Medical Monitoring Often Missing From Care of Patients on SGAs

Studies of lab orders for patients receiving second-generation antipsychotic (SGA) medications reveal that few are getting screened or monitored for cardiovascular and metabolic risk factors, reported Elaine Morrato, Dr.P.H., at a symposium at APA's Institute on Psychiatric Services last month in Chicago.

Both patient reports and lab order results suggest that the actual rate of screening and monitoring is lower than the self-reports of psychiatrists—a fact that may be explained by patient failure to follow up on referrals for lab screening.

Moreover, warnings by the Food and Drug Administration regarding cardiometabolic risk factors associated with use of SGAs and recommendations by APA and the American Diabetes Association (ADA) appear to have done little to change prescriber behavior regarding screening and monitoring. Rather, trends in screening and monitoring of patients on SGAs appear to follow those for the general population.

Also, she said, children and adolescents who might benefit most from primary prevention of cardiovascular disease and metabolic syndrome are even less likely than adults to receive screening and monitoring.

“There is a disparity that continues to exist between guideline recommendations for cardiometabolic monitoring and screening and the monitoring that actually exists in practice, with a gap between what psychiatrists are telling us in terms of their practice and what we are seeing when we look at lab claims for glucose and lipid testing,” she said.

She is an assistant professor in the departments of pediatrics, health system management and policy, and clinical pharmacy at the University of Colorado Health Sciences Center.

Morrato spoke at the symposium “Why Psychiatry Is a Branch of Medicine: An Update on Screening and Monitoring Cardiometabolic Risk Factors During Mental Health Treatment.” She was joined by psychiatrists and other public health experts who emphasized the need for psychiatrists to assume responsibility for the medical care of severely mentally ill patients at high risk for diabetes, cardiovascular disease, and metabolic syndrome.

Joseph Parks, M.D., chair of the Medical Directors Council of the National Association of State Mental Health Program Directors, noted that half of patients in the original Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study had high triglycerides and cholesterol, and that of those, 88 percent were not getting treated for those conditions.

Parks said that means that if the CATIE population is representative of patients being seen by clinicians, 40 percent of them have a dyslipidemia that isn't getting treated. “For every two or three patients you screen, you are going to find one,” he said. “Where else can you get that kind of hit rate on a screening?”

And he said that psychiatrists can no longer claim that they “don't do blood pressure” or “don't do cholesterol.”

“We don't necessarily have to treat these medical issues,” he said, “but we have to attend to them in the mental health system or someone else will lead on it.”

In an April 2003 national survey of 300 psychiatrists chosen from the AMA's Masterfile—prior to the FDA warning—62 percent reported monitoring changes in weight for some or all patients (not only patients using SGAs), and 43 percent said they monitor changes in glucose, according to Morrato.

However, just 29 percent of the psychiatrists said they monitor lipid levels in all or some of their patients.

Moreover, she reported data from a retrospective cohort study of Medicaid laboratory-test claims for 55,436 patients using SGAs in California, Oregon, Tennessee, and Utah between January 1, 1998, and December 31, 2003, showing that in spite of what psychiatrists were reporting, the rate of actual screening was low.

On average, less than 20 percent of patients initiating SGA therapy received baseline glucose testing, and less than 10 percent received baseline lipid testing. Testing was more likely in patients with preexisting diabetes and in patients with a diagnosis of schizophrenia. The data were published in the February Journal of Clinical Psychiatry.

The study also found that the adjusted likelihood of screening increased for older patients, suggesting that younger patients using SGAs were being screened even less than the general population of SGA users.

“There is a significant opportunity to increase screening for patients who can benefit most from primary prevention, especially children and adolescents,” Morrato said. “As these drugs are used more and more in that age group, it becomes ever more critical that they receive early identification and intervention [for cardiometabolic problems].”

Similar results were found in a study of commercially insured patients. Laboratory-test claims for serum glucose and lipid testing were identified for an incident cohort of 18,176 adults initiating widely used SGA drugs in a U.S. commercial health plan between 2000 and 2006—a period encompassing the FDA warnings and APA-ADA recommendations. For the seven-year period, SGA users had low rates of glucose testing (23 percent) and lipid testing (8 percent) at drug initiation.

(The study was originally presented at the 24th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in August in Copenhagen, Denmark, and was published in Pharmacoepidemiology and Drug Safety the same month.)

That study used a statistical analytic method known as “interrupted time series models” to measure the effect of the FDA warning on trends in baseline screening and monitoring. It also looked at screening among a control group of individuals not using SGAs and found that the levels of screening for SGA users and nonusers followed a similar trend across the seven-year period.

What the analysis and the similarity in trends in screening for the control group and the patients on SGAs suggest is that increases in screening and monitoring after the FDA warnings and professional recommendations were more likely to be due to general background trends rather than to the warnings and recommendations; that is, screening and monitoring became more common for all patients with increased nationwide awareness of obesity and metabolic illness, Morrato said.

“I believe that the FDA warning and APA-ADA recommendations were associated with increased awareness and concern about metabolic risks,” she explained later in remarks to Psychiatric News. “This is good news. However, when we look at actual glucose and lipid laboratory claims, we did not see an increase in testing attributable to the warning and medical recommendations.

“So the question is why there is this gap between intended and observed behavior. One possibility is that we all tend to report what we know we should be doing rather than what we actually do, or the psychiatrists participating in the surveys were not representative of all prescribers of SGA drugs. However, another possibility is that psychiatrists are ordering the labs, but the patient is not following through and getting [his or her] blood drawn.

“We need to understand what is happening so that the appropriate strategy for improving screening and monitoring is implemented,” Morrato said.

“The Atypical Antipsychotic Therapy and Metabolic Issues National Survey” is posted at<www.psychopharmacology.com>.“ Awareness of Metabolic Concerns and Perceived Impact of Pharmacotherapy in Patients With Bipolar Disorder:A Survey of 500 U.S. Psychiatrists” is posted at<www.medworksmedia.com/psychopharmbulletin/pdf/21/PB-40-2-04-Suppes.pdf>.▪