In less than a decade, the practice of prescribing antipsychotic drugs to children dramatically increased in the US. While only a couple of these drugs are approved by the FDA for use in children, many taken by children are “adult” medications prescribed for offlabel usage.

Legal action has been pursued in a number of states in response to allegations of undue influence and financial gain by pharmaceutical companies and agents involved in the development, manipulation, and adoption of screening standards and drug formularies, and of inappropriate marketing of certain drugs. A multi-million dollar national civil settlement was reached last summer between Bristol-Myers Squibb (and its former subsidiary, Apothecon Inc.) and 43 states to the tune of about $500 million for alleged practices of
inappropriate marketing of Abilify, an atypical antipsychotic used to treat children and dementia patients, for whom the drug was not approved for use. The industry’s controversial marketing and pricing practices resulted in excessively high costs to state Medicaid programs and suspect increase in the prescribing of certain drugs, including psychotropic drugs to children.

In children, psychotropic medications have been associated with significant side effects and potential adverse reactions, including change in weight or metabolic parameters (including high blood sugar), cardiovascular symptoms, and suicidality (suicide). Policy makers across the country are concerned about these issues, and PPC, with an initial grant from the Sadie and Harry Davis
Foundation and additional funding from New Hampshire’s Endowment for Health, is in the process of researching, analyzing, and developing best practice materials to bring more attention to the issue and highlight how the federal government and some states are working to ensure safer and more effective prescribing of psychotropic drugs to kids.

Examples include the FDA’s black-box warning on antidepressants in October 2004, which described possible suicide risk(s) in children. Following the release of information about safety risks and the inclusion of the black-box warning, studies found evidence of substantial declines in the use of antidepressants among both children and adults. While it’s difficult to know if
the decline in pediatric antidepressant use was the result of FDA action, media coverage of new risk information, regulatory action by other countries, or other causes, it’s clear the disclosure of the risk associated with the prescribing of antidepressants to children created significant change.

Last year, Florida started requiring doctors to seek approval before prescribing antipsychotics to young children (age 5 and under) with Medicaid coverage. According to an article in the St. Petersburg Times, prescribing of the drugs dropped by nearly 75%. In addition, the company monitoring the prescribing of antipsychotics for Florida’s Medicaid program indicated there was no major outcry from doctors, when ordinarily they would have heard.

Several states are involved in a project sponsored by the Agency of Health Research and Quality (AHRQ) to study this issue. The project was developed in response to an increase in Medicaid expenditures for atypical antipsychotics, where a 21% growth rate was seen in costs and utilization between 2000 and 2007. The project involves assisting clinical leaders in at least 16 states in constructing a data dictionary and workbook, where common data regarding the prescribing of AAPs is gathered. The intent is to use the information to gain an understanding in variations of prescribing patterns in an effort to draw correlations between gaps in therapy and evaluate best practices for reducing AAP prescribing practices.

PPC will work with state policy makers in reviewing preliminary data from the AHRQ study and other related information in an effort to document and promote best practices and policy recommendations to improve children’s access to quality mental health care and safe medicine in the US.

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Download a more in-depth version of this article with specific examples of such prescribing, as well as citations by clicking the link under Related Documents.

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