Incidence of adverse drug reactions in paediatric in/out‐patients: a systematic review and meta‐analysis of prospective studies

Impicciatore, P.; Choonara, Imti; Clarkson, A; Provasi, Davide; Pandolfini, Chiara; Bonati, Maurizio

doi:10.1046/j.0306-5251.2001.01407.x

Cited by 419 publications

(382 citation statements)

References 39 publications

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“…They are considered somewhere between the fourth and sixth leading cause of death in the USA, even when the drugs are used in a proper manner, in appropriate doses and for approved indications. 19 According to a meta-analysis, 20 the overall incidence of ADR in hospitalised children was 9.53% and severe reactions accounted for 12.29%. The overall rate of paediatric hospital admissions due to ADRs was 2.09%; 39.3% of these were life-threatening reactions.…”

Section: Discussionmentioning

confidence: 99%

Drug provocation tests to betalactam antibiotics: experience in a paediatric setting

Chambel

Martins

Silva

et al. 2010

Allergologia et Immunopathologia

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Background: Few studies have been performed in children with suspected betalactam allergy. We aimed to assess the role of the drug provocation test (DPT) with betalactams in a paediatric setting and to study the association between allergy to betalactam antibiotics and other allergic diseases. Methods: We included all the patients under 15 years old who were consecutively referred to the Immunoallergy Department, Dona Estefânia Hospital, Portugal (January 2002 to April 2008) for a compatible history of allergic reaction to betalactam. All were submitted to a DPT. Children were proposed to perform skin tests (ST) to betalactam antibiotics followed by DPT. If they decline ST, a DPT with the culprit drug was performed. Results: We studied 161 children, 60% were boys, with a median age of 5 years old at the time of the DPT. Thirty-three patients (20.5%) had an immediate reaction and 33 (20.5%) a non-immediate reaction. The severity of the reported reactions was low in most cases. Skin tests to betalactams were performed in 47 children and were positive in 8. DPT was positive in only one (3.4%) of the patients skin tested and in 11 (13.4%) of those not skin tested. The severity of the DPT reaction was low. Asthma and food allergy were associated with a positive DPT in the later group. Conclusions: DPT seems a safe procedure even in the absence of ST in non-severe cases. This could be a practical option in infants and pre-school children, where ST are painful and difficult to perform. Additional caution should be taken in children with asthma and food allergy.

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Section: Discussionmentioning

confidence: 99%

Drug provocation tests to betalactam antibiotics: experience in a paediatric setting

Chambel

Martins

Silva

et al. 2010

Allergologia et Immunopathologia

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“…A review study of ADRs in pediatric patients estimated an overall incidence of ADRs in inpatients to be 9.53% and that in outpatients to be 1.46%. 27 Under-reporting of minor or non serious ADRs like nausea or vomiting which were either not detected or reported could contribute to low reporting in India. Also none of the ADR was reported from PHC, which suggests there is a need for expansion of the awareness about the ADR reporting to the grass root level of health care.…”

Section: Discussionmentioning

confidence: 99%

Pharmacoepidemiological profile and appropriateness of drug use in paediatric diarrhoea patients: a cross sectional study in western India

Chaudhari

Patel

Shah

et al. 2017

Int J Basic Clin Pharmacol

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Background: The background of the study was to analyze the prescribing pattern and appropriateness of drug treatment of diarrhoea.Methods: Total 194 pediatric patients with diarrhoea (140 admitted at tertiary care centre and 54 patients attended primary health care centre) were included and their demographic details; disease related parameters, drug treatment and adverse drug reactions were recorded. Appropriateness of drug treatment was analyzed using the WHO and Indian Academy of Pediatrics (IAP) guidelines for management of diarrhoea.Results: Most patients (27.32%) were less than 1 year of age and majority 54.64% were males. Most common presenting symptoms was diarrhoea with dehydration (100%) followed by vomiting (60%), fever (54.29%). Stool cultures were carried out only in 22.86% patients at tertiary health care centre while no investigations were carried out at PHC. Average number of drugs prescribed per patient was 8.25 ± 1.3. All the patients were given fluid replacement therapy. 94.29% and 85.19% patients were prescribed antimicrobials at tertiary centre (THC) and PHC respectively. Most common antibiotic used was cephalosporins (82%) followed by aminoglycosides (48.57%) of patients at THC while ofloxacin (82.60%) and metronidazole (17.40%) were commonly used at PHC. Analgesic/antipyretic was required in 70.71% and 85.19% of patients at THC and PHC respectively. Comparing with the WHO diarrhoea management guidelines and IAP guidelines, only 8 (14.81%) prescriptions were considered as rational. 2.85% patients developed mucocutaneous rash as ADR.Conclusions: Inappropriate prescribing for diarrhoea is highly prevalent in society. Emphasis on proper diagnosis and treatment, education and availability of locally effective guidelines may help in a better and judicious use of drugs in children.

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“…7 Meta-analysis of 17 prospective studies conducted in the US and Europe showed incidence of ADRs among hospitalized children to be 9.5% with severe reactions accounting for 12% of the total. 8 One study reported that AEDs were responsible for 11% of overall ADRs. Specific drugs lorazepam (3%) and VPA (3%) were associated most commonly with ADRs.…”

Section: Introductionmentioning

confidence: 99%

Study of adverse drug effects of antiepileptic drugs used in pediatric patients in a tertiary care rural hospital – a Pharmacovigilance study

Suman¹,

Gosavi²

2017

JYP

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Objective: To assess the prescription pattern & Adverse Drug Reaction (ADR)) profile of Antiepileptic drug (AEDs) therapy in children of rural population. Materials and Methods: This prospective open label, observational study was carried out over one and half year duration on 142 newly diagnosed epileptic children below 12 yrs age receiving AEDs in pediatric department in a tertiary care rural hospital. Follow up was done every month for 6 months duration. Prescription pattern and incidence, causality and severity of ADRs due to AEDs were assessed at each visit. Results: Out of 142 patients on AEDs, 97.2% patients were on mono-therapy and 2.8% patients were on poly-therapy. Valproic acid was the most commonly prescribed drug (58) and Lorazepam was the least prescribed drug (1). Central nervous system related ADRs (50%) were most common followed by gastrointestinal system (14.7%). Sedation and gastrointestinal distress were among the most frequently reported ADRs and29.4% of probable category while 70.5% ADR's were possible category. 72% ADRs were mild, 22% were moderate and 5.8% of ADRs were severe. Conclusions: Children receiving AEDs should be closely monitored for the development of any ADRs, especially related to their behavior and cognition. as it can influence their learning and memory, Active surveillance can help in knowing the exact incidence of ADRs. This study emphasizes on the role of patient / parent education and importance of health care professionals in pharmacovigilance studies.

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Incidence of adverse drug reactions in paediatric in/out‐patients: a systematic review and meta‐analysis of prospective studies

Cited by 419 publications

References 39 publications

Drug provocation tests to betalactam antibiotics: experience in a paediatric setting

Drug provocation tests to betalactam antibiotics: experience in a paediatric setting

Pharmacoepidemiological profile and appropriateness of drug use in paediatric diarrhoea patients: a cross sectional study in western India

Study of adverse drug effects of antiepileptic drugs used in pediatric patients in a tertiary care rural hospital – a Pharmacovigilance study

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