Methodological and motivational factors affecting the surveillance of adverse events in hospitalized patients.

This is a critical review of the methodological and motivational aspects of two experiences of adverse event (AE) monitoring using a surveillance diary incorporated into the progress notes of medical records. Methodological aspects of the study were that (1) AE monitoring was to become an everyday activity of ward physicians; (2) the physicians were to express their opinions concerning the causality of each AE, which was to allow the systematic detection of adverse drug reactions and unexplained AEs; (3) the surveillance diary was to include all AEs and all prescriptions, thus allowing prescription-event monitoring; (4) the time trends of unexplained AEs were to be monitored using control cards. The experiences were discontinued because the necessary investments were attributed to other competing priorities. It follows that it is essential to develop an awareness that AE surveillance requires continuous involvement insofar as it is an essential element of quality of care.

[Surveillance of adverse reactions of drugs and monitoring of drug prescriptions as routine in hospital activities]. / La sorveglianza delle reazioni avverse da farmaci e il monitoraggio delle prescrizioni mediche come attività "normali" di reparti ospedalieri.

Since January 1988 is taking place a multicentre experience on pharmaco-epidemiology named ARIES (Adverse Reaction Identification Evaluation System), with two primary aims: surveillance of drug adverse reactions and monitoring of medical prescriptions. At present 5 departments of internal medicine are involved in the study. The factual cooperation of the departmental doctors depends on the evaluation of benefits and costs of the study. The benefits for doctor are: (a) the possibility of contributing to the research in a field which has not been systematically investigated in a hospital setting; b) the acquisition of skill in monitoring adverse reactions: to facilitate doctors cooperation an algorithm has been developed to select the events to be entered into the system; c) the possibility of evaluating and improving the prescription habits. At present, data on 9,000 patients and 60,000 prescriptions are available. As an example of utilization study, we report a research on antibiotics prescribed for bronchopneumonia in two departments involved in the ARIES project. The remarkable differences in the prescription settings lead to some rethinking on the strategies of such different prescription choices. In each department, the contribution of doctors is integrated by a monitor, entering additional information on drugs and patients into the system. Thanks to the cooperation of doctors and contribution of monitors, the pharmaco-epidemiology research may become a "normal" component of the hospital activities, thus allowing to systematically retrieve and process some basic knowledges, which are not routinely used, derived from the daily activity of the departmental doctor.

Comparison of Vivalan (viloxazine hydrochloride) with imipramine in the treatment of depression. A double-blind study.

Twenty-eight hospitalized patients with depressive illness entered a double-blind trial to compare viloxazine hydrochloride (Vivalan) with imipramine. Both drugs produced a statistically significant improvement in the depressive symptoms as early as the 7th day, measured by the HRS. A side effects check-list showed no significant difference between Vivalan and imipramine. A lack of anticholinergic effects was noted in the Vivalan group although upper gastro-intestinal side effects were more frequent. Two patients in the Vivalan group withdrew due to gastric symptoms.

The multipurpose surveillance-oriented medical record: a tool for quality of care management.

Medical records were oriented towards quality of care surveillance by adding dedicated sections to the progress notes in which to list admission problems, medical interventions and adverse events (AEs). Two types of simple code were used: indication codes, which identify the indication for any given medical intervention; and attribution codes, which indicate the causes of any AE. During the first 6 months (302 patients), 24 AEs were attributed to drugs, three to procedures, and 42 were unexplained. The incidence of 7.9 suspected adverse drug reactions per 100 patients exceeds that obtained with other hospital-based adverse drug reporting programmes. Unexplained events are kept under constant statistical control to detect possible alerting signals. As a tool for quality of care management, the surveillance-oriented record can be used to monitor the appropriateness of medical interventions, identify "high risk" areas and deduce outcome indicators which constitute useful screens for the identification of potential problems.

Unwanted symptoms in depressed patients treated with viloxazine: an algorithm for identification of illness-related symptoms.

Ninety-six depressed outpatients from 5 centres were given viloxazine 200-400 mg/day. The treatment produced significant clinical improvement as evaluated by the Hamilton Rating Scale for Depression. Thirteen patients dropped-out because of possible side effects. Many untoward symptoms were described by all the patients. To distinguish between illness-related symptoms (IRSs) and potential side effect symptoms (SESs) a new approach was taken, using an algorithm that provides a decision strategy based on the time course both of the symptom and the illness. By this procedure, 90 of the 187 claimed untoward symptoms were identified as IRSs. Of the 97 potential SESs, only 36 were spontaneously volunteered, and the remaining 61 symptoms were elicited on specific questioning. Whenever possible, volunteered potential SESs were assessed to determine the relationship between the drug treatment and the adverse reaction. It was found that only a few instances of gastric disturbance and exacerbation of anxiety were probably viloxazine-related.

[Therapeutical comparison between atenolol and nifedipine in effort angina (author's transl)]. / Comparazione terapeutica fra atenololo e nifedipina nell'angina da sforzo.

In order to assess the therapeutical efficacy of atenolol in stable angina pectoris of effort, we studied 40 patients with a positive exercise stress test. Our double-blind study included a first group of 20 patients treated with atenolol, 100 mg once daily, and a second group of 20 subjects, treated with nifedipine (10 mg 3 times daily). The exercise test was performed before the treatment, after one month of placebo and after one month of therapy with nifedipine or atenolol. The variables examinated were the frequency of anginal chest pain, the quantity of nitroglycerin taken by the patients, the arterial pressure, the heart rate and the double product at the peak of the exercise testing. Differences between the results obtained in the two groups weren't statistically significant.

A surveillance-oriented medical record as a source of data for both drug and quality of care surveillance.

The medical record for hospitalized patients has been modified in order to orient it towards two types of surveillance: adverse drug reactions (ADRs) and the quality of medical care. The modification consists of an adaptation of the progress notes; the transfer of the information to a special database is facilitated by the use of a simple system of codes that identify and correlate the items necessary for surveillance purposes. During the 6 months of observation of the 1103 pediatric patients included in the study, 35 clinically important suspected ADRs were noted by physicians. For the quality of medical care surveillance, all drug prescriptions were evaluated and areas in which to intervene in order to improve the appropriateness of prescriptions were identified. Quality surveillance was also extended to the monitoring of 'unexplained' adverse events for which no particular cause was attributable. We consider it advantageous to carry out these two types of surveillance simultaneously because they require many common items of information. The use of an oriented medical record as a source of data makes it possible to integrate surveillance with everyday ward activities.