DEA changes rules to allow post-dating of schedule II substances
In a ruling certain to make psychiatrists and their patients happy, the DEA has finally said that doctors may give patients 90 days worth of prescriptions for schedule II controlled substances, which includes stimulants and narcotics. Before this ruling, we were formally required to have all our ADHD patients come for monthly visits in order to get their stimulant prescriptions. Of course, few of us actually did this, and post-dating scripts has become standard practice for stable patients who have continued on the same dose of the same medication for the long term. With this ruling, issued on December 19, 2007, we are finally no longer breaking the law. See http://www.deadiversion.usdoj. gov/fed_regs/rules/2007/fr1119.htm
TCPR’s Take: Check with your state’s board of pharmacy website (see the following site for a comprehensive listing of all board of pharmacy websites: http://www.edhayes. com/sbp-main.html). Not all states have to agree with this federal ruling, and in states where the controlled substance laws are more restrictive, you may not be able to take advantage of the DEA’s new policy.
Placebo more effective than antipsychotics for aggression in mental retardation
In a multi-center study conducted in Great Britain and Australia, 86 adults with mental retardation (IQ < 75) and aggressive behavior were randomized to double-blind treatment with Risperdal (mean dose, 1.8 mg/day), Haldol (mean dose, 2.9 mg/day), or placebo. The primary outcome was score on the modified overt aggression scale (MOAS) at 4 weeks. The results were that placebo reduced the MOAS score by more than either of the active treatments, with the difference close to being statistically significant (p=.07 vs. Risperdal and p=.06 vs. Haldol) (Tyrer P, et al., Lancet 2008;371(9606):57-63).
TCPR’s Take: These results are different from some prior studies which showed a benefit of Risperdal in this population. One likely reason is that past studies included a “placebo run-in” phase, in which patients who responded rapidly to placebo were excluded from the double-blind study. This had the effect of minimizing the placebo effect in the main study and increasing the likelihood of a drug vs. placebo difference. These investigators did not include the placebo run-in in order to make the design more similar to clinical practice. These results imply that in aggressive mentally retarded adults, placebo effects are extremely powerful, and perhaps prescribing a multivitamin (with great fanfare and high expectations) is as effective as prescribing an antipsychotic, with far fewer side effects.
Criteria proposed to predict which prodromal patients will become psychotic
The North American Prodrome Longitudinal Study is a consortium of 8 academic centers (all but one in the U.S.) seeking to develop predictors of the development of psychosis in young patients who present with prodromal symptoms. Using the Structured Interview for Prodromal Syndromes (SIPS), researchers identified 291 subjects who met criteria for a “prodromal syndrome.” Most of the subjects meeting the prodromal critiera had “attenuated positive symptoms.” Psychotic symptoms were defined as “attenuated” when patients were not completely convinced of the veracity of their delusions or hallucinations. The researchers then followed prodromal subjects for 2 ½ years to see who would develop full-blown psychosis. The overall risk for conversion to psychosis over this time period was 35%. The investigators scanned their data in search of factors that were predictive. The most accurate predictions (74-81%) occurred when combining three factors: genetic risk for schizophrenia plus recent functional decline, unusual thought content, and either suspicion/paranoia or impaired social functioning (Cannon TD et al., Arch Gen Psychiatry 2008;65(1):28-37).
TCPR’s Take: These results garnered a fair amount of media attention, with headlines such as “Scientists Can Predict Psychotic Illness in up to 80 Percent of High-Risk Youth” (from NIH’s press release). But when you actually look at the study, these results are neither particularly surprising nor very clinically useful. In order to be enrolled, patients were pretty close to being psychotic already, with significant psychotic ideation, defined as “prodromal” by the researchers. Chances are that most of these prodromal patients would have received treatment for psychosis if they had shown up in your office or mine. On the plus side, the study reminds us of the importance of certain factors, such as family history of schizophrenia and deteriorating social functioning, that we should make sure to explore systematically in at-risk patients.
New lab test recommended before prescribing Tegretol or Lamictal to Asians
The FDA has issued a warning that Asian patients with a specific human leukocyte antigen (HLA) are at increased risk of developing life-threatening Stevens Johnson syndrome rash, and should be tested for this antigen before initiating treatment. The HLA in question is identified as “HLA-B 1502.” About 10% of Asian people have this allele, according to the FDA. Patients who are HLA-B 1502 positive should be prescribed Tegretol only if the potential benefits far outweigh the risks. While the FDA’s warning focuses on Tegretol, it does mention that other anticonvulsants associated with SJS should be accorded the same treatment, and this would include Lamictal (lamotrigine). (The FDA alert can be accessed at http://www.fda.gov/cder/drug/InfoSheets/ HCP/carbamazepineHCP.htm.)