Despite concerns
about suicidal thoughts and behavior for patients using antidepressants, a
new study in the August issue of the peer-reviewed American Journal of
Managed Care shows that few patients on these drugs received even the
minimum level of follow-up care. The Food and Drug Administration (FDA)
requires a "black box" warning, the strongest alert possible, on all
antidepressants for increased risk of suicidal thoughts and behavior in
children and adolescents, and has issued a public health advisory about
those risks for adults.
Current FDA guidelines for both pediatric and adult patients recommend
at least weekly face-to-face visits with a health practitioner during the
first four weeks of antidepressant treatment, then every other week during
the next four weeks, and then a visit after 12 weeks. But according to the
study by Medco Health Solutions, Inc. (NYSE: MHS), nearly half of all
patients have no follow-up visits during the first month of taking
antidepressants, and fewer than 18 percent of patients see a practitioner
specifically for mental health follow-up care during that time period.
The new study found that few patients were monitored closely during the
first three months following the start of antidepressant therapy. The
study, which reviewed medical and pharmacy claims of 84,500 pediatric and
adult patients, found that less than 15 percent of patients received the
FDA's current recommended level of follow-up care in the first four weeks
of drug treatment, 18 percent at eight weeks, and 23 percent at 12 weeks.
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"This study brings to light potentially serious inadequacies in the
follow-up care of patients on antidepressants," said Dr. Glen Stettin,
senior vice president of clinical solutions for Medco and lead author of
the study. "Not only is close monitoring needed to reduce the risk of
adverse outcomes including suicidal tendencies, but also to assess a
patient's response to the treatment, make adjustments to drug dosages when
necessary and help manage side-effects that can lead to poor compliance or
the discontinuation of therapy, which can have extremely negative
consequences as well."
While fewer than half of children 18 years and younger saw a
practitioner at least once for mental health care follow-up in the first
few months of antidepressant treatment, adult visits were even less
frequent:
-- 66 percent of children and 83 percent of adults did not see a
clinician for a mental health care visit in the first four weeks
after antidepressant therapy had begun
-- 58 percent of children and 78 percent of adults had not had such a
visit within 8 weeks
-- 53 percent of children and nearly 76 percent of adult patients had no
mental health care visits during the first 12 weeks of drug therapy
While the study found that general medical visits were more common than
mental health care visits in the first few weeks and months of
antidepressant treatment, still 45 percent of patients saw no health
clinician at all in the first four weeks of drug therapy, more than 30
percent did not see a health provider within eight weeks and 23 percent had
no medical visits at all within 12 weeks.
The retrospective study included 84,500 adult and pediatric patients
who started on a new course of antidepressant therapy between July 2001 and
September 2003. Using an integrated database of medical and pharmacy
claims, the number of health provider visits was identified by reviewing
medical claim information for these patients. The patients all had mental
health care coverage as participants in medical and pharmacy benefit plans
administered by a large managed care organization in the northeastern
United States.
"Although this study assesses clinical practices prior to the current
FDA recommendations, the level of follow-up care seen during this period of
time would be considered substandard even according to older guidelines,"
said Stettin. "It is essential for all patients being placed on
antidepressants to be monitored properly, even if the medication is being
used for indications other than depression."
Antidepressant risks
After considerable debate and litigation through the 1990s to the early
part of this decade, there have been concerns about the risk of suicide
linked to antidepressant use. The difficulty of this debate stems from
whether suicides were caused by the antidepressants or the depression they
were meant to treat. The FDA first proposed the black box warning -- the
agency's strongest safety measure short of recalling the drug -- in October
2004 after analysis of available data showed an increase in the risk of
suicidal tendency ("suicidality") among children being treated with certain
antidepressants. The label change was given final approval on January 12,
2005. The new FDA ruling mandates that all antidepressants bear a black box
warning regarding the potential risk of pediatric suicidality.
The FDA is currently reviewing data regarding a possible increased risk
of suicidality in adults using antidepressant medications.
Medco addresses safety
Last year, following the FDA's call for expanded warning labels on
antidepressants, Medco implemented a broad-reaching integrated
communication effort to contact patients, pharmacists and physicians about
the potential risks associated with antidepressant use. Medco immediately
posted product alerts on medco, the company's online pharmacy website.
As quickly as possible, all antidepressant prescriptions filled through
Medco's mail-service pharmacies included updated patient product
information. The company also provided its 3,500 customer service
representatives with up-to-date product information to address patient and
caregiver questions related to use of antidepressants in pediatric
patients.
To reach physicians and pharmacists, Medco continued the use of its
detailed pediatric drug utilization alerts related specifically to
antidepressants. Medco expanded its safety alert rules in its RationalMed
patient safety system, which identifies patients at risk for adverse drug
events which could lead to hospitalization. During 2005, RationalMed issued
222,094 safety alerts for antidepressant use, of which 15 percent were tied
to age considerations of the patient and another 10 percent were tied to
potential interactions with other drugs or other health conditions. Overall
prescription drug savings from therapy changes in response to the alerts
totaled $4.5 million. Medco also distributed practice summaries to
physicians identifying the patients under the age of 18 within their
practice on antidepressants to help physicians evaluate any necessary
changes in therapy.
About Medco
Medco Health Solutions, Inc. (NYSE: MHS) is the nation's leading
pharmacy benefit manager based on its 2005 total net revenues of nearly $38
billion. Medco's prescription drug benefit programs are designed to drive
down the cost of pharmacy health care for private and public employers,
health plans, labor unions and government agencies of all sizes, and for
individuals served by the Medicare Part D Prescription Drug Program.
Medco's technologically advanced mail-order pharmacies and award-winning
Internet pharmacy have been recognized for setting new industry benchmarks
for pharmacy dispensing quality. Medco serves the needs of patients with
complex conditions requiring sophisticated treatment through its specialty
pharmacy operation, which became the nation's largest with the 2005
acquisition of Accredo Health, Incorporated. Medco is the highest-ranked
pharmacy benefit manager on the 2006 Fortune 500 list. On the Net:
medco.
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995. These
statements involve risks and uncertainties that may cause results to differ
materially from those set forth in the statements. No forward-looking
statement can be guaranteed, and actual results may differ materially from
those projected. We undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the risks and uncertainties that affect
our business, particularly those mentioned in the Risk Factors section of
the Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission.
Medco Health Solutions, Inc.
medco
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