissions and being serious (31%) and life-threatening (2%) events. There 19,180 patient-days were included in the study ( were no fatal ADEs. The organ systems most fre-quently affected by ADEs were the central nervous system (127/191; 66.5%), cardiovascular (18/191; 9.4%) and Characteristics of patients (n = 1559) and admissions (n = 1871) ADEs (error) ADEs (no error) [n = 191] misses Schizophrenia and other psychotic disorders Anxiety, dissociative and somatoform disorders DSM-IV, Diagnosis and Statistical Manual of Mental Disorders, Fourth J.M. Rothschild et al. / General Hospital Psychiatry 29 (2007) 156 – 162 admissions (Table 2). The most common types of MEs were wrong dose (50/203; 24.6%), drug–drug interaction (DDI; Ordering, Transcription, Administration, Othera, 35/191; 17.2%) and omitted medication (28/191; 13.8%).
MEs were most frequently associated with physician orders errors (20%) and administration errors (10%; Table 4). Errors during transcription and administration deserve additional consideration because they were infrequently intercepted (4/ 50), unlike ordering errors that were often intercepted bdownstreamQ by pharmacists or nurses (77/125). Examples a Includes pharmacy filling, monitoring and dispensing.
Human factors and systems-related causes for errors were allergic or dermatologic reactions (13/191; 6.8%). While judged to be most frequently due to performance deficit approximately 50% of all medication orders were psychi- such as a slip or lapse (34.5%), knowledge deficits (21.7%) atric related, they were responsible for 92% of all ADEs.
and technical errors such as errors in transcription (19.2%) The most common class of drugs associated with ADEs was atypical antipsychotics (37%; . Nonpsychiatric Physician raters judged that the serious MEs in this study drugs, also associated with approximately 50% of all could have been prevented by computerized physician order medication orders, accounted for only 4% of nonpreventable entry (CPOE) with decision support such as DDI and drug– ADEs but were associated with 30% of all preventable dose checking (44%), basic CPOE alone to ensure legibility ADEs. Cardiovascular drugs were the most common and completeness (16.7%) and bar-coded medication nonpsychiatric drug class associated with near misses.
administration (BCMA) with an electronic MAR (15.2%).
We found 178 near misses, including 95 nonintercepted near misses, and 25 preventable ADEs resulting in a serious We found that ADEs were common in an academic ME rate of 6.3 per 1000 patient-days and 6.4 per 100 psychiatric hospital; the overall rate was about a third higher A patient with a history of depression and a known allergy to sulfa drugs was started ontrimethoprim/sulfamethoxazole and developed an immediate rash.
A patient admitted with manic psychosis developed hyponatremia after starting divalproex. Urine electrolytesconfirmed the diagnosis of SIADH. Salt tablets were added but the hyponatremia worsened. The divalproexwas discontinued 2 weeks later.
Life threatening An elderly patient with a history of dementia and increasing agitation was given a total of 275 mg, po, of quetiapine and 50 mg, po, of trazodone at night. The next morning, the patient was found lethargic and fellout of bed resulting in a cervical spine fracture.
A young patient with a history of schizoaffective disorder developed severe restlessness after an increase inthe dose of risperidone. The symptoms resolved with the addition of benztropine.
A patient with a history of schizoaffective disorder developed tremors and severe lethargy after startingperphenazine.
Life threatening An elderly patient with a history of bipolar disease was treated with trazodone, divalproex and clozapine.
The patient developed difficulty with swallowing, delirium and unsteady gait.
A young patient admitted for a suicide attempt was ordered bisacodyl (Dulcolax) 20 mg every 4 h. Theorder was intercepted and changed to every 4 days.
A patient with no history of diabetes was admitted for polysubstance abuse and was ordered glargine insulin(Lantus) 10 U, sc, daily. The order was intended for a different patient but, later, the physician interceptedthe error and placed the order on the correct patient’s chart.
Life threatening A young patient with a history of substance abuse was ordered benztropine 50 mg, im or po, for chemical restraint. The order was intercepted by the pharmacy and was replaced by an order for diphenhydramine50 mg.
An elderly patient with Alzheimer’s disease and increasingly aggressive behavior did not receive a doseof his daily morning dose of 22 U, sc, glargine insulin. His blood glucose was stable.
A patient admitted for possible drug overdose and erratic behavior was ordered Lithobid 300 mg twice dailyand ibuprofen 600 mg every 4 h as needed. The patient did not receive the ibuprofen (potential DDI).
Life threatening An elderly patient with a history of depression and suicidal ideation was ordered and given extended release metoprolol 125 mg instead of the correct dose of 25 mg. The patient’s heart rate and blood pressureremained stable.
SIADH, syndrome of inappropriate antidiuretic hormone.
