In the past decade, much concern has been raised about the increasing, excessive and inappropriate use of off-label psychiatric medications for children. In addition, the use of medication cocktails (polypharmacy) has become increasing common in child psychiatry. These medications have significant potential for harm. Many have serious, long-term side effects such as weight gain, obesity, diabetes, high cholesterol, movement disorders, seizures, cardiac arrhythmias, neurological disorders, gynecomastia in boys, violence and suicide.
Several medication-related deaths have been reported in the past ten years. In 2006, the Food and Drug administration (FDA) received reports of at least 29 children dying and at least 165 more suffering serious side effects in which an antipsychotic was listed as the “primary suspect.” That was a substantial jump from 2000, when there were at least 10 deaths and 85 serious side effects among children linked to the drugs. Since reporting of bad drug effects is mostly voluntary, these numbers likely represent a fraction of the toll. Poor children who are covered by Medicaid insurance and children in State Care (foster care), also covered by Medicaid insurance are more likely to be prescribed psychiatric medication. In addition, the use of antipsychotics in children with Medicaid coverage is five times that of children in the private sector.
The pharmaceutical industry has been wildly profitable in their quest to create and market psychiatric medications to doctors and consumers. In 2012 the top 11 global drug companies made $85 billion in net profits. In the past decade these companies have spent large amounts of money providing gifts, expensive dinners etc for doctors in hopes of influencing their prescribing patterns. Psychiatric medications are among the most widely prescribed and biggest selling class of drugs in the U.S. So why are so many children being prescribed off label psychiatric medication?
Off-label use is defined as the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration. The Federal Drug Administration (FDA) does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label.
Under the Federal Food and Drug Cosmetic act it is illegal for pharmaceutical companies to promote their products for uses not approved by the FDA, and corporations that market drugs for off-label indications may be subject to civil liability under the False Claims Act as well as criminal penalties. Despite this law, many pharmaceutical companies heavily marketed off-label psychiatric medications for use in children to psychiatrists and primary care physicians such as pediatricians and family practitioners. Several successful lawsuits have been bought against companies such as Bristol Myers Squibb, Eli Lilly, Astra Zeneca, Forrest and Pfizer since 2007 for off-label marketing of psychiatric medications for children.
The pharmaceutical industry spends more than any other industry group each year to influence lawmakers. They spent 2.6 billion dollars on lobbying activities from 1998 to 2012 according to Opensecrets.org. This amount is significantly larger than the 1.6 billion spent by the Oil and gas industry during the same time frame. One may wonder why Medicaid would pay for children to be prescribed off-label psychiatric medications or worse, dangerous medication cocktails that are not supported by any valid practice guideline. There is little doubt that the lobbyists have influenced decision makers regarding which medications are available on Medicaid Formularies.
In my own clinical work with children in a Non-profit outpatient clinic, I am frequently in the position of taking over the care of a child who is already on a medication cocktail (3+ psychotropic medications). Most of these kids have been hospitalized several times with each hospitalization resulting in higher dosages and/or the addition of off-label medications. In general I do my best to make sure these children are receiving quality, evidence based therapy with a well-trained clinician and then I try to safely taper the medications.
As I proceed to have informed consent discussions with parents/guardians about the medications, I immediately notice that most parents/legal guardians have no awareness of the potential risks or side effects of their child’s current medications. Theoretically, these same parents/legal guardians already provided consent and therefore participated in an informed consent discussion for the use of these medications while their child was on an inpatient unit or other treatment setting.
While the following recommendations will likely be unpopular among my physician colleagues who value their autonomy, it is my attempt to address the obvious safety issues for vulnerable children in the current mental health system:
- Physicians should be required by law to disclose and document said disclosure to legal guardians when prescribing off-label medications to pediatric patients.
- Tax payer funded Medicaid formularies should only allow the prescription of unapproved psychiatric medications or multiple medications for children after the physician has provided a written request/explanation for such medications and the request has been approved by a state employed board certified child psychiatrist.
- Ex-pharmaceutical executives should be banned for ten years from serving on government Medicaid Committees where formulary decisions are made.