A systematic review on the application of pharmaco­epidemiology in assessing prescription drug-related adverse events in pediatrics

Luo, Xuemei; Cappelleri, Joseph C.; Frush, Karen

doi:10.1185/030079907x182211

Cited by 18 publications

(6 citation statements)

References 40 publications

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“…Children who receive multiple diagnoses as a result of complex emotional and behavioural problems often are refractory to focal treatment regimens and receive costly and fragmented multiple-component treatment regimens (Comer, Olfson, & Mojtabai, 2010;Grella & Joshi, 2003;Lau & Weisz, 2003;Mueser & Taub, 2008;Saldana et al, 2014). Polypharmacological and/or poly-psychotherapeutic treatment is at best only partially and temporarily effective with chronic and severe psychiatric disorders (Grella & Joshi, 2003;Holtmann et al, 2011;Jacobs et al, 2008;Jucksch et al, 2011) and may lead to severe adverse reactions (Barbui et al, 2007;Luo, Cappelleri, & Frush, 2007;Schorr, Loonen, Brouwers, & Taxis, 2008). Treatment targeted to address trauma-related symptoms could provide a complementary or alternative approach for poly-victimized and poly-diagnosed children and adolescents (D'Andrea et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

Comorbidity of developmental trauma disorder (DTD) and post-traumatic stress disorder: findings from the DTD field trial

Kolk

Ford

Spinazzola³

2019

European Journal of Psychotraumatology

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Background: Developmental trauma disorder (DTD) has been proposed to describe the biopsychosocial sequelae of exposure to interpersonal victimization in childhood that extend beyond the symptoms of post-traumatic stress disorder (PTSD).Objective: To characterize the psychopathology comorbid with DTD and to determine whether this comorbidity is distinct from, and extends beyond, comorbidities of PTSD.Method: DTD was assessed by structured interview, and probable Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) psychiatric disorders were identified with screening modules on the Kiddie Schedule for Affective Disorders and Schizophrenia, Present/Lifetime version (K-SADS-PL), in a multi-site sample of 236 children (7–18 years old; 50% female) referred by paediatric or mental health providers.Results: DTD (N = 80, 34%) and PTSD (N = 69, 29%) were highly comorbid and shared several DSM-IV internalizing disorder and DSM, 5th Edition (DSM-5) dysregulation disorder comorbidities. However, DTD, but not PTSD, was associated with comorbid panic disorder and disruptive behaviour disorders. On a multivariate basis including all probable DSM-IV disorders and DSM-5 dysregulation disorders, DTD was associated with separation anxiety disorder and attention deficit hyperactivity disorder after controlling for PTSD, while PTSD was associated with major depression and generalized anxiety disorder after controlling for DTD.Conclusions: DTD’s comorbidities overlap with but extend beyond those of PTSD to include panic, separation anxiety, and disruptive behaviour disorders. DTD warrants further investigation as a potential diagnosis or a complex variant of PTSD in children, similar to the adult symptoms of disturbances of self-organization in the proposed International Classification of Diseases, 11th revision (ICD-11) complex post-traumatic stress disorder subtype.

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Section: Introductionmentioning

confidence: 99%

Comorbidity of developmental trauma disorder (DTD) and post-traumatic stress disorder: findings from the DTD field trial

Kolk

Ford

Spinazzola³

2019

European Journal of Psychotraumatology

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“…In this review we used a sensitive search strategy and systematically reviewed a large number of titles and abstracts seeking relevant studies, approaches similar to other reviews in this area . Using search terms, either MeSH headings or as free text, proved of limited value in focusing a search strategy without losing key references.…”

Section: Discussionmentioning

confidence: 99%

Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

Black

Tagiyeva

Helms

et al. 2015

Brit J Clinical Pharma

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Aims A systematic review of the literature published in English over 10 years was undertaken in order to describe the use of electronic healthcare data in the identification of potential adverse drug reactions (ADRs) in children. Methods MEDLINE and EMBASE were searched using MESH headings and text words. Titles, keywords and abstracts were checked for age <18 years, potential ADRs and electronic healthcare data. Information extracted included age, data source, pharmacovigilance method, medicines and ADRs. Studies were quality assessed. Results From 14 804 titles, 314 had a full text review and 71 were included in the final review. Fifty were published in North America, 10 in Scandinavia. Study size ranged from less than 1000 children to more than 10 million. Sixty per cent of studies used data from one source. Comparative observational studies were most commonly reported (66.2%) with 15% using passive surveillance. Electronic healthcare data set linkage and the quality of the data source were poorly reported. ADRs were classified using the International Classification of Disease (ICD10). Multi‐system reactions were most commonly studied, followed by central nervous system and mental and behavioural disorders. Vaccines were most frequently prescribed followed by corticosteroids, general anaesthetics and antidepressants. Conclusions Routine electronic healthcare records were increasingly reported to be used for pharmacovigilance in children. This growing and important health protection activity could be enhanced by consistent reporting of studies to improve the identification, interpretation and generalizability of the evidence base.

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“…Routine data linkage would permit creation of a continuous virtual cohort to monitor for long-term outcomes, for example, after exposure to pharmacotherapy, and enable a more efficient screening for side effects or ADRs due to an ever increasing data pool 26. Creating a large cohort can sometimes be challenging in children if the group of patients is below 1000, as can be the case for orphan drugs or rare conditions 27. In addition, off-label or unlicensed drugs, often used in paediatrics, are not subject to the rigorous postmarketing surveillance schemes, which leaves the evidence in this field incomplete 28.…”

Section: Background and Significancementioning

confidence: 99%

Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians

et al. 2014

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ObjectiveThe inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data.DesignQualitative study using semistructured face-to-face interviews addressing the study aims.ParticipantsPurposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach.ResultsParticipants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important factors to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified.ConclusionsA large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source datasets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership and responsibilities of data owners.

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A systematic review on the application of pharmacoepidemiology in assessing prescription drug-related adverse events in pediatrics

Cited by 18 publications

References 40 publications

Comorbidity of developmental trauma disorder (DTD) and post-traumatic stress disorder: findings from the DTD field trial

Comorbidity of developmental trauma disorder (DTD) and post-traumatic stress disorder: findings from the DTD field trial

Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians

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A systematic review on the application of pharmaco­epidemiology in assessing prescription drug-related adverse events in pediatrics

Cited by 18 publications

References 40 publications

Comorbidity of developmental trauma disorder (DTD) and post-traumatic stress disorder: findings from the DTD field trial

Comorbidity of developmental trauma disorder (DTD) and post-traumatic stress disorder: findings from the DTD field trial

Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians

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A systematic review on the application of pharmacoepidemiology in assessing prescription drug-related adverse events in pediatrics