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PubMed2005

Adverse drug events in emergency department population: a prospective Italian study.

PURPOSE: There is little evidence concerning adverse drug events (ADEs) in outpatients and related hospital admissions. In Italy, only one investigation was conducted on this important health issue. We therefore carried out a study to determine ADE incidence and ADE-related hospital admissions among emergency department (ED) visits, and to identify the risk factors for serious ADE leading to ED visit. METHODS: During the year 2000, we performed a prospective study in two observational periods of 10 days each in 22 Italian EDs. Demographic, clinical and pharmacological data about all patients admitted to ED were collected by trained and qualified monitors. Records related to ADE were analysed and validated by a specific scientific committee. RESULTS: On 18,854 enrolled patients, 629 (3.3%) were affected by ADE. Among these, 244 (38.8% of ADE patients) reported a serious event. Patients with ADE, accounting for 4.3% (193 cases) of total hospitalisations, were significantly more likely to be hospitalised (30.7% vs. 23.7%; p<0.0001), females (57.2% vs. 46.3%; p<0.0001) and elders, compared with the total sample. Serious ADE resulted significantly associated with male gender and old age. NSAIDs (16.5% of total ADE visits) and antibiotics (12.9%) were the drugs mostly involved in ADE occurrence. ADE affected mostly skin (213 ADE visits) and gastrointestinal system (211). CONCLUSION: Old age and male gender resulted risk factors involved in the development of serious ADE. The high ADE-related hospitalisation incidence highlights the need for prevention strategies targeted to reduce the impact of ADE in the general population.

Adolescent↗

PubMed1986

Zeatin biosynthesis from N-(Delta-isopentenyl)adenine in Actinidia and other woody plants.

Tissue cultures of Actinidia kolomikta can be maintained as callus through repeated passages on a nutrient medium devoid of cytokinin but containing inorganic nutrients, sucrose, and other basal organics plus auxin. Under these conditions, actively growing callus contained 2 and 0.5 nmol of the cytokinins zeatin [io(6)Ade; 6-(4-hydroxy-3-methylbut-2-enylamino)purine] and N(6)-(Delta(2)-isopentenyl)adenine (i(6)Ade), respectively, per gram (fresh weight). When tissues were transferred from cytokininless medium to 30 muM i(6)Ade, endogenous io(6)Ade increased linearly to 160 nmol/g (fresh weight) during 8 hr, and i(6)Ade increased to 5 nmol/g (fresh weight) in 2 hr and then declined. The apparent K(m) for i(6)Ade in A. kolomikta and Actinidia chinensis x Actinidia arguta callus and in tissue slices of A. arguta stems was 12 muM. In addition, the reaction(s) converting i(6)Ade to io(6)Ade was O(2)-requiring and specific for i(6)Ade versus N(6)-(Delta(2)-isopentenyl)adenosine (i(6)A). When A. kolomikta callus was fed 30 muM i(6)A, io(6)Ade increased and reached a concentration corresponding to 6 nmol/g (fresh weight) in 8 hr. Ribosylzeatin (io(6)A) did not increase. Under N(2) during i(6)A feeds, i(6)A accumulated rather than being metabolized to i(6)Ade, suggesting that i(6)A normally may be metabolized via i(6)AMP and i(6)Ade to io(6)Ade. A survey of 30 species of woody plants in 20 families of dicotyledonous angiosperms indicated that the ability to accumulate io(6)Ade (>/=10 nmol/g) in 24-hr feeds with 30 muM i(6)Ade was restricted to certain systematic groups-e.g., order Ericales, families Oleaceae and Rubiaceae. This suggests that plants may differ in their pathways for io(6)Ade biosynthesis and that cytokinin biochemistry has potential as a taxonomic character above the species and genus levels.

Journal Article↗

PubMed2002

Conformational preferences of anticodon 3'-adjacent hypermodified nucleic acid base cis-or trans-zeatin and its 2-methylthio derivative, cis-or trans- ms(2)zeatin.

