Adverse drug events in children during hospitalization and after discharge in a Norwegian university hospital.

UNLABELLED: The frequency and characteristics of adverse drug events (ADEs) in children hospitalized in the paediatric department of Ullevaal University Hospital, Norway, were determined using intensive monitoring. Of 579 children treated with drugs, 28% experienced ADEs; 7% at the time of admission, 18% during hospitalization and 9% after discharge. All children treated for cancer, 19% treated with anti-infective drugs, 15% treated with antiasthmatics and 10% treated with drugs affecting the nervous system experienced ADEs. The most frequent events were gastrointestinal, CNS- and skin reactions and 19% were considered as serious. ADEs caused 6% of the admissions and 44% required interventions. Most ADEs were found by screening patient records, where physicians mostly described adverse drug events requiring interventions and nurses described less serious events. Parents reported 14% of the events, of which a majority were CNS reactions. CNS reactions may be more common than expected and observations by parents are important when investigating such reactions in children. CONCLUSIONS: ADEs, mainly gastrointestinal, CNS and skin reactions related to drugs affecting the nervous system, anti-infectives and antiasthmatics, were seen in 28% of the patients. The reporting of events by parents was a useful supplement to the screening of patient records.

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.

Fatal adverse drug events: the paradox of drug treatment.

OBJECTIVE: Study patient characteristics, morbidity patterns and drug regimens associated with fatal adverse drug events (FADEs) amongst medical department inpatients. DESIGN: An observational, descriptive study using aggregated medical records, autopsies and pre and postmortem drug analyses. SETTING: A department of internal medicine at a Norwegian county hospital. SUBJECTS: All patients dying in the department over a 2-year period. RESULTS: The incidence of FADEs were 18.2% (133/732). Compared with non-FADE cases, FADE cases were older, used more drugs both on admission and at death, and had higher comorbidity (P < 0.001). Drugs suspected to cause or contribute to fatal outcome were mainly those used for treating chronic pulmonary diseases (terbutaline, theophylline), antithrombotic drugs (aspirin, warfarin, heparines) and drugs for treating coronary heart disease and heart failure (e.g. diuretics, nitrates, angiotensin converting enzymes (ACE) inhibitors, calcium channel blockers). Bronchodilatory drugs, antithrombotic drugs and cardiovascular drugs account for 26, 31 and 30 FADE cases, respectively. Patients dying from gastrointestinal diseases had the highest relative FADE occurrence (42%), cancer patients the lowest occurrence (4%). Serious drug-drug and drug-disease interactions were frequently suspected. Various degrees of inappropriateness in choice of drug, dosage or administration route were seen in 50% of FADE cases. CONCLUSIONS: This study shows a high incidence of FADEs associated with high age, high comorbidity and polypharmacy, and partly to inappropriate drug prescribing or use. Treatments frequently associated with FADEs were bronchodilatory treatment of patients with both chronic obstructive lung disease and coronary heart disease, vasodilatory treatment in patient with endstage heart failure and the combination of several antithrombotic drugs. A systematic strategy is needed to avoid unnecessary adverse drug events (ADEs).

[Statins--the pattern of adverse effects with empahsis on mental reactions. Data from a national and an international database]. / Statiner--bivirkningsmønster med vekt på psykiske reaksjoner. Data fra nasjonal og internasjonal database.

We report on adverse drug reactions to statins recorded internationally and in Norway. The use of HMG-CoA reductase inhibitors (statins) has increased with a factor of 30 in Norway over the period 1989-96. Recently published clinical trials conclude that statins are safe; adverse drug reactions being infrequent and non-serious. The reactions observed are mostly increased hepatic enzymes and myopathy. Data from the Norwegian spontaneous reporting system, and from WHO's international database covering the period of 1988-95, includes reports of adverse drug reactions relating to other organ systems, such as the nervous system, the gastrointestinal tract, skin and cardiovascular organs. Psychiatric disorders represent 15% of the reactions to statins in the Norwegian database. Reactions include aggression, nervousness, depression, anxiety, sleeping disorders and impotence. The pharmacological mechanisms are not elucidated, but may be an effect of falling serum cholesterol.

[Drugs as a cause of death. A prospective quality assurance project in a department of medicine]. / Legemidler som årsak til dødsfall. Et prospektivt kvalitetssikringsprosjekt i en medisinsk avdeling.

This study is part of a prospective quality assurance project in a Norwegian county hospital. The major aims of the study were to estimate the number of drug-related deaths; assess whether these were recognized by the clinicians, and (if not) discuss why the clinicians had difficulties in recognizing drug-related deaths. A panel of two internists, one pathologist, one pharmacologist and one pharmacist evaluated all inpatients deaths over a six-month period. Among 3,082 hospitalized patients, 169 died. Of these deaths, 20 were classified as probably (nine) or possibility (11) drug-related. Only two of the deaths were recognized as such by the clinicians in the ward. The reasons for the clinicians failure to recognize adverse drug reactions include frequent presence of multiple diseases, polypharmacy and inadequate guidelines on how to look for adverse reactions to drugs. A two-year survey aimed at studying these aspects in depth is in progress.

[Frequency, reporting and classification of drug-related deaths]. / Forekomst, rapportering og klassifisering av legemiddelrelaterte dødsfall.

In order to reach an estimate of drug-related deaths, the Adverse Drug Reaction Committee/the Norwegian Medicines Control Authority obtained access to data from the Department of Internal Medicine in a Norwegian county hospital. The criteria for classifying possible/probable cause of drug-related deaths were assessed. 6.5 deaths per 1,000 hospitalized persons were found to be probably or possibly drug-related. This figure far exceeds the numbers reported in the literature (0.9-4.4 per 1,000 hospitalized). Only two cases were detected by the clinician, one of which was reported to the Adverse Drug Reaction Committee via the spontaneous reporting system. The current criteria for assessing drug-related causes of death appear to be inadequate.