New research has highlighted the alleged overuse of psychotropic medications in both nursing home and foster care settings. Last year, a report released by the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG)—Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents—noted numerous problems with the use of these medications in this patient population.
In addition, a report released by the U.S. Government Accountability Office (GAO) in December 2011 noted that children in foster care were prescribed psychotropic medications at much higher rates than those not in this type of care. These data need to be reviewed so that clinicians can focus on better managing these vulnerable patient populations.
At the request of Sen. Chuck Grassley (R-IA), OIG examined the extent to which psychotropic drugs were prescribed to residents of nursing homes for off-label indications or used in patients who met specific criteria for boxed warnings (i.e., dementia-related psychosis) that antipsychotics should not be used. In addition, OIG assessed whether drugs associated with Medicare claims were given in compliance with CMS standards for drug therapy in nursing homes.
One such CMS standard is that nursing home residents be free from unnecessary drugs, including drugs used in an excessive dose, for an excessive duration, without adequate monitoring, without adequate indications for use, and/or in the presence of adverse consequences. In terms of antipsychotic drugs, CMS requires that patients new to these therapies only be given these agents to treat specific conditions as diagnosed and documented in the medical record and that residents receive gradual dose reductions and behavioral interventions in an effort to discontinue these drugs unless clinically contraindicated.
OIG assessed claims billed to Medicare Part D and/or Part B from January 1 through June 30, 2007, for second-generation antipsychotics, also known as atypical antipsychotics, for nursing home residents 65 years or older, and a sample of medical records was reviewed to assess use. A total of 1,678,874 Part D or B claims for second-generation antipsychotic drugs among 304,983 older nursing home residents were found for the review period. This accounted for 14% of the nearly 2.1 million older patients residing in nursing homes and totaled $309 million for the 6-month period. The top three antipsychotics used were quetiapine, risperidone, and olanzapine.
OIG found some astonishing results, reporting that 83% of second-generation antipsychotic claims were for off-label uses and that 88% of the drug claims were for residents diagnosed with dementia. OIG also noted that 726,000 of the 1.4 million claims (51%) for second-generation antipsychotics did not comply with Medicare reimbursement criteria and that this amounted to $116 million in payment for erroneous claims. In addition, 317,971 of the 1.4 million claims were for drugs not administered according to CMS standards for drug therapy in nursing homes (i.e., unnecessary drug use); this amounted to $63 million in erroneous payment.
OIG presented its findings to CMS and made the following recommendations:
CMS responded by stating that it concurred with the second, third, and fourth recommendations but not the first, because diagnosis information is not a required data element of pharmacy billing transactions, nor is it generally included on prescriptions. In addition, CMS expressed some concerns about the report, stating that OIG’s methodology may be overstating the inappropriate use of antipsychotic drugs. CMS noted that it will continue to explore alternative strategies within its statutory authority that address more directly the financial incentives in contractual agreements among drug manufacturers, long-term care pharmacies, long-term care facilities, and consultant pharmacists in nursing homes.
GAO analyzed prescribed psychotropic medications in children from five states who were 0 to 17 years of age and on Medicaid; the states were Florida, Massachusetts, Michigan, Oregon, and Texas. They noted that foster children in each of the five states were prescribed psychotropic drugs at higher rates then nonfoster children during 2008. Specifically, foster children were given psychotropic agents at rates 2.7 to 4.5 times higher than nonfoster children, and this trend remained consistent for all age categories reviewed (0–5 y, 6–12 y, and 13–17 y).
GAO reported that psychotropic drug claims for foster children were more likely to show indicators of potential health risks. Thousands of children were prescribed doses exceeding maximum levels cited in guidelines or FDA-approved labels, some were given five or more concomitant psychotropic medications, and many were at an increased risk for adverse events. In addition, both foster and nonfoster children younger than 1 year were prescribed psychotropic medications; there is no established use for these agents in this patient population.
GAO assessed the selected states’ monitoring programs for psychotropic drugs provided to foster children and concluded that these programs fall short of best-principle practice guidelines published by the American Academy of Child and Adolescent Psychiatry. GAO noted that this variation was expected because states currently set their own guidelines. GAO stated in its report, “HHS-endorsed guidance could help close gaps in oversight of psychotropic prescriptions and increase protections for these vulnerable children.”
An article published in the December issue of Pediatrics further supported the results of the GAO study. Medicaid fee-for-service and managed care claims data processed in 2003 were assessed for 637,924 Medicaid-enrolled youth to compare concomitant antipsychotic treatment among patients in foster care with those in other Medicaid program categories such as Supplemental Security Income (SSI) for people with disabilities, Temporary Assistance for Needy Families (TANF), and adoption. Because children tend to move between categories, the investigators grouped the comparisons as follows: foster care only, foster care/SSI, foster care/TANF, or foster care/adoption.
Of the 637,924 children younger than 20 years, 16,969 had a health or behavioral health visit associated with a psychiatric diagnosis and received an antipsychotic medication. The investigators reported that average antipsychotic use ranged from 222 ± 110 days in foster care only to 135 ± 101 in TANF (P < 0.001). In addition, concomitant antipsychotic use for 180 days or more was 19% in foster care only and 24% in foster care/adoption, compared with less than 15% in the other categories.
The investigators commented that, compared with youths who qualify for Medicaid because of a disability or low income, those in foster care are more likely to receive antipsychotics concomitantly and for longer periods of time, despite the lack of evidence to support such regimens.
Pharmacists working for long-term care facilities should be aware of the potential misuse of antipsychotics in this patient population and assess patient profiles for any adverse consequences, excessive doses, use for an excessive duration, adequate monitoring, and adequate indications for use.
The patient population of foster children may be harder to reach, but appropriate prescription review at the time of dispensing and education of caregivers and prescribers can help with misuse of psychotropics in these patients.
In the May 2010 issue of Today, we described proposed changes for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V). It is now 2 years later and the final version of DSM-V has yet to be released. According to the DSM-V website, publication is anticipated in May 2013, and preliminary draft revisions to the current diagnostic criteria are available for public review. In the spring of this year, a third and final round of comments will be accepted from the public, with all comments being systematically reviewed by the various work groups for consideration of additional changes.
The latest draft is now in field testing at two major sites: large, academic medical institutions and a wide selection of clinical practice settings, including solo and small-group settings. Field testing of various diagnostic criteria is expected to be completed later this year; no changes will be made to these criteria until that testing is complete.
Additional information about the status of DSM-V can be accessed at www.dsm5.org.