Conformational preferences of the hypermodified nucleic acid bases N6-(Delta(2)-cis-hydroxyisopentenyl)adenine, cis-io(6)Ade also known as cis-zeatin, and N(6)-(Delta(2)-trans-hydroxyisopentenyl)adenine, trans-io(6)ade or trans-zeatin, and 2-methylthio derivatives of these cis-ms(2)io(6)Ade or cis-ms(2)zeatin, and trans-ms(2)io6Ade or trans-ms(2)zeatin have been investigated theoretically by the quantum chemical Perturbative Configuration Interaction with Localized Orbitals (PCILO) method. Automated geometry optimization using quantum chemical MNDO, AM1 and PM3 methods has also been made to compare the salient features. The predicted most stable conformation of cis-io(6)Ade, trans-io(6)Ade, cis-ms(2)io(6)Ade and trans-ms(2)io(6)Ade are such that in each of these molecules the isopentenyl substituent spreads away (has "dista" conformation) from the five membered ring imidazole moiety of the adenine. The atoms N(6), C(10) and C(11) remain coplanar with the adenine ring in the predicted preferred conformation for each of these molecules. In cis-io(6)Ade as well as cis-ms(2)io(6)Ade the hydroxyl oxygen may participate in intramolecular hydrogen bonding with the H-C(10)-H group. In trans-io(6)Ade the hydroxyl group is oriented towards the H-C(2) instead. This orientation is retained in trans-ms(2)io(6)Ade, possible O-H...S hydrogen bonding may be a stabilizing factor. In all these four modified adenines C(11)-H is favourably placed to participate in intramolecular hydrogen bonding with N(1). In cis-ms(2)io(6)Ade as well as trans-ms(2)io(6)Ade the 2-methylthio group preferentially orients on the same side as C(2)-N(3) bond, due to this non-obstrusive placing, orientation of the hydroxyisopentenyl substituent remains unaffected by 2-methylthiolation. Thus the N(1) site remains shielded irrespective of the 2-methylthiolation status in these various cis-and trans-zeatin analogs alike. Firmly held orientation of hydroxyisopentenyl substituent in zeatin isomers and derivatives, in contrast to adaptable orientation of isopentenyl substituent in i(6)Ade and ms(2)i(6)Ade, may account for the increased efficiency of suppressor tRNA and reduced codon context sensitivity accompanied with the occurrence of ms(2)-zeatin (ms(2)io(6)Ade) modification.

Anticodon↗

PubMed1998

Adverse drug events in hospitalized elderly.

BACKGROUND: The study objectives were (a) to describe the occurrence, types, and preventability of adverse drug events (ADEs) in hospitalized patients 70 years of age and older; (b) to examine the association between potential risk factors and ADEs; and (c) to examine the relationship of an ADE occurrence and hospital length of stay (LOS) and functional decline. METHOD: Consecutive general medical admissions (n = 157) of community-dwelling persons were prospectively monitored daily for ADE occurrence. Admission assessment included demographic factors, cognition, preadmission medication use, and functional status. Discharge assessment included functional status. LOS, discharge diagnoses, and medication use during the hospitalization. RESULTS: Twenty-three patients (14.6%) experienced 28 probable ADEs, of which 54.2% (13/24) were judged to be potentially preventable. Patients experiencing an ADE had a significantly lower mean Mini-Mental State Examination score (23.6 +/- 4.3 vs 25.5 +/- 3.6, p = .039) and were prescribed significantly more new inpatient medications (4.0 +/- 2.3 vs 2.6 +/- 1.7, p = .01) compared to non-ADE patients. Age, gender, functional status prior to admission, percent with more than four active diagnoses, or number of preadmission medications were not associated with ADE status. Upon discharge, 50.0% of ADE patients experienced a decline in one or more activities of daily living (ADLs), compared with 24.1% of non-ADE patients (p = .017). ADE patients had a longer LOS (8.7 +/- 4.9 vs 6.6 +/- 3.0 days, p = .022) compared to non-ADE patients. CONCLUSIONS: ADEs were associated with number of new inpatient medications and admission cognitive status, but not demographic, disease, or physical function variables. Patients experiencing an ADE were more likely to experience a longer LOS and to decline in ADL function. ADEs may be one factor contributing to functional decline during hospitalization. Future research in this area should include larger samples and multivariable analyses controlling for potential confounders.

Activities of Daily Living↗

PubMed2006

Development of an alcohol deprivation and escalation effect in C57BL/6J mice.

