A Healthesystems publication

Spring 2012

Antipsychotic Use Moves into Uncharted, Unexpected Treatment Territory

In the past three years, the off-label use of atypical antipsychotic (AAP) medications in the U.S. has risen to alarming levels. In 2010 alone, more than 50,000,000 prescriptions were written for these products, mostly by non-psychiatric physicians.1,2 Largely a result of aggressive direct-to-consumer and physician marketing, this group – including agents such as Risperdal® (risperidone), Zyprexa® (olanzapine), Geodon® (ziprasidone), Invega® (paliperidone), and Seroquel® (quetiapine) – is now the “best-selling” medication class in America.

Once reserved for serious psychiatric conditions such as schizophrenia and bipolar disorder, AAPs have found their way into the treatment of conditions such as low back pain, anxiety, elderly “agitation” and sedation.

Driving this unfortunate trend is how these products are marketed: as safer, more efficacious alternatives to the “typical” members of the drug class (e.g., Haldol, Thorazine). Older drugs, such as Haldol, have well-documented use risks, including permanent abnormal movement disorders and neuroleptic malignant syndrome, a rare but potentially fatal side effect of antipsychotic use. AAPs were promoted to the psychiatric community as a better, safer choice. Unfortunately, post-marketing studies of the newer AAPs have found otherwise. In fact, AAPs have been shown to be no more effective than their older counterparts. Plus, their safety profile offers no pronounced benefit and can even be interpreted as less effective than the older meds. Antipsychotics are implicated in tens of thousands of ER admissions yearly. Seroquel, for example, is ranked eighth in the Drug Abuse Warning Network’s list of the top 10 medications causing lethal and non-lethal poisonings.3 The FDA also has mandated that all AAPs carry a warning to alert prescribers to the risk of suicide, diabetes and significant weight gain in patients using these meds chronically.

Additionally, pharmaceutical manufacturers’ marketing practices have been an issue with the Department of Justice (DOJ). In 2010, the DOJ levied fines of more than a half-billion dollars against Astra-Zeneca for the company’s off-label Seroquel promotion. In 2009, Eli Lilly received a $1.4 billion fine – one of the largest sanctions of its kind in U.S. history — for illegally marketing the off-label use of their blockbuster drug, Zyprexa.4 Worst of all, physicians may be unaware of the risks AAP meds bring, in addition to them not having any added benefit. To combat that trend, Healthesystems began an educational effort in 2009 to alert prescribers within the patient population to the dangers of inappropriate AAP use. In a recent analysis (accounting for the rise in Average Wholesale Price), an interesting trend has emerged — among certain populations in which Healthesystems made educational efforts, the average rate of AAP use increase was 4% between 2009-2011 (this increase was largely due to the doubling, from three to seven, of available agents in this class). However, in a similar physician population without educational efforts, the utilization rate increase was 37%.4

With cumulative annual sales exceeding $14 billion, it is likely that the number of heavily marketed AAPs will continue to grow.

In the interest of patient safety and cost savings, Healthesystems will continue to engage in proactive education efforts targeted towards prescribers. As illustrated by the results, our efforts have achieved positive outcomes, for all stakeholders.

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SOURCES

1 -Lieberman, Joseph. The Use of Antipsychotics in Primary Care. Primary Care Companion J Clin Psychiatry. 2003;5[suppl 3]:3–8.
2 -IMS Institute for Healthcare Informatics. The Use of Medicines in the United States: Review of 2010. Available at: http://www.imshealth.com/imshealth/Global/Content/IMS%20Institute/Documents/IHII_UseOfMed_report%20.pdf. Accessed February 27, 2012.
3 -Substance Abuse and Mental Health Services Administration (SAMHSA). 2009: National Estimates of Drug-Related Emergency Department Visits. Available at: http://www.samhsa.gov/data/DAWN.aspx. Accessed February 27, 2012.
4 -US Department of Justice. Pharmaceutical Company Eli Lilly to Pay Record 1.415 Billion for Off-label Drug Marketing. Available at: http://www.justice.gov/usao/pae/News/2009/jan/lillyrelease.pdf. Accessed February 27, 2012.
5 -Healthesystems 2011 data.
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