Questionable Prescribing Practices Have Officials Searching for Answers
Abstract
Some clinically questionable prescribing practices appear to be relatively common, according to a review of Medicaid prescription claims data for patients with mental illness in New York state.
Such practices include polypharmacy, including the use of as many as four or more psychotropic drugs by the same patient, use of drugs with moderate to high risk of metabolic complications in patients with existing cardiometabolic conditions, failure to screen for metabolic conditions when prescribing second-generation antipsychotic medications, and use of valproic-acid-based mood stabilizers in women of childbearing age.
The report on prescribing practices for New York state Medicaid patients with mental illness appeared in the December 2009 Psychiatric Ser vices. “Clinically questionable” practices were identified from claims data using a set of indicators established by an expert panel of neuropharmacologists convened by the New York State Office of Mental Health (OMH).
Molly Finnerty, M.D., director of OMH Evidence-Based Services and Implementation Science, said the indicators denoted practices that could suggest quality problems, but that might also—under certain clinical circumstances—be appropriate. “For each of our indicators, no one knows what level of any of these practices—such as antipsychotic polypharmacy—should be expected,” she told Psychiatric News. “Certainly, there will be rare situations where a clinician has tried everything the evidence base would suggest without success and so moves on beyond the evidence base. And sometimes these generally questionable practices may be appropriate—such as prescribing valproate as a first-line treatment to a reproductive-age woman who is actively preventing pregnancy.
“Before setting target thresholds for what would raise a flag of concern, we felt it important to identify what experts deemed clinically questionable and to determine the prevalence of those practices.”
OMH has undertaken a number of initiatives to correct questionable prescribing practices (see OMH Takes Steps to Improve Prescribing Practices).
In addition to Finnerty, authors included OMH Medical Director Lloyd Sederer, M.D., and others from OMH; researchers from Columbia University and the New York State Psychiatric Institute; as well as members of the OMH Scientific Advisory Committee (SAC), the 27-member panel of neuropharmacology experts who developed the clinical indicators for the study.
The SAC was formed in August 2007 and subdivided into six work groups—schizophrenia, bipolar disorder, depression, women, youth, and older adults. The work groups then identified clinically questionable practices that can be measured using pharmacy claims.
The list of questionable practices for adult patients included the following areas of concern in treatment of schizophrenia, bipolar disorder, and depression:
| •. | Polypharmacy as defined as a period of simultaneous prescribing of psychotropic medications for longer than 90 days, both within and across drug class (antipsychotics, antidepressants, sedative-hypnotics, nonantipsychotic mood stabilizers, and stimulants). | ||||
| •. | Underuse of certain indicated drugs. | ||||
| •. | Inappropriate use of certain medications (for instance, of benzodiazepines for substance abusers, or of both a sedative-hypnotic and a benzodiazepine concurrently). | ||||
| •. | Inappropriate dosing and duration of medications. | ||||
| •. | Lack of medical monitoring, monitoring of laboratory tests, or monitoring of adherence. | ||||
| •. | Inadequate provision of patient-centered services. | ||||
A similar but somewhat more abbreviated list was derived for youth, older adults, and women.
Each of those areas may have included as many as a dozen specific practices, so that the entire list for all patient groups included more than 60 questionable practices.
The researchers applied the list of questionable prescribing practices to Medicaid claims data for 156,103 beneficiaries who had one or more prescriptions for a psychotropic drug for 90 days or more.
Notable findings included the following:
| •. | About 10 percent of adults were prescribed four or more psychotropics concurrently, and 13 percent of children and 2 percent of older adults were prescribed three or more concurrently. | ||||
| •. | Prescribing an antipsychotic with a moderate-to-high risk of causing metabolic abnormalities approached 50 percent among individuals who had existing cardiometabolic conditions. | ||||
| •. | Among patients presribed second-generation antipsychotics with a moderate to high risk of causing metabolic abnormalities, over 60 percent had not received a metabolic screening test in the past year. | ||||
| •. | Among women of reproductive age prescribed mood stabilizers, over 30 percent were prescribed a valproic-acid-based formulation. Valproic acid (brand name Depakote) is associated with an increased risk for the development of polycystic ovary syndrome in women and has teratogenic effects on their exposed offspring, including increased rates of malformations and lower IQ. There was no information about whether women were also prescribed contraceptives and folic acid. | ||||
| •. | Only 2 percent of youth under age 18 were prescribed benzodiazepines, but 48 percent of those had trials longer than 90 days' duration. | ||||
Finnerty says the number of individuals on psychotropic polypharmacy is comparable to that seen in other settings.
“The practice of antipsychotic polypharmacy, in particular, has grown over the years despite an absence of an evidence base to support it,” she told Psychiatric News. “Our estimates here are very conservative, in that we require concurrent use for greater than 90 days, which should eliminate switching and cross tapers.
“Antipsychotic polypharmacy rates reported in the literature vary widely depending upon population, treatment setting, and how polypharmacy is defined,” Finnerty said. “The concern is that people are being subjected to the side effects and other risks associated with two medications for uncertain benefit, that multiple medication regimens make adherence more difficult, and that costs are increased without any data from clinical trials to suggest that this is an effective practice.”
OMH findings about the use of antipsychotic medications that carry cardiometabolic risks and the related failure of clinicians to screen patients for cardiometabolic risk factors reflect concerns that have been raised nationally about comorbid medical conditions experienced by seriously mentally ill individuals.
“The cardiometabolic indicator highlights the differences between antipsychotics in their levels of cardiometabolic risk,” Finnerty said. “No antipsychotic is without risk, but particularly for people who already have cardiometabolic conditions, the relative risks between agents should be considered.”
She added that under Sederer's leadership, outpatient mental health clinics operated by OMH have begun screening blood pressure, body mass index and smoking status(see Innovations Planned for MH Care Include 'One-Stop Shopping').
Regarding the high number of women of childbearing age who were prescribed valproic-acid-based formulations, Finnerty noted that the FDA only recently issued a black-box warning, which may help increase awareness of risks.
“Studies documenting risks for mother and infant have largely been published in the neurological literature, and psychiatrists may not be aware of the findings,” she said.
“Identifying Clinically Questionable Psychotropic Prescribing Practices for Medicaid Recipients in New York State” is posted at <http://psychservices.psychiatryonline.org/cgi/content/full/60/12/1595>.
