Adverse drug reactions in children in Camaguey Province, Cuba

Arencibia, Zeina Bárzaga; Sotomayor, D Novoa; Mollinedo, N Caballero; Choonara, Imti; Manzano, Edita Fernández; Leyva, Alberto López

doi:10.1136/adc.2009.180786

Cited by 17 publications

(9 citation statements)

References 21 publications

(31 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We described the ADRs detected in children in Camagüey Province in 2008 [1]. Although we demonstrated an ADR reporting rate of 634 per million children per year in Cuba, we recognised that this figure was likely to be a significant underestimate of the true rate of ADRs.…”

Section: Introductionmentioning

confidence: 82%

“…For children who experienced more than one ADR, the clinical impact of the separate ADRs was considered together and one severity classification was given. Severity was classified as severe/moderate/mild [1, 11].

severe: fatal or potentially life threatening or causing permanent disability;

moderate: requiring treatment or prolonging stay in hospital or causing interference with normal daily activities;

mild: minor reactions that do not require treatment and do not prolong stay in hospital.

…”

Section: Methodsmentioning

confidence: 99%

“…We previously demonstrated an ADR reporting rate of 634 per million children per year in Cuba [1]. Others have described 226 reports per million children per year in Sweden [2].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Pharmacovigilance in children in Camagüey Province, Cuba

Arencibia

Leyva

Peña

et al. 2012

Eur J Clin Pharmacol

Self Cite

View full text Add to dashboard Cite

PurposeOur aim was to describe the adverse drug reactions (ADRs) detected following increased education about pharmacovigilance and drug toxicity in children in Camagüey Province, Cuba.MethodsOver a period of 24 months (January 2009 to December 2010), all reports of suspected ADRs in children to the Provincial Pharmacovigilance Centre in Camagüey Province were analysed. ADRs were classified in relation to causality and severity.ResultsThere were 533 reports involving suspected ADRs in children in the period. Almost one third of the reports received were classified as moderate (155, 29%) or severe (10, 2%). There was one fatality in association with the use of ceftriaxone. Vaccines and antibiotics were responsible for most of the ADR reports (392, 74%) and for all ten severe ADRs. After an intensive educational package, both within the community and the Children’s Hospital, the number of reports increased from 124 in 2008 to 161 in 2009 and 372 in 2010. This was equivalent to a reporting rate of 879 and 2,031 reports per million children per year for 2009 and 2010, respectively.ConclusionsThe incidence of ADRs in children Camagüey Province, Cuba, is greater than previously reported. An educational intervention about pharmacovigilance and drug toxicity in children can improve the reporting of ADRs.

show abstract

Section: Introductionmentioning

confidence: 82%

severe: fatal or potentially life threatening or causing permanent disability;

moderate: requiring treatment or prolonging stay in hospital or causing interference with normal daily activities;

mild: minor reactions that do not require treatment and do not prolong stay in hospital.

…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacovigilance in children in Camagüey Province, Cuba

Arencibia

Leyva

Peña

et al. 2012

Eur J Clin Pharmacol

Self Cite

View full text Add to dashboard Cite

show abstract

“…Finally, health care professionals may be reluctant to report a suspected ADR if a medicine being used is unlicensed or "off-label", because of potential liability issues [34]. Underreporting is more relevant for ADRs in children, and educational intervention for health professional are effective also in setting characterised by an high rate of spontaneous reporting [35].…”

Section: Discussionmentioning

confidence: 99%

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Gallo¹,

Clavenna²,

Bonati³

et al. 2012

OJPed

View full text Add to dashboard Cite

Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%; 95% CI 0.2% -1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.

show abstract

“…It is important to note that this percentage does not indicate the risk of ADRs for children taking part in RCTs but merely the proportion of trials in which ADRs were detected [6]. Previous studies have shown that the overall incidence of ADRs in the paediatric population is 634 per million children per year [24] and approximately 10% for hospitalised children [25]. It is important that ADRs are assessed in the setting of a trial so they can be established before the medicine is used in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Systematic review of safety in paediatric drug trials published in 2007

Aripin

Choonara

Sammons

2011

Eur J Clin Pharmacol

View full text Add to dashboard Cite

BackgroundThere is now greater involvement of children in drug trials to ensure that paediatric medicines are supported by sound scientific evidence. The safety of the participating children is of paramount importance. Previous research shows that these children can suffer moderate and severe adverse drug reactions (ADRs) in clinical trials, yet very few of the trials designated a data safety monitoring board (DSMB) to oversee the trial.MethodsSafety data from a systematic review of paediatric drug randomised controlled trials (RCTs) published in 2007 were analysed. All reported adverse events (AEs) were classified and assessed to determine whether an ADR had been experienced. ADRs were then categorised according to severity. Each trial report was examined as to whether an independent DSMB was in place.ResultsOf the 582 paediatric drug RCTs analysed, 210 (36%) reported that a serious AE had occurred, and in 15% mortality was reported. ADRs were detected in more than half of the RCTs (305); 66 (11%) were severe, and 79 (14%) were moderate. Severe ADRs involved a wide range of organ systems and were frequently associated with cytotoxic drugs, antiparasitics, anticonvulsants and psychotropic drugs. Two RCTs reported significantly higher mortality rates in the treatment group. Only 69 (12%) of the RCTs stated there was a DSMB. DSMBs terminated five RCTs and changed the protocol in one.ConclusionsChildren participating in drug RCTs experience a significant amount and a wide range of ADRs. DSMBs are needed to ensure the safety of paediatric participants in clinical drug trials.

show abstract

Adverse drug reactions in children in Camaguey Province, Cuba

Abstract: ADRs in children are more frequent than previously reported. A successful pharmacovigilance programme can be established in lower middle income countries.

Cited by 17 publications

References 21 publications

Pharmacovigilance in children in Camagüey Province, Cuba

Pharmacovigilance in children in Camagüey Province, Cuba

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Systematic review of safety in paediatric drug trials published in 2007

Contact Info

Product

Resources

About