Some physician attitudes regarding ADEs are associated with underreporting.

A single, short educational session to primary care doctors can improve their prescribing standards during long periods of > or = 9 months. Of the 2 strategies followed in the trial, one-to-one education has shown to be the most effective. Results also show that the effectiveness of these interventions increases when presented together with written material.

At the time a new drug is placed on the market, information on its therapeutic effect and toxicity is limited. Because of its simplicity and widespread use, the voluntary reporting by clinical physicians is the main method for detecting rare or unexpected adverse drug events (ADEs). However, the usefulness of this method may be compromised if the reporting rate is low. We present the results of a questionnaire-based case-control study carried out among 692 physicians from Galicia (north-west region of Spain), in which we assessed their attitudes and opinions towards ADEs. In general, the Galician physicians think it is difficult to link a given ADE with a drug (P < 0.05) and have very heterogeneous opinions on the fact that very severe ADEs are known before the drug is commercialized. They globally disagree with the proposal that ADE reporting should be renumerated and the fact that ADE reporting can be risky for the physician. Some of the beliefs concerning ADEs are incorrect. It is crucial to improve the training of the physicians through active educational strategies based on personal contact.

The postprandial insulin requirements after three mixed meals of equal carbohydrate and energy content were assessed in 10 type-1 and 12 type-2 diabetics by a glucose-controlled insulin infusion system. These were compared with the glycemic response to the same meals of 10 healthy individuals (glycemic index). In type-1 diabetics, we found the highest insulin requirements after consumption of a continental breakfast (low fibre, low protein, high fat). Ten percent less insulin was infused after milk (low fat, high protein) and 30% less after an English breakfast (high fibre, high protein). Type-2 diabetics showed no significant differences in insulin requirements between the three test meals. The glycemic response in healthy individuals had no relation to these insulin requirements. Continental and English breakfast had a similar glycemic effect, whereas milk produced only 30% of the blood glucose response observed after the continental breakfast. These results indicate that neither the carbohydrate content (exchange lists) nor the glycemic index enable prediction of postprandial insulin requirements in insulin-deficient diabetes. For this purpose, we propose the insulin-need index, elaborated by testing whole meals in closed-loop experiments with type-1 diabetics.

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Spontaneous reporting of adverse drug reactions (ADRs), although commonly used, is of limited efficacy for the establishment of causation, and must be complemented by more rigorous epidemiologic studies. This article presents a decision algorithm that could be used as a tool in the selection of the most appropriate study design to investigate the causal relationship between a given ADR and a drug. It is based on the incidence of the ADR, on the objective of the study--determination of all the adverse effects of a given drug, or all the drugs increasing the risk of occurrence of a given adverse event--and on the funds available to the researcher.

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