Changing Rx Practices in the Treatment of Mental Illness: Impact on Forensic Evidence

"Off-label" prescription practices are increasingly used in the treatment of symptoms related to mental illness. In support of this conclusion, evidence is reviewed on the antidepressant treatment of numerous non-depressive disorders and on the antipsychotic drug treatment of non-psychotic disorders. The impact of this evidence is discussed in light of the Daubert decision rendered by the U.S. Supreme Court. It is concluded that such practices challenge the application of the decision and increase the potential for testimonial error. Finally, a promising trend of identifying drugs by their neurochemical action is briefly discussed.

One trend that has revolutionized the face of Clinical Psychopharmacology is a breakdown in the disorder-specific nature of drug treatment (i.e., the use of antidepressant drugs to treat depression, antipsychotic drugs to treat psychosis, etc.). This "off-label" prescription practice has resulted in a clear broadening of the range of possible psychological symptoms that can be positively influenced by a specific class of drugs. The purpose of this article is to present examples of this practice in the published literature and suggest how this trend has impacted forensic considerations in the area of Clinical Psychopharmacology. Although no attempt has been made to exhaust coverage of this trend, an attempt has been made to present examples representative of different classes of drugs.

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UPDATE 3-US lets drugmakers advise doctors on unapproved uses

U.S. health officials finalized guidelines that allow pharmaceutical companies to tell doctors about unapproved uses of their medicines, a practice opposed by critics of industry marketing.

The Food and Drug Administration (FDA) guidelines allow manufacturers such as Pfizer Inc (PFE.N) and Merck & Co (MRK.N) to distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.

The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.

By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.

Distribution of medical literature suggesting a drug may have merit for an unapproved use is a marketing area that has been in dispute for years.

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Study Calls for Greater Scrutiny of 'Off-Label' Drug Use Doctors often prescribe medicines for conditions that haven't been studied thoroughly

It's called "off-label" prescribing, and it's the common practice of doctors prescribing a drug to treat a disease or condition that's different from the one studied by federal regulators that led to the drug's approval in the first place.

Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found.

The study by American researchers has identified 14 widely prescribed medications that they think need additional study to see how effective and safe they are for off-label use. Many of the drugs are antidepressants and antipsychotics.

"Off-label prescribing is not based on the same level of evidence as on-label prescribing," said study lead researcher Surrey Walton, an assistant professor of pharmacy administration at the University of Illinois at Chicago.

Most patients aren't aware that once a drug is approved for one use, any doctor can prescribe it for any other use, Walton explained. Doctors may turn to a drug for off-label use, because studies or evidence suggest that it might benefit a patient with a disease or condition that was not studied when U.S. Food and Drug Administration regulators approved the drug in the first place.

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Prozac on the Playground - The dangers of off-label use of psychiatric medications in children.

Problem: We are now more aware of emotional illness in children and much more likely to diagnose and treat conditions like attention deficit disorders. But as difficult and expensive as it is to test new medications on adults, it's even harder to do the testing on children. Many treatments applied to children reflect "off-label" use of medications that have been specifically approved for adults—but not for kids. When the FDA grants a license to a new prescription medication, it lists its permitted uses ("indications") and the patients for whom it is intended (including their age range), usually reflecting the population it was tested on—children with strep throat, women with breast cancer. If a drug company even mentions a use not specifically approved, it has violated FDA rules and can be fined or otherwise punished. However, once a drug has received FDA approval, physicians are free to use it for applications or populations for which it was not formally approved. After (usually adult) FDA approval has been obtained, manufacturers often don't bother with expensive testing that would allow them to request a label extension for use in kids, since they'll have the (off-label) market, anyway. Off-label use accounts for somewhere between half and three-quarters of all medications used in children and is also commonly used for adult treatment. Pediatricians are often uncomfortable with this practice, but they consider it the lesser of two evils when confronting an illness with effective adult treatment but nothing for children. Most medications behave similarly in children and adults, but that rule has exceptions, as we sometimes discover too late. Aspirin can lead to a horribly dangerous liver and brain disease in children or teens. Tetracycline, a common antibiotic, can damage the teeth of children under 8 years old. The problem is particularly troublesome when it comes to prescribing psychiatric medications to kids, which is increasingly common.

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