BACKGROUND: Relapse-like drinking has been studied through the expression of the alcohol deprivation effect (ADE), which is measured by a pronounced increase in ethanol preference and consumption after imposed abstinence. No studies have characterized the ADE in C57BL/6J (B6) mice. The present study examined the effects of length and number of deprivations on the expression of the ADE in B6 mice. METHODS: Adult male B6 mice received 24-hour continuous access to ethanol and water for 6 weeks (baseline). Experiment 1 determined the ADE in mice receiving weekly access to 15% ethanol (i.e., exposed 1 day a week and deprived during the other 6 days) for a total of 10 weeks. Experiments 2 and 3 determined the ADE after a single 2-week deprivation period in mice receiving a single concentration of 15% ethanol or multiple concentrations of 7.5, 15, and 30% ethanol, respectively, followed by weekly access to their respective ethanol solutions for 10 weeks. Experiment 4 determined the ADE after a single 2-week deprivation period, followed by daily access to 15% ethanol. Mice never deprived of ethanol (i.e., continuous access) were used as age-matched drinking controls. RESULTS: The ADE was observed after the initial 6-day deprivation period and was profoundly enhanced (i.e., escalation of the ADE) following weekly reexposure to 15% ethanol. Compared with a single concentration of 15% ethanol, concurrent access to multiple ethanol concentrations resulted in a near 2-fold increase in baseline ethanol consumption. Regardless of having access to single or multiple concentrations of ethanol, the ADE was not observed immediately after a 2-week deprivation period. The ADE was observed (although to a lesser magnitude and duration) following weekly reexposure to single or multiple concentrations of ethanol. Alternatively, following a 2-week deprivation period, mice receiving daily access to 15% ethanol showed a significant decrease in ethanol intake and preference (i.e., negative ADE). CONCLUSIONS: Short-term deprivations followed by repeated intermittent (weekly) reexposure to ethanol produces a robust ADE in B6 mice. Increasing the initial deprivation length to 2 weeks produces various opposing effects, including erasure of an initial ADE, diminished expression and magnitude of the ADE following weekly exposure, and complete reversal of the ADE following daily exposure to ethanol.

Alcohol Drinking↗

PubMedDate not supplied

The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group.

OBJECTIVE: To assess the additional resource utilization associated with an adverse drug event (ADE). DESIGN: Nested case-control study within a prospective cohort study. PARTICIPANTS: The cohort included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary-care hospitals over a 6-month period. Cases were patients with an ADE, and the control for each case was the patient on the same unit as the case with the most similar pre-event length of stay. MAIN OUTCOME MEASURES: Postevent length of stay and total costs. METHODS: Incidents were detected by self-report stimulated by nurses and pharmacists and by daily chart review, and were classified as to whether they represented ADEs. Information on length of stay and charges was obtained from billing data, and costs were estimated by multiplying components of charges times hospital-specific ratios of costs to charges. RESULTS: During the study period, there were 247 ADEs among 207 admissions. After outliers and multiple episodes were excluded, there were 190 ADEs, of which 60 were preventable. In paired regression analyses adjusting for multiple factors, including severity, comorbidity, and case mix, the additional length of stay associated with an ADE was 2.2 days (P=.04), and the increase in cost associated with an ADE was $3244 (P=.04). For preventable ADEs, the increases were 4.6 days in length of stay (P=.03) and $5857 in total cost (P=.07). After adjusting for our sampling strategy, the estimated postevent costs attributable to an ADE were $2595 for all ADEs and $4685 for preventable ADEs. Based on these costs and data about the incidence of ADEs, we estimate that the annual costs attributable to all ADEs and preventable ADEs for a 700-bed teaching hospital are $5.6 million and $2.8 million, respectively. CONCLUSIONS: The substantial costs of ADEs to hospitals justify investment in efforts to prevent these events. Moreover, these estimates are conservative because they do not include the costs of injuries to patients or malpractice costs.

Boston↗

PubMed1998

Optimal myocardial preconditioning in a human model of ischemia and reperfusion.

