Frequency of Provider Contact After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

University of Colorado, Denver, CO 80262, USA.
American Journal of Psychiatry (Impact Factor: 12.3). 02/2008; 165(1):42-50. DOI: 10.1176/appi.ajp.2007.07010205
Source: PubMed


The Food and Drug Administration (FDA) issued a public health advisory in October 2003 on the risk of suicide in pediatric patients taking antidepressants and advised maintaining "close supervision" of such patients. In this study, the authors compared trends in the frequency of provider contacts for patients with depression before and after the advisory was issued.
Retrospective cohorts of children (N=27,370) and adults (N=193,151) with new episodes of depression treated with antidepressants were created from a national claims database of managed care plans (1998-2005). Two standards were used in measuring patient monitoring: the Health Plan Employer Data and Information Set (HEDIS) quality-of-care criterion calling for three contacts in 3 months and the FDA-recommended contact schedule totaling seven visits in 3 months. Time-series models compared postadvisory trends to the expected trend based on preadvisory measures.
Less than 5% of all patients met FDA contact recommendations before the advisory, and the rate did not change after the advisory. A greater proportion of patients met the HEDIS contact criterion before the advisory (60% for children and 40% for adults), and the rate did not change after the advisory. A greater proportion of pediatric patients seen by a psychiatrist (80%) met the HEDIS criterion than those seen by a pediatrician (60%) or a non-pediatrician primary care physician (54%), and than adults seen by a psychiatrist (65%) or a primary care physician (37%). The proportions of pediatric patients who met the FDA recommendations did not differ by specialty.
Contrary to expectations, the frequency of visits by patients with new episodes of depression treated with antidepressants did not increase after the October 2003 FDA advisory was issued.

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Available from: Robert J Valuck, Sep 03, 2015
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    • "Our results show monitoring was undertaken far less frequently than recommended and was not done in a systematic nor precise way. This is consistent with previous US research [19]. Our previous work regarding clinicians’ perceived lack of expertise and time to undertake systematic monitoring, particularly of medication induced adverse side effects [15]. "
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    ABSTRACT: Literature has shown that dissemination of guidelines alone is insufficient to ensure that guideline recommendations are incorporated into every day clinical practice. We aimed to investigate the gaps between guideline recommendations and clinical practice in the management of young people with depression by undertaking an audit of medical files in a catchment area public mental health service for 15 to 25 year olds in Melbourne, Australia. The results showed that the assessment and recording of depression severity to ensure appropriate treatment planning was not systematic nor consistent; that the majority of young people (74.5%) were prescribed an antidepressant before an adequate trial of psychotherapy was undertaken and that less than 50% were monitored for depression symptom improvement and antidepressant treatment emergent suicide related behaviours (35% and 30% respectively). Encouragingly 92% of first line prescriptions for those aged 18 years or under who were previously antidepressant-naïve was for fluoxetine as recommended. This research has highlighted the need for targeted strategies to ensure effective implementation. These strategies might include practice system tools that allow for systematic monitoring of depression symptoms and adverse side effects, particularly suicide related behaviours. Additionally, youth specific psychotherapy that incorporates the most effective components for this age group, delivered in a youth friendly way would likely aid effective implementation of guideline recommendations for engagement in an adequate trial of psychotherapy before medication is initiated.
    Full-text · Article · Jun 2012 · BMC Health Services Research
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    • "Although controversially discussed (Gibbons, 2007; Jureidini , 2007; Olfson and Shaffer, 2007), there is evidence of a parallel increase of suicide rates in the United States and the Netherlands between 2003 and 2005 (Gibbons et al, 2007) for the first time in a decade. The intended effect of the FDA warning to improve supervision of patients treated with antidepressants has not yet occurred (Morrato et al, 2008). Moreover, the decline in treating major depression continued, without compensation by substitute care (Libby et al, 2009). "
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    ABSTRACT: Emergence of suicidal ideation (TESI) during treatment with antidepressants in major depression led to a black box warning. We performed a genome-wide association study to identify genetic markers, which increase the risk for this serious side effect. TESI was evaluated in depressed in-patients (N=397) and defined by an emergence of suicidal thoughts during hospitalization without suicidal thoughts at admission using the suicide item (3) of the Hamilton Depression Rating Scale. Genotype distribution of 405.383 single-nucleotide polymorphisms (SNPs) in patients with TESI (N=32/8.1%) was compared to patients without increase in suicidal ideation (N=329/82.9%) and to a subgroup never reported suicidal ideation (N=79/19.9%). Top results were analyzed in an independent sample (N=501). None variant reached genome-wide significance, the best associated SNP was rs1630535 (p-value=1.3 × 10(-7)). The top 79 SNPs could be analyzed in an independent sample, and 14 variants showed nominal significant association with the same risk allele in the replication sample. A discriminant analysis classifying patients using these 79 SNPs revealed a 91% probability to classify TESI vs non-TESI cases correctly in the replication sample. Although our data need to be interpreted carefully owing to the small numbers in both cohorts, they suggest that a combination of genetic markers might indeed be used to identify patients at risk for TESI.
    Full-text · Article · Feb 2012 · Neuropsychopharmacology: official publication of the American College of Neuropsychopharmacology
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    • "Al igual que en otros estudios, se detectó un descenso en la prescripción de antidepresivos, aunque la mayoría de los encuestados no seguían las recomendaciones de la FDA por considerar clínicamente justifi cado el uso de antidepresi- vos 9 . Morrato y cols (2008), investigaron el posible impacto de la alerta sobre el manejo clínico , mediante el análisis retrospectivo de una base de datos asistenciales entre 1998 y 2005 con 27 370 menores (5-18 años) y 193 151 adultos. Ambos grupos, con diagnóstico de TDM en tratamiento, se evaluaron midiendo el cumplimiento de dos instrumentos: el HEDIS (examina el contacto óptimo con salud mental, midiendo la duración del tratamiento las primeras 12 semanas y los 6 primeros meses) y las recomendaciones de la guía de la FDA en 2005 (7 visitas durante los primeros 3 meses de tratamiento). "
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    ABSTRACT: Objective: To analyze the use and research in efficacy and safety of antidepressants in Mayor Depressive Disorder (MDD) in paediatric population after the 2003 international warning from regulatory agencies (EMA, FDA) about an increased suicide risk in children and adolescents treated with antidepressants. Method: A review of the last 10 years publications regarding the prescription trends and efficacy and safety of antidepressants in paediatric depression was carried out. Cochrane and Pub Med databases were used. Results: Since the alert there has been a change in previous ascending trends of antidepressant prescription to children and adolescents with a decrease in their use, as well as an increase in the completed suicide rate in this population. Clinical management and monitoring of these patients have been slightly modified. Since 2004, two studies (escitalopram, citalopram) showed significant efficacy vs placebo for paediatric depression, adding more evidence to previous Fluoxetine results. Three studies show significant efficacy in adolescent MDD but only one with sertraline was designed to detect subgroup age differences. No more evidence of increased suicide risk has been found. Conclusions: Safety warnings from regulatory agencies EMA and FDA about antidepressant use in paediatric population has modified sligthtly clinical practice, with a decreased trend in prescription. More research has been conducted since 2004, adding evidence for efficacy but not for an increased risk of suicide. Methodological flaws of conducted studies after the warnings remain similar to previous research.
    Preview · Article · Aug 2011 · Revista chilena de pediatría
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