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New Study: Despite Suicidality Risks, Patients on Antidepressants Have Received Far Less Follow-Up Care Than is Currently Recommended

Posted on: Wednesday, 9 August 2006, 09:00 CDT

FRANKLIN LAKES, N.J., Aug. 9 /PRNewswire-FirstCall/ -- 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. , 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.

"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.com, 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. 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: http://www.medco.com/.

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.

CONTACT: Jennifer Leone Luddy of Medco Health Solutions,+1-201-269-6402, jennifer_luddy@medco.com; Janet Schiller or Erin Drelick,Coyne Public Relations for Medco Health Solutions, Inc., +1-973-316-1665

Web site: http://www.medco.com/

Source: PRNewswire-FirstCall

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