BACKGROUND: Adenosine (ADE) may mediate the protective effects of preconditioning (PC). However, human data are lacking, and the optimal method of ADE administration and the mechanism of protection remain unresolved. METHODS AND RESULTS: We have developed a model of simulated "ischemia" (I) and "reperfusion" (R) in quiescent human ventricular cardiomyocytes. Cellular injury and metabolic parameters were assessed after various interventions: Cells were preconditioned with anoxia (PC0), hypoxia (PC16), anoxic supernatant (SUP0), or hypoxic supernatant (SUP16) with or without the ADE receptor antagonist (SPT) or ADE deaminase (ADA). ADE was applied before, during, or after I or continuously with and without SPT. Cells were treated with the PKC agonist PMA. PC cells were incubated with the protein kinase-C (PKC) antagonist Calphostin-C (Cal-C). PKC translocation and PKC activity were assessed. PC0 was most protective. Protection was transferable via SUP0, which produced the highest concentrations of ADE. Protection was lost with SPT or ADA. Intracellular ATP fell after PC and prolonged I and R. Exogenous ADE was most protective when administered before I at 50 mumol. ADE during I was partially protective. No additional protection was provided with continuous ADE treatment. ADE prevented ATP degradation but increased lactate immediately after its administration. SPT abolished the protective effects of ADE. PMA conferred protection, which was abolished with Cal-C. ADE stimulated PKC translocation and PKC activity in the absence of SPT. CONCLUSIONS: Maximal I confers maximal PC. The degree of I is reflected in supernatant ADE concentrations. The initial ATP fall with PC may account for a lack of ATP preservation after I and R. ADE reproduces the protective effects of PC, preserves ATP, and increases lactate production, perhaps by stimulating glycolysis. Clinical trials of ADE administered during cardiac surgery are necessary to further define its beneficial effects in humans.

Adenosine↗

PubMed2003

Incidence and impact of adverse drug events in pediatric inpatients.

OBJECTIVES: To determine the incidence and causes of adverse drug events (ADEs) and potential ADEs in hospitalized children, and to examine the consequences of these events. DESIGN: Prospective review of medical records and staff interviews were performed. The ADEs were defined as injuries from medications or lack of an intended medication, and potential ADEs, as errors with the potential to result in injury. SETTING: A general pediatric unit and a pediatric intensive care unit in a metropolitan medical center. PATIENTS: A total of 1197 consecutive patient admissions were studied from September 15, 2000, to May 10, 2001. The admissions represented a total of 922 patients and 10,164 patient-days. RESULTS: The ADEs (6/100 admissions, 7.5/1000 patient-days) and potential ADEs (8/100 admissions, 9.3/1000 patient-days) were common in hospitalized children. Demographic variables associated with the occurrence of these events were the length of hospital stay, case-mix index, and amount of medication exposure. After adjusting for length of stay, medication exposure continued to have a significant influence on ADEs and potential ADEs. For ADEs, 18 (24%) were judged to be serious or life threatening. Most ADEs were not associated with major or permanent disability. Patients with both ADEs and potential ADEs were less likely to be routinely discharged and more likely to be discharged with home health care or to another institution, suggesting that patient disposition was not related to the adverse event. CONCLUSIONS: Both ADEs and potential ADEs are common among hospitalized children with greater disease burden and medication exposure. These findings suggest that these events were a consequence, rather than a cause, of more severe illness.

Child↗

PubMedDate not supplied

Adverse drug events in hospitalized patients treated with cardiovascular drugs and anticoagulants.

