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[Adverse drug effect notifications by nurses and comparison with cases reported by physicians].

The aim of the present study was to investigate the characteristics of adverse drug reactions reported by hospital doctors and nurses from Toulouse University Hospital between 1992 and 1993. During these two years, doctors and nurses reported 1498 and 164 adverse drug reactions respectively. Nurses reported significantly more cutaneous side effects than doctors (50 vs 24 per cent). Doctors reported significantly more neuropsychiatric, haematologic, hepatic or renal side effects than nurses. Imputability (causal relation) score of adverse drug reactions given by nurses was higher than that of doctors: nurses reported more observations with imputability equal to I3 (likely: 55 vs 46 per cent) and less with imputability equal to I1 (doubtful: 3 vs 23 per cent). Serious side effects (as defined by WHO) were more often seen by doctors (19 per cent) than by nurses (10 per cent). The more frequently suspected drugs were antiinfectious agents (35 per cent) and analgesics (7 per cent) for nurses, and neurotropic drugs (23 per cent) for doctors. Side effects reported by nurses were mainly observed after parenteral administration (48 per cent) whereas doctors reported mostly side effects seen after oral route (66 per cent). This study underlines the characteristics of adverse drug reactions which can be reported by nurses.

Adverse Drug Reaction Reporting Systems↗

[Can the sub-notification of drug adverse effects by capture/recapture method be evaluated?].

The incidence of adverse effects of a drug can be evaluated from the relationship between adverse effects reported to the drug company and to French drug surveillance centres and the number of patients exposed to the drug. Many adverse effects are never reported and this under-reporting is variable. The capture/recapture method can be used in drug surveillance to evaluate the importance of under-reporting for an adverse effect of a drug. This method, based upon the intersection of two different data sources with the aim of identifying the number of common cases, can estimate the number of unreported cases if at least two independent data sources are available. Scrupulous identification of each case and of common cases and study of the independence of the two systems are essential for this method. The application of the capture/recapture method to spontaneous reporting permits the estimation of the total number of cases and the completeness of registration of the two data sources (the drug company and the French drug surveillance centres). This application of the capture/recapture method needs to be validated by comparing the results to the results of prospective studies whenever possible.

Adverse Drug Reaction Reporting Systems↗

[Monitoring of a whooping cough epidemic 1994/95 in Switzerland using the sentinel notification system. Sentinella Registry].

Since June 1991 pertussis cases have been reported in the Swiss Sentinel Network (Sentinella). A total of 150-200 general practitioners, physicians specialized in internal medicine, and pediatricians participate in this system on a voluntary basis. Of the three specialties involved, this non-randomized sample represents 3.0%-3.5% of all physicians registered in Switzerland. The objective of this surveillance system is to monitor clinical pertussis over time. The case definition included all patients with a cough illness lasting at least 14 days with one of the following: paroxysms of cough, inspiratory "whoop", post-tussive vomiting (sporadic cases), or an epidemiological link to a pertussis case (epidemic cases). A laboratory diagnosis based on the polymerase chain reaction technique (PCR) was available for 82.7% of cases reported in 1994 and 1995. Of these, 27.7% had a positive PCR result. Reports of epidemic pertussis tested for Bordetella pertussis by PCR were confirmed by the laboratory in 46.5% of cases. The laboratory confirmation rate was more than twice as high among epidemic cases than among sporadic cases (20.7%). The crude incidence rate of whooping cough was 70 cases per 100,000 population per year in 1992 and 1993. Compared to previous years, pertussis incidence was significantly higher in 1994 and 1995 (370 cases per 100,000 population and 280 cases per 100,000 population respectively). The increase in reports was especially marked between July and October 1994 and whooping cough became epidemic in the third trimester of 1994 and at the beginning of 1995. In these 2 years, Switzerland experienced an estimated 40,000 clinical pertussis cases. Based on the proportion of PCR-positive pertussis cases in the sentinel sample, 12,500 of these would have been laboratory-confirmed. Most cases were observed in infants and in children up to 6 years of age. Assuming a vaccination coverage of 90%, the global efficacy of vaccination (3 or more doses versus less than 3) for 1994 and 1995 among children aged 12 to 47 months and not born before 1991 was 0.74 (0.59 and 0.88 for a vaccination coverage of 85% and 95% respectively). Vaccine efficacy was higher in PCR-positive cases (0.87; 0.79; 0.94) than in PCR-negative cases (0.54; 0.27; 0.78). Vaccination efficacy estimates on the basis of surveillance data are certainly less precise than those inferred from clinical trials. However, our results indicate that the efficacy of vaccination in children significantly declined with increasing age. Whooping cough still has the potential to cause epidemics in Switzerland in spite of a high vaccination coverage. With the introduction of acellular pertussis vaccines and new vaccination schemes in Switzerland, the Swiss Sentinel Network fulfills an important task as a monitoring system and contributes to the evaluation of new vaccination strategies.

Bordetella pertussis↗

[Screening for notification of seropositivity: ethical and psychological aspects].

HIV testing can be generated either by the physician or by the patient. In all cases it should be integrated in a comprehensive approach of the patient and his history. This consultation will allow to give preventive recommendations--if the test is negative--and will help patient management-if the test is positive--in the setting of a good relationship aiming to offer the best medical, psychological and social follow-up to the patient. In this context it appears that pre-counselling should be systematically provided. The reasons for asking the test should be carefully analyzed. The pre and post-counselling should be used to try to improve preventive measures. On the other hand these first consultations should allow to detect and manage the psychological impact in case of seropositivity.

AIDS Serodiagnosis↗