Adverse drug reactions in children reported by means of the yellow card in Spain

Morales‐Olivas, Francisco J.; Martínez-Mir, Inocencia; Ferrer, José M.; Rubio, E.; Palop, Vicente María Escuin y

doi:10.1016/s0895-4356(00)00190-6

Cited by 61 publications

(42 citation statements)

References 18 publications

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“…Antibiotics were the group of medicines most likely to be associated with an ADR, which is in keeping with other studies 5 18. It is important to recognise, however, that antibiotics are the most widely prescribed group of medicines for children 19 20.…”

Section: Discussionsupporting

confidence: 80%

“…This rate is higher than that in the UK but considerably lower than that in Camagüey Province. Unfortunately, other community based studies of the reporting of ADRs in children in Spain5 and the Netherlands6 did not include details of the number of children included in the surveillance scheme and therefore it is not possible to establish the incidence of reports per million children in these two countries.…”

Section: Discussionmentioning

confidence: 99%

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Adverse drug reactions in children in Camaguey Province, Cuba

Arencibia

Sotomayor²,

Mollinedo³

et al. 2010

Archives of Disease in Childhood

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Adverse drug reactions in children in Camaguey Province, Cuba

Arencibia

Sotomayor²,

Mollinedo³

et al. 2010

Archives of Disease in Childhood

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show abstract

“…A number of studies have been conducted with the aim of describing and assessing medication prescription patterns among children and adolescents, and any possible repercussions on their health [3][4][5][6][7][8][9][10][11][12][13]. Other studies have focused on identifying the pattern of use of so-called 'over-the-counter' (OTC) specialties in the paediatric population.…”

Section: Introductionmentioning

confidence: 99%

Medication consumption in the Spanish paediatric population: related factors and time trend, 1993–2003

Carrasco‐Garrido

Jiménez‐García

Hernández-Barrera

et al. 2009

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? • Health authorities undertake specific campaigns targeted at making the population more keenly aware of the need to use medications rationally. • Parents are increasingly turning to medications prescribed for the ‘over‐the‐counter’ (OTC) specialties as substitutes, using them – not always correctly – to treat symptoms such as acute cough, fever or pain. WHAT THIS STUDY ADDS? • Our study constitutes an approach to self‐reported drug consumption in the Spanish paediatric population, based on a representative nationwide sample. • There was a significant decline in overall drug consumption in the Spanish paediatric population from 1993 to 2003. • Nevertheless, the prevalence of consumption of analgesics, antipyretics and antibiotics has risen. AIMS To ascertain the prevalence of consumption of medications in the Spanish paediatric population and to identify the factors associated with such consumption. METHODS This was a descriptive, cross‐sectional study covering the Spanish adult population, using data drawn from the 1993 and 2003 Spanish National Health Surveys (SNHS). The 1993 and 2003 SNHS include data on 5280 and 6463 children, respectively, age range 0–15 years. The independent variables were sociodemographic and health‐related, and the dependent variable was medications use. Using logistic multivariate regression models, we analysed the temporal evolution of medication consumption between 1993 and 2003. RESULTS The 1993 SNHS data revealed that 36.81% of the paediatric population had consumed some type of medication, whereas in 2003 this figure had dropped to 34%. Over the decade of study, there was a significant decrease in use of medications for catarrh, influenza, throat (P < 0.05), and an increase in consumption of pain‐relieving drugs and/or fever‐lowering, antibiotics and anti‐allergy remedies. Multivariate analysis highlighted the association between medication consumption, negative perception of the child's health [odds ratio (OR) 2.84, 95% confidence interval (CI) 2.16, 3.72 in 1993, and OR 3.54, 95% CI 2.74, 4.56 in 2003] and medical visits to the physician across the 2 years (OR 12.09, 95% CI 10.13, 14.42 in 1993, and OR 7.17, 95% CI 6.06, 8.47 in 2003). CONCLUSIONS Although there was a significant decline in overall drug consumption in the Spanish paediatric population from 1993 to 2003, the prevalence of consumption of certain groups, such as analgesics, antipyretics and antibiotics, has risen.

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“…[9] The degree of severity was minor in 72.9% of the reports, moderate in 22.4%, severe in 4.4%, and fatal in 0.3% (4 cases). [10] In our study, 4 (0.42%) lethal effects were observed; among these, 3 (0.32%) from female and 1 (0.11%) from male patients, which is in contrast to a study that showed 28 (2.3%) patients died as a direct result of the index ADRs and gastrointestinal bleeding was responsible for 15 (54%) deaths, while aspirin individually or in combination with other drugs was implicated in 17 (61%) deaths. [11] Causality assessment was used to describe the causal relationship between offending drugs and the reaction and it was done by using the Naranjo's causality assessment scale and shows that 20 (2.11%) ADRs were definitely related to drugs, 759 (79.89%) ADRs were probably related to drugs, 165 (17.37%) ADRs were possibly related to drugs, and 6 (0.63%) ADRs were unlikely related to drugs.…”

Section: Discussionmentioning

confidence: 99%

Knowledge assessment in adverse drug reactions and reporting

Senthilnathan¹,

Kumaran²,

Rajasekaran³

2013

Arch Pharma Pract

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Objectives: In India, adverse drug reaction (ADR) monitoring activity is in infancy. This study was conducted to determine the pattern and extent of occurrence of ADRs in the hospital, to analyze the ADRs reporting behaviors in healthcare professionals (HCPs), to analyze the knowledge about ADRs in HCP, to analyze and compare the ADRs reported by HCP and to analyze the barriers involved in nonreporting of suspected ADRs. Materials and Methods:The study was carried out at Kovai Medical Center and Hospital (KMCH). A questionnaire containing 19 questions was distributed to the teaching faculties of pharmacy college, physicians, nurses, and students of the study setting. Results and Conclusion:The response rate of faculties, physicians, nurses, and students for the questionnaire in phase-I were found to be 66.67%, 40.00%, 66.67%, and 73.33%, respectively. But the response rates remarkably increased in phase-II when compared with phase-I study viz., 100% from faculties and students, 93.33% from physicians, and 86.67% from nurses. Almost all the participants said that ADR monitoring is done in their institution. Majority of the participants said that ADR should be reported if it causes both inconvenience and death to the patients. In our study, physicians (93%) knew the objectives of ADR monitoring very well in phase-II, when compared with phase-I study (75%), which was followed by faculties (83%), nurses (77%), and students (73%). Spontaneous reporting of ADRs is denoted by all faculties, 93% physician, 80% students, and 77% nurses in phase-II study. All participants in the phase-II survey knew any one method to monitor ADRs but in phase-I, 10% nurses and 9% students did not know about any method of monitoring ADR. Lack of knowledge about ADR reporting center is the mainstay in under-reporting or nonreporting of observed ADRs noted by only 6.67% of faculties, 19.23% nurses, and 10% students. The reason for underreporting was very much reduced in phase-II than in phase-I.

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Adverse drug reactions in children reported by means of the yellow card in Spain

Cited by 61 publications

References 18 publications

Adverse drug reactions in children in Camaguey Province, Cuba

Adverse drug reactions in children in Camaguey Province, Cuba

Medication consumption in the Spanish paediatric population: related factors and time trend, 1993–2003

Knowledge assessment in adverse drug reactions and reporting

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