PURPOSE: To evaluate the incidence of serious adverse drug events (ADEs) caused by cardiovascular drugs during hospitalization in a department of internal medicine, and to identify patients at highest risk. PATIENTS AND METHODS: All the patients treated with cardiovascular drugs and/or anticoagulants in the department between November 1999 and January 2000 were recruited into the study. During hospitalization the patients' charts were reviewed by a pharmacist and a clinician, and the occurrence of serious ADEs was assessed using the Naranjo algorithm. 'Possible' and 'doubtful' ADEs were not counted. RESULTS: Of 496 patients who were enrolled in the study, 20 (4%) had serious ADEs. Compared to patients without ADEs, patients in the ADE group were older (72 +/- 12.6 years (mean +/- SD) vs. 65 +/- 13 years, p = 0.048), their average stay in hospital was longer (7.3 +/- 5.5 days vs. 5.2 +/- 3.7 days, p = 0.018) and their mean urea levels were higher (10.8 +/- 9.3 mmol/l vs. 7.8 +/- 5.3 mmol/l, p = 0.027). The most frequent background pathologies of the 20 patients with ADEs were hypertension (in 18 (90%)) and atrial fibrillation (in nine (45%)). In 50% of the the ADE group there was a history of drug allergies. The ADEs recorded were bleeding in four (20%), arrhythmias in six (30%), orthostatic hypotension in six (30%) and skin necrosis, paranoid reaction, acute hepatitis and acute renal failure in four (20%). The causative drugs were warfarin (which accounted for 25% of the ADEs), beta-blockers (15%), propafenone (5%), amiodarone (5%), and Ca(2+)-channel blockers, nitrates and diuretics (together accounting for 50% of ADEs). Drug combinations were implicated in 50% of ADE. CONCLUSIONS: Serious ADEs were developed by 4% of hospitalized patients taking cardiovascular drugs. Those at highest risk were older, were receiving multiple drug therapy and had higher urea levels. Warfarin and beta-blockers were the drugs causing the largest number of adverse effects. ADEs are an important cause of preventable morbidity, often with serious economic implications and special attention should be given to their prevention.

Adverse Drug Reaction Reporting Systems↗

PubMed1975

Extrachromosomal elements in a super-suppression system of yeast. III. Enhanced detection of weak suppressors in certain non-suppressed psi-strains.

Individual colonies of an adenine-requiring strain of the genotype ade 2-1, SUPQ5, [psi minus] exhibit high and uniform frequencies of ADE+ revertants (5-1 times 10-5). The frequencies for strains of the genotypes ade 2-1, SUPQ5+, [psi+] and ade 2-1 SUPQ5+, [psi minus] are by contrast 1-2 times 10-7 and 0-5 times 10-7 respectively. Mutation from [psi minus] to [psi+] can occur. This suggests that the original mutation from [psi+] to [psi minus] is not necessarily a physical loss of, or extensive deletion, the extrachromosomal elements. Although mutation from [psi minus] to [psi+] occurs, the majority of ADE+ revertants from ade 2-1, SUPQ5, [psi minus] strains contain other types of mutation. Crosses between most ADE+ revertants and ade 2-1, SUPO5+, [psi minus] strains yield adenine-requiring diploids and tetrad segregations of 0:4, 1:3 and 2:2 ADE+ :ade minus. It is argued that most mutations give rise to weak recessive suppressors (SUPX) which are themselves incapable of suppressing the ochre allele ade 2-1, unless the allele SUPQ5 is also present. Tests with two suppressors, S-theta and S-zeta, isolated by Dr R. A. Gilmore, which are themselves incapable of suppressing ade 2-1, show that they do not do so even in the presence of SUPQ5. Thus the set of suppressors isolated by us is a special class which can perhaps only be observed in the genetic background ade 2-1, SUPQ5, [psi minus]. There is evidence that some of the new suppressors are capable, in the absence of SUPQ5, of weakly suppressing trp 5-48 and perhaps can 1-100. All ochre alleles are, however, suppressed by the combination SUPQ5, SUPX. SUPQ5 is able to suppress trp 5-48, his 5-2, lys 1-1 and can 1-100 in a [psi minus] background, although it does so variably. It is incapable of suppressing ade 2-1 in such a background. It is argued that the alteration in the [psi] determinant results in a lowered efficiency of suppression by SUPQ5 rather than a changed specificity.

Adenine↗

PubMed2004

Pharmacist surveillance of adverse drug events.

PURPOSE: The incidence of adverse drug events (ADEs), preventable ADEs, and potential ADEs was determined using pharmacist surveillance. Drug classes associated with ADEs were also identified. METHODS: The study was conducted in a 30-bed hospital ward of a Canadian teaching hospital between April 28, 2003, and May 26, 2003. All patients admitted to the general medicine service were eligible for study enrollment. A pharmacist performed surveillance to identify new or worsening symptoms, critical laboratory values, and medication errors. Surveillance consisted of daily communications with staff, daily chart reviews for all inpatients, and investigation of spontaneous incident reports. Data were collected to describe all identified outcomes. This information was rated independently by two clinicians to determine if the outcome was an ADE, a preventable ADE, or a potential ADE. Descriptive statistics were used to calculate outcome rates, which were reported as events per 100 patient-days. RESULTS: During 543 patient-days of observation, 24 ADEs occurred (4.4 per 100 patient-days), of which 14 were preventable (2.6 per 100 patient-days); 13 potential ADEs also occurred (2.4 per 100 patient-days). Of all ADEs, 3 (13%) were life threatening, 11 (46%) were serious, and 10 (42%) were significant. The 24 ADEs were associated with nine different drug classes. Four drug classes accounted for 17 ADEs (71%): antidiabetic agents, antibiotics, glucocorticoids, and sedatives and hypnotics. CONCLUSION: Pharmacist surveillance revealed that 4.4 ADEs occurred per 100 patient-days, over half of which were preventable. All preventable and potential ADEs occurred during the ordering and administration stages of medication delivery.

