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This study was designed to investigate attitudes to and incentive for reporting adverse drug reactions (ADRs) in general and towards nurses as reporters of ADRs in particular in a sample of hospital physicians. A questionnaire was sent to 1,201 randomly selected hospital physicians. The main factors for the decision to report an ADR were the severity of the reaction, a reaction to a new drug, and an unusual reaction. The most important factor for refraining from reporting was that the reaction was well known. There were no significant differences between males and females or between age groups in these aspects. A majority were positive or neutral to nurses as reporters. Only 6% stated that their willingness to report ADRs would be affected in a negative way if nurses were involved in the program for reporting. The results of this survey showed that inclusion of hospital nurses as reporters will not decrease the reporting rate from the physicians. [ABSTRACT FROM AUTHOR]

The main aim of the WHO International Drug Monitoring Programme, started in 1968, is to identify the earliest possible pharmacovigilance signals. The program now has more than 80 member countries from all parts of the world contributing individual case safety reports (ICSRs) to the WHO Global ICSR Database System, VigiBase. VigiBase is maintained and developed on behalf of WHO by the Uppsala Monitoring Centre (UMC), situated in Uppsala, Sweden. The database system includes the ICH E2B compatible ICSR database, the WHO Drug Dictionaries (WHO-DD and -DDE), and the medical terminologies WHO Adverse Reaction Terminology (WHO-ART), International Classification of Diseases (ICD), and the Medical Dictionary for Regulatory Activities (MedDRA). Apart from data management and quality assurance tools, the VigiBase system includes a web-based reporting tool, an automated signal detection process using advanced data mining, and search facilities, available to the member countries and, on request, to other stakeholders. [ABSTRACT FROM AUTHOR]

Objective: The selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRIs) are extensively used in the treatment of depression, panic disorder and obsessive-compulsive disorder, and are now being evaluated in the treatment of a number of other psychiatric disorders. The aim of this study was to investigate the pattern of adverse reactions reported on SSRIs in Sweden and assess possible risk factors associated with the occurrence of adverse reactions to these agents.Methods: A survey was made of 1202 reports describing 1861 adverse reactions to SSRIs submitted to the Swedish Adverse Drug Reactions Advisory Committee.Results: The most often reported adverse reactions were neurological symptoms (22.4%), psychiatric symptoms (19.5%) and gastrointestinal symptoms (18.0%); however, dermatological symptoms (11.4%) and general symptoms (9.8%) were also frequent. Compared with other drugs, gastrointestinal symptoms were more often reported for fluvoxamine, psychiatric symptoms were more often reported for sertraline and dermatological symptoms were more often reported for fluoxetine. In total, the diagnoses most frequently reported were nausea (n = 139), rash (n = 90), anxiety (n = 84), paraesthesias (n = 69), headache (n = 63) and diarrhoea (n = 63). Parkinsonism, confusion, hallucinations, euphoria, hyponatraemia, bradycardia and hypotension were more often reported in the elderly, whereas urticaria, akathisia, and haematological, endocrinological, sexual and some visual reactions were more often reported in individuals who were younger than average. Dermatological reactions, fatigue, hyponatraemia and cough were more common in women, whereas dyskinesias/akathisia and aggression more often were seen in men. The median SSRI dosages were above average in patients experiencing seizures, hypomania/mania, personality changes, malaise, bodyweight gain, gynaecomastia and hyperprolactinaemia/galactorrhoea. Severe symptoms, such as seizures, hyponatraemia and the serotonin syndrome, were rarely reported.Conclusion: Although the design of the study makes it difficult to draw conclusions about causality, a variety of adverse reactions were reported. Therefore, the awareness that a particular symptom in a patient treated with an SSRI might be an adverse reaction should be high. [ABSTRACT FROM AUTHOR]

The article reports on a study which examines the benefits of the establishment of a regional paediatric registry in the detection of side effects of anticoagulants in children. An overview of the study, which was conducted at a paediatric anticoagulation service at Skåne University Hospital in Sweden, is given. The study suggests that centralising of paediatric anticoagulation improves care for children receiving anticoagulants.