Adults and children who began a new course of antidepressant therapy before
the appearance of black-box warnings pertaining to SSRIs' risk of suicidality
received far less follow-up monitoring than is recommended by the Food and
Drug Administration (FDA).
That was the finding from a study following a cohort of more than 84,000
patients in a large managed care organization for 12 weeks. The findings
appeared in the august American Journal of Managed Care.
The study is a retrospective examination of practice patterns in a
commercial population before the FDA held hearings and subsequently issued
black-box warnings regarding risk of suicidality with SSRIs. The new warning
labels recommend at least seven visits during the first 12 weeks of treatment:
weekly visits during the first four weeks, visits every other week during the
next four weeks, and a visit during the 12th week.
The results of the study appear to underscore in a general way the poor
rate of follow-up care for patients receiving antidepressant therapy."
The results of our study suggest that follow-up care in practice is far
less frequent than what is recommended by the current product labeling,"
wrote Glen Stetin, M.D., and colleagues. "in this study sample, more
than 80 percent of patients had no mental health visits with health care
providers during the first four weeks after starting antidepressant therapy,
and the average patient had only one or two face-to-face visits for any
purpose during that period."
Stein is with Medco Health Solutions Inc., a pharmacy benefits management
company that manages prescription benefits for the population that was
studied. Drug-utilization data for the study were drawn from a prescription
claims database maintained by Medco. Medical utilization data, including
mental health care claims data, were drawn from an administrative claims
database maintained by the managed care organization.
Experts who reviewed the study, and the authors themselves, said it
provides only the roughest kind of approximation of what is happening to
patients who are prescribed antidepressants. Moreover, it remains unknown what
the optimal cost-effective level of follow-up care is; the target of seven
visits in 12 weeks is an arbitrary figure, which, if followed consistently by
clinicians and patients, would substantially increase costs.
"It is clear from the results of this study that improvements are
needed in the timing and frequency of follow-up care for patients who start
antidepressant therapy," said Stetin and colleagues. "However, it
is difficult to define what level of follow-up care is a cost-effective and
clinically appropriate target for health care providers... .If increased visit
frequency translates into improved recovery rates, the increased costs of
follow-up care may be offset by reductions in other direct costs, such as
hospitalization or by reductions in indirect costs, such as absenteeism. In
the absence of solid research data, these linkages remain
A monitoring system tailored to the needs of each patient is what is
needed, according to Darrel Regier, M.D., M.P.H., director of APA's Division
of Research and the American Psychiatric Institute for Research and Education.
Moreover, monitoring of patients has to include valid and reliable
measurements of symptom severity, treatment response, and suicide risk, such
as is provided by instruments like the nine-item Patient Health Questionnaire
"We have argued all along that an arbitrary target of seven visits is
not the way to go," Regier told Psychiatric News. "One
needs to have a way of monitoring that is more effective and tailor it to the
patient. If you simply took an across-the-board recommendation that everyone
has to have seven visits in 12 weeks, it would probably not be a
cost-effective way to advance safety or efficacy."
Regier noted that there has been a significant decrease in the prescribing
of antidepressant medication for children since the FDA black-box warnings
"The question is, given this drop in the rate of prescribing, has it
resulted in a higher proportion of those receiving medications having the
recommended visit rate? More important, what is the outcome in disability and
suicide risk for those not receiving treatment because of this FDA
requirement? and what is the treatment response and suicide risk reduction for
those with an increased visit rate?
"If the entire health system devoted more visits out of its current
capacity to monitoring antidepressant use in face-to-face visits instead of
allowing some telephone contact, what other medical and psychiatric disorders
would receive less treatment?" Regier asked.
Edward Gordon, M.D., chair of APA's Medicare Advisory Corresponding
Committee, emphasized the role of managed care in restricting access to
treatment for depression.
"One of the real problems with patients getting adequate care of
depression is that their insurance coverage is inadequate," he said."
Very often it allows as few as 20 visits a year, including for the
family and children, and the fees are so low that it has caused a real
shortage of people to do the treatment."
Gordon also criticized the report noting that it revealed nothing about the
actual clinical outcome of depressed patients.
"The [FDA] recommendations are inadequate themselves," he said."
Patients need care depending on how sick they are. This study is done
by a pharmaceutical [benefit] management company and is an entirely
nonclinical report. It has nothing to do with whether patients get
And Gordon added that he believes the cost of mental health care should go
up, if appropriate insurance coverage is provided.
"If the insurance companies really wanted adequate treatment they
would increase fees and availability of services," he said.
The study included 84,514 adult and pediatric patients who started a new
course of antidepressant therapy for any indication between July 2001 and
September 2003. Patients were members of a large managed care organization in
the north-eastern United States. Ambulatory visits during the first 12 weeks
of treatment were identified using medical claims data. Outcome measures were
time to first follow-up visit, frequency of follow-up visits, and percentage
of patients receiving recommended levels of care.
During the first four weeks of antidepressant treatment, only 55.0 percent
of patients saw a health care provider for any purpose, and only 17.7 percent
saw a provider for mental health care. Ambulatory visits during the first
four, eight, and 12 weeks were significantly lower than the minimum levels
recommended in product labeling.
Only 14.9 percent of patients received the FDA-recommended level of
follow-up care during the first four weeks, 18.1 percent at eight weeks, and
22.6 percent at 12 weeks, according to the study.
APA Trustee and child psychiatrist David Fassler, M.D., said the analysis
does not distinguish between patients who received a prescription from a
psychiatrist as opposed to a pediatrician, internist, or other primary care
physician. Moreover, the database appears to encompass claims from all mental
health care clinicians, Fassler said.
"Accordingly, there's no way to know whether the follow-up visits
actually incorporated any clinically meaningful aspect of `monitoring,'"
he said. "Nonmedical visits would also fall outside the parameters
contained in the guidelines eventually issued by the FDA."
Fassler observed that the results reveal little about current practice
patterns with respect to follow-up for children, adolescents, and adults who
are being treated with SSRIs.
"We have seen a reduction of over 20 percent in overall prescriptions
of SSRIs for patients under the age of 18," Fassler said. "In
actual clinical practice, my impression is that most physicians are attempting
to individualize the frequency of follow-up visits and phone contact to the
clinical needs of the child and family."
He added, however, that "it's clear that the specific schedule
recommended by the FDA has not been widely adopted. As the authors of this
article noted, the FDA guideline was not based on any specific data or study
demonstrating improved outcome. Rather, it was adopted from a research
protocol. The real issue isn't simply how many visits a child has; it's
whether they're getting appropriate treatment that is based on a comprehensive
evaluation and an accurate diagnosis."
Fassler said that advocacy organizations such as Families for Depression
Awareness have also developed "monitoring kits" for families to
help them gather as much information as possible between office visits.
"In some parts of the country, child and adolescent psychiatrists are
working with pediatricians and family practice physicians to develop local
`standards of care' that are clinically based while also acknowledging
regional variations with respect to access and utilization of limited
resources," he said.
"Frequency of Follow-up Care for Adult and Pediatric Patients
During Initiation of Antidepressant Therapy" is posted at<www.ajmc.com/Article.cfm?Menu=1&ID=3169>.▪