Frequency of provider contact after FDA advisory on risk of pediatric suicidality with SSRIs
ABSTRACT 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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ABSTRACT: Continuity of care is a critical indicator of quality of care and key to effective antidepressant medication management in children and adolescents. Little is known about the characteristics associated with receiving guidelines concordant care. Using a retrospective, longitudinal cohort design of youth with a new episode of depression, this study reviewed records and pre-existing data to (1) examine rates of conformance to continuity of care treatment guidelines (Health Plan Employer Data and Information Set [HEDIS]) for antidepressant management; (2) identify individual- and community-level characteristics associated with continuity of antidepressant treatment; and (3) investigate the relationship between continuity of care and antidepressant adherence. Two-thirds of youth met the HEDIS optimum contact criteria of three outpatient mental health contacts during the first 3 months of treatment. Good continuity of care was associated with prior outpatient treatment and taking other psychotropic medications while inadequate follow-up was associated with older adolescents, disabled children, and youths living in rural areas. Guidelines concordant follow-up was associated with better antidepressant adherence. Findings underscore the need to deliver guidelines concordant care, particularly among vulnerable subgroups.Social Work in Mental Health 05/2013; 11(3):267-287. DOI:10.1080/15332985.2012.749826
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ABSTRACT: The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.Drug Safety 09/2014; 37(11). DOI:10.1007/s40264-014-0225-0 · 2.62 Impact Factor
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ABSTRACT: It is important that depressed patients receive adequate and safe care as described in clinical guidelines. The aim of this study was to evaluate the implementation of the Dutch depression guideline for children and adolescents, and to identify factors that were associated with the uptake of the guideline recommendations. The study took place in specialised child and adolescent mental healthcare. An implementation project was initiated to enhance the implementation of the guideline. An evaluation study was performed alongside the implementation project, using structured registration forms and interviews with healthcare professionals. Six multidisciplinary teams participated in the implementation study. The records of 655 patients were analysed. After 1 year, 72 % of all eligible patients had been screened for depression and 38 % were diagnosed with the use of a diagnostic instrument. The severity of the depression was assessed in 77 % of the patients during the diagnostic process, and 41 % of the patients received the recommended intervention based on the depression severity. Of the patients that received antidepressants, 25 % received weekly checks for suicidal thoughts in the first 6 weeks. Monitoring of the patients' response was recorded in 32 % of the patients. A wide range of factors were perceived to influence the uptake of guideline recommendations, e.g. the availability of capable professionals, available time, electronic tools and reminders, and the professionals' skills and attitudes. With the involvement of the teams, recommendations were provided for nationwide implementation of the guideline. In conclusion, a systematic implementation programme using stepped care principles for the allocation of depression interventions seems successful, but there remains room for further improvement.European Child & Adolescent Psychiatry 01/2015; DOI:10.1007/s00787-014-0670-4 · 3.70 Impact Factor