Judgments of trained observers on adverse drug reactions.

Patients (672) admitted to a department of medicine during five consecutive months were followed by an investigator who identified 110 clinical manifestations which could have been considered adverse drug reactions. From these, 42 were excluded because they did not correspond to the definition of adverse reaction or they were inadequately documented. The remaining 68 cases were submitted to three independent observers who had to reply to a series of questions; from these replies five degrees of probability for the reaction itself were deduced. Reactions (54; 49% of the manifestations reported) were considered as certain or probable by at least two observers, but only 27 rections of these (25%) were attributed to the same drug by all three observers. There was a low level of agreement between any two observers (paired agreement ratio: 0.6 to 0.7) and little difference of agreement between any one observer and each of the others (personal agreement ratio: 0.6 to 0.7).

[Frequency of drug prescriptions and their adverse effects in a medical department]. / Fréquence des prescriptions de médicaments et de leurs effets indésirables dans un département de médecine.

The enquiries carried out in our unit since 1971, in some 1600 patients who received in all more than 13000 drug prescriptions and who were observed during 3 periods whose total duration was 12 months, prompt the following conclusions. The number of adverse reactions in which the relationship of cause and effect with one or several drugs was either definite or probable amounted to 217, 2--3% among patients at admission and 5--11% of patients during their hospital stay. The average number of prescriptions per patient remained stable and the average number of drug reactions per 100 prescriptions varied from 0.6 to 1.6. Severe drug reactions occurred in 1.1% of patients at admission and 1.1% of patients during their hospital stay.

Development of long-term care data systems. 20. Problems of data collection in long-term health care.

Data collection involves decisions of what to count, how to count, and what to do with the count. The first of these will be determined by the third, since it is the goals which decide what data should be collected. Ways of categorizing and classifying patients, services, treatments, and personnel in relation to long-term medical care must be formulated, and development of comparable data requires definition of baselines or units of observation. Many decision makers with widely varying interests will be competing for information, and to ensure timeliness and accuracy, data collection should be restricted to a minimum of simple, easily obtained, and unambiguous items. Routine reporting of events, periodic censuses relating to persons, and sample surveys all have advantages and limitations. Probably the most useful tools are long-term care registers, as they enable longitudinal studies of patient cohorts. Reliable but confidential means for linking personal records must be found and all records in the system must flow into a central collecting point.

[Factors that intervene in adverse drug reactions]. / Quelques facteurs intervenant dans les réactions adverses médicamenteuses

Drug prescriptions and adverse reactions occurring during 2 periods of 3 months in a department of medicine were analyzed by computer programs. Among 148 reactions suspected, 130 were considered definite or probable by one physician (1.6 reaction per 100 drug prescriptions). The patients who suffered from an adverse reaction were older, were hospitalized for a longer period of time and received more drugs than the others. The data were submitted to two physicians who were asked to determine the degree of probability of each reaction independently. There were many discrepancies between physicians' judgements (52% of the reactions) if one of them had a brief summary of the case history and the other had all the data available. The discrepancies were far fewer (18.1%) if both physicians had all the data available, and were due to the drug(s) suspected (8.8%) or to the influence of the disease (9.3%).