Aged↗

PubMed1994

Antibody-dependent enhancement of HIV-1 infection in human term syncytiotrophoblast cells cultured in vitro.

We examined if Fc receptor-mediated antibody-dependent enhancement (FcR-ADE) or complement-mediated antibody-dependent enhancement (C'-ADE) of virus infection can contribute to increasing replication of HIV-1 in human syncytiotrophoblast (ST) cells. Here we report that both FcR-ADE and C'-ADE may result in enhanced virus release from HIV-1-infected ST cells. We show that FcR-ADE of HIV-1 infection in ST cells is mediated by FcRIII and other FcR(s) belonging to undetermined Fc classes and does not require CD4 receptors, whereas C'-ADE uses both CD4 and CR2-like receptors. FcR-ADE seems to be more efficient in enhancing HIV-1 replication than C'-ADE. While FcR-ADE leads to increased internalization of HIV-1, C'-ADE does not result in enhanced endocytosis of the virus. In addition, antibodies mediating FcR-ADE are reactive with the gp120 viral envelope antigen, whereas antibodies involved in C'-ADE react with the viral transmembrane glycoprotein gp41. Data suggest that both FcR-ADE and C'-ADE may contribute to the spread of HIV-1 from mother to the fetus.

Cells, Cultured↗

PubMed2005

Promethazine adverse events after implementation of a medication shortage interchange.

BACKGROUND: Prochlorperazine and droperidol were commonly used antiemetics at the University of Pittsburgh Medical Center-Presbyterian Hospital until a shortage of prochlorperazine occurred and a black box warning was added to droperidol prescribing information. Subsequently, promethazine was selected as the approved intravenous antiemetic for therapeutic interchange in December 2001. Promethazine use and adverse drug events (ADEs) were investigated following review of a serious ADE that identified promethazine use as a probable contributing factor. OBJECTIVE: To illustrate ADEs associated with promethazine and characterize high-risk patients. METHODS: An ADE database analysis identified promethazine ADEs reported from 2000 to 2003. Promethazine utilization and ADEs were compared with those of other antiemetics during the pre- and post-interchange periods. RESULTS: Promethazine utilization increased significantly during the post-interchange period compared with all other antiemetics (p < 0.001). Promethazine ADEs increased from one event during the pre-interchange period to 13 events during the post-interchange period. Causality assessment using the Naranjo algorithm ranged from possible to probable. The promethazine ADE rate per 10 000 doses was significantly higher than the combined ADE rate for all other antiemetics (p < 0.001; incident rate ratio [IRR] 4.32). Elderly patients (aged > or =65 y) experienced more promethazine ADEs than younger patients (p = 0.005; IRR 4.68). Concurrent use of opioids and/or sedating drugs contributed to promethazine ADEs in 11 of 14 (78.6%) patients. CONCLUSIONS: Geriatric status is a significant risk factor for promethazine ADEs. Concomitant use of sedating drugs may further increase the risk for ADEs. Therapeutic interchange programs should be monitored for both ADEs and utilization.

Adult↗

PubMed2005

Epidemiology, comparative methods of detection, and preventability of adverse drug events.