J.M. Rothschild et al. / General Hospital Psychiatry 29 (2007) 156 – 162 than previously found in a similar study in general hospitals, or forensic ward and a diagnosis of schizophrenia [20].
although a lower proportion were preventable: 13% Following a 2003 study of MEs collected by versus 28% [2]. In addition, in contrast to findings in incident reports from 44 Japanese psychiatric hospitals [21], general hospitals, there were fewer life-threatening and no an analysis of organizational and human factors fatal ADEs, possibly due to the lower potential toxicity of conducted to predict failures to intercept near misses [22].
commonly used psychiatric medications compared with Near misses that reached the patient were associated with those used in general care. While ADEs due to psychotropic patients with frequent admissions, receiving more tablets medications were far more common than nonpsychotropic and being exposed to a higher patient-to-staff ratio during medications, nonpsychotropic medication ADEs were more likely to be associated with an error and are, therefore, Other studies have addressed the frequency of ADEs in preventable. We also found many near misses, both hospitalized patients in general and have assessed the intercepted and nonintercepted. We found a higher propor- frequency associated with psychotropic drugs. In a tertiary tion of errors committed during the ordering (68%) and care general hospital setting, Bates et al. found 6.5 ADEs transcription stages (20%) when compared to a similar study per 100 admissions, of which nearly a third were judged to in general hospitals (49% and 11%, respectively) be preventable. While psychotropic medications were However, the rate of administration errors was lower responsible for only 2% of the ADEs, they represented (10%) than the general hospital study (26%) 7% of the preventable ADEs. In a later study, Bates et al.
This represents what could probably be the largest found that psychotropic drugs accounted for 0.41% of prospective study of medication safety that has been done serious MEs in an academic medical–surgical hospital. After in the psychiatric hospital setting. While there has been a CPOE and a team intervention to prevent MEs, this rate fell tremendous reduction in the number of hospitalized to 0.16% ( P = .15) In a 9-year study in a teaching psychiatric patients, due in large part to advances in hospital, Lesar et al. found more than 11,000 prescribing psychopharmacotherapy, these patients still represent a large errors, of which 146 (1.3%) were associated with psycho- proportion of the national inpatient population. There are nearly a quarter of a million 24-h hospital and residential Older patients may be particularly vulnerable to the psychiatric treatment beds in the United States and harmful effects of psychotropic medications. The reasons more than a quarter of all hospital admissions are for are multifactorial and include the following: more frequent use of psychotropic medications among the elderly, the This study is also important because previous studies of increased susceptibility of older patients to drug effects inpatient psychiatric medication safety have most common- (both intended and unintended), the greater risk of DDIs ly been retrospective and studied nonpreventable ADEs associated with polypharmacy use among older patients and [also known as adverse drug reactions (ADRs)], studied the increased difficulty in diagnosing ADEs as a cause of psychotropic medication use among general medical– older patients’ new or worsening symptoms We found surgical patients or included psychiatric inpatients as part several falls that may have been associated with medications of general hospital medication safety studies.
in our study. Falls are a particular risk among elderly A 1984 epidemiologic study of a psychiatric hospital patients who are prescribed psychotropic medications, found that 75% of randomly selected patients had suffered especially SSRIs In a meta-analysis of psychotropic ADRs However, this study included very broad ADR drugs and falls in the elderly, only 2 of 54 studies were inclusion criteria (e.g., drugs were continued without change conducted in inpatient psychiatric settings in two thirds of patients with an ADR), and independent There is now a growing body of literature that addresses case reviews were not performed. A more recent study psychotropic ADEs in the general population and nursing conducted at McLean Hospital found that over a 2.5-year homes. The FDA Medwatch reported 6894 deaths from period, among 10,994 admissions, 29 (0.26%) required ADRs, including 848 (12.3%) deaths due to psychotropic transfer to a general hospital due to an ADR medications, the third largest category of drugs after In a state psychiatric hospital, Grasso et al. antineoplastic/immunosuppressive drugs and cardiovascular conducted a retrospective study of 31 admissions with drugs A recent analysis of the quality of antipsychotic 1448 patient-days and found 2194 MEs. Their unusually drug prescribing in U.S. nursing homes found that most high rate of MEs was, in part, due to the inclusion of errors atypical antipsychotics were inappropriately prescribed with little potential for harm and an unusually high In a 1-year study among 18 nursing homes, 35% of ADEs frequency of missing documentation for medication admin- were due to psychotropic and antidepressant medications. A istration. In a 1-day audit of 241 United Kingdom greater proportion of ADEs due to psychotropic medications psychiatric wards, 20% of patients were prescribed total (63%), as compared to all other drug classes (43%), were doses of antipsychotic medication that exceeded guideline preventable This finding is similar to data described recommendations These researchers found that anti- earlier in a hospital-based study but contrasts to our psychotic polypharmarcy was associated with younger age, finding that a higher proportion of the ADEs associated being male, being detained for admission on a rehabilitation with errors were associated with nonpsychiatric medications J.M. Rothschild et al. / General Hospital Psychiatry 29 (2007) 156 – 162 (8/15; 53%) rather than with psychiatric medications