Despite concerns about suicidal thoughts and behaviors in patients using antidepressants, a new study (Am J Manag Care. 2006; 12:453-461) has revealed that very few patients are receiving the FDA's recommended level of follow-up care during the first crucial weeks and months of treatment.
In January 2005, the FDA called for a black box warning for all antidepressants to call attention to reports of an increased risk of suicidal thoughts and behavior in children and adolescents who take these drugs. The agency also issued a public health advisory about the same risks in adults.
Current FDA guidelines call for all patients, regardless of age, to have at least weekly face-to-face visits with a healthcare provider during the first 4 weeks of antidepressant therapy, followed by every other week during the next 4 weeks, followed by another visit after 12 weeks. But this retrospective review of the medical and pharmacy claims of 84,500 pediatric and adult patients found that only 18% had received the recommended follow-up care at 8 weeks and only 23% at 12 weeks (Figure).
"This study brings to light potentially serious inadequacies in the follow-up care of patients on antidepressants," said lead author Glen Stettin, MD, senior vice president of clinical solutions, Medco Health Solutions. "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 side effects that can lead to poor compliance or the discontinuation of therapy, which can have extremely negative consequences as well."
Fewer than half of the children aged ≤18 years saw a clinician at least once for mental healthcare follow-up during the first few months of antidepressant treatment, and follow-up in adults was even poorer. The following percentages of patients did not see a physician for mental health evaluation in the specified number of weeks after starting antidepressant therapy:
? 66% of children and 83% of adults, within the first 4 weeks after starting therapy
? 58% of children and 78% of adults, within the first 8 weeks
? 53% of children and nearly 76% of adults, within the first 12 weeks.
There were more general medical visits than mental healthcare visits during the first few months of antidepressant treatment. But 45% of patients did not visit any healthcare provider during the first 4 weeks of antidepressant treatment, more than 30% did not see a healthcare provider within 8 weeks of receiving treatment, and 23% had no medical visits at all during the first 12 weeks of treatment.
"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 Dr Stettin.
"It is essential for all patients that are being placed on antidepressants to be monitored properly, even if the medication is being used for indications other than depression," he reminds physicians.