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- Bygdell, Maria, et al.
(författare)
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Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population.
- 2012
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Ingår i: Pharmacoepidemiology and drug safety. - : Wiley. - 1099-1557 .- 1053-8569. ; 21:1, s. 79-86
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Psychiatric Adverse Drug Reactions (ADRs) are frequent in the pediatric population. The aim of the present study was to analyze spontaneously reported psychiatric ADRs in children during a 10-year period. Methods All spontaneously reported Individual Case Safety Reports (ICSRs) concerning children (<18 years old) and psychiatric adverse reactions assessed as at least possible, registered in the Swedish Drug Information System (SWEDIS) during the period 2001–2010, were extracted and characterized. Age and sex distribution and labeling/registration status were studied. Results A total of 600 ICSRs concerning 744 psychiatric adverse reactions were identified and included in the analysis. Boys were overrepresented among included ICSRs (60.3% vs. 39.7%; p < .001). After exclusion of vaccines, the three most frequently suspected drugs were montelukast, centrally working sympathomimetic drugs, and inhaled glucocorticoids. Serious adverse reactions were reported more frequently for drugs used off-label than for drugs used according to the Swedish Physician’s Desk Reference. Aggressiveness was reported more frequently for boys than for girls as were suicidal conditions. Conclusions Psychiatric ADRs in the pediatric population have been reported for a wide range of reactions and drugs and display age and sex differences including a higher number of suicidal reactions in boys. An association was seen between serious reactions and off-label drug use. Further studies are needed to elucidate safety aspects of unlicensed drugs and drugs used off-label and whether there are differences in children’s susceptibility to develop ADRs.
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- Johansson, Marie-Louise, et al.
(författare)
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Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports.
- 2009
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Ingår i: European journal of clinical pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 65:5, s. 511-4
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Spontaneous reporting of adverse drug reactions (ADRs) is one approach to increasing our knowledge on the risks of drugs in clinical practice. Under-reporting is a shortcoming of this system. OBJECTIVES: To evaluate if repeated e-mails with attachments on ADR information can affect (1) the reporting of ADRs and (2) the quality of the ADR reports. METHODS: All 117 heads of primary health care units in the region of Västra Götaland in Sweden were randomly allocated (1:1) to an intervention group or a control group. The intervention consisted of e-mails with attachments sent out to each of the 117 heads in January, May and September 2007. These e-mails included (1) the heading "Every ADR report is important", (2) a current case report of an ADR and (3) instructions on how to report. The number of reports from each primary health care unit run by the same head was registered, as was the quality of the report. The quality was defined as high if the ADR was (1) serious, (2) unexpected or (3) related to the use of new drugs and not labeled as common in the summary of product characteristics. All other reports were regarded as low-quality reports. RESULTS: The total number of reports increased from 89 in 2006 to 111 in 2007 (P = 0.037). No difference in the number of reports between intervention (n = 56) and control (n = 55) units could be detected. The proportion of high-quality reports before and after the intervention was 36 and 48%, respectively (intervention, P = 0.11) and 40 and 36%, respectively (control, P = 0.55). CONCLUSIONS: No apparent effect of repeated ADR e-mails on the reporting of ADRs could be detected, although an increase in the reporting rate in general was noted.
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- Wallerstedt, Susanna Maria, 1970, et al.
(författare)
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Montelukast and psychiatric disorders in children.
- 2009
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Ingår i: Pharmacoepidemiology and drug safety. - : Wiley. - 1099-1557 .- 1053-8569. ; 18:9, s. 858-64
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: A signal has been raised concerning montelukast and adverse drug reactions (ADRs) in children. The purpose of the present study was to evaluate psychiatric ADRs during treatment with montelukast in children. METHODS: We analyzed all reports of psychiatric disorders during treatment with montelukast in children (<18 years) in the Swedish ADR database SWEDIS (1998-2007). The Bayesian Confidence Propagation Neural Network (BCPNN) method was used to screen for disproportional reporting rates of these reactions. An information component (IC) with a positive 95% lower confidence limit indicates a statistically significant disproportionality between the expected and the reported rate for a drug and an ADR. RESULTS: A total of 48 reports of psychiatric disorders in children during treatment with montelukast were found in SWEDIS. Reports appeared every year after registration. Psychiatric disorders reported more than once included nightmares (n = 15), unspecified anxiety (n = 11), aggressiveness (n = 11), sleep disorders (n = 10), insomnia (n = 3), irritability (n = 3), hallucination (n = 3), hyperactivity (n = 3), and personality disorder (n = 2). In 23 reports (48%), the child experiencing psychiatric ADRs was < or = 3 years old. Time from exposure to ADR was indicated in 35 reports. In 28 of these (80%), the time from exposure to ADR was less than 1 week. A statistical signal for psychiatric disorders appeared in the fourth quarter of 1998 (three reports, IC-value: 2.34, 95% lower confidence limit: 0.62). CONCLUSIONS: Psychiatric ADRs can occur during montelukast treatment in children, indicating that attention to this is essential. Further studies are needed to establish the magnitude of the problem.
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| 6. |
- Wallerstedt, Susanna Maria, 1970, et al.
(författare)
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Reporting of adverse drug reactions may be influenced by feedback to the reporting doctor
- 2007
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Ingår i: Eur J Clin Pharmacol. - : Springer Science and Business Media LLC. - 0031-6970. ; 63:5, s. 505-8
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The purpose of this study was to investigate two different feedback alternatives to doctors reporting adverse drug reactions (ADRs) concerning (1) effects on reporting rates and (2) doctors' opinions. METHODS: When reporting an ADR during January through March 2006, doctors in the western part of Sweden were randomised according to working address to receive feedback I or feedback II. Feedback I consisted of the conventional mode of feedback. Feedback II consisted of the contents of feedback I supplemented with information on the reported drug from the regional drug information centre. A questionnaire was administered 2 weeks after the feedback. The doctors were asked to give their opinion on the feedback concerning amount of information, quality and overall impression on a 6-point scale, where 1 corresponded to too little/very bad and 6 to too much/very good. During the inclusion period and the 6-month follow-up period, additional ADR reports originating from receivers of either feedback I or II were identified and compared. RESULTS: Sixty-six doctors received feedback I, and 49 received feedback II. The number of doctors reporting more than once was greater in the group receiving feedback II (39% vs. 22%; P = 0.039). Feedback II was judged to contain more information than feedback I (4.1 +/- 0.8 vs. 3.6 +/- 0.9; P = 0.014). No difference between the feedback alternatives concerning doctors' opinions on quality and overall impression could be detected. Sixty-five doctors (70%) stated that the content of the feedback letter could affect their willingness to report ADRs. CONCLUSION: The content of the feedback to doctors reporting ADRs may influence reporting rates.
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