Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

Objective To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people. Design Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends. Setting Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network. Participants Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million). Main outcome measures Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides. Results Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were −31.0% (95% confidence interval −33.0% to −29.0%) among adolescents, −24.3% (−25.4% to −23.2%) among young adults, and −14.5% (−16.0% to −12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100 000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, −6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100 000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group. Conclusions Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting

Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors

Purpose In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. Methods We analyzed data (2005–2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). Findings The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. Implications The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes

Trends in antibiotic use in Massachusetts children, 2000-2009.

ObjectiveAntibiotic use rates have declined dramatically since the 1990s. We aimed to determine if, when, and at what level the decline in antibiotic-dispensing rates ended and which diagnoses contributed to the trends.MethodsAntibiotic dispensings and diagnoses were obtained from 2 health insurers for 3- to <72-month-olds in 16 Massachusetts communities from 2000 to 2009. Population-based antibiotic-dispensing rates per person-year (p-y) were determined according to year (September-August) for 3 age groups. Fit statistics were used to identify the most likely year for a change in trend. Rates for the first and last years were compared according to antibiotic category and associated diagnosis.ResultsFrom 2000-2001 to 2008-2009, the antibiotic-dispensing rate for 3- to <24-month-olds decreased 24% (2.3-1.8 antibiotic dispensings per p-y); for 24- to <48-month-olds, it decreased 18% (1.6-1.3 antibiotic dispensings per p-y); and for 48- to <72-month-olds, it decreased 20% (1.4-1.1 antibiotic dispensings per p-y). For 3- to <48-month-olds, rates declined until 2004-2005 and remained stable thereafter; the downward trend for 48- to <72-month-olds ended earlier in 2001-2002. Among 3- to <24-month-olds, first-line penicillin use declined 26%. For otitis media, the dispensing rate decreased 14% and the diagnosis rate declined 9%, whereas the treatment fraction was stable at 63%.ConclusionsThe downward trend in antibiotic dispensings to young children in these communities ended by 2004-2005. This trend was driven by a declining otitis media diagnosis rate. Continued monitoring of population-based dispensing rates will support efforts to avoid returning to previous levels of antibiotic overuse

Trends in antibiotic use in Massachusetts children, 2000-2009.

ObjectiveAntibiotic use rates have declined dramatically since the 1990s. We aimed to determine if, when, and at what level the decline in antibiotic-dispensing rates ended and which diagnoses contributed to the trends.MethodsAntibiotic dispensings and diagnoses were obtained from 2 health insurers for 3- to <72-month-olds in 16 Massachusetts communities from 2000 to 2009. Population-based antibiotic-dispensing rates per person-year (p-y) were determined according to year (September-August) for 3 age groups. Fit statistics were used to identify the most likely year for a change in trend. Rates for the first and last years were compared according to antibiotic category and associated diagnosis.ResultsFrom 2000-2001 to 2008-2009, the antibiotic-dispensing rate for 3- to <24-month-olds decreased 24% (2.3-1.8 antibiotic dispensings per p-y); for 24- to <48-month-olds, it decreased 18% (1.6-1.3 antibiotic dispensings per p-y); and for 48- to <72-month-olds, it decreased 20% (1.4-1.1 antibiotic dispensings per p-y). For 3- to <48-month-olds, rates declined until 2004-2005 and remained stable thereafter; the downward trend for 48- to <72-month-olds ended earlier in 2001-2002. Among 3- to <24-month-olds, first-line penicillin use declined 26%. For otitis media, the dispensing rate decreased 14% and the diagnosis rate declined 9%, whereas the treatment fraction was stable at 63%.ConclusionsThe downward trend in antibiotic dispensings to young children in these communities ended by 2004-2005. This trend was driven by a declining otitis media diagnosis rate. Continued monitoring of population-based dispensing rates will support efforts to avoid returning to previous levels of antibiotic overuse

Creating Enduring Change: Demonstrating the Long-Term Impact of a Faculty Development Program in Palliative Care

BACKGROUND: Improved educational and evaluation methods are needed in continuing professional development programs. OBJECTIVE: To evaluate the long-term impact of a faculty development program in palliative care education and practice. DESIGN: Longitudinal self-report surveys administered from April 2000 to April 2005. PARTICIPANTS: Physician and nurse educators from North America and Europe. All program graduates (n = 156) were invited to participate. INTERVENTION: Two-week program offered annually (2000 to 2003) with 2 on-site sessions and 6-month distance-learning period. Learner-centered training addressed teaching methods, clinical skill development, and organizational and professional development. MEASURES: Self-administered survey items assessing behaviors and attitudes related to palliative care teaching, clinical care, and organizational and professional development at pre-, postprogram, and long-term (6, 12, or 18 months) follow-up. RESULTS: Response rates: 96% (n = 149) preprogram, 73% (n = 114) follow-up. Participants reported increases in: time spent in palliative care practice (38% preprogram, 47% follow-up, P < .01); use of learner-centered teaching approaches (sum of 8 approaches used “a lot”: preprogram 0.7±1.1, follow-up 3.1±2.0, P < .0001); and palliative care topics taught (sum of 11 topics taught “a lot”: preprogram 1.6±2.0, follow-up 4.9±2.9, P < .0001). Reported clinical practices in psychosocial dimensions of care improved (e.g., assessed psychosocial needs of patient who most recently died: 68% preprogram, 85% follow-up, P = .01). Nearly all (90%) reported launching palliative care initiatives, and attributed their success to program participation. Respondents reported major improvements in confidence, commitment to palliative care, and enthusiasm for teaching. Eighty-two percent reported the experience as “transformative.” CONCLUSIONS: This evidence of enduring change provides support for the potential of this educational model to have measurable impact on practices and professional development of physician and nurse educators