BACKGROUND: Adverse drug events (ADEs) continue to be of concern to all health professionals. Even serious ADEs are underreported in all patient-care environments. OBJECTIVE: To discover the incidence and the best detection methods and preventability for ADEs at Al Qassimi Hospital, a 360-bed facility in the United Arab Emirates. METHODS: During the first and fourth quarters of 2003, data collection for ADEs was limited to spontaneous reporting. During the second and third quarters, active monitoring for ADEs took place in the adult, pediatric medical, and intensive care wards. ADEs were assessed for causality using the Naranjo algorithm and for severity and preventability. The incidence of ADEs was calculated and the detection methods were compared. RESULTS: The incidence of ADEs detected through surveillance was significantly higher (p < 0.001) than for ADEs reported spontaneously for both inpatients (3.592 vs 0.068/100 patient days) and outpatients (0.299 vs 0.022/100 patient visits). Most ADEs were judged to be of mild to moderate severity. About 56% of ADEs were judged definite or probable and, of these, 13.8% were consistently judged preventable. The most prevalent drugs implicated were central nervous system (23.6%), antiinfective (17.1%), and cardiovascular (16.5%) agents. The best ADE detection method was using physicians' notes. CONCLUSIONS: Active surveillance for ADEs, with the aid of ADE trigger alerts, yields a significantly higher number of reports than spontaneous reporting. Such surveillance is useful in identifying areas where improvements in the safe use of drugs can be made.

Adverse Drug Reaction Reporting Systems↗

PubMed2004

Adverse drug events caused by medication errors in medical inpatients.

PRINCIPLES: In view of growing concern in recent years regarding medication errors as causes of adverse drug events (ADEs), we explore the frequency and characteristics of error-associated ADEs in medical inpatients. METHODS: All patients with ADEs or ADErelated hospital admission in a cohort of medical inpatients identified by "event monitoring" (SAS/CHDM database, Br J Clin Pharmacol 2000:49:158-67) were evaluated independently by two experienced physicians. ADEs were first divided into ADEs occurring during cohort stay (incident ADE) and ADE present prior to/at admission. ADEs were then grouped as error-associated ADEs (eADEs: indication error, missed contraindication, wrong dosage regimen or inadequate surveillance) and adverse drug reactions (ADRs: indication established, no contraindications, appropriate dosage regimen and adequate surveillance). RESULTS: Among the 6383 patients analysed (100%), 481 (7.5%) experienced at least one incident ADE. Incident ADRs occurred in 457 (7.2%). Incident eADEs were recorded in 28 patients, corresponding to an eADE incidence of 0.4% (95% CI: 0.2, 0.7). Error types were missing/inappropriate indication (4 cases), missed contraindications (9), relative overdoses (8), absolute overdoses (3) and inadequate clinical surveillance (4). The responsible drugs included antithrombotics (6), cardiovascular drugs (5), antibiotics (5), hypnotics (4) and non-steroidal anti-inflammatory drugs (3). ADE-related hospital admissions were observed in 262 patients (4.1%); 183 (2.9%) were classified as ADRs and 79 (1.2%) as eADEs. CONCLUSIONS: Incident eADEs were observed in 1 out of 250 patients and accounted for approximately 6% of ADEs. In contrast, eADEs accounted for 30% of ADE-related hospital admissions. Hence, in medical inpatients, eADEs represented a small fraction of total incident ADEs, whereas they contributed significantly to hospital admissions.

Adverse Drug Reaction Reporting Systems↗

PubMed1991

Computerized surveillance of adverse drug events in hospital patients.

OBJECTIVE: To develop a new method to improve the detection and characterization of adverse drug events (ADEs) in hospital patients. DESIGN: Prospective study of all patients admitted to our hospital over an 18-month period. SETTING: LDS Hospital, Salt Lake City, Utah, a 520-bed tertiary care center affiliated with the University of Utah School of Medicine, Salt Lake City. PATIENTS: We developed a computerized ADE monitor, and computer programs were written using an integrated hospital information system to allow for multiple source detection of potential ADEs occurring in hospital patients. Signals of potential ADEs, both voluntary and automated, included sudden medication stop orders, antidote ordering, and certain abnormal laboratory values. Each day, a list of all potential ADEs from these sources was generated, and a pharmacist reviewed the medical records of all patients with possible ADEs for accuracy and causality. Verified ADEs were characterized as mild, moderate, or severe and as type A (dose-dependent or predictable) or type B (idiosyncratic or allergic) reactions, and causality was further measured using a standardized scoring method. OUTCOME MEASURE: The number and characterization of ADEs detected. RESULTS: Over 18 months, we monitored 36,653 hospitalized patients. There were 731 verified ADEs identified in 648 patients, 701 ADEs were characterized as moderate or severe, and 664 were classified as type A reactions. During this same period, only nine ADEs were identified using traditional detection methods. Physicians, pharmacists, and nurses voluntarily reported 92 of the 731 ADEs detected using this automated system. The other 631 ADEs were detected from automated signals, the most common of which were diphenhydramine hydrochloride and naloxone hydrochloride use, high serum drug levels, leukopenia, and the use of phytonadione and antidiarrheals. The most common symptoms and signs were pruritus, nausea and/or vomiting, rash, and confusion-lethargy. The most common drug classes involved were analgesics, anti-infectives, and cardiovascular agents. CONCLUSION: We believe that screening for ADEs with a computerized hospital information system offers a potential method for improving the detection and characterization of these events in hospital patients.