Interventions to reduce serious MEs include CPOE (17/176; 9.7%). Our findings might be explained in two pharmacist participation in intensive care unit rounds [32] ways: psychiatric medications could have a higher risk for and medireconciliation at hospital admission and nonpreventable adverse effects, and the total number of discharge [33]. However, few safety intervention studies ADEs unrelated to error may be much greater; just as have been conducted in the inpatient psychiatric setting. A nonpsychiatrists with less experience and knowledge than review of the impact of clinical pharmacists on psychiatric psychiatrists may have led to more errors when prescribing patients suggested that pharmreduced unnecessary psychiatric medications, psychiatrists may also commit and often costly medications [34]. In some hospitals, more MEs when managing diabetes, anticoagulation or pharmacists function as drug information officers who are available as consultants to physicians to enhance safe Improving inpatient psychiatric medication safety will medication prescribing. PDAs have been demonstrated to entail adopting lessons learned from general hospitals and improve medication reconciliation at the time of discharge other settings as well as developing strategies targeting the from a psychiatric hospital and may provide additional unique challenges of inpatient psychiatry. Leape et al. medication safety benefits in this setting The data from found that systems-related factors are responsible for many this study suggest that the interventions that would prevent errors in the general hospital setting, including deficient the largest proportion of serious MEs are CPOE with drug knowledge, deficient patient-specific information, decision support and BCMA. In the study hospital, several inadequate allergy defense, lack of standardization of interventions have been undertaken or are in the early processes, poor communication between services and planning stages and include the introduction of improved inadequate monitoring and feedback of ADEs.
physician–nursing communication techniques CPOE It has been posited that psychiatry has been slower to address medical errors than other specialties. Dr. Miles The overwhelming majority of ADEs related to psychi- Shore, cochair of the APA Task Force on Patient Safety, has atric care in this study were considered nonpreventable suggested that psychiatry’s blate arrivalQ on the medical (159/176; 90%). Advances in pharmacogenomics may error scene may be due to several factors the type of provide individual drug metabolism profiles for future medical errors that come to public attention more commonly patients and could allow the prevention of many of these are nonpsychiatric, such as those involving invasive procedures; psychiatry practice is more private and confi- This study has several limitations. It was conducted at a dential such that near misses may be less often seen or single institution so that the results may not be generalizable reported; and psychotherapy training’s emphasis on indi- to other organizations or settings. Our detection approach vidual responsibility may make psychiatrists less acceptable relied on finding events from the chart, and some ADEs of the nonpunitive system’s approach to error reduction that may have not been reported in the medical record.
has been adopted in other medical specialties.
Assessing whether or not a specific set of symptoms are Inpatient psychiatric pharmacotherapy may be associated ADEs provides particular challenges in psychiatry, espe- with different rates and types of MEs because of differences cially in severely ill patients, in whom it may be acceptable associated with psychiatric patients, psychopharmacologic to have certain symptoms if a regimen appears to be agents and the psychiatric inpatient setting. For example, effective in treating the underlying disorder.
inpatient diabetes management is more complicated forpsychiatric patients who intermittently refuse to eat or unexpectedly refuse to take their medications. Such noncom-pliance is rare in the general medical–surgical inpatient In conclusion, this study in a psychiatric hospital showed population. Psychiatric patients may also differ from non- that MEs and ADEs are common and occur with the same psychiatric patients with respect to their longer lengths of stay frequency as they do in general hospitals. They cause harm and reduced capacities to report prior drug allergies or to psychiatric inpatients but tend to be less life threatening potential active drug side effects. Characteristics of the and fatal than in general hospitals. Additional studies are psychiatric inpatient setting that may differ, as compared needed to determine which intervention strategies are most with general medical–surgical units, include lower ratios of efficacious in this setting, although computerization of nursing staff to patient, greater physician expertise in the use prescribing and implementation of BCMA appear to have of psychotropic agents but possibly less knowledge great potential. In addition, strategies should address concerning other medication classes, different nursing nonpsychiatric medication use especially since this is likely processes for patient monitoring and other systems-related factors. Medication regimens for psychiatric inpatients maybe associated with increased risks for errors due to the greater incidence of DDIs associated with psychotropic use In recent years, several interventions have been found to Funding support was provided by a grant from the be effective in reducing inpatient MEs in general care.
Agency for Healthcare Research and Quality (PO1 J.M. Rothschild et al. / General Hospital Psychiatry 29 (2007) 156 – 162 HS11534-01). The funding organization had no role in the An epidemiological study at psychiatric hospitals. Acta Psychiatr design and conduct of the study; in the collection, [17] Popli AP, Hegarty JD, Siegel AJ, Kando JC, Tohen M. Transfer of management, analysis and interpretation of the data; and psychiatric inpatients to a general hospital due to adverse drug in the preparation, review or approval of the manuscript.
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