Adolescent↗

PubMed2001

Drug-related deaths in a department of internal medicine.

BACKGROUND: Drug therapy is associated with adverse effects, and fatal adverse drug events (ADEs) have become major hospital problems. Our study assesses the incidence of fatal ADEs in a major medical department and identifies possible patient characteristics signifying fatal ADE risk. METHODS: During a 2-year period, a multidisciplinary study group examined all 732 patients who died--5.2% of the 13992 patients admitted to the Department of Internal Medicine, Central Hospital of Akershus, Nordbyhagen, Norway. Decisions about the presence or absence of fatal ADEs were based on aggregated clinical records, autopsy results, and findings from premortem and postmortem drug analyses. RESULTS: In 18.2% of the patients (133/732) (95% confidence interval, 15.4%-21.0%), deaths were classified as being directly (64 [48.1%] of 133) or indirectly (69 [51.9%] of 133) associated with 1 or more drugs (this equals 9.5 deaths per 1000 hospitalized patients). Those with fatal ADEs (cases) were older, had more diseases, and used more drugs than those without fatal ADEs (noncases). In 75 of the 133 patients with fatal ADEs, autopsy findings and/or drug analysis data were decisive for recognizing the ADEs; in 62 of the remaining 595 patients, similar data proved necessary to exclude the suspicion of a fatal ADE. Major culprit drugs were cardiovascular, antithrombotic, and sympathomimetic agents. CONCLUSIONS: Fatal ADEs represent a major hospital problem, especially in elderly patients with multiple diseases. A higher number of drugs administered was associated with a higher frequency of fatal ADEs, but whether a high number of drugs is an independent risk factor for fatal ADEs is unsettled. Autopsy results and the findings of premortem and postmortem drug analyses were important for recognizing and excluding suspected fatal ADEs.

Adolescent↗

PubMed2005

High rates of adverse drug events in a highly computerized hospital.

BACKGROUND: Numerous studies have shown that specific computerized interventions may reduce medication errors, but few have examined adverse drug events (ADEs) across all stages of the computerized medication process. We describe the frequency and type of inpatient ADEs that occurred following the adoption of multiple computerized medication ordering and administration systems, including computerized physician order entry (CPOE). METHODS: Using explicit standardized criteria, pharmacists classified inpatient ADEs from prospective daily reviews of electronic medical records from a random sample of all admissions during a 20-week period at a Veterans Administration hospital. We analyzed ADEs that necessitated a changed treatment plan. RESULTS: Among 937 hospital admissions, 483 clinically significant inpatient ADEs were identified, accounting for 52 ADEs per 100 admissions and an incidence density of 70 ADEs per 1000 patient-days. One quarter of the hospitalizations had at least 1 ADE. Of all ADEs, 9% resulted in serious harm, 22% in additional monitoring and interventions, 32% in interventions alone, and 11% in monitoring alone; 27% should have resulted in additional interventions or monitoring. Medication errors contributed to 27% of these ADEs. Errors associated with ADEs occurred in the following stages: 61% ordering, 25% monitoring, 13% administration, 1% dispensing, and 0% transcription. The medical record reflected recognition of 76% of the ADEs. CONCLUSIONS: High rates of ADEs may continue to occur after implementation of CPOE and related computerized medication systems that lack decision support for drug selection, dosing, and monitoring.

Clinical Pharmacy Information Systems↗